Memantine Hydrochloride 14 mg/1
Memantine Hydrochloride · CAPSULE, EXTENDED RELEASE · Amneal Pharmaceuticals LLC
Memantine Hydrochloride is a capsule, extended release containing memantine hydrochloride at 14 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Memantine Hydrochloride
- Generic Name
- Memantine Hydrochloride
- NDC Code (Product)
65162-783- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 14 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205825
- Marketing Start
- 12/22/2017
Recall History
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
The Harvard Drug Group LLC
Failed Dissolution Specifications
The Harvard Drug Group
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
The Harvard Drug Group
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride tablets is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day. Memantine hydrochloride tablets can be taken with or without food. If a patient misses a single dose of memantine hydrochloride tablets, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride tablets for several days, dosing may need to be resumed at lower doses and retitrated as described above. Specific Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 to 29 mL/min based on the Cockcroft-Gault equation). Hepatic Impairment Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology (12.3) ] . May be taken …
Contraindications
4 CONTRAINDICATIONS Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs that Make the Urine Alkaline The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse effects. Urine pH is altered by diet, drugs (e.g. carbonic anhydrase inhibitors, sodium bicarbonate) and clinical state of the patient (e.g. renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions. 7.2 Use with Other N-methyl-D-aspartate (NMDA) Antagonists The combined use of memantine hydrochloride with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Memantine hydrochloride was evaluated in eight double-blind placebo-controlled trials involving a total of 1862 dementia (Alzheimer’s disease, vascular dementia) patients (940 patients treated with memantine hydrochloride and 922 patients treated with placebo) for a treatment period up to 28 weeks. 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 clinical practice. Adverse Events Leading to Discontinuation In placebo-controlled trials in which dementia patients received doses of memantine hydrochloride up to 20 mg/day, the likelihood of discontinuation because of an adverse reaction was the same in the memantine hydrochloride group (10.1%) as in the placebo group (11.5%). No …
Frequently Asked Questions
What is Memantine Hydrochloride used for?
Memantine Hydrochloride contains Memantine Hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Memantine Hydrochloride a controlled substance?
Memantine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Memantine Hydrochloride?
The generic name for Memantine Hydrochloride is Memantine Hydrochloride. There are 4 other brand versions of Memantine Hydrochloride.
What is the NDC code for Memantine Hydrochloride 14 mg/1?
The NDC (National Drug Code) for Memantine Hydrochloride 14 mg/1 is 65162-783, listed by Amneal Pharmaceuticals LLC.
Other Memantine Hydrochloride Dosages
- Memantine Hydrochloride10 mg/129300-172
- Memantine Hydrochloride10 mg/146708-452
- Memantine Hydrochloride5 mg/150090-6291
- Memantine Hydrochloride2 mg/mL62135-943
- Memantine Hydrochloride5 mg/163629-2513
- Memantine Hydrochloride28 mg/165162-785
- Memantine Hydrochloride10 mg/165862-653
- Memantine Hydrochloride5 mg/171610-979
Other Memantine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)