Synthivan

Synthivan

Manufacturer:

Cipla

Distributor:

Phil Pharmawealth
Concise Prescribing Info
Contents
Atazanavir sulfate 300 mg, ritonavir 100 mg
Indications/Uses
In combination w/ other antiretroviral agents for HIV-1 infection.
Dosage/Direction for Use
Adult & ped patient at least 6 yr & 35 kg 1 tab daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity (eg, erythema multiforme, toxic skin eruptions, or SJS). Co-administration w/ drugs that are highly dependent on CYP3A or UGT1A1 for clearance & strong CYP3A inducers.
Special Precautions
Discontinue treatment if severe rash/reactions develop. SJS, erythema multiforme, & toxic skin eruptions including DRESS; anaphylaxis. Prolongs the PR interval. Increased risk for developing further transaminase elevations or hepatic decompensation in patients w/ underlying hepatitis B or C viral infections or marked elevations in transaminases. New-onset DM, exacerbation of preexisting DM, & hyperglycemia (persisted in some cases when therapy is discontinued) in HIV-infected patients. Diabetic ketoacidosis. May develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, or TB) during the initial phase of treatment. Autoimmune disorders (eg, Graves' disease, polymyositis, & Guillain-Barré syndrome). Fat redistribution/accumulation including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral/facial wasting, breast enlargement, & cushingoid appearance. Increased bleeding, including spontaneous skin hematomas & hemarthrosis in patients w/ hemophilia type A & B. Resistance/cross resistance. Pregnancy (risk of lactic acidosis syndrome & hyperbilirubinemia). Do not use during lactation. Atazanavir: Preexisting conduction system disease (eg, marked 1st degree AV block or 2nd or 3rd degree AV block). Hyperbilirubinemia. Consider alternative therapy if jaundice or scleral icterus associated w/ bilirubin elevations present concerns for patients. Ritonavir: Allergic reactions including urticaria, mild skin eruptions, bronchospasm, & angioedema. Increased risk for developing cardiac conduction abnormalities in patients w/ underlying structural heart disease, preexisting conduction system abnormalities, ischemic heart disease, cardiomyopathies. Preexisting liver diseases, liver enzyme abnormalities, or hepatitis; hepatic dysfunction in patients w/ multiple concomitant medications &/or w/ advanced AIDS. Monitor increase in AST/ALT especially during the 1st 3 mth of treatment. Increased risk of elevated triglycerides & pancreatitis in patients w/ advanced HIV disease; discontinue therapy if signs or symptoms of pancreatitis occur. Should not be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Co-administration w/ drugs that prolong PR interval (including Ca channel blockers, β-adrenergic blockers), particularly those metabolized by CYP3A. Perform triglyceride & cholesterol testing prior to initiating therapy & at periodic intervals during therapy. Increased triglycerides, cholesterol, SGOT (AST), SGPT (ALT), GGT, CPK, & uric acid. May reduce the efficacy of combined hormonal contraceptive, use alternative contraceptive method or additional barrier method of contraception.
Adverse Reactions
2nd & 3rd degree AV block. Atazanavir: Oedema, left bundle branch block, QTc prolongation; pancreatitis, hepatic function abnormalities; cholelithiasis, cholecystitis, cholestasis; DM, hyperglycemia; arthralgia; nephrolithiasis, interstitial nephritis; alopecia, maculopapular rash, pruritus, angioedema. Ritonavir: Dehydration, usually associated w/ GI symptoms; syncope, orthostatic hypotension, & renal insufficiency w/o known dehydration; 1st degree AV block, right bundle branch block; seizure; TEN.
Drug Interactions
Atazanavir: May increase plasma conc of drugs primarily metabolized by CYP3A or UGT1A1. May decrease plasma conc & reduce therapeutic effects w/ CYP3A4 inducers. Decreased solubility as pH increases. Reduced plasma conc w/ PPIs, antacids, buffered medications, or H2-receptor antagonists. Ritonavir: May increase plasma conc of agents primarily metabolized by CYP3A. Increased AUC of CYP2D6 substrates. Induced CYP3A, CYP1A2, CYP2C9, CYP2C19, & CYP2B6 enzymes, including glucuronosyl transferase.
MIMS Class
Antivirals
ATC Classification
J05AR23 - atazanavir and ritonavir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Synthivan FC tab
Packing/Price
10's;30's
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