clorazepate dipotassium

clorazepate dipotassium

Apo-Clorazepate (CA), Novo-Clopate (CA), Tranxene, Tranxene-SD, Tranxene-SD Half Strength, Tranxene-T

Pharmacologic class: Benzodiazepine

Therapeutic class: Anticonvulsant, anxiolytic

Controlled substance schedule IV

Pregnancy risk category D

Action

Unclear. Thought to potentiate effects of gamma-aminobutyric acid and other neurotransmitters, promoting inhibitory neurotransmission at excitatory synapses.

Availability

Tablets: 3.75 mg, 7.5 mg, 15 mg

Indications and dosages

Anxiety

Adults: 7.5 to 15 mg P.O. two to four times daily

Adjunctive therapy in partial seizure disorder

Adults and children older than age 12: Initially, 7.5 mg P.O. t.i.d.; increase by no more than 7.5 mg/week. Don't exceed 90 mg/day.

Children ages 9 to 12: Initially, 7.5 mg P.O. b.i.d.; increase by no more than 7.5 mg/week. Don't exceed 60 mg/day.

Management of alcohol withdrawal

Adults: Initially, 30 mg P.O., followed by 15 mg P.O. two to four times daily on first day. On second day, give 45 to 90 mg P.O. in divided doses, then decrease gradually over subsequent days to 7.5 mg to 15 mg P.O. daily.

Dosage adjustment

• Elderly or debilitated patients

Contraindications

• Benzodiazepine hypersensitivity
• Acute angle-closure glaucoma
• Psychosis
• Concurrent ketoconazole or itraconazole therapy
• Children younger than age 9

Precautions

Use cautiously in:
• depression or suicidal ideation
• psychotic reaction
• elderly patients
• females of childbearing age
• pregnant or breastfeeding patients.

Administration

• If GI upset occurs, give with food.
• When discontinuing therapy after long-term use, taper dosage gradually over 4 to 8 weeks to avoid withdrawal symptoms.
• Take suicide precautions if patient is depressed or anxious.

Adverse reactions

CNS: dizziness, drowsiness, lethargy, sedation, depression, fatigue, nervousness, confusion, irritability, headache, slurred speech, difficulty articulating words, stupor, rigidity, tremor, poor coordination

CV: hypertension, hypotension, palpitations

EENT: blurred or double vision

GI: dry mouth

Hematologic: neutropenia

Hepatic: jaundice

Skin: rash, diaphoresis

Other: weight gain or loss, drug dependence or tolerance

Interactions

Drug-drug.Antacids: altered clorazepate absorption rate

Antidepressants, antihistamines, opioids: additive CNS depression

Barbiturates, MAO inhibitors, other antidepressants, phenothiazines: potentiation of clorazepate effects

Cimetidine, disulfiram, fluoxetine, hormonal contraceptives, isoniazid, itraconazole, ketoconazole, metoprolol, propoxyphene, propranolol, valproic acid: decreased clorazepate metabolism, causing enhanced drug action or markedly increased CNS effects

Levodopa: decreased antiparkinsonian effect

Probenecid: rapid onset or prolonged action of clorazepate

Rifampin: increased metabolism and decreased efficacy of clorazepate

Theophylline: decreased sedative effect of clorazepate

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase: increased levels

Drug-herbs.Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors.Alcohol use: increased CNS depression

Smoking: decreased drug absorption

Patient monitoring

• Assess for pregnancy before initiating therapy.
• Evaluate patient for depression, drug dependence, and drug tolerance.
• Monitor blood counts and liver function test results during long-term therapy; drug may cause neutropenia and jaundice.

Patient teaching

• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Tell patient to avoid smoking and use of alcohol or other CNS depressants.

Caution patient not to stop therapy abruptly, because withdrawal symptoms may occur.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

clorazepate dipotassium

(klôr-ăz′ə-pāt′)
n.
A benzodiazepine drug used to treat anxiety disorders, alcohol withdrawal, and partial seizures.

clorazepate dipotassium

[klôraz′əpāt dī-potassium]
a benzodiazepine antianxiety drug.
indications It is prescribed in the treatment of anxiety, nervous tension, and alcohol withdrawal.
contraindications Psychosis, acute narrow-angle glaucoma, or known hypersensitivity to this drug prohibits its use.
adverse effects Among the more serious adverse reactions are withdrawal symptoms that occur on discontinuation of treatment. Drowsiness and fatigue commonly occur.

clorazepate dipotassium (klor´əzepāt´ dī´pətas´ēəm),

n brand names: Tranxene, Gen-Xene, Apo-Chlorazepate, Tranxene-SD;
drug class: benzodiazepine, controlled substance schedule IV;
action: produces central nervous system depression;
uses: anxiety, acute alcohol withdrawal.
References in periodicals archive ?
Drugs such as Diazepam and Clorazepate Dipotassium potentiate the effect of pain relievers by decreasing the patient's anxiety thus decreasing their perception of pain.
Taro also received ANDA approval for Diflorasone Diacetate Cream, all three strengths of Clorazepate Dipotassium Tablets, all four strengths of Nortriptyline Hydrochloride Capsules, and Clobetasol Emollient Cream, as well as a supplemental ANDA approval for an additional strength of Etodolac Tablets.
Food and Drug Administration to manufacture and market Clorazepate Dipotassium Tablets USP, 3.
During the second quarter of 2000, Taro received FDA approval for its New Drug Application for Clotrimazole 3-Day Vaginal Cream, its ANDAs for Diflorasone Diacetate Cream, Clorazepate Dipotassium Tablets, Nortriptyline Hydrochloride Capsules, and Clobetasol E Cream, as well as a supplemental ANDA approval for an additional strength of Etodolac Tablets.
Earlier this quarter, Taro's NDA for Clotrimazole Three-Day Cream 2% was approved, as well as ANDAs for Diflorasone Diacetate Cream, Clorazepate Dipotassium Tablets and a supplemental ANDA approval for Etodolac Tablets, 500mg.
The cases were filed on behalf of all consumers in these jurisdictions who since January 1998 purchased Clorazepate Dipotassium or since March 1998 purchased Lorazepam, generic drugs manufactured by Mylan.
Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets USP, 3.
Clorazepate Dipotassium Latest Vertically Integrated Product
Clorazepate Dipotassium Tablets are indicated for the management of anxiety disorders and are bioequivalent to Abbott Laboratories' Tranxene(R).