Valeant Pharmaceuticals International
Address Valeant Pharmaceuticals International, One Enterprise Aliso Viejo, California 92656Contact DetailsPhone: (800) 548-5100

Nizoral Shampoo
Generic Name: ketoconazole Dosage Form: shampooNizoral® (ketoconazole) 2% Shampoo Nizoral Shampoo Description

NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium monolauryl ether sulfosuccinate, F.D.&C. Red No. 40, hydrochloric acid, imidurea, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, perfume bouquet, sodium chloride, sodium hydroxide, sodium lauryl ether sulfate, and purified water.

Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3 - dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:

Nizoral Shampoo - Clinical Pharmacology

Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.

NIZORAL® (ketoconazole) was not detected in plasma in 39 patients who shampooed 4–10 times per week for 6 months, or in 33 patients who shampooed 2–3 times per week for 3–26 months (mean: 16 months).

An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole 2% shampoo was significantly less than that of 2.5% selenium sulfide shampoo.

A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to NIZORAL® (ketoconazole) 2% Shampoo.

Mode of Action: Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum ovale. Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor. Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of ketoconazole 2% shampoo were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). There had been mycological confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen. While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not.

Microbiology: NIZORAL® (ketoconazole) is a broad spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur). Development of resistance by these microorganisms to ketoconazole has not been reported.

Indications and Usage for Nizoral Shampoo

NIZORAL® (ketoconazole) 2% Shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

Contraindications

NIZORAL® (ketoconazole) 2% Shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Precautions

Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of NIZORAL® (ketoconazole) Shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Information for Patients:

Patients should be advised of the following:

NIZORAL® (ketoconazole) 2% Shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided.

Compro
prochlorperazine Dosage Form: suppositoryCompro®

Idomethine Kowa

Idomethine Kowa may be available in the countries listed below.

Ingredient matches for Idomethine Kowa Indometacin

Indometacin is reported as an ingredient of Idomethine Kowa in the following countries:

Japan

International Drug Name Search

Piperacillin/Tazobactam
Pronunciation: PI-per-a-SIL-in/TAZ-oh-BAK-tamGeneric Name: Piperacillin/TazobactamBrand Name: Zosyn

sumatriptan oral/nasal

Generic Name: sumatriptan (oral/nasal) (soo ma TRIP tan) Brand Names: Imitrex, Imitrex Nasal

What is sumatriptan?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sumatriptan? You should not use this medication if you are allergic to sumatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using sumatriptan, tell your doctor if you have liver or kidney disease, seizures, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

What should I discuss with my healthcare provider before using sumatriptan? You should not use this medication if you are allergic to sumatriptan, or if you have:

coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

a history of heart disease, heart attack, or stroke, including "mini-stroke";

severe or uncontrolled high blood pressure;

severe liver disease;

ischemic bowel disease; or

a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

liver disease; kidney disease;

epilepsy or other seizure disorder;

high blood pressure, a heart rhythm disorder; or

coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using sumatriptan. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. This medicine should not be given to anyone under 18 or over 65 years of age. How should I use sumatriptan?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Take one sumatriptan tablet whole with a full glass of water. Do not split the tablet.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than 200 mg of sumatriptan oral tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Sumatriptan nasal spray comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Blow your nose to clear your nasal passages before using the nasal spray. Try not to sneeze or blow your nose just after using the spray.

After using the nasal spray: If your headache does not completely go away after using the spray, call your doctor before using a second spray of sumatriptan. If your headache goes away and then comes back, you may use a second spray if it has been at least two hours since you used the first spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours. If your symptoms do not improve, contact your doctor before using any more sprays.

Contact your doctor if you have more than four headaches in one month (30 days).

Store sumatriptan at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors or shaking, skin redness, breathing problems, blue-colored lips or fingernails, vision problems, watery eyes or mouth, weakness, lack of coordination, or seizure (convulsions).

What should I avoid while using sumatriptan? Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or

ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Sumatriptan side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using sumatriptan and call your doctor if you have a serious side effect such as:

feeling of pain or tightness in your jaw, neck, or throat;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden and severe stomach pain and bloody diarrhea;

seizure (convulsions);

numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

(if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

mild headache (not a migraine);

pressure or heavy feeling in any part of your body;

feeling hot or cold;

dizziness, spinning sensation;

drowsiness;

nausea, vomiting, drooling;

unusual taste in your mouth after using the nasal spray;

burning, numbness, pain or other irritation in your nose or throat after using the nasal spray; or

warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sumatriptan Dosing Information

Usual Adult Dose for Cluster Headache:

Initial dosage when symptoms of headache appear:Subcutaneously: 4 to 6 mg; may repeat if needed at least 1 hour after initial dose; maximum: 12 mg/day.

Loroxide

Generic Name: benzoyl peroxide topical (BEN zoyl per OX ide) Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, Benziq, Benziq Wash, BPO Foaming Cloths, Brevoxyl, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-8, Loroxide, NeoBenz Micro, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Zaclir

What is Loroxide (benzoyl peroxide topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Benzoyl peroxide topical (for the skin) is used to treat acne.

Benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Loroxide (benzoyl peroxide topical)?

There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

What should I discuss with my healthcare provider before using Loroxide (benzoyl peroxide topical)? Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation. FDA pregnancy category C. It is not known whether benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzoyl peroxide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Loroxide (benzoyl peroxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying this medication. Shake the lotion well just before each use.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.

Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Loroxide (benzoyl peroxide topical)? Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.

Loroxide (benzoyl peroxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

mild stinging or burning;

itching or tingly feeling;

skin dryness, peeling, or flaking; or

redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Loroxide (benzoyl peroxide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Loroxide resources Loroxide Side Effects (in more detail)Loroxide Use in Pregnancy & BreastfeedingLoroxide Drug InteractionsLoroxide Support Group0 Reviews for Loroxide - Add your own review/rating Loroxide Topical Advanced Consumer (Micromedex) - Includes Dosage Information Acne Treatment Cream MedFacts Consumer Leaflet (Wolters Kluwer) BenzEFoam Foam MedFacts Consumer Leaflet (Wolters Kluwer) Benzac AC Wash MedFacts Consumer Leaflet (Wolters Kluwer) Benzefoam Prescribing Information (FDA) Benzefoam Ultra Prescribing Information (FDA) Brevoxyl Gel MedFacts Consumer Leaflet (Wolters Kluwer) Brevoxyl Creamy Wash Prescribing Information (FDA) Desquam-X Wash Prescribing Information (FDA) Inova Pads MedFacts Consumer Leaflet (Wolters Kluwer) NeoBenz Micro Wash Plus Pack Cream MedFacts Consumer Leaflet (Wolters Kluwer) Neobenz Micro SD Prescribing Information (FDA) Neobenz Micro Wash Plus Pack Prescribing Information (FDA) Oxy Balance Topical Advanced Consumer (Micromedex) - Includes Dosage Information Pacnex LP Prescribing Information (FDA) PanOxyl Bar MedFacts Consumer Leaflet (Wolters Kluwer) Triaz Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Triazolam Monograph (AHFS DI) Compare Loroxide with other medications AcnePerioral Dermatitis Where can I get more information? Your pharmacist can provide more information about benzoyl peroxide topical.

See also: Loroxide side effects (in more detail)

Seconal Sodium

Generic Name: secobarbital (SEE koe BAR bi tal) Brand Names: Seconal Sodium

What is Seconal Sodium (secobarbital)?

Secobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Secobarbital slows the activity of your brain and nervous system.

Secobarbital is used short-term to treat insomnia, or as a sedative before surgery.

Secobarbital may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Seconal Sodium (secobarbital)? Secobarbital may cause a severe allergic reaction. Stop taking secobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take secobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, and later having no memory of the activity. If this happens to you, stop taking secobarbital and talk with your doctor about another treatment for your sleep disorder.

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Do not use secobarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Secobarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking secobarbital. Secobarbital may be habit-forming and should be used only by the person it was prescribed for. Secobarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. What should I discuss with my healthcare provider before taking Seconal Sodium (secobarbital)?

Some people using this medicine have engaged in activity such as driving, and later having no memory of the activity. If this happens to you, stop taking secobarbital and talk with your doctor about another treatment for your sleep disorder.

Do not take this medication if you are allergic to secobarbital, or if you have porphyria.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take secobarbital:

severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder;

a blood cell disorder such as anemia (lack of red blood cells);

epilepsy or other seizure disorder;

liver disease;

heart disease;

overactive thyroid;

a history of depression, mental illness, or suicide attempt; or

a history of drug or alcohol addiction.

Secobarbital may be habit-forming and should be used only by the person it was prescribed for. Secobarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use secobarbital without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Secobarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking secobarbital. Secobarbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Seconal Sodium (secobarbital)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take secobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Take this medicine with a full glass of water.

If you are taking this medicine to treat insomnia, take it only at bedtime. Do not use secobarbital for longer than 2 weeks to treat insomnia, unless your doctor has told you to.

Do not change your dose of secobarbital without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Store secobarbital at room temperature away from moisture and heat.

Keep track of how many pills have been used from each new bottle of this medicine. Secobarbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Seconal Sodium dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Take secobarbital only when you are getting ready for several hours of sleep. If you do not have time to get a full night's sleep after taking the medication, skip the missed dose and take the medicine at your next regularly scheduled sleep time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of secobarbital can be fatal.

Overdose symptoms may include slow or shallow breathing, blurred vision, extreme drowsiness, feeling light-headed, or fainting.

What should I avoid while taking Seconal Sodium (secobarbital)? Secobarbital can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by secobarbital. Tell your doctor if you regularly use any of these other medicines. Avoid drinking alcohol. It can increase some of the side effects of secobarbital. Seconal Sodium (secobarbital) side effects Secobarbital may cause a severe allergic reaction. Stop taking secobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

restless muscle movements in your eyes, tongue, jaw, or neck;

slow heartbeat, shallow breathing;

feeling like you might pass out;

a fever or a sore throat;

sores in your mouth;

easy bruising or bleeding; or

ongoing nightmares or increased dreaming.

Less serious side effects may include:

drowsiness or dizziness;

problems with memory or concentration;

excitement (especially in children or older adults);

upset stomach, constipation;

headache; or

"hangover" effect (drowsiness the day after a dose).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Seconal Sodium (secobarbital)?

Many drugs can interact with secobarbital. Below is just a partial list. Tell your doctor if you are using:

acetaminophen (Tylenol);

a blood thinner such as warfarin (Coumadin);

an antibiotic such as doxycycline (Adoxa, Doryx, Mondox, Oracea, Vibramycin, and others), griseofulvin (Grisactin, Fulvicin PG, Grifulvin V), or metronidazole (Flagyl);

birth control pills or estrogen hormone replacement, including estrogen (Premarin), estradiol (Estrace, Femtrace, and others), progesterone (Progest, Prometrium), and others;

theophylline (Theo-Dur, Theochron, Theolair, Slo-Bid, others);

a heart rhythm medication such as quinidine (Cardioquin, Quinidex, Quinora, Quinaglute);

seizure medications such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene);

heart or blood pressure medication such as atenolol (Tenormin), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), felodipine (Plendil) nifedipine (Procardia, Adalat), verapamil (Calan);

an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

steroids such as prednisone (Orasone, Deltasone), prednisolone (Prelone, Delta Cortef), methylprednisolone (Medrol), and others.

This list is not complete and there may be other drugs that can interact with secobarbital. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Seconal Sodium resources Seconal Sodium Side Effects (in more detail)Seconal Sodium DosageSeconal Sodium Use in Pregnancy & BreastfeedingDrug ImagesSeconal Sodium Drug InteractionsSeconal Sodium Support Group2 Reviews for Seconal Sodium - Add your own review/rating Seconal Sodium Prescribing Information (FDA) Secobarbital MedFacts Consumer Leaflet (Wolters Kluwer) Compare Seconal Sodium with other medications InsomniaLight SedationSedation Where can I get more information? Your pharmacist can provide more information about secobarbital.

See also: Seconal Sodium side effects (in more detail)

Ellimans Universal Muscle Rub Lotion
1. Name Of The Medicinal Product

Ellimans Universal Muscle Rub Lotion

2. Qualitative And Quantitative Composition

Ellimans Universal Muscle Rub Lotion contains:

Turpentine oil BP 35.41%

Glacial acetic acid EP 3.562%

For excipients, see 6.1

3. Pharmaceutical Form

Cutaneous emulsion

A creamy, white liniment having an odour of turpentine and acetic acid

4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic relief of muscular pain and stiffness including backache, sciatica, lumbago, fibrositis, and rheumatic pain and the massage by athletes of arm or leg muscles.

4.2 Posology And Method Of Administration

Shake the bottle immediately before use.

Adults and children aged 12 years and over.

Rub lotion freely onto affected part until thoroughly absorbed.

For the first 24 hours, apply every three hours, then twice daily.

Athletes: Massage of arm and leg muscles before and after activity.

Not to be used on children under 12 years of age.

The elderly

The adult directions for use apply.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not apply when skin is broken or inflammed

Keep away from the eyes and other sensitive areas.

Keep out of reach and sight of children.

If symptoms persist, consult your doctor.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation is not contra-indicated, however, as with all medicines, care should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

There have been reports that application to the skin of liniments containing Turpentine Oil may cause vesicular eruption, urticaria and vomiting in susceptible persons.

4.9 Overdose

Excessive percutaneous absorption as a result of over-application may rarely lead to reversible toxic nephritis.

Products containing turpentine, if ingested, could cause burning pain in the mouth and throat, abdominal pain, nausea, vomiting and occasionally diarrhoea.

This may be followed by painful urination, respiratory distress and convulsions. In high overdose, death may follow due to respiratory failure.

Treatment on Ingestion

The stomach should be emptied by aspiration and lavage, after which treatment is symptomatic.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

MA02A X – Other topical products for joint and muscular pain

Turpentine oil is a rubefacient and counter-irritant.

Acetic acid is a counter irritant.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No data of relevance which is additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Dried whole egg powder (melange)

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Clear, white flint glass oval section bottles, with a screw-on wadless plastic cap fitted with an internal gasket contained in printed boxboard cartons, containing 100 ml of product

6.6 Special Precautions For Disposal And Other Handling

Shake the bottle before each use.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjav?kurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0075

9. Date Of First Authorisation/Renewal Of The Authorisation

15 January 2003

10. Date Of Revision Of The Text

4 February 2009

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Mag-Delay

Generic Name: magnesium chloride (mag NEE see um KLOE ride) Brand Names: Mag 64, Mag-Delay, Mag-SR, Slow-Mag

What is Mag-Delay (magnesium chloride)?

Magnesium is a mineral that occurs naturally in the body and is found in certain foods. Magnesium is important for many systems in the body especially the muscles, nerves, heart, and bones.

Magnesium chloride is used to treat or prevent magnesium deficiency (lack of natural magnesium in the body).

Magnesium chloride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Mag-Delay (magnesium chloride)? You should not use this medication if you are allergic to it, or if you have kidney disease, a stomach ulcer or disorder, or if you are dehydrated.

Before taking magnesium chloride, tell your doctor if you have any other medical conditions or any type of allergy.

Tell your doctor if you are pregnant or breast-feeding. It is not known whether magnesium chloride could harm an unborn baby, or if it passes into breast milk and could harm a nursing baby. Your dose needs may be different while you are pregnant or breast-feeding.

Avoid using antacids or laxatives without your doctor's advice. These medications may contain minerals and if you take certain products together you may get too much magnesium.

Tell your doctor about all other medications you use, especially antibiotics, ADHD medication, thyroid medication, or medication for osteoporosis or Paget's disease.

Magnesium chloride is only part of a complete program of treatment that may also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have signs of too much magnesium in your blood, such as depression, feeling tired or irritable, muscle cramps, or severe or ongoing diarrhea. What should I discuss with my healthcare provider before taking Mag-Delay (magnesium chloride)? You should not use this medication if you are allergic to it, or if you have: kidney disease;

a stomach ulcer or disorder; or

if you are dehydrated.

Before taking magnesium chloride, tell your doctor if you have any other medical conditions or any type of allergy.

It is not known whether magnesium chloride is harmful to an unborn baby. Your dose needs may be different during pregnancy. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether magnesium chloride passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Mag-Delay (magnesium chloride)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medication with a full glass of water. Magnesium chloride should be taken with food if it upsets your stomach or causes diarrhea. Follow your doctor's instructions. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

It is important to use magnesium chloride regularly to get the most benefit. Try to take your dose(s) at the same time each day.

Magnesium chloride is only part of a complete program of treatment that may also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to help control your condition.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Store magnesium chloride at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include thirst, confusion, severe drowsiness, slow heart rate, urinating less than usual or not at all, swelling, weight gain, feeling short of breath, or fainting.

What should I avoid while taking Mag-Delay (magnesium chloride)?

Avoid using antacids or laxatives without your doctor's advice. Use only the specific type of antacid your doctor recommends. These medications may contain minerals and if you take certain products together you may get too much magnesium.

If you are taking a tetracycline antibiotic, avoid taking it within 2 hours before or 3 hours after you take magnesium chloride. Tetracycline antibiotics include doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap, and others).

Mag-Delay (magnesium chloride) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe dizziness, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have signs that you magnesium blood levels are too low, such as:

depression, feeling tired or irritable;

muscle cramps; or

severe or ongoing diarrhea.

Less serious side effects may include:

mild diarrhea;

nausea, stomach pain; or

upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mag-Delay (magnesium chloride)?

Tell your doctor about all other medications you use, especially:

digoxin (Lanoxin, Lanoxicaps);

sodium polystyrene sulfonate (Kalexate, Kayexalate, Kionex);

an amphetamine such as ADHD medication (Adderall, Vyvanse, Dexedrine, and others);

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others;

medication for osteoporosis or Paget's disease, such as alendronate (Fosamax), ibandronate (Boniva), etidronate (Didronel), pamidronate (Aredia), or risedronate (Actonel); or

thyroid replacement medication such as levothyroxine (Synthroid, Levothroid, Unithroid).

This list is not complete and there may be other drugs that can interact with magnesium chloride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Mag-Delay resources Mag-Delay Side Effects (in more detail)Mag-Delay Use in Pregnancy & BreastfeedingMag-Delay Drug InteractionsMag-Delay Support Group0 Reviews for Mag-Delay - Add your own review/rating Magnesium Chloride Professional Patient Advice (Wolters Kluwer) Chloromag Prescribing Information (FDA) Mag-SR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mag-Delay with other medications Heart AttackHypomagnesemia Where can I get more information? Your pharmacist can provide more information about magnesium chloride.

See also: Mag-Delay side effects (in more detail)

Daktarin Aktiv Cream (McNeil Products Ltd)
1. Name Of The Medicinal Product

Daktarin Aktiv Cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2.0% w/w

(Each gram of cream contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cream

White homogeneous cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of athlete's foot.

4.2 Posology And Method Of Administration

For all ages.

Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Method of administration: Cutaneous application.

4.3 Contraindications

Daktarin Aktiv Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.

4.4 Special Warnings And Precautions For Use

Daktarin Aktiv Cream must not come into contact with the eyes.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

4.6 Pregnancy And Lactation

Pregnancy

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1,000 and < 1/100

Rare > 1/10,000, < 1/1,000

Very rare < 1/10,000, including isolated reports

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema.

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation.

General disorders and administration site conditions

Rare: application site reactions, including application site irritation.

4.9 Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

5.2 Pharmacokinetic Properties

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG 32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.

Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g.

*Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0304

9. Date Of First Authorisation/Renewal Of The Authorisation

01 July 2008

10. Date Of Revision Of The Text

10 July 2008

Isopto-Dex

Isopto-Dex may be available in the countries listed below.

Ingredient matches for Isopto-Dex Dexamethasone

Dexamethasone is reported as an ingredient of Isopto-Dex in the following countries:

Germany

International Drug Name Search

Pro-Banthine
propantheline bromide Dosage Form: Tablets Pro-Banthine Description

Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.

The structural formula of propantheline bromide is:

Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.

Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.

Pro-Banthine - Clinical Pharmacology

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.

The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.

Indications and Usage for Pro-Banthine

Pro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.

Contraindications

Propantheline bromide is contraindicated in patients with:

Glaucoma, since mydriasis is to be avoided. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.) Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy). Intestinal atony of elderly or debilitated patients. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis. Unstable cardiovascular adjustment in acute hemorrhage. Myasthenia gravis. Warnings

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.

Precautions General

Propantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.

In patients with ulcerative colitis, large doses of propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.

Information for patients

Propantheline bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking this drug product.

Drug Interactions

Anticholinergics may delay absorption of other medication given concomitantly.

Excessive cholinergic blockade may occur if propantheline bromide is given concomitantly with belladonna alkaloids, synthetic or semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline bromide may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of propantheline bromide with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline bromide.

Pregnancy Pregnancy Category C

Animal reproduction studies have not been conducted with propantheline bromide. It is also not known whether propantheline bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline bromide should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations.

Overdosage

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) immediate induction of emesis or lavage of the stomach, (2) injection of physostigmine 0.5 to 2 mg intravenously, repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.

Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously, or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.

The oral LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.

Pro-Banthine Dosage and Administration

The usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient's individual response and tolerance. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.

How is Pro-Banthine Supplied

Pro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).

Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).

Store below 25°C (77°F).

Rev. 2/00 073 0117 004

Cardene 20mg and 30mg capsules

UK

Cardene 20 mg and 30 mg capsules

Nicardipine hydrochloride

Please read this leaflet carefully before you start to take your medicine.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is Cardene?

Cardene contains the active ingredient nicardipine hydrochloride which belongs to the class of drugs called calcium channel blockers. These cause relaxation of the smooth muscle of the blood vessels causing these vessels to widen or dilate.

Cardene capsules come in two strengths. Each capsule contains either 20 mg or 30 mg of nicardipine hydrochloride.

The 20 mg capsule is coloured blue and white. The 30 mg capsule is coloured blue and pale blue.

They also contain the additional ingredients: starch, magnesium stearate, gelatin, indigotine E132, titanium dioxide El71.

Both strengths of capsules are available in packs of 56.

The Product Licence holder is

Astellas Pharma Limited Lovett House Lovett Road Staines Middx TW18 3AZ UK

This medicine is made by

Farmasierra, S.A. Carretera de Ir?n Km. 26,200 San Sebasti?n de los Reyes 28700 Madrid Spain

The site where batch release takes place is

Astellas Pharma Europe BV Hogemaat 2 Meppel The Netherlands What is Cardene used for?

Your medicine is used for the treatment of mild to moderate high blood pressure (hypertension) and to help prevent attacks of chest pain diagnosed by your doctor as chronic stable angina. Chronic stable angina is a pattern of attacks of chest pain that are predictable and reproducible under certain conditions such as after exercise, stress or in cold weather. They are short in duration and can be relieved by rest or certain drugs.

When must Cardene not be used? If you are allergic to nicardipine or other dihydropyridines, or any of the ingredients Cardene contains. If you have had a recent heart attack (ie. within the last month), or a condition called advanced aortic stenosis which is narrowing of your aortic heart valve. If your chest pain is diagnosed by your doctor as unstable angina. For example, if the pattern of attacks of chest pain changes and occur without exertion, you should contact your doctor immediately. If you need immediate relief of chest pain in a sudden or acute angina attack. This situation should be treated with a different class of medicine. to try to prevent the occurrence of future heart attacks (if you have already had at least one heart attack). Cardene is not recommended for patients under the age of 18. When should you be extra careful when using/while taking Cardene?

Make sure your doctor knows if you:

have a heart, liver or kidney condition, or have had a stroke. are taking other medicines including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of either Cardene or other medicines. Examples of such effects have been reported for Cardene when also taking digoxin, cimetidine, cyclosporin and other blood pressure lowering drugs amongst other medicines. Rifampicin or grapefruit juice should not be taken with Cardene, since they could also interact and alter the effects of Cardene. are about to undergo an operation. You must tell the doctors in the hospital that you are taking Cardene. if you experience sudden dizziness, light-headedness or palpitations on treatment with Cardene, let your doctor know. Sometimes Cardene can cause too great a fall in blood pressure which, if not dealt with, could damage your heart or brain. May Cardene be used during pregnancy or while breast feeding? You should NOT take these capsules if you are pregnant. You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You should NOT breast feed if you are taking these capsules. How should Cardene be taken? Always take your medicine exactly as your doctor tells you to and do not stop treatment unless he/she tells you to do so: The usual dose is 20-30 mg, every 8 hours. Your doctor may vary this according to your symptoms and blood pressure. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist. Capsules should be swallowed with a glass of water, preferably at the same time each day. (NB. Do not use grapefruit juice). If you forget to take a dose, take another dose as soon as you remember provided there are at least 3 hours between doses. If this is not possible, do not take the missed dose. Do not take two doses together. Do not change the prescribed dose of your medicine yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. What are the possible unwanted effects of Cardene?

This medicine sometimes causes side-effects. These are usually mild and tend to pass with time, but if they trouble you consult your doctor.

Common side effects are:

Headache, ankle swelling (oedema), heat sensation, facial flushing, sensation of fast heart beats (palpitations), nausea, dizziness.

In some patients Cardene may cause an attack of angina (chest pain) shortly after first starting to take the capsules. If this happens to you, do not take any further doses and contact your doctor. In addition a few patients experience an increase in the severity or frequency of chest pain during treatment with Cardene. If this happens to you, you must inform your doctor as soon as possible.

Other less frequent side-effects include heart complaints, drowsiness, sleeplessness, ringing in the ears, pins and needles, psychological upset, itching, rashes, diffculty in passing urine or an increase in passing urine, shortness of breath, stomach upsets, and rarely, depression, increase in bruising and impotence.

If you are concerned about these or any other unwanted effects talk to your doctor.

How should Cardene be stored? Keep this medicine out of the reach and sight of children. Do not store above 25 °C. This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to. REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours. Further information:

You can get more information on Cardene from your doctor or pharmacist.

Date of last review

July 2005

118143

14121/3

Zypram Cream with Cleansing Wipes
Pronunciation: HYE-droe-KOR-ti-sone AS-e-tate/pram-OX-eenGeneric Name: Hydrocortisone Acetate/PramoxineBrand Name: Zypram

Humulin 70/30

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar) Brand Names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30

What is Humulin 70/30 (insulin isophane and insulin regular)?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane and insulin regular is used to treat diabetes.

Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Humulin 70/30 (insulin isophane and insulin regular)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Humulin 70/30 (insulin isophane and insulin regular)? Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin isophane and insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Humulin 70/30 (insulin isophane and insulin regular)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.

It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Humulin 70/30 (insulin isophane and insulin regular)? Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular. Humulin 70/30 (insulin isophane and insulin regular) side effects Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Humulin 70/30 (insulin isophane and insulin regular)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

albuterol (Proventil, Ventolin);

clonidine (Catapres);

reserpine;

guanethidine (Ismelin); or

beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. More Humulin 70/30 resources Humulin 70/30 Side Effects (in more detail)Humulin 70/30 Use in Pregnancy & BreastfeedingHumulin 70/30 Drug InteractionsHumulin 70/30 Support Group0 Reviews for Humulin 70/30 - Add your own review/rating Humulin 70/30 Prescribing Information (FDA) Humulin 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer) Humulin 50/50 Prescribing Information (FDA) Novolin 70/30 Prescribing Information (FDA) Novolin 70/30 InnoLets MedFacts Consumer Leaflet (Wolters Kluwer) Compare Humulin 70/30 with other medications Diabetes, Type 1Diabetes, Type 2Gestational Diabetes Where can I get more information? Your pharmacist can provide more information about insulin isophane and insulin regular.

See also: Humulin 70/30 side effects (in more detail)

Iron/Succinic Acid/Folic Acid
Pronunciation: EYE-urn/suk-SIN-ik AS-id/FOE-lik AS-idGeneric Name: Iron/Succinic Acid/Folic AcidBrand Name: Irospan 24/6

Dibenzazepine anticonvulsants

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Anticonvulsants are drugs that prevent or reduce the severity and frequency of seizures in various types of epilepsy. The different types of anticonvulsants may act on different receptors in the brain and have different modes of action.

Two mechanisms that appear to be important in anticonvulsants are enhancement of GABA action and inhibition of sodium channel activity. Other mechanisms are inhibition of calcium channels and glutamate receptors.

See also

Medical conditions associated with dibenzazepine anticonvulsants:

AnxietyBipolar DisorderDiabetic Nerve DamageDystoniaEpilepsyLennox-Gastaut SyndromePeripheral NeuropathyReflex Sympathetic Dystrophy SyndromeSchizoaffective DisorderSeizuresTrigeminal NeuralgiaVulvodynia Drug List:Tegretol-Xr-Sustained-Release-TabletsEpitolTegretolEquetro

Adcal 1500mg chewable tablets
1. Name Of The Medicinal Product

Adcal 1500mg Chewable Tablets

2. Qualitative And Quantitative Composition

Per tablet:

Calcium carbonate: 1500mg

equivalent to 600mg of elemental calcium

3. Pharmaceutical Form

Chewable Tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Adcal is a chewable tablet recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy as an adjunct to more specific conventional treatments. Adcal chewable tablets can be used as a phosphate binding agent in the management of renal failure.

4.2 Posology And Method Of Administration

Oral.

Adults, elderly and children

Dietary deficiency and as an adjunct in osteoporosis therapy; 2 chewable tablets per day, preferably one tablet each morning and evening.

For use in binding phosphate in the management of renal failure in patients on renal dialysis, the dose should be adjusted for the individual patient and is dependent on the serum phosphate level.

The tablets should be chewed, not swallowed whole and taken just prior to, during or immediately following a meal.

4.3 Contraindications

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

4.4 Special Warnings And Precautions For Use

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.

Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours.

Allowances should be made for calcium and vitamin D supplements from other sources.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.

Calcium absorption is reduced in patients receiving systemic corticosteroid therapy. This should be taken in to account when patients are receiving concomitant therapy.

4.6 Pregnancy And Lactation

During pregnancy and lactation treatment with Adcal should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Adcal and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5).

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea.

4.9 Overdose

Overdosage may cause gastro-intestinal disturbances but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering serum calcium levels through a high fluid intake and low calcium diet. In severe cases treatments with corticosteroid and other specialist treatment may be necessary. Alkalosis is a potential but rare risk.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Calcium carbonate is a well established medicinal material and is used extensively for supplementation in deficiency states. Calcium carbonate is also widely used as an antacid.

5.2 Pharmacokinetic Properties

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

5.3 Preclinical Safety Data

Calcium carbonate is a well known and widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Xylitol, polydextrose, pre-gelatinised starch, sodium saccharin, magnesium stearate, fruit flavour (contains propylene glycol and maltodextrin).

6.2 Incompatibilities

Not applicable, oral preparation.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original package. Keep container in the outer carton.

6.5 Nature And Contents Of Container

PVC/PVdC aluminium foil blister packs of 10 (Physicians sample), or 100 tablets in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

No special conditions

7. Marketing Authorisation Holder

ProStrakan Ltd.

Galabank Business Park

Galashiels

Scotland

TD1 1QH

8. Marketing Authorisation Number(S)

PL16508/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

04/10/2005

10. Date Of Revision Of The Text

November 2008

11 LEGAL CATEGORY

P

ZAMADOL 24hr 150 (200 / 300 / 400)mg TABLETS
1. Name Of The Medicinal Product

ZAMADOL 24hr 150 (200/300/400) mg prolonged release tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 150 (200/300/400) mg of tramadol hydrochloride

Excipient: Each prolonged-release tablet contains 0.60 (1.00/1.40/1.80) mg lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged release tablet

White film coated tablets marked T 150 (200/300/400)

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

ZAMADOL 24hr tablets should be taken at 24-hourly intervals and must be swallowed whole and not chewed.

As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient. The correct dosage for any individual patient is that which controls the pain with no or tolerable side effects for a full 24 hours. Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the ZAMADOL 24hr range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported. (See Section 4.4 Special Warnings and Precautions for Use).A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.

Adults and children over 12 years: The usual initial dose is one 150 mg tablet daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.

Elderly patients: Dosing as for adults. The elimination half-life of tramadol may be prolonged in patients over 75 years . A starting dose of 150 mg daily is recommended. Dose titration upwards should be carefully monitored.

Patients with renal or hepatic insufficiency: The elimination half-life of tramadol may be prolonged in these patient populations. A starting dose of 150 mg daily is recommended. Dose titration upwards should be carefully monitored. Tramadol is not recommended for patients with severe renal impairment and/or severe hepatic impairment.

As tramadol is only removed very slowly by haemodialysis or by haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.

Children under 12 years: ZAMADOL 24hr has not been studied in children. Safety and efficacy of ZAMADOL 24hr have not been established and the product should not be used in children.

4.3 Contraindications

Hypersensitivity to tramadol or to any of the excipients; acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.

Tramadol must not be used for narcotic withdrawal treatment.

4.4 Special Warnings And Precautions For Use

Warnings

At therapeutic doses withdrawal symptoms have been reported at a frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly.

In patients with a tendency to drug abuse or dependence, treatment should be for short periods and under strict medical supervision.

Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.

Precautions

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold. (See Section 4.5 Interactions with other Medicaments and other forms of Interaction).

Tramadol should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock.

Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent administration of tramadol with other centrally acting drugs, including alcohol, may potentiate CNS depressant effects.

Simultaneous treatment with carbamazepine may shorten the analgesic effect as a result of a reduction in serum levels of tramadol and its active metabolite.

Co-administration with cimetidine is associated with a small prolongation of the half-life of tramadol, but this is not clinically relevant.

Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors (SSRIs), tricyclic anti-depressants (TCAs), anti-psychotics and other seizure threshold lowering drugs to cause convulsions (see Section 4.4 Special Warnings and Special Precautions for Use and 5.2 Pharmacokinetic Properties). Co-administration with SSRIs may lead to an increase of 5HT associated effects.

Co-administered ritonavir may increase serum concentration of tramadol resulting in tramadol toxicity.

Digoxin toxicity has occurred rarely during co-administration of digoxin and tramadol.

MAO inhibitors: A serotoninergic syndrome is likely to occur: diarrhoea, tachycardia, sweating, tremor, confusion, coma. In case of recent treatment with MAOIs, treatment with tramadol should not be started until 15 days after cessation of treatment with MAOIs.

Other morphine derivatives (including anti-tussives, substitution treatments), benzodiazepines, barbiturates: Increased risk of respiratory depression, that may be fatal in overdosage.

Mixed agonists/antagonists (eg buprenorphine, nalbuphine, pentazocine): The analgesic effect of tramadol which is a pure agonist may be reduced, and a withdrawal syndrome may occur.

There have been isolated reports of interaction with coumarin anticoagulants resulting in an increased INR and so care should be taken when commencing treatment with tramadol in patients on anticoagulants.

The analgesic effect of tramadol is in part mediated by inhibition of the re-uptake of norepinephrine and enhancement of the release of serotonin (5-HT). In studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirements of tramadol in patients with postoperative pain.

4.6 Pregnancy And Lactation

There are no adequate data from the use of tramadol in pregnant women. Animal studies have shown reproductive toxicity, but not teratogenic effects (see section 5.3). Tramadol crosses the placental barrier and chronic use during pregnancy can cause withdrawal symptoms in the new-born baby. Therefore, it should not be used during pregnancy.

Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in respiratory rate which are not usually clinically relevant.

During lactation very small amounts of tramadol and its metabolites (approximately 0.1% of an intravenous dose) are found in human breast milk. Therefore tramadol should not be administered during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Tramadol may cause drowsiness, blurred vision and dizziness which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery.

4.8 Undesirable Effects

The following frequency categories form the basis for classification of the undesirable effects:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000) not known (cannot be estimated from the available data)

 

Very Common

Common

Uncommon

Rare

Very Rare

Immune system disorders

 

 

 

 

 

 

Hypersensitivity

Anaphylactic reaction

 

 

Psychiatric disorders

 

 

 

 

 

 

Hallucinations

Nightmare

Mood altered

Elevated mood

Dysphoria

Decreased activity

Illusion

Agitation

Anxiety

Nervousness

Insomnia

Nervous system disorders

Dizziness

 

 

Headache

Paraesthesia

Increased activity

Cognitive disorder

Sensory disturbance

Judgement impaired

Convulsion

Hyperkinesia

Tremor

Eye disorders

 

 

 

 

 

 

Blurred vision

 

 

Cardiac disorders

 

 

 

 

Palpitations

Tachycardia

Bradycardia

 

 

Vascular disorders

 

 

 

 

Orthostatic hypotension

Circulatory collapse

Hypertension

Flushing

 

 

Respiratory, thoracic and mediastinal disorders

 

 

 

 

 

 

Dyspnoea

Asthma

Respiratory depression

Bronchospasm

Wheezing

 

 

Gastro-intestinal disorders

Nausea

Vomiting

Dry mouth

Retching

Constipat-ion

Abdominal discomfort

Anorexia

Diarrhoea

Gastro-intestinal disorder

Hepatobiliary disorders

 

 

 

 

 

 

 

 

Hepatic enzyme increased

Skin and subcutaneous tissue disorders

 

 

Hyperhidrosis

Pruritus

Rash

Urticaria

Angioedema

 

 

Renal and urinary disorders

 

 

 

 

 

 

Micturition disorder

Dysuria

Urinary retention

 

 

Musculoskeletal and connective tissue disorders

 

 

 

 

 

 

Muscular weakness

 

 

General disorders and administration site conditions Investigations

 

 

 

 

 

 

 

 

Drug withdrawal syndrome

4.9 Overdose

Symptoms of overdosage are typical of other opioid analgesics, and include miosis, vomiting, cardiovascular collapse, sedation and coma, seizures and respiratory depression. In severe cases tramadol overdose may result in a fatal outcome.

Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam.

Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with tramadol with haemodialysis or haemofiltration alone is not suitable for detoxification.

Emptying the gastric contents is useful to remove any unabsorbed drug, particularly when a modified release formulation has been taken.

5. Pharmacological Properties

Pharmacotherapeutic group: N02A X02

5.1 Pharmacodynamic Properties

Tramadol is a centrally acting analgesic (N02A X02). It is a non selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms that may contribute to its analgesic effect are inhibition of neuronal re-uptake of noradrenaline and 5HT.

5.2 Pharmacokinetic Properties

Following oral administration of a single dose, tramadol is almost completely absorbed and the absolute bioavailability is approximately 70%. Tramadol is metabolised to O

Following administration of one ZAMADOL 24hr tablet 200 mg in the fasting state, a mean peak plasma concentration (Cmax) of 192 ng.ml-1 was attained. This was associated with a median tmax of 6 hours (range 4-8 hours). The availability of tramadol from the ZAMADOL 24hr tablet 200 mg was complete when compared with an immediate release tramadol solution 100 mg, after dose adjustment. In the presence of food, the availability and controlled release properties of ZAMADOL 24hr tablets were maintained, with no evidence of dose-dumping.

A single dose-proportionality study has confirmed a linear pharmacokinetic response (in relation to tramadol and O-desmethyltramadol) following administration of the 200 mg, 300 mg and 400 mg tablets. A steady state study has confirmed the dose adjusted bioequivalence of the 150 mg and 200 mg tablets administered once-daily. This study also confirmed that the ZAMADOL 24hr tablet 150 mg provided an equivalent peak concentration and extent of availability of tramadol to an immediate release capsule 50 mg administered 8-hourly. On this basis it is recommended that patients receiving immediate release tramadol should be transferred initially to the nearest daily dose of ZAMADOL 24hr tablets. It may be necessary to titrate the dose thereafter.

A further steady state study has demonstrated that immediate release tramadol tablets 50 mg, administered 6-hourly, provided plasma concentrations that were greater than would have been anticipated following administration of a single dose. This observation is consistent with a non-linear elimination of the drug substance. In contrast, the plasma concentrations from ZAMADOL 24hr tablet 200 mg administered once-daily were in line with single dose data, confirming that the controlled delivery of tramadol from ZAMADOL 24hr minimises the non-linearity associated with faster-releasing preparations. The more predictable plasma concentrations may lead to a more manageable dose titration process.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.

Studies in rats and rabbits have revealed no teratogenic effects. However, embryotoxicity was shown in the form of delayed ossification. Fertility, reproductive performance and development of offspring were unaffected.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core

Hydrogenated vegetable oil

Talc

Magnesium stearate

Film coat

Lactose Monohydrate

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol 4000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30oC.

6.5 Nature And Contents Of Container

1) PVC blisters with aluminium backing foil (containing 2, 7, 10, 14, 15, 20, 28, 30, 50,56, 60 or 100 tablets).

2) Polypropylene containers with polyethylene lids (containing 2, 7, 10, 14, 15, 20, 28, 30, 50,56, 60 or 100 tablets).

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

UK

8. Marketing Authorisation Number(S)

PL 16950/0084 (85/86/87)

9. Date Of First Authorisation/Renewal Of The Authorisation

7 November 2001/19 June 2006

10. Date Of Revision Of The Text

August 2009

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