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Friday, October 10, 2014

Omeprazole






Omeprazole



Generic Name: omeprazole 


What is omeprazole  ?


Omeprazole (Prilosec, Zegerid) belongs to group of drugs called proton pump inhibitors. It 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. It is not for immediate relief of heartburn symptoms.
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).

Important information

Omeprazole is not for immediate relief of heartburn symptoms.
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
You should not take this medication if you are allergic to omeprazole or to any other benzimidazole medication such as albendazole or mebendazole.
Ask a doctor or pharmacist if it is safe for you to take omeprazole if you have liver disease or heart disease, or low levels of magnesium in your blood.
Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice./p>
Take omeprazole for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared./p>
Prilosec OTC (over-the-counter) should be taken for no longer than 14 days in a row. Allow at least 4 months to pass before you start another 14-day treatment./p>

Before taking this medicine

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
You should not take this medication if you are allergic to omeprazole or to any other benzimidazole medication such as albendazole or mebendazole.
Ask a doctor or pharmacist if it is safe for you to take omeprazole if you have liver disease or heart disease, or if you have low levels of magnesium in your blood.
Do not use over-the-counter omeprazole (Prilosec OTC) without the advice of a doctor if you have:
  • trouble or pain with swallowing;
  • bloody or black stools;
  • vomit that looks like blood or coffee grounds;
  • heartburn that has lasted for over 3 months;
  • frequent chest pain;
  • heartburn with wheezing;
  • unexplained weight loss;
  • osteoporosis, low bone mineral density;
  • nausea or vomiting; or
  • stomach pain.
Some people taking omeprazole may have an increased risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people taking omeprazole long term or at high doses, and in people who are age 50 and older. Omeprazole may not be the actual cause of increased fracture risk. Before you take this medication, tell your doctor if you have a bone disorder.
Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
FDA pregnancy category C. It is not known whether omeprazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
Omeprazole can pass into breast milk and may harm a nursing baby. Do not take this medicine without your doctor's advice if you are breast-feeding.
Do not give this medication to a child younger than 1 year old without the advice of a doctor.


How should I take omeprazole  ?

Omeprazole is usually taken before eating. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Prilosec OTC (over-the-counter) should be taken only once every 24 hours for 14 days. Take the medicine in the morning before you eat breakfast. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.
Allow at least 4 months to pass before you start another 14-day treatment with Prilosec OTC. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.
Do not crush, chew, or break an enteric coated pill, or a Prilosec OTC tablet. Swallow the pill whole.
You may open the delayed-release capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow the mixture right away without chewing. Do not save for later use.
Dissolve the powder in a small amount of water. Use 1 teaspoon of water for the 2.5-mg packet, or 1 Tablespoon of water for the 10-mg packet. Let the mixture stand for 2 or 3 minutes, then stir and drink right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
This mixture can also be given through a nasogastric (NG) feeding tube using only a catheter-tipped syringe. Shake the syringe well, then attach it to the NG tube and push the plunger down to empty the syringe into the tube. Refill the syringe with water and flush the tube to wash the contents down.
Use this medication for the full prescribed length of time. Your symptoms may improve before your condition is completely cleared.
Call your doctor if your symptoms do not improve, or if they get worse while using omeprazole.
Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
This medicine 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 omeprazole.
Store at room temperature away from moisture and heat.

What happens if I miss a dose ?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose  ?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid  ?

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

Omeprazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction to omeprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
  • diarrhea that is watery or bloody; or
  • low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure).
Common omeprazole side effects may include:
  • fever;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • stomach pain, gas;
  • nausea, vomiting, mild diarrhea; or
  • headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)

Omeprazole dosing information

Usual Adult Dose for Duodenal Ulcer:
20 mg orally once a day before a meal. Most patients heal within 4 to 8 weeks.
Usual Adult Dose for Helicobacter pylori Infection:
Dual therapy: omeprazole 40 mg orally once a day in the morning plus clarithromycin 500 mg orally 3 times a day on days 1 to 14. Beginning on day 15, omeprazole 20 mg orally once a day in the morning on days 15 to 28.

Triple therapy: omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg all given orally twice a day for 10 days. If an ulcer is present at the initiation of therapy, continue omeprazole 20 mg orally once a day for an additional 18 days.

Study (n=294) - Canadian Adult Dyspepsia Empiric Treatment-Helicobacter pylori positive (CADET-Hp): omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 500 mg, twice daily for 7 days.
Usual Adult Dose for Gastric Ulcer:
40 mg orally once a day before a meal for 4 to 8 weeks.
Usual Adult Dose for Erosive Esophagitis:
20 mg orally once a day before a meal. This dosage may be increased to 40 mg per day based on desired clinical response and patient tolerance. Studies have been completed up to 12 months for maintenance therapy of erosive esophagitis.
Usual Adult Dose for Zollinger-Ellison Syndrome:
Initial: 60 mg orally once a day. Dosage should be individualized to patient's needs.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.
Usual Adult Dose for Gastroesophageal Reflux Disease:
Initial: 20 mg orally once a day before a meal for 4 to 8 weeks. This dosage may be increased to 40 mg per day if needed.

Maintenance: long-term treatment with doses of 10 to 20 mg per day may be required for maintenance therapy of refractory disease and appears to be safe.
Usual Adult Dose for Multiple Endocrine Adenomas:
Initial: 60 mg orally once a day before a meal. This dosage may be titrated based on desired clinical response and patient tolerance.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.
Usual Adult Dose for Systemic Mastocytosis:
Initial: 60 mg orally once a day before a meal. This dosage may be titrated based on desired clinical response and patient tolerance.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.
Usual Adult Dose for Dyspepsia:
Prevention of frequent heartburn: 20 mg orally once daily, before a meal, for 14 days.
Usual Pediatric Dose for Erosive Esophagitis:
Oral:
Infants:
GERD: 0.7 mg/kg/dose once daily reduced the percentage of time gastric and esophageal pH less than 4, as well as the number of reflux episodes in 10 neonates [mean PMA: 36.1 weeks, (34 to 40 weeks)] in a trial. Higher doses of 1 to 1.5 mg/kg/day have been reported

Children and Adolescents 1 to 16 years:
GERD, ulcers, esophagitis:
Manufacturer recommendations:
5 kg to less than 10 kg: 5 mg once daily
10 kg to less than or equal to 20 kg: 10 mg once daily
Greater than 20 kg: 20 mg once daily

Alternate dosing:
Children 1 to 16 years:
1 mg/kg/dose once or twice daily

Adjunctive therapy of duodenal ulcers associated with Helicobacter pylori (in combination with antibiotic therapy either clarithromycin or clarithromycin and amoxicillin) in children:
15 to 30 kg: 10 mg twice daily
Greater than 30 kg: 20 mg twice daily

Comment: The safety and efficacy of omeprazole use in patients less than 1 year of age and for pediatric uses other than the treatment of GERD and maintenance of healing of erosive esophagitis has not been established.
Usual Pediatric Dose for Gastroesophageal Reflux Disease:
Oral:
Infants:
GERD: 0.7 mg/kg/dose once daily reduced the percentage of time gastric and esophageal pH less than 4, as well as the number of reflux episodes in 10 neonates [mean PMA: 36.1 weeks, (34 to 40 weeks)] in a trial. Higher doses of 1 to 1.5 mg/kg/day have been reported

Children and Adolescents 1 to 16 years:
GERD, ulcers, esophagitis:
Manufacturer recommendations:
5 kg to less than 10 kg: 5 mg once daily
10 kg to less than or equal to 20 kg: 10 mg once daily
Greater than 20 kg: 20 mg once daily

Alternate dosing:
Children 1 to 16 years:
1 mg/kg/dose once or twice daily

Adjunctive therapy of duodenal ulcers associated with Helicobacter pylori (in combination with antibiotic therapy either clarithromycin or clarithromycin and amoxicillin) in children:
15 to 30 kg: 10 mg twice daily
Greater than 30 kg: 20 mg twice daily

Comment: The safety and efficacy of omeprazole use in patients less than 1 year of age and for pediatric uses other than the treatment of GERD and maintenance of healing of erosive esophagitis has not been established.

What other drugs will affect omeprazole  ?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with omeprazole, especially:
  • clopidogrel; or
  • HIV or AIDS medication--atazanavir, nelfinavir, rilpivirine.
This list is not complete. Other drugs may interact with omeprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.


Omeprazole in Bangladesh




OMEPRAZOLE


Oral
Peptic ulcer: Adult: 20mg daily as a single dose or 40mg daily in severe cases. Treatment duration: Duodenal ulcers: 4 wk gastric ulcers: 8wk Maintenance: 10-20mg once daily.
NSAID – associated ulceration:
Adult: 20mg daily. Same dose may also be used for prophylaxis of ulceration in patients who require continue NSAID therapy.
H.pylori infection: Adult: dose varies w/ regimen. As triple therapy: 20mg bid or 40 mg once daily; requires combination therapy w/ antibiotics. Therapy is given for 1 wk. Omeprazole may be continued for another 4-8wk on its own.
Gastro –oesophageal reflux disease:
Adult: 20mg once daily for 4 wk , may continue for another 4-8 wk if necessary. Maintenance: 10mg daily.
Child: Neonate 1 mth -2yr: 700mcg/kg/day, or may increase up to 3 mg /kg / day, or 20 mg daily>2yr : <20 kg: 10mg once daily. > 20 kg: 20mg daily. Doses may be doubled if necessary.
Zollinger-Ellison Syndrome:
Adult: Initially, 60 mg once daily, adjust according to response. Maintenance: 20-120 mg daily. Doses >80mg are administered usually in 2 divided doses.
Prophylaxis of acid aspiration during general anaesthesia: Adult: initially, 40mg given the evening before surgery & another 40mg 2-6 hr before the procedure.
Acid-related dyspepsia: Adult: 10 or 20mg daily for 2-4 wk.
Erosive oesophagitis: Adult: 20mg/day for 4-8wk. Maintenance of healing: 20mg /day for up to 12mth of total therapy (including treatment period).
Intravenous
Reflux oesophagitis; Gastric & duodenal ulcers: Adult: by infusion over 20-30 mins or slow inj over 5 minutes : 40mg once daily until oral admin is possible.
Prophylaxis of acid aspiration during general anaesthesia: adult: 40mg, to be given & completed 1 hr before the surgery. May be given via inj over 5 mins or infusion over 20-30 minutes.
Safety Alert
Sp: Exclude malignancy, prolonged use, hepatic impairment. Pregnancy, lactation, child<1yr. Elderly & Asians (increased bioavailability)
Int: Decreases absorption of itraconazole , Ketoconazole, dasatinib, oral Fe salts. Decreases levels of nelfinavier. Increases levels of benzodiazepines (e.g. diazam, midazolam, triazolam) HMG-CoA reductase inhibitors, CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide, phenytoin, propranolol, & sertraline), & CYP2C 9 substrotes (e.g. bosentan, dapsone, fluoxetine, gilmepiride, glipizide, losartan, montelukast, nateglinide, paclitaxel, Phenytoin, warfarin, & zafirlukast). Decreases levels /effects w/ CYP2c19 inducers (e.g. aminogllutethimide, carbamazepine, phenytoin, & rifampin). Decreases excretion of methotrexate. Enhances the advers/toxic o\effects of cilostazol. May alter the concentrations / effects of clozapine. Avoid concurrent use w/ clopidogrel.
ADR: Diarrhoea , nausea, fatigue, constipation, vomiting, flatulence, acid regurgitation, taste perversion, arthralgia, myalgia, urticaria, dry mouth, dizziness, headache, paraesthesia, abdominal pain, skin rashes weakness, back pain, upper resp infection, cough. Anaphylaxis.





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