What is Viriton?
Viriton is used alone or in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Viriton will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Viriton will not keep you from spreading HIV to other people. People who receive Viriton may continue to have other problems related to AIDS or HIV disease.
Viriton is available only with your doctor's prescription.
Viriton indications
Viriton is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
How should I use Viriton?
Use Viriton solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Viriton solution. Talk to your pharmacist if you have questions about this information.
- Take Viriton solution by mouth with food.
- Shake well before each use.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- To improve the taste of Viriton solution, you may mix it with 8 ounces of certain liquids (eg, chocolate milk, Ensure, or Advera) as directed in the patient leaflet. If you mix Viriton solution with these fluids, be sure to take it within 1 hour of mixing. As your doctor, nurse, or pharmacist if you have any questions about this information.
- Continue to take Viriton solution even if you feel well. Do not miss any doses.
- If you miss a dose of Viriton solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Viriton solution. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Viriton solution.
Uses of Viriton in details
Off Label Uses
HIV-1 infection, as a pharmacokinetic enhancer for other protease inhibitors
Based on the Department of Health and Human Services (HHS) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Centers for Disease Control and Prevention, US Department of Health and Human Services updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV, Viriton is recommended as a pharmacokinetic enhancer for other protease inhibitors in certain antiretroviral treatment regimens for HIV-infected patients and in certain antiretroviral regimens for postexposure prophylaxis of HIV-1 infection following nonoccupational exposure (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that may contain HIV.
Viriton description
An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. [PubChem]
Viriton dosage
General Dosing and Administration Recommendations
- Viriton must be used in combination with other antiretroviral agents.
- Viriton Tablets are administered orally. Viriton Tablets should be swallowed whole, and not chewed, broken or crushed. Take Viriton Tablets with meals.
Recommended Adult Dosage
Recommended Dosage for Treatment of HIV-1:
The recommended dosage of Viriton Tablets is 600 mg twice daily by mouth to be taken with meals. Use of a dose titration schedule may help to reduce treatment-emergent adverse events while maintaining appropriate Viriton plasma levels. Viriton Tablets should be started at no less than 300 mg twice daily and increased at 2 to 3 day intervals by 100 mg twice daily. The maximum dose of 600 mg twice daily should not be exceeded upon completion of the titration.
Recommended Pediatric Dosage
Viriton Tablets must be used in combination with other antiretroviral agents. The recommended dosage of Viriton Tablets in pediatric patients older than 1 month is 350 to 400 mg per m2 twice daily by mouth to be taken with meals and should not exceed 600 mg twice daily. Viriton Tablets should be started at 250 mg per m2 twice daily and increased at 2 to 3 day intervals by 50 mg per m2 twice daily. If patients do not tolerate 400 mg per m2 twice daily due to adverse events, the highest tolerated dose may be used for maintenance therapy in combination with other antiretroviral agents, however, alternative therapy should be considered.
Body surface area (BSA) can be calculated as follows1:
Dose Modification due to Drug Interaction
Dose reduction of Viriton is necessary when used with other protease inhibitors: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir.
Prescribers should consult the full prescribing information and clinical study information of these protease inhibitors if they are co-administered with a reduced dose of Viriton.
Viriton interactions
See also:
What other drugs will affect Viriton?
Viriton has been found to be an inhibitor of cytochrome P450 3A (CYP3A) both in vitro and in vivo (Table 2). Agents that are extensively metabolized by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in AUC (>3-fold) when co-administered with Viriton. Viriton also inhibits CYP2D6 to a lesser extent. Co-administration of substrates of CYP2D6 with Viriton could result in increases (up to 2-fold) in the AUC of the other agent, possibly requiring a proportional dosage reduction. Viriton also appears to induce CYP3A as well as other enzymes, including glucuronosyl transferase, CYP1A2, and possibly CYP2C9.
Drugs that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse events are listed both in CONTRAINDICATIONS Table 3 and under Contraindicated Drugs in Table 4.
Those drug interactions that have been established based on drug interaction studies are listed with the pharmacokinetic results in CLINICAL PHARMACOLOGY, Table 2. The clinical recommendations based on the results of these studies are listed in Table 4 Established Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies.
A systematic review of over 200 medications prescribed to HIV-infected patients was performed to identify potential drug interactions with Viriton. 2 There are a number of agents in which CYP3A or CYP2D6 partially contribute to the metabolism of the agent. In these cases, the magnitude of the interaction and therapeutic consequences cannot be predicted with any certainty.
When co-administering Viriton with calcium channel blockers, immunosuppressants, some HMG-CoA reductase inhibitors, some steroids, or other substrates of CYP3A, or most antidepressants, certain antiarrhythmics, and some narcotic analgesics which are partially mediated by CYP2D6 metabolism, it is possible that substantial increases in concentrations of these other agents may occur, possibly requiring a dosage reduction (>50%); examples are listed in Table 4 Predicted Drug Interactions: Use With Caution, Dose Decrease May be Needed.
When co-administering Viriton with any agent having a narrow therapeutic margin, such as anticoagulants, anticonvulsants, and antiarrhythmics, special attention is warranted. With some agents, the metabolism may be induced, resulting in decreased concentrations.
DRUGS THAT ARE CONTRAINDICATED WIT NORVIR USE
Viriton side effectsSee also: sponsored
The following adverse reactions are discussed in greater detail in other sections of the labeling.
When co-administering Viriton with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.
Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults The safety of Viriton alone and in combination with other antiretroviral agents was studied in 1,755 adult patients. Table 2 lists treatment-emergent Adverse Reactions (with possible or probable relationship to study drug) occurring in greater than or equal to 1% of adult patients receiving Viriton in combined Phase II/IV studies. The most frequently reported adverse drug reactions among patients receiving Viriton alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia.
Laboratory Abnormalities in Adults Table 3 shows the percentage of adult patients who developed marked laboratory abnormalities.
Adverse Reactions in Pediatric Patients Viriton has been studied in 265 pediatric patients greater than 1 month to 21 years of age. The adverse event profile observed during pediatric clinical trials was similar to that for adult patients. Vomiting, diarrhea, and skin rash/allergy were the only drug-related clinical adverse events of moderate to severe intensity observed in greater than or equal to 2% of pediatric patients enrolled in Viriton clinical trials. Laboratory Abnormalities in Pediatric Patients The following Grade 3-4 laboratory abnormalities occurred in greater than 3% of pediatric patients who received treatment with Viriton either alone or in combination with reverse transcriptase inhibitors: neutropenia (9%), hyperamylasemia (7%), thrombocytopenia (5%), anemia (4%), and elevated AST (3%).
Postmarketing ExperienceThe following adverse events (not previously mentioned in the labeling) have been reported during post-marketing use of Viriton. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to Viriton exposure. Body as a Whole Dehydration, usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency has been reported. Syncope, orthostatic hypotension, and renal insufficiency have also been reported without known dehydration. Co-administration of Viriton with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system. Cardiovascular System First-degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported. Cardiac and neurologic events have been reported when Viriton has been co-administered with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. The possibility of drug interaction cannot be excluded. Endocrine System Cushing's syndrome and adrenal suppression have been reported when Viriton has been co-administered with fluticasone propionate or budesonide. Nervous System There have been postmarketing reports of seizure. Also, see Cardiovascular System. Skin and subcutaneous tissue disorders Toxic epidermal necrolysis (TEN) has been reported. Viriton contraindicationsSee also: Viriton is contraindicated in patients with known hypersensitivity to Viriton or any of its ingredients. Viriton should not be administered concurrently with the drugs listed in the list below because competition for primarily CYP3A by Viriton could result in inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening reactions such as cardiac arrhythmias, prolonged or increased sedation, and respiratory depression. Postmarketing reports indicate that co-administration of Viriton with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities. DRUGS THAT ARE CONTRAINDICATED WITH Viriton USE:Antiarrhythmics: amiodarone, bepridil, flecainide, propafenone, quinidineAntihistamines: astemizole, terfenadineAntimigraine: dihydroergotamine, ergotamineSedative/hypnotics: midazolam, triazolamGI motility agent: cisapride Neuroleptic: pimozide Active ingredient matches for Viriton:
References
ReviewsThe results of a survey conducted on ndrugs.com for Viriton are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Viriton. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reportsConsumer reported usefulNo survey data has been collected yetConsumer reported price estimatesNo survey data has been collected yetConsumer reported time for resultsNo survey data has been collected yetConsumer reported ageNo survey data has been collected yetConsumer reviews
Information checked by Dr. Sachin Kumar, MD Pharmacology More about ViritonClinician Information
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