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SIZE:
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GENERIC NAME:
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MANUFACTURER:
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DAR AL-DAWA DEVP. & INV.CO.
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UNIT:
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ADMINISTRATION ROUTE:
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FDA PREGNANCY GROUP:
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B
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INDICATIONS:
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Esophagitis, erosive |
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Gastroesophageal Reflux Disease |
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Ulcer, duodenal |
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SIDE EFFECTS:
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Generalized skin reactions, including toxic epidermal necrolysis |
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Stevens-Johnson syndrome |
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erythema multiforme |
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hematologic abnormalities, specifically anemia |
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agranulocytosis |
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hemolytic anemia |
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leukocytosis |
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neutropenia |
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pancytopenia or thrombocytopenia |
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hematuria |
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proteinuria |
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urinary tract infection |
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Abdominal pain or colic |
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Asthenia |
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back pain |
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central nervous system (CNS) disturbances , specifically dizziness |
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headache |
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somnolence |
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unusual tiredness |
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chest pain |
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gastrointestinal disturbances, specifically acid regurgitation |
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constipation |
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diarrhea or loose stools |
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flatulence |
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nausea and vomiting |
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skin rash or itching |
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ABSOLUTE
CONTRAINDICATIONS :
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RELATIVE
CONTRAINDICATIONS : |
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>> Hepatic disease, chronic, current |
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ADULT DOSE:
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Dyspepsia (treatment)-
Oral, 20 mg once a day for four weeks. Some patients respond adequately to a dose of 10 mg once a day .
Gastroesophageal reflux disease (treatment) -
Oral, 20 mg once a day for the relief of heartburn and regurgitation. Further investigation is needed if symptom control in not achieved after four weeks of treatment .
Some patients respond adequately to a dose of 10 mg once a day .
In patients requiring maintenance therapy, doses of 10 mg once a day have been used .
For the treatment of reflux esophagitis, 20 mg once a day is recommended .
The dosage may be increased to 40 mg once a day for esophagitis refractory to other treatment regimens .
In patients requiring maintenance therapy, doses of 10 mg once a day have been used .
If reflux esophagitis recurs, the dose may be increased to 20 or 40 mg once a day .
Gastric hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas) -
Oral, 60 mg once a day, the dosage being adjusted as needed, and therapy continued for as long as clinically indicated. Doses of up to 120 mg three times a day have been used. If the total daily dose is greater than 80 mg, it should be administered in divided doses and given two times a day .
Duodenal ulcer-
Oral, 20 mg once a day. For patients not healed after the initial course of therapy (healing usually occurs within two weeks), an additional two weeks of treatment is needed. The dosage may be increased to 20 to 40 mg once a day for duodenal ulcer refractory to other treatment regimens. In patients requiring maintenance therapy, doses of 10 mg once a day, increased to 20 to 40 mg once a day as needed, have been used.
Gastric ulcer (treatment)-
Oral, 20 mg once a day. For patients not healed after the initial course of therapy (healing usually occurs within four weeks), an additional four weeks of treatment is needed. The dosage may be increased to 40 mg once a day for gastric ulcer refractory to other treatment regimens .
In patients requiring maintenance therapy, doses of 20 mg once a day, increased to 40 mg once a day as needed, have been used .
Peptic ulcer associated with H. pylori infection-
Oral, triple therapy regimens of omeprazole 20 mg, plus clarithromycin 500 mg, plus amoxicillin 1000 mg or omeprazole 20 mg, plus clarithromycin 250 mg, plus metronidazole 500 mg, in which all three medications are taken twice a day for seven days .
These regimens are followed by further treatment with omeprazole, 20 mg once a day for up to three weeks for active duodenal ulcer, and 20 to 40 mg once a day for up to twelve weeks for active gastric ulcer .
Peptic ulcer, nonsteroidal anti-inflammatory drug-induced (treatment)-
Oral, 20 mg once a day .
For patients not healed after the initial course of therapy (healing usually occurs within four weeks), an additional four weeks of treatment is needed .
In patients requiring maintenance therapy, doses of 20 mg once a day for up to six months have been used . |
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MAXIMUM ADULT DOSE:
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PEDIATRIC DOSE:
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Safety and efficacy have not been established.
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MAXIMUM PEDIATRIC
DOSE:
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ELDERLY DOSE:
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Dyspepsia (treatment)-
Oral, 20 mg once a day for four weeks. Some patients respond adequately to a dose of 10 mg once a day .
Gastroesophageal reflux disease (treatment) -
Oral, 20 mg once a day for the relief of heartburn and regurgitation. Further investigation is needed if symptom control in not achieved after four weeks of treatment .
Some patients respond adequately to a dose of 10 mg once a day .
In patients requiring maintenance therapy, doses of 10 mg once a day have been used .
For the treatment of reflux esophagitis, 20 mg once a day is recommended .
The dosage may be increased to 40 mg once a day for esophagitis refractory to other treatment regimens .
In patients requiring maintenance therapy, doses of 10 mg once a day have been used .
If reflux esophagitis recurs, the dose may be increased to 20 or 40 mg once a day .
Gastric hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas) -
Oral, 60 mg once a day, the dosage being adjusted as needed, and therapy continued for as long as clinically indicated. Doses of up to 120 mg three times a day have been used. If the total daily dose is greater than 80 mg, it should be administered in divided doses and given two times a day .
Duodenal ulcer-
Oral, 20 mg once a day. For patients not healed after the initial course of therapy (healing usually occurs within two weeks), an additional two weeks of treatment is needed. The dosage may be increased to 20 to 40 mg once a day for duodenal ulcer refractory to other treatment regimens. In patients requiring maintenance therapy, doses of 10 mg once a day, increased to 20 to 40 mg once a day as needed, have been used.
Gastric ulcer (treatment)-
Oral, 20 mg once a day. For patients not healed after the initial course of therapy (healing usually occurs within four weeks), an additional four weeks of treatment is needed. The dosage may be increased to 40 mg once a day for gastric ulcer refractory to other treatment regimens .
In patients requiring maintenance therapy, doses of 20 mg once a day, increased to 40 mg once a day as needed, have been used .
Peptic ulcer associated with H. pylori infection-
Oral, triple therapy regimens of omeprazole 20 mg, plus clarithromycin 500 mg, plus amoxicillin 1000 mg or omeprazole 20 mg, plus clarithromycin 250 mg, plus metronidazole 500 mg, in which all three medications are taken twice a day for seven days .
These regimens are followed by further treatment with omeprazole, 20 mg once a day for up to three weeks for active duodenal ulcer, and 20 to 40 mg once a day for up to twelve weeks for active gastric ulcer .
Peptic ulcer, nonsteroidal anti-inflammatory drug-induced (treatment)-
Oral, 20 mg once a day .
For patients not healed after the initial course of therapy (healing usually occurs within four weeks), an additional four weeks of treatment is needed .
In patients requiring maintenance therapy, doses of 20 mg once a day for up to six months have been used . |
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