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Emergence of resistance mutations could decrease drug effectiveness. Other factors for example, changes in viral virulence might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Amantadine hydrochloride capsules, USP. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's 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. Contraindications Amantadine hydrochloride capsules are contraindicated in patients with known hypersensitivity to Amantadine hydrochloride or to any of the other ingredients in Amantadine hydrochloride capsules.

Warnings Deaths Deaths have been reported from overdose with Amantadine hydrochloride. The lowest reported acute lethal dose was 1 gram. 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. 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 hydrochloride 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 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 "seizures" should be observed closely for possible increased seizure activity.

Patients receiving Amantadine hydrochloride 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. Patients with Parkinson's disease improving on Amantadine hydrochloride should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.

Because Amantadine Hydrochloride has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma. Precautions Amantadine hydrochloride should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i. 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.

Therefore, patients should be observed carefully when the dosage of Amantadine hydrochloride is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. 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.

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. 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. The management of NMS should include: 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.

Renal Disease Because Amantadine hydrochloride is mainly excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Dosage for Impaired Renal Function. Liver Disease Care should be exercised when administering Amantadine hydrochloride to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving Amantadine hydrochloride, though a specific relationship between the drug and such changes has not been established. Patients may be unable to control these urges while taking one or more of the medications that are generally used for the treatment of Parkinson's 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 Parkinson's 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 Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Amantadine hydrochloride forany indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals e. Other The dose of Amantadine hydrochloride may need careful adjustment in patients with congestive heart failure, peripheral edema, or orthostatic hypotension. Care should be exercised when administering Amantadine hydrochloride to patients with a history of recurrent eczematoid rash, or to patients with psychosis or severe psychoneurosis not controlled by chemotherapeutic agents.

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Amantadine hydrochloride has not been shown to prevent such complications. Information for Patients Patients should be advised of the following information: Gradually increase physical activity as the symptoms of Parkinson's disease improve. Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, light-headedness and orthostatic hypotension. Avoid getting up suddenly from a sitting or lying position.

If dizziness or lightheadedness occurs, notify physician. 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. Consult physician before discontinuing medication. Seek medical attention immediately if it is suspected that an overdose of medication has been taken. Drug Interactions Careful observation is required when Amantadine hydrochloride 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. The concurrent use of Amantadine hydrochloride 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 or 48 hours after administration of Amantadine hydrochloride, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus.

Trivalent inactivated influenza vaccine can be administered at any time relative to use of Amantadine hydrochloride. Carcinogenesis and Mutagenesis Long-term in vivo animal studies designed to evaluate the carcinogenic potential of Amantadine have not been performed. In several in vitro assays for gene mutation, Amantadine did not increase the number of spontaneously observed mutations in four strains of Salmonella typhimurium Ames Test or in a mammalian cell line Chinese Hamster Ovary cells when incubations were performed either with or without a liver metabolic activation extract. Impairment of Fertility The effect of Amantadine hydrochloride on fertility has not been adequately tested, that is, in a study conducted under Good Laboratory Practice GLP and according to current recommended methodology.

Thiazide diuretics may decrease the excretion of amantadine. What to do if overdose? Consult your nearest emergency animal hospital. How can I store Amantadine 100 mg Capsule? Helpful Tips: Since this drug is newer to veterinary medicine, cautions used in human medicine should be exercised. Pharmacists are standing by to offer Pet Parent counseling regarding prescription medication purchased from Allivet before and after dispensing. Pharmacists on duty are available Monday-Friday, 9: Dosage and administration: Always use as directed by your veterinarian.

Gocovri Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187. 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. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. The capsule shells and imprinting ink contain: Amantadine - Clinical Pharmacology Mechanism of Action Antiviral The mechanism by which Amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein.

In certain cases, Amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine. Antiviral Activity Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitro susceptibility of influenza A virus to Amantadine and the clinical response to therapy has not been established in man. Influenza viruses with reduced in vitro sensitivity have been shown to be transmissible and to cause typical influenza illness.

The quantitative relationship between the in vitro sensitivity of influenza A variants to Amantadine and the clinical response to therapy has not been established. Mechanism of Action Parkinson's Disease The mechanism of action of Amantadine hydrochloride in the treatment of Parkinson's disease and drug-induced extrapyramidal reactions is not known. Data from earlier animal studies suggest that Amantadine hydrochloride may have direct and indirect effects on dopamine neurons. Although Amantadine hydrochloride has not been shown to possess direct anticholinergic activity in animal studies, clinically, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation.

Pharmacokinetics Amantadine hydrochloride is well absorbed orally. It is primarily excreted unchanged in the urine by glomerular filtration and tubular secretion. Eight metabolites of Amantadine have been identified in human urine. AcetylAmantadine was not detected in the plasma of the remaining seven volunteers. The contribution of this metabolite to efficacy or toxicity is not known. There appears to be a relationship between plasma Amantadine concentrations and toxicity. As concentration increases, toxicity seems to be more prevalent, however, absolute values of Amantadine concentrations associated with adverse effects have not been fully defined.

Amantadine pharmacokinetics were determined in 24 normal adult male volunteers after the oral administration of a single Amantadine hydrochloride 100 mg soft gel capsule. The time to peak concentration was 3. The apparent oral clearance was 0. After 15 days of Amantadine 100 mg b. The administration of Amantadine tablets as a 200 mg single dose to 6 healthy subjects resulted in a Cmax of 0. Across studies, the time to Cmax Tmax averaged about 2 to 4 hours. Plasma Amantadine clearance ranged from 0. In six healthy volunteers, the ratio of Amantadine renal clearance to apparent oral plasma clearance was 0.

The apparent oral plasma clearance of Amantadine is reduced and the plasma half-life and plasma concentrations are increased in healthy elderly individuals age 60 and older. What special precautions are there? Amantadine is not for pets with kidney disease, seizure disorders, behavioral disorders, liver disease or congestive heart disease. Pets with untreated glaucoma or pregnant or nursing should not take Amantadine. Amatidine should not be taken with Trimethoprim-sulfa an antibiotic or quinidine a heart medication. Thiazide diuretics may decrease the excretion of amantadine. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of amantadine can be fatal. Overdose symptoms may include confusion, agitation , behavior changes, hallucinations, severe headache or pounding in your ears, muscle stiffness, problems with balance or walking, trouble breathing, fast heartbeats, or seizure. What should I avoid while taking amantadine? Do not receive a nasal flu vaccine while using amantadine, and for at least 48 hours after your last dose. The vaccine may not work as well during this time, and may not fully protect you from disease. Do not drink alcohol. Dangerous side effects could occur. Avoid driving or operating machinery until you know how amantadine will affect you.

Amantadine may impair your thinking or reactions. Some people taking amantadine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert. If you become pregnant while taking amantadine, call your doctor immediately. Amantadine may cause harm to the fetus. Do not drive a car, operate machinery, or participate in potentially dangerous activities until you know how this medication affects you.

Alcohol can make the side effects from amantadine worse. This is more common when you first start taking amantadine or if your dose has been increased. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem. What special dietary instructions should I follow? Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose? If you are taking the capsules, tablets, or liquid, take the missed dose as soon as you remember it.

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