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Amantadine Hydrochloride (Amantadine Hydrochloride)

Trade Name : AMANTADINE HYDROCHLORIDE

Pharmaceutical Associates, Inc.

SOLUTION

Strength 50 mg/5mL

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

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Pharmaceutical Associates, Inc.. It is available in strength of 50 mg/5mL 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
  • Rx only
  • Amantadine Hydrochloride Oral Solution USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.
  • Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.
  • Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.
  • Amantadine Hydrochloride Oral Solution USP contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: artificial raspberry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution. May contain sodium hydroxide to adjust pH to approximately 2.3.
  • No data
  • Amantadine hydrochloride oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
  • Amantadine hydrochloride oral solution USP is contraindicated in patients with known hypersensitivity to amantadine hydrochloride or any of the other ingredients in the drug.
  • No data
  • Amantadine hydrochloride 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 hydrochloride 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 hydrochloride (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 (n n n n ).n nn
  • Other adverse reactions reported during postmarketing experience with amantadine hydrochloride 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 and agranulocytosis;
  • Special Senses
  • keratitis and mydriasis;
  • Skin and Appendages
  • pruritus and diaphoresis;
  • Miscellaneous
  • neuroleptic malignant syndrome (n n n n ), allergic reactions including anaphylactic reactions, edema and fever.n nn
  • Laboratory Tests
  • elevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT.
  • Deaths have been reported from overdose with amantadine hydrochloride. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine hydrochloride, prescriptions should be written for the smallest quantity consistent with good patient management.
  • Acute toxicity may be attributable to the anticholinergic effects of amantadine hydrochloride. 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 - 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 hydrochloride. However, slowly administered intravenous physostigmine in 1 and 2 mg doses in an adultn n n at 1- to 2-hour intervals and 0.5 mg doses in a childn n n 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 hydrochloride. Since the excretion rate of amantadine hydrochloride 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.n nn
  • Care should be exercised when administering adrenergic agents, such as isoproterenol, to patients with an amantadine hydrochloride overdose, since the dopaminergic activity of amantadine hydrochloride 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 may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function. (n n n n ).n nn
  • Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL is colorless with a raspberry flavor and is supplied in the following oral dosage forms:
  • NDC 0121-0646-10 (Unit dose cups of 100 mg/10 mL, 10 unit dose cups per tray, 10 trays per case) and NDC 0121-0646-16 (16 fl oz or 473 mL bottles).
  • Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • No data
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n
  • R10/11
  • Delivers n n n n
  • NDC 0121-0646-10
  • Arrayn- An n n Hn n n n On n n Sn n n USPn n n
  • Each 10 mL contains: Amantadine Hydrochloriden n n n n Usage Dosage: See Insertn nn
  • Rx ONLY
  • A06461000

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

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GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

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