Monday, September 2, 2013

Gasec (rest of pamphlet)

Gasec (rest of pamphlet)
H2-blocker maintenance therapy, is a promising alternative.
Gastritis, hyperacidity:
The current recommended adult dosage is 20-40 mg twice a day. Duration of treatment: 1-2 weeks is usually sufficient.
Aspiration syndrome:
40 mg given the night before and again on the morning of elective caesarian section effectively increases gastric pH and reduces gastric volume.
Zollinger-Ellison Syndrome:
Daily dosage 60 mg. Dosages should be adjusted to indkidual patient needs and should continue as long as clinically indicated. A dosage range of 20 mg to 120 mg/day may be employed depending on the severity of the disease. Dosages of up to 360 mg/day have been employed in patients with severe disease. With doses in excess of 80 mg daily, the dose should be equally divided and given twice daily.
Special dosage instructions Gasec-20 will be most effective when taken with or shortly before meals; effectiveness is likely to be significantly compromised if taken during a prolonged fasting period. 
Gasec-20 should not be coadministered with another anti- secretory agent Higher dosages or more frequent administration is indicated if greater antisecretory eftec tivenes
is required.
Renal impairment:
No dose adjustment is needed. Hepatic impairment:
The dose should be adjusted; maximum daily dose is 20 mg. In most subjects, the 20 mg dosage will not become fully effective until after about four days of therapy. Continuing H2-blockers will be counterproductive. In the elderly, safety and efficacy appear similar to those of younger age. 
Restrictions of use Contraindications
There are no known contraindications to the use of Gasec-20. 
Precautions (1) Stomach ulcers: it is advisable to establish the benign nature of the ulcer before any treatment. Complaints caused by carcinoma of the stomach can be alleviated by omeprazole, and non-diagnosed carcinomas, in particular early carcinomas, may appear to heal initially with omeprazole therapy. Therefore, the diagnosis and healing of a stomach ulcer must be checked endoscopically and by biopsy. (2) Helicobacter pylon is associated with hyperacidity and peptic ulcer disease, contributing to gastritis and ulcer recurrence. In patients known to be allergic to amoxycillin, clarithromycin may
be a useful alternative in dual therapy. Omeprazole 40 mg daily, amoxycillin 1500 mg daily and metronidazole 1200 mg daily for 14 days achieved an overall Helicobacter eradication rate of 89% to 96%.
(3) Pregnancy, lactation. There are no adequate or well-controlled studies in pregnant women and Gasec-20 should only be used when potential benefits outweigh the potential hazards to the fetus.
It is not known whether omeprazole is excreted in human milk. Because of the potential for senous adverse reactions in nursing infants from omeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, patients taking omeprazole should not breast feed.
(4) Paediatric use. Safety and effectiveness in children have not been established. 
Side effects
Gasec-20 is a drug 
with a very low incidence of minor side effects and is generally well tolerated. Occasionally, nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain, skin disorders, have been reported. These events have been transient and usually mild. Liver enzyme changes, haematological
changes, angioedema, fatigue, par‘‘‘HI
150227018011
aesthesia, Insomnia, muscle and joint pains, have also been reported, but are rare, and there has been no consistent relationship with treatment. 
interactions Gasec-20 can prolong the elimination of diazepam, phenytoin and warfarin, drugs that are metabolized by oxidation in the liver by subsets of the cytochrome P.450 enzyme system. This effect is minor at clinically relevant doses. However, monitoring of patients also receiving warfarin or phenytoin is recommended and a reduction of dose of phenytoin and warfarin may be necessary.
No interaction with propranolol or theophylline has been found, but interactions with other drugs also metabolized via the cytochrome P-450 enzyme system cannot be excluded. No interaction with concomitantly administered antacids has been found. 
Presentation Packings of 7 and 14 Gastrocaps.
Manufactured by
Medical union Pharmaceuticals
Abu Sultan 
Ismailia Egypt
In Cooperation with
Mepha Pharma Egypt S.A.E
under Supervision of
Mepha Ud, Basel, Switzerland

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