Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation.
Short-Term Treatment of Erosive Esophagitis.
For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with PREVACID, refer to WARNINGS and PRECAUTIONS sections of those prescribing information. CDAD has been reported with use of nearly all antibacterial agents.
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.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2) ]. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
Endocrine System – diabetes mellitus, goiter, hypothyroidism.
Controlled studies did not extend beyond eight weeks. PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use.
at 1-877-TAKEDA-7 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America Inc.
The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 1.4%, 4.2%, and 7.4%, respectively). Headache was also seen at greater than 1% incidence but was more common on placebo.
PREVACID Capsules – Oral Administration.
PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD for up to eight weeks.
PREVACID is indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.
( 4 ). Contraindicated in patients with known severe hypersensitivity to any component of the PREVACID formulations.
The following adverse reactions 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 in Table 1.
PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. Eradication of H. pylori. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis.
Short-Term Treatment of Symptomatic GERD.
However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7) ]. Administration Options. Renal impairment patients and geriatric patients do not require dosage adjustment.
Revised: 10/2016. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
In the risk reduction study of PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, misoprostol, and placebo was 5%, 22%, and 3%, respectively.
The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen. Dual Therapy: PREVACID/amoxicillin. There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens.
Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy.
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.
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Dual Therapy: PREVACID /amoxicillin.
Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy.
In adults, symptomatic response to therapy with PREVACID 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.
PREVACID Capsules – Nasogastric Tube (≥16 French) Administration.
Controlled studies do not extend beyond 12 months. PREVACID is indicated to maintain healing of duodenal ulcers.
Please refer to the full prescribing information for amoxicillin.
Triple Therapy: PREVACID /amoxicillin/clarithromycin.
Please refer to the full prescribing information for amoxicillin and clarithromycin.
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.
PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.
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.
Updated October 31, 2016.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Both are available in 15 mg and 30 mg strengths. PREVACID capsule and SoluTab SHOULD NOT BE CRUSHED OR CHEWED. PREVACID is available as a capsule and as an orally disintegrating tablet (SoluTab). Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID should be taken before eating. In the clinical trials, antacids were used concomitantly.
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.
PREVACID is indicated for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer.
Additional isolated laboratory abnormalities were reported. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. 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 plaets, increased gastrin levels and positive fecal occult blood.
The following serious adverse reactions are described below and elsewhere in labeling:
Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. 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.
Generally, histological findings were observed without organ involvement. 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.
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.
PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, MICROBIOLOGY section). pylori has been shown to reduce the risk of duodenal ulcer recurrence. Eradication of H.
The following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions:
For patients who do not heal with PREVACID for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of PREVACID may be considered. PREVACID is indicated for short-term treatment (up to eight weeks) for healing and symptom relief of all grades of erosive esophagitis.
PREVACID is contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
Triple Therapy: PREVACID/amoxicillin/clarithromycin. In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or clarithromycin.
Patients should be instructed not to take two doses at one time to make up for a missed dose. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed that if a dose is missed, it should be taken as soon as possible.
For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the ADVERSE REACTIONS section of their prescribing information.
Literature suggests that concomitant use of PPIs 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 PPI may be considered in some patients [see Drug Interactions (7.6) and Clinical Pharmacology (12.3) ].
Discontinue PREVACID if acute interstitial nephritis develops. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Acute interstitial nephritis has been observed in patients taking PPIs including PREVACID.
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.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.
For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the ADVERSE REACTIONS section of their prescribing information.
Metabolism and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss.
Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:
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.
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.
( 6 ). Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation.
This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed. Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature.
( 3 ). Capsules and Tablets: 15 mg and 30 mg.
PREVACID is a proton pump inhibitor (PPI) indicated for:
Avoid administration of PPIs for longer than medically indicated. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. Most patients improve with discontinuation of the PPI alone in four to 12 weeks. If signs or symptoms consistent with CLE or SLE are noted in patients receiving PREVACID, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.
In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials. 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.
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID, refer to the CONTRAINDICATIONS section of their prescribing information.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED. PREVACID SoluTab.
The most frequently reported adverse reactions for patients who received PREVACID three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with PREVACID three times daily plus amoxicillin three times daily dual therapy than with PREVACID alone.
Controlled studies did not extend beyond 12 months. PREVACID is indicated to maintain healing of erosive esophagitis.
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.
Additional reactions from this study not previously observed in other clinical trials with PREVACID included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment. Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study.
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.
These events are listed below by COSTART body system. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. Additional adverse experiences have been reported since PREVACID has been marketed.
This diagnosis should be considered for diarrhea that does not improve. Published observational studies suggest that proton pump inhibitor (PPI) therapy like PREVACID may be associated with an increased risk of Clostridium difficile associated diarrhea (CDAD), especially in hospitalized patients.
PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
As with other drugs that decrease the intragastric acidity, the absorption of drugs such as ampicillin esters, ketoconazole, atazanavir, nelfinavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with PREVACID. Due to its effects on gastric acid secretion, lansoprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability.Prevacid