Memantine 10 mg/1
Memantine · TABLET · NorthStar RxLLC
Memantine is a tablet containing memantine at 10 mg/1, taken oral. Manufactured by NorthStar RxLLC.
Key Facts
- Brand Name
- Memantine
- Generic Name
- Memantine
- NDC Code (Product)
72603-119- Manufacturer
- NorthStar RxLLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090048
- Marketing Start
- 09/13/2022
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.
Forest Pharmaceuticals Inc
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Forest Pharmaceuticals Inc
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
The Harvard Drug Group LLC
Failed Dissolution Specifications
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Forest Pharmaceuticals Inc
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
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.
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 used for?
Memantine contains Memantine. It is a tablet taken oral. Consult your doctor for specific uses.
Is Memantine a controlled substance?
Memantine is not classified as a controlled substance by the DEA.
What is the generic name for Memantine?
The generic name for Memantine is Memantine. There are 11 other brand versions of Memantine.
What is the NDC code for Memantine 10 mg/1?
The NDC (National Drug Code) for Memantine 10 mg/1 is 72603-119, listed by NorthStar RxLLC.
Other Memantine Dosages
Other Memantine Brands
See all →- Memantine and Donepezil Hydrochlorides Extended-release10 mg/173190-004
- Memantine Hydrochloride10 mg/129300-172
- Memantine Hydrochloride10 mg/146708-452
- Memantine Hydrochloride5 mg/150090-6291
- memantine hydrochloride5 mg/152605-071
- Memantine hydrochloride10 mg/152605-072
- Memantine hydrochloride5 mg/153746-173
- MEMANTINE HYDROCHLORIDE7 mg/159651-404
- Memantine Hydrochloride2 mg/mL62135-943
- Memantine Hydrochloride5 mg/163629-2513
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)