Vilona 400mg 18 Caps, Ribavirin
Each capsule contains :
Ribavirin 400 mg
Excipient c.b.p. 1 capsule .
INDICATIONS: Treatment of viral infections such as chickenpox ( in immunocompetent and immunodeficient ), herpes zoster, primary and recurrent genital herpes , cold sores and herpetic gingivostomatitis , mumps , viral hepatitis A, B and C viral hepatitis ( acute and chronic ) , infections respiratory syncytial virus infection , influenza and parainfluenza. Prophylaxis of recurrent genital herpes.
Pharmacokinetics HUMAN : Ribavirin is a synthetic nucleoside analogue antiviral that is activated by enzymes encoded by the virus not , allowing it to act against a wide variety of viruses.
Inhibits guanylation process of viral messenger RNA and additionally , inhibits the activity of RNA and DNA polymerases at the respective virus , and HIV reverse transcriptase . Among the RNA viruses are sensitive : respiratory syncytial , influenza A and B , coronavirus , coxsackievirus , measles virus , parainfluenza, mumps , hepatitis A and C virus , Lassa fever virus and human immunodeficiency virus .
Among the DNA viruses are : herpes simplex 1 and 2, cytomegalovirus , varicella zoster virus , adenovirus , and hepatitis virus B.
It is absorbed orally and reaches its maximum at 90 min plasma concentration. Intravenously at 30 minutes in both cases above the minimum inhibitory concentrations for susceptible virus levels. Your initial oral half life is 2 hours and 15 minutes parenterally . Its terminal half-life is 40 hours .
It is widely distributed including liver, salivary glands, adrenal , spleen, kidney and passes LCR in concentrations of 60-95 % compared to plasma .
Partially metabolized , causing two metabolites , one of them active . Is eliminated primarily in the urine ( 53%), to a lesser extent in the bile and breathing . Approximately two thirds of the administered dose is eliminated as an active ingredient and an active metabolite 1 , 2, 4 triazole-3- carboxamide.
CONTRAINDICATIONS : Pregnancy.
PRECAUTIONS: In higher doses higher than recommended treatments 4 weeks and / or should be regular practice determinations of hemoglobin and hematocrit .
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING use is not recommended during pregnancy.
Not known whether passes into breast milk.
Studies in lactating animals have shown no toxic effects or side reactions.
ADVERSE REACTIONS : Recommended up to 20 days duration with 1,200 mg / day therapeutic regimens have shown no side effects on hemoglobin , hematocrit and erythrocytes. At higher than recommended doses or for periods longer than 4 weeks, have been reported in some cases , relative and transient decrease in the numbers of these parameters , which has not prevented further treatment .
DRUG INTERACTIONS : Partnering with dideoxyinosine (ddI ) has a synergistic effect against human immunodeficiency virus . Other interactions are unknown.
CHANGES IN RESULTS OF LABORATORY TESTS : No reported .
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis , Impairment of Fertility: No carcinogenic or mutagenic effects shown . Studies in rodents have shown some teratogenic effect which was not observed in higher species as the mandrel . To date, no effects were found on fertility.
DOSAGE AND ADMINISTRATION:
Standard daily dose
1,200 mg / day
in 3 divided doses
(C / 8 hours)
15-20 mg / kg / day
in 3 divided doses
(C / 8 hours)
Herpes zoster, varicella and acute genital herpes ( primary or recurrent ) :
VILONA ® capsules : 1 capsule 3 times daily for 6 days at least.
Prophylaxis of recurrent genital herpes :
VILONA ® capsules : 1 capsule daily (single dose ) for an indefinite period.
VILONA ® capsules : 1 capsule 3 times daily for 10 days.
Acute hepatitis B or C :
VILONA ® capsules : 1 capsule 3 times daily for 20 days.
Hepatitis B or C infection :
VILONA ® capsules : 1 capsule 3 times daily for 6-12 months depending on the response in serum parameters. Gradually reduce the dose until stopping.
Chickenpox, herpes infections , hepatitis and rubella .
School and preschool :
VILONA ® oral solution: 1 ml / kg / day in 3 divided doses ( every 8 h ) .
PEDIATRIC VILONA ® Solution drops : 10 drops / kg / day divided into 3 doses ( every 8 h ) .
The duration of treatment is similar to the one for adults.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION : No reported cases of overdose in humans. 12.6 g daily dose for 7 days produced only moderate anemia and reversible upon discontinuation of therapy . Other side effects were evident .
VILONA ® capsules : Box of 18 (6 days of treatment) .
Box with bottle of 120 ml and metering measure ( each 5 ml containing 100 mg).
VILONA ® PEDIATRIC drops Solution : 15 ml dropper bottle ( each 20 drops or 1 ml contains 40 mg).
RECOMMENDED STORAGE: Store at room temperature not exceeding 30 ° C.