Cymbatex 60 mg 30 capsules

Cymbatex 60 mg 30 Hard Gelatin Capsules

Composition:

Active ingredient:

Duloxetine Hydrochloride 67.3 mg (equivalent to Duloxetine 60 mg)

Description:

Cymbatex is a delayed-release capsule containing duloxetine, a serotonin and noradrenaline reuptake inhibitor (SNRI). It has weak inhibition of dopamine reuptake and negligible affinity for other receptors. It increases extracellular serotonin and noradrenaline levels and modulates pain pathways in the central nervous system.

Indications for Use:

Major depressive disorder (MDD)

Diabetic peripheral neuropathic pain

Generalized anxiety disorder (GAD) in adults

Dosage and Method of Administration:

MDD: Start and maintain at 60 mg once daily, with or without food. Max: 120 mg/day.

GAD: Start at 30 mg once daily; increase to 60 mg. Max: 120 mg/day.

Diabetic Neuropathy: Start and maintain at 60 mg/day. Max: 120 mg/day in divided doses.

Elderly: No adjustment needed, but caution at high doses.

Children: Not recommended.

Hepatic impairment: Contraindicated.

Renal impairment: Avoid in severe impairment (<30 ml/min).

Discontinuation: Taper gradually over at least 1–2 weeks.

Administration: For oral use.

Contraindications:

Hypersensitivity to duloxetine or excipients

Use with non-selective, irreversible MAOIs

Liver disease with hepatic impairment

Concomitant use with CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin)

Severe renal impairment (<30 ml/min)

Uncontrolled hypertension

Precautions:

Use caution in patients with bipolar disorder, seizures, increased intraocular pressure, or cardiac conditions

Monitor blood pressure and heart rate

Avoid abrupt discontinuation

Increased risk of suicidal thoughts in early treatment, especially in young adults

Risk of hyponatremia, especially in elderly or those on diuretics

Risk of serotonin syndrome, akathisia, and SIADH

Avoid in children and adolescents

Side Effects:

Very common:

Nausea, dry mouth, headache, somnolence

Common:

Insomnia, dizziness, decreased appetite, constipation, fatigue, blurred vision, increased sweating

Uncommon to rare:

Suicidal ideation, mania, mydriasis, liver injury, hyponatremia, Stevens-Johnson syndrome, aggression, hallucinations, sexual dysfunction, orthostatic hypotension, urinary retention, weight changes

Withdrawal symptoms (e.g., dizziness, agitation, insomnia) may occur upon discontinuation.

Pregnancy and Breastfeeding:

Not recommended during breastfeeding; limited data in infants

Duloxetine passes into breast milk in low amounts

Storage Conditions:

Store in a dry place at temperature not exceeding 30°C. Keep out of reach of children.

Packaging:

Carton box containing 3 blister 10 hard gelatin capsules and a leaflet insert.