Amantadine Hydrochloride 50 mg/5mL
Amantadine Hydrochloride · SOLUTION · American Health Packaging
Amantadine Hydrochloride is a solution containing amantadine hydrochloride at 50 mg/5mL, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Amantadine Hydrochloride
- Generic Name
- Amantadine Hydrochloride
- NDC Code (Product)
60687-797- Manufacturer
- American Health Packaging
- Strength
- 50 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074509
- Marketing Start
- 02/26/2024
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Jubilant Cadista Pharmaceuticals, Inc.
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 solution 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 3 other brand versions of Amantadine Hydrochloride.
What is the NDC code for Amantadine Hydrochloride 50 mg/5mL?
The NDC (National Drug Code) for Amantadine Hydrochloride 50 mg/5mL is 60687-797, listed by American Health Packaging.
Other Amantadine Hydrochloride Dosages
- Amantadine Hydrochloride100 mg/10832-1015
- Amantadine Hydrochloride100 mg/116571-834
- Amantadine Hydrochloride100 mg/171335-2919
- Amantadine Hydrochloride100 mg/10615-8263
- Amantadine Hydrochloride100 mg/182804-196
- Amantadine Hydrochloride100 mg/150090-0020
- Amantadine Hydrochloride100 mg/160760-779
- Amantadine Hydrochloride100 mg/164380-862
- Amantadine Hydrochloride100 mg/10mL68999-011
Other Amantadine 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)