Milran

Milran12.5 mg

Tablet

Milnacipran Hydrochloride

Beacon Pharmaceuticals PLC

Product Code : 10771
MRP 6.02
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Medicine overview

Indications of Milran 12.5 mg

Milnacipran is indicated for the management of fibromyalgia. Milnacipran is not approved for use in pediatric patients

Theropeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Pharmacology

Milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake. It inhibits norepinephrine uptake with approx 3-fold higher potency in vitro than serotonin with directly affecting the uptake of dopamine or other neurotransmitters.

Dosage of Milran 12.5 mg

The recommended dose of Milnacipran is 100 mg/day (50 mg twice daily). Based on efficacy and tolerability dosing may be titrated according to the following schedule:Day 1: 12.5 mg onceDays 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). Doses above 200 mg/day have not been studied.

Administration of Milran 12.5 mg

Should be taken with food. Preferably taken during meals.

Interaction of Milran 12.5 mg

Increased risk of bleeding with aspirin, NSAIDs, warfarin and other drugs that affect coagulation. Increased CNS effects with centrally-acting drugs (e.g. clomipramine). Increased risk of serotonin syndrome and NMS-like reactions with 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 with digoxin. Paroxysmal HTN and cardiac arrhythmia may occur when taken concurrently with epinephrine or norepinephrine.

Contraindications

Uncontrolled narrow-angle glaucoma. Concomitant use with MAOI or within 2 wk after withdrawal of MAOI.

Side Effects of Milran 12.5 mg

Increased heart rate, HTN, increased liver enzymes, severe liver injury, hyponatraemia, abnormal bleeding, dysuria, mydriasis, nausea, vomiting, constipation, headache, insomnia, dizziness, hot flushes, hyperhidrosis, palpitations, dry mouth, migraine.

Pregnancy & Lactation

Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Milnacipran therapy. Patients should be encouraged to enroll in the Milnacipran Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy. Nursing: Advise patients to notify their physician if they are breast feeding

Precautions & Warnings

Patient with 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.

Overdose Effects of Milran 12.5 mg

Symptoms: Increased BP, cardio-resp arrest, changes in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes. Management: Symptomatic treatment with gastric lavage and activated charcoal. Maintain adequate airway, oxygenation and ventilation and monitor cardiac rhythm and vital signs. May give cyproheptadine with adequate temp control to treat serotonin syndrome.

Storage Conditions

Store at 25° C.

Use In Special Populations

Renal Impairment: Severe (CrCl 5-29 mL/min): 25 mg bid, may increase to 50 mg bid according to response. End stage renal disease (ESRD): Not recommended.Pediatric use: Safety and effectiveness of Milnacipran in a fibromyalgia pediatric population below the age of 18 have not been established. The use of Milnacipran is not recommended in pediatric patients.

Drug Classes

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Mode Of Action

Milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake. It inhibits norepinephrine uptake with approx 3-fold higher potency in vitro than serotonin with directly affecting the uptake of dopamine or other neurotransmitters.

Pregnancy

Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Milnacipran therapy. Patients should be encouraged to enroll in the Milnacipran Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy. Nursing: Advise patients to notify their physician if they are breast feeding

Pediatric Uses

Renal Impairment: Severe (CrCl 5-29 mL/min): 25 mg bid, may increase to 50 mg bid according to response. End stage renal disease (ESRD): Not recommended.Pediatric use: Safety and effectiveness of Milnacipran in a fibromyalgia pediatric population below the age of 18 have not been established. The use of Milnacipran is not recommended in pediatric patients.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.