FDA Section 4 \u2022 who must NOT take this

Clarithromycin - Contraindications

These conditions, allergies, and situations mean Clarithromycin should NOT be used. From the US FDA-approved drug label Section 4.

4 CONTRAINDICATIONS VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK : Known hypersensitivity to vonoprazan, amoxicillin or any other beta-lactams, clarithromycin or any other macrolide antimicrobial or any component of VOQUEZNA TRIPLE PAK.

Known hypersensitivity to vonoprazan, amoxicillin or any other beta-lactams or any component of VOQUEZNA DUAL PAK.

Rilpivirine-containing products.

VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component : Pimozide.

Lomitapide, lovastatin, and simvastatin.

Ergot alkaloids (ergotamine or dihydroergotamine).

Colchicine in renal or hepatic impairment.

History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin.

4.1 Contraindications to VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Hypersensitivity Reactions VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with a known hypersensitivity to any component of VOQUEZNA TRIPLE PAK: vonoprazan, amoxicillin (or other β-lactam antibacterials, e.g., penicillins and cephalosporins), or clarithromycin (or other macrolide antibacterial drugs, e.g., erythromycin) or VOQUEZNA DUAL PAK: vonoprazan or amoxicillin (or other β-lactam antibacterials, e.g., penicillins and cephalosporins) [see Warnings and Precautions ].

Rilpivirine-containing Products VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated with rilpivirine-containing products [see Drug Interactions ].

4.2 Additional Contraindications to VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component Serious Adverse Reactions/Risks Due to Drug Interactions Because of the clarithromycin component, VOQUEZNA TRIPLE PAK is contraindicated with concomitant use of: Pimozide: There have been postmarketing reports of drug interactions when clarithromycin is co-administered with pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin.

Fatalities have been reported [see Warnings and Precautions and Drug Interactions ].

Lipid-lowering Agents: Lomitapide, simvastatin, and lovastatin [see Warnings and Precautions and Drug Interactions ] Ergot Alkaloids: Ergotamine or dihydroergotamine [see Drug Interactions ] Colchicine in patients with renal or hepatic impairment [see Warnings and Precautions and Drug Interactions ] Lurasidone: Coadministration of clarithromycin and lurasidone may lead to an increase in lurasidone exposure and the potential for serious adverse reactions [see Drug Interactions ] .

Cholestatic Jaundice/Hepatic Dysfunction VOQUEZNA TRIPLE PAK is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

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