REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog
with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide
and has the following structural formula:
Ribavirin is a white, crystalline powder. It is freely soluble in water and
slightly soluble in anhydrous alcohol. The empirical formula is C8H12N4O5
and the molecular weight is 244.21.
REBETOL Capsules consist of a white powder in a white, opaque, gelatin capsule.
Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
The capsule shell consists of gelatin, and titanium dioxide. The capsule is
printed with edible blue pharmaceutical ink which is made of shellac, anhydrous
ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium
hydroxide, and FD&C Blue #2 aluminum lake.
INTRON A is Schering Corporation's brand name for interferon alfa-2b, recombinant,
a purified, sterile, recombinant interferon product.
Interferon alfa-2b, recombinant has been classified as an alpha interferon
and is a water-soluble protein composed of 165 amino acids with a molecular
weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained
from the bacterial fermentation of a strain of Escherichia coli bearing
a genetically engineered plasmid containing an interferon alfa-2b gene from
human leukocytes. The fermentation is carried out in a defined nutrient medium
containing the antibiotic tetracycline hydrochloride at a concentration of 5
to 10 mg/L; the presence of this antibiotic is not detectable in the final product.
INTRON A Injection is a clear, colorless solution. The 3 million IU vial of
INTRON A Injection contains 3 million IU of interferon alfa-2b, recombinant
per 0.5 mL. The 18 million IU multidose vial of INTRON A Injection contains
a total of 22.8 million IU of interferon alfa-2b, recombinant per 3.8 mL (3
million IU/0.5 mL) in order to provide the delivery of six 0.5 mL doses, each
containing 3 million IU of INTRON A (for a label strength of 18 million IU).
The 18 million IU INTRON A Injection multidose pen contains a total of 22.5
million IU of interferon alfa-2b, recombinant per 1.5 mL (3 million IU/0.2 mL)
in order to provide the delivery of six 0.2-mL doses, each containing 3 million
IU of INTRON A (for a label strength of 18 million IU). Each mL also contains
7.5 mg sodium chloride, 1.8 mg sodium phosphate dibasic, 1.3 mg sodium phosphate
monobasic, 0.1 mg edetate disodium, 0.1 mg polysorbate 80, and 1.5 mg m-cresol
as a preservative.
Based on the specific activity of approximately 2.6 x 108 IU/mg
protein as measured by HPLC assay, the corresponding quantities of interferon
alfa-2b, recombinant in the vials and pen described above are approximately
0.012 mg, 0.088 mg, and 0.087 mg protein, respectively.
Mechanism of Action
Ribavirin/Interferon alfa-2b, recombinant
The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy
with REBETOL and INTRON A has not been established.
What are the possible side effects of interferon alfa-2b and ribavirin (Rebetron)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- pale or yellowed skin, dark colored urine;
- fever, chills, body aches, flu symptoms, easy bruising or bleeding, unusual weakness;
- confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;
- vision problems;
- high fever with...
Read All Potential Side Effects and See Pictures of Rebetron »
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.