CIPLADOC - Cipla Therapeutic Index

Therapeutic Index

Antiretrovirals

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Viraday

Efavirenz and Emtricitabine and Tenofovir Disoproxil Fumarate Tablet

COMPOSITION

VIRADAY Tablet

Each film-coated tablet contains:
Efavirenz ..................................................... 600 mg
Emtricitabine ............................................... 200 mg
Tenofovir disoproxil fumarate ..................... 300 mg
e quivalent to Tenofovir disoproxil .................. 245 mg

INDICATIONS

VIRADAY Tablet is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

DOSAGE AND ADMINISTRATION

Adults
The dose of VIRADAY Tablet is one tablet once daily taken on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms associated with efavirenz.

Pediatric Use
VIRADAY Tablet is not recommended for use in patients <18 years of age.

Renal Impairment
Because VIRADAY Tablet is a fixed-dose combination, they should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (creatinine clearance <50 mL/min).

CONTRAINDICATIONS

Hypersensitivity

VIRADAY Tablet is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Contraindicated Drugs
For some drugs, competition for CYP3A by efavirenz could result in the inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with VIRADAY Tablet are listed in Table 1.

Table 1: Drugs that are contraindicated or not recommended for use with VIRADAY Tablets

Drug Class: Drug Name	Clinical Comment
Antifungal voriconazole	Efavirenz significantly decreases voriconazole plasma concentrations, and co-administration may decrease the therapeutic effectiveness of voriconazole. Also, voriconazole significantly increases efavirenz plasma concentrations, which may increase the risk of efavirenz-associated side effects. Because VIRADAY Tablet is a fixed-dose combination product, the dose of efavirenz cannot be altered.
Ergot derivatives ( dihydroergotamine, ergonovine, ergotamine, methylergonovine)	Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Benzodiazepines midazolam, triazolam	Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.
Calcium channel blocker b epridil	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Gastrointestinal motility agent cisapride	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Neuroleptic pimozide	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
St. John`s wort ( Hypericum perforatum )	May lead to loss of virologic response and possible resistance to efavirenz or to the class of NNRTIs.

PACKAGING INFORMATION

VIRADAY Tablet……………………… Container of 30 tablets

For full prescribing information, click here

Last Updated: Feb 2010

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