DORMITA 15 (tab)
-
Chemical Name:
Midazolam -
Therapeutic Category:
Central nervous system drugs -
Pharmacologic Category:
Benzodiazepine -
Pharmaceutical Form:
Tablets -
Composition:
Midazolam 15mg
DORMITA
Film Coated Tablets
Midazolam
1.PHARMACOLOGY:
Midazolam, is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water.
The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of DORMITA to form water soluble salts with acids.
The pharmacological action of DORMITA is characterized by rapid onset and short duration because of rapid metabolic inactivation. Because of its very low toxicity, DORMITA has a wide therapeutic range.
DORMITA has a very rapid sedative and sleep-inducing action of pronounced intensity and short duration. It also exerts an anticonvulsant and a muscle –relaxant effect.
2.PHARMACOKINETICS:
Midazolam is completely obsorbed in the body. The primary metabolite is α-hydroxy-midazolam, which can be traced in the plasma. Its half-life is shorter than that of the parent substance. Immediately after its formation, it is conjugated with glucuronic acid (inactivation) and eliminated by the kidneys.
95% of Midazolam becomes bound to plasma proteins. The elimination half-life is between 1½ and 2 ½ hours.
Even after prolonged administration no accumulation of the active ingredient occurs, the pharmacokinetic profile and the metabolism remain constant.
Hepatic disfunction and advanced age have little or no influence on the pharmacokinetics of Midazolam.
3.INDICATIONS:
- Disturbances of sleep rhythm and all forms of insomnia, particularly difficulty in falling asleep either initially or after premature awakening.
- Sedation in premedication before surgical or diagnostic procedures.
4.CONTRA-INDICATIONS:
DORMITA must not be given to patients who are hypersensitive to benzodiazepines.
5.SIDE EFFECTS:
No changes in the blood picture or in hepatic or renal function have been observed. When therapy is continued over long period habituation may develop in predisposed patients as with all sleep inducing agents, sedatives and tranquilizers. In rare cases patients who are woken by unusual stimuli during the first two to three hours of sleep after taking the tablet may notice a loss of memory (amnesic episodes) with regard to day-to-day activities during these wake phases. DORMITA is well tolerated.
6.PRECAUTIONS:
- DORMITA is not indicated for primary therapy of insomnia in psychosis and severe depression. In such cases the underlying disorder should be treated first. As with other sedative drugs, caution is recommended in patients with organic brain damage severe respiratory insufficiency or whose general health is not good (increased drug sensitivity).
- Particular care is needed when administering DORMITA to a patient with myasthenia gravis, owing to preexisting muscle weakness.
- There are no reports of embryotoxicity, teratogenic or mutagenic effects. DORMITA like any other drug-should not be used in the first three months of pregnancy unless considered absolutely necessary by the physician.
- Care is needed when administering Midazolam to nursing woman because it is excreted by breast milk.
- Patients should be warned not to drive a vehicle or operate dangerous machinery in the first six hours after taking the drug.
7 .DRUG INTERACTIONS:
No interactions were observed when administered together with antidiabetics, anticoagulants and cardiovascular agents.
DORMITA enhances the central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing drugs, analgesics and anesthetics. This potentiation can be of advantage therapeutically in certain cases. Special attention must be paid to the possibility of potentiation in patients at particular risk. In some cases the mutual potentiation of alcohol and DORMITA can produce unforeseeable reactions.
8.DOSAGE & ADMINISTRARION:
F.C.Tablets:
The usual adult doses is (7.5-15) mg.
Because of the short sojourn of DORMITA in the body, DORMITA can be taken at any time of the day, provided the patient is subsequently assured of at least four hours undisturbed sleep.
In elderly and debilitated patients the recommended dose is 7.5 mg.
9.OVERDOSAGE:
In the event of an overdose, the following symptoms may occur: fatigue, ataxia, amnesia and respiratory depression. Such cases call for general supportive measures and gastric lavage if it can be performed within a short time of ingestion of the drug.
As in the case of overdosage with other sedatives or sleep-inducing agents, it is essential to keep the respiratory tract free and to monitor functioning of vital organs.
10.PACKAGING & COMPOSITION:
- DORMITA 7.5 – F.C.Tablets: A pack of 10 or 20 film coated tablets in blister. Each film coated tablet contains Midazolam 7.5 mg.
- DORMITA 15 – F.C.Tablets: A pack of 10 or 20 film coated tablets in blister. Each film coated tablet contains Midazolam 15 mg.
11.STORAGE CONDITIONS:
Store DORMITA – F.C.Tablets at temperature below 30°C. Protect from light.
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