Kaletra Capsules (Lopinavir, Ritonavir Capsules) Drug Information: Overdosage and Contraindications

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May 27, 2012

Kaletra Capsules

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OVERDOSE

KALETRA oral solution contains 42.4% alcohol (v/v). Accidental ingestion of the product by a young child could result in significant alcohol-related toxicity and could approach the potential lethal dose of alcohol.

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 known hypersensitivity 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 events. These drugs are listed in Table 9.

Table 9: Drugs That Are Contraindicated With KALETRA

Drug Class	Drugs Within Class That Are
Alpha 1-Adrenoreceptor antagonist	Alfuzosin
Antihistamines	Astemizole, Terfenadine
Ergot Derivatives	Dihydroergotamine, Ergonovine, Ergotamine, Methylergonovine
GI motility agent	Cisapride
Neuroleptic	Pimozide
PDE5 enzyme inhibitor	Sildenafil* (Revatio®) when used for the treatment of pulmonary arterial hypertension
Sedative/Hypnotics	Midazolam, Triazolam
* see WARNINGS – DRUG INTERACTIONS and PRECAUTIONS, Table 11. Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction for co-administration of sildenafil in patients with erectile dysfunction. For additional information for these contraindicated drugs, see also PRECAUTIONS – Table 10**. Drugs That Should Not Be Co-administered With KALETRA.