Approval Date: Month of Year
Date of revision.
Ribavirin Tablets Instructions
Please read the instruction manual carefully and use under the guidance of your physician
Warning
Ribavirin alone is not effective in treating chronic hepatitis C virus (HCV) infection. Therefore, ribavirin alone should not be used to treat chronic hepatitis C.
Ribavirin-induced hemolytic anemia may cause worsening of heart disease leading to fatal and nonfatal myocardial infarction. Ribavirin should not be used in patients with a history of severe or unstable heart disease. (See [Precautions], [Adverse Reactions], [Contraindications])
Severe teratogenic and fetal lethal effects have been reported in all animal species exposed to ribavirin, and morphological changes in testicular sperm have been reported. In addition, ribavirin has a half-life of 12 days when administered in multiple doses and may remain in the plasma for up to 6 months. Therefore, ribavirin is contraindicated in women during pregnancy and in women and their male partners who are planning to become pregnant. In particular, women and their male partners should take effective measures to avoid pregnancy during treatment with ribavirin and for 6 months after discontinuation of the drug. (See [Contraindications, Precautions], [Use in Pregnant and Lactating Women])
[Medication Name].
Generic Name: Ribavirin Tablets
Trade Name: Huaroxa
English Name: Ribavirin Tablets
Hanyu Pinyin: Libaweilin Pian
[Ingredients].
The main ingredient of this product is ribavirin.
Chemical name: 1-β-D-ribofuranosyl-1H-1,2,4-triazol-3-carboxamide.
Chemical structure formula.
Molecular formula: C8H12N4O5
Molecular weight: 244.21
[Properties] This product is a film-coated tablet, which appears white or off-white after removing the coating.
[Indications].
Indicated for viral pneumonia and bronchitis caused by respiratory syncytial virus; cutaneous herpesvirus infection.
In combination with interferon alfa for the treatment of chronic hepatitis C in adults.
[Specification] 100mg
[Dosage].
Orally
1. Viral pneumonia and bronchitis: 0.15g once for adults. 3 times a day for 7 days. Skin herpes virus infection: adults 0.3g (3 tablets) once. 3 times a day for 7 days. Children: 10mg/kg per day by weight: divided into 4 doses for 7 days.
2. Adults with chronic hepatitis C: Ribavirin dose is 800 mg to 1200 mg daily for adults, or 15 mg/kg in two divided doses or as directed by the physician. The recommended course of treatment is 24 to 48 weeks. Ribavirin preparations should not be used alone to treat chronic hepatitis C. Dosing must be individualized according to disease characteristics (e.g., genotype), treatment response, and tolerability under the guidance of a physician.
Refer to the relevant instructions for the dosage of interferon alfa.
Dose adjustment principles.
Ribavirin dose should be adjusted or discontinued in the event of serious adverse reactions or laboratory abnormalities associated with the combination of ribavirin and interferon alfa.
(1), the dose should be reduced to 600 mg daily in the following cases.
For patients without cardiac disease, hemoglobin <10 g/dl.
For patients with stable cardiac disease, a decrease in hemoglobin of ≥2 g/dl within 4 weeks.
Indirect bilirubin >5 mg/dl.
(2), the following conditions should discontinue.
Hemoglobin <8.5 g/dl in patients without cardiac disease.
For patients with stable heart disease, hemoglobin <12g/dl even after 4 weeks of reduced therapy.
White blood cells 9/l.
Neutrophils 9/l.
platelets 9/l.
Direct bilirubin >2.5 times the upper limit of normal.
Indirect bilirubin >4 mg/dl (>4 weeks).
Blood creatinine >2.0 mg/dl.
Creatinine clearance 50 ml/min.
Alanine aminotransferase (ALT) >2 times baseline and 10 times upper limit of normal.
Aspartate aminotransferase (AST) > 2x baseline and 10x upper limit of normal.
The above criteria also apply to other adverse reactions or laboratory abnormalities. After discontinuation for an adverse reaction or laboratory abnormality, if the adverse reaction resolves or decreases in severity, restart of therapy at a dose of 600 mg daily and further increases to 800 mg daily may be attempted; increases to the starting dose are not recommended; if the adverse reaction persists the drug should be discontinued.
Patients should be monitored for HCV RNA levels during treatment. If HCV RNA is reduced by less than 2log10 after 12 weeks of treatment or if HCV RNA is still detectable after 24 weeks of treatment, discontinuation of interferon should be considered/ribavirin therapy. .
If liver failure occurs during treatment, the drug should be discontinued.
[Adverse Reactions].
Ribavirin in combination with interferon alpha can lead to a variety of serious adverse reactions, the most common or life-threatening serious adverse reactions include hemolytic anemia, pancytopenia, allergic reactions, depression, suicide, bacterial infection, hepatic failure, and teratogenicity (see [WARNINGS] and [PRECAUTIONS]).
Adverse reactions reported during clinical trials and postmarketing applications of ribavirin in combination with interferon alfa are listed below according to system organ classification and frequency. Frequencies are defined as very common (1/10), common (1/100 to <1/10), occasional (1/1000 to <1/100), rare (1/10,000 to <1/1000), very rare (<1/10,000), and unknown (frequency unknown).
System Organ ClassificationAdverse effectsInfectionVery commonViral infection, pharyngitisCommonBacterial infections (including sepsis), fungal infections, influenza, respiratory tract infections, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infectionsEventuallyInjection site infection, lower respiratory tract infectionRare PneumoniaPneumoniaBenign, malignant and tumors of unknown nature (including cysts and polyps)CommonTumors of unknown natureBlood and lymphatic disordersVery commonAnemia, neutropeniaCommon
Hemolytic anemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphocytopeniaVery rare Aplastic anemiaunknownPure red blood cell aplastic anemia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpuraImmune system disordersOccasional Drug hypersensitivity reactionsRareNodular disease, rheumatoid arthritis (new or worsening)unknownVogt-Koyanagi- Harada syndrome, systemic lupus erythematosus, vasculitis, acute allergic reactions including urticaria, angioedema, bronchospasm, anaphylactic reactionsEndocrine System DisordersCommonLow thyroid function, hyperthyroidismMetabolic and nutritional disordersVery commonAnorexiaCommonHyperglycemia, hyperuricemia, hypocalcemia, dehydration, increased appetiteSometimesDiabetes mellitus, hypertriglyceridemia Mental illnessVery commonDepression, anxiety, emotional instability, insomniaCommonSuicidal ideation, psychosis, aggressive behavior, psychosis, agitation, irritability, mood changes, abnormal behavior, neuroticism, sleep disorders, hypersexuality, dreaming, cryingSee you occasionallySuicide attempts, panic attacks, hallucinations RareBilateral affective disorderVery rareSuicideunknownHomicidal ideation, mania, altered mental statusNeurological disordersVery commonHeadache, dizziness, dry mouth, concentration disorderCommonAmnesia, memory impairment, syncope, migraine, ataxia, sensory abnormalities, dysphonia, loss of taste, hyperalgesia, sensory hypersensitivity, increased muscle tone, drowsiness, distraction, tremor, taste disorderSometimes neuropathy, peripheral neuropathyRareEpilepsy (convulsions)Very rareBrain hemorrhage, ischemic cerebrovascular disease, encephalopathy, polyneuropathyunknownFacial nerve palsy, mononeuropathyEye DiseaseCommonVisual impairment, blurred vision, conjunctivitis, eye irritation, eye pain, abnormal vision, lacrimal gland disease, dry eyesRareRetinal hemorrhage, retinopathy (including macular edema), retinal artery obstruction, retinal vein obstruction, optic neuritis, optic papilla edema, loss of vision or visual field defects, retinal exudates Ear and disorientation disordersCommonVertigo, hearing impairment/loss, tinnitus, ear pain Heart disease