GASTRODOMINA TABLETS
COMPOSITION :
per tablet: Gastrodomina 20mg
Gastrodomina 40mg
Famotidine 20 mg
Excipient,q.s.
PROPERTIES :
Famotidine is an H, antagonist with prolonged action, rapid onset of effects, and a high degree of specificity for H, receptors.
INDICATIONS :
Benign stomach ulcer, duodenal ulcer ,hypersecretory processes such a Zollinger-Ellison’s Syndrome, and in the therapy of support for reducing the relapse of dUodenal ulcer.
DOSAGE :
Duodenal ulcer
One 40 mg. tablet daily at night. A 20 mg. tablet twice daily may also be administered. Treatment should be Maintained from 4 to 8 weeks although this period may be reduced if endoscopy reveals healing of the ulcer. In the majOrity of cases o~rcer,neal~Within
4 weeks. If the ulcer does not heal alter 4 weeks treatment, it should be continued for 4 more weeks.
Therapy of support
To reduce the relapses of duodenal ulcer it is recommended to continue with a daily dose of 20 mg, at night. Nevertheless it must be taken into consideration that control/ed studies for periods of more than one year have not been carried out.
Benign gastric ulcer
Recommended dosage is 40 mg. daily at night. Treatment must be last from 4 to 8 weeks. But it can be reduced if endoscopy reveals healing of the ulcer.
zollinger-Ellison’s Syndrome
In patients without prior hypersecretory treatment it must be initiated with 20 mg. four times daily. This dose must be adjusted according to the patient’s individual needs and should be maintained for as long as the patient requires. Doses of even 480 mg. daily have been used during 1 year without significative side effects nor tachYPhYlaxy. In patients with prim antisecretory treatment, initial dose of Famotidine should be higher than the recommended one for initial cases, depending on the severity of clinical history and of dose H, antagonist previously used.
CONTRAINOICATlONS :
No known Contra indications exist. The drug should be discontinued if hypersensitivity appears.
PRECAUTIONS :
Existence of gastric neoplasia should be discarred before beginning the treatment with Famotidine. Symptomatic relief of gastric ulcer during the treatment doesn’t discard the presence of a malign
Gastric ulcer.The drug should be used with caution in patients with
liver or renal disorders. If clearance of creatinine drops till or under 30 ml/min., A reduction of the dose should be considered. Famotidine is not recommended during pregnancy and it should only be prescribed if it was clearly necessary. Before using Famotidine in pregnant women, potential benefits should be considered against possible risks. It is unknown if Famotidine is excreted in mother’s milk. Nursing mothers must discontinue
Famotidine or avoid lactation. Its efficacy and safety have not been confirmed in children. Any increase in the incidence or change in the kinds of side effects have not been remarked when Famelidine was administered to elderly patients. Treatment should always be interrupted gradually to avoid recurrencies.
INCOMPATIBILlTlES :
None have been reported.
INTERACTIONS :
No interactions with other drugs have been encountered. Studies carried out show that no significative interferences are produced with the metabolization of compounds at the level of hepatic
microsomal enzymes. There is no interactions at all with these drugs,
SIDE EFFECTS :
On rare occasions, diarrhoea, headache, and tiredness have been reported. Other even less frequent side-effects are: constipation, a dry mouth, nausea and vomiting, abdominal discomfort, flatulence, loss of apetite, and a skin rash. Nevertheless, it is not possible for the moment, to exclude the possibility of appearing other side effects of the type of the ones remarked in other H, antagonists.
Hepatobiliary disorder:
very rare: liver enzyme abnormalities, hepatitis,
cholestatic jaundice.
INTOXICATION AND TREATMENT :
No experience with over dosage has been acquired. In patients with hypersecretory syndromes doses of even 640 mg/day have been used, and not severe side effects have been reported. In the case of accidental overdosage the usual measures should be applied to
remove the non-absorbed drug from the gastrointestinal tract. The patient should be carefully monitored and supportive measures applied.
PACKAGES :
GASTRODOMINA 40 mg. Pack containing 10 tablets.
GASTRODOMINA 40 mg. Pack containing 30 tablets.
GASTRODOMINA 20 mg. Pack containing 20 tablets.
Manufactured by :
Medical Union Pharmaceuticals,
Abu·Sultan, lsmailia, Egypt
Under licence fromAlmirall Prodesfarma, SA Spain
