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Otic anesthetics

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

Otic anesthetics are agents that act locally to relieve pain in the ears. Some of these agents are available with other medicines such as analgesics, decongestants, etc. They are generally available as ear drops.

See also

Medical conditions associated with other immunosuppressants:

Acute Lymphoblastic LeukemiaAcute Lymphocytic LeukemiaAcute Nonlymphocytic LeukemiaAnemiaAsthma, MaintenanceAtopic DermatitisAutoimmune HepatitisBehcet's DiseaseBiliary CirrhosisBladder CancerBrain TumorBreast CancerBullous PemphigoidCervical CancerChoriocarcinomaChronic Active HepatitisChronic Inflammatory Demyelinating PolyradiculoneuropathyCogan's SyndromeColorectal CancerCrohn's DiseaseCrohn's Disease, AcuteCrohn's Disease, MaintenanceDermatomyositisEctopic PregnancyEczemaEsophageal CarcinomaGastric CancerGlomerulonephritisGraft-versus-host diseaseHead and Neck CancerHodgkin's LymphomaIdiopathic Thrombocytopenic PurpuraInflammatory Bowel DiseaseLeprosy, Erythema Nodosum LeprosumLymphomaMeningeal LeukemiaMultiple MyelomaMultiple SclerosisMyasthenia GravisMycosis FungoidesMyopathyNeoplastic DiseasesNephrotic SyndromeNeurosarcoidosisNon-Hodgkin's LymphomaNon-Small Cell Lung CancerOrgan Transplant, Rejection ProphylaxisOsteosarcomaOvarian CancerPancreatic CancerPemphigoidPemphigusPityriasis rubra pilarisPsoriasisPsoriatic ArthritisRenal TransplantRheumatoid ArthritisSarcoidosisSmall Cell Lung CancerSoft Tissue SarcomaSolid TumorsSystemic Lupus ErythematosusSystemic SclerosisTakayasu's ArteritisTrophoblastic DiseaseUlcerative ColitisUveitis Drug List:Xolair Imuran Thalomid Trexall

Organ Transplant, Rejection Reversal Medications
Drugs associated with Organ Transplant, Rejection Reversal

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

Topics under Organ Transplant, Rejection ReversalRejection Reversal (1 drug) Drug List:Neoral Sandimmune

Onyx Pharmaceuticals, Inc
Address Onyx Pharmaceuticals, Inc, 2100 Powell Street Emeryville, CA 94608Contact DetailsPhone: (510) 597-6500

Oruvail I.M. Injection
1. Name Of The Medicinal Product

Oruvail IM Injection

2. Qualitative And Quantitative Composition

In terms of the active ingredient

Ketoprofen BP 100mg in 2 ml.

3. Pharmaceutical Form

Solution for IM injection

4. Clinical Particulars 4.1 Therapeutic Indications

Oruvail injection is recommended in the management of acute exacerbations of:

• Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

• Periarticular conditions such as fibrositis, bursitis, capsulitis, tendinitis and tenosynovitis.

• Low back pain of musculoskeletal origin and sciatica.

• Other painful musculoskeletal conditions.

• Acute gout.

• Control of pain and inflammation following orthopaedic surgery.

4.2 Posology And Method Of Administration

Adults: 50 to 100 mg every four hours, repeated up to a maximum of 200 mg in twenty-four hours. Following a satisfactory response, oral therapy should be instituted with ketoprofen capsules. It is recommended that the injection should not normally be continued for longer than three days.

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric dosage: not established.

Oruvail IM Injection is for intramuscular injection only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4

4.3 Contraindications

Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, any other ingredients in this medicine, ASA or other NSAIDs.

Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug.

Ketoprofen is also contraindicated in the third trimester of pregnancy.

Ketoprofen is contraindicated in the following cases:

-severe heart failure

-active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

-haemorrhagic diathesis

-severe hepatic insufficiency

-severe renal insufficiency

-third trimester of pregnancy

Ketoprofen is contraindicated in cases of cerebrovascular bleeding or any other active bleeding.

Ketoprofen is contraindicated in patients with haemostatic disorders or ongoing anticoagulant therapy.

4.4 Special Warnings And Precautions For Use

Oruvail injection is for intramuscular use only.

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

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

Elderly:

The elderly have an increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see Section 4.2 Posology and method of administration).

Cardiovascular, Renal and Hepatic impairment:

At the start of treatment, renal function must be carefully monitored in patients with heart impairment, heart failure, liver dysfunction, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition (see Section 4.3 Contra-indications).

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 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). There are insufficient data to exclude such a risk for ketoprofen.

Respiratory disorders:

Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3).

Gastrointestinal bleeding, ulceration and perforation:

GI 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.

Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses (see also section 4.2 and 4.3).

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAlD doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

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

Patients with a history of gastrointestinal toxicity, particularly 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).

When GI bleeding or ulceration occurs in patients receiving ketoprofen, the treatment should be withdrawn.

SLE and mixed connective tissue disease:

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

Impaired female fertility:

The use of ketoprofen, as with other NSAIDs, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ketoprofen should be considered.

Skin reactions:

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 the use of NSAlDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Infectious disease:

As with other NSAIDs, in the presence of an infectious disease, it should be noted that the anti-inflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

Risk of gastrointestinal bleeding: the relative risk increases in subjects who have a low body weight. If gastrointestinal bleeding or ulcer occur, treatment must be discontinued immediately.

Blood counts and liver and kidney function tests should be carried out during long-term treatment.

Hyperkalaemia:

Hyperkalaemia promoted by diabetes or concomitant treatment with potassium-sparing agents (see section 4.5 Interactions).

Potassium levels must be monitored regularly under these circumstances.

In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy.

Patients with active or a past history of peptic ulcer.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (i.e. ticlopidine, clopidogrel):

Increased risk of bleeding (see section 4.4).

If co-administration is unavoidable, patient should be closely monitored

Lithium:

Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy.

Other analgesics/NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates:

Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, particularly gastrointestinal ulceration and bleeding (see section 4.4 Special warnings and precautions for use).

Methotrexate:

Serious interactions have been recorded after the use of high dose methotrexate with NSAIDs, including ketoprofen, due to decreased elimination of methotrexate. At doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (> 15mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.

Allow at least 12 hours between the discontinuation or initiation of ketoprofen treatment and the administration of methotrexate.

At doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.

Mifepristone:

NSAlDs should not be used for 8-12 days after mifepristone administration as NSAlDs can reduce the effect of mifepristone.

Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics):

Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).

Diuretics:

Risk of reduced diuretic effect. Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started (see section 4.4 Special warnings and precautions for use).

Cardiac glycosides:

NSAlDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Ciclosporin: Increased risk of nephrotoxicity, particularly in elderly subjects.

Quinolone antibiotics:

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

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus, particularly in elderly subjects.

Thrombolytics:

Increased risk of bleeding.

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

ACE inhibitors and Angiotensin II Antagonists:

In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.

Zidovudine:

Increased risk of haematological toxicity when NSAlDs 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.

Risks related to hyperkalaemia:

Certain medicinal products or therapeutic categories can promote hyperkalaemia, i.e. potassium salts, potassium-sparing diuretics, converting enzyme inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular-weight or unfractioned), ciclosporin, tacrolimus and trimethoprim. The occurrence of hyperkalaemia can depend on the presence of co-factors. This risk is enhanced when the drugs mentioned above are administered concomitantly.

Risks related to antiplatelet effect:

Several substances are involved in interactions due to their antiplatelet effects: tirofiban, eptifibarid, abcixiab, and iloprost. The use of several antiplatelet drugs enhances the risk of bleeding.

4.6 Pregnancy And Lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ketoprofen should not be given unless clearly necessary. If ketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of the pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- Inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.

Lactation

No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned about the potential for somnolence, dizziness or convulsions and be advised not to drive or operate machinery if these symptoms occur.

Patients should be warned of possible visual disturbances. If patients experience this, they should not drive or use machines.

4.8 Undesirable Effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been r3eported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Local reactions can occur and may include pain or a burning sensation. In all cases of major adverse effects Oruvail should be withdrawn at once.

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 an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Other adverse reactions reported less commonly include:

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.

Hepatic: abnormal liver function, hepatitis and jaundice.

Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune 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, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

4.9 Overdose

Symptoms

In adults, the principal signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. Disorientation, excitation, coma, tinnitus, fainting, occasionally convulsions may also occur. During severe intoxication, hypotension, respiratory depression and gastrointestinal bleeding have been observed.

Adverse effects seen after overdose with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated.

In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures:

The patient must be transferred immediately to a specialised hospital setting where symptomatic treatment can begin.

There is no specific antidote.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

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

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ketoprofen is a pharmacopoeial non-steroidal anti-inflammatory drug (NSAID). It is a strong inhibitor of prostaglandin synthetase and potent analgesic agent. Studies in vitro and in vivo show that ketoprofen possesses powerful anti-inflammatory, antipyretic, antibradykinin and lysosomal membrane stabilising properties.

5.2 Pharmacokinetic Properties

Peak concentrations of approximately 10 mg/L are reached at about 0.5-0.75 H after a 100 mg dose. The elimination half life is approximately 1.88 H. Apart from earlier Tmax values, there are no significant differences between the pharmacokinetics of Oruvail IM injection and conventional release capsules (Orudis).

5.3 Preclinical Safety Data

No additional data of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arginine

Benzyl Alcohol

Citric Acid anhydrous (E330)

Water For Injections

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C. Protect from light.

6.5 Nature And Contents Of Container

Cartons containing 10 ampoules each having 2 ml. of injection.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0377

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2005

10. Date Of Revision Of The Text

11 May 2011

LEGAL CATEGORY

POM

Ocular Tuberculosis Medications

There are currently no drugs listed for "Ocular Tuberculosis".

Definition of Ocular Tuberculosis: Tuberculosis infection of the eye(s).

Learn more about Ocular Tuberculosis

Micromedex Care Notes:

Tuberculosis

Medical Encyclopedia:

Disseminated tuberculosis Drug List:

One-Alpha Injection
1. Name Of The Medicinal Product

One-Alpha® Injection

2. Qualitative And Quantitative Composition

Alfacalcidol (1?-hydroxyvitamin D3) 2 micrograms/ml.

3. Pharmaceutical Form

Injection

4. Clinical Particulars 4.1 Therapeutic Indications

One-Alpha® is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 ?-hydroxylation such as when there is reduced renal function.

The main indications are:

a) Renal osteodystrophy

b) Hyperparathyroidism (with bone disease)

c) Hypoparathyroidism

d) Neonatal hypocalcaemia

e) Nutritional and malabsorptive rickets and osteomalacia

f) Pseudo - deficiency (D - dependent) rickets and osteomalacia

g) Hypophosphataemic vitamin D resistant rickets and osteomalacia

4.2 Posology And Method Of Administration

One-Alpha® Injection should be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

The dosage of One-Alpha® Injection is the same as for One-Alpha® in its oral presentations.

Initial dosage for all indications is:

Adults

1 microgram/day

Dosage in the elderly

0.5 microgram/day

Neonates and premature infants

0.05 - 0.1 microgram/kg/day

Children under 20 kg bodyweight

0.05 microgram/kg/day

Children over 20 kg bodyweight

1 microgram/day

The dose of One-Alpha® should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.

Maintenance doses are generally in the range of 0.25 - 1 microgram per day.

When administered as intravenous injection to patients undergoing haemodialysis the initial dosage for adults is 1 microgram per dialysis. The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis.

(a) Renal bone disease:

Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha®. Other therapeutic measures may be indicated.

Before and during treatment with One-Alpha®, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.

(b) Hyperparathyroidism:

In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha® for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, One-Alpha® should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.

In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha®. Severe hypocalcaemia is corrected more rapidly with higher doses of One-Alpha® (eg 3-5 micrograms) together with calcium supplements.

(d) Neonatal hypocalcaemia:

Although the normal starting dose of One-Alpha® is 0.05-0.1 microgram/kg/day (followed by careful titration), in severe cases, doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease.

(e) Nutritional and malabsorptive rickets and osteomalacia:

Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha®. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha®.

(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia:

Although large doses of parent vitamin D would be required, effective doses of One-Alpha® are similar to those required to heal nutritional Vitamin D deficiency rickets and osteomalacia.

(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:

Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha® at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.

4.3 Contraindications

Hypercalcaemia, metastatic calcification.

Hypersensitivity to alfacalcidol or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

One-Alpha® Injection should be avoided in patients with known sensitivity to injections containing propylene glycol.

One-Alpha® should be used with caution for:

• small premature infants

• patients being treated with cardioactive glycosides or digitalis as hypercalcaemia may lead to arrhythmia in such patients

• patients with nephrolithiasis

During treatment with One-Alpha® serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. To maintain serum phosphate at an acceptable level in patients with renal bone disease a phosphate binding agent may be used.

Hypercalcaemia may appear in patients treated with One-Alpha®, the early symptoms are as follows:

• polyurina

• polydipsia

• weakness, headache, nausea, constipation

• dry mouth

• muscle and bone pain

• metallic taste

Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). One-Alpha® treatment may then be restarted at a reduced dose (half the previous dose).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients taking barbiturates or anticonvulsants may require larger doses of One-Alpha® to produce the desired effect due to the induction of hepatic detoxification enzymes.

Use with caution in patients being treated with thiazide diuretics as they may have an increased risk of developing hypercalcaemia.

4.6 Pregnancy And Lactation

There are no adequate data from the use of alfacalcidol in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risks for humans are unknown. Caution should be taken when prescribing to pregnant women as hypercalcaemia during pregnancy may produce congenital disorders in the offspring.

Although it has not been established, it is likely that increased amounts of 1,25 dihydroxyvitamin D will be found in the milk of lactating mothers treated with One-Alpha®. This may influence calcium metabolism in the infant.

4.7 Effects On Ability To Drive And Use Machines

One-Alpha® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

The most frequently reported undesirable effects are hypercalcaemia and various skin reactions. Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). One-Alpha® treatment may then be restarted at half the previous dose.

Based on data from post-market use the total undesirable effect 'reporting rate' is rare or very rare being approximately 1:10,000 patients treated.

•Metabolism and Nutrition Disorders

Hypercalcaemia

Hyperphosphataemia

•Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

Urticaria

•Renal and Urinary Disorders

Nephrocalcinosis

Renal impairment

4.9 Overdose

Hypercalcaemia is treated by suspending the administration of One-Alpha®.

In severe cases of hypercalcaemia general supportive measures should be undertaken. Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Alfacalcidol is converted rapidly in the liver to 1,25 dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of One-Alpha® and 1,25 dihydroxyvitamin D are very similar.

Impaired 1 ?-hydroxylation reduces 1,25 dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of One-Alpha®.

The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of One-Alpha® is the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment.

5.2 Pharmacokinetic Properties

In patients on regular haemodialysis administration of doses between 1 - 4 micrograms of intravenous 1 ?-hydroxyvitamin D3 resulted in increased levels of 1,25 dihydroxyvitamin D. Formation of 1,25 dihydroxyvitamin D3 occurred within 1 hour after intravenous 1 ?-hydroxyvitamin D3 and peak concentrations were reached between 2 and 5 hours. Elimination half life of the formed 1,25 dihydroxyvitamin D was between 14 and 30 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric acid, ethanol, sodium citrate, propylene glycol and water for injection.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store at 2-8°C.

Keep the ampoule in the outer carton in order to protect it from light.

6.5 Nature And Contents Of Container

10 x 0.5ml amber glass ampoules.

10 x 1.0ml amber glass ampoules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0183

9. Date Of First Authorisation/Renewal Of The Authorisation

11/11/2005

10. Date Of Revision Of The Text

May 2009

Orelox Paediatric Granules for Oral Suspension (sanofi-aventis)
1. Name Of The Medicinal Product

OreloxTM Paediatric Granules for Oral Suspension.

2. Qualitative And Quantitative Composition

When reconstituted each 5ml volume contains 52mg of cefpodoxime proxetil (equivalent to 40mg cefpodoxime).

3. Pharmaceutical Form

Granules for the preparation of an oral suspension.

4. Clinical Particulars 4.1 Therapeutic Indications

Orelox is a bactericidal cephalosporin antibiotic active against a wide range of Gram-negative and Gram-positive organisms. It is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity.

Indications include:

Upper respiratory tract infections caused by organisms sensitive to cefpodoxime, including acute otitis media, sinusitis, tonsillitis and pharyngitis.

Orelox should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics.

Lower respiratory tract infections caused by organisms sensitive to cefpodoxime. Including pneumonia, acute bronchitis and when bacterial super-infection complicates bronchiolitis.

Upper and lower urinary tract infections caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis.

Skin and soft tissue infections caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers.

4.2 Posology And Method Of Administration

Route of administration: oral.

Adults and Elderly:

Not applicable for this product.

Children:

The recommended mean dosage for children is 8mg/kg/day administered in two divided doses at 12 hour intervals.

The following dosage regimen is proposed as a guide to prescribing:-

Below 6 months: 8mg/kg/day in 2 divided doses

6 months-2 years: 5.0 ml twice daily

3-8 years : 10.0 ml twice daily

Above 9 years : 12.5ml twice daily or 100mg tablet twice daily

Orelox should not be used in infants less than 15 days old, as no experience yet exists in this age group.

A measuring spoon (5ml) is provided with the bottle to aid correct dosing. One measuring spoon (5ml) contains the equivalent of 40 mg cefpodoxime.

The product should be taken during meals for optimal absorption.

Renal Impairment:

The dosage of Orelox does not require modification if creatinine clearance exceeds 40 ml.min-1/1.73m2.

Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately.

CREATININE CLEARANCE

(ML/MIN)

39 – 10

Unit dose1 administered as a single dose every 24 hours (i.e half of the usual adult dose).

< 10

Unit dose1 administered as a single dose every 48 hours (i.e quarter of the usual adult dose).

Haemodialysis Patients

Unit dose1 administered after each dialysis session.

NOTE:

1The unit dose is either 100mg or 200mg, depending on the type of infection.

Hepatic Impairment:

The dosage does not require modification in cases of hepatic impairment.

Instructions for Reconstitution:

Before preparing the suspension the silica gel desiccant contained in a capsule inside the cap must be removed and disposed of. The suspension is prepared by adding water to the bottle up to the calibrated mark and shaking thoroughly to obtain an evenly dispersed suspension

4.3 Contraindications

Patients with hypersensitivity to cephalosporin antibiotics.

Patients with phenylketonuria since the product contains aspartame.

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

4.4 Special Warnings And Precautions For Use

Preliminary enquiry about allergy to penicillin is necessary before prescribing cephalosporins since cross allergy to penicillins occurs in 5-10% of cases.

Particular care will be needed in patients sensitive to penicillin: strict medical surveillance is necessary from the very first administration. Where there is doubt, medical assistance should be available at the initial administration, in order to treat any anaphylactic episode.

In patients who are allergic to other cephalosporins, the possibility of cross allergy to Orelox should be borne in mind. Orelox should not be given to those patients with a previous history of immediate type hypersensitivity to cephalosporins.

Hypersensitivity reactions (anaphylaxis) observed with beta-lactam antibiotics can be serious and occasionally fatal.

The onset of any manifestation of hypersensitivity indicates that treatment should be stopped.

Orelox is not the preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia.

In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance.

Antibiotics should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. Orelox may induce diarrhoea, antibiotic associated colitis and pseudomembranous colitis. These side-effects, which may occur more frequently in patients receiving higher doses for prolonged periods, should be considered as potentially serious. The presence of C. difficile should be investigated. In all potential cases of colitis, the treatment should be stopped immediately. The diagnosis should be confirmed by sigmoidoscopy and specific antibiotic therapy (vancomycin) substituted if considered clinically necessary. The administration of products which cause faecal stasis must be avoided. Although any antibiotic may cause pseudomembranous colitis, the risk may be higher with broad-spectrum drugs, such as the cephalosporins.

As with all beta-lactam antibiotics, neutropenia, and more rarely agranulocytosis may develop, particularly during extended treatment. For cases of treatment lasting longer than 10 days, blood count should therefore be monitored, and treatment discontinued if neutropenia is found.

Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibiotics directed against the drug. This can produce a positive Coombs' test and very rarely, haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.

The product should not be used in infants less than 15 days old as no clinical trial data in this age group yet exists.

Changes in renal function have been observed with antibiotics of the same class, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potent diuretics. In such cases, renal function should be monitored.

As with other antibiotics, the prolonged use of cefpodoxime proxetil may result in the overgrowth of non-susceptible organisms. With oral antibiotics the normal colonic flora may be altered, allowing overgrowth by clostridia with consequent pseudomembranous colitis. Repeated evaluation of the patient is essential and if superinfection occurs during therapy, appropriate measures should be taken.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions have been reported during the course of clinical studies.

Histamine H2-antagonists and antacids reduce the bioavailibility of cefpodoxime. Probenecid reduces the excretion of cephalosporins. Cephlasporins potentially enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of oestrogens.

As with other cephalosporins, isolated cases showing development of a positive Coombs' test have been reported (see Precautions).

Studies have shown that bioavailability is decreased by approximately 30% when Orelox is administered with drugs which neutralise gastric pH or inhibit acid secretions. Therefore, such drugs as antacids of the mineral type and H2 blockers such as ranitidine, which cause an increase in gastric pH, should be taken 2 or 3 hours after Orelox administration.

In contrast, drugs which decrease gastric pH such as pentagastrine will increase bioavailability. The clinical consequences remain to be established.

The bioavailability increases if the product is administered during meals.

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Possible side effects include gastrointestinal disorders such as diarrhoea and rarely antibiotic-associated colitis, including pseudomembranous colitis (see Section 4.4: Special Warnings and Precautions for Use), nausea, vomiting and abdominal pain and rash, urticaria and itching. Changes in renal function have been observed with antibiotics from the same group as Cefpodoxime, particularly when co-prescribed with aminoglycosides and/or potent diuretics.

Occasional cases have been reported of headaches, dizziness, tinnitus, parethesia, asthenia and malaise. Rare cases of allergic reactions include hypersensitivity mucocutaneous reactions, skin rashes and pruritus. Occasional cases of bullous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have also been received. Transient moderate elevations of ASAT, ALAT and alkaline phosphatases and/or bilirubin have been reported. These laboratory abnormalities which may be explained by the infection, may rarely exceed twice the upper limit of the named range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic.Slight increases in blood urea and creatinine have also been reported. Exceptionally rare are the occurrence of liver damage and of haematological disorders such as reduction in haemoglobin, thrombocytosis, thrombocytopenia, leucopenia and eosinophilia. Haemolytic anaemia has extremely rarely been reported.

As with other ?-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may develop during treatment with Cefpodoxime, particularly if given over long periods.

As with other cephalosporins, there have been rare reports of anaphylactic reactions, bronchospasm, purpura and angiodema, serum-sickness-like reactions with rashes, fever and arthralgia.

4.9 Overdose

In the event of overdosage with Orelox, supportive and symptomatic therapy is indicated.

In cases of overdosage, particularly in patients with renal insufficiency, encephalopathy may occur. The encephalopathy is usually reversible once cefpodoxime plasma levels have fallen.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Orelox (Cefpodoxime proxetil) is a beta-lactam antibiotic, a 3rd generation oral cephalosporin. It is the prodrug of cefpodoxime.

Following oral administration, Orelox is taken up by the gastro-intestinal wall where it is rapidly hydrolysed to cefpodoxime, a bactericidal antibiotic, which is then absorbed systemically.

BACTERIOLOGY:

The mechanism of action of cefpodoxime is based on inhibition of bacterial cell wall synthesis. It is stable to numerous beta-lactamases.

Cefpodoxime has been shown to possess in vitro bactericidal activity against numerous Gram-positive and Gram-negative bacteria.

ANTIBACTERIAL ACTIVITY:

It is highly active against the Gram-positive organisms:

• Streptococcus pneumoniae

• Streptococci of Groups A (S. pyogenes), B (S. agalactiae), C, F and G

• Other streptococci (S. mitis, S. sanguis and S. salivarius)

• Propionibacterium acnes

• Corynebacterium diphtheriae

It is highly active against the Gram-negative organisms:

• Haemophilus influenzae (beta-lactamase and non beta-lactamase producing strains)

• Haemophilus para-influenzae (beta-lactamase and non beta-lactamase producing strains)

• Moraxella catarrhalis (beta-lactamase and non beta-lactamase producing strains)

• Escherichia coli

• Klebsiella Spp. (K. pneumoniae)

• Proteus mirabilis

It is moderately active against:

• Meticillin-sensitive staphylococci, penicillinase and non-penicillinase producing strains (S. aureus and S. epidermidis)

In addition, as with many cephalosporins, the following are resistant to cefpodoxime.

• Enterococci

• Meticillin-resistant staphylococci (S. aureus and S. coagulase (negative))

• Staphylococcus saprophyticus

• Pseudomonas aeruginosa and Pseudomonas Spp.

• Clostridium difficile

• Bacteroides fragilis and related species

As with all antibiotics, whenever possible, sensitivity should be confirmed by in vitro testing.

5.2 Pharmacokinetic Properties

Orelox is taken up in the intestine and is hydrolysed to the active metabolite cefpodoxime. When cefpodoxime proxetil is administered orally to fasting subjects as a tablet corresponding to 100mg of cefpodoxime, 51.5% is absorbed and absorption is increased by food intake. The volume of distribution is 32.3 l and peak levels of cefpodoxime occur 2 to 3 hrs after dosing. The maximum plasma concentration is 1.2mg/l and 2.5mg/l after doses of 100mg and 200mg respectively. Following administration of 100mg and 200mg twice daily over 14.5 days, the plasma pharmacokinetic parameters of cefpodoxime remain unchanged.

Serum protein binding of cefpodoxime, 40% principally to albumin. This binding is non saturable in type.

Concentrations of cefpodoxime in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.

As the majority of cefpodoxime is eliminated in the urine, the concentration is high. (Concentrations in 0-4, 4-8, 8-12 hr fractions after a single dose exceed MIC90 of common urinary pathogens). Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12hrs after an administration of a single 200mg dose (1.6-3.1µG/G). Concentrations of cefpodoxime in the medullary and cortical tissues is similar.

Studies in healthy volunteers show median concentrations of cefpodoxime in the total ejaculate 6-12hrs following administration of a single 200mg dose to be above the MIC90 of N. gonorrhoeae.

The main route of excretion is renal, 80% is excreted unchanged in the urine, with an elimination half life of approx 2.4 hours.

CHILDREN

In children, studies have shown the maximum plasma concentration occurs approximately 2-4 hours after dosing. A single 5mg/kg dose in 4-12 year olds produced a maximum concentration similar to that in adults given a 200mg dose.

In patients below 2 years receiving repeated doses of 5mg/kg 12 hourly, the average plasma concentrations, 2hrs post dose, are between 2.7mg/l (1-6 months) and 2.0mg/l (7 months-2 years).

In patients between 1 month and 12 years receiving repeated doses of 5mg/kg 12 hourly, the residual plasma concentrations at steady state are between 0.2-0.3mg/l (1 month-2 years) and 0.1mg/l (2-12 years).

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The product contains anhydrous colloidal silica, aspartame, banana flavour, carboxymethylcellulose calcium, carboxymethylcellulose sodium, citric acid monohydrate, hydroxypropylcellulose, yellow iron oxide, lactose monohydrate, monosodium glutamate, potassium sorbate, sodium chloride, sorbitan trioleate, sucrose and talc.

6.2 Incompatibilities

None reported during clinical studies.

6.3 Shelf Life

24 months.

Reconstituted suspension: can be stored for up to 10 days refrigerated (2-8°C).

6.4 Special Precautions For Storage

Bottles: unreconstituted product should be stored below 30°C.

6.5 Nature And Contents Of Container

Amber glass bottle with a calibration marking. This is fitted with a polyethylene dehydrating capsule containing silica gel, closed by a cardboard disc make up part of closure. There is a polyethylene pilfer and childproof screw cap fitted with tight triseal joint.

Pack sizes of 100ml of suspension.

A 5ml plastic spoon is supplied with the pack.

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 04425/0251

9. Date Of First Authorisation/Renewal Of The Authorisation

23rd July 2004

10. Date Of Revision Of The Text

8 October 2010

LEGAL CATEGORY

POM

Opioid Overdose Medications
Drugs associated with Opioid Overdose

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

Drug List:Revex

Opiate Dependence Medications
Drugs associated with Opiate Dependence

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

Topics under Opiate DependenceOpiate Withdrawal (8 drugs) Drug List:Suboxone Vivitrol

Omacor

OMACOR

1000 mg soft capsules

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may want 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 any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Omacor is and what it is used for 2. Before you take Omacor 3. How to take Omacor

Osteopenia Medications
Drugs associated with Osteopenia

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

Drug List: Cal-Gest Calcarb Calci-Mix Calci-Chew Calcium-Concentrate Calcium-Liquid-Softgel Calcium-Oyster-Shell Caltrate Nephro-Calci Os-Cal-500 Oysco-500 Oyst-Cal-500 Oyster-Cal Oyster-Calcium Oyster-Shell Tums-Kids-Chewable-Tablets

Oilatum Plus
1. Name Of The Medicinal Product

Oilatum Plus

Oilatum Junior Flare-Up

2. Qualitative And Quantitative Composition

Light liquid paraffin 52.5% w/w, benzalkonium chloride solution 12.0% w/w, triclosan 2% w/w

3. Pharmaceutical Form

Solution

4. Clinical Particulars 4.1 Therapeutic Indications

Topical as a bath additive.

For the prophylactic treatment of eczemas at risk from infection.

4.2 Posology And Method Of Administration

Oilatum Plus must always be used diluted in water. It is an effective cleanser and should not be used with soap.

Use once daily. Do not exceed the recommended dose:

Adults and children: In an eight inch bath add 2 capfuls, in a four inch bath add 1 capful

Infants: Add 1 ml (just sufficient to cover the bottom of the cap) and mix well with water.

Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

Do not use for babies younger than 6 months

4.3 Contraindications

Patients with a known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

Oilatum Plus contains benzalkonium chloride which is irritant and may cause skin reactions.

Avoid contact of the undiluted product with the eyes and skin.

If the undiluted product comes into contact with the eye, reddening may occur. Eye irrigation should be performed for 15 minutes and then the eye examined under fluorescein stain. If there is persistent irritation or any uptake of fluorescein, the patient should be referred for ophthalmological opinion.

If undiluted product is applied directly to the skin, it may cause application site skin irritation and hypersensitivity reactions including skin exfoliation, pain, blister, caustic injury and necrosis.

The patient should be advised to use care to avoid slipping in the bath.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No restrictions on the use of the product in pregnancy and lactation are proposed.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Post-marketing data

Skin and subcutaneous tissues disorders

• Erythema, pruritus, skin reactions, contact dermatitis, atopic dermatitis , skin burning sensation

Immune System disorders

• Application site hypersensitivity

4.9 Overdose

The product is intended for topical use only. Accidental ingestion may cause gastro intestinal irritation with vomiting and diarrhoea. Vomiting may result in foam aspiration. In the case of accidental ingestion, give 1 to 2 glasses of milk or water to drink. If a large quantity of the product is ingested, the patient should be observed in hospital and the use of activated charcoal may be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benzalkonium chloride and triclosan are anti-bacterial agents with proven efficacy against Staphylococcus aureus, the principal causative organism in infected eczemas.

Light liquid paraffin is an emollient widely used in the treatment of eczema.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acetylated lanolin alcohols

Isopropyl palmitate

Oleyl alcohol

Polyoxyethylene lauryl ether

6.2 Incompatibilities

None known.

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

White polyvinyl chloride or high density polyethylene bottles containing 20ml, 25ml, 150ml, 250ml, 350ml, 500ml, 600ml, 1000ml with white urea cap.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Oilatum Plus/Oilatum Junior Flare-Up.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0060

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 16th February 1990

Date of latest renewal: 25th February 2009

10. Date Of Revision Of The Text

14 December 2010

Ophthalmic diagnostic agents

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

Ophthalmic diagnostic agents are given intravenously to perform diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. A few preparations also contain a local anesthetic to reduce pain in the nerves of the eyes.