Teevir

Teevir

Manufacturer:

Viatris

Distributor:

Atlanta Medicare
Concise Prescribing Info
Contents
Tenofovir disoproxil fumarate 300 mg, efavirenz 600 mg, emtricitabine 200 mg
Indications/Uses
HIV-1 infections w/ virologic suppression to HIV-1 RNA levels.
Dosage/Direction for Use
1 tab once daily.
Administration
Should be taken on an empty stomach: Take preferably at bedtime. Swallow whole.
Contraindications
Hypersensitivity. Severe hepatic (CPT grade C) impairment.
Special Precautions
Moderate or severe renal impairment. Hepatic impairment. Hepatomegaly, hepatitis or other known risk factors for liver disease & hepatic steatosis; discontinue use in symptomatic hyperlactataemina & metabolic/lactic acidosis, progressive hepatomegaly or rapidly elevating aminotransferase levels. Closely monitor patients w/ HIV-associated diseases. Mild to moderate liver disease; monitor preexisting liver dysfunction including chronic active hepatitis. Patients w/ chronic hepatitis B or C. Monitor patients w/ HIV infection co-infected w/ HBV for at least 4 mth after discontinuation of therapy. Prior history of psychiatric disorders. History of seizures. Periodic monitoring of plasma levels in patients receiving concomitant anticonvulsant drugs. Monitor renal function every 4 wk during the 1st yr of therapy then every 3 mth. Discontinue if severe rash associated w/ blistering, desquamation, mucosal involvement or fever develops. Lipodystrophy. Childn possible w/ mitochondrial dysfunction. Severe immunodeficiency. Osteonecrosis in patients w/ advanced HIV disease &/or long-term exposure to combination antiretroviral therapy. Bone abnormalities. Concomitant use w/ didanosine. HIV-1 harbouring the K65R, M184V/I or K103N mutation. May impair ability to drive or operate machinery. Childn <18 yr. Elderly. Pregnancy & lactation.
Adverse Reactions
Dizziness, nausea, abnormal dreams, rash. Somnolence, stupor, lethargy, headache, disturbance of attention; vertigo; diarrhoea, vomiting, abdominal pain, flatulence, abdominal distension, dry mouth; pruritus, skin hyperpigmentation, dermatitis; increased/decreased appetite; hot flush; fatigue, fever; nightmares, depression, insomnia, sleep disorder, euphoric mood.
Drug Interactions
Cytidine analogues eg, lamivudine. Altered efavirenz exposure w/ grapefruit juice. May inhibit metabolism of terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil or ergot alkaloids. Voriconazole; St. John's wort; atazanavir/ritonavir; didanosine. Increased serum conc of emtricitabine & tenofovir w/ cidofovir. Aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, interlukin-2.
MIMS Class
ATC Classification
J05AR06 - emtricitabine, tenofovir disoproxil and efavirenz ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Teevir FC tab
Packing/Price
30's
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