Milnacipran Hydrochloride 25 mg/1
Milnacipran Hydrochloride · TABLET · Breckenridge Pharmaceutical, Inc.
Milnacipran Hydrochloride is a tablet containing milnacipran hydrochloride at 25 mg/1, taken oral. Manufactured by Breckenridge Pharmaceutical, Inc..
Key Facts
- Brand Name
- Milnacipran Hydrochloride
- Generic Name
- Milnacipran Hydrochloride
- NDC Code (Product)
51991-876- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205071
- Marketing Start
- 03/19/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Milnacipran hydrochloride tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)] . Milnacipran hydrochloride tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (1) . Milnacipran hydrochloride tablets are not approved for use in pediatric patients (1) .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Milnacipran hydrochloride tablets are given orally with or without food. Taking milnacipran hydrochloride tablets with food may improve the tolerability of the drug. • Administer milnacipran hydrochloride tablets in two divided doses per day (2.1) . • Based on efficacy and tolerability, dosing may be titrated according to the following schedule (2.1) : Day 1: 12.5 mg once Days 2 to 3: 25 mg/day (12.5 mg twice daily) Days 4 to 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily) • Recommended dose is 100 mg/day (2.1) . • May be increased to 200 mg/day based on individual patient response (2.1) . • Adjust dose in patients with severe renal impairment (2.2) . 2.1 Recommended Dosing The recommended dose of milnacipran hydrochloride tablet 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 once Days 2 to 3: 25 mg/day (12.5 mg twice daily) Days 4 to 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/da…
Contraindications
4 CONTRAINDICATIONS Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with milnacipran hydrochloride or within 5 days of stopping treatment with milnacipran hydrochloride. Do not use milnacipran hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start milnacipran hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 , 5.2 ). 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with milnacipran hydrochloride or within 5 days of stopping treatment with milnacipran hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of milnacipran hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . Starting milnacipran hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.6) , Warnings a…
Drug Interactions
7 DRUG INTERACTIONS Milnacipran undergoes minimal CYP450 related metabolism, with the majority of the dose excreted unchanged in urine (55%) and has a low binding to plasma proteins (13%). In vitro and in vivo studies showed that milnacipran hydrochloride is unlikely to be involved in clinically significant pharmacokinetic drug interactions [see Pharmacokinetics in Special Populations (12.3)] . • Milnacipran hydrochloride is unlikely to be involved in clinically significant pharmacokinetic drug interactions (7) . • Pharmacodynamic interactions of milnacipran hydrochloride with other drugs can occur (7) . 7.1 Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of SSRIs and SNRIs, including milnacipran hydrochloride, with MAOIs increases the risk of serotonin syndrome. The use of MAOIs intended to treat psychiatric disorders with milnacipran hydrochloride or within 5 days of stopping treatment with milnacipran hydrochloride is contraindicated. The use of milnacipran hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. In addition, do not initiate milnacipran hydrochloride in a patient who is being treated with MAOIs su…
Adverse Reactions
6 ADVERSE REACTIONS The most frequently occurring adverse reactions (≥ 5% and greater than placebo) were nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Patient Exposure Milnacipran hydrochloride was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with milnacipran hydrochloride and 652 patients treated with placebo) for a treatment period up to 29 weeks. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occ…
Frequently Asked Questions
What is Milnacipran Hydrochloride used for?
Milnacipran Hydrochloride contains Milnacipran Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Milnacipran Hydrochloride a controlled substance?
Milnacipran Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Milnacipran Hydrochloride?
The generic name for Milnacipran Hydrochloride is Milnacipran Hydrochloride. There are 7 other brand versions of Milnacipran Hydrochloride.
What is the NDC code for Milnacipran Hydrochloride 25 mg/1?
The NDC (National Drug Code) for Milnacipran Hydrochloride 25 mg/1 is 51991-876, listed by Breckenridge Pharmaceutical, Inc..