Rimantalist
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Uses
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.
INDICATIONS FOR USE Lister-V is intended for the clinical nutritional management of the metabolic processes associated with viral infections, including common cold and influenza (flu) viruses.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
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 FDandC 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 C12H21N•HCl, a molecular weight of 215.77 and the following structural formula:
PRODUCT DESCRIPTION Primary Ingredients Lister-V consists of a proprietary blend of amino acids, cocoa, caffeine, cinnamon, and flavonoids in specific proportions. These ingredients fall into the category of “Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186. Amino Acids Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in Lister-V are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Patients with a viral disease may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Choline, for example, is an obligatory amino acid. The body cannot make choline and must obtain choline from the diet. Choline is required to fully potentiate nitric oxide synthesis in the nasal passage and lungs. A deficiency of choline leads to reduced nitric oxide production in the nasal passage and lungs. Flavonoids potentiate the production of nitric oxide in the nasal passage and lungs. Choline deficient diets and diets deficient in flavonoid rich foods can result in inadequate flavonoid concentrations, impeding nitric oxide production. Provision of arginine, choline, and flavonoids with antioxidants, in specific proportions can restore the production of beneficial nitric oxide, thereby inhibiting viral growth. Flavonoids Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Lister-V cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response. Physical Description Lister-V is a yellow to light brown powder. Lister-V contains L-Arginine, L-Glutamic Acid, Lecithin, Echinacea Angustifolia, Green Tea Extract, Licorice Extract, Cinnamon, Cocoa, Hydrolyzed Whey Protein, Caffeine, Ginkgo Biloba, and Grape Seed Extract. Other Ingredients Lister-V contains the following inactive or other ingredients, as fillrs, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
Sources
Rimantalist Manufacturers
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Physician Therapeutics Llc
![Rimantalist (Rimantadine Hydrochloride, Arginine) Kit [Physician Therapeutics Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rimantalist | Physician Therapeutics Llc
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®.1 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)
1
Ora-Sweet® is a registered trademark of Paddock Laboratories
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 suspension.
(Rounded mg of rimantadine hydrochloride) ÷ (100 mg/tablet) = (Number of tablets)
For example, 800 mg ÷100 mg/tablet = 8 tablets
5. Calculate the Total Volume of compounded oral suspension (10 mg/mL) (Rounded mg of rimantadine hydrochloride) ÷ (10 mg/mL) = (Total Volume)
For example, 800 mg ÷ 10 mg/mL = 80 mL
Step B: Once the total Number of Tablets and Volume are determined then follow the procedures below for compounding the oral suspension (10 mg/mL) from rimantadine hydrochloride tablets 100 mg
Verify your calculations before you begin to compound an oral suspension.
A 100 mg tablet of rimantadine hydrochloride is required for each 10 mL's of compounded oral suspension to make a concentration of 10 mg/mL.
1. Place the required number of rimantadine hydrochloride 100 mg tablets into a clean mortar of sufficient size to contain the tablets and volume of vehicle, Ora-Sweet® used in Step 3.
2. Grind the tablets and triturate to a fine powder using a pestle. Powder on the sides of the mortar or pestle should be removed using a spatula and incorporated into the trituration throughout the process.
3. Slowly add approximately one-third (1/3) of the total volume of vehicle to the mortar while triturating until a uniform suspension is achieved.
4. Transfer the suspension to an amber glass or a PET plastic bottle. Other types of bottles, such as non-PET plastic or uncolored bottles, have not been evaluated and should not be used. A funnel may be used to eliminate any spillage.
5. Slowly add the second one-third (1/3) of the total volume of vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the contents into the bottle.
6. Repeat the rinsing (Step 5) with the remaining one-third (1/3) of the vehicle, transferring the remaining contents to the fullest extent possible. Verify that the suspension is at the desired total volume or add additional vehicle if needed.
7. Close the bottle using a child-resistant cap.
8. Shake well to ensure homogeneous suspension. (Note: The active drug, rimantadine HCl readily dissolves in the specified vehicle. The suspension is caused by some of the inert ingredients of rimantadine hydrochloride tablets 100 mg which are insoluble in this vehicle.)
Labeling and Dispensing Information for the Compounded Oral Suspension
1. Include an ancillary label on the bottle indicating "Shake Gently Before Use." This compounded suspension should be gently shaken prior to administration to minimize the tendency for air entrapment with the Ora-Sweet® preparation. The need to shake the compounded oral suspension gently prior to administration should be reviewed with the parent or guardian when the suspension is dispensed.
2. Provide an oral dosing device (a graduated oral syringe or spoon) that will measure the prescribed dose (in mL). If possible, mark or highlight the graduation corresponding to the appropriate dose on the oral syringe or spoon for each patient.
3. Include an Expiration Date label according to storage condition (see below) and a "Discard any Unused Portion" label to the bottle. Instruct the parent or guardian that any remaining material following completion of therapy or after the expiration date on the label must be discarded.
STORAGE OF THE PHARMACY-COMPOUNDED SUSPENSION
Room Temperature: Stable for 14 days when stored in ambient room temperature conditions. Other storage conditions have not been studied.
Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicle, which was placed in amber glass and PET plastic bottles at 25°C (77°F). Stability studies have not been conducted with other vehicles or bottle types.DOSAGE AND ADMINISTRATION Recommended Administration For the nutritional management of the metabolic processes associated with viral infections. Lister-V can be administered to ameliorate the symptoms and shorten the duration of a viral infection. At the first signs of viral infection take (3) capsules four times a day for five days. Lister-V may be used to enhance immune function after exposure to a viral disease. Lister-V may be taken by those susceptible to upper respiratory infections during airline travel. As with most amino acid formulations Lister-V should be taken without food to increase the absorption of key ingredients.
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