Namzaric 10 mg/1
memantine hydrochloride and donepezil hydrochloride · CAPSULE · Allergan, Inc.
Namzaric is a capsule containing memantine hydrochloride and donepezil hydrochloride at 10 mg/1, taken oral. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- Namzaric
- Generic Name
- memantine hydrochloride and donepezil hydrochloride
- NDC Code (Product)
0456-1207- Manufacturer
- Allergan, Inc.
- Strength
- 10 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA206439
- Marketing Start
- 07/18/2016
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 NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For patients on donepezil hydrochloride 10 mg only, the recommended starting dose of NAMZARIC is 7 mg/10 mg, taken once daily in the evening. The dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg/10 mg. The minimum recommended interval between dose increases is one week. ( 2.1 ) Patients on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg once daily can be switched to NAMZARIC 28 mg/10 mg, taken once daily in the evening. ( 2.1 ) NAMZARIC can be taken with or without food, whole or sprinkled on applesauce; do not divide, chew, or crush. ( 2.2 ) Severe renal impairment: the recommended maintenance dose for NAMZARIC is 14 mg/10 mg once daily in the evening. ( 2.3 ) 2.1 Recommended Dosing The recommended dose of NAMZARIC is 28 mg/10 mg once daily. For patients stabilized on donepezil and not currently on memantine: For patients stabilized on donepezil hydrochloride 10 mg and not currently on memantine hydrochloride, the recommended starting dose of NAMZARIC is 7 mg/10 mg, taken once a day in the evening. The dose should be increased in 7 mg increments of…
Contraindications
4 CONTRAINDICATIONS NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation . NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Combined use with NMDA antagonists: use with caution. ( 7.2 ) NAMZARIC may interfere with anticholinergic medications. ( 7.4 ) Concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists may lead to synergistic effect. ( 7.5 ) 7.1 Use of Memantine with 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 reactions. 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 of Memantine 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. 7.3 Effect of Other Drugs on the Metabolism of Done…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling. Cardiovascular Conditions [see Warnings and Precautions (5.2) ] Peptic Ulcer Disease and Gastrointestinal Bleeding [see Warnings and Precautions (5.3) ] Nausea and Vomiting [see Warnings and Precautions (5.4) ] Genitourinary Conditions [see Warnings and Precautions (5.5) ] Seizures [see Warnings and Precautions (5.6) ] Pulmonary Conditions [see Warnings and Precautions (5.7) ] The most common adverse reactions, occurring at a frequency of at least 5% and greater than placebo with memantine hydrochloride extended-release 28 mg/day, were headache, diarrhea, and dizziness. ( 6.1 ) The most common adverse reactions, occurring at a frequency of at least 5% in patients receiving donepezil hydrochloride and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 clinic…
Frequently Asked Questions
What is Namzaric used for?
Namzaric contains memantine hydrochloride and donepezil hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Namzaric a controlled substance?
Namzaric is not classified as a controlled substance by the DEA.
What is the generic name for Namzaric?
The generic name for Namzaric is memantine hydrochloride and donepezil hydrochloride. There are 2 other brand versions of memantine hydrochloride and donepezil hydrochloride.
What is the NDC code for Namzaric 10 mg/1?
The NDC (National Drug Code) for Namzaric 10 mg/1 is 0456-1207, listed by Allergan, Inc..