Isentress
Pronunciation: ral-TEG-ra-virGeneric Name: RaltegravirBrand Name: Isentress

Voltaren XR Extended-Release Tablets
Pronunciation: dye-KLOE-fen-akGeneric Name: DiclofenacBrand Name: Voltaren XR

Drapolene Cream (Chefaro UK Ltd)
1. Name Of The Medicinal Product

Drapolene Cream

2. Qualitative And Quantitative Composition

Drapolene contains:

Benzalkonium chloride solution 0.02% w/w

Equivalent to benzalkonium chloride 0.01% w/w

Cetrimide 0.2% w/w

3. Pharmaceutical Form

Cream for topical application.

4. Clinical Particulars 4.1 Therapeutic Indications

Drapolene is indicated for the relief of nappy rash and for use as an adjunct to baby care hygiene for the prevention of nappy rash.

Drapolene is indicated for the relief of urinary dermatitis in adults, and as an adjunct to patient care hygiene for the prevention of urinary dermatitis.

Drapolene is indicated for the symptomatic relief of minor burns, limited sunburn and the effects of weather.

4.2 Posology And Method Of Administration

Route of administration:

Topical

Dosage:

Babies: The nappy area should be washed then dried thoroughly at each change of nappy. Drapolene Cream should be applied, paying particular attention to folds in the skin.

Adults: The affected area (or the area of application) should be washed and dried thoroughly before applying Drapolene. Regular routine application is advised.

Drapolene should be applied as required for minor burns, limited sunburn and the effects of weather.

Use in the Elderly

No special comment

4.3 Contraindications

It is inadvisable to apply Drapolene Cream to a baby or adult who has an established hypersensitivity to benzalkonium chloride, cetrimide or lanolin. Use should be discontinued if an allergic hypersensitivity reaction is suspected.

4.4 Special Warnings And Precautions For Use

The packs carry the following additional warnings:

Store below 25°C

For external use only

Keep out of the reach of children

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

When used in accordance with the specified indications, systemic absorption of the specified components is not envisaged and so there are no special precautions/warnings appropriate to pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Allergic hypersensitivity reactions may occur in individuals who are sensitive to one or several components of Drapolene Cream.

Hypersensitivity to lanolin is recognised but is rare.

In a few individuals, benzalkonium chloride, used as a preservative in ophthalmic solutions, was associated with oedema and conjunctivitis. Dermatitis as a result of contact allergy to benzalkonium chloride in plaster of Paris has also been reported.

Hypersensitivity to cetrimide is also known to occur, presenting as a localised contact dermatitis. In severe cases the rash may be generalised.

4.9 Overdose

There are no reports of adverse events resulting from excessive application or accidental ingestion of Drapolene Cream.

In cases of accidental ingestion, symptomatic treatment is appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benzalkonium chloride and cetrimide are both quaternary ammonium disinfectants with properties typical of cationic surfactants. This preparation is useful in the treatment of and prevention of nappy rash, acting to suppress the development of ammonia producing organisms usually associated with this condition.

5.2 Pharmacokinetic Properties

No data is available on the pharmacokinetics of the active ingredients of Drapolene Cream, when used for the specified indications. Systemic absorption of the active ingredients is not envisaged.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

White soft paraffin

Wool fat (purified lanolin)

Cetyl alcohol

Polawax

Chlorocresol

Amaranth

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Tube - 36 months unopened.

Other packs - 36 months unopened.

6.4 Special Precautions For Storage

Store below 25° C.

6.5 Nature And Contents Of Container

25, 75, 150, 200 or 300 g - white pigmented polypropylene containers with white-pigmented LDPE snap-fit caps or white-pigmented polypropylene containers with white pigmented LDPE/HDPE snap-fit caps.

500 g polypropylene pots with PVDC faced wad and polypropylene screw caps.

100 g polyolefin/foil/polyolefin laminate tubes with polypropylene caps.

6.6 Special Precautions For Disposal And Other Handling

None applicable.

7. Marketing Authorisation Holder

Chefaro UK Ltd.

4th Floor,Hamilton House

Mabledon Place,Bloomsbury

LONDON,WC1H 9BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 02855/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

17th January 2005

10. Date Of Revision Of The Text

14th November 2010

zinc sulfate

Generic Name: zinc sulfate (ZINK SUL fate) Brand names: Orazinc 110, Orazinc 220, Verazinc, Zinc-220, Zincate, Zinca-pak, Mar-Zinc, Zinc CR, Micro-Zn, Zinc 50 mg Pink

What is zinc sulfate?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.

Zinc sulfate is used to treat and to prevent zinc deficiency.

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

What is the most important information I should know about zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc sulfate.

What should I discuss with my healthcare provider before taking zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

It is not known whether zinc sulfate will harm an unborn baby. Do not take zinc sulfate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc sulfate 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 take zinc sulfate?

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.

Take zinc sulfate with a full glass of water. Take zinc sulfate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc sulfate. The recommended dietary allowance of zinc sulfate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

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

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.

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.

What should I avoid while taking zinc sulfate? Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa. Zinc sulfate 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.

Less serious side effects may include:

nausea; 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 zinc sulfate?

The following drugs can interact with or be made less effective by zinc sulfate. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);

methyltestosterone (Android, Methitest, Oreton);

penicillamine (Cuprimine, Depen);

risedronate (Actonel);

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

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

This list is not complete and other drugs may interact with zinc sulfate. Tell your healthcare provider 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 zinc sulfate resources Zinc sulfate Use in Pregnancy & BreastfeedingDrug ImagesZinc sulfate Drug InteractionsZinc sulfate Support Group1 Review for Zinc sulfate - Add your own review/rating Zinc Sulfate MedFacts Consumer Leaflet (Wolters Kluwer) Zinc Sulfate Professional Patient Advice (Wolters Kluwer) Orazinc 110 Advanced Consumer (Micromedex) - Includes Dosage Information Compare zinc sulfate with other medications Vitamin/Mineral Supplementation and Deficiency Where can I get more information? Your pharmacist can provide more information about zinc sulfate.

Sodium Chloride Injection 23.4%
Sodium Chloride Injection, USP 23.4% 4 meq/ml 30 ml single dose vial Sodium Chloride Injection 23.4% Description

Sodium Chloride Injection, USP, 23.4%, is a concentrated, nonisotonic, sterile, nonpryogenic solution of sodium chloride 234 mg in Water for Injection. pH adjusted with sodium hydroxide or hydrochloric acid if necessary. pH 4.5-7.0 when diluted to a concentration of 0.9%, 8008 mOsmol/L.

Sodium chloride is an electrolyte replenisher. It occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water; it is soluble in glycerin and slightly soluble in alcohol.

The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

Photofrin
Pronunciation: POR-fi-merGeneric Name: PorfimerBrand Name: Photofrin

furazolidone

fure-a-ZOL-i-done

Available Dosage Forms:

Suspension Tablet

Therapeutic Class: Antibiotic

Chemical Class: Nitrofuran

Uses For furazolidone

Furazolidone is used to treat bacterial and protozoal infections. It works by killing bacteria and protozoa (tiny, one-celled animals). Some protozoa are parasites that can cause many different kinds of infections in the body.

Furazolidone is taken by mouth. It works inside the intestinal tract to treat cholera, colitis, and/or diarrhea caused by bacteria, and giardiasis. furazolidone is sometimes given with other medicines for bacterial infections.

Furazolidone may cause some serious side effects when taken with certain foods, beverages, or other medicines. Check with your health care professional for a list of products that should be avoided.

Furazolidone is available only with your doctor's prescription.

Before Using furazolidone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For furazolidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to furazolidone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because furazolidone may cause anemia, use in infants up to 1 month of age is not recommended.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of furazolidone in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking furazolidone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using furazolidone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amitriptyline Apraclonidine Atomoxetine Benzphetamine Brimonidine Citalopram Clovoxamine Cyclobenzaprine Cyproheptadine Dexmethylphenidate Dextroamphetamine Diethylpropion Escitalopram Femoxetine Fluoxetine Fluvoxamine Guanadrel Guanethidine Isocarboxazid Levomethadyl Maprotiline Mazindol Methamphetamine Methyldopa Methylphenidate Milnacipran Morphine Morphine Sulfate Liposome Nefazodone Nefopam Opipramol Paroxetine Phendimetrazine Phenmetrazine Phentermine Phenylalanine Pseudoephedrine Reserpine Sertraline Sibutramine Tapentadol Tetrabenazine Tranylcypromine Venlafaxine Zimeldine

Using furazolidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol Altretamine Amphetamine Arformoterol Avocado Bambuterol Bitolterol Bitter Orange Broxaterol Clenbuterol Difenoxin Diphenoxylate Droperidol Ephedrine Ethchlorvynol Fenoterol Fentanyl Formoterol Guarana Hexoprenaline Hydromorphone Indacaterol Isoetharine Kava Levalbuterol Licorice Lisdexamfetamine Ma Huang Mate Meperidine Metaraminol Norepinephrine Oxycodone Phenylephrine Phenylpropanolamine Pirbuterol Procaterol Reboxetine Rimiterol Ritodrine Salmeterol St John's Wort Terbutaline Tulobuterol Tyrosine

Using furazolidone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ginseng Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using furazolidone with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using furazolidone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use furazolidone, or give you special instructions about the use of food, alcohol, or tobacco.

Tyramine Containing Food Other Medical Problems

The presence of other medical problems may affect the use of furazolidone. Make sure you tell your doctor if you have any other medical problems, especially:

Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Patients with G6PD-deficiency may develop mild anemia while taking furazolidone Proper Use of furazolidone

Do not give furazolidone to infants up to 1 month of age, unless otherwise directed by your doctor. furazolidone may cause anemia in these patients.

Furazolidone may be taken with food to lessen the chance of an upset stomach.

To use the oral suspension:

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep taking furazolidone for the full time of treatment, even if you begin to feel better after a few days. If you stop taking furazolidone too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of furazolidone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of furazolidone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (oral suspension or tablets): For cholera or diarrhea caused by bacteria: Adults—100 milligrams (mg) taken four times a day for five to seven days. Children up to 1 month of age—Use is not recommended. Children 1 month of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.25 mg per kilogram (kg) (0.56 mg per pound) of body weight taken four times a day for five to seven days. For giardiasis: Adults—100 mg taken four times a day for seven to ten days. Children up to 1 month of age—Use is not recommended. Children 1 month of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.25 mg to 2 mg per kg (0.56 to 0.90 mg per pound) of body weight taken four times a day for seven to ten days. Missed Dose

If you miss a dose of furazolidone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using furazolidone

It is important that your doctor check your progress at regular visits. This is to check whether or not the infection is cleared up completely.

If your symptoms do not improve within a week, or if they become worse, check with your doctor.

Drinking alcoholic beverages or taking other alcohol-containing preparations (for example, elixirs, cough syrups, tonics, or injections of alcohol) while taking furazolidone may rarely cause problems. These problems include increased side effects such as redness of the face, difficult breathing, fainting, and a feeling of tightness in the chest. These side effects usually go away within 24 hours without treatment. However, these effects may occur if you drink alcoholic beverages for up to 4 days after you stop taking furazolidone. Therefore, you should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking furazolidone and for 4 days after stopping it.

Certain foods, drinks, or other medicines may cause very dangerous reactions, such as severe high blood pressure, when taken with furazolidone. Aged or fermented foods and drinks commonly contain tyramine or other substances that increase blood pressure. To avoid such reactions, the following measures are recommended:

Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; yeast or meat extracts; fava or broad bean pods; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; or any overripe fruit. If a list of these foods is not given to you, ask your health care professional to provide one. Do not drink alcoholic beverages or alcohol-free or reduced-alcohol beer and wine. Do not eat or drink large amounts of caffeine-containing food or beverages such as chocolate, coffee, tea, or cola. Do not take any other medicines unless approved or prescribed by your doctor. This includes nonprescription (over-the-counter [OTC]) appetite suppressants (diet pills) or medicine for colds, sinus problems, or hay fever or other allergies. Do not take any of the above-listed foods, drinks, or medicine for at least 2 weeks after you stop taking furazolidone. They may continue to react with furazolidone during that time. Other foods may also contain tyramine or other substances that increase blood pressure. However, these products generally do not cause serious problems when taken with furazolidone, especially if eaten when fresh and in small amounts. These include yogurt, sour cream, cream cheese, cottage cheese, chocolate, and soy sauce. If you have any questions about this, ask your health care professional. Also ask for a list of foods, beverages, or medicines that may cause serious problems when taken with furazolidone. furazolidone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Fever itching joint pain skin rash or redness sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Abdominal or stomach pain diarrhea headache nausea or vomiting

furazolidone commonly causes dark yellow to brown discoloration of urine. This side effect does not usually need medical attention.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More furazolidone resources Furazolidone Drug InteractionsFurazolidone Support Group0 Reviews · Be the first to review/rate this drug

Gyno-Pevaryl 1 Vaginal Pessary

Gyno-Pevaryl 1 vaginal pessary

Econazole nitrate

Gyno-Pevaryl is a registered trademark

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet 1. What Gyno-Pevaryl 1 is and what it is used for 2. Before you use Gyno-Pevaryl 1 3. How to use Gyno-Pevaryl 1 4. Possible side effects 5. How to store Gyno-Pevaryl 1 6. Further information What Gyno-Pevaryl 1 is and what it is used for

The name of your medicine is Gyno-Pevaryl 1 vaginal pessary. It is called ‘Gyno-Pevaryl 1’ in this leaflet.

Gyno-Pevaryl 1 is a solid, bullet-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole. This belongs to a group of medicines called ‘antifungals’.

Gyno-Pevaryl 1 is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).

Before you use Gyno-Pevaryl 1 Do not use Gyno-Pevaryl 1 if: You are allergic to anything in Gyno-Pevaryl 1 (listed in section 6 below) You are allergic to any other medicine used to treat thrush or other fungal infections You are under 16 years old

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl 1.

Take special care with Gyno-Pevaryl 1

Check with your doctor or pharmacist before using this medicine if:

You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 1 can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol Pregnancy and breast-feeding

Please tell your doctor before using Gyno-Pevaryl 1 if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Gyno-Pevaryl 1 if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

How to use Gyno-Pevaryl 1

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using the pessary Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary Inserting the pessary with the applicator Remove the pessary from the plastic packet using the easy open tab Pull the plunger of the applicator out until it sticks Gently push the pessary into the cup. Do not force it because it might stick Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first Push the plunger to release the pessary Remove the applicator and dispose of it safely in your household waste If you swallow Gyno-Pevaryl 1

If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Gyno-Pevaryl 1 can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 1 and tell your doctor straight away if you notice the following. You may need urgent medical treatment. Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects less than 1 in 10,000 people) Other side effects: Itchy and red skin around or inside the vagina. This is much milder than an allergic reaction. Tell your doctor or pharmacist if this feeling lasts for more than a few minutes or gets worse (rash, burning or swelling)

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Gyno-Pevaryl 1

Keep out of the reach and sight of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 1: After the expiry date which is stated on the label. The expiry date refers to the last day of that month If the plastic packet is broken or missing If the pessary is not light beige in colour

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further information

The active substance in Gyno-Pevaryl 1 is econazole nitrate. The pessary contains 150mg econazole nitrate.

The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate.

What Gyno-Pevaryl 1 looks like and contents of the pack

Gyno-Pevaryl 1 comes in a plastic strip containing one pessary. It is bullet-shaped and light beige in colour.

The product licence is held by: JANSSEN-CILAG LTD 50-100 Holmers Farm Way High Wycombe Bucks HP12 4EG UK Gyno-Pevaryl 1 is made by: Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse Belgium

OR

McGregor Cory Ltd Middleton Close Banbury Oxfordshire OX16 8RS UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last approved in August 2008.

Wockhardt USA
Address Wockhardt USA , 20 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Contact DetailsPhone: (973) 257-4960Website: http://www.wockhardtusa.com/

Metamucil
Pronunciation: SILL-i-umGeneric Name: PsylliumBrand Name: Metamucil

Brolene Eye Drops
1. Name Of The Medicinal Product

Brolene Eye Drops.

2. Qualitative And Quantitative Composition

Propamidine isetionate 0.1% w/v.

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

4.2 Posology And Method Of Administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3 Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4 Special Warnings And Precautions For Use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye drops are unsuitable for use with hard or soft contact lenses.

The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

Hypersensitivity may occur.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

4.9 Overdose

Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli, the activity of the diamidines being retained in the presence of organic matter such as tissue fluids, pus and serum.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.

6.4 Special Precautions For Storage

Store below 25oC.

6.5 Nature And Contents Of Container

10 ml plastic dropper bottle and tamper-proof cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 04425/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

07 November 2002

10. Date Of Revision Of The Text

12 April 2010

LEGAL CLASSIFICATION

P

Rubella Medications

Definition of Rubella: Rubella is a contagious viral infection with mild symptoms associated with a rash.

Drugs associated with Rubella

The following drugs and medications are in some way related to, or used in the treatment of Rubella. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Rubella

Medical Encyclopedia:

Rubella Drug List:Gamastan-S-D

Jutadilat

Jutadilat may be available in the countries listed below.

Ingredient matches for Jutadilat Nifedipine

Nifedipine is reported as an ingredient of Jutadilat in the following countries:

Germany

International Drug Name Search

Napratec OP
1. Name Of The Medicinal Product

NAPRATEC™ OP

2. Qualitative And Quantitative Composition

Napratec is a combination pack containing 56 Naproxen 500mg tablets and 56 Cytotec (misoprostol) 200mcg tablets.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet

Naproxen 500mg tablets are yellow, oblong and engraved 'NXN500' with a breakline on one side and CP on the reverse.

Cytotec is a white/off-white hexagonal tablet, scored on both sides, engraved SEARLE 1461 on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

Napratec combination pack is indicated for patients who require Naproxen 500mg twice daily and Cytotec 200mcg twice daily.

Naproxen is indicated for the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis) and ankylosing spondylitis.

Cytotec is indicated for the prophylaxis of nonsteroidal anti-inflammatory drug (NSAID)-induced gastroduodenal ulceration.

4.2 Posology And Method Of Administration

For oral administration

Adults

1 tablet of Naproxen and 1 tablet of Cytotec to be taken together twice daily with or after food.

Elderly

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly.

With Cytotec the usual dosage may be used in the elderly.

Napratec should only be used in those patients for whom 500mg naproxen twice daily is appropriate and in whom no reduction of naproxen dosage is necessary (see also sections on renal and hepatic impairment).

The elderly are at an increased risk of the serious consequences of adverse reactions. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Renal Impairment

As the final pathway for the elimination of naproxen metabolites is largely (95%) by urinary excretion via glomerular filtration it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients. Naproxen is not recommended in patients having a baseline creatinine clearance of less than 20ml/minute.

Certain patients, specifically those whose renal blood flow is compromised, such as in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure, and pre-existing renal disease, should have renal function assessed before and during naproxen therapy. Some elderly patients in whom impaired renal function may be expected could also fall within this category. Where there is a possibility of accumulation of naproxen metabolites, such patients may not be suitable to receive naproxen 500mg twice daily.

With Cytotec no dosage alteration is necessary in patients with impaired renal function.

Hepatic Impairment

Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased.

With Cytotec no dosage alteration is necessary in patients with impaired hepatic function.

Children

Napratec is not recommended.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

4.3 Contraindications

Use in Pregnancy and Lactation

Napratec is contraindicated in pregnancy and lactation (see section 4.6)

This medicine is also contraindicated in patients planning to become pregnant.

Napratec is contraindicated in patients with a known hypersensitivity to naproxen, or to misoprostol or to any of the excipients.

As the potential exists with naproxen for cross-sensitivity to aspirin and other nonsteroidal anti-inflammatory drugs, Napratec should not be administered to patients in whom aspirin, ibuprofen and other NSAIDs induce asthma, rhinitis, urticaria or angioedema.

As Napratec is a "prevention pack" it should not be used for treating arthritis in patients with active gastric or duodenal ulceration / haemorrhage. Such patients may be treated with a healing dose of Cytotec, 800 micrograms daily in divided doses with meals, and the NSAID continued or discontinued at the physician's discretion.

Use in pre-menopausal women

Napratec should not be used in pre-menopausal women unless the patient is at high risk of complications from NSAID-induced ulceration. In such patients it is advised that Napratec should only be used if the patient:

- takes effective contraceptive measures

- has been advised of the risks of taking the product if pregnant

Napratec is contraindicated in patients with severe heart failure, hepatic failure and renal failure (see section 4.4).

4.4 Special Warnings And Precautions For Use

Precautions

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

The use of Naproxen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Naproxen, in common with other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be considered when bleeding times are determined.

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2)

Respiratory disorders:

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma or allergic disease since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3).

Mild peripheral oedema has been observed in a few patients receiving naproxen. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking naproxen.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Gastrointestinal bleeding, ulceration and perforation:

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. When GI bleeding or ulceration occurs in patients receiving Napratec OP, the treatment should be withdrawn. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly if complicated when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin. (see section 4.5)

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8)

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with use of NSAID (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: onset of the reaction occurring in the majority of cases within the first month of treatment. Napratec should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Sporadic abnormalities in laboratory tests (e.g. liver function tests) have occurred in patients on naproxen, but no definite trend was seen in any test indicating toxicity.

Cytotec should be used with caution in disease states where hypotension might precipitate severe complications, e.g. cerebrovascular disease, coronary artery disease or severe peripheral vascular disease including hypertension.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drug Interactions

Due to the high plasma protein binding of naproxen, patients simultaneously receiving hydantoins, anti-coagulants or a highly protein-bound sulphonamide should be observed for signs of over dosage of these drugs. No interactions have been observed in clinical studies with naproxen and anti-coagulants or sulphonylureas, but caution is nevertheless advised since interaction has been seen with other non-steroidal agents of this class.

Diuretics: NSAIDs may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins. NSAIDs may also cause a reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Ciclosporin: Because of their effect on renal prostaglandins, cyclo-oxygenase inhibitors such as naproxen can increase the nephrotoxicity of ciclosporin

Other analgesics including cyclooxygenase-2-selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse events (see section 4.4).

Lithium: NSAIDs including naproxen have been reported to increase steady state plasma lithium levels. It is recommended that these are monitored whenever initiating, adjusting or discontinuing naproxen products.

Cardiac glycosides: Concomitant administration of Naproxen with cardiac glycosides may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Anti-hypertensives: Concomitant administration of naproxen with beta-blockers may reduce their antihypertensive effect.

Corticosteroids: Concomitant administration of naproxen with corticosteroids increases the risk of gastrointestinal ulceration or bleeding (see section 4.4) and may increase the frequency of side effects generally.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Probenecid: Increases naproxen plasma levels and extends its plasma half-life considerably.

Methotrexate: Caution is advised when methotrexate is administered concurrently because of possible enhancement of its toxicity since naproxen, among other NSAIDs, has been reported to induce the tubular secretion of methotrexate in an animal model.

Mifepristone: NSAIDs should not be used for 8 – 12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulatnts, such as warfarin (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Naproxen therapy should be temporarily withdrawn before adrenal function tests are performed as it may artificially interfere with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with some assays of urinary 5-hydroxyindoleacetic acid.

Cytotec is predominantly metabolised via fatty acid oxidising systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. No drug interactions have been attributed to Cytotec, and in specific studies, no clinically significant pharmacokinetic or pharmacodynamic interaction has been demonstrated with antipyrine, diazepam, propranolol or NSAIDs.

4.6 Pregnancy And Lactation

Napratec is contraindicated in pregnancy and lactation. The product is contraindicated in pregnancy on the basis that Cytotec is contraindicated in pregnancy or women planning a pregnancy as it increases uterine tone and contractions in pregnancy which may cause partial or complete expulsion of the products of conception.

Teratology studies with naproxen in rats and rabbits at dose levels equivalent on a human multiple basis to those which have produced foetal abnormality with certain other NSAIDs, e.g. aspirin, have not produced evidence of foetal damage with naproxen. As with other drugs of this type, naproxen delays parturition in animals (the relevance of this finding to human patients is unknown) and also affects the human foetal cardiovascular system (closure of the ductus arteriosus).

4.7 Effects On Ability To Drive And Use Machines

Dizziness, drowsiness, fatigue, visual disturbances or headaches are possible undesirable effects after taking NSAIDs. If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Naproxen:

Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain or discomfort and epigastric distress, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration. The more serious reaction, colitis, may occasionally occur. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Naproxen also causes gastrointestinal bleeding and gastric and duodenal ulceration, the consequences of which may be haemorrhage and perforation. The inclusion of Cytotec in the combination pack is to prevent naproxen-induced gastric and duodenal ulceration.

Hypersensitivity and Dermatological: Non-specific allergic reactions and anaphylaxis, respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, assorted skin disorders including rashes of various types,, pruritus, purpura, urticaria, angio-oedema.. Anaphylactic reactions to naproxen and naproxen sodium formulations; eosinophilic pneumonitis, alopecia, photosensitivity reactions and more rarely epidermolysis bullosa, epidermal necrolysis, erythema multiforme, pseudoporphyria, Stevens Johnson syndrome and toxic epidermal necrolysis (very rare).

Cardiovascular and cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Neurological and special senses: Headache, visual disturbances, insomnia, optic neuritis, paraesthesia, inability to concentrate, cognitive dysfunction, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4), depression, confusion, hallucinations, tinnitus, hearing impairment, vertigo, dizziness, malaise, fatigue and drowsiness.

Renal: As a class NSAIDs have been associated with renal pathology including nephropathy, papillary necrosis, interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic: Abnormal liver function, fatal hepatitis and jaundice.

Haematological: Thrombocytopenia, neutropenia, granulocytopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia may occur rarely.

Other: Mild peripheral oedema, vasculitis, and haematuria.

Cytotec:

Gastrointestinal: Diarrhoea has been reported and is occasionally severe and prolonged, and may require withdrawal of the drug. It can be minimised by taking Cytotec with food and by avoiding the use of predominantly magnesium-containing antacids when an antacid is required. Abdominal pain with or without associated dyspepsia can follow Cytotec therapy. Other gastrointestinal adverse effects reported include dyspepsia, flatulence, nausea and vomiting.

Female Reproductive System: Menorrhagia, vaginal bleeding and intermenstrual bleeding have been reported in both pre- and post-menopausal women.

Other Adverse Effects: Skin rashes have been reported. Dizziness has been infrequently reported.

4.9 Overdose

Naproxen:

Symptoms - Symptoms include drowsiness, heartburn, indigestion, nausea, vomiting, headache, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientataion, excitation, coma, dizziness, tinnitus, fainting, occasionally convulsions. A few patients have experienced seizures, but it is not clear whether these were naproxen-related or not. In cases of significant poisoning acute renal failure and liver damage are possible. It is not known what dose of the drug would be life-threatening.

Therapeutic measures - In the event of overdosage with naproxen, the stomach may be emptied and usual supportive measures employed.

• Patients should be treated symptomatically as required.

• Within one hour of ingestion of a potential toxic amount, activated charcoal should be considered. Animal studies indicate that the prompt administration of activated charcoal in adequate amounts would tend to reduce markedly the absorption of the drug. Alternatively, in adult, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

• Good urine output should be insured.

• Renal and liver function should be closely monitored

• Patients should be observed for at least four hours after ingestion of potentially toxic amounts

• Frequent or prolonged convulsions should be treated with intravenous diazepam

• Other measures may be indicated by the patient's clinical condition.

Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding. However, haemodialysis may still be appropriate in a patient with renal failure who has taken naproxen.

Cytotec:

Intensification of pharmacological and adverse effects may occur with overdose. In the event of overdosage with Cytotec, symptomatic and supportive therapy should be given as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Naproxen is a non-steroidal anti-inflammatory drug with well-documented properties, i.e. analgesic, antipyretic and anti-inflammatory.

Misoprostol is a synthetic prostaglandin E1 analogue which enhances several of the factors that maintain gastroduodenal mucosal integrity.

5.2 Pharmacokinetic Properties

Naproxen is readily absorbed from the GI tract. Peak plasma concentrations are obtained 2-4 hours after ingestion. At therapeutic concentrations, naproxen is more than 98% bound to plasma proteins and has an elimination half-life of between 12-15 hours.

Misoprostol is rapidly absorbed following oral administration with peak plasma levels of the active metabolite (misoprostol acid) occurring after about 30 minutes. The plasma elimination half-life of misoprostol acid is 20-40 minutes.

Increases in Cmax and AUC for misoprostol acid have been observed when co-administered with naproxen in a single dose study. These changes are not thought to be clinically significant since the higher values are still well within the variation seen after 200 micrograms misoprostol in other studies. No accumulation of misoprostol acid in plasma occurs after repeated dosing of 400 micrograms twice daily.

5.3 Preclinical Safety Data

Naproxen causes gastric erosions when given orally or subcutaneously to fasting rats. There is no evidence of mutagenicity or carcinogenicity when administered to rats in studies of two years duration. There is no evidence of teratogenicity in mice, rats or rabbits.

Misoprostol in multiples of the recommended therapeutic dose in animals has produced gastric mucosal hyperplasia. This characteristic response to E-series prostaglandins reverts to normal on discontinuation of the compound.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Naproxen 500mg tablets contain: Lactose, maize starch, povidone, sodium starch glycolate, magnesium stearate, yellow lake CLF 3076 (E104 and E172).

Cytotec 200mcg tablets contain: microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil and hypromellose.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30?C. Store in the original package.

6.5 Nature And Contents Of Container

Combination pack containing 8 x 7 day blisters containing 56 Naproxen 500mg tablets and 56 Cytotec 200mcg tablets in cold-formed aluminium blisters.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL00057/1018

9. Date Of First Authorisation/Renewal Of The Authorisation

26 June 2002

10. Date Of Revision Of The Text

June 2011

11. LEGAL CATEGORY

POM

Ref: NA 5_0 UK

fluocinolone ophthalmic implant

Generic Name: fluocinolone ophthalmic implant (floo oh SIN oh lone off THAL mik IM plant) Brand Names: Retisert

What is fluocinolone ophthalmic implant?

Fluocinolone is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Fluocinolone ophthalmic (for the eye) implant is used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months. Fluocinolone will not treat an eye infection.

Fluocinolone ophthalmic implant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluocinolone ophthalmic implant?

The fluocinolone ophthalmic implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Before receiving the implant, tell your doctor if you are allergic to any drugs, or if you have glaucoma, herpes simplex or other eye infection, or if you have recently had cataract surgery.

Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant? You should not receive this medication if you are allergic to fluocinolone, or if you have:

a viral, bacterial, or fungal infection of your eye; or

a history of allergy to a steroid medicine.

If you have certain conditions, you may need special tests or other medications after receiving a fluocinolone implant. Tell your doctor if you are allergic to any drugs, or if you have:

glaucoma;

herpes simplex or other eye infection; or

if you have recently had cataract surgery.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

FDA pregnancy category C. It is not known whether the fluocinolone ophthalmic implant is harmful to an unborn baby if you receive the implant while you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is not known whether fluocinolone from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Do not receive this implant without telling your doctor if you are breast-feeding a baby. How is the fluocinolone ophthalmic implant put into place?

This implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Your doctor may prescribe other medications to help control the pressure inside your eyes. Increased pressure inside the eye (also called ocular hypertension) can damage the optic nerve and lead to permanent blindness.

You may need to use the medications to control pressure inside your eyes for several weeks after receiving the fluocinolone ophthalmic implant. Be sure to use this medication as directed by your doctor to avoid complications or needing further surgical procedures to control ocular hypertension.

To be sure the implant is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Since the fluocinolone ophthalmic implant is surgically put into place, you will not be on a dosing schedule for this medication.

If you are taking medication to control pressure inside your eyes and you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of fluocinolone is unlikely to occur with the ophthalmic implant.

What should I avoid after receiving a fluocinolone ophthalmic implant? Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid wearing contact lenses after receiving the fluocinolone ophthalmic implant unless your doctor has told you to.

Fluocinolone ophthalmic implant side effects

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

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:

sudden vision loss, eye pain or redness;

bleeding, oozing, or crusting of your eyes;

cloudiness in the pupils or iris of your eyes;

seeing flashes of light, halos around lights, or "floaters" in your vision; or

tunnel vision, problems with peripheral (side) vision.

Less serious side effects may include:

swelling of the eyelids;

mild eye irritation;

dry or watery eyes;

itching, mild skin rash;

the feeling that something is in your eye;

headache, dizziness;

runny or stuffy nose, sore throat, fever, cough;

nausea, vomiting; or

back pain, joint or muscle pain.

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.

Fluocinolone ophthalmic implant Dosing Information

Usual Adult Dose for Uveitis:

Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

Usual Pediatric Dose for Uveitis:

12 years to 18 years:Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

What other drugs will affect fluocinolone ophthalmic implant?

Before using this medication, tell your doctor if you are using any other steroid medications, including:

nasal or inhaled steroids such as budesonide (Pulmicort, Rhinocort, Symbicort), flunisolide (AeroBid, Nasarel), fluticasone (Advair, Flonase, Flovent), mometasone (Asmanex, Nasonex), or triamcinolone (Azmacort); or

steroid medication taken by mouth such as betamethasone (Celestone), budesonide (Entocort), dexamethasone (Decadron, Hexadrol), fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone), prednisone (Deltasone, Meticorten, Orasone, others), methylprednisolone (Medrol), triamcinolone (Aristocort).

There may be other drugs that can affect fluocinolone ophthalmic implant. 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 fluocinolone ophthalmic implant resources Fluocinolone ophthalmic implant Use in Pregnancy & BreastfeedingFluocinolone ophthalmic implant Drug InteractionsFluocinolone ophthalmic implant Support Group3 Reviews for Fluocinolone - Add your own review/rating Compare fluocinolone ophthalmic implant with other medications Uveitis Where can I get more information? Your doctor can provide more information about fluocinolone ophthalmic implant written for health professionals that you may read.

Nexiclon XR Suspension
clonidine Dosage Form: oral suspension, extended releaseFULL PRESCRIBING INFORMATION INDICATIONS & USAGE

NEXICLON XR is indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents.

DOSAGE & ADMINISTRATION Maintenance dose: Further increments of 0.09 mg (1 mL) once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily (2.2)

The dose of NEXICLON XR must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration in adults.

Initial Dose

Dosing with NEXICLON XR should be initiated 0.17 mg (2 mL) once daily. Elderly patients may benefit from a lower initial dose [see Use is Specific Populations (8.4)]. Initial dose is recommended to be administered at bedtime.

Maintenance Dose

Further increments of 0.09 mg (1 mL) once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg (2 mL to 0.52 mg (6 mL) once daily.

NEXICLON XR was studied at doses of 0.17 to 0.52 mg to 0.52 mg (2 to 6 mL) once daily. Doses higher than 0.52 mg (6 mL) per day were not evaluated and are not recommended.

Patients Currently Using Clonidine Hydrochloride Immediate Release Tablets

The recommended does of NEXICLON XR for patients who are currently taking clonidine hydrochloride immediate-release tablets is provided in the table below.

NEXICLON XR (Clonidine Extended Release)Oral Suspension Equivalent dose of Clonidine HCl Immediate-Release Tablets Initial Dose 0.17 mg (2 mL) once daily 0.1 mg twice daily Maintenance Dose Titration Increments 0.09 mg (1 mL) once daily 0.05 mg twice daily Common Doses Used for Blood Pressure Effect 0.17 mg (2 mL) once daily 0.1 mg twice daily 0.34 mg (4 mL) once daily 0.2 mg twice daily   0.52 mg (6 mL) once daily 0.3 mg twice daily   Renal Impairment

Adjust dosage according to the degree of impairment. In patients with end stage kidney disease on maintenance dialysis, start at 0.09 mg (1 mL) per day and up-titrate slowly to minimize dose related adverse events.

Monitor patients carefully, especially for bradycardia, sedation and hypotension. Only a minimal amount of clonidine is removed during routine hemodialysis.

In patients with moderate to severe kidney impairment not undergoing dialysis, initiate clonidine at the same dose as for patients without renal impairment. Up-titrate slowly and monitor for dose-related adverse events.

DOSAGE FORMS & STRENGTHS CONTRAINDICATIONS

NEXICLON XR should not be used in patients with known hypersensitivity to clonidine [see Warnings and Precautions (5.2)]

WARNINGS AND PRECAUTIONS Withdrawal

Instruct patients not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with NEXICLON XR, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms.

An excessive rise in blood pressure following discontinuation of NEXICLON XR can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of NEXICLON XR.

Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

General Precautions

In patients who have developed localized contact sensitization to a clonidine transdermal system, substitution of oral clonidine therapy may be associated with the development of a generalized skin rash.

In patients who develop an allergic reaction to a clonidine transdermal system, substitution of oral clonidine may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema).

Monitor carefully and uptitrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Perioperative Use

NEXICLON XR may be administered up to 28 hours prior to surgery and resumed the following day. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

ADVERSE REACTIONS

The following serious adverse reactions are discussed in detail elsewhere in the labeling:

Withdrawal [seeWarnings and Precautions (5.1)] Allergic reactions [see Warnings and Precautions (5.2)]   NEXICLON XR Clinical Trial Experience

There is very limited experience with NEXICLON XR in controlled trials.  Based on this limited experience, the adverse event profile appears similar with to the immediate-release clonidine formulation.

  Experience with Immediate-Release Clonidine

Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%); drowsiness (approximately 33%; dizziness (approximately 16%); constipation and sedation (approximately 10% each).

The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome.  Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System (CNS): Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

DRUG INTERACTIONS

No drug interaction studies have been conducted with NEXICLON XR. The following have been reported with other oral formulations of clonidine.

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats [see Nonclinical Toxicology (13.2)].

Alcohol: Based on in vitro studies, high concentration of alcohol may increase the rate of release of NEXICLON XR.

USE IN SPECIFIC POPULATIONS   Pregnancy

Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg).

No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Clonidine is secreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Elderly patients may benefit from a lower initial dose [see Dosage and Administration (2)].

Patients with Renal Impairment

The initial dosage should be based on the degree of impairment. Monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. Only a minimal amount of clonidine is removed during routine hemodialysis.

OVERDOSAGE

Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma, and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children.

There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.

The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

DESCRIPTION

NEXICLON XR (clonidine) Extended-Release Oral Suspension is available for oral administration in one extended-release dose strength 0.09 mg/mL. The 0.09 mg/mL suspension is equivalent to 0.1 mg/mL of immediate-release clonidine hydrochloride.

Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:

[IC]

C9H9Cl2N3·HCl Mol. Wt. 266.56

Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.

The inactive ingredients are: citric acid anhydrous, flavor, glycerin, high fructose corn syrup, methylparaben, modified food starch, polyvinyl acetate, polysorbate 80, povidone, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, triacetin, and xanthan gum.

CLINICAL PHARMACOLOGY Mechanism of Action

Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. The patient’s maximum blood pressure decrease occurred within 6 to 8 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

  Pharmacodynamics

NEXICLON XR was studied in an open-label crossover, force titration, partially randomized trial in patients with mild and moderate essential hypertension who were on two or fewer antihypertensive medications.   The trial was designed to compare steady-state exposures between the NEXICLON XR and clonidine immediate-release tablets.  There were up- and down-titration phases.  There was no washout period between phases or treatments.

Studies with immediate-release clonidine hydrochloride have demonstrated a moderate reduction (15% to 20%) in cardiac output in the supine position with no change in the peripheral resistance. At a 45° tilt, there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use.

  Pharmacokinetics

Following single doses of NEXICLON XR Oral Suspension 0.17 mg, clonidine mean (S.D.) peak plasma concentrations of 0.49 (±0.09) ng/mL occurred at 7.8 (±1.7) hours. The plasma half-life of clonidine was 13.7 (±3.0) hours. There was no effect of food on the pharmacokinetic parameters.

[IC]

A = NEXICLON XR Oral Suspension (0.17 mg QD) Fasted

B = Clonidine IR Tablet (0.1 mg clonidine hydrochloride Q 12h) Fasted

C = NEXICLON XR Oral Suspension (0.17 mg QD) Fed

In the multi-dose study, mild to moderate hypertensive patients were randomized to ER and BID IR clonidine formulations. The following plot shows the sitting blood pressure values for each treatment group at Day 22.

[IC]

The half-life may increase up to 41 hours in patients with severe impairment of renal function. Following oral administration of clonidine about 40 to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity.

Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m2 basis).

Animal Toxicology and/or Pharmacology

In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.

In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.

CLINICAL STUDIES

[see Clinical Pharmacology (12.3)]

HOW SUPPLIED/STORAGE AND HANDLING

NEXICLON XR (Clonidine Extended Release) Oral Suspension 0.09 mg/mL is supplied as light beige to tan viscous suspension containing 0.09 mg clonidine base per mL in bottles of 4 fl oz (118 mL). NDC 27808-029-01.

Store at 25?C (77?F); excursions permitted from 15? to 30?C (59? to 86?F). [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant container.

Distributed By: NextWave Pharmaceuticals, Inc.

Cupertino, CA 95014

 

www.nextwavepharma.com

 

Manufactured By: Tris Pharma, Inc.

Monmouth Junction, NJ 08852

 

www.trispharma.com

 

LB8151

Rev 00

10/10

PATIENT COUNSELING INFORMATION Information for Patients

Caution patients against interruption of NEXICLON XR therapy without their healthcare provider’s advice.

Advise patients who engage in potentially hazardous activities, such as operating machinery or driving, of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Directions for using the enclosed adapter and syringe: Shake bottle well with vigorous back and forth motion for 5 to 10 seconds and then insert adapter into the neck of bottle. Insert syringe tip into the adapter and invert the bottle. Draw out amount of suspension as prescribed by doctor or physician. Dispense directly into mouth. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEXICLON XR® (Clonidine Extended Release) Oral Suspension

0.09 mg/mL

Alpha-adrenoreceptor antagonists
Drug List:

Antihemophilic Factor/von Willebrand Factor (Human)
Pronunciation: AN-tee-hee-moe-FIL-ik FAK-tor/von WILL-a-brand FAK-torGeneric Name: Antihemophilic Factor/von Willebrand Factor (Human)Brand Name: Alphanate

Inderide

Generic Name: hydrochlorothiazide and propranolol (HYE droe klor oh THYE a zide and proe PRAN oh lol) Brand Names: Inderide

What is Inderide (hydrochlorothiazide and propranolol)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

The combination of hydrochlorothiazide and propranolol is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and propranolol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Inderide (hydrochlorothiazide and propranolol)? You should not use this medication if you have asthma, severe or uncontrolled heart failure, a heart condition called "sick sinus syndrome" or "AV block," or if you are unable to urinate.

Before using this medication, tell your doctor if you have congestive heart failure, kidney or liver disease, cirrhosis, glaucoma, bronchospastic lung disease, gout, lupus, diabetes, a thyroid disorder, or if you are allergic to sulfa drugs or penicillin.

If you are diabetic, check your blood sugar carefully. Using propranolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and propranolol. Talk with your doctor before changing any doses.

Drinking alcohol can further lower your blood pressure and may increase your blood levels of propranolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

There are many other medicines that can interact with hydrochlorothiazide and propranolol. Tell your doctor about all the prescription and over-the-counter medications you use.

What should I discuss with my doctor before taking Inderide (hydrochlorothiazide and propranolol)? You should not use this medication if you are allergic to hydrochlorothiazide or propranolol, or if you have:

asthma;

severe or uncontrolled heart failure;

a heart condition called "sick sinus syndrome" or "AV block" (2nd or 3rd degree); or

if you are unable to urinate.

To make sure you can safely take hydrochlorothiazide and propranolol, tell your doctor if you have any of these other conditions:

congestive heart failure;

kidney disease; liver disease (or cirrhosis);

glaucoma;

bronchospastic lung disease;

a thyroid disorder;

lupus;

gout;

diabetes; or

if you are allergic to sulfa drugs or penicillin.

FDA pregnancy category C. It is not known whether hydrochlorothiazide and propranolol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide and propranolol 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 Inderide (hydrochlorothiazide and propranolol)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not stop using hydrochlorothiazide and propranolol suddenly, or you could have a serious or life-threatening heart problem. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

If you are diabetic, check your blood sugar carefully. Using propranolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and propranolol. Talk with your doctor before changing any doses.

Hydrochlorothiazide and propranolol can affect the results of certain thyroid tests or vision tests for glaucoma. Tell any doctor who treats you that you are using this medication.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and propranolol. You may need to stop using the medicine for a short time. Keep using hydrochlorothiazide and propranolol even if you feel fine. High blood pressure often has no symptoms. Store this medication in a tightly closed container at room temperature, away from heat and moisture.

See also: Inderide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled 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 slow heart rate, feeling like you might pass out, trouble breathing, or increased urination.

What should I avoid while taking Inderide (hydrochlorothiazide and propranolol)?

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb hydrochlorothiazide and propranolol.

Drinking alcohol can further lower your blood pressure and may increase your blood levels of propranolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Inderide (hydrochlorothiazide and propranolol) 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 this medication and call your doctor at once if you have any of these serious side effects:

eye pain, vision problems;

swelling, rapid weight gain, feeling short of breath, even with mild exertion;

fast, slow, or uneven heartbeat;

easy bruising or bleeding;

numbness or tingly feeling in your hands or feet;

feeling weak, drowsy, restless, or light-headed;

nausea, vomiting, dry mouth, extreme thirst, headache, confusion, hallucinations, seizure (convulsions);

increased urination, leg discomfort, muscle pain or weakness or limp feeling;

urinating less than usual or not at all;

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

diarrhea, constipation, upset stomach;

dizziness, spinning sensation;

sore throat, body aches;

blurred vision;

depressed mood; or

sleep problems (insomnia).

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 Inderide (hydrochlorothiazide and propranolol)? Tell your doctor if you regularly use other medicines that make you light-headed (especially narcotic pain medication or barbiturates). They can add to the side effects of hydrochlorothiazide and propranolol.

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

chlorpromazine (Thorazine);

cimetidine (Tagamet);

haloperidol (Haldol);

insulin or oral diabetes medication;

phenytoin (Dilantin);

rifampin (Rifadin, Rifamate, Rimactane);

theophylline (Elixophyllin, Respbid, Slo-Bid, Theo-Dur, Uniphyl, and others);

steroids (prednisone and others);

other blood pressure medications, (especially reserpine);

a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and propranolol. 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 Inderide resources Inderide Side Effects (in more detail)Inderide DosageInderide Use in Pregnancy & BreastfeedingDrug ImagesInderide Drug InteractionsInderide Support Group0 Reviews for Inderide - Add your own review/rating Inderide Prescribing Information (FDA) Inderide Advanced Consumer (Micromedex) - Includes Dosage Information Inderide MedFacts Consumer Leaflet (Wolters Kluwer) Compare Inderide with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and propranolol.

See also: Inderide side effects (in more detail)

Tolnaftate

Class: ThiocarbamatesATC Class: D01AE18VA Class: DE102

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