Remeron SolTab

Remeron SolTab

mirtazapine

Manufacturer:

MSD

Distributor:

DKSH
Concise Prescribing Info
Contents
Mirtazapine
Indications/Uses
Dosage/Direction for Use
Adult & elderly 15-45 mg daily. Starting dose: 15 or 30 mg. May be increased up to max dose, if there is insufficient response.
Administration
May be taken with or without food: Place tab on the tongue to dissolve then swallow w/o water.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs.
Special Precautions
Carefully monitor if suicidal symptoms occur especially in patients w/ a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to treatment; patients w/ history of mania/hypomania. Discontinue treatment if symptoms of bone marrow depression eg, fever, sore throat, stomatitis or other signs of infection; jaundice, seizure, manic phase; serotonin syndrome occurs. Patients w/ epilepsy & organic brain syndrome; micturition disturbances-like prostate hypertrophy & w/ acute narrow-angle glaucoma & increased IOP. Cardiac diseases like conduction disturbances, angina pectoris & recent MI; low BP. May worsen psychotic symptoms in patients w/ schizophrenia or other psychotic substances. Avoid abrupt w/drawal. CV disease or family history of QT prolongation. Concomitant use w/ drugs that prolong QTc interval, cause hyponatremia, serotonergic active substances; insulin &/or oral hypoglycemics in patients w/ DM. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Phenylketonuria. May affect ability to drive & use machines. Mild to moderate hepatic impairment & moderate to severe renal impairment (CrCl <40 mL/min). Pregnancy & lactation. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
Increased wt & appetite; somnolence, sedation, headache; dry mouth. Abnormal dreams, confusion, anxiety, insomnia; lethargy, dizziness, tremor; orthostatic hypotension; nausea, diarrhea, vomiting, constipation; exanthema; arthralgia, myalgia, back pain; peripheral oedema; fatigue.
Drug Interactions
MAOIs. Serotonin syndrome may occur w/ serotonergic drugs (eg, L-tryptophan, triptans, tramadol, linezolid, methylene blue, SSRIs, venlafaxine, lithium & St. John's wort). May increase sedating properties of benzodiazepines & other sedatives (eg, antipsychotics, histahime H1-antagonists, opioids). May increase CNS depressant effect of alcohol. Increased INR w/ warfarin. Increased risk of QT prolongation &/or ventricular arrhythmias w/ QTc interval prolonging drugs (eg, some antipsychotics & antibiotics). Increased clearance w/ CYP3A4 inducers eg, carbamazepine & phenytoin. Increased peak plasma levels & AUC w/ potent CYP3A4 inhibitors eg, ketoconazole. Increased mean plasma conc w/ potent CYP3A4 inhibitors, HIV PIs, azole antifungals, erythromycin, cimetidine or nefazodone.
MIMS Class
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Remeron Soltab 15 mg
Packing/Price
5 × 6's
Form
Remeron Soltab 30 mg
Packing/Price
5 × 6's
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