Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
SUSTIVA TABLETS |
| Manufacturer |
|
Bristol-Myers Squibb Virology |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Non-nucleoside reverse transcriptase inhibitor. |
| Generic Name |
|
Efavirenz 600mg. |
| Also |
|
• SUSTIVA
|
| Indications |
|
HIV-1 infection. |
| Adults and Children |
|
Give once daily on an empty stomach, preferably at bedtime. Consider pretreating with antihistamine (for children) or steroid to minimize rash. <3years: not recommended. ≥3years (10kg to <15kg): 200 mg; (15kg to <20kg): 250mg; (20kg to <25kg): 300mg; (25kg to <32.5kg): 350mg; (32.5kg to <40kg): 400mg; (≥40kg) and adults: 600mg. |
| Contraindications |
|
Concomitant cisapride, ergots, midazolam, triazolam, voriconazole. |
| Precautions |
|
CNS or psychiatric disturbances. Seizures. Hepatic dysfunction. Monitor cholesterol and triglycerides; monitor liver function in suspected or known history of hepatitis B or C. Discontinue if severe rash (w. blistering, desquamation, mucosal involvement, or fever) occurs. Obtain (–) pregnancy test before starting; use adequate (barrier + hormonal) contraception. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
|
See Contraindications. Avoid alcohol, other psychoactive and/or hepatotoxic drugs. Antagonized by St. John's wort: not recommended. Caution with drugs metabolized by, or that affect activity of, CYP2C9, CYP2C19, CYP3A4. Efavirenz levels decreased by phenobarbital, rifampin, rifabutin. May decrease levels of indinavir (increase indinavir to 1g every 8 hours), amprenavir, clarithromycin, methadone, rifabutin (increase dose: see literature). Efavirenz increases nelfinavir, ethinyl estradiol plasma levels. Levels of both drugs increased with ritonavir (monitor liver function and for adverse events). Levels of both drugs are decreased with saquinavir (do not use as sole protease inhibitor). Closely monitor warfarin, anticonvulsants (esp. phenytoin, phenobarbital, carbamazepine), rifabutin, others. May cause false (+) cannabis screening test (CEDIA DAU multi-level THC assay). |
| Adverse Reactions |
|
CNS effects (eg, drowsiness, dizziness, insomnia, impaired concentration, abnormal dreams), psychiatric effects (eg, severe depression, suicidal ideation/attempt, aggression, paranoia, mania, delusions, psychosis), rash (may be severe; eg, Stevens-Johnson, erythema multiforme), GI upset, fever, cough, dyspnea, redistribution of body fat. |
| Extra Text |
|
Note: Register pregnant patients exposed to efavirenz by calling (800) 258-4263. |
| How Supplied |
Caps 50mg, 100mg—30
200mg—90
Tabs 600mg—30 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
