Nexium 24HR

Pregnancy

There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)

Lactation

Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Oral Administration

If unable to swallow capsule whole, capsule can be opened, emptied on applesauce, mixed, and swallowed immediately

IV Compatibilities

Solution: NS, LR, D5W

IV Preparation

IV injection

• Reconstitute contents of 1 vial with 5 mL NS
• Store at room temp (no refrigeration required) and administer within 12 hr

Intermittent IV infusion

• Reconstitute 1 vial with 5 mL NS, LR, or D5W
• Further dilute to 50 mL
• Store at room temp (no refrigeration required) and administer within 12 hr if diluted in NS or LR, and within 6 hr if diluted in D5W

Continuous IV infusion

• Reconstitute two 40 mg vials with 5 mL each of 0.9% NaCl
• Further dilute the 2 reconstituted vials in 100 mL 0.9% NaCl

IV Administration

IV injection

• Injection: Over no less than 3 min

Intermittent IV infusion

• Infuse over 10-30 min regardless of amount
• Flush IV line with NS, LR, or D5W prior to and after administration
• Do not administer with any other drugs

Continuous IV infusion

• Administer initial 80 mg IV dose over 30 min, THEN follow with
• Continuous IV infusion of 8 mg/hr for total treatment duration of 72 hr

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• Take 1 hour before a meal.
• Swallow whole. Do not chew, break, or crush.
• Keep taking Nexium 24HR as you have been told by your doctor or other health care provider, even if you feel well.
• Ask your doctor before you take antacids with this medicine.

Capsule:

• You may sprinkle contents of capsule on 1 tablespoon (15 mL) of applesauce. Take right away and do not chew granules.
• Those who have feeding tubes may make a liquid. Empty contents of capsule into a 60 mL syringe with 50 mL of water. Replace plunger and shake for 15 seconds. Flush feeding tube before and after Nexium 24HR is taken.

Nexium 24HR:

• Take with a full glass of water.
• Do not use for more than 14 days or more often than every 4 months unless told to do so by the doctor.

What do I do if I miss a dose?

All products:

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Nexium 24HR:

• Do not take more than 1 dose of this medicine in the same day.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling sleepy.
• Belly pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Gas.
• Dry mouth.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to esomeprazole: oral capsule delayed release, oral packet, oral tablet delayed release

Other dosage forms:

• oral capsule delayed release
• intravenous powder for solution

Along with its needed effects, esomeprazole (the active ingredient contained in Nexium 24HR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking esomeprazole:

• 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 side effects of esomeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste

• Sleepiness or unusual drowsiness

• Acne
• back pain

• 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

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 24HR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.