Drugplain

amantadine hydrochloride 100 mg/1

amantadine hydrochloride · CAPSULE · Coupler LLC

No Recall HistoryCurrently in Shortage
Plain English

amantadine hydrochloride is a capsule containing amantadine hydrochloride at 100 mg/1, taken oral. Manufactured by Coupler LLC.

Key Facts

Brand Name
amantadine hydrochloride
Generic Name
amantadine hydrochloride
NDC Code (Product)
67046-1508
Manufacturer
Coupler LLC
Strength
100 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA208278
Marketing Start
01/27/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinic…

Dosage & Administration

DOSAGE AND ADMINISTRATION The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function ).

Warnings

WARNINGS Deaths Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension (see OVERDOSAGE ). Deaths due to drug accumulation (overdosage) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of amantadine hydrochloride for their level of renal function [see DOSAGE AND ADMINISTRATION: Dosage of Impaired Renal Function and OVERDOSAGE ]. Suicide Attempts Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness. Amantadine can exacerbate mental problems in patients with a history of psychiatric disorders …

Contraindications

CONTRAINDICATIONS Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules, USP.

Drug Interactions

Drug Interactions Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine. Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease, however, it is not known if other phenothiazines produce a similar response. Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson’s disease 1 . It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response. Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%. The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before o…

Adverse Reactions

ADVERSE REACTIONS The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy. Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see WARNINGS ). Other adverse reactions reported during postmarketing experience…

Frequently Asked Questions

What is amantadine hydrochloride used for?

amantadine hydrochloride contains amantadine hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is amantadine hydrochloride a controlled substance?

amantadine hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for amantadine hydrochloride?

The generic name for amantadine hydrochloride is amantadine hydrochloride. There are 11 other brand versions of amantadine hydrochloride.

What is the NDC code for amantadine hydrochloride 100 mg/1?

The NDC (National Drug Code) for amantadine hydrochloride 100 mg/1 is 67046-1508, listed by Coupler LLC.

Product NDC

67046-1508

Package NDC

67046-1508-3

Other amantadine hydrochloride Dosages

Other Amantadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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