Amantadine Hydrochloride (Amantadine Hydrochloride)

Trade Name : Amantadine Hydrochloride

Lannett Company, 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 Lannett Company, 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.

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 187.71 with a molecular formula CHNCl.u00a0 It has the following structural formula:
  • Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.u00a0
  • Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.u00a0
  • Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, corn starch, croscarmellose sodium, ethylcellulose, magnesium stearate, sodium lauryl sulfate, and purified water. The capsule shell contains: gelatin, titanium dioxide, and FD&C Red #40. The imprinting ink contains: shellac glaze, titanium dioxide, isopropyl alcohol, ammonium hydroxide, n-butyl alcohol, propylene glycol, and simethicone.
  • 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.u00a0
  • 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.u00a0
  • 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.u00a0
  • 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.u00a0
  • 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.u00a0
  • 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.
  • u00a0Amantadine 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 ).u00a0
  • 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 ).
  • 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.u00a0
  • CNS Effects:
  • Patients with a history of epilepsy or other u201cseizuresu201d should be observed closely for possible increased seizure activity.u00a0
  • 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.n
  • 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.u00a0
  • 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.u00a0
  • 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.u00a0
  • Neuroleptic Malignant Syndrome (NMS):
  • Sporadic cases of possible Neuroleptic Malignant Syndrome (NMS) have been reported in association with dose reduction or withdrawal of amantadine therapy. Therefore, patients should be observed carefully when the dosage of amantadine is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.u00a0
  • NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia; neurologic findings including muscle rigidity, involuntary movements, altered consciousness; mental status changes; other disturbances such as autonomic dysfunction, tachycardia, tachypnea, hyper- or hypotension; laboratory findings such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin.u00a0
  • The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.u00a0
  • The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring, and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies.u00a0
  • Renal Disease:
  • Because amantadine is mainly excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine should be reduced in patients with renal impairment and in individuals who are 65 years of age or older (see n ).n
  • Liver Disease
  • Care should be exercised when administering amantadine to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving amantadine, though a specific relationship between the drug and such changes has not been established.u00a0
  • Impulse Control/Compulsive Behaviors:
  • Postmarketing reports suggest that patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Patients may be unable to control these urges while taking one or more of the medications that are generally used for the treatment of Parkinsonu2019s disease and that increase central dopaminergic tone, including amantadine hydrochloride. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with amantadine hydrochloride. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking amantadine hydrochloride.
  • Melanoma:
  • Epidemiological studies have shown that patients with Parkinsonu2019s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinsonu2019s disease or other factors, such as drugs used to treat Parkinsonu2019s disease, is unclear.u00a0
  • For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using amantadine for indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).u00a0
  • Other:
  • The dose of amantadine may need careful adjustment in patients with congestive heart failure, peripheral edema, or orthostatic hypotension. Care should be exercised when administering amantadine to patients with a history of recurrent eczematoid rash, or to patients with psychosis or severe psychoneurosis not controlled by chemotherapeutic agents.u00a0
  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Amantadine has not been shown to prevent such complications.u00a0
  • Information for Patients:
  • Patients should be advised of the following information:u00a0
  • Blurry vision and/or impaired mental acuity may occur.u00a0
  • Gradually increase physical activity as the symptoms of Parkinsonu2019s disease improve.u00a0
  • Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, light-headedness and orthostatic hypotension.u00a0
  • Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician.
  • Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur.u00a0
  • Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician.u00a0
  • Consult physician before discontinuing medication.u00a0
  • Seek medical attention immediately if it is suspected that an overdose of medication has been taken.u00a0
  • The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia.u00a0
  • 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.u00a0
  • 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.u00a0
  • 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 ).u00a0
  • Other adverse reactions reported during postmarketing experience with amantadine usage include:u00a0
  • 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;n
  • Cardiovascular:
  • cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia;u00a0
  • Respiratory:
  • acute respiratory failure, pulmonary edema, and tachypnea;n
  • Gastrointestinal:
  • dysphagia;n
  • Hematologic:
  • leukocytosis, agranulocytosis;n
  • Special Senses:
  • keratitis and mydriasis;n
  • Skin and Appendages:
  • pruritus and diaphoresis;n
  • Miscellaneous:
  • neuroleptic malignant syndrome (see ), allergic reactions including anaphylactic reactions, edema, 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.u00a0
  • 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.u00a0
  • 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.u00a0
  • Electrocardiographic monitoring may be required after ingestion, since malignant tachyarrhythmias can appear after overdose.u00a0
  • 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.u00a0
  • 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 (see n ).
  • Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg size #2 Red Opaque/Red Opaque capsules, imprinted with logo u201cLannettu201d on the cap and u201c1868u201d on the body. The capsules are supplied as:u00a0
  • NDC 0527-1868-01 bottles of 100u00a0
  • NDC 0527-1868-05 bottles of 500u00a0
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) (see USP Controlled Room Temperature).u00a0
  • Dispense in a tight container as defined in the USP.
  • Manufactured by:Lannett Company, Inc.Philadelphia, PA 19154
  • CIB71785A
  • Rev. 05/17
  • u00a0NDC 0527--01
  • AmantadineHydrochlorideCapsules, USP
  • 100 mg
  • Rx Only
  • 100 CAPSULES
  • Lannett

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