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Fulsed
Midazolam Maleate Tablets

COMPOSITION
FULSED TABLETS 7.5 MG
Each film-coated tablet contains
Midazolam Maleate equivalent to Midazolam 7.5 mg

FULSED TABLETS 15 MG
Each film-coated tablet contains
Midazolam Maleate equivalent to Midazolam 15 mg

PRODUCT DESCRIPTION
FULSED TABLETS 7.5 MG
White to off-white, round, biconvex film-coated tablets

FULSED TABLETS 15 MG
Blue to deep blue colored, round, biconvex film-coated tablets

DESCRIPTION
FULSED TABLET (Midazolam Maleate Tablet) contains Midazolam Maleate which is a water-soluble benzodiazepine. Chemically, midazolam maleate is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a] [1,4] benzodiazepine maleate. Midazolam maleate has the empirical formula C18H13CIFN3.C4H4O4 and a calculated molecular weight of 441.84. Its structural formula is as follows:

Fulsed Tablets


PHARMACOLOGY
Mechanism of action
Midazolam is a short-acting benzodiazepine CNS depressant and binds to specific receptors in the CNS. The benzodiazepine receptors in the CNS have a close functional connection with receptors of the GABA-ergic transmitter system. After binding to the benzodiazepine receptor, midazolam augments the inhibitory effect of GABA-ergic transmission. The effects of midazolam on the CNS are dependent on the dose administered, the route of administration, and the presence or absence of other medications.

Midazolam is a sleep-inducing agent characterized by a rapid onset and short duration of action. It also exerts an anxiolytic, anticonvulsant and muscle-relaxant effect.

Pharmacokinetics
Absorption
Midazolam is absorbed rapidly and completely after oral administration. With a dose of 15 mg, maximum plasma concentrations 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 midazolam. The absorption half-life is 5-20 minutes.

Due to the substantial first-pass effect, absolute bioavailability is 30-50%. The pharmacokinetics of midazolam is linear in the 7.5-15 mg oral dose range.

Distribution
The tissue distribution of midazolam is very rapid and in most cases a distribution phase is not apparent or is essentially finished within 1-2 hours after oral administration. The volume of distribution at steady state is 0.7-1.2 L/kg. Midazolam is 96-98% bound to plasma proteins mainly albumin. There is a slow and insignificant passage of midazolam into cerebrospinal fluid. In humans, midazolam has been shown to cross the placenta slowly and enter into fetal circulation. Small quantities of midazolam are found inhuman milk.

Metabolism
Midazolam is almost entirely eliminated by biotransformation. Midazolam is hydroxylated by cytochrome P4503A4 isozyme. Alpha-hydroxy-midazolam (1-hydroxy-midazolam) is the major urinary and plasma metabolite. Plasma concentrations of alpha-hydroxymidazolam are 30-50% those of the parent compound. After oral administration, there is a substantial first-pass metabolism of 30-60%. The elimination half-life of the metabolite is shorter than 1 hour. Alpha-hydroxy-midazolam is pharmacologically active and contributes significantly (about 34%) to the effects of oral midazolam. There is no evidence of a genetic polymorphism in the oxidative metabolism of midazolam.

In young healthy volunteers, the elimination half-life is between 1.5 and 2.5 hours. Midazolam is anon-accumulating medicine when given once nightly. Repeated administrations of midazolam do not induce drug-metabolizing enzymes.

Elimination
Less than 1 % of the dose is recovered in urine as the unchanged substance. Sixty to eighty percent of the dose is excreted in the urine as glucuroconjugated α-hydroxymidazolam.

Pharmacokinetics in Special Populations
Elderly. Patients above 60 years of age has little or no influence on the pharmacokinetics of oral midazolam.

Patients with hepatic impairment: Liver cirrhosis has no effect, or may increase the absolute bioavailability of midazolam because of reduced metabolism.

INDICATIONS
FULSED TABLET (Midazolam Maleate Tablet) is indicated for the short-term treatment of insomnia.

Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. FULSED TABLET (Midazolam Maleate Tablet) is also used for sedation in premedication before surgical or diagnostic procedures.

DOSAGE AND ADMINISTRATION
In order to minimize the risk of dependence, benzodiazepines should only be prescribed after careful consideration of the indication and should be taken for the shortest possible duration. Generally the duration of treatment varies from a few days to a maximum of 2 weeks. The tapering-off process should be tailored to the individual. The necessity of continuing treatment should be closely monitored.

In certain cases extension beyond the maximum treatment period may be necessary; it so, it should not take place without reevaluation of the patients status. Owing to the rapid onset of action FULSED TABLETS should betaken immediately before going to bed, and swallowed whole with fluid.

Standard dosage
Adults:

Initial dose : 7.5 mg

Dosage range : 7.5-15 mg.

In elderly and debilitated patients the recommended dose is 7.5 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.

Special dosage instructions
In patents with impaired liver function, the recommended dose is 7.5 mg. FULSED TABLETS can betaken at any time of the day, provided the patient is subsequently assured of at least 7-8 hours undisturbed sleep.

Premedication
In premedication,15mg of FULSED TABLETS should be given 30-60 minutes before the procedure.

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