Rimantadine Hydrochloride 100 mg Tablet, Film Coated, 500-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Influenza A M2 Protein Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Rimantadine is used to prevent and treat infections caused by influenza A virus. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Rimantadine is an antiviral that fights influenza A, which is one of the main strains of flu. It works by blocking the virus from multiplying inside your cells. It won't 'cure' the...
- What exactly does rimantadine do — and will it cure my flu?
- It depends on your child's age and what you need it for. For kids ages 1 to 16, rimantadine is approved to prevent influenza A — for example, if there's an outbreak at school and y...
- The most common ones are stomach-related — nausea, vomiting, stomach pain, and loss of appetite — plus some nervous system effects like trouble sleeping, dizziness, and headache. T...
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2.27 | $1,134.80 / 500 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rimantadine Hydrochloride 100 mgthis 00115-1911-02 | Amneal | 500 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00115-1911-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01) | 2021-11-16 | Active |
| 00115-1911-02 You're viewing this | 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02) | 2021-11-16 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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). Prophylaxis In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 years of age and older), rimantadine hydrochloride has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus.
Since rimantadine hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, rimantadine hydrochloride prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of rimantadine hydrochloride prophylaxis have not been demonstrated for longer than 6 weeks.
Treatment Rimantadine hydrochloride therapy should be considered for adults (17 years and older) who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, rimantadine hydrochloride has been shown to reduce the duration of fever and systemic symptoms. The following points should be considered before initiating treatment or prophylaxis with rimantadine hydrochloride: Rimantadine hydrochloride is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. 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 rimantadine hydrochloride.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For Prophylaxis in Adults and Children Adults (17 years and older) The recommended adult dose of rimantadine hydrochloride is 100 mg twice a day. Study durations ranged from 11 days to 6 weeks in adult and elderly patients. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and in elderly nursing home patients, a dose reduction to 100 mg daily is recommended.
Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects. Children (1 year to 16 years of age) Study duration ranged from 5 weeks to 6 weeks in pediatric subjects. In children 1 year to 9 years of age, rimantadine hydrochloride should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg.
For children 10 years of age or older, use the adult dose. (see Directions for Compounding of an Oral Suspension from Rimantadine Hydrochloride Tablets to prepare an oral suspension for administration to children and patients with difficulty swallowing tablets). Children (Birth to 11 months) The safety and efficacy of rimantadine hydrochloride for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.
For Treatment in Adults Adults (17 years and older) The recommended adult dose of rimantadine hydrochloride is 100 mg twice a day for 7 days. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects.
Rimantadine hydrochloride therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms. Children (16 years of age and younger) Rimantadine hydrochloride is not indicated for treatment of influenza in pediatric patients 16 years or younger.
Directions for the Compounding of an Oral Suspension from Rimantadine Hydrochloride Tablets (Final Concentration = 10 mg/mL) 1 These directions are provided for use only during emergency situations, for patients who have difficulty swallowing tablets or where lower doses are needed. The pharmacist may compound a suspension (10 mg/mL) from rimantadine hydrochloride tablets, 100 mg using Ora-Sweet ® † . Other vehicles have not been studied.
To make an oral suspension (10 mg/mL) from 100 mg rimantadine hydrochloride tablets, you will need the following: 100 mg tablets of rimantadine hydrochloride Ora-Sweet ® (a vehicle manufactured by Paddock Laboratories) a graduated cylinder a mortar and pestle an Amber Glass or Polyethylene terephthalate plastic (PET) bottle a funnel (optional) Compounding Procedures A 100 mg tablet of rimantadine hydrochloride is required for each 10 mL of compounded oral suspension to make a concentration of 10 mg/mL. A compounded oral suspension is stable for 14 days.
Therefore, the maximum amount of oral suspension that can be dispensed to a patient should not exceed a 14 day supply. Step A: Guidance for how to determine the Number of Tablets and Total Volume needed to compound a 10 mg/mL oral suspension for each patient. 1.
Verify the prescribed dose is correct. 2. Calculate the mg amount of rimantadine hydrochloride needed for the duration of therapy.
(Daily Dose) × (Number of days) = (mg of rimantadine hydrochloride) For example, 75 mg/day × 10 days = 750 mg 3. Round up the mg of rimantadine hydrochloride amount to the next 100 mg designation. For example, Round up 750 mg to 800 mg 4.
Calculate the Number of 100 mg tablets that are required for the compounded oral susp…
⛔ Contraindications ▾
CONTRAINDICATIONS Rimantadine hydrochloride tablet is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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. Rimantadine (n=1,027) 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 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 200 mg/day (n=145) Placebo (n=143) Amantadine 200 mg/day (n=148) Nervous System 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 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 patients over the age of 65 were evaluated for safety in controlled clinical trials with 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 CLINCAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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.
Co-administration 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 were no statistically significant differences in rimantadine C max 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 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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects : There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/d (11 times the MRHD based on mg/m 2 ).
At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), but evidence of a developmental abnormality in the form of a change in the ratio of fetuses with 12 or 13 ribs were noted. This ratio is normally about 50:50 in a litter but was 80:20 after rimantadine treatment.
However, in a repeat embryofetal toxicity study in rabbits at doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), this abnormality was not observed. Nonteratogenic Effects: Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30 mg/kg/d, 60 mg/kg/d and 120 mg/kg/d (1.7, 3.4 and 6.8 times the MRHD based on mg/m 2 ). 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.
🧒 Pediatric Use ▾
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.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action 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 2 gene plays an important role in the susceptibility of influenza A virus to inhibition by rimantadine.
Microbiology Rimantadine inhibits the replication in cell culture of influenza A virus isolates from each of the three antigenic subtypes, i.e., H1N1, H2N2 and H3N2, that have been isolated from man. Rimantadine has little or no activity against influenza B virus (Ref. 1, 2).
Rimantadine does not appear to interfere with the immunogenicity of inactivated influenza A vaccine. A quantitative relationship between the susceptibility in cell culture of influenza A virus to rimantadine and clinical response to therapy has not been established. Susceptibility test results, expressed as the concentration of the drug required to inhibit virus replication by 50% or more in a cell culture system, vary greatly (from 19 nM to 93 µM) depending upon the assay protocol used, size of the virus inoculum, isolates of the influenza A virus strains tested, and the cell types used (Ref.
2). Resistance Influenza A virus isolates resistant to rimantadine have been selected in cell culture and in vivo as a result of treatment. Rimantadine-resistant strains of influenza A virus have emerged among freshly isolated strains in closed settings where rimantadine has been used.
Resistant viruses have been shown to be transmissible and to cause typical influenza illness (Ref. 3, 9). Substitutions at any one of five amino acid positions in the transmembrane domain of M 2 confer resistance to rimantadine.
The most common substitution causing resistance among influenza A (H1N1) and A (H3N2) is S31N. Other less common substitutions that cause resistance include substitutions A30F, V27A, V30A, and L26F. Rimantadine resistance has been observed in circulating seasonal influenza and pandemic isolates from individuals who have not received rimantadine.
Swine-origin influenza A (H1N1) (S-OIV) viruses that were resistant to rimantadine have been shown to contain the S31N substitution. Existing primers used for detection of adamantine resistance in seasonal viruses do not work with all tested S-OIVs (Ref. 11).
The CDC should be consulted for questions regarding resistance to rimantadine in circulating influenza strains. Cross-Resistance Cross-resistance among the adamantanes, rimantadine and amantadine, has been observed. Resistance to rimantadine confers cross-resistance to amantadine and vice-versa.
Substitutions that confer resistance to rimantadine include (most frequently) M 2 S31N, as well as the less common changes V27A, V30A, L26F and A30T (Ref. 10). Pharmacokinetics Although the pharmacokinetic profile of rimantadine hydrochloride has been described, no pharmacodynamic data establishing a correlation between plasma concentration and its antiviral effect are available.
Rimantadine hydrochloride is absorbed after oral administration. The mean ± SD peak plasma concentration after a single 100 mg dose of rimantadine hydrochloride was 74 ± 22 ng/mL (range: 45 to 138 ng/mL). The time to peak concentration was 6 ± 1 hours in healthy adults (age 20 to 44 years).
The single dose elimination half-life in this population was 25.4 ± 6.3 hours (range: 13 to 65 hours). The single dose elimination half-life in a group of healthy 71 to 79 year-old subjects was 32 ± 16 hours (range: 20 to 65 hours). After the administration of rimantadine 100 mg twice daily to healthy volunteers (age 18 to 70 years) for 10 days, area under the curve (AUC) values were approximately 30% greater than predicted from a single dose.
Plasma trough levels at steady state ranged between 118 and 468 ng/mL. In these patients no age-related differences in pharmacokinetics were detected. However,…
🧬 Mechanism of Action ▾
Mechanism of Action 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 2 gene plays an important role in the susceptibility of influenza A virus to inhibition by rimantadine.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Rimantadine Hydrochloride Tablets USP, 100 mg — Each orange, oval, film-coated, convex-faced tablet is debossed with "G" on one side and "1911" on the other side. They are available as follows: Bottles of 100: NDC 0115-1911-01 Bottles of 500: NDC 0115-1911-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No.
6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol. Rimantadine hydrochloride, USP is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C).
Chemically, rimantadine hydrochloride, USP is tricyclo [3.3.1.1 3.7 ]-decane-1-methanamine, α-methyl-, hydrochloride, with a molecular formula of C 12 H 21 N•HCl, a molecular weight of 215.77 and the following structural formula: 1