Incepta Pharmaceuticals Ltd.
Mitaprex 15 is indicated for Depression, Major depressive disorder
Precautions and warnings
Epilepsy or history of seizures; avoid completely in unstable cases. Hepatic or renal impairment, cardiac disorders e.g. conduction disturbances, angina pectoris, recent MI. Hypotension, DM, psychoses, history of bipolar disorder. Stop treatment if jaundice develops. Micturition disturbances, angle-closure glaucoma, raised intraocular pressure. Monitor patient for signs of bone marrow depression. Monitor patient for suicidal tendency. Avoid abrupt withdrawal. May impair ability to drive or operate machinery. Pregnancy and lactation. Elderly.
Increase in appetite and wt, oedema; drowsiness or sedation; dizziness, headache, increased liver enzyme levels; jaundice. Orthostatic hypotension, rash, nightmares, agitation, mania, hallucinations, paraesthesia, convulsions, tremor, myoclonus, akathisia, restless legs syndrome, arthralgia, myalgia, reversible agranulocytosis, leucopenia, granulocytopenia, hyponatraemia.
Potentiation of sedative effects with alcohol or benzodiazepines. Increased plasma levels with potent CYP3A4 inhibitors (e.g. HIV-protease inhibitors, azole antifungals including ketoconazole, erythromycin, nefazodone). Reduced plasma levels with carbamazepine and other inducers of CYP3A4. Increased bioavailability with cimetidine.
Potentially Fatal: Do not use with or within 2 wk of stopping an MAOI; at least 1 wk should elapse between discontinuing mirtazapine and initiating any drug which may provoke a serious reaction (e.g. phenelzine).
Mirtazapine Tablets are contraindicated in patients with a known hypersensitivity to mirtazapine or to any of the excipients.
Mode of actions
Mirtazapine, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic ?2-receptors.
Dosage & Administration
Adult: PO Initial: The recommended starting dose for (mirtazapine) Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the treatment of major depressive disorder, the effective dose range was generally 15-45 mg/day as 1-2 divided doses.
Pregnancy & Lactation
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks