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Clorazepate Dipotassium (Tablet)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2358

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PredicateObject
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Clorazepate Dipotassium (Tablet)
dailymed-instance:dosage
For the Symptomatic Relief of Anxiety: Clorazepate dipotassium tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient. In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 mg to 15 mg. Clorazepate dipotassium tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. After the initial dose, the response of the patient may require adjustment of subsequent dosage. Lower doses may be indicated in the elderly patient. Drowsiness may occur at the initiation of treatment and with dosage increment.<br/>For the Symptomatic Relief of Acute Alcohol Withdrawal: The following dosage schedule is recommended: Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient's condition is stable. The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days.<br/>As an Adjunct to Antiepileptic Drugs: In order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.<br/>Adults: The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 90 mg/day.<br/>Children: (9 to 12 years): The maximum recommended initial dose is 7.5 mg two times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 60 mg/day.
dailymed-instance:descripti...
Chemically, clorazepate dipotassium, USP is a benzodiazepine. The structural formula may be represented as follows: MW=408.92CHClKNO The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate Dipotassium Tablets, USP for oral administration, contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium (Type A), magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, sodium chloride, sodium lauryl sulfate and the following coloring agents: 3.75 mg - FD&C Blue #2 Aluminum Lake 7.5 mg - FD&C Yellow #6 Aluminum Lake
dailymed-instance:clinicalP...
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 decarboxylated to form nordiazepam, there is essentially no circulating parent drug. Nordiazepam, the primary metabolite, quickly appears in the blood and is eliminated from the plasma with an apparent half-life of about 40 to 50 hours. Plasma levels of nordiazepam increase proportionally with clorazepate dipotassium dose and show moderate accumulation with repeated administration. The protein binding of nordiazepam in plasma is high (97 to 98%). Within 10 days after oral administration of a 15 mg (50��Ci) dose ofC-clorazepate dipotassium to two volunteers, 62 to 67% of the radioactivity was excreted in the urine and 15 to 19% was eliminated in the feces. Both subjects were still excreting measurable amounts of radioactivity in the urine (about 1% of theC-dose) on day ten. Nordiazepam is further metabolized by hydroxylation. The major urinary metabolite is conjugated oxazepam (3-hydroxynordiazepam), and smaller amounts of conjugated p-hydroxynordiazepam and nordiazepam are also found in the urine.
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dailymed-instance:contraind...
Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
dailymed-instance:supply
Clorazepate dipotassium is available as tablets containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium. The 3.75 mg tablets are blue, round, flat-faced, beveled edge, scored tablets debossed with M above the score and 30 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0030-01bottles of 100 tablets NDC 0378-0030-05bottles of 500 tablets The 7.5 mg tablets are peach, round, flat-faced, beveled edge, scored tablets debossed with M above the score and 40 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0040-01bottles of 100 tablets NDC 0378-0040-05bottles of 500 tablets The 15 mg tablets are white, round, flat-faced, beveled edge, scored tablets debossed with M above the score and 70 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0070-01bottles of 100 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] PROTECT FROM LIGHT. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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dailymed-instance:overdosag...
Overdosage is usually manifested by varying degrees of CNS depression ranging from slight sedation to coma. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. The treatment of overdosage should consist of the general measures employed in the management of overdosage of any CNS depressant. Gastric evacuation either by the induction of emesis, lavage, or both, should be performed immediately. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though rarely reported, may occur with large overdoses. In such cases the use of agents such as norepinephrine bitartrate injection or metaraminol bitartrate injection should be considered. While reports indicate that individuals have survived overdoses of clorazepate dipotassium as high as 450 to 675 mg, these doses are not necessarily an accurate indication of the amount of drug absorbed since the time interval between ingestion and the institution of treatment was not always known. Sedation in varying degrees was the most common physiological manifestation of clorazepate dipotassium overdosage. Deep coma when it occurred was usually associated with the ingestion of other drugs in addition to clorazepate dipotassium. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
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Clorazepate Dipotassium
dailymed-instance:fullName
Clorazepate Dipotassium (Tablet)
dailymed-instance:adverseRe...
The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech. There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit. Decrease in systolic blood pressure has been observed.
dailymed-instance:indicatio...
Clorazepate dipotassium tablets 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 are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets 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 are indicated for the symptomatic relief of acute alcohol withdrawal.
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dailymed-instance:name
Clorazepate Dipotassium