Amantadine Hydrochloride (Amantadine Hydrochloride)

Trade Name : Amantadine Hydrochloride

Actavis Pharma, Inc.

CAPSULE

Strength 100 mg/1

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

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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 Actavis Pharma, Inc.. 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

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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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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 Capsules, USP
  • Rx Only
  • Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula CHNCl. It has the following structural formula:
  • Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.
  • Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug.
  • Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, pregelatinized starch, magnesium stearate. The capsule shell is composed of titanium dioxide, gelatin, sodium lauryl sulphate and the printing ink contains: shellac, propylene glycol, strong ammonia solution, black iron oxideu00a0and potassium hydroxide.
  • Meets USP dissolution test 2.
  • No data
  • Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
  • Influenza A Prophylaxis
  • Amantadine hydrochloride capsules 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 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 clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients.
  • There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.
  • The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules.
  • Parkinsonu2019s Disease/Syndrome
  • Amantadine hydrochloride capsules are indicated in the treatment of idiopathic Parkinsonu2019s disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinsonu2019s disease, amantadine is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.
  • Drug-Induced Extrapyramidal Reactions
  • Amantadine hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.
  • 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.
  • 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 ).
  • Deaths dueu00a0to drug accumulation (overdosage)u00a0haveu00a0been reported in patients with renal impairment, who wereu00a0prescribed higheru00a0than recommended doses ofu00a0amantadine hydrochlorideu00a0foru00a0theiru00a0level ofu00a0renal function (seeu00a0; u00a0and ).
  • 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 or substance abuse. Patients who attempt suicide may exhibit abnormal mental states which include disorientation, confusion, depression, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic reactions and somnolence or insomnia. Because of the possibility of serious adverse effects, caution should be observed when prescribing amantadine hydrochloride capsules to patients being treated with drugs having CNS effects, or for whom the potential risks outweigh the benefit of treatment.
  • CNS Effects
  • Patients with a history of epilepsy or other u201cseizuresu201d should be observed closely for possible increased seizure activity.
  • Patients receiving amantadine hydrochloride capsules who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.
  • Other
  • Patients with a history of congestive heart failure or peripheral edema should be followed closely as there are patients who developed congestive heart failure while receiving amantadine hydrochloride capsules.
  • Patients with Parkinsonu2019s disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.
  • Because Amantadine Hydrochloride Capsules, USP has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.
  • Amantadine should not be discontinued abruptly in patients with Parkinsonu2019s 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 (see ).
  • 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;
  • Misn- cellaneous
  • neuroleptic malignant syndrome (see ), 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 heartu00a0failure, peripheral edema, orthostatic hypotension, or impaired renal function (see ).
  • Amantadine hydrochloride capsules, USP for oral administration are available as:
  • 100 mg: n- A973
  • Bottles of 100 u00a0 (NDC 0591-4930-01)Bottles of 500u00a0u00a0 (NDC 0591-4930-05)
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP.
  • 1. W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can Med Assoc
  • J. 129:974-975, 1983.
  • 2. D.F. Casey, N. Engl. J. Med. 298:516, 1978.
  • 3. C.D. Berkowitz, J. Pediatr. 95:144, 1979.
  • Manufactured by:Watson Pharma Private Ltd.Verna, Salcette Goa 403 722 INDIA
  • Distributed by:Actavis Pharma Inc.Parsippany, NJ 07054 USA
  • Revised: January 2017ttu00a0u00a0u00a0u00a0u00a0nt
  • NDC 0591-4930-01Amantadine HydrochlorideCapsules100 mg100 Capsulesnttu00a0u00a0u00a0u00a0u00a0nt

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