Section :
Zepam
COMPOSITION :
Each tablet contains : Bromazepam B.P. 1.5mg , 3mg and 6mg.
DESCRIPTION :
Zepam (Bromazepam) is a benzodiazepine derivative with anxiolytic properties in low doses, but sedative
and musculoskeletal relaxant properties appear in high doses. Bromazepam is well absorbed after oral
administration and peak plasma concentrations are achieved within 1 - 2 hours. The average half life range
from 10 - 20 hours. It is excreted in urine in the form of inactive conjugated metabolites.
INDICATIONS :
Zepam is indicated for the treatment of a wide range of anxiety disorders including :
- Emotional disturbances such as anxiety and tension, depressive mood, agitation, nervous tension and
insomnia.
- Psychosomatic disturbances such as psychogenic headache and psychogenic dermatosis.
- Anxiety and tension accompanied with functional or organic diseases such as gastrointestinal,
cardiovascular, respiratory and genitourinary
DOSAGE & ADMINISTRATION :
Adults : 1.5 - 3 mg up to 3 times daily. Doses up to 6 - 12 mg two to three times daily may be taken in
severe cases.
N.B. : Elderly and debilitated patients: initial therapy is started with the lowest possible dose usually up to
3 mg/day in divided doses.The dose can be increased gradually to the optimum level.
Sudden discontinuation of the medicine should be avoided and gradual withdrawal of the dose is advised i
case of more than three months treatment are needed.
RESTRICTIONS ON USE :
Contraindications
Hypersensitivity to benzodiazepines, severe respiratory failure, sleep apnea syndrome, myasthenia gravis
and severe liver failure.
Precautions
- Concomitant administration with drugs which depress the CNS like alcohol should be avoided.
- Caution should be exercised when driving a vehicle or operating a machinery for the possible drowsiness
Use in pregnancy and lactation
It should be avoided in pregnancy and nursing mothers unless otherwise specified by the physician.
ADVERSE EFFECTS :
Bromazepam is usually well tolerated. Adverse effects are rare and may occur in large doses e.g. sedation,
drowsiness, fatigue and muscle weakness.
DRUG INTERACTIONS :
The effect of Bromazepam is enhanced with the use of drugs which depress the CNS e.g. alcohol.
STORAGE INSTRUCTIONS :
Store below 30oC in a dry place, protect from light.
PRESENTATIONS :
Zepam 1.5 mg Tablets : Pack of 20 tablets and hospital packs of different sizes.
Zepam 3 mg Tablets : Pack of 20 tablets and hospital packs of different sizes.
Zepam 6 mg Tablets : Pack of 20 tablets and hospital packs of different sizes.