Drug: Nexium I.V.

Nexium I.V.

Generic Name: esomeprazole (ES-oh-MEP-ra-zole)
Brand Name: Nexium I.V.

Nexium I.V. is used for:

Short-term treatment of gastroesophageal reflux disease (GERD) in patients with irritation and swelling of the esophagus when medicine cannot be taken by mouth. It is also used to reduce the risk of bleeding ulcers after a certain procedure (endoscopy). It may also be used for other conditions as determined by your doctor.

Nexium I.V. is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.

Do NOT use Nexium I.V. if:

  • you are allergic to any ingredient in Nexium I.V. or to any similar medicine (eg, omeprazole)
  • you are taking atazanavir, clopidogrel, dasatinib, nelfinavir, rifampin, rilpivirine, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nexium I.V.:

Some medical conditions may interact with Nexium I.V.. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood potassium or magnesium levels, low blood vitamin B12 levels or vitamin B12 deficiency, liver problems, or stomach or bowel cancer
  • if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Nexium I.V.. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased
  • Voriconazole because it may increase the risk of Nexium I.V.'s side effects
  • Ginkgo biloba, rifampin, or St. John's wort because they may decrease Nexium I.V.'s effectiveness
  • Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, methotrexate, saquinavir, or tacrolimus because the risk of their side effects may be increased by Nexium I.V.
  • Atazanavir, bosutinib, clopidogrel, dasatinib, erlotinib, indinavir, iron, itraconazole, ketoconazole, mycophenolate, nelfinavir, nilotinib, posaconazole, rilpivirine, or sorafenib because their effectiveness may be decreased by Nexium I.V.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexium I.V. may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nexium I.V.:

Use Nexium I.V. as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nexium I.V. is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Nexium I.V. at home, a health care provider will teach you how to use it. Be sure you understand how to use Nexium I.V.. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Nexium I.V. if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Nexium I.V. should only be used for a short time (up to 10 days), until you are able to take medicine by mouth. Discuss any questions or concerns with your doctor.
  • Continue to use Nexium I.V. even if you feel well. Do not miss any doses.
  • If you miss a dose of Nexium I.V., use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nexium I.V..

Important safety information:

  • Nexium I.V. may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nexium I.V. with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT change your dose, stop taking Nexium I.V., or take Nexium I.V. for longer than prescribed without checking with your doctor.
  • Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.
  • Nexium I.V. may increase the risk of a serious form of diarrhea. Contact your doctor right away if stomach pain or cramps, severe or persistent diarrhea, or bloody or watery stools occur. Discuss any questions or concerns with your doctor.
  • Nexium I.V. may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Nexium I.V. in high doses, for long periods of time, or if you are older than 50 years old. Contact your doctor if you have any questions about this information.
  • Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Nexium I.V. for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).
  • Long-term treatment (eg, longer than 3 years) with medicines like this one has rarely caused low vitamin B12 levels. Discuss any questions or concerns with your doctor.
  • Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Nexium I.V..
  • Nexium I.V. may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Nexium I.V..
  • Use Nexium I.V. with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nexium I.V. while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using Nexium I.V..

Possible side effects of Nexium I.V.:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drowsiness; dry mouth; gas; headache; mild diarrhea or stomach pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or watery stools; bone pain; chest pain; confusion; dark urine; difficult or painful urination; fast heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe or persistent diarrhea or stomach pain; severe or persistent nausea or vomiting; shortness of breath; sluggishness; sore joints; stomach cramps; swelling of the hands, ankles, or feet; symptoms of kidney problems (eg, not able to pass urine, change in the amount of urine produced, blood in the urine, a big weight gain); unexplained weight loss; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nexium I.V.:

Nexium I.V. is usually handled and stored by a health care provider. If you are using Nexium I.V. at home, store Nexium I.V. as directed by your pharmacist or health care provider. Keep Nexium I.V. out of the reach of children and away from pets.

General information:

  • If you have any questions about Nexium I.V., please talk with your doctor, pharmacist, or other health care provider.
  • Nexium I.V. is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Nexium I.V. or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nexium I.V.. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nexium I.V.. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Nexium I.V..

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Source: http://www.drugs.com/

Note: This page contains side effects data for the generic drug esomeprazole. It is possible that some of the dosage forms included below may not apply to the brand name Nexium IV.

It is possible that some side effects of Nexium IV may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to esomeprazole: oral capsule delayed release, oral packet

As well as its needed effects, esomeprazole (the active ingredient contained in Nexium IV) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking esomeprazole, check with your doctor immediately:

Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • chills
  • constipation
  • cough
  • darkened urine
  • difficulty with swallowing
  • dizziness
  • drowsiness
  • fast heartbeat
  • fever
  • indigestion
  • joint or muscle pain
  • loss of appetite
  • mood or mental changes
  • muscle spasms (tetany) or twitching
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • 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
  • seizures
  • skin rash, hives, itching
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • trembling
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Some esomeprazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
Less common
  • Sleepiness or unusual drowsiness
Rare
  • Acne
  • back pain
Incidence not known
  • Agitation
  • dry mouth
  • excess air or gas in the stomach or intestines
  • full feeling
  • hair loss or thinning of the hair
  • muscular weakness
  • passing gas
  • seeing, hearing, or feeling things that are not there
  • swelling of the breasts or breast soreness in both females and males
  • swelling or inflammation of the mouth
  • swollen joints

For Healthcare Professionals

Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release

General

The most frequently occurring adverse reactions were headache and diarrhea.
The most frequently reported adverse reactions for patients who received triple therapy for 10 days were diarrhea, taste perversion, and abdominal pain.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, headache, abdominal pain, nausea, vomiting, regurgitation
Uncommon (0.1% to 1%): Abdomen enlargement, bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting
Frequency not reported: Duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration
Postmarketing reports: Pancreatitis; stomatitis; microscopic colitis, GI candidiasis, Clostridium difficile associated diarrhea[Ref]

Hepatic

Common (1% to 10%): Increased liver enzymes
Uncommon (0.1% to 1%): Bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased
Postmarketing reports: Hepatic failure, hepatitis with or without jaundice[Ref]

Respiratory

Common (1% to 10%): Tachypnea (in pediatrics)
Uncommon (0.1% to 1%): Asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis, chest pain, substernal chest pain
Postmarketing reports: Bronchospasm[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, hypertension, tachycardia
Frequency not reported: Irregular heartbeat[Ref]

Dermatologic

Uncommon (0.1% to 1%): Acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria
Postmarketing reports: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)[Ref]

Endocrine

Uncommon (0.1% to 1%): Goiter[Ref]

Genitourinary

Uncommon (0.1% to 1%): Abnormal urine, albuminuria, dysuria, hematuria, micturition frequency, polyuria, impotence, vaginitis, cystitis, fungal infection, moniliasis, genital moniliasis, dysmenorrhea, menstrual disorder
Postmarketing reports: Gynecomastia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, pancytopenia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Postmarketing reports: Anaphylactic reaction/shock[Ref]

Metabolic

Uncommon (0.1% to 1%): Glycosuria, hyperuricemia, hyponatremia, increased alkaline
phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease, appetite increased, anorexia
Postmarketing reports: Hypomagnesemia, with or without hypocalcemia and/or hypokalemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic, back pain, fracture of the hip, wrist or spine
Postmarketing reports: Muscular weakness, myalgia, bone fracture[Ref]

An increased risk of hip fracture has been reported in a cohort study. The risk was significantly increased among patients prescribed long-term high PPIs.[Ref]

Nervous system

Uncommon (0.1% to 1%):Dizziness, hypertonia, nervousness, hypoesthesia, migraine, migraine aggravated, paresthesia, somnolence, tremor, visual field defect, parosmia, taste loss, taste perversion
Postmarketing reports: Hepatic encephalopathy, taste disturbance[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision
Postmarketing reports: Blurred vision[Ref]

Other

Uncommon (0.1% to 1%): Earache, tinnitus, facial edema, peripheral edema, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors, fatigue, asthenia, vertigo, otitis media[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression aggravated, apathy, confusion, insomnia, sleep disorder
Postmarketing reports: Aggression, agitation, depression, hallucination[Ref]

Renal

Very rare (less than 0.01%): Interstitial nephritis concomitantly with renal failure
Postmarketing reports: Interstitial nephritis[Ref]

Source: http://www.drugs.com/

Esomeprazole Pregnancy Warnings

US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU: This drug should be used only if clearly needed. UK: Caution is recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, changes in bone morphology were observed in offspring of rats, dosed through most of the pregnancy and lactation, at doses equal to or greater than 33.6 times an oral human dose of 40 mg. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Esomeprazole Breastfeeding Warnings

Esomeprazole is the S-isomer of omeprazole and limited data indicate that maternal doses of omeprazole 20 mg daily produce low levels in human milk. No studies in lactating women have been performed. Esomeprazole strontium: Studies showed effects of esomeprazole strontium on developing bone in rats, at high doses.

AU, UK: Use is not recommended. US: Caution is recommended. Esomeprazole Strontium: US: A decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

Source: http://www.drugs.com/

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