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Duloxetine hydrochloride tablets

Dolmen

Duloxetine hydrochloride Tablets

Composition:

Each enteric coated tablet contains:

Duloxetine Hydrochloride B.P.

Equivalent to Duloxetine ……………. 30mg

Excipients ……………………………………. q.s.

Color Titanium Dioxide B.P.& Brilliant Blue FCF.

Description:

Dolmen (Duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNR) for oral administration. Its chemical designation is (+)-(S)-N-methyl-g-(1-nepthyloxy)-2-thiophepropylamine hydrochloride. The empirical formula is C18H19NOS.HCL, which corresponds to a molecular weight of 33.88.

Pharmacological action:

Preclinical studies have shown that duloxetine is a potent inhibiter of neuronal serotonin and norepinephrine reuptake and a less potent inhibiter of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro.

Duloxetine does not inhibit monoamine oxidase (MAO).Duloxetine is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with Duloxetine, consideration should be given to the possibility that they might be drug re-related.

Pharmacokinetics:

Duloxetine has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics are dose proportional over the therapeutic range.

Steady-state plasma concentration are typically achieved after 3 days of dosing. Elimination of duloxetine is mainly through hepatic metabolism involving two p450 isozymes, CYP1A2 and CYP2D6.

Indications:

• Treatment of major depressive disorder (MDD).
• Management of neuropathic pain associated with diabetic peripheral neuropathy.
• Chronic musculoskeletal pain
• Urinary stress incontinence.
• In the treatment of generalized anxiety disorder.