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Flumadine

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Flumadine

Indications
Dosage
How Supplied

INDICATIONS

Flumadine (rimantadine) is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older).

Flumadine (rimantadine) 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), Flumadine (rimantadine) has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since Flumadine (rimantadine) 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, Flumadine (rimantadine) prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Flumadine (rimantadine) prophylaxis have not been demonstrated for longer than 6 weeks.

Treatment

Flumadine (rimantadine) 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, Flumadine (rimantadine) has been shown to reduce the duration of fever and systemic symptoms.

The following points should be considered before initiating treatment or prophylaxis with FLUMADINE (rimantadine) :

  • FLUMADINE (rimantadine) 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 FLUMADINE (rimantadine) .

DOSAGE AND ADMINISTRATION

For Prophylaxis In Adults And Children

Adults (17 years and older)

The recommended adult dose of Flumadine (rimantadine) 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 (CrCI ≤ 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 durations ranged from 5 weeks to 6 weeks in pediatric subjects.
  • In children 1 year to 9 years of age, Flumadine (rimantadine) should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg.
  • For children 10 to 16 years of age, use the adult dose.

(see Directions for Compounding of an Oral Suspension from Flumadine (rimantadine) 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 Flumadine (rimantadine) 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 Flumadine (rimantadine) 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 (CrCI ≤ 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. Flumadine (rimantadine) 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)

Flumadine (rimantadine) is not indicated for treatment of influenza in pediatric patients 16 years or younger.

Directions for the Compounding of an Oral Suspension from FLUMADINE (rimantadine) 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 Flumadine (rimantadine HCl) Tablets, 100 mg using Ora-Sweet®.† Other vehicles have not been studied.

To make an oral suspension (10 mg/mL) from 100 mg Flumadine (rimantadine) tablets, you will need the following:

  • 100 mg tablets of Flumadine (rimantadine)
  • 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 Flumadine (rimantadine) 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 Flumadine (rimantadine) needed for the duration of therapy.
    (Daily Dose) x (Number of days) = (mg of Flumadine (rimantadine) )
    For example, 75 mg/day x 10 days = 750 mg
  3. Round up the mg of Flumadine (rimantadine) 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 Flumadine (rimantadine) ) (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 Flumadine (rimantadine) ) (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 Flumadine (rimantadine) Tablets 100 mg

Verify your calculations before you begin to compound an oral suspension.

A 100 mg tablet of Flumadine (rimantadine) 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 Flumadine (rimantadine) 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 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 Flumadine (rimantadine) 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.

HOW SUPPLIED

Flumadine® tablets (rimantadine hydrochloride tablets) are supplied as 100 mg tablets (orange, oval-shaped, film-coated) in bottles of 100 (NDC 49708-521-88). Imprint on tablets: (Front) FLUMADINE (rimantadine) 100; (Back) FOREST.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Rev. 4/2010. Manufactured by: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO 63045. Distributed By: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202

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

Indications
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