Medscape Medical News
The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
Human experience of acute overdosage with KALETRA is limited. Treatment of overdose with KALETRA should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with KALETRA. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since KALETRA is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the drug.
- KALETRA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir.
- Co-administration of KALETRA is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions. These drugs are listed in Table 1.
- Co-administration of KALETRA is contraindicated with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance. These drugs are listed in Table 1.
Table 1: Drugs That are Contraindicated with KALETRA
|Drug Class||Drugs within Class That are Contraindicated with KALETRA||Clinical Comments|
|Alpha 1- Adrenoreceptor Antagonist||Alfuzosin||Potentially increased alfuzosin concentrations can result in hypotension.|
|Antimycobacterial||Rifampin||May lead to loss of virologic response and possible resistance to KALETRA or to the class of protease inhibitors or other co-administered antiretroviral agents [see DRUG INTERACTIONS].|
|Potential for serious and/or life-threatening reactions. Potential for cardiac arrhythmias.|
|Ergot Derivatives||Dihydroergotamine, ergotamine, methylergonovine||Potential for acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.|
|GI Motility Agent||Cisapride||Potential for cardiac arrhythmias.|
|Herbal Products||St. John's Wort (hypericum perforatum)||May lead to loss of virologic response and possible resistance to KALETRA or to the class of protease inhibitors.|
|HMG-CoA Reductase Inhibitors||Lovastatin, simvastatin||Potential for myopathy including rhabdomyolysis.|
|PDE5 Enzyme Inhibitor||Sildenafila (Revatio®) when used for the treatment of pulmonary arterial hypertension||A safe and effective dose has not been established when used with KALETRA. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope [see DRUG INTERACTIONS].|
|Sedative/Hypnotics||Triazolam; orally administered midazolamb||Prolonged or increased sedation or respiratory depression.|
|a see DRUG INTERACTIONS, Table 6 for
co-administration of sildenafil in patients with erectile dysfunction.
b see DRUG INTERACTIONS, Table 6 for parenterally administered midazolam.
Last reviewed on RxList: 12/8/2016
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