Cymbatex 60 mg 30 capsules
Eva Pharma
Eva Pharma
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.