Product Data
Composition:
Each tablet contains the active ingredient: Milnacipran Hydrochloride 25 mg or 50 mg
Indications And Usage:
Myodonia is indicated for the management of fibromyalgia.
Contraindications:
Monoamine Oxidase Inhibitors (MAOIs)
Adverse Reactions:
Adverse Reactions Leading to Discontinuation: Nausea, palpitations ,headache , constipation , heart rate increased, hyperhidrosis vomiting and dizziness. Lists of all adverse reactions that occurred in at least 2% of patients treated with Milnacipram at either 100 or 200 mg/day and at an incidence greater than that of placebo:Cardiac Disorders, Palpitations, Tachycardia, Eye Disorders, Vision blurred, Gastrointestinal Disorders, Nausea, Constipation, Vomiting, Dry mouth, Abdominal pain, General Disorders, Chest pain, Chills, Chest discomfort , Infections, Upper respiratory tract infection, Metabolism and Nutrition Disorders, Decreased appetite, Nervous System Disorders, Headache, Dizziness, Migraine, Paresthesia, Tremor, Hypoesthesia, Tension headache, Psychiatric Disorders, Insomnia, Anxiety, Respiratory Disorders, Dyspnea, Skin Disorders, Hyperhidrosis, Rash, Pruritus, Vascular Disorders, Hot flush, Hypertension, Flushing, Weight Changes 7. DRUG INTERACTIONS: 7.1 Monoamine Oxidase Inhibitors (MAOIs) 7.2 Serotonergic Drugs 7.3 Triptans 7.4 Catecholamines 7.5 CNS-active drugs
Dosage & Administration:
The recommended dose of Myodonia is 100 mg/day (50 mg twice daily).
Drug Interactions:
In vitro studies have shown that the biotransformation rate of milnacipran by human hepatic microsomes and hepatocytes was low. A low biotransformation was also observed following incubation of milnacipran with cDNA-expressed human CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 isozymes. No significant interaction with: Carbamazepine, Clomipramine, Digoxin, Fluoxetine, Lithium, Lorazepam, Pregabalin & Warfarin
How Supplied:
Carton Box containing (AL/Colorless transparent Aclar) strip of 10 Film Coated Tablet
Precautions:
1.Suicide Risk Patients, both adult and pediatric, with depression or other psychiatric disorders may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) 2.Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Milnacipram, Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g.,nausea, vomiting, diarrhea).Patients should be monitored for the emergence of serotonin syndrome. 3.Elevated Blood Pressure 4.Elevated Heart Rate 5.Seizures 6.Hepatotoxicity 7.Discontinuation of treatment with Myodonia: withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran as with other SNRIs and SSRIs 8.Hyponatremia 9.Abnormal Bleeding 10.Activation of Mania 11.Patients with a History of Dysuria Caution is advised in use of Milnacipram in patients with a history of dysuria, notably in male patients with prostatic hypertrophy, prostatitis, and other lower urinary tract obstructive disorders. Male patients are more prone to genitourinary adverse effects, such as dysuria or urinary retention, and may experience testicular pain or ejaculation disorders. 12.Angle Closure Glaucoma 13. Concomitant Use with Alcohol 14. The product contains Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
Nursing Mothers:
Milnacipran is present in the milk of lactating women treated with Myodonia. Because of the limited data regarding infant exposure to Myodonia, caution should be exercised when Myodonia is administered to a nursing woman.
Pediatric Use:
not recommended in pediatric patients.
Pregnancy & Lactation:
Pregnancy Category C There are no adequate or well-controlled studies in pregnant women. Milnacipram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
