Ixel Capsules (Hard Gelatin)
Milnacipran Hydrochloride
25mg
PIERRE FABRE MEDICAMENT LABORATORIES
| Pack size | 56's (14's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | CITY MEDICAL STORE |
| Retail Price | 79.50 AED |
Available as:
Indications
Ixel Capsules (Hard Gelatin) is used for:
Depression, Fibromyalgia
Adult Dose
Oral
Fibromyalgia
Adult:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Depression
Adult: 50 mg bid.
Hepatic impairment
Mild or moderate (Child-Pugh A or B): No dosage adjustment required
Severe (Child-Pugh C): Caution advised
Child Dose
<17 years: Safety and efficacy not established
Renal Dose
Renal impairment
Mild (CrCl 50-80 mL/min): No dosage adjustment required
Moderate (CrCl 30-49 mL/min): Use with caution
Severe (CrCl 5-29 mL/min): Reduce maintenance dosage by 50% (ie, to 50 mg/day divided q12hr)
End-stage renal disease (ESRD): Use not recommended
Administration
Should be taken with food. Preferably taken during meals.
Contra Indications
Uncontrolled narrow-angle glaucoma. Concomitant use w/ MAOI or w/in 2 wk after withdrawal of MAOI.
Precautions
Patient w/ major depressive disorder or other psychiatric disorders, history of dysuria, controlled narrow-angle glaucoma, pre-existing HTN, tachyarrhythmias or other CV disease, history of seizure disorder or condition predisposing to seizures (e.g. brain damage, alcoholism). Avoid abrupt withdrawal. Severe hepatic and moderate to severe renal impairment including ESRD. Pregnancy and lactation.
Lactation: Drug is excreted in human milk; peak breast milk concentration is observed within 4 hours after maternal dose, and estimated infant exposure is 5% of maternal dose; limited data are available regarding infant exposure, but caution is advised
Pregnancy-Lactation
Pregnancy category: C
Lactation: Drug is excreted in human milk; peak breast milk concentration is observed within 4 hours after maternal dose, and estimated infant exposure is 5% of maternal dose; limited data are available regarding infant exposure, but caution is advised
Interactions
Increased risk of bleeding w/ aspirin, NSAIDs, warfarin and other drugs that affect coagulation. Increased CNS effects w/ centrally-acting drugs (e.g. clomipramine). Increased risk of serotonin syndrome and NMS-like reactions w/ serotonergic drugs (e.g. tramadol), SSRIs, other selective serotonin-norepinephrine reuptake inhibitors, 5-HT1 receptor agonists (e.g. sumatriptan), antipsychotic agents and other dopamine antagonists. May inhibit antihypertensive effect of clonidine. May potentiate adverse haemodynamic effects w/ digoxin. Paroxysmal HTN and cardiac arrhythmia may occur when taken concurrently w/ epinephrine or norepinephrine.
Potentially Fatal: Increased risk of serotonin syndrome and NMS-like reactions w/ MAOIs (e.g. linezolid, IV methylene blue).
Adverse Effects
Side effects of Milnacipran Hydrochloride :
>10%
Nausea (37%), Headache (18%), Constipation (16%), Hot flush (12%), Insomnia (12%)
1-10% (selected)
Dizziness, Hyperhidrosis, Hypertension, Migraine, Palpitations, Tachycardia, Vomiting, Xerostomia
Frequency Not Defined
Abnormal bleeding, Depression (worsening), Serotonin syndrome, Suicidal thoughts, Withdrawal signs or symptoms
Potentially Fatal: Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions, suicidal thinking/behaviour.
Mechanism of Action
SNRI; has no affinity for other neurotransmitter receptors (including gamma-aminobutyric acid [GABA], beta-adrenergic, opiate, histaminergic, and benzodiazepine receptors) and has no MAOI activity.
Note
Ixel 25mg Capsules (Hard Gelatin) manufactured by PIERRE FABRE MEDICAMENT LABORATORIES. Its generic name is Milnacipran Hydrochloride. Ixel is availble in United Arab Emirates.
Farmaco UAE drug index information on Ixel Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.