RIBAZOLE Capsule

- Patients with a history of known hypersensitivity to ribavirin or any of its components.

- Ribavirin therapy is contraindicated for use in pregnant women or in women expected to be pregnant.

- Patients with autoimmune hepatitis must not be treated with combination of ribavirin and interferon alfa therapy because use of these medicines can worsen the hepatitis.

- Patients with hemoglobinopathies (e.g. thalassemia major, sickle-cell anemia) should not be treated with ribavirin.

- Patients with a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease.

The primary toxicity of ribavirin is hemolytic anemia. Patients receiving ribavirin by mouth have experienced hemolytic anemia, sometimes with associated increased serum concentrations of bilirubin and uric acid. The most commonly reported adverse reactions with ribavirin were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy. They include depression, irritability, anxiety, alopecia, nausea/vomiting, and flu like symptoms such as fatigue, pyrexia, myalgia, headache and rigors.

Ribavirin/Interferon alfa Combination Therapy

There are significant adverse events caused by ribavirin/interferon alfa combination therapy, which includes severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. It is recommended that patients be carefully monitored by the prescribing physician.

Other less frequent adverse reactions were pruritis, dermatitis, dizziness, arthralgia, neutropenia, insomnia, diarrhoea, dyspnea, dry skin and skin rashes.

Pediatric patients

Conversely, pediatric patients experienced less fatigue, dyspepsia, arthralgia, insomnia, irritability, impaired concentration, dyspnea, and pruritis compared to adult patients.

There is no clinically relevant interaction when ribavirin is concomitantly administered with antacids.

Nucleoside analogues

See the package insert about the details below:

- Zidovudine and Stavudine

- Didanosine

Pregnancy

Extreme care must be taken to avoid pregnancy in female patients and in partners of male patients. Ribavirin accumulates intracellularly and is cleared from the body very slowly. Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Any birth control method can fail. Therefore, it is critically important that women of childbearing potential and their partners must use 2 forms of effective contraception simultaneously, during treatment and for 6 months after treatment has been concluded. Routine monthly pregnancy tests must be performed during this time.

Lactation

It is not known whether ribavirin is excreted in human milk. Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment.

See the package insert about the details below:

- Haemolysis and cardiovascular system

- Liver function

- Psychiatric and Central Nervous System (CNS)

- Renal impairment

Ribavirin is a synthetic guanine analogue that acts in a manner similar to the other nucleoside analogues. It shows in vitro activity against some RNA and DNA viruses. RNA is essential in the synthesis of proteins, as the messenger with the genetic code of RNA and DNA viruses. Ribavirin blocks messenger RNA, prevents viral replication and stops the infection. Ribavirin suppresses viral replication without effect on normal cellular function.