Lipantil Micro 200

1. Name Of The Medicinal Product

Lipantil^® Micro 200 mg, capsules.

2. Qualitative And Quantitative Composition

Each capsule contains 200 mg fenofibrate.

For excipients, see 6.1

3. Pharmaceutical Form

Orange, hard gelatin capsule.

4. Clinical Particulars

4.1 Therapeutic Indications

Lipantil^® Micro 200mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

4.2 Posology And Method Of Administration

Adults

The recommended initial dose is one capsule taken daily during a main meal. In elderly patients without renal impairment, the normal adult dose is recommended. Since it is less well absorbed from an empty stomach, Lipantil Micro 200 should always be taken with food. Dietary restrictions instituted before therapy should be continued.

4.3 Contraindications

Lipantil Micro 200 is contra-indicated in children, in patients with severe liver dysfunction, gallbladder disease, biliary cirrhosis, severe renal disorders and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.

Use during pregnancy and lactation (see section 4.6).

4.4 Special Warnings And Precautions For Use

Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated.

Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-C, triglycerides). If an adequate response has not been achieved after several months (e.g. 3 months) complementary or different therapeutic measures should be considered.

Renal function

In renal dysfunction the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance. In this case, Lipantil Micro 67 (micronised fenofibrate) should be used, e.g. 2 capsules of Lipantil Micro 67 daily for creatinine clearance levels of <60 ml/min and 1 capsule of Lipantil Micro 67 daily for creatinine clearance levels of <20 ml/min.

It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically. Treatment should be interrupted in case of an increase in creatinine levels > 50% of (upper limit of normal)

Use of Lipantil Micro 67 is also to be preferred in elderly patients with renal impairment where dosage reduction may be required.

Liver function abnormalities

Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment. However, it is recommended that serum transaminases should be monitored every three months during the first twelve months of treatment. Treatment should be interrupted in the event of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range or more than one hundred international units.

Pancreatitis

Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.

Myopathy

Muscle toxicity, including rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency. Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up.

Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped.

The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.

For hyperlipidaemic patients taking oestrogens or contraceptives containing oestrogen it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen).

For patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption: although the amount of lactose contained in Lipantil Micro 200 mg is low, caution should be exercised in these patients (as no study has been formally conducted in this special population).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Oral Anti-coagulants

Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by about one-third at the commencement of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.

HMG-CoA reductase inhibitors or Other Fibrates

The risk of serious muscle toxicity is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity ( see section 4.4.).

There is currently no evidence to suggest that fenofibrate affects the pharmacokinetics of simvastatin.

Cyclosporin

Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and cyclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

Other

No proven clinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed-function oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes.

4.6 Pregnancy And Lactation

There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3). The potential risk for humans is unknown.

There are no data on the excretion of fenofibrate and/or its metabolites into breast milk. It is therefore recommended that Lipantil Micro 200 should not be administered to women who are pregnant or are breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No effect noted to date.

4.8 Undesirable Effects

Adverse reactions observed during Lipantil Micro 200 treatment are not very frequent (2 - 4 % of cases): they are generally minor, transient and do not interfere with treatment.

The most commonly reported adverse reactions include:

Gastrointestinal: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence) moderate in severity.

Uncommon: Pancreatitis*

Cardiovascular system

Uncommon: Thromboembolism (pulmonary embolism, deep vein thrombosis)*

Skin: Reactions such as rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after many months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (e.g. sun lamp).

Neurological disorders: Headache.

General disorders: Fatigue.

Disorders of the ear: Vertigo.

Less frequently reported adverse reactions:

Liver: Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment (see also section 4.4). Episodes of hepatitis have been reported very rarely. When symptoms (e.g. jaundice, pruritus) indicative of hepatitis occur, laboratory tests are to be conducted for verification and fenofibrate discontinued, if applicable (see Special Warnings). Development of gallstones has been reported.

Muscle: As with other lipid lowering agents, cases of muscle toxicity (diffuse myalgia, myositis, muscular cramps and weakness) and very rare cases of rhabdomyolysis have been reported. These effects are usually reversible when the drug is withdrawn (see Special Warnings).

In rare cases, the following effects are reported: Sexual asthenia and alopecia. Increases in serum creatinine and urea, which are generally slight, and also a slight decrease in haemoglobin and leukocytes may be observed.

Very rare cases of interstitial pneumopathies have been reported.

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

4.9 Overdose

No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates. ATC code:C10 AB 05.

Lipantil Micro 200 is a formulation containing 200mg of micronised fenofibrate; the administration of this product results in effective plasma concentrations identical to those obtained with 3 capsules of Lipantil Micro 67 containing 67mg of micronised fenofibrate.

The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I, A-II and of HDL cholesterol.

Epidemiological studies have demonstrated a positive correlation between abnormally increased serum lipid levels and an increased risk of coronary heart disease. The control of such dyslipidaemia forms the rationale for treatment with Lipantil Micro 200. However the possible beneficial and adverse long term consequences of drugs used in the management of dyslipidaemia are still the subject of scientific discussion. Therefore the presumptive beneficial effect of Lipantil Micro 200 on cardiovascular morbidity and mortality is as yet unproven.

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%). In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (

Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol. HDL cholesterol levels are frequently increased. LDL and VLDL triglycerides are reduced. The overall effect is a decrease in the ratio of low and very low density lipoproteins to high density lipoproteins, which epidemiological studies have correlated with a decrease in atherogenic risk. Apolipoprotein-A and apolipoprotein-B levels are altered in parallel with HDL and LDL and VLDL levels respectively.

Regression of xanthomata has been observed during fenofibrate therapy.

Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease. Lipantil Micro 200 has a uricosuric effect and is therefore of additional benefit in such patients.

Patients with raised levels of fibrinogen and Lp(a) have shown significant reductions in these measurements during clinical trials with fenofibrate.

5.2 Pharmacokinetic Properties

Absorption

The unchanged compound is not recovered in the plasma. Fenofibric acid is the major plasma metabolite. Peak plasma concentration occurs after a mean period of 5 hours following dosing.

Mean plasma concentration is 15μg/ml for a daily dose of 200mg of micronised fenofibrate, equivalent to 3 capsules of Lipantil Micro 67.

Steady state levels are observed throughout continuous treatments.

Fenofibric acid is highly bound to plasma albumin; it can displace antivitamin K compounds from protein binding sites and may potentiate their anti-coagulant effect.

The plasma half-life of elimination of fenofibric acid is approximately 20 hours.

Metabolism and excretion

The product is mainly excreted in the urine; 70% in 24 hours and 88% in 6 days, at which time the total excretion in urine and faeces reaches 93%. Fenofibrate is mainly excreted as fenofibric acid and its derived glucuroconjugate.

Kinetic studies after administration of repeated doses show the absence of accumulation of the product.

Fenofibric acid is not eliminated during haemodialysis.

5.3 Preclinical Safety Data

Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.

Studies on mutagenicity of fenofibrate have been negative.

In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation. These changes are specific to small rodents and have not been observed in other animal species. This is of no relevance to therapeutic use in man.

Studies in mice, rats and rabbits did not reveal any teratogenic effect. Embryotoxic effects were observed at doses in the range of maternal toxicity. Prolongation of the gestation period and difficulties during delivery were observed at high doses. No sign of any effect on fertility has been detected.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Excipients: lactose monohydrate, pregelatinised starch, sodium laurilsulfate, crospovidone and magnesium stearate.

Composition of the capsule shell: gelatin, titanium dioxide (E171), ferrous oxide (E172) and erythrosine (E127).

6.2 Incompatibilities

No effect noted to date.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

Pack of 10, 28, 30 capsules in blisters (PVC/Aluminium).

*Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

-

7. Marketing Authorisation Holder

Abbott Healthcare Products Ltd

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00512/0390

9. Date Of First Authorisation/Renewal Of The Authorisation

November 1993/December 2003

10. Date Of Revision Of The Text

June 2011

11. LEGAL CATEGORY

POM

Clobetasol

Dosage Form: ointment
Clobetasol Propionate

Ointment USP, 0.05%

Rx Only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE

Clobetasol Description

Clobetasol propionate ointment contains the active compound Clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:

C25H32ClFO5                                               Molecular Weight: 467

Each gram of the 0.05% ointment contains Clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

Clobetasol - Clinical Pharmacology

Like other topical corticosteroids, Clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the Clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with Clobetasol propionate gel, cream and ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Clobetasol

Clobetasol propionate ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contraindications

Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, Clobetasol propionate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Clobetasol propionate should be discontinued until the infection has been adequately controlled.

Clobetasol propionate ointment should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or axillae.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1.

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2.

This medication should not be used for any disorder other than that for which it was prescribed.

3.

The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.

4.

Patients should report any signs of local adverse reactions to the physician.

5.

Patients should inform their physicians that they are using Clobetasol propionate if surgery is contemplated.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Clobetasol propionate. Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 0.33 and 0.01 times, respectively, the human topical dose of Clobetasol propionate ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, Clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of Clobetasol propionate ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of Clobetasol propionate in pregnant women. Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol propionate ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Clobetasol propionate ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In controlled clinical trials, the most frequent adverse events reported for Clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Overdosage

Topically applied Clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Clobetasol Dosage and Administration

Apply a thin layer of Clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)

Clobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate ointment should not be used with occlusive dressings.

How is Clobetasol Supplied

Clobetasol Propionate Ointment USP, 0.05% is supplied in 15 g (NDC 60429-901-15), 30 g (NDC 60429-901-30), 45 g (NDC 60429-901-45), and 60 g (NDC 60429-901-60) tubes.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Marketed by: Golden State Medical Supply, Inc., Camarillo, CA 93012

Issued: April, 2010

PRINCIPAL DISPLAY PANEL - 15 g Tube Label

NDC 60429-901-15

GSMS™

incorporated

Clobetasol Propionate

Ointment USP, 0.05%

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

15 g

Rx only

Each gram contains: 0.5 mg Clobetasol propionate in an ointment base of propylene glycol,

sorbitan sesquioleate, and white petrolatum.

Usual dosage: A thin layer of Clobetasol propionate ointment should be applied with gentle

rubbing to the affected skin areas twice daily, once in the morning and once at night.

See package insert for full prescribing information.

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. Do not refrigerate.

To Open: Use pointed end on cap to puncture seal.

For lot number and expiry date see crimp of tube.

Mfd. by:

Taro Pharmaceuticals Inc.

Brampton, Ontario, Canada L6T 1C1

Marketed by:

Golden State Medical Supply, Inc.

Camarillo, CA 93012

PK-6480-0 0410-0

Clobetasol PROPIONATE  Clobetasol propionate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 60429-901 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clobetasol Propionate (Clobetasol) Clobetasol Propionate 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   sorbitan sesquioleate   petrolatum

Product Characteristics Color WHITE (White to cream-colored) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 60429-901-15 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (60429-901-15) 2 60429-901-30 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (60429-901-30) 3 60429-901-45 1 TUBE In 1 CARTON contains a TUBE 3 45 g In 1 TUBE This package is contained within the CARTON (60429-901-45) 4 60429-901-60 1 TUBE In 1 CARTON contains a TUBE 4 60 g In 1 TUBE This package is contained within the CARTON (60429-901-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074248	07/12/1996

Labeler - Golden State Medical Supply, Inc. (603184490)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (173762329)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Revised: 11/2010Golden State Medical Supply, Inc.

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• Clobetasol Side Effects (in more detail)
• Clobetasol Use in Pregnancy & Breastfeeding
• Clobetasol Drug Interactions
• Clobetasol Support Group
• 48 Reviews for Clobetasol - Add your own review/rating

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Fluvoxamine

Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Depromel in the following countries:

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International Drug Name Search

Chloroquine Tablets

Pronunciation: KLOR-oh-kwin
Generic Name: Chloroquine
Brand Name: Aralen

Chloroquine is used for:

Treating and suppressing acute attacks of certain strains of malaria and a certain type of parasitic infection (extraintestinal amebiasis). It may also be used for other conditions as determined by your doctor.

Chloroquine is an aminoquinoline. It is thought to kill sensitive malaria parasites by stopping normal metabolism inside the parasite.

Do NOT use Chloroquine if:

• you are allergic to any ingredient in Chloroquine


• you have vision problems or retinal changes


• you are taking astemizole, terfenadine, cisapride, nilotinib, quinacrine, tetrabenazine, or dofetilide

Contact your doctor or health care provider right away if any of these apply to you.

Before using Chloroquine:

Some medical conditions may interact with Chloroquine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines or other substances


• if you have porphyria or any other blood disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or a history of seizures


• if you have psoriasis, stomach or intestinal problems, liver disease, hearing problems, or central nervous system problems


• if you have a history of alcohol addiction or abuse


• if you will be having a rabies vaccine

Some MEDICINES MAY INTERACT with Chloroquine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Mefloquine because the risk of seizures may be increased


• Antiarrhythmics (eg, amiodarone, disopyramide), arsenic, astemizole, bepridil, cisapride, dofetilide, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, lithium, macrolide antibiotics (eg, erythromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), telithromycin, tetrabenazine, tyrosine kinase receptor inhibitors (eg, lapatinib), terfenadine, or ziprasidone because the risk of severe side effects, including irregular heartbeat, may be increased


• Quinacrine or medicines that may harm the liver (eg, acetaminophen, methotrexate) because they may increase the risk of Chloroquine's side effects. Ask your doctor if you are unsure if any of your medicines may harm the liver.


• Cyclosporine because the risk of its side effects may be increased by Chloroquine


• Rabies vaccine because its effectiveness may be decreased by Chloroquine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chloroquine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Chloroquine:

Use Chloroquine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chloroquine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take antacids or products containing kaolin within 4 hours before or after taking Chloroquine.


• If you also take ampicillin, do not take it within 2 hours before or after you take Chloroquine.


• If you miss a dose of Chloroquine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chloroquine.

Important safety information:

• Chloroquine may cause blurred vision. Do not drive, operate machinery, or perform other possibly unsafe tasks until you know how you react to it. Using Chloroquine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


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


• Chloroquine may cause you to become sunburned more easily. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Chloroquine. Use a sunscreen or protective clothing if you must be outside for more than a short time.


• Contact your health care provider if you notice any muscle weakness or problems with vision or hearing. Your knee and ankle reflexes will be tested periodically.


• Tell your doctor or dentist that you take Chloroquine before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, such as complete blood cell counts and eye tests, may be needed to monitor your progress. Be sure to keep appointments.


• Use Chloroquine with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Chloroquine in CHILDREN because they may be more sensitive to its effects.


• Accidental ingestion of Chloroquine in children has been fatal. Keep Chloroquine out of the reach of children. In case of overdose, call a doctor or poison control center right away.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Chloroquine, discuss with your doctor the benefits and risks of using Chloroquine during pregnancy. Chloroquine is excreted in breast milk. Do not breast-feed while taking Chloroquine.

Possible side effects of Chloroquine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; diarrhea; mild headache; nausea; stomach cramps; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; change in the color of the skin or the inside of mouth; difficulty seeing or reading (words, letters, or parts of objects missing when reading); dizziness; fever or sore throat; hair loss; hearing loss; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; sensitivity to sunlight; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent nausea or stomach pain); unusual bleeding or bruising; unusual weakness; vision problems (eg, blurred vision, trouble focusing); weight loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Chloroquine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; drowsiness; excessive excitability; fainting; headache; irregular heartbeat; loss of consciousness; mood changes; seizures; severe drowsiness or dizziness; slow, shallow breathing.

Proper storage of Chloroquine:

Store Chloroquine in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chloroquine out of the reach of children and away from pets.

General information:

• If you have any questions about Chloroquine, please talk with your doctor, pharmacist, or other health care provider.


• Chloroquine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Chloroquine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chloroquine resources

• Chloroquine Side Effects (in more detail)
• Chloroquine Dosage
• Chloroquine Use in Pregnancy & Breastfeeding
• Drug Images
• Chloroquine Drug Interactions
• Chloroquine Support Group
• 0 Reviews for Chloroquine - Add your own review/rating

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Alendronato

Alendronato may be available in the countries listed below.

Ingredient matches for Alendronato

Alendronic Acid

Alendronic Acid is reported as an ingredient of Alendronato in the following countries:

• Peru

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronato in the following countries:

• Colombia


• Venezuela

International Drug Name Search

Bieskadog

Bieskadog may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Bieskadog

Framycetin

Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Bieskadog in the following countries:

• France

Sulfaguanidine

Sulfaguanidine is reported as an ingredient of Bieskadog in the following countries:

• France

International Drug Name Search

Carbatrol

Generic Name: carbamazepine (Oral route)

kar-ba-MAZ-e-peen

Oral route(Tablet;Tablet, Chewable;Suspension;Tablet, Extended Release;Capsule, Extended Release)

Serious and sometimes fatal dermatologic reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported, especially in patients with the inherited allelic variant HLA-B*1502. Genetically at-risk patients should be screened prior to receiving carbamazepine. Carbamazepine should not be started in patients who test positive for the allele. Aplastic anemia and agranulocytosis have also been reported. Complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops .

Commonly used brand name(s)

In the U.S.

• Carbatrol


• Epitol


• Equetro


• Tegretol


• Tegretol-XR

Available Dosage Forms:

• Tablet, Chewable


• Tablet, Extended Release


• Suspension


• Capsule, Extended Release


• Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Dibenzazepine Carboxamide

Uses For Carbatrol

Carbamazepine is used to control certain types of seizures in the treatment of epilepsy. It is also used to relieve pain due to trigeminal neuralgia (tic douloureux). It should not be used for other more common aches or pains. This medicine can also be used in the treatment of bipolar disorder (manic-depressive illness).

Carbamazepine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, carbamazepine is used in certain patients with the following medical conditions:

• Alcohol withdrawal.


• Bipolar disorder (manic-depressive illness), prevention.


• Central partial diabetes insipidus (water diabetes).


• Neurogenic pain (a type of continuing pain).


• Psychotic disorders (severe mental illness).

Before Using Carbatrol

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of carbamazepine extended-release capsules to treat bipolar disease in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of carbamazepine to treat epilepsy in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of carbamazepine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of carbamazepine in the elderly. However, elderly patients are more likely to have confusion or agitation, which may require caution in patients receiving carbamazepine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine 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.

• Boceprevir


• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nefazodone


• Nialamide


• Nifedipine


• Pargyline


• Phenelzine


• Praziquantel


• Procarbazine


• Ranolazine


• Rilpivirine


• Selegiline


• Toloxatone


• Tranylcypromine


• Voriconazole

Using this medicine 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.

• Abiraterone


• Adenosine


• Cabazitaxel


• Clozapine


• Crizotinib


• Darunavir


• Dasatinib


• Delavirdine


• Dronedarone


• Erlotinib


• Etravirine


• Everolimus


• Ezogabine


• Imatinib


• Irinotecan


• Ixabepilone


• Ketorolac


• Lapatinib


• Linagliptin


• Lopinavir


• Maraviroc


• Naproxen


• Nelfinavir


• Nilotinib


• Pazopanib


• Propoxyphene


• Rivaroxaban


• Roflumilast


• Romidepsin


• Sirolimus


• Sunitinib


• Tacrolimus


• Temsirolimus


• Ticagrelor


• Tolvaptan


• Tramadol


• Vandetanib


• Vemurafenib


• Vigabatrin

Using this medicine 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.

• Acetaminophen


• Acetylcysteine


• Alprazolam


• Amitriptyline


• Amoxapine


• Anisindione


• Aprepitant


• Aripiprazole


• Caspofungin


• Clarithromycin


• Clonazepam


• Dalfopristin


• Danazol


• Desipramine


• Desogestrel


• Dicumarol


• Dienogest


• Diltiazem


• Doxepin


• Drospirenone


• Efavirenz


• Erythromycin


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethosuximide


• Ethynodiol Diacetate


• Etonogestrel


• Etretinate


• Felbamate


• Fentanyl


• Fluconazole


• Flunarizine


• Fluoxetine


• Fosphenytoin


• Ginkgo


• Haloperidol


• Hydrochlorothiazide


• Imipramine


• Indinavir


• Influenza Virus Vaccine


• Isoniazid


• Lamotrigine


• Levetiracetam


• Levonorgestrel


• Lithium


• Loxapine


• Medroxyprogesterone Acetate


• Mestranol


• Methylphenidate


• Methylprednisolone


• Metronidazole


• Mianserin


• Midazolam


• Miokamycin


• Nafimidone


• Nevirapine


• Niacinamide


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Nortriptyline


• Olanzapine


• Omeprazole


• Oxcarbazepine


• Phenprocoumon


• Phenytoin


• Pipecuronium


• Primidone


• Protriptyline


• Psyllium


• Quinine


• Quinupristin


• Remacemide


• Rifampin


• Rifapentine


• Risperidone


• Ritonavir


• Rocuronium


• Rufinamide


• Sabeluzole


• Sertraline


• Simvastatin


• St John's Wort


• Telithromycin


• Terfenadine


• Theophylline


• Tiagabine


• Ticlopidine


• Topiramate


• Trazodone


• Troleandomycin


• Valnoctamide


• Valproic Acid


• Vecuronium


• Verapamil


• Viloxazine


• Warfarin


• Ziprasidone


• Zolpidem

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 this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Allergy to certain medicines for depression (e.g., such as amitriptyline, desipramine, imipramine, nortriptyline, or protriptyline) or


• Bone marrow depression, history of—Should not be used in patients with these conditions.

• Anemia or other blood problems or


• Behavioral or mental problems or


• Blood vessel disease or


• Depression, history of or


• Diabetes or


• Glaucoma or


• Heart block or


• Heart disease or


• Heart rhythm problems, history of or


• Liver disease, history of or


• Porphyria (an inherited disease) or


• Problems with urination or


• Seizures, history of or


• Skin diseases (e.g., Lyell's syndrome or Stevens-Johnson syndrome)—Use with caution. May make these conditions worse.

• Asian ancestry (e.g., Filipino, Chinese, Japanese, Korean, or Taiwanese)—Carbamazepine may increase the risk for dangerous skin reactions. Before prescribing carbamazepine for you, your doctor may test for a risk factor (called HLA-B*1502) for these skin reactions.

• Fructose intolerance (rare inherited problem)—Tegretol® suspension contains sorbitol and should not be given in patients with this condition.

Proper Use of carbamazepine

This section provides information on the proper use of a number of products that contain carbamazepine. It may not be specific to Carbatrol. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand before taking this medicine.

Carbamazepine suspension and tablets should be taken with meals to lessen the chance of stomach upset (nausea and vomiting).

Carbamazepine extended-release capsules do not need to be taken with meals unless they upset your stomach. The contents of the extended-release capsules may be sprinkled over a teaspoonful of applesauce or other similar food. The capsule or its contents should not be crushed or chewed.

The extended-release tablets must be swallowed whole and should not be crushed or chewed. Do not take extended-release tablets that are damaged or have chips or cracks.

Grapefruit and grapefruit juice may increase the effects of carbamazepine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

If you are taking this medicine for pain relief:

• Carbamazepine is not an ordinary pain reliever. It should be used only when a doctor prescribes it for certain kinds of pain. Do not take carbamazepine for any other aches or pains.

If you are taking Tegretol® oral suspension:

• Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


• Do not take any other liquid medicines at the same time that you take your dose of Tegretol® without first checking with your doctor.

Tegretol® tablets works differently than Tegretol® oral suspension, even at the same dose (number of milligrams). Do not switch from the tablets to the oral suspension unless your doctor tells you to.

Tegretol® may be used alone or together with other seizure medicines. Ask your doctor first before taking any other seizure medicine together with Tegretol®.

Dosing

The dose of this medicine 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 this medicine. 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 form (extended-release capsules):
  
  • For bipolar disorder:
    
    • Adults—At first, 400 milligrams (mg) per day, given in divided doses, two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1600 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For epilepsy:
    
    • Adults and teenagers—At first, 200 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
    
    
    • Children younger than 12 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually not more than 1000 mg per day.
    
    
  
  
  • For trigeminal neuralgia:
    
    • Adults and teenagers—At first, 200 milligrams (mg) a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For epilepsy:
    
    • Adults and teenagers—At first, 200 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
    
    
    • Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For trigeminal neuralgia:
    
    • Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (suspension):
  
  • For epilepsy:
    
    • Adults and teenagers—100 milligrams (mg) or 1 teaspoon four times a day (400 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
    
    
    • Children 6 to 12 years of age—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
    
    
    • Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 35 mg/kg of body weight per day.
    
    
  
  
  • For trigeminal neuralgia:
    
    • Adults and teenagers—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets and chewable tablets):
  
  • For epilepsy:
    
    • Adults and teenagers—At first, 200 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
    
    
    • Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
    
    
    • Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 35 mg/kg of body weight per day.
    
    
  
  
  • For trigeminal neuralgia:
    
    • Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Carbatrol

It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to have certain tests done to see if you are receiving the right amount of medicine or if certain side effects may be occurring without your knowing it. Also, the amount of medicine you or your child are taking may have to be changed often.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

Birth control pills containing estrogen may not work properly if you take them while you are taking carbamazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking carbamazepine. If you have any questions about this, check with your doctor. .

Do not take carbamazepine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitors (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Also, do not take nefazodone (Serzone®) and other medicines (prescription, over-the-counter [OTC] or herbal products) unless they have been discussed with your doctor.

Carbamazepine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Carbamazepine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally, especially when they are starting treatment or increasing the dose. It may also cause blurred or double vision, weakness, or loss of muscle control in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well-coordinated or able to see well.

Some people who take carbamazepine may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For diabetic patients:

• Carbamazepine may affect urine sugar levels. While you are using this medicine, be especially careful when testing for sugar in your urine. If you notice a change in the results of your urine sugar tests or have any questions about this, check with your doctor.

Before having any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some pregnancy tests and the metyrapone test may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking carbamazepine together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects and cause other unwanted effects.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent worsening of seizures.

Carbatrol 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:

More common

• Blurred vision or double vision


• continuous back-and-forth eye movements

Less common

• Actions that are out of control


• behavioral changes (especially in children)


• confusion, agitation, or hostility (especially in the elderly)


• diarrhea (severe)


• discouragement


• drooling


• fear


• feeling of unreality


• feeling sad or empty


• headache (continuing)


• increase in seizures


• irritability


• lack of appetite


• loss of balance control


• loss of interest or pleasure


• muscle trembling, jerking, or stiffness


• nausea and vomiting (severe)


• other problems with muscle control or coordination


• sense of detachment from self or body


• shakiness and unsteady walk


• shuffling walk


• stiffness of the limb


• sudden, wide mood swings


• talking, feeling, and acting with excitement


• thoughts or attempts of killing oneself


• tiredness


• trouble concentrating


• trouble sleeping


• twisting movements of the body


• uncontrolled movements, especially of face, neck, and back


• unusual drowsiness

Rare

• Black, tarry stools


• blood in the urine or stools


• bone or joint pain


• chest pain


• cough or hoarseness


• darkening of the urine


• difficulty with speaking or slurred speech


• fainting


• frequent urination


• irregular, pounding, or unusually slow heartbeat


• lower back or side pain


• mental depression with restlessness and nervousness or other mood or mental changes


• muscle or stomach cramps


• nosebleeds or other unusual bleeding or bruising


• numbness, tingling, pain, or weakness in the hands and feet


• pain, tenderness, swelling, or bluish color in the leg or foot


• painful or difficult urination


• pale stools


• pinpoint red spots on the skin


• rapid weight gain


• rigidity


• ringing, buzzing, or other unexplained sounds in the ears


• shortness of breath


• skin rash, hives, or itching


• sore throat, chills, and fever


• sores, ulcers, or white spots on the lips or in the mouth


• swelling of the face, hands, feet, or lower legs


• swollen or painful glands


• sudden decrease in the amount of urine


• trembling


• uncontrolled body movements


• unusual tiredness or weakness


• visual hallucinations (seeing things that are not there)


• wheezing, tightness in the chest, or troubled breathing


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Body spasm in which head and heels are bent backward and body is bowed forward


• clumsiness or unsteadiness


• convulsions (seizures)—especially in small children


• dizziness (severe) or fainting


• drowsiness (severe)


• fast or irregular heartbeat


• irregular, slow, or shallow breathing


• large pupils


• nausea or vomiting (severe)


• overactive reflexes followed by underactive reflexes


• poor control in body movements (for example, when reaching or stepping)


• trembling, twitching, or abnormal body movements

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:

More common

• Dizziness (mild)


• drowsiness (mild)


• lightheadedness


• nausea or vomiting (mild)

Less common or rare

• Accidental injury


• aching joints or muscles


• acid or sour stomach


• back pain


• belching


• constipation


• diarrhea


• dryness of mouth


• headache


• heartburn


• increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)


• increased sweating


• indigestion


• irritation or soreness of the tongue or mouth


• itching skin


• lack or loss of strength


• loss of hair


• loss of memory


• problems with memory


• sexual problems in males


• sleepiness


• stomach pain, upset, or discomfort

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.

See also: Carbatrol side effects (in more detail)

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 Carbatrol resources

• Carbatrol Side Effects (in more detail)
• Carbatrol Use in Pregnancy & Breastfeeding
• Drug Images
• Carbatrol Drug Interactions
• Carbatrol Support Group
• 5 Reviews for Carbatrol - Add your own review/rating

• Carbatrol Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Carbatrol Prescribing Information (FDA)


• Carbamazepine Professional Patient Advice (Wolters Kluwer)


• Carbamazepine Prescribing Information (FDA)


• Carbamazepine Monograph (AHFS DI)


• Carbamazepine MedFacts Consumer Leaflet (Wolters Kluwer)


• Epitol Prescribing Information (FDA)


• Equetro Consumer Overview


• Equetro Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Equetro Prescribing Information (FDA)


• Tegretol Prescribing Information (FDA)


• Tegretol Consumer Overview


• Tegretol XR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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