PRESCRIBING INFORMATION
Presentation
D-pam Tablet: Each tablet contains Diazepam BP 5 mg.

Pharmacodynamic Properties
The pharmacodynamic effects of diazepam are also produced primarily by its actions with the result being enhancement of the inhibitory effects of GABA on the CNS. Skeletal muscle relaxation is most likely secondary to the CNS effects of diazepam, and may also involve inhibition of a presynaptic neural conduction at GABA mediated sites in the spinal cord.

Pharmacokinetic Properties
Diazepam is rapidly and completely absorbed from the gastrointestinal tract, peak plasma concentrations appearing 30-90 minutes after oral ingestion. Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam is mainly metabolized to the pharmacologically active metabolites such as N-desmethyldiazepam, temazepam and oxazepam. The acute half-life is six to eight hours with a slower decline thereafter (half-life up to 48 hours). Diazepam and its metabolites are excreted mainly in the urine.

Indications
D-Pam is indicated in the following conditions-
         * Short-term use in anxiety or insomnia
         * Adjunct in acute alcohol withdrawal
         * Muscle spasm
         * Febrile convulsions
         * Premedication for surgical procedures
         * Excitation states
         * Status epilepticus

Dosage & Administration
Adult:
Anxiety: 2 mg 3 times daily; upto 15-30 mg daily in divided doses
Insomnia associated with anxiety: 5-15 mg at bedtime
Muscle spasm: 2-10 mg three to four times daily
Elderly (or debilitated): Half of adult dose
Children: Not recommended.

Contraindications
Diazepam is contraindicated in respiratory depression, myasthenia gravis, acute pulmonary insufficiency, severe hepatic impairment, in infants and to known hypersensitivity to benzodiazepines.

Side Effects
Drowsiness and light-headedness the next day; confusion and ataxia; amnesia; dependence; aggression; muscle weakness; occasionally: headache, vertigo, hypotension, salivation change, visual disturbance, tremor, change in libido, etc.

Precautions
Precaution should be taken in respiratory diseases, muscle weakness, myasthenia gravis, drug or alcohol abuse, marked personality disorder, pregnancy, breast feeding, elderly, hepatic & renal impairment and in children.

Drug Interactions
It interacts with MAO inhibitors, phenytoin, cimetidine, levodopa, lithium; it may also interact with other anticonvulsant, analgesics and anesthetics.

Use in Pregnancy and Lactation
Diazepam should be avoided during pregnancy and breastfeeding.

Overdose
Treatment of overdose is symptomatic because of the relatively low toxicity of diazepam. If respiratory depression is the major concern the administration of flumazenil is advisable. But it is wise to make gastric lavage if carried out within 2 or less of the time of ingestion; maintenance of clear airways; good nursing care with regular position changes; etc.

Storage Conditions
Store in a cool and dry place and away from light. Keep all medicines out of the reach of children.

Commercial Pack
D-pam Tablet: Each box contains 10 blister packs of 10 tablets.