Acriptega

Acriptega

Manufacturer:

Viatris GmbH & Co

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Concise Prescribing Info
Contents
Dolutegravir Na 50 mg, lamivudine 300 mg, tenofovir disoproxil fumarate 300 mg
Indications/Uses
HIV-infected adults & adolescents >12 yr weighing at least 40 kg.
Dosage/Direction for Use
Adult & adolescent >12 yr & weighing ≥40 kg 1 tab once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ dofetilide.
Special Precautions
Discontinue use if hypersensitivity reactions occur. Concomitant use w/ other cytidine analogues eg, emtricitabine, adefovir dipivoxil; integrase class resistance; nephrotoxic drugs (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2); drugs that reduce exposure (eg, Mg/Al-containing antacid, Fe & Ca supplements, multivit & inducing agents, etravirine, tipranavir/ritonavir, rifampicin, St. John's wort & certain antiepileptics); metformin; didanosine. Patients w/ severe liver disease; chronic hepatitis B or C; CrCl <50 mL/min or serum phosphate <1 mg/dL. Discontinue use in patients co-infected w/ HIV & HBV; closely monitor for at least 4 mth after discontinuation of therapy. Monitor liver biochemistries in patient w/ hepatitis B &/or C co-infection. Bone abnormalities associated w/ proximal renal tubulopathy. Lactic acidosis; lipodystrophy; immune reactivation syndrome. Mitochondrial dysfunction. Discontinue immediately if pancreatitis occur. Opportunistic infections. Osteonecrosis in patients w/ advanced HIV-disease &/or long-term exposure to CART. Galactose intolerance eg, galactosaemia, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machinery. Pregnancy & lactation. Avoid use at the time of conception through 1st trimester of pregnancy.
Adverse Reactions
Hypophosphataemia; dizziness; diarrhea, nausea, vomiting. Headache, insomnia; cough, nasal symptoms; abdominal pain/cramps, flatulence; rash; hair loss; arthralgia, muscle disorder; abnormal dreams, depression; dizziness; upper abdominal pain; abdominal discomfort; pruritus; fatigue; ALT & AST elevation; creatinine phosphokinase elevations.
Drug Interactions
Increased adverse effects & decreased CD4 cells w/ didanosine. Increased serum conc w/ drugs that reduce renal function or compete for active tubular section via transport proteins hOAT1, hOAT3 or MRP4 (eg, cidofovir). Nephrotoxic drugs eg, aminogycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2. Renal function may be affected by tacrolimus. Adefovir dipivoxil. Atazanavir. Integrase class resistance. Decreased plasma conc w/ drugs that induce UGT1A3, UGT1A9, CYP3A4, P-gp & BCRP substrates. Reduced absorption by antacids. May increase plasma conc of drugs which excretion is dependent upon OCT2 or MATE-1 eg, dofetilide, metformin; drugs which excretion is dependent upon OAT3.
MIMS Class
Antivirals
ATC Classification
J05AR27 - lamivudine, tenofovir disoproxil and dolutegravir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Acriptega FC tab
Packing/Price
30's
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