"On January 7, 2010, FDA approved an updated Atripla label including new efficacy, safety and resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy "...
- Patient Information:
Details with Side Effects
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.
Treatment of overdose with SUSTIVA should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with SUSTIVA. Since efavirenz is highly protein bound, dialysis is unlikely to significantly remove the drug from blood.
SUSTIVA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.
For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with SUSTIVA are listed in Table 2.
Table 2: Drugs That Are Contraindicated or Not
Recommended for Use With SUSTIVA
|Drug Class: Drug Name||Clinical Comment|
|Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)||Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm an< ischemia of the extremities and other tissues.|
|Benzodiazepines: midazolam, triazolam||Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.|
|Calcium channel blocker: bepridil||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|GI motility agent: cisapride||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|Neuroleptic: pimozide||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|St. John's wort (Hypericum perforatum)||May lead to loss of virologic response and possible resistance to efavirenz or to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).|
Last reviewed on RxList: 5/31/2013
This monograph has been modified to include the generic and brand name in many instances.
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