Dulox 30 mg Tablet, 1 strip

Dulox 30 mg Tablet, 1 strip

DESCRIPTION

Dulox (Duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) that is indicated for the treatment of major depressive disorder (MDD) and for the management of neuropathic pain associated with diabetic peripheral neuropathy

(DPN). The exact mechanism of the antidepressant and central pain inhibitory actions of Duloxetine is unknown, it is thought to be related to the potentiation of the serotonergic and noradrenergic central nervous system activity. In addition to inhibiting the reuptake of serotonin and norepinephrine, Duloxetine also inhibits the reuptake of dopamine, although to a lesser degree.

COMPOSITION

Dulox 20 : Each enteric coated tablet contains Duloxetine Hydrochloride INN 22.45 mg equivalent to Duloxetine 20 mg.

Dulox 30 : Each enteric coated tablet contains Duloxetine Hydrochloride INN 33.67 mg equivalent to Duloxetine 30 mg.

INDICATIONS

Dulox is indicated for:

● Major Depressive Disorder (MDD)

● Generalized Anxiety Disorder (GAD)

● Diabetic Peripheral Neuropathic Pain (DPNP)

● Fibromyalgia (FM)

DOSAGE AND ADMINISTRATION

Dulox should generally be administered once daily without regard to meals. Dulox should be swallowed whole and should not be chewed.

Indication Recommended Dose

Major Depressive Disorder

● Generalized Anxiety Disorder 60 mg/day (once daily)

● Diabetic Peripheral 60 mg/day (once daily)

● Neuropathic Pain

● Fibromyalgia 60 mg/day (once daily)

Some patients may benefit from starting at 30 mg once daily. Discontinuing Dulox: A gradual dose reduction is recommended.

OR AS DIRECTED BY THE PHYSICIAN.

CONTRAINDICATIONS

Dulox (Duloxetine hydrochloride) is contraindicated in patients with known hypersensitivity to Duloxetine or any of the inactive ingredients. Concomitant use of Dulox (Duloxetine hydrochloride) with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated.

SIDE EFFECTS

The most common observed side effects in Dulox (Duloxetine hydrochloride) treated major depressive disorder (MDD) patients are nausea, dry mouth, constipation, decreased appetite, fatigue, somnolence, and increased sweating. In case of Dulox (Duloxetine hydrochloride) treated diabetic peripheral neuropathy (DPN) patients the most commonly observed side effects are nausea, somnolence, dizziness, dry mouth, constipation, decreased appetite, hyperhidrosis and asthenia.

PRECAUTIONS

Dulox (Duloxetine hydrochloride) treatment is associated with mean increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment.

Dulox (Duloxetine hydrochloride) should be prescribed with care in patients with a history of seizure disorder and mania. Dulox (Duloxetine hydrochloride) is associated with an increase risk of mydriasis; therefore it should be used cautiously in patients with controlled narrow- angle glaucoma.

USE IN PREGNANCY

There are no adequate and well-controlled studies in pregnant women; therefore, Dulox (Duloxetine hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

USE IN LABOR AND DELIVERY

The effect of Duloxetine on labor and delivery in humans is unknown.

Dulox (Duloxetine hydrochloride) should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

USE IN LACTATION

It is unknown whether or not Duloxetine and/or its metabolites are excreted into human milk, but nursing while on Dulox (Duloxetine hydrochloride) is not recommended.

USE IN CHILDREN

Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of Dulox (Duloxetine hydrochloride) in a child or adolescent must balance the potential risks with the clinical need.

USE IN ELDERLY

No overall differences in safety and effectiveness are observed between elder and younger.

DRUG INTERACTIONS

Both CYP1A2 and CYP2D6 are responsible for Duloxetine metabolism. Concomitant use of Duloxetine with Fluvoxamine, an inhibitor of

CYP1A2, results in approximately a 6- fold increase in AUC and about a 2.5- fold increase in Cmax of Duloxetine. Some quinolone antibiotics would be expected to have similar effects and these combinations

should be avoided. Concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine

OVERDOSAGE

There is limited clinical experience with Duloxetine overdose in humans. In clinical trials, no cases of fatal acute overdose of Duloxetine have been reported.

SUPPLY

Dulox 20 : Each box contains 1 x 10's tablets in blister strip.

Dulox 30 : Each box contains 1 x 10's tablets in blister strip.