RIBAVIRIN (Page 4 of 4)

OVERDOSAGE

No overdosage with ribavirin for inhalation solution, USP by aerosol administration has been reported in humans. The LD50 in mice is 2 g orally and is associated with hypoactivity and gastrointestinal symptoms (estimated human equivalent dose of 0.17 g/kg, based on body surface area conversion). The mean plasma half-life after administration of aerosolized ribavirin for inhalation solution, USP for pediatric patients is 9.5 hours. ribavirin for inhalation solution, USP is concentrated and persists in red blood cells for the life of the erythrocyte (see Pharmacokinetics).

DOSAGE AND ADMINISTRATION

BEFORE USE, READ THOROUGHLY THE VALEANT SMALL PARTICLE AEROSOL GENERATOR SPAG-2 OPERATOR’S MANUAL FOR SMALL PARTICLE AEROSOL GENERATOR OPERATING INSTRUCTIONS. AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP SHOULD NOT BE ADMINISTERED WITH ANY OTHER AEROSOL GENERATING DEVICE.

The recommended treatment regimen is 20 mg/mL ribavirin for inhalation solution, USP as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12-18 hours per day for 3 to 7 days. Using the recommended drug concentration of 20 mg/mL the average aerosol concentration for a 12 hour delivery period would be 190 micrograms/liter of air. Aerosolized ribavirin for inhalation solution, USP should not be administered in a mixture for combined aerosolization or simultaneously with other aerosolized medications.

Non-mechanically ventilated infants

Ribavirin for inhalation solution, USP should be delivered to an infant oxygen hood from the SPAG-2 aerosol generator. Administration by face mask or oxygen tent may be necessary if a hood cannot be employed (see SPAG-2 manual). However, the volume and condensation area are larger in a tent and this may alter delivery dynamics of the drug.

Mechanically Ventilated Infants

The recommended dose and administration schedule for infants who require mechanical ventilation is the same as for those who do not. Either a pressure or volume cycle ventilator may be used in conjunction with the SPAG-2. In either case, patients should have their endotracheal tubes suctioned every 1-2 hours, and their pulmonary pressures monitored frequently (every 2-4 hours). For both pressure and volume ventilators, heated wire connective tubing and bacteria filters in series in the expiratory limb of the system (which must be changed frequently, i.e., every 4 hours) must be used to minimize the risk of ribavirin for inhalation solution, USP precipitation in the system and the subsequent risk of ventilator dysfunction. Water column pressure release valves should be used in the ventilator circuit for pressure cycled ventilators, and may be utilized with volume cycled ventilators (SEE SPAG-2 MANUAL FOR DETAILED INSTRUCTIONS).

Method of Preparation

Ribavirin for inhalation solution, USP is supplied as 6 grams of lyophilized powder per 100 mL vial for aerosol administration only. By sterile technique, reconstitute drug with a minimum of 75 mL of sterile water for injection, USP or sterile water for inhalation, USP in the original 100 mL glass vial. Shake well. Transfer to the clean, sterilized 500 mL SPAG-2 reservoir and further dilute to a final volume of 300 mL with Sterile Water for Injection, USP, or Inhalation. The final concentration should be 20 mg/mL. Important: This water should NOT have had any antimicrobial agent or other substance added. The solution should be inspected visually for particulate matter and discoloration prior to administration. Solutions that have been placed in the SPAG-2 unit should be discarded at least every 24 hours and when the liquid level is low before adding newly reconstituted solution.

HOW SUPPLIED

Ribavirin for inhalation solution, USP is supplied in four packs containing 100 mL glass vials with 6 grams of Sterile, lyophilized drug (NDC 68382-395-04) which is to be reconstituted with 300 mL Sterile Water for Injection or Sterile Water for Inhalation (no preservatives added) and administered only by a small particle aerosol generator (SPAG-2). Vials containing the lyophilized drug powder should be stored in a dry place at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature (20-30°C, 68-86°F) for 24 hours. Solutions which have been placed in the SPAG-2 unit should be discarded at least every 24 hours.

REFERENCES

  1. Hruska JF, Bernstein JM, Douglas Jr., RG, and Hall CB. Effects of Ribavirin on respiratory syncytial virus in vitro. Antimicrob Agents Chemother 17:770-775, 1 1980.
  2. Hruska JF, Morrow PE, Suffin SC, and Douglas Jr., RG. In vivo inhibition of respiratory syncytial virus by Ribavirin. Antimicrob Agents Chemother 21:125-130, 1982.
  3. Taber LH, Knight V, Gilbert BE, McClung HW et al. Ribavirin aerosol treatment of bronchiolitis associated with respiratory tract infection in infants. Pediatrics 72:613-618, 1983.
  4. Hall CB, McBride JT, Walsh EE, Bell DM et al. Aerosolized Ribavirin treatment of infants with respiratory syncytial viral infection. N Engl J Med 308:1443-7, 1983.
  5. Hendry RM, Mclntosh K, Fahnestock ML, and Pierik LT. Enzyme-linked immunosorbent assay for detection of respiratory syncytial virus infection J Clin Microbiol 16:329-33, 1982.
  6. Smith, David W., Frankel, Lorry R., Mather, Larry H., Tang, Allen T.S., Ariagno, Ronald L., Prober, Charles G. A Controlled Trial of Aerosolized Ribavirin in Infants Receiving Mechanical Ventilation for Severe Respiratory Syncytial Virus Infection. The New England Journal of Medicine 1991; 325:24-29.
  7. Decker, John, Shultz, Ruth A., Health Hazard Evaluation Report: Florida Hospital, Orlando, Florida. Cincinnati OH: U.S. Department of Health and Human Services, Public Health Service, Centers for NIOSH Report No. HETA 91-104-2229.*
  8. Barnes, D.J. and Doursew, M. Reference dose: Description and use in health risk assessments. Regul Tox. and Pharm. Vol. 8; p. 471-486, 1988.
  9. Federal Register Vol. 53 No. 126 Thurs. June 30, 1988 p. 24834-24847.
  10. American Association for Respiratory Care [1991]. Aerosol Consensus Statement-1991. Respiratory Care 36(9): 916-921.

*Copies of the Report may be purchased from National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161; Ask for Publication PB 93119-345

Distributed by:

Zydus Pharmaceuticals Inc.

Pennington, NJ 08534

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vial-label
(click image for full-size original)
figure 02
(click image for full-size original)
RIBAVIRIN
ribavirin powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-395
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIBAVIRIN (RIBAVIRIN) RIBAVIRIN 6 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-395-04 4 VIAL in 1 CARTON contains a VIAL
1 1 POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (68382-395-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207366 12/15/2016
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Registrant — Navinta LLC (130443810)

Revised: 12/2022 Zydus Pharmaceuticals USA Inc.

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