Ribavirin 6 g/1
Ribavirin · POWDER, FOR SOLUTION · Oceanside Pharmaceuticals
Ribavirin is a powder, for solution containing ribavirin at 6 g/1, taken respiratory (inhalation). Manufactured by Oceanside Pharmaceuticals.
Key Facts
- Brand Name
- Ribavirin
- Generic Name
- Ribavirin
- NDC Code (Product)
68682-019- Manufacturer
- Oceanside Pharmaceuticals
- Strength
- 6 g/1
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA018859
- Drug Class
- Nucleoside Analog Antiviral [EPC]
- Marketing Start
- 04/14/2017
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014; DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Valeant Pharmaceuticals North America LLC
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with ribavirin for inhalation solution, USP. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, USP aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with ribavirin for inhalation solution, USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized ribavirin fo…
Dosage & Administration
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 thi…
Warnings
WARNINGS SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized ribavirin for inhalation solution, USP treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitant administration of bronchodilators. Use with Mechanical Ventilators USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED. Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures. These procedures include the use of bacteria filters in series in the expiratory limb of the ventilator circuit with frequent changes (every 4 hours), water column p…
Contraindications
CONTRAINDICATIONS Ribavirin for inhalation solution, USP is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). Therefore, although clinical studies have not been performed, it should be assumed that ribavirin for inhalation solution, USP may cause fetal harm in humans. Studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.
Drug Interactions
Drug Interactions Clinical studies of interactions of ribavirin for inhalation solution, USP with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. Interference by ribavirin for inhalation solution, USP with laboratory tests has not been evaluated.
Adverse Reactions
ADVERSE REACTIONS The description of adverse reactions is based on events from clinical studies (approximately 200 patients) conducted prior to 1986, and the controlled trial of aerosolized ribavirin for inhalation solution, USP conducted in 1989-1990. Additional data from spontaneous post-marketing reports of adverse events in individual patients have been available since 1986. Deaths Deaths during or shortly after treatment with aerosolized ribavirin for inhalation solution, USP have been reported in 20 cases of patients treated with ribavirin for inhalation solution, USP (12 of these patients were being treated for RSV infections). Several cases have been characterized as "possibly related" to ribavirin for inhalation solution, USP by the treating physician; these were in infants who experienced worsening respiratory status related to bronchospasm while being treated with the drug. Several other cases have been attributed to mechanical ventilator malfunction in which ribavirin for inhalation solution, USP precipitation within the ventilator apparatus led to excessively high pulmonary pressures and diminished oxygenation. In these cases the monitoring procedures described in the …
Frequently Asked Questions
What is Ribavirin used for?
Ribavirin contains Ribavirin. It is a powder, for solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Ribavirin a controlled substance?
Ribavirin is not classified as a controlled substance by the DEA.
What is the generic name for Ribavirin?
The generic name for Ribavirin is Ribavirin. There are 8 other brand versions of Ribavirin.
What is the NDC code for Ribavirin 6 g/1?
The NDC (National Drug Code) for Ribavirin 6 g/1 is 68682-019, listed by Oceanside Pharmaceuticals.