Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1097
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Diazepam (Tablet)
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Dosage should be individualized for maximum beneficial effect. While the usual dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
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Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water and has a molecular weight of 284.75. Its structural formula is: Diazepam is available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1); magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.
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Diazepam is contraindicated inpatients with a known hypersensitivity to this drug and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. It may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow angle glaucoma.
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Diazepam Tablets USP are available as white, round, bisected tablets, debossed with company logo and 3925 on front and 2 on back, containing 2 mg of diazepam USP, packaged in bottles of 100, 500 and 1000 tablets. Diazepam Tablets USP are available as yellow, round, bisected tablets, debossed with company logo and 3926 on front and 5 on back, containing 5 mg of diazepam USP, packaged in bottles of 100, 500 and 1000 tablets. Diazepam Tablets USP are available as light blue, round, bisected tablets, debossed with company logo and 3927 on front and 10 on back, containing 10 mg of diazepam USP, packaged in bottles of 100, 500 and 1000 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20��-25��C (68��-77��F) (See USP Controlled Room Temperature). MANUFACTURED FOR IVAX PHARMACEUTICALS, INC MIAMI, FL 33137 by 0172 Ivax Pharmaceuticals Ireland 07/04 Waterford, Ireland B15 Made in Ireland
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If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed���particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants. The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary. The usual precautions in treating patients with impaired renal or hepatic function should be observed. In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2��mg once or twice daily, initially, to be increased gradually as needed and tolerated). The clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration. The clinical significance of this is unclear.<br/>Information for Patients: To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.<br/>Pediatric Use: Safety and effectiveness in pediatric patients below the age of 6 months have not been established.
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Diazepam
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Diazepam (Tablet)
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Side effects most commonly reported were drowsiness, fatigue and ataxia. Infrequently encountered were confusion, constipation, depression, diplopia, dysarthria, headache, hypotension, incontinence, jaundice, changes in libido, nausea, changes in salivation, skin rash, slurred speech, tremor, urinary retention, vertigo and blurred vision. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued. Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during longterm therapy. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance.
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Diazepam is not of value in the treatment of psychotic patients and should not be employed in lieu of appropriate treatment. As is true of most preparations containing CNS-acting drugs, patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. As with other agents which haveanticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures. Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneousingestion of alcohol and other CNS-depressant drugs during diazepam therapy.<br/>Usage in Pregnancy: An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide), during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs rarely is a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapyshould be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
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Diazepam
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