Suicidal Thoughts Or Actions
Suicidal thoughts or actions are a rare side effect of amantadine, occurring in fewer than 0.1% of people.
Many people affected in this way have taken amantadine for influenza prevention or treatment. This side effect can develop in people with no history of psychiatric illness.
People taking amantadine, and those close to them, should look carefully for any behavioral changes, including agitation, personality changes, paranoia, depression, and anxiety.
Some Side Effects Can Be Serious If You Experience Any Of These Symptoms Call Your Doctor Immediately:
- believing things that are not true
- not trusting others or feeling that others want to hurt you
- lack of interest, enthusiasm, or concern
- dizziness, lightheadedness, fainting, or blurred vision
- swelling of the hands, feet, ankles, or lower legs
- difficulty urinating
- shortness of breath
Amantadine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .
Clinical Features Associated With Anti
Of the 30 participants who completed the study, 20 patients responded to amantadine. The demographical and clinical features were included for analysis using multivariate logistic regression models. Results showed that patients with a higher age of Parkinson’s disease onset /10 years) and higher doses of dopamine agonists /100mg LDED) were more likely to respond to amantadine.
Randomization And Treatment Interventions
Patients were judged eligible by neurologists at the participating hospitals and were consented for enrollment peripheral blood was sampled at each hospital, and creatinine clearance was calculated at the coordination center. Eligible participants were provided unique subject identification numbers according to study criteria and were assigned to Arm 1 or Arm 2 by a research technician , according to a computer-generated, randomization plan, which included stratification by severity of dyskinesia . Study medications were sent to each hospital from the coordinating center, according to the schedule. A list of subject identification numbers and corresponding treatment assignments was restricted to K.H. and were concealed from other study personnel.
Arm 1 intervention consisted of an observation period , amantadine hydrochloride treatment period , washout period , and placebo treatment period . Arm 2 intervention consisted of an observation period, placebo period, a washout period, and an amantadine treatment period . Amantadine was increased in a step-by-step manner , followed by a decreased treatment regimen . Placebo was also administered in a similar manner. The subjects were interviewed every 7th day, and adverse effects were monitored. Trial drugs were not increased if the patients did not desire the increase or if adverse effects were detected.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to amantadine.
If you are taking the extended-release tablets , you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and does not mean that you did not get your complete dose of medication.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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How Should This Medicine Be Used
Amantadine comes as a capsule, extended-release capsule , tablet, extended-release tablet , and liquid to take by mouth. The capsules, tablets, and liquid medications are usually taken once or twice a day. The extended-release capsules are usually taken once a day at bedtime. The extended-release tablets are usually taken once a day in the morning. Take amantadine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amantadine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release capsules and extended-release tablets whole do not split, chew, or crush them. If you have difficulty swallowing the extended-release capsule, you may open the capsule and sprinkle the entire contents on a teaspoonful of soft food, like applesauce. Eat the mixture right away and swallow without chewing.
If you are taking amantadine for Parkinson’s disease, your doctor may start you on a low dose of amantadine and gradually increase your dose.
Do not stop taking amantadine without talking to your doctor. If you suddenly stop taking amantadine, you may experience fever, confusion, changes in mental state, or severe muscle stiffness. Your doctor will probably decrease your dose gradually.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
Efficacy Outcomes And Analyses
The primary efficacy outcome measure in both studies was change from baseline in the Unified Dyskinesia Rating Scale total score, as assessed at week 12 . Relevant to the present analyses, as a key secondary outcome, all patients completed home diaries for the two consecutive days prior to each scheduled visit, in which they categorized their predominant motor state during each half-hour interval of the 24-h day as: ON without dyskinesia, ON with non-troublesome dyskinesia, ON with troublesome dyskinesia, OFF, or asleep . Patients and caregivers received training on how to use the diaries during the screening period, and concordance with the diary was confirmed during the baseline period. Diaries with 4 missing entries per day were considered unevaluable for analysis. Otherwise, missing data were imputed by assigning the 30 min of each missing interval, in equal portions of 15 min each, to the responses of the immediately preceding and subsequent completed intervals.
All analyses were set at a two-sided, 5% significance level and were performed using SAS version 9.4 .
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For People With Parkinson’s Disease
- Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. During the first few weeks of treatment in particular, your dose may require adjusting.
- Stay as active as possible and exercise regularly as much as you are able. You may walk more slowly than before but a daily walk is good exercise and may help to loosen up stiff muscles.
- If you are a driver you should tell the DVLA and your insurance company that you have Parkinson’s disease. Depending on the severity of symptoms and the medicines that you are taking, you may still be allowed to drive following a medical assessment.
- Treatment with medicines for Parkinson’s disease can sometimes cause problems with impulsive types of behaviour. If you notice any changes in your behaviour, such as an increased desire to gamble, binge eat, or spend excessively, or an increased sex drive, you must let your doctor know as soon as possible.
- Continue to take amantadine regularly. Stopping treatment suddenly can cause serious problems. Your doctor will probably want you to reduce your dose gradually if this becomes necessary.
There Is Not Enough Evidence About The Safety And Effectiveness Of Amantadine For People With Parkinson’s Disease
Parkinson’s disease causes progressive muscle rigidity, tremors and other symptoms. The most common drug used to try and relieve these symptoms is levodopa, but serious physical and psychiatric adverse effects are common. Amantadine is another option, used alone or with levodopa. Amantadine can have serious adverse effects , and people can become resistant to the drug. The review found that there is not enough evidence from trials about the effects of amantadine for people with Parkinson’s disease. Adverse effects in trials so far have not been severe, and included skin rash, dry mouth and blurred vision.
A considerable amount of evidence on the effectiveness of amantadine has accrued from non-controlled trials, often in patients with Parkinsonian conditions other than idiopathic Parkinson’s disease. However, rigorous analysis of the six randomised controlled trials of amantadine reveals insufficient evidence of its efficacy and safety in the treatment of idiopathic Parkinson’s disease.
Although levodopa is the most common drug prescribed to relieve the symptoms of Parkinson’s disease it is associated with motor and psychiatric side-effects. Consequently, interest has turned to alternative drugs with improved side-effect profiles to replace or augment levodopa. Amantadine, originally used as an antiviral drug, has been shown to improve the symptoms of Parkinson’s disease.
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Drug Interactions And Contraindications
Other drugs that have anticholinergic effects can worsen the anticholinergic adverse effects of amantadine. Doses may need to be reduced if anticholinergic AEs occur .4
Amantadine has an excretion rate related to the acidity of the urine. Any drug, change in diet, or patient state that influences urine pH may alter the elimination or accumulation of amantadine and will need to be monitored.
Alcohol increases sedation and orthostatic hypotension and should not be taken with amantadine. Live influenza vaccines are also not recommended as amantadine may interfere with the efficacy of the vaccine.
Amantadine is contraindicated in patients with end-stage renal disease .
Gocovri First Drug Approved For Dyskinesia In Patients With Parkinsons Disease
Parkinsons disease, a neurodegenerative disorder, affects approximately 1 million individuals in the United States, and 60,000 new cases are diagnosed annually.1 Characterized by low dopamine concentrations and progressive brain-cell destruction, Parkinsons disease affects the bodys motor system, including neurotransmitters.2,3 Accurately diagnosing Parkinsons disease can be challenging and generally requires a medical history, neurologic examination, and laboratory tests to rule out other disorders.1
The symptoms of Parkinsons disease include trembling or tremor, limb rigidity, bradykinesia , and impaired balance and coordination.1 The disease can also cause difficulty speaking, swallowing, and performing everyday activities. Overall, Parkinsons disease can have a considerable impact on the patients quality of life.2
When the symptoms of Parkinsons disease are being controlled, the episode is referred to as on time.2 Conversely, when symptoms are not responding to treatment, the episode is called an off time.2 Treatments for Parkinsons disease include levodopa plus carbidopa, dopamine agonists, monoamine oxidase -B inhibitors, catechol-O-methyltransferase inhibitors, anticholinergic drugs, and amantadine.3
FDA Approves Gocovri for Dyskinesia Associated with Parkinsons Disease
Mechanism of Action
Dosing and Administration
Amantadine is available as an extended-release formulation in 68.5-mg or 137-mg capsules.8
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Characteristics Of Included Studies
Randomised, doubleblind crossover study. Method of randomisation not stated. Data presented from the amantadine group only after the first arm of the trial. Per protocol analysis. Location: One centre in the USA. Duration: The first crossover lasted 4 weeks but the whole of this complex study lasted 13 months.
23 patients with 7 withdrawals . 10 patients were male and 13 were female. Mean age: 66 years . Mean number of years since diagnosis: 7.6 . Ethnicity: 19 white and 4 black. Hoehn and Yahr scores: 3 patients in Stage I 9 in Stage II 8 in Stage III 2 in Stage IV and 1 in Stage V. Mean = 2.5. Inclusion criteria: IPD no previous levodopa or amantadine therapy no severe medical illnesses. Exclusion criteria: none stated.
Amantadine hydrochloride 100 mg twice daily or placebo for 2 weeks, followed by opposite treatment for 2 weeks. Patients maintained on most effective drug for 5 months plus a slowly increasing dose of levodopa . Followed by 2 weeks of amantadine or placebo , then 2 weeks of opposite treatment. Most effective treatment plus levodopa continued for next 5 months. Followed by amantadine or placebo for 2 weeks then 2 weeks of opposite treatment . Anticholinergic drugs continued during trial but reduced to a single drug if more than one being taken.
2. Neurological examination with scoring of parkinsonian signs. 3. Timed tasks.
Can Amantadine Cause Problems
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the common ones associated with amantadine. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
|Very common amantadine side-effects||What can I do if I experience this?|
|Swollen ankles, red skin blotches||If troublesome, speak with your doctor|
|Common amantadine side-effects||What can I do if I experience this?|
|Loss of appetite, feeling sick , constipation||Eat a well-balanced diet and drink plenty of water|
|Blurred vision feeling dizzy, light-headed or tired||Do not drive and do not use tools or machines while affected. Do not drink alcohol|
|Dry mouth||Try chewing sugar-free gum or sucking sugar-free sweets|
|Headache, muscle pain||Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know|
|Feeling anxious or confused, changes in your mood, difficulties sleeping, lack of concentration, slurred speech, a fast heartbeat, increased sweating, hearing or seeing things that are not real||If any of these become troublesome, speak with your doctor|
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Getting The Most From Your Treatment
- Sometimes people taking medicines like amantadine can fall asleep suddenly with little or no warning of being tired beforehand. Until you know how you react, take extra care if you operate machinery or drive. If you do find yourself falling asleep suddenly, you should see your doctor as soon as possible for advice, and avoid driving or using tools and machines in the meantime.
What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture .
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
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Literature Selection And Study Characteristics
Finally, a total of eleven literatures fulfilled the inclusion criteria and were selected for meta-analysis . The search strategy was demonstrated in Figure . The included literatures were published between 1998 and 2016. In addition, the included trials were all RCTs. Compared the final published data in 2004, one study was excluded due to the preliminary results . One study was excluded because of not RCTs . One study was excluded because of the changed dosage of other anti-PD drugs during the trials . Three studies was excluded because of the reviews and meta-analysis type .
Flow chart of studies by screening, inclusion and exclusion
What Is The Most Important Information I Should Know About Amantadine
You should not use amantadine if you are allergic to it, or if:
- you have severe kidney disease or
- you received a “live” nasal flu vaccine within the past 14 days.
Tell your doctor if you have ever had:
- kidney disease
- daytime drowsiness
- congestive heart failure
- low blood pressure, fainting spells
- alcoholism or drug addiction or
- mental illness, psychosis, or suicidal thoughts or actions.
People with Parkinson’s disease may have a higher risk of skin cancer . Talk to your doctor about this risk and what skin symptoms to watch for.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
Amantadine is not approved for influenza in a child younger than 1 year old. Gocovri is not approved for use by anyone younger than 18 years old.
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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. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
If you are taking the extended-release capsules or the extended-release tablets, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have forgotten to take the extended-release capsules or extended-release tablets for several days, call your doctor.
Kidney Or Liver Disease
The kidneys primarily excrete amantadine via the urine. In people with impaired kidney function, the drug can build up in the body. The doctor will lower the dose of amantadine, as a result.
Amantadine can also increase liver enzyme numbers. Anyone with a history of liver disease should take amantadine with caution.
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