Menelat 30

Menelat 30

mirtazapine

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Mirtazapine
Indications/Uses
Dosage/Direction for Use
Initially 15 or 30 mg (preferably in the evening). Maintenance: Usually between 15 & 45 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs.
Special Precautions
Closely observe patients for clinical worsening, suicidality & unusual changes in behavior, especially during the initial few mth of drug therapy, or at times of dose changes (either increases or decreases). Adequately screen patients for risk of bipolar disorder prior to initiation of treatment. Not approved for use in treating bipolar depression. Closely monitor patient & discontinue treatment if patient develops sore throat, fever, stomatitis or other signs of infection along w/ low WBC count during treatment. Reports of serotonin syndrome, particularly w/ other serotonergic drugs (including triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone & St. John's wort) & drugs that impair serotonin metabolism (particularly, MAOIs). May trigger an angle-closure attack in patient w/ anatomically narrow angles who does not have patent iridectomy. Reports of somnolence; dizziness; increased appetite & wt gain; increased non-fasting cholesterol above ULN; increased non-fasting triglyceride; transaminase elevations. Patients w/ known CV disease or family history of QT prolongation or concomitantly using drugs that prolong QTc interval; patients w/ hepatic impairment; history of mania/hypomania; seizure; known CV or cerebrovascular disease that could be exacerbated by hypotension; conditions that would predispose patients to hypotension. May impair judgment, thinking & motor skills. May impair ability to drive, use machines or perform tasks that require alertness. Avoid alcoholic beverages. Reduced clearance of mirtazapine in patients w/ moderate to severe renal/hepatic impairment & elderly. Pregnancy & lactation.
Adverse Reactions
Akathisia, anticholinergic effects, arrhythmia, agranulocytosis, hyperlipidemia, hyponatremia, increased sedation & risk of suicidal ideation, angle closure glaucoma, orthostatic hypotension, increased transaminase levels, increased appetite, wt gain; anemia, leucopenia, lymphocytosis, pancytopenia, thrombocytopenia; angina pectoris, bradycardia, MI; deafness, hyperacusis, otitis media; goiter, hyperprolactinemia; abnormal accommodation/lacrimation, conjunctivitis, diplopia, blepharitis, eye pain; abdominal pain, acute abdominal syndrome, colitis, constipation, diarrhea, dry mouth, enlarged abdomen, eructation, gastritis, glossitis, hiccup, intestinal obstruction, pancreatitis, salivary gland enlargement, stomatitis, tongue discoloration, nausea, vomiting, ulcer; abnormal healing, asthenia, ataxia, fatigue, fever, malaise, edema; cholecystitis, jaundice, liver cirrhosis; asphyxia, bone fracture, phlebitis, tendon rupture; increased acid phosphatase & creatine kinase; anorexia, frequent thirst; dehydration; peripheral edema; arthralgia, arthritis, back pain, bursitis, gout, hypotonia, myalgia, myositis, neck rigidity, rhabdomyolysis, tenosynovitis; agitation, amnesia, cerebral ischemia, convulsions, dizziness, dyskinesia, dystonia, extrapyramidal syndrome, headache, hypokinesia, hypoesthesia, nystagmus, myasthenia, myoclonus, migraine, paralysis, paresthesia, restless legs syndrome, stupor, tremors, vertigo; anxiety, apathy, aphasia, confusion, delirium, delusions, dementia, depersonalization, depression, dysarthria, emotional lability, euphoria, hallucination, hostility, insomnia; manic reaction, neurosis, paranoid reaction, somnolence, abnormal dreams/thinking; cystitis, dysuria, polyuria, urinary frequency/retention, UTI; breast engorgement & enlargement, amenorrhea, dysmenorrhea, hematuria, increased libido, leucorrhea, metrorrhagia, impotence; cough, dyspnea, bronchitis, asthma, laryngitis, flu syndrome, pneumonia, pneumothorax, pulmonary embolus, sinusitis; acne, alopecia, exanthema, erythema multiforme, exfoliative dermatitis, urticaria, herpes simplex, herpes zoster, petechiae, rash, seborrhea, skin hypertrophy & photosensitivity; epistaxis, HTN, hypotension, syncope, vasodilation; serotonin syndrome, severe skin reactions (eg, SJS, TEN).
Drug Interactions
Increased sedative effects w/ benzodiazepines (eg, alprazolam, clonazepam, diazepam). Increased risk of serotonin syndrome w/ SSRIs (eg, escitalopram, fluoxetine, sertraline), SNRIs (eg, venlafaxine, duloxetine, sibutramine), TCAs (eg, amitriptyline, clomipramine, imipramine), triptans (eg, sumatriptan, zolmitriptan, almotriptan), amphetamine, buspirone, fentanyl, lithium, tramadol & tryptophan. Increased serum plasma conc w/ potent CYP3A4 inhibitors eg, HIV-PIs (eg, ritonavir), azole antifungals (eg, itraconazole, ketoconazole), erythromycin & nefazodone. Decreased serum plasma conc w/ potent CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin). Increased serum plasma conc w/ cimetidine. Increased risk of QT prolongation w/ QTc interval prolonging drugs (eg, azithromycin, fluconazole, chloroquine). Diminished antihypertensive effect of α2-agonist (eg, clonidine, methyldopa). Enhanced anticoagulant effect of warfarin. Increased risk of serotonin syndrome when concurrently administered w/ or w/in 14 days of discontinuing MAOIs (eg, isocarboxazid, linezolid, IV methylene blue, phenelzine, selegiline, tranylcypromine). Increased sedative effect w/ alcohol. Increased risk of serotonin syndrome w/ St. John's wort.
MIMS Class
Antidepressants
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Menelat 30 FC tab 30 mg
Packing/Price
30's (P2,280/pack)