Rapine 7.5

Rapine 7.57.5mg

Type:10 Tablets

Generic Name:Mirtazapine

Manufacturer:ACI Limited

Price:60.00

Ad

Indication

Depression, Major depressive disorder

Administration

May be taken with or without food.

Adult Dose

Oral Depression Adult: Initially, 15 mg daily; may be increased gradually depending on clinical response. Change dose at intervals of at least 1-2 wk. Usual effective dose: 15-45 mg daily given as single dose, preferably at bedtime, or in 2 divided doses. Elderly Depression 7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 45 mg/day Alzheimer Dementia-related Depression 7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 60 mg/day Hepatic impairment: Clearance is reduced; monitor closely

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment (CrCl <39 mL/min): Clearance is reduced; monitor closely

Contraindication

Mirtazapine Tablets are contraindicated in patients with a known hypersensitivity to mirtazapine or to any of the excipients.

Mode of Action

Mirtazapine, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic alpha 2-receptors.

Precaution

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. Lactation: Avoid

Side Effect

>10% Somnolence (54%),Weight gain (>7% increase in <49% of pediatric patients),Xerostomia (25%),Increased appetite (17%),Constipation (13%) 1-10% Asthenia (8%),lWeakness (8%),Weight gain (>7% increase in 8% of adults),Dizziness (7%),Serum TGs increased (6%),Dream disorder (4%),Disturbance in thinking (3%),ALT increased (2%),Peripheral edema (2%),Myalgia (2%),Confusion (2%),Urinary frequency (2%),Tremor (2%),Back pain (2%),Dyspnea (1%) <1% Mania (0.2%),Grand mal seizure (less than 0.1%) Frequency Not Defined Depression exacerbation,Status epilepticus,Suicidal thoughts, suicide (rare),Agranulocytosis,Neutropenia

Interaction

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).

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Sun Pharmaceutical (Bangladesh) Ltd.

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