TDPAM
DIAZEPAM · by AMSON
Composition
Inj: Per ml: Diazepam 5 mg; 2 ml (10 mg) amp. Tab 2 mg/5 mg/10 mg: Diazepam 2 mg/5 mg/10 mg. Soln/Enema Rectal 10 mg/5 mg/2 mg: Per 5 ml: Diazepam 10 mg/5 mg/2 mg. Suppository Rectal 10 mg/5
Indications & Dosage
Muscle spasm of varied aetiology: ORAL: Adult: 2-15 mg daily in divided doses, then increased if necessary to 60 mg daily, adjusted according to response, dose only increased in spastic conditions. Acute muscle spasm: BY IM INJ, OR BY SLOW IV INJ: Adult: 10 mg, then 10 mg after 4 hours if required, IV injection to be administered into a large vein at a rate of no more than 5 mg/minute. Tetanus: BY IV INJ: Adult & Children: 100-300 mcg/kg every 1-4 hrs. BY IV INF: Adult& Children: 3-10 mg/kg, adjusted according to response, tobe given over 24 hrs. Muscle spasm in cerebral spasticity or in postoperative skeletal muscle spasm: ORAL: Children 1-11 months: Initially 250 mcg/kg twice daily; 1-4 years: Initially 2.5 mg twice daily; 5-11 years: Initially 5 mg twice daily; 12-17 years: Initially 10 mg twice daily; max.40 mg per day. Anxiety: ORAL: Adult: 2 mg 3 times a day, then increased if necessary to 15-30 mg daily in divided doses, for debilitated patients, use elderly dose. Elderly: 1 mg 3 times a day, then increased if necessary to 7.5-15 mg daily in divided doses. Insomnia associated with anxiety: ORAL: Adult: 5-15 mg daily, to be taken at bedtime. Severe acute anxiety, Control of acute panic attacks, Acute alcohol withdrawal: BY IM INJ, OR BY SLOW IV INJ: Adult: 10 mg, then 10 mg after at least 4 hours if required, intravenous injection to be administered into a large vein, at a rate of not more than 5 mg/minute. Acute drug-induced dystonic reactions: BY IV INJ: Adult: 5-10 mg, then 5-10 mg after at least 10 minutes as required. Acute anxiety and agitation: BY RECTUM: Adult: 500 mcg/kg then 500 mcg/kgafter 12 hours as required. Elderly: 250 mcg/kg, then 250 mcg/kgafter 12 hours as required. Premedication: ORAL: Adult: 5-10 mg, to be given 1-2 hours before procedure, for debilitated patients, use elderly dose. Elderly: 2.5-5 mg, to be given 1-2 hours before procedure. BY IV INJ: Adult: 100-200 mcg/kg, to be administered immediately before procedure. Sedation in dental procedures: ORAL: Adult: Up to 20 mg, to be given 1-2 hours before procedure. Conscious sedation for procedures, and in conjunction with local anaesthesia: ORAL: Adult: 5-10 mg, to be given 1-2 hours before procedure, for debilitated patients, use elderly dose. Elderly: 2.5-5 mg, to be given 1-2 hours before procedure. Sedative for minor surgical and medical procedures: BY IV INJ: Adult: 10-20 mg, to be administered immediately before procedure. Convulsions due to poisoning, Status epilepticus, Febrile convulsions: BY IV INJ: Adult: 10 mg, then 10 mg after 10 minutes if required. Children: Neonate: 300-400 mcg/kg, then300-400 mcg/kg after 10 minutes if required; 1 month-11 years: 300-400 mcg/kg (max. per dose 10 mg), then 300-400 mcg/kg after 10 minutes if required; 12-17 years: 10 mg, then 10 mg after 10 minutes if required, all doses to be given over 3-5 minutes. BY RECTUM: Adult: 10-20 mg, then 10-20 mg after 10-15 minutes if required Children: Neonate: 1.25-2.5 mg, then 1.25-2.5 mg after 10 minutes if required; 1 month-1 year: 5 mg, then 5 mg after 10 minutes if required; 2-11 years: 5-10 mg, then 5-10 mg after10 minutes if required; 12-17 years: 10-20 mg, then 10-20 mg after10 minutes if required. Life-threatening acute drug-induced dystonic reactions: BY IV INJ: Children 1 month-11 yrs: 100 mcg/kg, repeated if necessary; 12-17 years: 5-10 mg, repeated if necessary, to be given over 3-5 minutes. Dyspnoea associated with anxiety in palliative care, Pain of muscle spasm in palliative care: ORAL: Adult: 5-10 mg daily.
Administration
Continuous infusion is not recommended because of precipitation in IV fluids and absorption of drug into infusion bags and tubing. In children, do not exceed 1-2 mg/min IVP; in adults 5 mg/min. By IV injection, 10 mg at a rate of 1 ml (5 mg) per min, repeated once after 10 min if necessary. Children under 12 years, 300-400 mcg/kg (maximum 10 mg). IM: Administration by this route is painful and absorption is slow and erratic. This route should be avoided where possible. If the IM route is used, inject undiluted. Most stable at pH 4-8, hydrolysis occurs at pH <3.
Compatibility
Do not mix IV product with other medications.
Stability
Stable at room temperature. Potency is retained up to 3 months. Protect from light.
Contraindications
Acute pulmonary insufficiency, chronic psychosis respiratory depression, compromised airway, hyperkinesis, sleep apnoea, phobic or obsessional state, unstable myasthenia gravis, severe hepatic impairment. Not recommended for use as monotherapy to treat depression or anxiety associated with depression.
Precautions
Muscle weakness, organic brain changes, parenteral administration (close observation required until full recovery from sedation), chronic pulmonary insufficiency, myasthenia gravis, renal impairment, mild to moderate hepatic impairment, history of drugs or alcohol abuse, personality disorders, elderly, avoid long-term use. Withdraw gradually. High risk of venous thrombophlebitis with intravenous use (reduced by using an emulsion formulation)
Interactions
Alcohol, CNS depressants, anticonvulsants, CYP3A4 inhibitors or inducers (e.g. cimetidine, rifampicin).
Pregnancy
Use only if potential benefit outweighs risk
Lactation
Contraindicated, avoid
Side Effects
Amnesia, muscle weakness, paradoxical increase in aggression, ataxia, confusion, dependence, drowsiness, lightheadedness, dizziness, dysarthria, GI disturbances, gynaecomastia, headache, hypotension, incontinence, salivation changes, slurred speech, tremor, urinary retention, vertigo, visual disturbances. Rare: Apnoea, blood disorders, jaundice, respiratory depression, skin reactions