RIMANTADINE HYDROCHLORIDE tablet, film coated

Rimantadine Hydrochloride by

Drug Labeling and Warnings

Rimantadine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., Impax Laboratories Inc, Global Pharmaceuticals, Division of Impax Laboratories Inc., Impax Laboratories Taiwan Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

  • HOW SUPPLIED

    Rimantadine Hydrochloride Tablets, 100 mg—Each orange, oval, film-coated, convex-faced tablet is debossed with a "G" on one side and "1911" on the other side.

    Bottles of 100NDC: 0115-1911-01
    Bottles of 500NDC: 0115-1911-02

    Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

  • REFERENCES

    1. Belshe RB, Burk B, Newman F, et al. J. Infect. Dis. 1989; 159(3):430-435.
    2. Sim IS, Cerruti RL, Connell EV. J. Resp. Dis. 1989(Suppl): S46-S51.
    3. Hayden FG, Belshe RB, Clover RD, et al. N.Engl. J. Med. 1989; 321(25), 1696-1702.
    4. Hall CB, Dolin R, Gala CL, et al. Pediatrics 1987; 80(2): 275-282.
    5. Thompson J, Fleet W, Lawrence E et al. J.Med. Virol. 1987; 21(3): 249-255.
    6. Belshe RB, Smith MH, Hall CB, et al. J. Virol.1988; 62(5): 1508-1512.
    7. Casey DE. N Engl J Med. 1978; 298(9):516.
    8. Berkowitz CD. J. Pediatri. 1979; 95(1): 144-145.
    9. Hayden FG, Sperber SJ, Belshe RB, et al. Antimicrob Agents Chemother. 1991; 35(9): 1741-1747
    10. Deyde VM, Xu X, Bright RA, et al. J Infect Dis. 2007; 196(2): 249-257.
    11. CDC MMWR Morb Mortal Wkly Rep. 2009; 58(16): 433-435.

    Dist. by:
    Global Pharmaceuticals
    Division of IMPAX Laboratories, Inc.
    Philadelphia, PA 19124 USA

    Repacked by:
    H.J. Harkins Company, Inc.
    Nipomo, CA 93444 USA

    September 2011

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    GLOBAL®

    NDC: 0115-1911-01

    Rimantadine
    Hydrochloride
    Tablets

    100 mg

    Rx only
    100 Tablets

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    RIMANTADINE HYDROCHLORIDE 
    rimantadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 52959-305(NDC:0115-1911)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Rimantadine Hydrochloride (UNII: JEI07OOS8Y) (Rimantadine - UNII:0T2EF4JQTU) Rimantadine Hydrochloride100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVAL (convex-faced) Size11mm
    FlavorImprint Code G;1911
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 52959-305-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613204/01/2005
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Impax Laboratories Inc790947167MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Pharmaceuticals, Division of Impax Laboratories Inc.116732830REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Impax Laboratories Taiwan Inc.656139511MANUFACTURE

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