the package insert of the medicine Pylorid. Therapeutic class of Antiulcerosos. Active principles Citrate Bismuth Ranitidine. Sale under medical prescription.
Treatment and prevention of recurrence of duodenal ulcer and benign gastric ulcer. As an adjunct in the eradication of H. pylori when given in combination with clarithromycin or amoxicillin.
How it works?
The citrate bismuth ranitidine after ingested is hydrolysed in the gastric juice, releasing the ranitidine and bismuth. Ranitidine and bismuth are rapidly absorbed, and the time for the maximum plasma concentration of each of the substances is reached is 1 to 3 hours, and 15 and 60 minutes, respectively. The absorption of bismuth pill PYLORID is pH-dependent intragastric and increases if the pH of the intragastric get to 6 or more, prior to administration. However, the absorption of the bismuth is not changed by the concomitant administration of antacids (see Interactions). The absorption of bismuth pill PYLORID is less than 1% of the dose of bismuth administered and is similar in healthy volunteers, men and women, and in patients with peptic ulcer disease or gastritis. Ranitidine is eliminated primarily by the clearance renal (approximately 500 ml/min), which is responsible for 70% of clearance total, which is approximately 70 ml/min. Ranitidine is rapidly eliminated from the body, with a half-life of approximately 3 hours after oral administration, and does not accumulate in plasma after administration of twice the daily dose. Exposure to ranitidine and bismuth is increased in patients with renal insufficiency and in the elderly, as a result of decreased clearance renal. Any patient with kidney failure a very serious (clearance creatinine < 25 ml/min) should not receive PYLORID (see Dosage and Precautions). The bismuth in the systemic circulation is debugged from the body primarily by the clearance renal (approximately 50 ml/min). The half-life in plasma for the elimination of bismuth is approximately 5 to 10 days. The bismuth accumulates in the plasma at doses from twice the daily dose prescribed PYLORID. The plasma concentrations close to steady state are achieved after 4 weeks of administration.
When should I not use?
The tablets PYLORID are contraindicated in patients who have hypersensitivity to any components of the product.
How to use?
The recommended dose should be administered 2 times a day, morning and evening, with or without food. Disease ulcerative peptic: duodenal Ulcer: 1 tablet of 400 mg PYLORID, two times a day, during 4 weeks. The treatment can be extended for 4 more weeks. Benign gastric ulcer: 1 tablet of 400 mg PYLORID, two times a day, for 8 weeks. H. pylori associated with duodenal ulcer: 1 tablet of 400 mg PYLORID, two times a day, associated with clarithromycin in a dose of 500 mg, two to three times a day, or 250 mg four times daily (total daily dose between 1 g and 1.5 g) or associated with to amoxicillin in a dose of 500 mg, four times daily (2 g/day) during the first two weeks of treatment, followed by administration of 1 tablet of 400 mg PYLORID, two times a day, for two more weeks.
Warnings and Precautions
what should I know before using?
In patients with gastric ulcer, the possibility of malignancy should be excluded before the start of the treatment, since therapy with PYLORID may mask symptoms of gastric carcinoma. Ranitidine and bismuth are excreted by the kidney, so that plasma levels are increased in patients with renal insufficiency and in the elderly (see Dosage). As with all products that contain bismuth, tablets PYLORID should not be used in patients with severe renal insufficiency (clearance of creatinine 10 ml/min). Tablets PYLORID should be avoided in patients with a history of acute porphyria. When the prescription PYLORID associated with clarithromycin or amoxicillin are clinically indicated, should consult the information for the prescription, before the start of therapy. Children: No data are available about the use of tablets PYLORID in children. Therefore, they are not recommended for use in children. Renal insufficiency: The exposure to ranitidine and bismuth is increased in patients with renal failure due to the decrease of clearance of creatinine. However, for patients with renal insufficiency mild or moderate (clearance creatinine < 50 ml/min), it is not necessary to adjust the dose. In cases of acute renal failure, (clearance creatinine < 10 ml/min), the tablets PYLORID should not be administered. Hepatic insufficiency: there is No information with regard to the use of tablets PYLORID in patients with liver failure. However, such as ranitidine and bismuth are eliminated from the systemic circulation primarily by the clearance renal, it is not necessary dose adjustment in patients with hepatic insufficiency. Elderly patients: The exposure to ranitidine and bismuth is increased in elderly patients, as a result of decreased clearance of creatinine. However, it is not necessary to adjust the dose, unless the clearance of creatinine to fall below 10 ml/min. In this situation, the pills PYLORID should not be administered (see renal Insufficiency). Pregnancy and lactation: reproduction studies in animals demonstrated that, with repeated doses, low levels of ranitidine crosses the placenta. There was no evidence that the citrate bismuth ranitidine induced teratogenicity in high doses. The safety of citrate bismuth ranitidine in human pregnancy has not been established. As reproduction studies in animals do not always predict the response in the human being, the tablets PYLORID are not recommended in pregnancy. It was shown that during the period of administration of multiple doses of citrate of bismuth ranitidine to pussy lactating, are excreted in milk low levels of ranitidine and bismuth, with the consequent exposure of the offspring. The passage of the citrate bismuth ranitidine for human milk has not been evaluated. Consequently, the tablets PYLORID should not be used by lactating women. Effects on ability to drive and operate machinery: There was reported no effect. Side effects: it Is often reported the darkening of the stool with medications that have bismuth as one of its components. As with other drugs that have bismuth in their formula, the citrate bismuth ranitidine can cause darkening of the tongue. There have been reports of hypersensitivity reactions, including pruritus, rash, and anaphylaxis. Gastrointestinal disorders, including diarrhea, abdominal discomfort and pain gastric. Headache: treatment with tablets PYLORID can cause transient changes in liver enzymes SGPT (ALT) and SGOT (AST). It was reported anaemia discreet. The adverse effects listed below have been reported in patients treated with ranitidine. Such as ranitidine is used for long periods of treatment, do not know the relevance of these symptoms in the clinical use of tablets PYLORID. There have been occasional reports of hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, is usually reversible. Have been reported rare cases of agranulocytosis or pancytopenia, sometimes with hypoplasia or aplasia of the bone marrow. As with other antagonists of H2-receptor, there have been rare reports of bradycardia and blocking The V. a very small number of patients reported dizziness. Have been reported rare cases of mental confusion, reversible, depression and hallucinations, predominantly in elderly patients and severely ill. Have been reported rare cases of erythema multiforme. Symptoms musculoskeletal as arthralgia and myalgia have been rarely reported. There were a few reports of symptoms of breast in men making use of ranitidine.
what to do if someone use a larger amount than is recommended?
the administration of The citrate bismuth ranitidine in the animal studies at very high doses has been associated with nephrotoxicity. In cases of overdose, are given to gastric lavage and supportive therapy as appropriate. Ranitidine and bismuth must be removed from the plasma by hemodialysis.
Each tablet contains: Citrate bismuth ranitidine 400 mg; Excipient (sodium carbonate anhydrous, microcrystalline cellulose, polyvidone and magnesium stearate q. s. p. 1 pill.
PYLORID is presented in the form of tablets, containing 400 mg of citrate bismuth ranitidine, packaged in blister packs and packaged in cartridges containing 28 tablets.
Sale under medical prescription.
Citrate bismuth ranitidine
to Protect the product from moisture and heat. The validity of the product appears registered in the cartridge, together with the n batch and date of manufacture. Term of validity: 24 months. Do not use the product with the expired. The time of treatment should be determined by your doctor. If you are pregnant or want to become pregnant during treatment, please report this immediately to your doctor. The treatment should not be stopped without the doctor’s order, unless it appears tolguma unpleasant reaction related to it. Inform the doctor the appearance of reactions unpleasant such as: hives, skin rash, diarrhea, abdominal discomfort, headache and dizziness.
All medicine should be kept out of the reach of children.
do Not take medicine without the knowledge of your doctor. It can be dangerous to your health.
Mechanism of Action
The citrate bismuth ranitidine inhibits secretion of basal and stimulated gastric acid, reducing both the volume and the content of acid and pepsin secretion; it has bactericidal action against Helicobacter pylori in vitro and have protective actions on the mucous membrane.
This product is a new drug, and while surveys carried out have indicated the efficacy and safety when properly indicated, can occur adverse reactions unpredictable, not yet described or known. in the case of a suspected adverse reaction, the doctor should be notified.
Interaction With Other Medications and Food
The absorption of ranitidine from the tablets PYLORID is increased when there is concomitant administration of clarithromycin. The exposure increased the ranitidine is not medically worrying, because of the wide therapeutic index of ranitidine. The levels of clarithromycin are not altered with the administration of the citrate bismuth ranitidine. The food causes a decrease in the absorption of bismuth that has no clinical significance. Tablets PYLORID can be administered with or without food. The absorption of bismuth from the tablets PYLORID is not affected by the concomitant administration of antacids.
GlaxoSmithKline Brazil Lda.
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