Zenbar™

[Duloxetine]

Zenbar

Description / Properties

Zenbar™ (Duloxetine) is an antidepressant, serotonin-norepinephrine reuptake inhibitor (SNRI)

Indications

Zenbar™ Zenbar is indicated for the treatment of depression (as defined by DSM-IV criteria).

Contraindication

Known hypersensitivity to duloxetine or to any of the excipients, pregnancy and lactation sever hepatic function impairment. Concomitant use of MAOLs, and advanced renal impairment (creatinine clearance <30 ml/min).

Side Effects

In clinical trials the following were reported: Constipation, diarrhoea, dry mouth nausea and vomiting, dyspepsia, fatigue, rigours, weigh and appetite decreased, dizziness, headache, lethargy, somnolence, tremor, insomnia, anorgasmia, libido decreased, anxiety, sleep disorder, ejaculation disorder, erectile dysfunction, yawning, hyperhidrosis and hot flushes.

Spontaneous Post-Marketing Reported Side Effects
Rare-rash. Very rare-glaucoma, hepatitis, jaundice, anaphylactic reaction. AST increased, ALT increased, alkaline phosphatase increased bilirubin increased, hyponatreaemla, angloneurotic oedema, Stevens-Johnson syndrome, urticaria, orthostatic hypotension and syncope.

Warning and Precautions

MAOI (monoamine oxidase inhibitors): Not to be used concomitantly with a MAOI, or with in at least 14 days of discontinuing treatment with a MAOI, Based on the half-life of Zenbar, at least 5 days should be allowed after stopping Zenbar, before starting a MAOI.

Special Precautions
Zenbar should be used cautiously in patients with a history of seizure disorder. It may also be associated with an increase in blood pressure and also elevated liver enzymes in some patients. It should be used with caution in patients with substantial alcohol use. Mydriasis has been reported in association with duloxetine; therefore caution should be used when prescribing Zenbar in patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma. Increased plasma concentrations of Zenbar occur in patients with sever renal or hepatic impairment. A lower starting dose should be used in such patients. The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Zenbar is not intended for use in the patients under the age of 18. Studies from some antidepressants indicate a potential increased risk for suicidal ideation and behaviors in pediatric conditions compared to placebo.

Dosage

Starting dose: 60 mg once daily with out regard to meals
Age: No dosage adjustment is necessary for elderly patients
Zenbar has not been studied in patients under the age of 18 years

Presentations Available

  • Zenbar™ 20mg: Each oral capsule contains Duloxetine HCl equivalent to 20 mg duloxetine
  • Zenbar™ 30mg: Each oral capsule contains Duloxetine HCl equivalent to 30 mg duloxetine
  • Zenbar™ 60mg: Each oral capsule contains Duloxetine HCl equivalent to 60 mg duloxetine

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