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Pronunciation:

(lan SOE pra zole, a moks i SIL in, & kla RITH roe mye sin)

U.S. Brand Names:

Prevpac®

Synonyms:

Amoxicillin, Lansoprazole, and Clarithromycin; Clarithromycin, Lansoprazole, and Amoxicillin

Generic Available:

Canadian Brand Names:

Hp-PAC®; Prevpac®

Use:

Eradication of H. pylori to reduce the risk of recurrent duodenal ulcer

Pregnancy Risk Factor:

C (clarithromycin)

Pregnancy Implications:

See individual agents.

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to lansoprazole, amoxicillin (or any penicillin), clarithromycin (or erythromycin), or any component of the formulation; concurrent use with pimozide or cisapride

Warnings/Precautions:

Based on lansoprazole component: Severe liver dysfunction may require dosage reductions.

Based on amoxicillin component: In patients with renal impairment, doses and/or frequency of administration should be modified in response to the degree of renal impairment; a high percentage of patients with infectious mononucleosis have developed rash during therapy with amoxicillin; a low incidence of cross-allergy with other beta-lactams and cephalosporins exists

Based on clarithromycin component: Dosage adjustment required with severe renal impairment, decreased dosage or prolonged dosing interval may be appropriate; antibiotic-associated colitis has been reported with use of clarithromycin. Macrolides (including clarithromycin) have been associated with rare QT prolongation and ventricular arrhythmias, including torsade de pointes. Safety and efficacy in children <6 months of age have not been established.

Adverse Reactions:

Note: Frequencies noted refer to experience with combination therapy for 14 days with all components. Refer to individual monographs for more extensive information on adverse reactions reported with each component.

3% to 10%:

Central nervous system: Headache (6%)

Gastrointestinal: Diarrhea (7%), taste perversion (5%)

<3%: Abdominal pain, candidiasis (oral), confusion, dark stools, dermatologic reactions, dizziness, dry mouth, glossitis, myalgia, nausea, rectal itching, thirst, tongue discoloration, vaginitis, vomiting

Drug Interactions:

Lansoprazole: Substrate of CYP2C8/9 (minor), 2C19 (major), 3A4 (major); Inhibits CYP2C8/9 (weak), 2C19 (moderate), 2D6 (weak), 3A4 (weak); Induces CYP1A2 (weak)

Clarithromycin: Substrate of CYP3A4 (major); Inhibits CYP1A2 (weak), 3A4 (strong)

Also see individual agents.

Pharmacodynamics/Kinetics:

See individual agents.

Dosage:

Oral: Adults: Lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg taken together twice daily for 10 or 14 days

Patient Education:

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause drowsiness or dizziness; rarely large doses may produce confusion, hallucinations, and depression; penicillins have been reported to cause apprehension, illusions, agitation, insomnia, depersonalization, and encephalopathy; macrolides have been reported to cause nightmares, confusion, anxiety, and mood lability

Mental Health: Effects on Psychiatric Treatment:

Disulfiram may increase amoxicillin levels; macrolides are contraindicated with pimozide and increase carbamazepine and triazolam levels; monitor for signs of toxicity

Dosage Forms:

Combination package (Prevpac®) [each administration card contains]:

Capsule (Trimox®): Amoxicillin 500 mg (4 capsules/day)

Capsule, delayed release (Prevacid®): Lansoprazole 30 mg (2 capsules/day)

Tablet (Biaxin®): Clarithromycin 500 mg (2 tablets/day)

International Brand Names:

Hp-PAC® (CA); Prevpac® (CA)

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