First - Omeprazole

Name: First - Omeprazole

First - Omeprazole Side Effects

Along with its needed effects, a medicine 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:

Rare
  • Back, leg, or stomach pain
  • bleeding or crusting sores on the lips
  • blisters
  • bloody or cloudy urine
  • chills
  • continuing ulcers or sores in the mouth
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches or cramps
  • pain
  • red or irritated eyes
  • redness, tenderness, itching, burning, or peeling of the skin
  • skin rash or itching
  • sore throat
  • sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Drowsiness
  • fast, racing, or uneven heartbeat
  • mood or mental changes
  • muscle spasms (tetany) or twitching seizures
  • nausea or vomiting
  • trembling

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Blurred vision
  • confusion
  • dryness of the mouth
  • flushing
  • headache
  • increased sweating

Some side effects 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:

Less common
  • Body aches or pain
  • chest pain
  • constipation
  • cough
  • diarrhea or loose stools
  • difficulty with breathing
  • dizziness
  • ear congestion
  • gas
  • heartburn
  • loss of voice
  • muscle pain
  • nasal congestion
  • runny nose
  • sneezing
  • unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is First Omeprazole (omeprazole)?

Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Omeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. Omeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with helicobacter pylori (H. pylori).

Omeprazole is not for immediate relief of heartburn symptoms.

Omeprazole may also be used for purposes not listed in this medication guide.

Uses of First-Omeprazole

  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat heartburn.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It may be given to you for other reasons. Talk with the doctor.

What are some other side effects of First-Omeprazole?

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.
  • Belly pain.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Gas.

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.

What should I avoid while taking omeprazole?

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.

Usual Adult Dose for Erosive Esophagitis

Treatment: 20 mg orally once a day
-Duration of therapy: 4 to 8 weeks

Maintenance: 20 mg orally once a day

Comments:
-Controlled studies for maintenance therapy did not extend past 12 months.
-Patients who do not respond after 8 weeks of treatment may continue for an additional 4 weeks.
-If there is a recurrence of erosive esophagitis (EE) or gastroesophageal reflux disease (GERD) symptoms, an additional 4 to 8 week course of treatment should be considered.

Uses:
-Treatment of EE due to acid-mediated GERD
-Maintenance of healing of EE due to acid-mediated GERD

Usual Adult Dose for Multiple Endocrine Adenomas

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:
-Doses higher than 80 mg should be given in divided doses.
-The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:
-Doses higher than 80 mg should be given in divided doses.
-The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Gastroesophageal Reflux Disease

20 mg orally once a day
-Duration of therapy: Up to 4 weeks

Use: Treatment of symptomatic GERD

Usual Pediatric Dose for Erosive Esophagitis

TREATMENT:
1 month to less than 1 year:
3 to less than 5 kg: 2.5 mg orally once a day
5 to less than 10 kg: 5 mg orally once a day
10 kg and greater: 10 mg orally once a day
Duration of therapy: Up to 6 weeks

1 to 16 years:
5 to less than 10 kg: 5 mg orally once a day
10 to less than 20 kg: 10 mg orally once a day
20 kg and greater: 20 mg orally once a day
Duration of therapy: 4 to 8 weeks

16 to 18 years: 20 mg orally once a day
-Duration of therapy: 4 to 8 weeks

MAINTENANCE:
1 to 16 years:
5 to less than 10 kg: 5 mg orally once a day
10 to less than 20 kg: 10 mg orally once a day
20 kg and greater: 20 mg orally once a day

16 to 18 years: 20 mg orally once a day

Comments:
-Patients who do not respond after 8 weeks of treatment may continue for an additional 4 weeks.
-If there is a recurrence of EE or GERD symptoms, an additional 4 to 8 week course of treatment should be considered.
-Controlled studies for maintenance therapy did not extend past 8 weeks.

Uses:
-Treatment of EE due to acid-mediated GERD
-Maintenance of healing of EE due to acid-mediated GERD

Other Comments

Administration advice:
-Tablet and capsule formulations should be swallowed whole, without crushing/chewing.
-The delayed-release capsule may be opened and sprinkled onto a tablespoon of applesauce and swallowed immediately. Do not chew or crush granules.
-The delayed-release oral suspension may be emptied into a small volume of water, allowed to thicken (approximately 2 to 3 minutes), and swallowed within 30 minutes. Remaining material should be mixed with more water and swallowed immediately.
-The suspension may be mixed with water and administered via nasogastric tube.

Storage requirements: The manufacturer product information should be consulted.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: The manufacturer product information should be consulted.

General:
-The IV formulation should be used when oral formulations are inappropriate; IV use should be discontinued as soon as treatment with an oral formulation is possible. A single 10 mg IV dose was shown to be equivalent to a single 20 mg oral tablet dose.
-Antacids may be used concomitantly during treatment.

Monitoring:
-Magnesium levels, especially in patients taking other drugs that could result in hypomagnesemia or those on long-term therapy
-Vitamin B12 levels, especially in patients on long-term therapy
-Bone fractures, especially in patients at high risk for osteoporosis-related events

Patient advice:
-Patients should be advised that use is not intended for immediate relief. Patients may not experience full effects for up to 4 days.
-If using this drug to treat H pylori, tell patients that it is important to complete the full regimen.
-Instruct patients to seek medical attention if signs/symptoms of hypersensitivity, Clostridium difficile, or systemic cutaneous lupus erythematosus occur.
-Inform patients that this drug may cause drowsiness, dizziness, vertigo, and/or visual disturbances. They should avoid driving or operating machinery until the full effects of the drug are seen.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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