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Kaletra Capsules

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Kaletra Capsules

Kaletra Capsules

OVERDOSE

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.

CONTRAINDICATIONS

  • KALETRA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) 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].
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].
Neuroleptic Pimozide Potential for cardiac arrhythmias.
Sedative/Hypnotics Triazolam; orally administered midazolamb Prolonged or increased sedation or respiratory depression.
a see DRUG INTERACTIONS, Table 7 for co-administration of sildenafil in patients with erectile dysfunction.
b see DRUG INTERACTIONS, Table 7 for parenterally administered midazolam.

Last reviewed on RxList: 2/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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