Prevpac

What Is Prevpac?

Prevpac (lansoprazole, amoxicillin and clarithromycin) is a combination of a proton pump inhibitor (PPI), a penicillin antibiotic, and a macrolide antibiotic used to prevent stomach ulcer caused by infection with Helicobacter pylori (H. pylori).

What Are Side Effects of Prevpac?

Common side effects of Prevpac include:

• diarrhea,
• headache,
• nausea,
• vomiting,
• stomach pain,
• unusual or unpleasant taste in your mouth,
• constipation,
• dark colored stools,
• dry mouth,
• increased thirst, or
• vaginal itching or discharge.

Tell your doctor if you have rare but very serious side effects of Prevpac including:

• muscle weakness,
• dark urine,
• yellowing eyes or skin,
• easy bruising or bleeding,
• signs of infection (such as fever, persistent sore throat), or
• mental/mood changes (such as agitation, confusion).

Dosage for Prevpac

The recommended adult oral dose is 30 mg lansoprazole (Prevacid), 1 g amoxicillin, and 500 mg clarithromycin administered together twice daily (morning and evening) for 10 or 14 days.

What Drugs, Substances, or Supplements Interact with Prevpac?

Prevpac may interact with HIV/AIDS medications, blood thinners, clopidogrel, cyclosporine, digoxin, iron supplements, fluconazole or ketoconazole, probenecid, rifabutin, sildenafil, tacrolimus, theophylline, sulfa drugs, cholesterol-lowering medicines, heart rhythm medications, sedatives, seizure medications, or tetracycline antibiotics. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Prevpac During Pregnancy and Breastfeeding

During pregnancy, Prevpac should be used only when prescribed. Amoxicillin passes into breast milk. It is unknown if lansoprazole or clarithromycin pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

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Our Prevpac (lansoprazole, amoxicillin and clarithromycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Prevpac Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• liver problems--upper stomach pain, itching, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems--urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Serious side effects may be more likely in older adults.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prevpac (Lansoprazole, Amoxicillin and Clarithromycin)

 

Prevpac Professional Information

SIDE EFFECTS

PREVPAC

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions (≥3%) reported in clinical trials when all three components of this therapy were given concomitantly for 14 days are listed in Table 8.

Table 8: Adverse Reactions Most Frequently Reported in Clinical Trials (≥3%)

Adverse Reaction	Triple Therapy n=138 (%)
Diarrhea	7.0
Headache	6.0
Taste Perversion	5.0

The additional adverse reactions which were reported as possibly or probably related to treatment (less than 3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body system:

Body as a Whole -abdominal pain

Digestive System -dark stools, dry mouth/thirst, glossitis, rectal itching, nausea, oral moniliasis, stomatitis, tongue discoloration, tongue disorder, vomiting

Musculoskeletal System -myalgia

Nervous System -confusion, dizziness

Respiratory System -respiratory disorders

Skin and Appendages -skin reactions

Urogenital System -vaginitis, vaginal moniliasis

There were no statistically significant differences in the frequency of reported adverse events between the 10 and 14 day triple therapy regimens.

PREVACID

The following adverse reactions from the labeling for PREVACID are provided for information:

Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.

Incidence In Clinical Trials

The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients:

Table 9: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled PREVACID Studies

Body System/Adverse Event	PREVACID (N= 2768) %	Placebo (N= 1023) %
Body as a Whole
Abdominal Pain	2.1	1.2
Digestive System
Constipation	1.0	0.4
Diarrhea	3.8	2.3
Nausea	1.3	1.2

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:

Body as a Whole - abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System - abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System - diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System - anemia, hemolysis, lymphadenopathy

Metabolism and Nutritional Disorders - avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System - arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System - abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System - asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages - acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses - abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System - abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis

Postmarketing

Additional adverse experiences have been reported since PREVACID has been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system:

Body as a Whole - anaphylactic/anaphylactoid reactions, systemic lupus erythematosus

Digestive System - hepatotoxicity, pancreatitis, vomiting

Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura

Infections and Infestations - Clostridium difficile-associated diarrhea

Metabolism and Nutritional Disorders - hypomagnesemia

Musculoskeletal System - bone fracture, myositis

Skin and Appendages - severe dermatologic reactions including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, (some fatal), cutaneous lupus erythematosus

Special Senses - speech disorder

Urogenital System - interstitial nephritis, urinary retention

Amoxicillin

The following adverse reactions from the labeling for amoxicillin are provided for information:

The most common adverse reactions (>1%) observed in clinical trials of amoxicillin capsules were diarrhea, rash, vomiting and nausea.

The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

Infections and Infestations - Mucocutaneous candidiasis

Gastrointestinal - Black hairy tongue, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).

Hypersensitivity Reactions - Anaphylaxis (see WARNINGS), serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

Liver - A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.

Renal - Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems - Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System - Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes, and/or dizziness have been reported.

Miscellaneous - Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Clarithromycin

The following adverse reactions from the labeling for clarithromycin are provided for information:

The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting, and dysgeusia. These adverse reactions are consistent with the known safety profile of macrolide antibiotics.

There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.

Adverse Reactions Observed During Clinical Trials Of Clarithromycin

The following adverse reactions were observed in clinical trials with clarithromycin at a rate greater than or equal to 1%:

Gastrointestinal Disorders - Diarrhea, vomiting, dyspepsia, nausea, abdominal pain

Hepatobiliary Disorders - Liver function test abnormal

Immune System Disorders - Anaphylactoid reaction

Infections and Infestations - Candidiasis

Nervous System Disorders - Dysgeusia, headache

Psychiatric Disorders - Insomnia

Skin and Subcutaneous Tissue Disorders - Rash

Other Adverse Reactions Observed During Clinical Trials Of Clarithromycin

The following adverse reactions were observed in clinical trials with clarithromycin at a rate less than 1%:

Blood and Lymphatic System Disorders - Leukopenia, neutropenia, thrombocythemia, eosinophilia

Cardiac Disorders - Electrocardiogram QT prolonged, cardiac arrest, atrial fibrillation, extrasystoles, palpitations

Ear and Labyrinth Disorders - Vertigo, tinnitus, hearing impaired

Gastrointestinal Disorders - Stomatitis, glossitis, esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, abdominal distention, constipation, dry mouth, eructation, flatulence

General Disorders and Administration Site Conditions - Malaise, pyrexia, asthma, chest pain, chills, fatigue

Hepatobiliary Disorders - Cholestasis, hepatitis

Immune System Disorders - Hypersensitivity

Infections and Infestations - Cellulitis, gastroenteritis, infection, vaginal infection

Investigations - Blood bilirubin increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, albumin globulin ratio abnormal

Metabolism and Nutrition Disorders - Anorexia, decreased appetite

Musculoskeletal and Connective Tissue Disorders - Myalgia, muscle spasms, nuchal rigidity

Nervous System Disorders - Dizziness, tremor, loss of consciousness, dyskinesia, somnolence

Psychiatric Disorders - Anxiety, nervousness

Renal and Urinary Disorders - Blood creatinine increased, blood urea increased

Respiratory, Thoracic and Mediastinal Disorders - Asthma, epistaxis, pulmonary embolism

Skin and Subcutaneous Tissue Disorders - Urticaria, dermatitis bollus, pruritus, hyperhidrosis, rash maculopapular

The following adverse reactions have been identified during post approval use of clarithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders - Thrombocytopenia, agranulocytosis

Cardiac Disorders - Torsades de pointes, ventricular tachycardia, ventricular arrhythmia

Ear and Labyrinth Disorders - Deafness was reported chiefly in elderly women and was usually reversible.

Gastrointestinal Disorders - Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug.

Hepatobiliary Disorders - Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with clarithromycin (see WARNINGS, Hepatotoxicity)

Immune System Disorders - Anaphylactic reaction

Infections and Infestations - Pseudomembranous colitis

Investigations - Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.

Metabolism and Nutrition Disorders - Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.

Musculoskeletal and Connective Tissue Disorders - Myopathy, rhabdomyolysis was reported and in some of the reports, clarithromycin was administered concomitantly with statins, fibrates, colchicines or allopurinol (see CONTRAINDICATIONS and WARNINGS).

Nervous System Disorders - Convulsion, ageusia, parosmia, anosmia, paresthesia

Psychiatric Disorders - Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams. These disorders usually resolve upon discontinuation of the drug.

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

Renal and Urinary Disorders - Nephritis interstitial, renal failure

Skin and Subcutaneous Tissue Disorders - Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne

Vascular Disorders - Hemorrhage

There have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see WARNINGS AND PRECAUTIONS).

Laboratory Values

Prevacid

The following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported.

In the placebo-controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study.

Read the entire FDA prescribing information for Prevpac (Lansoprazole, Amoxicillin and Clarithromycin)