Recommended Topic Related To:

Flumadine

"Feb. 8, 2013 -- With winter cold and flu season in full swing -- and a new strain of norovirus circulating -- everyone's trying to dodge the bugs. Norovirus causes intestinal illness, and it's often the root of outbreaks at schools and in nursing"...

Flumadine

Flumadine

SIDE EFFECTS

In 1,027 patients treated with Flumadine (rimantadine) in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.

Incidence > 1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.

  Rimantadine
(n=1027)
Control
(n=986)
Nervous System
  Insomnia 2.1% 0.9%
  Dizziness 1.9% 1.1%
  Headache 1.4% 1.3%
  Nervousness 1.3% 0.6%
  Fatigue 1.0% 0.9%
Gastrointestinal System    
  Nausea 2.8% 1.6%
  Vomiting 1.7% 0.6%
  Anorexia 1.6% 0.8%
  Dry mouth 1.5% 0.6%
  Abdominal Pain 1.4% 0.8%
Body as a Whole    
  Asthenia 1.4% 0.5%

Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.

Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia. Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Flumadine (rimantadine) . In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.

Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence > 1 %.

  Rimantadine
200 mg/day
(n=145)
Placebo
(n=143)
Amantadine
200 mg/day
(n=148)
Nervous System
Insomnia 3.4% 0.7% 7.0%
Nervousness 2.1% 0.7% 2.8%
Impaired Concentration 2.1% 1.4% 2.1%
Dizziness 0.7% 0.0% 2.1%
Depression 0.7% 0.7% 3.5%
Total % of subjects with adverse reactions 6.9% 4.1% 14.7%
Total % of subjects withdrawn due to adverse reactions 6.9% 3.4% 14.0%

Geriatric Use

Approximately 200 subjects over the age of 65 were evaluated for safety in controlled clinical trials with Flumadine (rimantadine hydrochloride). Geriatric subjects who received either 200 mg or 400 mg of rimantadine daily for 1 to 50 days experienced considerably more central nervous system and gastrointestinal adverse events than comparable geriatric subjects receiving placebo. Central nervous system events including dizziness, headache, anxiety, asthenia, and fatigue, occurred up to two times more often in subjects treated with rimantadine than in those treated with placebo. Gastrointestinal symptoms, particularly nausea, vomiting, and abdominal pain occurred at least twice as frequently in subjects receiving rimantadine than in those receiving placebo. The gastrointestinal symptoms appeared to be dose related. In patients over 65, the recommended dose is 100 mg, daily (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Read the Flumadine (rimantadine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Acetaminophen: Flumadine (rimantadine) , 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen (650 mg four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for rimantadine by approximately 11%.

Aspirin: Flumadine (rimantadine) , 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of rimantadine were reduced approximately 10% in the presence of aspirin.

Cimetidine: When a single 100 mg dose of Flumadine (rimantadine) was administered with steady-state cimetidine (300 mg four times a day), there were no statistically significant differences in rimantadine Cmax or AUC between Flumadine (rimantadine) alone and Flumadine (rimantadine) in the presence of cimetidine.

Live Attenuated Influenza Vaccine (LAIV): The concurrent use of Flumadine (rimantadine) with live attenuated intranasal influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of Flumadine (rimantadine) and Flumadine (rimantadine) should not be administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus.

Read the Flumadine Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/26/2010
This monograph has been modified to include the generic and brand name in many instances.

A A A

Flumadine - User Reviews

Flumadine User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Flumadine sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Living Better

Find the secrets to longer life.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations