Prevpac

Each dose of PREVPAC contains four pills: one pink and black capsule (PREVACID), two opaque, yellow capsules (amoxicillin) and one yellow tablet (clarithromycin). Each dose should be taken twice per day before eating. Patients should be instructed to swallow each pill whole.

PREVPAC may interact with some drugs; therefore patients should be advised to report to their doctor the use of any other medications.

Patients should be counseled that antibacterial drugs including PREVPAC should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When PREVPAC is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by PREVPAC or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Patients should be advised to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea (see WARNINGS).

Patients should be advised to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia (see WARNINGS).

Advise patients to report any symptoms associated with cutaneous or systemic lupus erythematosus (see WARNINGS).

You should not take this medication if you are allergic to amoxicillin (Amoxil, Trimox, Dispermox), clarithromycin (Biaxin), lansoprazole (Prevacid), or to certain other antibiotics.

Before you take this medication, tell your doctor if you have kidney or liver disease, myasthenia gravis, or if you are allergic to any drugs.

There are many other drugs that can interact with this medication. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking amoxicillin, clarithromycin, and lansoprazole, do not take any of the following medications: ergotamine (Ergomar, Cafergot, Ercaf, Migergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), or pimozide (Orap).

A gout medication called colchicine (Colcrys) can interact with clarithromycin and cause serious or life-threatening medical problems. You should not take colchicine during your treatment with amoxicillin, clarithromycin, and lansoprazole, especially if you are an older adult with kidney disease.

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

If you also take sucralfate (Carafate), avoid taking it within 30 minutes after you take amoxicillin, clarithromycin, and lansoprazole. Sucralfate can make it harder for your body to absorb lansoprazole.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain or tenderness
• blistering, peeling, or loosening of the skin
• clay colored stools
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness or fainting
• fast, slow, or irregular heartbeat
• fever or chills
• headache
• hives, itching, or skin rash
• joint or muscle pain
• loss of appetite
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the body, feet, and ankles
• tightness in the chest
• unusual tiredness or weakness
• unusual weight gain
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual or unpleasant (after) taste
• change in taste

• Confusion
• discoloration of the tongue
• itching of the vagina or genital area
• pain during sexual intercourse
• redness, swelling, or soreness of the tongue
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.

Prevpac consists of a daily administration card containing two PREVACID 30 mg delayed release capsules, four amoxicillin 500 mg capsules, USP, and two clarithromycin 500 mg tablets, USP, for oral administration.

PREVACID (lansoprazole) Delayed-Release Capsules

The active ingredient in PREVACID delayed-release capsules is lansoprazole, a proton pump inhibitor. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. PREVACID has the following structure:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.

Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.

Amoxicillin Capsules, USP

Amoxicillin is a penicillin class antibacterial, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. The molecular formula is C16H19N3O5S ∙ 3H2O and the molecular weight is 419.45. Amoxicillin has the following structure:

Amoxicillin capsules are intended for oral administration.

Each capsule, with yellow opaque cap and body, contains 500 mg amoxicillin trihydrate. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents – cellulose microcrystalline and magnesium stearate.

Meets USP Dissolution Test 2.

BIAXIN Filmtab (clarithromycin tablets, USP)

Clarithromycin is a macrolide antimicrobial. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. Clarithromycin has the following structure:

Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.

Each yellow oval film-coated immediate-release tablet contains 500 mg of clarithromycin and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sorbic acid, sorbitan monooleate, titanium dioxide, and vanillin.

Acute Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with Prevpac careful inquiry should be made 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 Prevpac should be discontinued immediately and appropriate treatment should be urgently initiated.

Use in Pregnancy

CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE. IF PREGNANCY OCCURS WHILE TAKING CLARITHROMYCIN, THE PATIENT SHOULD BE INFORMED OF THE POTENTIAL HAZARD TO THE FETUS. CLARITHROMYCIN HAS DEMONSTRATED ADVERSE EFFECTS OF PREGNANCY OUTCOME AND/OR EMBRYO-FETAL DEVELOPMENT IN MONKEYS, RATS, MICE, AND RABBITS AT DOSES THAT PRODUCED PLASMA LEVELS TWO TO 17 TIMES THE SERUM LEVELS ACHIEVED IN HUMANS TREATED AT THE MAXIMUM RECOMMENDED HUMAN DOSES (see PRECAUTIONS, Pregnancy).

Hepatotoxicity

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been 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.

QT Prolongation

Clarithromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving clarithromycin. Fatalities have been reported. Clarithromycin should be avoided in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia (see CONTRAINDICATIONS) 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.

Presence of Gastric Malignancy

In adults, 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.

Acute Interstitial Nephritis

Acute interstitial nephritis (AIN) has been 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 (see CONTRAINDICATIONS).

Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including lansoprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Prevpac, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

Drug Interactions

Serious adverse reactions have been reported in patients taking 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 (see CONTRAINDICATIONS and PRECAUTIONS, Drug Interactions). Clarithromycin should be used with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme (see PRECAUTIONS, Drug Interactions).

Life-threatening and fatal drug interactions have been reported in patients treated with clarithromycin and colchicine. Clarithromycin is a strong CYP3A4 inhibitor and this interaction may occur while using both drugs at their recommended doses. If co-administration of clarithromycin and colchicine is necessary in patients with normal renal and hepatic function, the dose of colchicine should be reduced. Patients should be monitored for clinical symptoms of colchicine toxicity. Concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment (see CONTRAINDICATIONS and PRECAUTIONS, Drug Interactions).

Increased sedation and prolongation of sedation have been reported with concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and midazolam.

The concomitant use of clarithromycin and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia. With certain hypoglycemic drugs such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of CYP3A enzyme by clarithromycin may be involved and could cause hypoglycemia when used concomitantly. Careful monitoring of glucose is recommended.

There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin. INR and prothrombin times should be frequently monitored while patients are receiving clarithromycin and oral anticoagulants concurrently.

Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see CONTRAINDICATIONS) as these statins are extensively metabolized by CYP3A4, and concomitant treatment with clarithromycin increases their plasma concentration, which increases the risk of myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking clarithromycin concomitantly with these statins. If treatment with clarithromycin cannot be avoided, therapy with lovastatin or simvastatin must be suspended during the course of treatment.

Caution should be exercised when prescribing clarithromycin with statins. In situations where the concomitant use of clarithromycin with atorvastatin or pravastatin cannot be avoided, atorvastatin dose should not exceed 20 mg daily and pravastatin dose should not exceed 40 mg daily. Use of a statin that is not dependent on CYP3A metabolism (e.g. fluvastatin) can be considered. It is recommended to prescribe the lowest registered dose if concomitant use cannot be avoided.

Literature suggests that concomitant use of proton pump inhibitors (PPI) with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the Prevpac may be considered in some patients (see PRECAUTIONS, Drug Interactions).

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clarithromycin and/or amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

In addition, published observational studies suggest that PPI therapy, may be associated with an increased risk of CDAD, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.

NDC 64764-702-01

triple therapy
Prevpac®
LANSOPRAZOLE
AMOXICILLIN
CLARITHROMYCIN

14 DAILY PATIENT CARDS

EACH DAILY PATIENT
CARD CONTAINS:
2 PREVACID® (lansoprazole) 30-mg capsules;
4 AMOXICILLIN CAPSULES, USP, 500 mg; and
2 BIAXIN® Filmtab® (clarithromycin tablets, USP) 500 mg

Takeda

Rx only

Applies to amoxicillin / clarithromycin / lansoprazole: oral capsule, oral capsule delayed release, oral tablet

Along with its needed effects, amoxicillin / clarithromycin / lansoprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amoxicillin / clarithromycin / lansoprazole:

• Abdominal or stomach pain or tenderness
• blistering, peeling, or loosening of the skin
• clay colored stools
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness or fainting
• fast, slow, or irregular heartbeat
• fever or chills
• headache
• hives, itching, or skin rash
• joint or muscle pain
• loss of appetite
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the body, feet, and ankles
• tightness in the chest
• unusual tiredness or weakness
• unusual weight gain
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

Some side effects of amoxicillin / clarithromycin / lansoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual or unpleasant (after) taste
• change in taste

• Confusion
• discoloration of the tongue
• itching of the vagina or genital area
• pain during sexual intercourse
• redness, swelling, or soreness of the tongue
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

Applies to amoxicillin / clarithromycin / lansoprazole: oral kit

General

The most commonly reported side effects included diarrhea, headache, and taste perversion.

Amoxicillin: The most commonly reported side effects included nausea, diarrhea, rash, and vomiting.

Clarithromycin: The most commonly reported side effects included abdominal pain, diarrhea, nausea/vomiting, and dysgeusia.

Lansoprazole: The most commonly reported side effects included abdominal pain, diarrhea, and nausea.[Ref]

Nervous system

Common (1% to 10%): Headache, taste perversion
Frequency not reported: Dizziness

Amoxicillin:
Frequency not reported: Dizziness, hyperactivity

Clarithromycin:
Frequency not reported: Dizziness, dysgeusia, dyskinesia, headache, loss of consciousness, somnolence, tremor, vertigo
Postmarketing reports: Ageusia, anosmia, convulsion, paresthesia, parosmia

Lansoprazole:
Frequency not reported: Amnesia, cerebrovascular accident/cerebral infarction, convulsion, dementia, dizziness, headache, hemiplegia, hyperkinesia, hypertonia, hypesthesia, migraine, paresthesia, parosmia, somnolence, syncope, taste loss/perversion, vertigo
Postmarketing reports: Speech disorder[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea
Frequency not reported: Dark stools, dry mouth, glossitis, nausea, oral moniliasis, rectal itching, stomatitis, tongue discoloration/disorder, vomiting

Amoxicillin:
Common (1% to 10%): Diarrhea, nausea, vomiting
Frequency not reported: Black hairy tongue, hemorrhagic/pseudomembranous colitis, tooth discoloration/brown, yellow or gray staining of teeth

Clarithromycin:
Frequency not reported: Abdominal distension/pain, constipation, diarrhea, dry mouth, dyspepsia, eructation, esophagitis, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, glossitis, nausea, proctalgia, stomatitis, vomiting
Postmarketing reports: Acute pancreatitis, pseudomembranous colitis, tongue/tooth discoloration

Lansoprazole:
Common (1% to 10%): Abdominal pain, constipation, diarrhea, nausea
Frequency not reported: Abnormal stools, bezoar, cardiospasm, colitis, dry mouth, dyspepsia, dysphagia, enlarged abdomen, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, glossitis, gum hemorrhage, halitosis, hematemesis, increased salivation, melena, mouth ulceration, rectal disorder/hemorrhage, stomatitis, tenesmus, tongue disorder, ulcerative colitis/stomatitis, vomiting
Postmarketing reports: Clostridium difficile-associated diarrhea, pancreatitis, positive fecal occult blood[Ref]

Genitourinary

Frequency not reported: Vaginitis, vaginal moniliasis

Amoxicillin:
Frequency not reported: Crystalluria

Clarithromycin:
Frequency not reported: Vaginal infection
Postmarketing reports: Abnormal urine color

Lansoprazole:
Frequency not reported: Abnormal menses, breast enlargement/pain/tenderness, dysmenorrhea, dysuria, impaired urination, impotence, leukorrhea, menorrhagia, menstrual disorder, pelvic pain, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, vaginitis
Postmarketing reports: Albuminuria, hematuria, presence of crystal urine[Ref]

Dermatologic

Frequency not reported: Skin reactions

Amoxicillin:
Common (1% to 10%): Rash
Frequency not reported: Acute generalized exanthematous pustulosis, erythematous maculopapular rashes, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, mucocutaneous candidiasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Clarithromycin:
Frequency not reported: Cellulitis, dermatitis bollus, hyperhidrosis, maculopapular rash, pruritus, urticaria
Postmarketing reports: Acne, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis

Lansoprazole:
Frequency not reported: Acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, skin disorder, sweating, urticaria
Postmarketing reports: Cutaneous lupus erythematosus, erythema multiforme, severe dermatologic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)/fatal TEN[Ref]

Psychiatric

Frequency not reported: Confusion

Amoxicillin:
Frequency not reported: Agitation, anxiety, behavioral change, confusion, insomnia

Clarithromycin:
Frequency not reported: Anxiety, insomnia, nervousness
Postmarketing reports: Abnormal behavior/dreams, confusional state, depersonalization, depression, disorientation, hallucination, manic behavior, psychotic disorder

Lansoprazole:
Frequency not reported: Abnormal dreams/thinking, aggravated hostility, agitation, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hallucinations, insomnia, increased/decreased libido, nervousness, neurosis, sleep disorders[Ref]

Musculoskeletal

Frequency not reported: Myalgia

Clarithromycin:
Frequency not reported: Muscle spasms, myalgia, nuchal rigidity
Postmarketing reports: Myopathy, rhabdomyolysis

Lansoprazole:
Frequency not reported: Arthralgia, arthritis, back pain, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, neck pain/rigidity, synovitis
Postmarketing reports: Bone fracture, myositis, systemic lupus erythematosus[Ref]

Other

Frequency not reported: Thirst

Clarithromycin:
Frequency not reported: Candidiasis, chills, fatigue, hearing loss, infection, malaise, pyrexia, tinnitus
Postmarketing reports: Deafness

Lansoprazole:
Frequency not reported: Asthenia, candidiasis, chills, deafness, ear disorder, fever, flu syndrome, infection (not otherwise specified), malaise, otitis media, pain, thirst, tinnitus
Postmarketing reports: Increased globulins[Ref]

Respiratory

Frequency not reported: Respiratory disorders

Clarithromycin:
Very rare (less than 0.01%): Asthma, epistaxis, pulmonary embolism

Lansoprazole:
Frequency not reported: Asthma, bronchitis, cough, increased dyspnea, epistaxis, hemoptysis, hiccup, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor[Ref]

Hematologic

Amoxicillin:
Frequency not reported: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura

Clarithromycin:
Frequency not reported: Abnormal albumin globulin ratio, eosinophilia, leukopenia, neutropenia, thrombocythemia
Postmarketing reports: Agranulocytosis, decreased white blood cell count, increased INR, prolonged prothrombin time, thrombocytopenia

Lansoprazole:
Frequency not reported: Anemia, hemolysis, lymphadenopathy
Postmarketing reports: Abnormal AG ratio/red blood cells, abnormal/increased/decreased white blood cells/platelets, agranulocytosis, aplastic anemia, decreased hemoglobin, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura[Ref]

Hepatic

Amoxicillin:
Frequency not reported: Acute cytolytic hepatitis, cholestatic jaundice, hepatic dysfunction/cholestasis, moderate AST/ALT elevation

Clarithromycin:
Frequency not reported: Abnormal liver function tests, cholestasis, hepatitis, increased blood bilirubin,
Postmarketing reports: Hepatic dysfunction/failure, hepatocellular jaundice

Lansoprazole:
Frequency not reported: Cholelithiasis
Postmarketing reports: Abnormal liver function tests, bilirubinemia, hepatotoxicity, increased AST/ALT/gamma glutamyl transpeptidase[Ref]

Hypersensitivity

Amoxicillin:
Frequency not reported: Anaphylaxis

Clarithromycin:
Frequency not reported: Anaphylactoid reaction, hypersensitivity
Postmarketing reports: Anaphylactic reaction

Lansoprazole:
Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylactic/anaphylactoid reactions[Ref]

Metabolic

Clarithromycin:
Frequency not reported: Anorexia, decreased appetite, increased blood alkaline phosphatase/lactate dehydrogenase
Postmarketing reports: Hypoglycemia

Lansoprazole:
Frequency not reported: Anorexia, avitaminosis, dehydration, diabetes mellitus, gout, hyperglycemia, hypoglycemia, increased appetite, weight gain/loss
Postmarketing reports: Hyperlipidemia, hypomagnesemia, increased alkaline phosphatase/blood potassium/lactate dehydrogenase, increased/decreased electrolytes/cholesterol[Ref]

Cardiovascular

Clarithromycin:
Frequency not reported: Atrial fibrillation, cardiac arrest, chest pains, extrasystole, palpitations, QT prolongation
Postmarketing reports: Hemorrhage, torsade de pointes, ventricular arrhythmia/tachycardia

Lansoprazole:
Frequency not reported: Angina, arrhythmia, bradycardia, chest pain (not otherwise specified), edema, hypertension/hypotension, myocardial infarction, palpitations, peripheral edema, shock/circulatory failure, tachycardia, vasodilation[Ref]

Renal

Clarithromycin:
Frequency not reported: Increased blood creatinine/urea
Postmarketing reports: Interstitial nephritis, renal failure

Lansoprazole:
Frequency not reported: Kidney calculus, kidney pain
Postmarketing reports: Glycosuria, increased creatinine/urea, interstitial nephritis[Ref]

Ocular

Lansoprazole:
Frequency not reported: Abnormal vision, amblyopia, blepharitis, blurred vision, cataracts, conjunctivitis, diplopia, dry eyes, eye disorder, eye pain, glaucoma, photophobia, ptosis, retinal degeneration/disorder, visual field defect[Ref]

Endocrine

Lansoprazole:
Frequency not reported: Goiter, gynecomastia, hypothyroidism
Postmarketing reports: Increased glucocorticoids/gastrin levels[Ref]

Oncologic

Lansoprazole:
Frequency not reported: Carcinoma, laryngeal neoplasia, skin carcinoma[Ref]

Immunologic

Amoxicillin:
Frequency not reported: Serum sickness-like reaction[Ref]

Some side effects of Prevpac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.