Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)
Contract Pharmacy Services-PA
CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUM 7.5 mg
ORAL
PRESCRIPTION DRUG
Clorazepate dipotassium tablets, USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets, USP are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets, USP in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets, USP are indicated for the symptomatic relief of acute alcohol withdrawal. Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
Clorazepate dipotassium tablets, USP 7.5 mg are peach colored, round tablets, debossed with “ RX ” above the break-line and “ 553 ” below the break-line on one side and plain on the other side. They are supplied as follows: NDC 67046-904-07 blisterpacks of 7 NDC 67046-904-14 blisterpacks of 14 NDC 67046-904-15 blisterpacks of 15 NDC 67046-904-20 blisterpacks of 20 NDC 67046-904-21 blisterpacks of 21 NDC 67046-904-28 blisterpacks of 28 NDC 67046-904-30 blisterpacks of 30 NDC 67046-904-60 blisterpacks of 60 Clorazepate dipotassium tablets, USP 15 mg are red colored, round tablets debossed with “ RX ” above the break-line and “ 554 ” below the break-line on one side and plain on the other side. They are supplied as follows: NDC 67046-907-07 blisterpacks of 7 NDC 67046-907-14 blisterpacks of 14 NDC 67046-907-15 blisterpacks of 15 NDC 67046-907-20 blisterpacks of 20 NDC 67046-907-21 blisterpacks of 21 NDC 67046-907-28 blisterpacks of 28 NDC 67046-907-30 blisterpacks of 30 NDC 67046-907-60 blisterpacks of 60 Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20 - 25° C (68 - 77 ° F) [See USP Controlled Room Temperature]. Dispense in a USP tight, light–resistant container. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA September 2010
Abbreviated New Drug Application
Contract Pharmacy Services-PA ---------- MEDICATION GUIDE CLORAZEPATE DIPOTASSIUM TABLETS, USP Rx only Read this Medication Guide before you start taking clorazepate dipotassium tablets, USP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about clorazepate dipotassium tablets, USP? Do not stop taking clorazepate dipotassium tablets, USP without first talking to your healthcare provider. Stopping clorazepate dipotassium tablets, USP suddenly can cause serious problems. Clorazepate dipotassium tablets, USP can cause serious side effects, including: 1. Clorazepate dipotassium tablets, USP can make you sleepy or dizzy and can slow your thinking and motor skills • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clorazepate dipotassium tablets, USP affects you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clorazepate dipotassium tablets, USP without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clorazepate dipotassium tablets, USP may make your sleepiness or dizziness much worse. 2. Clorazepate dipotassium tablets, USP can cause abuse and dependence. • Do not stop taking clorazepate dipotassium tablets, USP all of a sudden. Stopping clorazepate dipotassium tablets, USP suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps. • Talk to your doctor about slowly stopping clorazepate dipotassium tablets, USP to avoid getting sick with withdrawal symptoms. • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. Clorazepate dipotassium tablets, USP is a federally controlled su Прочитайте повний документ
CLORAZEPATE DIPOTASSIUM- CLORAZEPATE DIPOTASSIUM TABLET CONTRACT PHARMACY SERVICES-PA ---------- 904 CLORAZEPATE 7.5 MG 907 CLORAZEPATE 15 MG RX ONLY DESCRIPTION Chemically, clorazepate dipotassium is a benzodiazepine. The molecular formula is C H ClK N O ; the molecular weight is 408.92; 1 _H_-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro- 2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows: The compound occurs as a light yellow, crystalline powder. It darkens on exposure to light. It is soluble in water but upon standing may precipitate from the solution, slightly soluble in alcohol and in isopropyl alcohol, practically insoluble in acetone, in benzene, in chloroform, in ether and in methylene chloride. Clorazepate dipotassium tablets, USP contain either 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration. Inactive ingredients for clorazepate dipotassium tablets, USP: colloidal silicon dioxide, FD&C Blue No. 2 aluminum lake (3.75 mg only), FD&C Yellow No. 6 aluminum lake (7.5 mg only), FD&C Red No. 40 aluminum lake (15 mg only), magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, and potassium chloride. CLINICAL PHARMACOLOGY Pharmacologically, clorazepate dipotassium has the characteristics of the benzodiazepines. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly appears in the blood stream. The serum half-life is about 2 days. The drug is metabolized in the liver and excreted primarily in the urine. Studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system. Prolonged administration of single daily doses as high as 120 mg was without toxic effects. Abrupt cessation of high doses was followed in some patients by nervousness, insomnia, irritability, diarrhea, muscle aches, or memory impairment. Since orally administered clorazepate dipotassium is rapidly Прочитайте повний документ