Rimantadine Hydrochloride

Trade Names:
Flumadine
- Tablets 100 mg

Pharmacology

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Inhibits viral replication cycle in various strains of influenza A virus.

Pharmacokinetics

Absorption

Well absorbed. C _max is 74 ng/mL (single dose). T _max is 6 h (single dose).

Distribution

Protein binding is 40%, mainly albumin.

Metabolism

Extensively metabolized in the liver to 3 hydroxylated metabolites.

Elimination

Eliminated in the urine (less than 25% as unchanged drug). Half-life is 25.4 h (single dose) and 32 h (older than 70 yr of age).

Special Populations

Apparent Cl for CrCl 31 to 50 mL/min was 37% lower; apparent Cl for CrCl 11 to 30 mL/min was 16% lower and plasma metabolite concentrations were higher; apparent Cl for CrCl 0 to 10 mL/min was 40% lower with a 1.6-fold increase in elimination half-life.

In patients older than 70 years of age, the average AUC, peak concentrations, and elimination half-life at steady state were 20% to 30% higher.

AUC was about 3-fold larger, elimination half-life was about 2-fold longer, and the apparent Cl was 50% lower.

Indications and Usage

Prophylaxis and treatment of infection caused by various strains of influenza A virus.

Prophylaxis against influenza A virus.

Per the CDC recommendations for treatment and chemoprophylaxis of H1N1 influenza A (swine flu) virus infection, refer to the oseltamivir and zanamivir A-Z monographs. The H1N1 virus is resistant to the antiviral medication rimantadine. For more information, refer to the CDC guidelines at http://www.cdc.gov/h1n1flu/recommendations.htm .

Contraindications

Hypersensitivity to drugs of adamantine class, including rimantadine and amantadine.

Dosage and Administration

PO 100 mg twice daily.

Reduce to 100 mg/day.

PO 100 mg twice daily.

General Advice

• Initiate treatment as soon as possible, preferably within 48 h after onset of signs and symptoms of influenza A infection.
• Continue therapy for approximately 7 days after initial onset of symptoms.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Decreased C _max and AUC of rimantadine.

Increased rimantadine serum concentration caused by decreased Cl.

Because of potential interference between these products, do not give LAIV until 48 h after cessation of rimantadine, and do not administer rimantadine until 14 days after cessation of LAIV.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Cardiac failure, heart block.

CNS

Insomnia (3%); dizziness, impaired concentration, nervousness (2%); asthenia, fatigue, headache (1%).

GI

Nausea (3%); anorexia, dry mouth, vomiting (2%); abdominal pain (1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined. Do not administer to breast-feeding mothers.

Children

Do not administer to children younger than 10 yr of age.

Elderly

CNS symptoms may occur more frequently.

Renal Function

Use with caution. Monitor patients for adverse reactions and adjust the dose as needed.

Hepatic Function

Use with caution.

Influenza-like symptoms

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during influenza; rimantadine has not been shown to prevent such complications.

Seizures

Increased incidence of seizures in patients with seizure history and who receive amantadine.

Transmission

Transmission of resistant virus should be considered when treating patients whose contacts are at high risk of influenza A illness.

Overdosage

Symptoms

Agitation, cardiac arrhythmias, death, hallucinations.

Patient Information

• Tell patient with history of seizures to discontinue drug and notify health care provider if seizure activity develops.
• Instruct patient to report abdominal pain, anorexia, asthenia, cough, dizziness, dry mouth, dyspnea, headache, impaired concentration, insomnia, nausea, nervousness, palpitations, persistent diarrhea, syncope, or vomiting.
• Caution patient to avoid driving or operating hazardous equipment if dizziness or confusion develops.
• Advise patient to take drug several hours before going to bed if insomnia develops.

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