VIRADAY CIPLA
Composition
VIRADAY
Each film-coated tablet contains:
Efavirenz ..................................................... 600 mg
Emtricitabine ...............................................200 mg
Tenofovir disoproxil fumarate ..................... 300 mg
equivalent to Tenofovir disoproxil ............... 245 mg
Dosage Form
Oral, fixed-dose tablet
Description
VIRADAY is a fixed-dose combination tablet containing efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF).
WARNINGS AND PRECAUTIONS).
Postmarketing Experience
The following adverse reactions below have been identified during post-approval use of efavirenz, emtricitabine, or tenofovir DF. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Efavirenz
Cardiac disorders: palpitations
Ear and labyrinth disorders: tinnitus, vertigo
Endocrine disorders: gynecomastia
Eye disorders: abnormal vision
Gastrointestinal disorders: constipation, malabsorption
General disorders and administration site conditions: asthenia
Hepatobiliary disorders: hepatic enzyme increase, hepatic failure, hepatitis.
Immune system disorders: allergic reactions
Metabolism and nutrition disorders: redistribution/accumulation of body fat (see Warnings and Precautions), hypercholesterolemia, hypertriglyceridemia
Musculoskeletal and connective tissue disorders: arthralgia, myalgia, myopathy
Nervous system disorders: abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor
Psychiatric disorders: aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide, catatonia
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: flushing, erythema multiforme, photoallergic dermatitis, Stevens-johnson syndrome.
Emtricitabine
No postmarketing adverse reactions have been identified for inclusion in this section.
Tenofovir DF
Immune system disorders: Allergic reaction, including angioedema
Metabolism and nutrition disorders: Lactic acidosis, hypokalemia, Hypophosphatemia
Respiratory, thoracic, and mediastinal disorders: Dyspnea
Gastrointestinal disorders: Abdominal pain, increased amylase, pancreatitis
Hepatobiliary disorders: hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT, gamma GT)
Skin and subcutaneous tissue disorders: Rash
Musculoskeletal and connective tissue disorders: rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal and Urinary disorders: acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
General disorders and administration site conditions: Asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.
If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024.
By reporting side effects you can help provide more information on the safety of this product.
Overdosage
If overdose occurs, the patient should be monitored for evidence of toxicity, including monitoring of vital signs and observation of the patient’s clinical status; standard supportive treatment should then be applied as necessary. Administration of activated charcoal may be used to aid the removal of unabsorbed efavirenz. Hemodialysis can remove both emtricitabine and tenofovir DF (refer to detailed information below), but is unlikely to significantly remove efavirenz from the blood.
Efavirenz
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.
Emtricitabine
Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.
Tenofovir DF
Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir DF, a 4-hour hemodialysis session removed approximately 10% of the administered tenofovir DF dose.
Storage and Handling Instructions
Store below 30°C. Protect from moisture
SOURCE: CIPLAMED
