Nexium Oral

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of esomeprazole for GERD in children. However, safety and efficacy have not been established for children younger than 1 month of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esomeprazole in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Bosutinib
• Cilostazol
• Citalopram
• Clopidogrel
• Dasatinib
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Gefitinib
• Ketoconazole
• Ledipasvir
• Methotrexate
• Mycophenolate Mofetil
• Nelfinavir
• Nilotinib
• Pazopanib
• Posaconazole
• Saquinavir
• Tacrolimus
• Thiopental
• Velpatasvir
• Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levothyroxine
• Risedronate
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (thinning of the bones) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

See also Precautions section.

Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

Rarely, proton pump inhibitors (such as esomeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Nexium (esomeprazole) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. It is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Nexium may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Nexium is not for immediate relief of heartburn symptoms.

Take Nexium exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

Take each dose with a full glass (8 ounces) of water.

Nexium should be taken at least one hour before a meal.

Do not crush or chew a delayed-release capsule. However to make swallowing easier, you may open the Nexium capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Nexium can be given through a nasogastric (NG) feeding tube. Open the capsule and sprinkle the medicine into a 60-milliliter syringe. Mix in 50 milliliters of water. Place the plunger into the syringe and shake the mixture well. Make sure there are no medicine granules stuck in the tip of the syringe. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

If you use Nexium for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.

Nexium can cause unusual results with certain medical tests, and you may need to stop using the medicine for a short time before a test. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

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

Tell your doctor about all your current medicines, and any you start or stop using during your treatment with Nexium, especially:

• cilostazol;

• clopidogrel;

• diazepam;

• digoxin;

• erlotinib;

• iron-containing medicines (ferrous fumarate, ferrous gluconate, ferrous sulfate, and others);

• methotrexate;

• mycophenolate mofetil;

• rifampin;

• St. John's wort;

• tacrolimus;

• warfarin (Coumadin, Jantoven);

• antifungal medication - ketoconazole, voriconazole; or

• HIV/AIDS medication - atazanavir, nelfinavir, saquinavir.

This list is not complete and other drugs may interact with esomeprazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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]

Nervous system

Very Common (10% or more): Headache (up to 10.9%)
Common (1% to 10%): Dizziness, somnolence, vertigo
Uncommon (0.1% to 1%): Paresthesia
Rare (0.01% to 0.1%): Taste disturbance
Very rare (less than 0.01%): Hepatic encephalopathy
Frequency not reported: Hypertonia, hypoesthesia, migraine/aggravated migraine, parosmia, taste loss/perversion, tremor[Ref]

Gastrointestinal

Very common (10% or more): Flatulence (up to 10.3%)
Common (1% to 10%): Abdominal pain, benign fundic gland polyps, constipation, diarrhea, dry mouth, duodenal ulcer hemorrhage, epigastric pain/aggravated epigastric pain, gastritis/aggravated gastritis, nausea/aggravated nausea, regurgitation, tooth disorder, vomiting/aggravated vomiting
Rare (0.01% to 0.1%): GI candidiasis, stomatitis
Very rare (less than 0.01%): Microscopic colitis
Frequency not reported: Barrett's esophagus, benign polyps or nodules, bowel irregularity, constipation aggravated, duodenitis, dyspepsia, dysphagia, dysplasia gastrointestinal (GI), enlarged abdomen, eructation, esophagitis, esophageal disorder, esophageal stricture, esophageal ulceration, esophageal varices, frequent stools, gastric ulcer, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hernia, hiccup, melena, mouth disorder, mucosal discoloration, pharynx disorder, rectal disorder, tongue disorder, tongue edema, ulcerative stomatitis
Postmarketing reports: Clostridium difficile associated diarrhea, hemorrhagic necrotic gastritis, pancreatitis[Ref]

Respiratory

Common (1% to 10%): Cough, respiratory infection, sinusitis, tachypnea (in pediatrics)
Uncommon (0.1% to 1%): Epistaxis
Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Asthma aggravated, dyspnea, larynx edema, pharyngitis, rhinitis[Ref]

Other

Common (1% to 10%): Accident or injury, fever/pyrexia
Rare (0.01% to 0.1%): Malaise
Frequency not reported: Asthenia, earache, facial edema, fatigue, flu-like disorder, leg edema, otitis media, pain, rigors, thirst, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Dermatitis, rash, urticaria
Rare (0.01% to 0.1%): Alopecia, increased sweating, photosensitivity
Very rare (less than 0.01): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)/ fatal TEN
Frequency not reported: Acne, pruritus ani, rash erythematous, rash maculopapular, skin inflammation, subacute cutaneous lupus erythematosus, sweating increased/hyperhidrosis
Postmarketing reports: Cutaneous lupus erythematosus, systemic lupus erythematosus[Ref]

Cardiovascular

Common (1% to 10%): Hypertension/aggravated hypertension
Uncommon (0.1% to 1%): Peripheral edema
Frequency not reported: Chest pain, flushing, generalized edema, hot flush, hypertension, irregular heartbeat, substernal chest pain, tachycardia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Fracture of the hip, wrist or spine
Rare (0.01% to 0.1%): Arthralgia, myalgia
Very rare (less than 0.01%): Muscular weakness
Frequency not reported: Arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, hyperuricemia/increased uric acid, increased alkaline phosphatase, polymyalgia rheumatic
Postmarketing reports: 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]

Endocrine

Common (1% to 10%): Increased serum gastrin
Very rare (less than 0.01%): Gynecomastia
Frequency not reported: Decreased/increased thyroxine, goiter, increased thyroid stimulating hormone[Ref]

Local

Common (1% to 10%): Administration/injection site reactions
Postmarketing reports: Tissue inflammatory reaction[Ref]

Immunologic

Common (1% to 10%): Viral infection[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased liver enzymes,
Rare (0.01% to 0.1%): Hepatitis with/without jaundice
Very rare (less than 0.01%): Hepatic failure
Frequency not reported: Abnormal hepatic function, ALT/AST increased, bilirubinemia, increased total bilirubin[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Visual accommodation disorder, visual field defect
Frequency not reported: Abnormal vision, conjunctivitis
Postmarketing reports: Irreversible visual impairment, loss of vision[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia
Rare (0.01% to 0.1%): Agitation, confusion, depression/aggravated depression
Very rare (less than 0.01%): Aggression, hallucinations
Frequency not reported: Apathy, irritability, nervousness, sleep disorder[Ref]

Hematologic

Rare (0.01% to 0.1%): Leukopenia, thrombocytopenia
Very rare (less than 0.01%): Agranulocytosis, pancytopenia
Frequency not reported: Anemia, anemia hypochromic, cervical lymphadenopathy, decreased/increased hemoglobin, decreased/increased platelets, decreased/increased white blood cell count, leukocytosis[Ref]

Metabolic

Rare (0.01% to 0.1%): Hyponatremia
Very rare (less than 0.01%): Hypomagnesemia with or without hypocalcemia and/or hypokalemia, severe hypomagnesemia
Frequency not reported: Anorexia, decreased/increased potassium, decreased/increased sodium, increased appetite, vitamin B12 deficiency, weight decrease/increase[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions
Frequency not reported: Allergic reaction[Ref]

Renal

Very rare (less than 0.01%): Interstitial nephritis with/without renal failure
Frequency not reported: Glycosuria
Postmarketing reports: Impaired renal function, increased creatinine, nephrosis[Ref]

Genitourinary

Frequency not reported: Abnormal urine, albuminuria, cystitis, dysmenorrhea, dysuria, fungal infection, genital moniliasis, hematuria, menstrual disorder, micturition frequency, moniliasis, polyuria, vaginitis
Postmarketing reports: Impotence[Ref]

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

• Nexium is a brand (trade) name of esomeprazole. Esomeprazole reduces the production of stomach acid by irreversibly blocking the actions of an enzyme responsible for acid production, called H+/K+ ATPase (also known as the gastric proton pump). The proton pump is located in the parietal cells of the stomach wall. Both baseline gastric acid secretion and stimulated gastric acid secretion are affected.
• This allows damaged tissue in the esophagus, stomach, and duodenum to heal.
• Nexium belongs to the class of medicines known as proton pump inhibitors (PPIs).