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Antifungals & Antivirals

Efavirenz STADA® 600 mg

 
 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains efavirenz 600 mg.

 

Shelf-life: 

48 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Antiviral combination treatment of human immunodeficiency virus HIV-1 infected adult, adolescents and children 3 years of age and older.
  • Post-exposure prophylaxis following occupational exposure to HIV (in combination with 2 other nucleosides).
  • Post-exposure prophylaxis following nonoccupational exposure to HIV (in combination with 2 other nucleosides).
     
  • Administered orally on an empty stomach. Avoid taking in a high fat meal (lipid) for increased absorption. Dosing at bedtime is recommended during the first 2 to 4 weeks of therapy to improve tolerability and minimize the adverse events on central nervous system (e.g., dizziness, insomnia, loss of concentration, drowsiness, nightmares). If there are no adverse effects on the central nervous system, efavirenz can be taken at a convenient time of the day for the patients.
  • If patients cannot swallow a whole capsule, the capsule may be opened and add the capsule contents to liquid food for use. The tablet should not be broken. Patients receiving this drug should not receive other efavirenz-containing preparations. Efavirenz is used in conjunction with other antiretrovirals, patients must be continuously monitored to evaluate the toxicity and disease progression, and if necessary, adjustment of therapeutic regimen should be made.
  • Must take this drug on time, if you forget to take this drug on time, take it as soon as you remember. If the administration time is close to the next dose, skip the missed dose. Do not take a double dose at once.
     
  • Treatment of HIV infection:
    Combined efavirenz with 2 other nucleoside: stavudine (d4T), lamivudine (3TC), efavirenz (EFV) or zidovudine (ZDV) + 3TC + EFV.
  • Adults, adolescents and children over 40 kg:
    600 mg once daily.
  • Post-exposure prophylaxis following occupational exposure to HIV:
    Efavirenz is administered in a dosage of 600 mg once daily at bedtime in conjunction with other antiretrovirals (efavirenz usually is used in conjunction with 2 nucleoside reverse transcriptase inhibitors). Should be started as soon as possible following occupational exposure (preferably within hours) and continued for 4 weeks.
  • Post-exposure prophylaxis following nonoccupational exposure to HIV:
    Efavirenz is administered in a dosage of 600 mg once daily at bedtime in conjunction with 2 other antiretrovirals. Should be started as soon as possible following nonoccupational exposure (preferably within 72 hours) and continued for 28 days.
  • Elderly patients:
    Efavirenz has not been studied in elderly patients. Patients should be monitored carefully and cautiously when taking efavirenz.
  • Renal impairment:
    The pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal.
  • Hepatic impairment:
    Patients with mild liver disease may be treated with their normally recommended dose of efavirenz. Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms.
    Dose adjustment in combination:
  • If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily. When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored.
  • If efavirenz is coadministered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day (four Efavirenz STADA® 200 mg capsules) may be considered.


Or as prescribed by physicians.

 

  • Know hypersensitivity to any ingredient in the formulation.
  • Patients with severe hepatic impairment.
  • Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil or ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse events (e.g. cardiac arrhythmias, prolonged sedation, or respiratory depression).
  • Herbal preparations containing Hypericum perforatum must not be used while taking efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz.

     

Very common

  • Rash.

Common

  • Hypertriglyceridaemia.
  • Abnormal dreams, anxiety, depression, insomnia.
  • Cerebellar coordination and balance disturbances, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%).
  • Abdominal pain, diarrhea, nausea, vomiting.
  • Aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, gamma-glutamyl transferase (GGT) increased.
  • Pruritus.
  • Fatigue.

Uncommon

  • Hypersensitivity.
  • Hypercholesterolemia.
  • Affect lability, aggression, confusional state, euphoric, mood, hallucination, mania, paranoia, psychosis, suicide attempt, suicide ideation.
  • Agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal, tremor.
  • Vision blurred.
  • Tinnitus, vertigo.
  • Flushing.
  • Pancreatitis.
  • Hepatitis acute.
  • Erythema multiform, Stevens-Johnson syndrome.
  • Gynecomastia.

     

  • Patients with severe hepatic impairment, and should be used with caution, and liver enzymes values monitored, in patients with mild to moderate liver disease.
  • Patients with a history of seizures or psychiatric disorders including depression.
  • Efavirenz should be stopped if a severe skin rash, associated with blistering, desquamation, mucosal involvement, or fever, develops.
  • Monitoring of serum lipids and blood-glucose may be considered during efavirenz treatment.
  • Nervous system symptoms: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies. Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks. Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
  • Seizures: Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures. Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels. In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz. Caution must be taken in any patient with a history of seizures.
  • Effect of food: The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions. It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
  • Immune reactivation syndrome: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathagen may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
  • Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
  • This drug contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take efavirenz.
  • Pregnancy: Efavirenz may cause fetal harm if administered during the first trimester of pregnancy. Women of childbearing potential should not receive efavirenz until pregnancy is excluded.
  • Lactation: Efavirenz has been shown to be excreted in human milk. There is insufficient information on the effects of efavirenz in infants. Risk to the infant can not be excluded. Breast-feeding should be discontinued during treatment with efavirenz. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
  • Efavirenz may cause dizziness, impaired concentration and/or somnolence. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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