Amoxicillin / Lansoprazole / Clarithromycin

Pronunciation: (uh-MOX-ih-sil-in/lan-SO-pruh-zole/kluh-RITH-row-MY-sin)Class: H. Pylori Agent

Trade Names:Prevpac- Capsules and tablets Two 30 mg lansoprazole capsules, four 500 mg amoxicillin capsules, two 500 mg clarithromycin tablets

Hp-PAC (Canada)

Pharmacology

Lansoprazole

Suppresses gastric acid secretion by blocking acid (proton) pump within gastric parietal cells.

Amoxicillin

Inhibits bacterial cell wall mucopeptide synthesis.

Clarithromycin

Inhibits microbial protein synthesis.

Indications and Usage

Eradication of H. pylori to reduce risk of duodenal ulcer recurrence.

Contraindications

Coadministration with cisapride or pimozide, known hypersensitivity to any component of formulation (ie, lansoprazole, any macrolide antibiotic, any penicillin).

Dosage and Administration

Adults

PO 30 mg lansoprazole/1 g amoxicillin/500 mg clarithromycin given together twice daily (morning and evening) for 14 days. Not recommended in patients with Ccr less than 30 mL/min.

General Advice

• Each dose consists of 4 pills (1 pink and black capsule; 2 maroon and light pink capsules; 1 yellow tablet).
• Administer all 4 pills twice daily before meals.
• Do not open capsules or chew or crush tablet. Instruct patient to swallow each pill whole.

Storage/Stability

Store at controlled room temperature. Protect from light and moisture.

Drug Interactions

Anticoagulants, oral

Coadministration may potentiate the effects of the oral anticoagulants. Carefully monitor prothrombin times while patients are receiving clarithromycin and oral anticoagulants simultaneously.

Carbamazepine

Coadministration of single doses of clarithromycin and carbamazepine has been shown to result in increased carbamazepine concentrations. Blood level monitoring of carbamazepine may be considered.

CYP-450 metabolized drugs

Concurrent use of clarithromycin and drugs metabolized by the CYP-450 system may be associated with elevations in serum levels of these other drugs: cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, disopyramide, bromocriptine, valproate, pimozide, and rifabutin. Closely monitor serum concentrations of drugs metabolized by the CYP-450 system in patients concurrently receiving these drugs.

Digoxin

Coadministration may potentiate the effects of digoxin. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Carefully monitor serum digoxin levels while patients are receiving digoxin and clarithromycin simultaneously.

Ergotamine or dihydroergotamine

Concurrent use of clarithromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysthesia.

HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin)

Clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors. Rhabdomyolysis has been reported.

Sucralfate

When coadministered, the absorption of lansoprazole was delayed and bioavailability was reduced 17%. Take lansoprazole 30  min prior to sucralfate.

Theophylline

Plasma theophylline levels may be increased which may necessitate additional titration of theophylline when lansoprazole is started or stopped.

Triazolam

Clarithromycin has been reported to decrease the Cl of triazolam and may increase the CNS effects (eg, somnolence, confusion) with concomitant use.

Laboratory Test Interactions

Amoxicillin

May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets (enzyme-based tests, eg, Clinistix , TesTape , are recommended); false-positive direct Coombs test result in certain patient groups; false-positive protein reactions, acetic acid test, biuret reaction, and nitric acid test (bromphenol blue test Multi-Stix , is recommended).

The following changes in laboratory parameters were reported as adverse reactions: abnormal liver function tests, AG ratio, RBC, bilirubinemia, eosinophilia, or hyperlipemia; increased AST, ALT, creatinine, alkaline phosphatase, globulins, GGTP, gluconcorticoids, LDH, or gastrin levels; increased, or decreased electrolytes, cholesterol; increased, decreased, or abnormal WBC or platelets. Additional isolated laboratory abnormalities were reported.

Adverse Reactions

CNS

Headache; confusion; dizziness.

Dermatologic

Skin reactions.

EENT

Taste perversion; glossitis.

GI

Diarrhea; abdominal pain; dark stools; dry mouth; rectal itching; nausea; oral moniliasis; stomatitis; tongue discoloration; tongue disorder; vomiting.

Genitourinary

Vaginitis; vaginal moniliasis.

Respiratory

Respiratory disorders.

Miscellaneous

Thirst; myalgia.

Precautions

Pregnancy

Category C .

Lactation

Amoxicillin is excreted in breast milk in very small amounts.

Children

Safety and efficacy not established.

Elderly

Because these patients may suffer from asymptomatic renal or hepatic function impairment, administer with caution.

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions may occur; because cross-allergenicity may occur with cephalosporins, use with caution in patients allergic to either class of antibiotic.

Renal Function

Use with caution and adjust dosage in patients with severe renal function impairment with or without impaired coexisting hepatic function impairment. Dosage adjustment is not necessary in patients with hepatic function impairment and healthy renal function.

Hepatic Function

Use with caution and adjust dosage in patients with severe renal function impairment with or without impaired coexisting hepatic function impairment. Dosage adjustment is not necessary in patients with hepatic function impairment and healthy renal function.

Superinfection

Prolonged use may result in bacterial and fungal overgrowth.

Pseudomembranous colitis

Consider possibility in patients in whom diarrhea develops.

Patient Information

• Inform patient that each dose consists of 4 pills and should be taken twice daily before meals.
• Advise patient not to open capsules or crush or chew tablet and to swallow whole.
• Advise patient that the entire course of therapy (10 or 14 days) must be completed to ensure maximal benefit and to complete full course of therapy even if symptoms have resolved.
• Inform patient that headache, abnormal taste, and GI symptoms are most common adverse reactions. Inform health care provider if any symptoms occur and are intolerable.
• Advise patient to notify health care provider if severe diarrhea or diarrhea lasting 2 to 3 days develops during or shortly after completing therapy.
• Advise patient to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, or shortness of breath occurs.

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