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5th May 2009
Dolphin has added seven more formulations to its growing Sri Lanka Portfolio

28th April 2009
The Board of Directors of the Company in its 154th meeting held on Tuesday, 28 April, 2009 has recommended 50% cash and 25% stock dividend (bonus share)

D-Diazepam Tablet
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 Description

SDiazepam (D-Diazepam) is a benzodiazepine derivative and is a safe tranquillizer with anxiolytic, anticonvulsant and central muscle relaxant actions. Intravenous D-Diazepam injection is widely used in obstetrics and control of status epilepticus.

 Composition

D-Diazepam Tablet: Each tablet contains Diazepam BP 5 mg.

 Mode of action

Diazepam attaches to the specific site on the GABA receptor/chloride channel complex and potentiates the effect of GABA, an important inhibitory transmitter in the CNS which acts by opening chloride ion channels into cells.

 Pharmacokinetics

Diazepam is metabolized to two active metabolites, one of which is desmethyl diazepam, has an extended half-life. Diazepam is therefore a long acting benzodiazepine and repeated doses may lead to accumulation. Diazepam is metabolized in the liver and excreted via the kidney. Impaired hepatic or renal function may prolong the duration of action of diazepam. It is recommended that elderly and debilitated patients receive initially one half of the normal recommended dose. During prolonged administration, for example in the treatment of tetanus, the dosage should generally be reduced after 6-7 days, to reduce the likelihood of accumulation and prolonged CNS depression.

 Indications

Diazepam is indicated for the short-term treatment of mild to moderate anxiety, excitation, agitation, fear, aggressiveness etc. Anxiety reactions caused by stressed conditions, anxiety states with somatic expression, acute alcohol withdrawal, status epilepticus, premedication for surgical procedures, febrile convulsions, insomnia of hospitalized patients.
Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly.

 Dosage & administration

Oral: Anxiety: 2 mg thrice daily increased if necessary to 15-30 mg daily in divided doses. Elderly (or debilitated), half of the adult dose. Insomnia associated with anxiety: 5-15 mg at bed time. Child: Night terrors and somnambulism, 1-5 mg at bed time. IM/slow IV injection (large vein, rate below 5 mg/minute): For severe acute anxiety, control of acute panic attacks, and acute alcohol withdrawal, 10 mg, repeated if necessary after not less than 4 hours. Febrile convulsion in children: Slow IV in a dose of 250 mcg/kg, or preferably rectally in solution in a dose of 500 mcg/kg (maximum 10 mg), repeated if necessary.

 Side effects

Diazepam is generally well tolerated. Higher doses may cause somnolence, dizziness, light headedness, confusion and ataxia.

It is advised to avoid antacid preparations in the first trimester of pregnancy.

 Contraindications

Diazepam is contraindicated in myasthenia gravis, pulmonary insufficiency and respiratory depression. Use in pregnancy & lactation Diazepam and its active metabolites cross the placental barrier and also pass into breast milk. So, it should be avoided if possible during pregnancy and lactation. Precautions Prolonged use and abrupt withdrawal should be avoided. Special precaution should be taken in case of IV administration (slow administration); drowsiness may hamper skilled tasks.

 Drug interactions

Concomitant intake with alcohol is not recommended. Sedation may be increased due to concomitant use of neuroleptics (antipsychotics), hypnotics, sedative antihistamines and CNS depressants e.g., general anesthetics, narcotic analgesics or antidepressants. Diazepam clearance is increased by concomitant administration of phonobarbitone and is decreased by administration of cimetidine. Omeprazole and isoniazide inhibit diazepam metabolism.

 Overdosage

Sedation, muscle weakness, profound sleep or paradoxical excitation. In more severe cases symptoms may include ataxia, hypotonia, hypotension, respiratory depression and rarely coma and death.

 Storage

Store in a cool and dry place, protected from light.

 Packaging

D-Diazepam Tablet: Each carton contains 10x10 tablets in blister pack.


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