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Prevacid pill: Prevacid 24Hr Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Prevacid Dosage Guide – Drugs.com

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Generic name: lansoprazole 15mg
Dosage form: capsule, delayed release, tablet, orally disintegrating, delayed release
Drug class: Proton pump inhibitors

Medically reviewed by Drugs.com. Last updated on Oct 28, 2022.

Recommended Adult Dosage by Indication

IndicationRecommended DoseFrequency
*
Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients.
Controlled studies did not extend beyond indicated duration.
For patients who do not heal with PREVACID or PREVACID SoluTab 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 or PREVACID SoluTab may be considered.
§
Controlled studies did not extend beyond 12 months.
Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with PREVACID for more than four years.
Duodenal Ulcers
Short-Term Treatment15 mgOnce daily for 4 weeks
Maintenance of Healed15 mgOnce daily
Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
PREVACID or PREVACID SoluTab30 mgTwice daily for 10 or 14 days
Amoxicillin1 gramTwice daily for 10 or 14 days
Clarithromycin500 mgTwice daily for 10 or 14 days
Dual Therapy:
PREVACID or PREVACID SoluTab30 mgThree times daily for 14 days
Amoxicillin1 gramThree times daily for 14 days
Benign Gastric Ulcer
Short-Term Treatment30 mgOnce daily for up to 8 weeks
NSAID-Associated Gastric Ulcer
Healing30 mgOnce daily for 8 weeks†
Risk Reduction15 mgOnce daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD15 mgOnce daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis30 mgOnce daily for up to 8 weeks‡
Maintenance of Healing of Erosive Esophagitis15 mgOnce daily§
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome60 mgOnce daily¶

Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of Age

In clinical studies, PREVACID was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations (8.4)].

IndicationRecommended DoseFrequency
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤30 kg15 mgOnce daily for up to 12 weeks
>30 kg30 mgOnce daily for up to 12 weeks

Pediatric Patients 12 to 17 Years of Age

IndicationRecommended DoseFrequency
Short-Term Treatment of Symptomatic GERD
Non-erosive GERD15 mgOnce daily for up to 8 weeks
Erosive Esophagitis30 mgOnce daily for up to 8 weeks

Hepatic Impairment

The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations (8. 6)].

Important Administration Information

  • Take PREVACID or PREVACID SoluTab before meals.
  • Do not crush or chew PREVACID capsule or PREVACID SoluTab.
  • Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate [see Drug Interactions (7)].
  • Antacids may be used concomitantly with PREVACID or PREVACID SoluTab.
  • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

PREVACID capsules

  • Swallow whole; do not chew.
  • For patients who have difficulty swallowing capsules, PREVACID capsules can be opened and administered orally or via a nasogastric tube in the soft foods or liquids specified below.
  • Administration of PREVACID in foods or liquids other than those discussed below have not been studied clinically and therefore are not recommended.
    Administration in Soft Foods (applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears):
    1. Open capsule.
    2. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
    3. Swallow immediately.

    Administration in Liquids (apple juice, orange juice or tomato juice):

    1. Open capsule.
    2. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces).
    3. Mix briefly.
    4. Swallow immediately.
    5. To ensure complete delivery of the dose, rinse the glass with two or more volumes of juice and swallow the contents immediately.

    Administration with Apple Juice Through a Nasogastric Tube (≥16 French)

    1. Open capsule.
    2. Sprinkle intact granules into 40 mL of apple juice.
    3. Mix briefly.
    4. Using a catheter -tipped syringe, draw up the mixture.
    5. Inject through the nasogastric tube into the stomach.
    6. Flush with additional apple juice to clear the tube.

PREVACID SoluTab

  • Do not break or cut.
  • Place the tablet on the tongue, allow it to disintegrate, with or without water, until the microgranules can be swallowed. Do not chew the microgranules.
  • The tablet typically disintegrates in less than one minute.
  • Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be administered with water via oral syringe or NG tube as follows:
    Administration with Water in an Oral Syringe
    1. Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
    2. Shake gently to allow for a quick dispersal.
    3. After the tablet has dispersed, administer the contents within 15 minutes of mixing into the mouth. Do not save the water and microgranule mixture for later use.
    4. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.

    Administration with Water via a NG Tube (≥8 French)

    1. Place a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or place a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water.
    2. Shake gently to allow for a quick dispersal.
    3. After the tablet has dispersed, shake the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach within 15 minutes of mixing. Do not save the water and microgranule mixture for later use.
    4. Refill the catheter-tip syringe with approximately 5 mL of water, shake gently, and flush the tube.

More about Prevacid (lansoprazole)

  • Check interactions
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  • Pricing & coupons
  • Reviews (60)
  • Drug images
  • Side effects
  • Patient tips
  • During pregnancy
  • Generic availability
  • Drug class: proton pump inhibitors
  • Breastfeeding
  • En español

Patient resources

  • Drug Information

Professional resources

  • Prescribing Information

Other formulations

  • Prevacid SoluTab
  • Prevacid OTC

Related treatment guides

  • Barrett’s Esophagus
  • Aspiration Pneumonia
  • Duodenal Ulcer
  • Duodenal Ulcer Prophylaxis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Prevacid – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Lansoprazole belongs to the family of medications called proton pump inhibitors (PPIs). These medications slow or prevent the production of acid within the stomach.

Lansoprazole is used to treat gastric (stomach) ulcers, duodenal (intestinal) ulcers, reflux esophagitis, and gastroesophageal reflux disease (GERD). It is also used in combination with antibiotics to treat and eradicate H. pylori bacteria (a major cause of duodenal ulcers).

Lansoprazole is used to treat gastric ulcers caused by a family of pain relievers known as nonsteroidal anti-inflammatory drugs (NSAIDs), and to reduce the risk of gastric ulcers for people who are taking NSAIDs. It is also used to treat conditions associated with the over-production of stomach acid, including Zollinger-Ellison syndrome.

This medication may be available under multiple brand names and/or in several different forms.  Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

15 mg
Each opaque, hard gelatin, delayed-release capsule of enteric-coated granules, with a pink cap printed with “PREVACID 15” and a bluish-green body printed with “TAP” logo contains 15 mg of lansoprazole.  Nonmedicinal ingredients: cellulosic polymers, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar spheres, talc, and titanium dioxide.

30 mg
Each opaque, hard gelatin, delayed-release capsule of enteric-coated granules, with a pink cap printed with “PREVACID 30” and a black body printed with “TAP” logo contains 30 mg of lansoprazole. Nonmedicinal ingredients: cellulosic polymers, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar spheres, talc, and titanium dioxide.

Prevacid FasTab

15 mg
Each white-to-yellowish-white with orange-to-dark-brown speckles, round, flat-faced, bevelled-edged, uncoated, orally disintegrating tablet of enteric-coated microgranules, with “15” debossed on one side and measuring approximately 9 mm (side to side), with a strawberry flavour, contains 15 mg of lansoprazole.  Nonmedicinal ingredients: aspartame (contains 2.5 mg of phenylalanine per 15 mg tablet), citric acid, crospovidone, ferric oxide, glyceryl monostearate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid, microcrystalline cellulose, polyacrylate, polyethylene glycol, polysorbate 80, strawberry flavor, talc, titanium dioxide, and triethyl citrate. May also contain soya lecithin.

30 mg
Each white-to-yellowish-white, with orange-to-dark brown speckles, round, flat-faced, bevelled-edged, uncoated, orally disintegrating tablet of enteric-coated microgranules, with “30” debossed on one side and measuring approximately 12 mm (side to side) with a strawberry flavour, contains lansoprazole 30 mg. Nonmedicinal ingredients: aspartame (contains phenylalanine 5.1 mg per 30 mg tablet), citric acid, crospovidone, ferric oxide, glyceryl monostearate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid, microcrystalline cellulose, polyacrylate, polyethylene glycol, polysorbate 80, strawberry flavor, talc, titanium dioxide, and triethyl citrate. May also contain soya lecithin.

How should I use this medication?

To treat duodenal (intestinal) ulcers, the recommended adult dose of lansoprazole is 15 mg daily, before breakfast, for 2 to 4 weeks. For duodenal ulcers that return, lansoprazole may be used for up to one year.

To treat gastric (stomach) ulcers, the recommended adult dose of lansoprazole is 15 mg daily, before breakfast, for 4 to 8 weeks. The usual recommended dose to treat gastric ulcers caused by NSAIDs is 15 mg to 30 mg daily, before breakfast, for up to 8 weeks. When used to reduce the risk of gastric ulcers for people who are taking NSAIDs, the usual dose is 15 mg daily, before breakfast, for up to 12 weeks.

To treat duodenal ulcers caused by H. pylori bacteria (as confirmed by a test), the recommended dose of lansoprazole is 30 mg along with clarithromycin 500 mg and amoxicillin 1,000 mg, all taken twice daily for 7, 10, or 14 days. All of these medications should be taken before meals. This combination of medications helps kill the bacteria that can cause duodenal ulcers.

To treat GERD and associated heartburn symptoms, the recommended dose of lansoprazole is 15 mg daily before breakfast for up to 8 weeks. Doses up to 30 mg daily are sometimes prescribed for reflux esophagitis or other conditions associated with increased secretion of acid by the stomach.  

To treat GERD in children 1 to 11 years of age, the recommended dose is 15 mg to 30 mg (depending on the child’s weight) once daily for up to 12 weeks. An increase in dose may be beneficial for some children. For adolescents 12 to 17 years old who have GERD, the adult dose can be used.

When treating Zollinger-Ellison syndrome or other conditions which overproduce stomach acid, the dose of lansoprazole varies, but is often higher than the doses used to treat ulcers. Doses larger than 60 mg daily are often needed.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.  If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Lansoprazole should be taken before breakfast or, if taken twice daily, before breakfast and another meal. The medication should not be crushed or chewed. The capsules should be swallowed whole with a glass of water. People who have difficulty swallowing capsules may open the capsule and sprinkle its contents on a tablespoon of applesauce, which should then be immediately swallowed.

Lansoprazole fast dissolving tablets should not be chewed or cut. They should not be swallowed whole; they should be placed on the tongue for about one minute to allow the tablet to dissolve. Once the tablet has dissolved, the particles can be swallowed. Alternatively, for adults and children who have trouble swallowing, the tablet may be dissolved in an oral syringe with water. Speak to your pharmacist for specific directions.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to lansoprazole or any ingredients of the medication
  • are taking the medication rilpivirine

What side effects are possible with this medication?

Many medications can cause side effects.  A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • burping
  • constipation
  • diarrhea
  • dizziness
  • dry mouth
  • flu-like symptoms
  • gas
  • headache
  • muscle pain
  • nausea
  • trouble sleeping
  • vomiting
  • weakness

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • joint or muscle pain
  • pain or burning while urinating
  • rash on the cheeks or arms that gets worse in the sun
  • sinus pain
  • skin rash
  • sore throat

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe diarrhea with blood or mucous in the stool
  • signs of a serious allergic reaction (swelling of face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Diarrhea: When gastric acid is decreased, the number of bacteria normally in the digestive system increases. Occasionally, this can cause serious infection in the digestive tract. If you experience severe watery or bloody diarrhea, fever, or abdominal pain while taking lansoprazole, contact your doctor as soon as possible.

Electrolyte balance: Long term use of lansoprazole may cause the levels of electrolytes such as magnesium, calcium, and potassium in the blood to decrease. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor may do blood tests periodically to monitor the levels of these electrolytes in your blood while you are taking this medication.

Phenylketonuria: The delayed-release tablet form of lansoprazole contains aspartame, an ingredient that cannot be broken down in the body by people who have phenylketonuria (a condition where you are lacking the enzyme needed to break down phenylalanine).  People with phenylketonuria should take lansoprazole delayed-release capsules instead.

Liver function: Decreased liver function may cause lansoprazole to build up in the body. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Methotrexate interaction: Lansoprazole, like other medications in this group, may interact with methotrexate when the two medications are used at the same time. This combination may lead to higher than expected amounts of methotrexate in the body and can cause serious side effects, including kidney damage, irregular heartbeat, anemia, or infection. If you take lansoprazole and are also going to receive a dose of methotrexate, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

More serious conditions of the stomach and intestines: Even if you experience improvement in acid-related symptoms, it is still possible to have serious underlying stomach problems such as stomach cancer. If you experience symptoms of a more serious condition of the stomach and intestines (e.g., trouble swallowing, unplanned weight loss, vomiting of blood or food, or black stools) while taking this medication, contact your doctor immediately.

Osteoporosis fractures: Long-term use of lansoprazole may be related to an increased risk of bone fractures in the hip, wrist, or spine, as a result of weakened bones. This risk is further increased if you are at risk of developing osteoporosis. If you have osteoporosis or have risk factors for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Subacute cutaneous lupus erythematosus (SCLE): Lansoprazole, like other PPIs, has been rarely associated with SCLE, an autoimmune disease. If you develop any skin lesions, especially in sun-exposed skin areas, and if accompanied by muscle aches or pains, contact your doctor immediately.

Vitamin B12: Long-term use of lansoprazole may lead to vitamin B12 deficiency. If you are a vegetarian or have low vitamin B12 levels, discuss with your doctor if any special monitoring is required.

Pregnancy: There are no adequate or well-controlled studies on the use of this medication by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if lansoprazole passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for use by children under one year old. For children 1 to 17 years old, this medication can be used to treat GERD for a maximum of 12 weeks.

What other drugs could interact with this medication?

There may be an interaction between lansoprazole and any of the following:

  • acalabrutinib
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • ampicillin
  • apalutamide
  • “azole” antifungals (e.g., itraconazole, ketoconazole, posaconazole)
  • bisphosphonates (e.g., alendronate, risedronate)
  • bosentan
  • bosutinib
  • capecitabine
  • carbamazepine
  • cefuroxime
  • clopidogrel
  • dabrafenib
  • dasatinib
  • deferasirox
  • dexmethylphenidate
  • digoxin
  • doxycycline
  • eslicarbazepine
  • elagolix
  • enzalutamide
  • erlotinib
  • fluoxetine
  • fluvoxamine
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e. g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • imatinib
  • iron salts
  • ledipasvir
  • lumacaftor and ivacaftor
  • mesalamine
  • methotrexate
  • methylphenidate
  • mitotane
  • moclobemide
  • multivitamins with minerals
  • mycophenolate
  • nilotinib
  • octreotide
  • pazopanib
  • phenobarbital
  • phenytoin
  • primidone
  • raltegravir
  • rifampin
  • rifabutin
  • rilpivirine
  • riociguat
  • St. John’s wort
  • siltuximab
  • sorafenib
  • sucralfate
  • tacrolimus
  • tocilizumab
  • velpatasvir
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Prevacid

Prevacid FDT/IV – instructions for use, dosage, composition, analogs, side effects / Pillintrip

See also:
What are the possible side effects of Prevacid FDT / IV?

Clinical

Worldwide, more than 10,000 patients have been treated with Prevacid FDT/IV in phase 2 or phase 3 clinical trials involving various doses and durations of treatment. Overall, Prevacid FDT/IV treatment was well tolerated in both short and long term trials.

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in clinical trials of a medicinal product cannot be directly compared with the frequency in clinical trials of another medicinal product and may not reflect rates observed in clinical practice.

The following adverse reactions were reported by the treating physician to be possibly or likely drug related in 1% or more of patients treated with Prevacid FDT/IV and occurred at a higher frequency in patients treated with Prevacid FDT/IV than placebo. patients in table 1.

Headache was also observed at an incidence greater than 1% but was more common with placebo. The incidence of diarrhea was similar in patients treated with placebo and patients treated with 15 and 30 mg prevacid FDT/IV, but higher in patients treated with 60 mg prevacid FDT/IV (2.9%, 1.4%, 4.2% and 7. 4% respectively).

The most common treatment-related adverse event during maintenance therapy was diarrhea.

In a risk reduction study of Prevacid FDT/IV in NSAID-associated gastric ulcers, the incidence of diarrhea in patients treated with Prevacid FDT/IV, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or Prevacid FDT/IV and naproxen, demonstrated that the safety profile was similar to the previous study. Additional reactions from this study not previously seen in other clinical trials with Prevacid FDT/IV included contusion, duodenitis, epigastric discomfort, esophageal upset, fatigue, hunger, oral hernia, hoarseness, impaired gastric emptying, metaplasia, and renal failure.

Additional side effects occurring in less than 1% of patients or subjects treated with Prevacid FDT/IV in home trials are shown below: chest pain (not otherwise specified), chills, swelling, fever, influenza syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck stiffness, pain, pelvic pain

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

Digestive system – abnormal stool, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, belching, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundicoid polyps, gastritis , gastroenteritis, gastrointestinal anomaly, gastrointestinal disorders, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea, 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

Metabolic and nutritional disorders – beriberi, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss 9000 6

Musculoskeletal system – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia gravis, ptosis, synovitis

Nervous system – abnormal dreams, agitation, amnesia, restlessness, apathy, confusion, convulsions , dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, exacerbation of hostility, hyperkinesia, hypertension, hypoesthesia, insomnia, decrease / increase in libido, nervousness, paresthesia, sleep disturbance, drowsiness, drowsiness

Respiratory system – asthma, bronchitis, increased cough, dyspnea, epistaxis, hemoptysis, laryngeal neoplasms, pulmonary fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorders, upper respiratory tract inflammation/infection, rhinitis, sinusitis, stridor

Skin and adnexa – acne, alopecia, contact dermatitis, dry skin, fixed rash, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin cancer, skin disease, sweating, urticaria

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

Urogenital system – abnormal menstruation, breast enlargement, chest pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, renal calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorders cycle, penile disorder, polyuria, testicular disorder, urinary pain, urinary tract retention, urinary urgency, vaginitis.

Post-marketing experience

Additional adverse events were reported as Prevacid FDT/IV delayed-release capsules and Prevacid FDT/IV delayed-release oral disintegrating tablets were marketed. Most of these cases involve a foreign source, and no relationship has been established with Prevacid FDT/IV delayed-release capsules and Prevacid FDT/IV delayed-release oral disintegrating tablets. Because these reactions have been reported voluntarily from a population of unknown size, frequency estimates cannot be made. These events are listed below by the COSTART body system.

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; Musculoskeletal system – bone fracture, myositis; Skin and appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis (some fatal) Special Senses – impaired speech; Urogenital system – interstitial nephritis, urinary retention.

Combination therapy with amoxicillin and clarithromycin

In clinical trials using combination therapy with Prevacid FDT / IV plus amoxicillin and clarithromycin, and Prevacid FDT / IV plus amoxicillin, no adverse reactions associated with these drug combinations were observed. Adverse reactions that have occurred have been limited to those previously reported with Prevacid FDT/IV, amoxicillin, or clarithromycin.

Triple therapy: Prevacid FDT / IV / amoxicillin / clarithromycin

The most common adverse reactions in patients treated with triple therapy for 14 days were diarrhea (7%), headache (6%) and taste perversion (5%). There were no statistically significant differences in reported adverse reactions between 10- and 14-day triple therapy regimens. No treatment-related adverse reactions were observed with significantly higher rates of triple therapy than with any dual therapy regimen.

Dual therapy: Prevacid FDT / IV / amoxicillin

The most common adverse reactions in patients treated with Prevacid FDT/IV three times daily plus amoxicillin three times daily as dual therapy were diarrhea (8%) and headache (7%). No treatment-related adverse reactions were observed at significantly higher rates with Prevacid FDT/IV three times daily plus amoxicillin three times daily dual therapy than with Prevacid FDT/IV alone.

For information on adverse reactions with amoxicillin or clarithromycin, see Full Prescribing Information sections.

Laboratory values ​​

The following changes in laboratory parameters in patients treated with Prevacid FDT / IV have been reported as adverse reactions:

Abnormal liver function, 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, elevated/decreased cholesterol , increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, elevated gastrin, and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria and hematuria have also been reported. Additional isolated laboratory abnormalities have been reported.

In placebo-controlled studies where SGOT (AST) and SGPT (ALT) were evaluated, placebo and Prevacid FDT/IV patients had enzyme elevations of 0.4% (4/978) and 0.4% (11/ 2677). more than three times the upper limit of the normal range at the final treatment visit. None of these patients treated with Prevacid FDT/IV reported jaundice at any time during the study.

In clinical trials using combination therapy with Prevacid FDT/IV plus amoxicillin and clarithromycin, and Prevacid FDT/IV plus amoxicillin, no elevated laboratory abnormalities were observed with these drug combinations.

For laboratory cost changes with amoxicillin or clarithromycin, see Full Prescribing Information, APPLIED REACTIONS.

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