Hameln Pharma Plus


Concise Prescribing Info
Relief of anxiety & provides sedation in severe acute anxiety or agitation & for the management of agitation associated w/ delirium tremens. Relief of acute muscle spasm & tetanus. Acute convulsions eg, status epilepticus, convulsions due to poisoning & febrile convulsions. Adjunct during endoscopy, in dentistry, surgery & radiology. Cardiac catheterisation; cardioversion; used pre-operatively to relieve anxiety, provide sedation, light anaesth & anterograde amnesia.
Dosage/Direction for Use
Adult Severe acute anxiety or agitation, acute muscle spasm 10 mg IV/IM, may be repeated w/ an interval of not less than 4 hr interval. Delirium tremens 10-20 mg IV/IM. Higher doses may be needed depending on severity of symptoms. Tetanus Initially 0.1-0.3 mg/kg IV, repeated at 1-4 hr intervals, or 3-10 mg/kg/24 hr by continuous IV infusion. The chosen dose should be related to the severity of the case & in extremely severe cases higher doses may be used. Status epilepticus, convulsions due to poisoning 10-20 mg IV/IM, repeat 30-60 min later if necessary. If indicated, follow a max dose of 3 mg/kg/24 hr by slow IV infusion. Pre-operative medication or premedication 10-20 mg or 0.2 mg/kg. Higher doses may be necessary according to the clinical response. Elderly or debilitated patients Doses should not exceed ½ those normally recommended. Childn Status epilepticus, convulsions due to poisoning, febrile convulsions 0.2-0.3 mg/kg IV/IM or 1 mg/1 yr of life. Tetanus Dose as adults. Pre-operative medication or premedication 0.2 mg/kg by slow inj (0.5 mL/min) into a large vein of antecubital fossa; patient in supine position throughout the procedure.
Hypersensitivity to diazepam, other benzodiazepines or propylene glycol. Acute pulmonary insufficiency or resp depression. Sleep apnoea syndrome. Marked neuromuscular resp weakness including unstable myasthenia gravis. Should not be used for chronic psychosis; or as monotherapy for depression or anxiety associated w/ depression. Severe hepatic impairment.
Special Precautions
IM use can lead to rise in serum creatinine phosphokinase activity. Extreme care must be taken when administering to very ill patients & to those w/ limited pulmonary reserve. Use w/ caution in patients w/ myasthenia gravis, known history of drug or alcohol abuse, or organic brain changes, particularly arteriosclerosis. Dependence potential particularly in patients w/ history of alcohol or drug abuse. Withdrawal symptoms may occur. Abuse of diazepam. May induce anterograde amnesia. Paradoxical reactions & disinhibition. Patients w/ personality disorders. Contains propylene glycol. May adversely affect the ability to drive or use machines. Renal &/or hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Daytime drowsiness, sedation, unsteadiness, ataxia.
Drug Interactions
Enhanced sedation or risk of resp or CV depression w/ CNS depressants (eg, anticonvulsants, anxiolytics/hypnotics, sedative antihistamines, alcohol, neuroleptics, antidepressants, analgesics, anaesth). Altered plasma conc of phenytoin. Reduced plasma levels w/ phenytoin & carbamazepine. Increased sedation or resp depression w/ barbiturates. Increased plasma levels w/ Na valproate, fluvoxamine. Reduced attention & psychomotor performance w/ SSRIs or TCAs. Increased plasma levels of zotepine. Occurrence of severe hypotension, collapse, loss of consciousness, resp depression, & potentially fatal resp arrest, salivary hypersecretion w/ clozapine. Hypotension, bradycardia & resp depression w/ IM olanzapine. Enhanced effects of Na oxybate (γ hydroxybutyrate, GHB). Inhibited metabolism w/ isoniazid & erythromycin; gastric acid suppressants (eg, cimetidine, omeprazole, esomeprazole); disulfiram. Increased clearance w/ hepatic enzyme inducer (eg, rifampicin). Reduced clearance w/ antivirals (eg, amprenavir, ritonavir). Increased effects w/ azole antifungals (eg, voriconazole, fluconazole, itraconazole). Enhanced sedative effects w/ alcohol; α-blockers or moxonidine; skeletal muscle relaxants (eg, baclofen or tizanidine). Enhanced hypotensive effects w/ antihypertensive agents. Antagonised effects of levodopa. Reduced effects w/ theophylline.
MIMS Class
ATC Classification
N05BA01 - diazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Diazepam-Hameln inj 5 mg/mL
2 mL x 10 × 1's
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