Lansoprazole-Amoxicillin-Clarithromycin

Lansoprazole-Amoxicillin-Clarithromycin is a combination of prescription medications used for the treatment of duodenal ulcers.

• Lansoprazole-Amoxicillin-Clarithromycin is available under the following different brand names: Prevpac

Adult dosage

• Capsule/capsule/tablet prepack
• 30mg/500mg/500mg
• amoxicillin component consists of 2 capsules (500 mg/capsule)

Duodenal Ulcer

Adult dosage

• Lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg administered together orally twice daily (morning and evening) for 10 or 14 days
• Each dose of this combination therapy contains 4 pills: 1 capsule lansoprazole 30 mg, 2 capsules amoxicillin 500 mg, and 1 tablet clarithromycin 500 mg
• Prevpac is clearly labeled for the administration of 1 dose (30 mg/1 g/500 mg) orally twice daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Lansoprazole-Amoxicillin-Clarithromycin include:

• nausea,
• vomiting,
• diarrhea,
• headache,
• vaginal itching or discharge,
• unusual or unpleasant taste in the mouth, and
• black or "hairy" tongue.

Serious side effects of the Lansoprazole-Amoxicillin-Clarithromycin include:

• hives,
• difficulty breathing,
• swelling in the face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• skin rash,
• swollen glands,
• muscle aches,
• severe weakness,
• unusual bruising,
• yellowing of the skin or eyes (jaundice),
• severe stomach pain,
• watery or bloody diarrhea,
• fast or pounding heartbeats,
• fluttering in the chest,
• shortness of breath,
• sudden dizziness,
• upper stomach pain,
• itching,
• loss of appetite,
• dark urine,
• urinating more or less than usual,
• blood in the urine,
• swelling,
• rapid weight gain,
• joint pain, and
• skin rash on the cheeks or arms that worsens in sunlight.

Rare side effects of the Lansoprazole-Amoxicillin-Clarithromycin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lansoprazole-Amoxicillin-Clarithromycin has no noted severe interactions with any other drugs.
• Lansoprazole-Amoxicillin-Clarithromycin has no noted serious interactions with any other drugs.
• Lansoprazole-Amoxicillin-Clarithromycin has no noted moderate interactions with any other drugs.
• Lansoprazole-Amoxicillin-Clarithromycin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Lansoprazole
  • Hypersensitivity to lansoprazole or other proton pump inhibitors
  • Coadministration with rilpivirine containing products
• Amoxicillin
  • History of severe hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or other beta-lactam antibiotics (e.g., penicillins and cephalosporins)
  • Infectious mononucleosis (relative)
• Clarithromycin
  • Documented hypersensitivity
  • Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl less than 25 mL/min); history of acute porphyria
  • QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes
  • Concomitant administration with HMG-CoA reductase inhibitors
  • History of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
  • Coadministration with colchicine in patients with renal or hepatic impairment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lansoprazole-Amoxicillin-Clarithromycin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lansoprazole-Amoxicillin-Clarithromycin?”

Cautions

• Consider the possibility of superinfections with fungal or bacterial pathogens during therapy; if superinfections occur, discontinue therapy and institute appropriate therapy; prescribing therapy either in absence of proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria
• Lansoprazole
  • Liver disease may require dosage reduction
  • Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (more than 1 yr), high-dose therapy
  • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to a specialist
  • Hypomagnesemia may occur with prolonged use (i.e., more than 1 year); adverse effects may result and include tetany, arrhythmias, or seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
  • PPIs are possibly associated with an increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider the diagnosis of CDAD for patients taking PPIs with diarrhea that does not improve
  • Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI; in older patients, also consider an endoscopy
  • PPIs may elevate and prolong methotrexate or its metabolite serum levels, possibly leading to toxicity
  • PPI therapy is associated with an increased risk of fundic gland polyp; risk increases with long-term use of above a year; the patient may be asymptomatic; the problem is usually identified incidentally on endoscopy; use the shortest duration of therapy appropriate to the condition being treated
  • Acute interstitial nephritis (AIN) is observed in patients taking proton pump inhibitors (PPIs) including lansoprazole; acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction; discontinue lansoprazole if AIN develops
• Amoxicillin
  • Allergy to cephalosporins, carbapenems
  • Endocarditis prophylaxis: use only for high-risk pts, per recent AHA Guidelines
  • High doses may cause false urine glucose tests by some methods
• Clarithromycin
• Caution in severe renal or hepatic impairment; in presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals of clarithromycin may be appropriate
• Do not refrigerate the oral solution
• Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines
• The drug has been associated with prolongation of QT interval and infrequent cases of arrhythmia; cases of torsades de pointes spontaneously reported during postmarketing surveillance; fatalities reported; avoid therapy in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; elderly patients may be more susceptible to drug-associated effects on the QT interval
• Concomitant use of clarithromycin and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia
• There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin; monitor INR and prothrombin times
• Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, is reported with drug; hepatic dysfunction may be severe and usually reversible; in some instances, hepatic failure with the fatal outcome is reported and generally associated with serious underlying diseases and/or concomitant medications; symptoms of hepatitis can include anorexia, jaundice, dark urine, pruritus, or tender abdomen; discontinue clarithromycin immediately if signs and symptoms of hepatitis occur
• Hypersensitivity reactions
  • Individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins reported
  • Before initiating therapy perform careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens
  • In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and Henoch-Schonlein purpura discontinue therapy immediately and urgently initiate appropriate treatment
• Drug interaction overview
  • Serious adverse reactions reported with clarithromycin concomitantly with CYP3A4 substrates; these include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; hypoglycemia with disopyramide, and hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine); most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or older; clarithromycin should be used with caution when administered concurrently with medications that induce cytochrome CYP3A4 enzyme

Pregnancy and Lactation

• Clarithromycin
  • No adequate and well-controlled studies on pregnant women; do not use clarithromycin in pregnant women except in circumstances in which no alternative therapy is appropriate
  • If pregnancy occurs while taking clarithromycin, inform the patient of potential hazard to the fetus; the drug has demonstrated adverse effects on pregnancy outcome and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma levels 2 to 17 times serum levels achieved in humans treated at the maximum recommended human doses
• Lansoprazole
  • Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment; estimated background risk of major birth defects and miscarriage for the indicated populations are unknown
  • Available data from published observational studies failed to demonstrate an association between adverse pregnancy-related outcomes and lansoprazole use; methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy
  • No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 0 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis
• Amoxicillin
  • Adverse events not observed in animal reproduction studies; maternal use has not resulted in an increased risk of adverse fetal effects; however, possible association with cleft lip with cleft palate observed in some studies; more data needed
• Contraception
  • Females: Therapy can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose
  • Males: Based on findings in animal studies, advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose
  • When is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for contraception information
• Infertility
  • Based on findings in animals, therapy may impair fertility in females and males of reproductive potential
• Lactation
  • Caution should be exercised when clarithromycin is administered to nursing women; the development and health benefits of human milk feeding should be considered along with the mother’s clinical need for clarithromycin and any potential adverse effects on human milk-fed child from the drug or from the underlying maternal condition