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Amantadine Hydrochloride (Amantadine Hydrochloride)

Trade Name : amantadine hydrochloride

Bryant Ranch Prepack

CAPSULE

Strength 100 mg/1

AMANTADINE HYDROCHLORIDE Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amantadine Hydrochloride (Amantadine Hydrochloride) which is also known as amantadine hydrochloride and Manufactured by Bryant Ranch Prepack. It is available in strength of 100 mg/1 per ml. Read more

Amantadine Hydrochloride (Amantadine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.7 with a molecular formula CHN.HCl. It has the following structural formula:
  • Amantadine hydrochloride, USP is a white or almost white, crystalline powder, freely soluble in water, ethanol and methanol; soluble in chloroform; sparingly soluble in methylene chloride; practically insoluble in ether.
  • Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.
  • Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg of amantadine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: crosscarmellose sodium, ethyl cellulose, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide.
  • Meets USP Dissolution Test 2
  • No data
  • 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.
  • 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.
  • No data
  • Amantadine should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of amantadine should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech.
  • 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 ().
  • Other adverse reactions reported during postmarketing experience with amantadine usage include:
  • Nervous System/Psychiatric
  • coma, stupor, delirium, hypokinesia, hypertonia, delusions, aggressive behavior, paranoid reaction, manic reaction, involuntary muscle contractions, gait abnormalities, paresthesia, EEG changes, and tremor. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech;
  • Cardiovascular
  • cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia;
  • Respiratory
  • acute respiratory failure, pulmonary edema, and tachypnea;
  • Gastrointestinal
  • dysphagia;
  • Hematologic
  • leukocytosis, agranulocytosis;
  • Special Senses
  • keratitis and mydriasis;
  • Skin and Appendages
  • pruritus and diaphoresis;
  • Miscellaneous
  • neuroleptic malignant syndrome (), allergic reactions including anaphylactic reactions, edema, and fever.
  • Laboratory Test
  • elevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT.
  • Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management.
  • 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. Pulmonary edema and respiratory distress (including adult respiratory distress syndrome u2013 ARDS) have been reported; renal dysfunction including increased BUN, decreased creatinine clearance and renal insufficiency can occur. Central nervous system effects that have been reported include insomnia, anxiety, agitation, aggressive behavior, hypertonia, hyperkinesia, ataxia, gait abnormality, tremor, confusion, disorientation, depersonalization, fear, delirium, hallucinations, psychotic reactions, lethargy, somnolence and coma. Seizures may be exacerbated in patients with prior history of seizure disorders. Hyperthermia has also been observed in cases where a drug overdose has occurred.
  • There is no specific antidote for an overdose of amantadine. However, slowly administered intravenous physostigmine in 1 and 2 mg doses in an adult at 1- to 2-hour intervals and 0.5 mg doses in a child at 5- to 10-minute intervals up to a maximum of 2 mg/hour have been reported to be effective in the control of central nervous system toxicity caused by amantadine hydrochloride. For acute overdosing, general supportive measures should be employed along with immediate gastric lavage or induction of emesis. Fluids should be forced, and if necessary, given intravenously. The pH of the urine has been reported to influence the excretion rate of amantadine. Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body. The blood pressure, pulse, respiration and temperature should be monitored. The patient should be observed for hyperactivity and convulsions; if required, sedation, and anticonvulsant therapy should be administered. The patient should be observed for the possible development of arrhythmias and hypotension; if required, appropriate antiarrhythmic and antihypotensive therapy should be given.
  • Electrocardiographic monitoring may be required after ingestion, since malignant tachyarrhythmias can appear after overdose.
  • Care should be exercised when administering adrenergic agents, such as isoproterenol, to patients with an amantadine overdose, since the dopaminergic activity of amantadine has been reported to induce malignant arrhythmias.
  • The blood electrolytes, urine pH and urinary output should be monitored. If there is no record of recent voiding, catheterization should be done.
  • The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function ().
  • Product: 71335-0469
  • NDC: 71335-0469-1 20 CAPSULE in a BOTTLE
  • NDC: 71335-0469-2 30 CAPSULE in a BOTTLE
  • NDC: 71335-0469-3 10 CAPSULE in a BOTTLE
  • NDC: 71335-0469-4 14 CAPSULE in a BOTTLE
  • NDC: 71335-0469-5 60 CAPSULE in a BOTTLE
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured by:
  • Cadila Healthcare Ltd.
  • Matoda, Ahmedabad, India
  • Distributed by:
  • Zydus Pharmaceuticals USA Inc.
  • Pennington, NJ 08534
  • Rev.: 12/16
  • Revision Date: 23/12/2016
  • No data

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