Voxamin Tablets (Fluvoxamine)

• Composition :
  Each tablet contains Fluvoxamine Maleate 50 mg/ 100 mg.
• Indications :
  In treatment of obsessive compulsive disorder and depression.
• Pharmacodynamics :
  The mechanism of action of fluvoxamine maleate is a potent inhibitor of the serotonin reuptake transporter.
• Dosage and administration :
  adults: Recommended starting dose in adult is 50 mg at bedtime, with increase of 50 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 300 mg/day. Daily doses over 100 mg should be divided. Children and adolescents (8-17 years): Recommended starting dose is 25 mg at bedtime, with increases of 25 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 200 mg/day (8-11 years) or 300 mg/day (12-17 years). Daily doses over 50mg should be divided
• Contraindications :
  Co-administration of tizanidine, thioridazine, alosetron, pimozide. Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with Fluvoxamine Maleate Tablets. Do not use Fluvoxamine Maleate Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Fluvoxamine Maleate Tablets in a patient who is being treated with linezolid or intravenous methylene blue.
• Precautions and warnings :
  Monitor for clinical worsening and suicide risk, screen for bipolar disorder, abrupt discontinuation not recommended. Avoid administering fluvoxamine in patients with unstable epilepsy; discontinue treatment if seizures occur or frequency increases.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy category C: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs late in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN). Nursing mothers: Fluvoxamine is secreted in human breast milk. The decision of whether to discontinue nursing or to discontinue the drug should take into account the potential for serious adverse effects from exposure to fluvoxamine in the nursing infant as well as the potential benefits of Fluvoxamine Maleate Tablets therapy to the mother. Pediatric: Monitor weight and growth; effects of long-term use on growth, cognitive behavioral development, and maturation have not been studied. Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established.
• Drug interactions :
  Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with co-administration Tricyclic Antidepressants (TCAs): Co-administration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated. Tryptophan: Severe vomiting with co-administration. Diltiazem: Bradycardia with co-administration. Propranolol or metoprolol: Reduce dose if co-administered and titrate more cautiously.
• Adverse reactions :
  Most common adverse reactions were nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting
• Therapy Area :
  Anti-Depressants