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Apo-Diazepam

Diazepam Tablets USP 2mg, 5mg and 10mg


Pharmacology:

Diazepam possesses anxiolytic and sedative properties which may be of value in the symptomatic relief of manifest anxiety and tension states in psychoneurotic patients. It has also and adjunctive value in the relief of certain neurospastic conditions. Peak blood levels after oral administration of diazepam are reached within one or two hours after single oral dosing. The acute half-life is six to eight hours with a slower decline thereafter, possibly due to tissue storage. However, after repeated doses, blood levels increase significantly over a period of 24 - 48 hours. In humans, comparable blood levels of diazepam were obtained in maternal and cord blood indicating placental transfer of the drug.


Indications

Diazepam is useful in symptomatic relief of excessive anxiety and tension in psychoneurotic patients, including those with somatic manifestations. In acute alcoholic withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor and impending acute delirium tremens. Diazepam is a useful adjunct to the relief of spasticity in neuromuscular disorders, such as cerebral palsy and athetosis.


Contraindications

Diazepam is contraindicated in patients with myasthenia gravis, glaucoma or known hypersensitivity to the drug.


Precautions

Use in Elderly: Elderly and debilitated patients or those with organic brain disorders have been found to be prone to central nervous system depression following even low doses. For these patients, it is recommended that the dosage be limited to the smallest effective amount to preclude development of ataxia, oversedation or other possible adverse effects.


Use In Emotional Disorders: Diazepam is not recommended in the treatment of psychotic or severely depressed patients. Precautions are indicated for severely depressed patients or those who show evidence of impending depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary. Since excitement and other paradoxical reactions may result from the use of the drug in psychotic patients, it should not be used in ambulatory patients suspected of having psychotic tendencies.

 

Use in Epileptic Patients: Since diazepam may exacerbate grand mal seizures in some patients, caution is required when it is used in epileptic patients. An adjustment may be necessary in their anti-convulsive medication. Abrupt withdrawal of diazepam in these patients should also be avoided.


Drug Dependence: Abrupt cessation of large doses of diazepam after prolonged periods may precipitate acute withdrawal symptoms, including convulsions, and, in these cases, the drug should be discontinued gradually. Caution should be exercised when it is considered necessary to administer diazepam to addiction-prone individuals.


General: Patients receiving diazepam should be advised to proceed cautiously wherever mental alertness and physical coordination are required. The usual precautions in treating patients with impaired renal and hepatic functions should be observed. If diazepam is administered for protracted periods, periodic blood counts and liver function tests are advisable.

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken.


Complex sleep-related behaviors which may include sleep driving, making phone calls, preparing and eating food (while asleep).


Drug Interactions

Careful consideration should be given if diazepam is to be combined with other psychotropic agents (phenothiazines, barbiturates, and MAO inhibitors and other anti-depressants) because the pharmacological action of these agents might potentiate the action of diazepam. Since this drug has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other central nervous system depressant drugs during diazepam therapy.


Adverse Reactions

The most common adverse reactions reported for diazepam are drowsiness and ataxia. Other reactions noted less frequently are fatigue, dizziness, nausea, blurred vision, diplopia, vertigo, headache, slurred speech, tremors, hypoactivity, dysarthria, euphoria, impairment of memory, confusion, depression, incontinence or urinary retention, constipation, skin rash, generalized exfoliative dermatitis, hypotension and changes in libido. The most serious adverse reaction occasionally reported are leucopenia, jaundice, hypersensitivity and paradoxical reactions (such as hyperexcited states, anxiety, excitement, hallucinations, increased muscle spasticity, insomnia, rage, as well as sleep disturbances and stimulation) - should these occur, the drug should be discontinued. Minor changes in EEG patterns have been observed in patients on diazepam therapy. These changes consist of low to moderate voltage fast activity, 20 to 30 cycles per second and are of no known significance.


Symptoms & Treatment of Overdosage

The main symptoms of diazepam overdosage are drowsiness, oversedation and ataxia. When the effects of the drug overdosage begin to wear off, the patient exhibits some jitteriness and overstimulation. The cardinal manifestations of overdosage are drowsiness and confusion, reduced reflexes and coma. There are minimum effects on respiration, pulse and blood pressure unless the overdosage is extreme. There is no specific antidote known. Gastric lavage may be beneficial if performed soon after oral ingestion of diazepam. If necessary, a CNS stimulant such as caffeine or methylphenidate may be administered with caution. Supportive measures should be instituted as indicated: maintenance of an adequate airway, levarterinol or metaraminol bitartrate for hypotension. Dialysis appears to be of little value.


Dosage & Administration

The average dosage of diazepam in adults is from 4-40mg daily in divided doses. However, the dosage must be individualized for maximal therapeutic effect depending on diagnosis, severity of symptoms and patient's response. A cumulative effect of the drug may occur in the first few days after initiation of treatment.


Usual Oral Dose In Adults

Symptomatic relief of excessive anxiety and tension in psychoneurotic patients. The recommended dose is 4-40mg daily administered in divided doses 2-3 times daily. Adjunctively for the relief of spasticity in neuromuscular disorders, such as cerebral palsy and athetosis. The recommended dose is 6-30mg daily in divided doses. Elderly and debilitated patients. The recommended initial dose is 2mg, once or twice daily. Increase gradually as needed and tolerated.

Mode of Administration: Oral


Availability:
APO-DIAZEPAM TABLETS - each round, flat-faced, bevelled edge, scored tablet contains diazepam 2mg, white, identified "APO" over "2"; 5mg - yellow, identified "APO" over "5"; 10mg - blue, identified "APO" over "10:. Available in PVC Blisters of 1000 tablets.

Storage Conditions: Store between 15-30C.

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