Dormicum

Country of origin - Switzerland, Hoffmann-La Roche Ltd. produced by Senexi SAS France, Egis pharmaceutical plant Hungary

Pharm-Group - Sleeping pills - benzodiazepine derivatives

Manufacturers - Hoffmann-La Roche (Switzerland), Hoffmann-La Roche Ltd. produced by Senexi SAS (France), Egis pharmaceutical plant (Hungary)

International name - Midazolam

Synonyms - Flormidal, Fulsed

Dosage forms - film-coated tablets 7.5 mg, film-coated tablets 15 mg, solution for injection, tablets 15 mg, solution for injection 5 mg/ml, solution for injection 15 mg/3 ml, solution for intravenous and intramuscular administration 15 mg/3 ml, solution for intravenous

Composition - Active substance: Midazolam.

Indications for use - Insomnia (difficulty falling asleep and/or early awakening) - orally, premedication before diagnostic and surgical procedures (orally, i.m.), long-term sedation during intensive care (i.m.), induction of anesthesia during inhalation anesthesia or as a sleeping pill in combined anesthesia (i.v.), ataralgesia in children (i.m. in combination with ketamine).

Contraindications - Hypersensitivity, sleep disorders in psychosis and severe depression, myasthenia gravis, pregnancy (first trimester), childbirth, breastfeeding, childhood (for oral administration).

Side effect - Orally, parenterally. From the nervous system and sensory organs: drowsiness, lethargy, muscle weakness, dullness of emotions, decreased reaction speed, headache, dizziness, ataxia, diplopia, anterograde amnesia (dose-dependent), paradoxical reactions (agitation, psychomotor agitation, aggressiveness, etc.) . Other: dyspeptic symptoms, skin reactions, local reactions (erythema and pain at the injection site, thrombophlebitis, thrombosis). The development of tolerance, drug dependence, withdrawal syndrome, and the “recoil” phenomenon is possible. With parenteral administration: a decrease in tidal volume and/or respiratory rate, temporary cessation of breathing and/or the heart, sometimes leading to death - the effects are dose-dependent and are observed mainly in elderly patients with chronic diseases when used simultaneously with narcotic analgesics, as well as with rapid intravenous administration; laryngospasm, shortness of breath; excessive sedation, convulsions (in premature and newborn babies), withdrawal syndrome (with sudden cancellation of long-term IV use); vasodilation, decreased blood pressure, tachycardia; nausea, vomiting, hiccups, constipation; allergic, incl. skin (rash, urticaria, itching) and anaphylactoid reactions.

Interaction - Potentiates the effects of tranquilizers, antidepressants, other hypnotics, analgesics, anesthetics, neuroleptics, anesthetic drugs, alcohol (mutually). Midazolam solution is incompatible in the same syringe with alkaline solutions. IV administration of midazolam reduces the minimum alveolar concentrations of halothane required for general anesthesia. IM administration of midazolam during premedication may necessitate a reduction in the dose of sodium thiopental by 15%. Itraconazole, fluconazole, erythromycin, saquinavir increase the half-life of midazolam administered parenterally (when prescribing large doses of midazolam or carrying out long-term induction, a reduction in its dose is necessary). The systemic effect of midazolam is enhanced by inhibitors of the CYP3A4 isoenzyme: ketoconazole, itraconazole and fluconazole (co-administration is not recommended), erythromycin, saquinavir, diltiazem and verapamil (simultaneous administration requires a reduction in the dose of midazolam by 50% or more), roxithromycin, azithromycin, cimetidine and ranitidine (clinically significant interaction is unlikely). Inducers of the CYP3A4 isoenzyme (carbamazepine, phenytoin, rifampicin) reduce the systemic effect of midazolam (when taken orally) and cause no