Mizolam 7.5 mg Tab, 1 strip

Mizolam 7.5 mg Tab, 1 strip

DESCRIPTION

MIZOLAM (Midazolam) is a sleep-inducing agent characterized by a rapid onset and short duration of action. It also exerts an anxiolytic, anticonvulsant & muscle-relaxant effect. The effects of MIZOLAM (Midazolam) on the CNS are dependent on the dose administered, the route of administration, and the presence or absence of other medications. MIZOLAM (Midazolam) is absorbed rapidly and completely after oral administration. With a dose of 15 mg maximum plasma concentration of 70-120 ng/ ml are reached within one hour. Food prolongs the time to peak plasma concentration by one hour, indicating a reduced absorption rate of MIZOLAM (Midazolam). The absorption half-life is 5-20 minutes. The tissue distribution of MIZOLAM (Midazolam) is very rapid and in most cases a distribution phase is not apparent or is essentially finished within 1- hours after oral administration. The volume of distribution at steady state is 0.7-1.21L/Kg. 96-98% of MIZOLAM (Midazolam) is bound to plasma proteins.

COMPOSITION

Tablet : Each film-coated tablet contains Midazolam BP 7.5 mg.

INDICATIONS

Short term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Sedation in premeditation before surgical or diagnostic procedures.

DOSAGE AND ADMINISTRATION

Patients should be advised to take MIZOLAM (Midazolam) for short-term treatment only.

Generally the duration of treatment varies from a few days to a maximum of two weeks.

The tapering-off process should be tailored to the individual. In certain cases extension

beyond the maximum treatment period may be necessary; if so, it should not take place without reevaluation of the patient's status. The product should be taken just before going to bed.

Standard dosage :

Adults : Dosage range: 7.5 mg - 15 mg

Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of CNS adverse effects. In patients with impaired liver function, the recommended dose is 7.5 mg. In premedication, 15 mg MIZOLAM (Midazolam) tablet should be given orally 30-60 minutes before the operation, unless the parenteral route is preferred.

OR AS DIRECTED BY THE PHYSICIANS

SIDE EFFECTS

Drowsiness during the day, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the start of the therapy and usually disappear with repeated administration.

USE IN PREGNANCY & LACTATION

Insufficient data are available on MIZOLAM (Midazolam) to assess its safety during pregnancy. Benzodiazepines should be avoided during pregnancy. Since MIZOLAM

(Midazolam) passes into breast milk, MIZOLAM (Midazolam) should not be administered to breast-feeding mothers.

CONTRAINDICATIONS

Severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, children, use in patients with known hypersensitivity to benzodiazepines or to any component of the product, myasthenia gravis.

PRECAUTIONS

The dose of MIZOLAM (Midazolam) should be carefully titrated against the response of the patients. Particular care, including a reduction in MIZOLAM (Midazolam) dosage, is required in patients also receiving opioid analgesics, in the elderly and children, and in patients with compromised cardiorespiratory function.

SUPPLY

Each box contains 3 x 10's tablets in blister strips.