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.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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. Additional adverse experiences have been reported since PREVACID has been marketed. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
1PREVACID 15 mg caps ules only.
REFERENCES. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric -coated microgranules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame 2, glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.
NDC Unit of use bottles of 30: 15 mg capsules NDC Bottles of 1000: 15 mg capsules NDC Unit dose package of 100: 15 mg capsules NDC Bottles of 100: 30 mg capsules NDC Bottles of 1000: 30 mg capsules NDC Unit dose package of 100: 30 mg capsules.
Body as a Whole - anaphylactic/anaphylactoid reactions; 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); Special Senses “ speech disorder ; Urogenital System - interstitial nephritis, urinary retention.
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.
PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Eradication of 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 package insert, MICROBIOLOGY section).
The degradation half-life of the drug substance in aqueous solution at 25°C is approximay 0.5 hour at pH 5.0 and approximay 18 hours at pH 7.0. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH.
Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximay 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.
PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.
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.
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.
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.
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.
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. 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.
PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets.
Hemic and Lymphatic System - anemia, hemolysis, lymphadenopathy.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
The tablets are available as follows:. The 30 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, with “30” debossed on one side of the tablet. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with orange to dark brown speckles, with “15” debossed on one side of the tablet.
PREVACID Delayed-Release Capsules - Nasogastric Tube (≥16 French) Administration.
PREVACID is indicated for the treatment of NSAID -associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks.
Musculoskeletal System - arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis.
Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:
Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident /cerebral infarction, hypertension / hypotension, migraine, myocardial infarction, palpitations, shock ( circulatory failure), syncope, tachycardia, vasodilation.
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. 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.
Revised: Dec 2015. Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015.
PREVACID (lansoprazole) Delayed-release Capsules & Delayed-release Orally Disintegrating Tablets.
PREVACID Delayed-Release Capsules - Oral Administration.
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.
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment.
Find Lowest Prices on.
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.
28, FD&C Blue No. 31, and FD&C Red No. 1, FD&C Green No. 40. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 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.
PREVACID SoluTab - Oral Syringe.
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.
PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD for up to eight weeks.
For administration via oral syringe, PREVACID SoluTab can be administered as follows:
No treatmentemergent adverse reactions were observed at significantly higher rates with PREVACID three times daily plus amoxicillin three times daily dual therapy than with PREVACID alone. 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%).
In the clinical trials, antacids were used concomitantly with PREVACID. PREVACID products SHOULD NOT BE CRUSHED OR CHEWED. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. PREVACID should be taken before eating.
The following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions:
NDC Unit dose packages of 100: 15 mg tablets NDC Unit dose packages of 100: 30 mg tablets.
The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.
PREVACID has the following structure:. Its empirical formula is C 16 H 14 with a molecular weight of 369.37. The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed- Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[ methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion.
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.
Table 1: 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.
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. 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.
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Metabolism and Nutritional Disorders - avitaminosis, gout, dehydration, hyperglycemia / hypoglycemia, peripheral edema, weight gain/loss.
PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.
For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the ADVERSE REACTIONS section of their package inserts.
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.
PREVACID SoluTab “ Nasogastric Tube (≥8 French) Administration.
home drugs a-z list side effects drug center prevacid (lansoprazole) drug.
Please refer to the full prescribing information for amoxicillin.
PREVACID is indicated for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer.
Stop using lansoprazole and call your doctor at once if you have symptoms of low magnesium:
Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or 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.
PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Endocrine System - diabetes mellitus, goiter, hypothyroidism.
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 short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.
2Phenylketonurics : Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.
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.
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.
PREVACID is supplied in delayed-release capsules and in delayed-release orally disintegrating tablets for oral administration.
The 30 mg capsules are opaque, hard gelatin, colored pink and black with “TAP” and “PREVACID 30” imprinted on the capsules. They are available as follows:. PREVACID Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with “TAP” and “PREVACID 15” imprinted on the capsules.
For administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:
There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. 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.
pylori. pylori has been shown to reduce the risk of duodenal ulcer recurrence. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. Eradication of H. PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
¶ Controlled studies did not extend beyond 12 months #Varies with individual patient. If there is a recurrence of erosive esophagitis, an additional eight week course of PREVACID may be considered. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. Dosages up to 90 mg twice daily have been administered. § The PREVACID dose was increased (up to 30 mg twice daily) in some pediatric patients after two or more weeks of treatment if they remained symptomatic. ‡ 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. † Controlled studies did not extend beyond indicated duration. Recommended adult starting dose is 60 mg once daily. For pediatric patients unable to swallow an intact capsule please see Administration Options. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: PREVACID 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: PREVACID 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≥ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily¶ Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily# *Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients with Zollinger-Ellison Syndrome have been treated continuously with PREVACID for more than four years. Daily dose of greater than 120 mg should be administered in divided doses.Prevacid