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  • Dormicum 15mg tablet Midazolam 7.5 mg; side effects, dosage

    Dormicum

    Midazolam BP

    Midazolam images

    Composition : Each film coated tablet contains midazolam BP 7.5 mg.

    Properties and effects : Dormicum 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.

    dormicum images

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

    Pharmacokinetics in special populations : Elderly: Advanced age (above 60 years) 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 : Short term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Sedation in premedication before surgical or diagnostic procedures.Midazolam images

    Dosage and administration : Treatment should be as short as possible. 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. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without reevalutation of the patient’s status Owing to the rapid ^n^eLpL^c^u^.DQanicLiri} tablets should be taken immediately before going to bed, and swallowed whole with fluid. Standard dosage: Adults: Dosage range : 75-15 mg. In elderly and debilitated patients the recommended dose is 75 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 Patients with impaired liver function, the recommended dose is 75 mg. Dormicum can be taken at any time of the day, provided the patient is subsequently assured of at least 7-8 hours undisturbed sleep. Premedication: In premedication Dormicum should be given 30-60 minutes before the procedure.

    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: Dependence: Use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompained by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage be decreased gradually.

    Pregnancy, nursing mothers: Insufficient date are available on midazolam to assess its safety during pregnancy. Benzodiazepines should be avoided during pregnancy unless there is no safer alternative, Since midazolam passes into breast milk, Dormicum should not be administered to breast-feeding mothers.

    Benzodiazepines are not recommended for the primary treatment of psychotic illness. Effect on ability to drive or to use machines:

    Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. If sleep duration is insufficient, the likelihood of impaired alertness may be increased.

    Undesirable 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 therapy and usually disappear with repeated administration. Amnesia: Anterograde amnesia may occur with therapeutic doses, the risk increasing at higher dosage. Amnestic effects may be associated with inappropriate behavior. Depression: Pre-existing depression may be unmasked during benzodiazepine use. Dependence: Use (even at therapeutic dose) may lead to the development of physical dependence; discontinuation of the therapy may result in withdrawal or rebound phenomena.

    Interactions: The metabolism of midazolam is predominately mediated by cytochrome P4503A4 (CYP3A4) isozyme. Approximately 25% of the total cytochrome P450 system in the adult liver is from CYP3A4 subfamily. Inhibitors and inducers of this isozyme may lead to drug interaction with midazolam. Interaction studies conducted with Dormicum Tablets : CYP3A4 inhibitors: Ketoconazole: Co-Administration of Dormicum and ketoconazole increased the systemic exposure (AUC) to midazolam 16 times. The pharmacokinetic and pharmacodynamic interaction between both drugs is clinically significant. Therefore, concomitant use of oral midazolam with ketoconazole is not recommended. Itraconazole: Concomitant administration of midazolam and itraconazole increased the systemic exposure (AUC) to midazolam 6-11 fold. The pharmacokinetic and pharmacodynamic interaction is clinicallv sinnifirant th*,-^™

    concomitant use of oral midazolam with itraconazole is not recommended. Fluconazoie: Co-administration of midazolam and fluconazole increased the systemic exposure (AUC) to midazolam 3-4 fold. The pharmacokinetic and pharmacodynamic interaction between midazolam and fluconazole is clinically significant. Therefore, concomitant use of oral midazolam with fluconazole is not recommended. Erythromycin: Co-administration of midazolam and erythromycin increased the systemic exposure (AUC) to midazolam 3-4 fold. The psychomotor test results also showed a clinically significant interaction between both compounds. Prescription of midazolam for patients receiving erythromycin is not recommended, or the dose of midazolam should be reduced by 50-75%. Roxithromycin: Concomitant use of midazolam with roxithromycin increased the systemic exposure (AUC) to midazolam by almost 50%. Therefore, the weak pharmacokinetic and pharmacodynamic interaction is unlikely to be clinically significant and should not jeopardize the safe therapeutic use of midazolam. Azithromycin: Co-administration of midazolam and azithromycin had no effect on the systemic exposure (AUC) to midazolam. The minor effect of azithromycin on the absorption rate of midazolam is unlikely to be clinically significant. Both drugs can be given concomitantly and no dosage adjustment of midazolam is required. Diltiazem: Co-administration of midazolam and diltiazem increased the systemic exposure (AUC) to midazolam almost 4-fold. The pharmacokinetic and pharmacodynamic interaction is clinically significant. Therefore, concomitant therapeutic use of midazolam and diltiazem is not recommended; however, if concomitant use cannot be avoided, the dose of midazolam should be reduced by at least 50%. Verapamil: Concomitant administration of midazolam and verapamil increased the systemic exposure (AUC) to midazolam almost 3-fold. The pharmacokinetic changes were clinically significant; therefore, the usual dose of midazolam should be reduced by at least 50% during concomitant verapamil treatment. Saquinavir Co-administration of a single oral dose of 7.5 mg midazolam after 3 of 5 days of saquinavir (1200 mg li.d.) dosing to 12 healthy volunteers increased the exposure to midazolam concentration more than 2-fold. Saquinavir increased the elimination half-life of midazolam from 4.3 to 10.9 h and the absolute bioavailability from 41 to 90%. Increased plasma concentrations of midazolam during saquinavir treatment intensified the sedative effects; therefore, during saquinavir treatment the dose of oral midazolam and cimetidine increased the sedative effects; therefore, during saquinavir treatment the dose of oral midazolam should be reduced by 50%. Cimetidine: Co-administration of midazolam and cimetidine increased the systemic exposure (AUC) to midazolam by about one third or had no effect at all on the pharmacokinetics of midazolam. The findings do not point to a clinically significant interaction between midazolam and cimetidine. Both drugs can be given concomitantly and dosage adjustment of midazolam is not required. Ranitidine: co-administration of midazolam and ranitidine increased the systemic exposure (AUC) to midazolam by 23-66% or had no effect at all on the pharmacokinetics of midazolam. The results suggest that a clinically significant interaction between midazolam and ranitidine is unlikely to occur in clinical practice and dosage adjustment of midazolam is not required. Terbinaline: Concomitant administration of

    pharmacodynamics of midazolam. CYP3A4 inducers: Carbamazepine and phenytoin: In patients with epilepsy receiving carbamazepine and/or phenytoin the systemic exposure (AUC) to midazolam was only 6% of that in healthy volunteers and sedative effects were minimal or absent The results show a clinically significant pharmacokinetic and pharmacodynamic interaction between midazolam and the antiepileptic drugs. Larger doses of midazolam are required in patients receiving carbamazepine and phenytoin. Rifampin: Co-administration of rifampin and midazolam decreased the systemic exposure (AUC) to midazolam by 96%. During concomitant treatment the pharmacodynamic effects were considerably smaller than those during treatment with midazolam alone. The results show a clinically significant pharmacokinetic and pharmacodynamic interaction between midazolam and rifampin. Therefore, in patients receiving rifampin treatment, larger doses are needed to produce sufficient sedation.

    Concomitant intake with alcohol is to be avoided. The sedative effect may be enhanced when the product is use in combination with alcohol. This affects the ability to drive or use machines.

    Overdosage: Symptoms: Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. The symptoms of Dormicum overdose are mainly an intensification of the pharmacological effects e.g. drowsiness, mental confusion, lethargy or paradoxical excitation. As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, areflexia, cardiorespiratory depression, apnea and rarely coma.

    Treatment: In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. Following overdose with oral benzodiazepines, vomiting should be induced (within 1 hour) if the patients in conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to the respiratory and cardiovascular functions in intensive care. The specific benzodiazepine antagonist flumazenil may be useful as an antagonist. Caution should be observed in the use of flumazenil in cases of mixed drug overdosage and in patients with epilepsy treated with benzodiazepines.

    Published on September 16, 2013 · Filed under: Science and Medicine; Tagged as: ,
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One Response to “Dormicum 15mg tablet Midazolam 7.5 mg; side effects, dosage”

  1. Iwant dormicum 15mg or7.5mg

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