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Rimantadine Hydrochloride
Overview
What is Rimantadine Hydrochloride?
Rimantadine hydrochloride is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate and FD&C Yellow No. 6 Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and macrogol.
Rimantadine hydrochloride is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride is alpha-methyltricyclo-[3.3.1.1/3.7]decane-1-methanamine hydrochloride, with an empirical formula of CHN•HCl, a molecular weight of 215.77 and the following structural formula:
What does Rimantadine Hydrochloride look like?
What are the available doses of Rimantadine Hydrochloride?
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What should I talk to my health care provider before I take Rimantadine Hydrochloride?
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How should I use Rimantadine Hydrochloride?
Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older).
Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).
What interacts with Rimantadine Hydrochloride?
Rimantadine hydrochloride is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
What are the warnings of Rimantadine Hydrochloride?
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What are the precautions of Rimantadine Hydrochloride?
GENERAL
An increased incidence of seizures has been reported in patients with a history of epilepsy who received the related drug amantadine. In clinical trials of rimantadine hydrochloride, the occurrence of seizure-like activity was observed in a small number of patients with a history of seizures who were not receiving anticonvulsant medication while taking rimantadine hydrochloride. If seizures develop, rimantadine hydrochloride should be discontinued.
The safety and pharmacokinetics of rimantadine in hepatic insufficiency have only been evaluated after single dose administration. In a study of 14 subjects with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with hepatic insufficiency are treated with rimantadine.
Following multiple-dose administration of rimantadine, there were no clinically relevant differences in rimantadine systemic exposure between subjects with mild or moderate renal impairment compared to healthy subjects. In subjects with severe renal impairment, rimantadine systemic exposure increased by 81%, compared with healthy subjects. Because of the potential for increased accumulation of rimantadine metabolites in renally impaired subjects, caution should be exercised when these patients are treated with rimantadine.
Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)
Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rimantadine hydrochloride has not been shown to prevent such complications.
DRUG INTERACTIONS
Acetaminophen
Rimantadine hydrochloride, 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
Rimantadine hydrochloride, 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 rimantadine hydrochloride was administered with steady-state cimetidine (300 mg four times a day), there was no statistically significant differences in rimantadine Cmax or AUC between rimantadine hydrochloride alone and rimantadine hydrochloride in the presence of cimetdine.
Live Attenuated Influenza Vaccine (LAIV)
The concurrent use of rimantadine hydrochloride 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 rimantadine hydrochloride and rimantadine hydrochloride should be not 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.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Carcinogenesis
Oral administration of rimantadine to rats for 2 years at doses up to 100 mg/kg/d [approximately 11 to 14 times the maximum recommended human dose (MRHD) based on AUC] showed no evidence of increased tumor incidence.
Mutagenesis
No mutagenic effects were seen when rimantadine was evaluated in several standard assays for mutagenicity.
Impairment of Fertility
A reproduction study in male and female rats did not show detectable impairment of fertility at dosages up to 60 mg/kg/day (3 times the MRHD based on mg/m).
PREGNANCY
Teratogenic Effects
Nonteratogenic Effects
Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30, 60 and 120 mg/kg/d (1.7, 3.4 and 6.8 times the MRHD based on mg/m). Maternal toxicity during gestation was noted at the two higher doses of rimantadine, and at the highest dose, 120 mg/kg/day, there was an increase in pup mortality during the first 2 to 4 days postpartum. Decreased fertility of the F1 generation was also noted for the two higher doses.
For these reasons, rimantadine hydrochloride should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
NURSING MOTHERS
Rimantadine hydrochloride should not be administered to nursing mothers because of the adverse effects noted in offspring of rats treated with rimantadine during the nursing period. Rimantadine is concentrated in rat milk in a dose-related manner: 2 to 3 hours following administration of rimantadine, rat breast milk levels were approximately twice those observed in the serum.
PEDIATRIC USE
In children (1 year to 16 years of age), rimantadine hydrochloride is recommended for the prophylaxis of influenza A. The safety and effectiveness of rimantadine hydrochloride in the treatment of symptomatic influenza infection in children (1 year to 16 years of age) have not been established. Prophylaxis studies with rimantadine hydrochloride have not been performed in children below the age of 1 year.
What are the side effects of Rimantadine Hydrochloride?
In 1,027 patients treated with rimantadine hydrochloride 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 to 3%) at the recommended dose in controlled clinical trials are shown in the table below.
Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: : diarrhea, dyspepsia; impairment of concentration, ataxia, somnolence, agitation, depression; : rash; tinnitus; dyspnea.
Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System:
Respiratory:
Cardiovascular:
Reproduction:
Special Senses:
Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of rimantadine hydrochloride. 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 (n=1027) | Control (n=986) | ||
|---|---|---|---|
| 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% | |
| 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% | |
| Asthenia | 1.4% | 0.5% | Rimantadine 200 mg/day (n=145) | Placebo (n=143) | Amantadine 200 mg/day (n=148) |
| Insomia | 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 of adverse reactions | 6.9% | 4.1% | 14.7% |
| Total % of subjects withdrawn due to adverse reactions | 6.9% | 3.4%` | 14.0% |
What should I look out for while using Rimantadine Hydrochloride?
Rimantadine hydrochloride is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
What might happen if I take too much Rimantadine Hydrochloride?
As with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.
How should I store and handle Rimantadine Hydrochloride?
Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Rimantadine Hydrochloride Tablets,
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of rimantadine is not fully understood. Rimantadine appears to exert its inhibitory effect early in the viral replicative cycle, possibly inhibiting the uncoating of the virus. Genetic studies suggest that a virus protein specified by the virion M gene plays an important role in the susceptibility of influenza A virus to inhibition by rimantadine.
Non-Clinical Toxicology
Rimantadine hydrochloride is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.An increased incidence of seizures has been reported in patients with a history of epilepsy who received the related drug amantadine. In clinical trials of rimantadine hydrochloride, the occurrence of seizure-like activity was observed in a small number of patients with a history of seizures who were not receiving anticonvulsant medication while taking rimantadine hydrochloride. If seizures develop, rimantadine hydrochloride should be discontinued.
The safety and pharmacokinetics of rimantadine in hepatic insufficiency have only been evaluated after single dose administration. In a study of 14 subjects with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with hepatic insufficiency are treated with rimantadine.
Following multiple-dose administration of rimantadine, there were no clinically relevant differences in rimantadine systemic exposure between subjects with mild or moderate renal impairment compared to healthy subjects. In subjects with severe renal impairment, rimantadine systemic exposure increased by 81%, compared with healthy subjects. Because of the potential for increased accumulation of rimantadine metabolites in renally impaired subjects, caution should be exercised when these patients are treated with rimantadine.
Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)
Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rimantadine hydrochloride has not been shown to prevent such complications.
In 1,027 patients treated with rimantadine hydrochloride 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 to 3%) at the recommended dose in controlled clinical trials are shown in the table below.
Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: : diarrhea, dyspepsia; impairment of concentration, ataxia, somnolence, agitation, depression; : rash; tinnitus; dyspnea.
Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System:
Respiratory:
Cardiovascular:
Reproduction:
Special Senses:
Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of rimantadine hydrochloride. 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%.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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