the package insert of the medicine Ranidin. Therapeutic class of the H2 Antagonists. Active ingredientsRanitidine. Sale under medical prescription.
RANIDIN is indicated for the treatment of duodenal ulcer, benign gastric ulcer, ulcer, post-operative, esophagitis reflux, Zollinger-Ellison syndrome, dyspepsia episodic, characterised by pain (epigastric or central chest), which is related to meals or during sleep, but not associated with the preceding conditions. As also in the following conditions where it is desirable for the reduction of gastric secretion and the production of acid: prophylaxis of gastrointestinal haemorrhage consequent ulcer from stress in patients, severely sick, the prevention of recurrent bleeding in patients with ulcers, bleeding, and in prevention of the syndrome of aspiration of acid (Syndrome of Mendelson).
RANIDIN has been used in patients undergoing renal transplant.
When should I not use?
The use of RANIDIN is contraindicated in patients with hypersensitivity to Ranitidine.
How to use?
– coated Tablets:
The usual dose is 150 mg, twice a day, morning and night. Alternatively, patients with duodenal ulcer or gastric can be treated with 1 pill 300 mg at night at bedtime. It is not necessary to correlate the dose with the time of meals. In the majority of cases of duodenal ulcer, benign gastric ulcer, and ulcer, post-operative, healing occurs in 4 weeks. In those patients in which the ulcer does not heal completely during this period, an extension of the therapy for 4 more weeks, will usually cause this to occur. It is recommended if maintenance treatment with a dose reduced by 1 tablet of 150 mg at bedtime, for patients whose ulcers responded well to therapy in the short term, particularly those with a history of ulcer recurring. In the control of esophagitis reflux, the recommended dosing schedule is 150 mg, twice a day, or 1 tablet of 300 mg at night at bedtime, for up to 8 weeks. In patients with Zollinger-Ellison syndrome, the initial dose is
150 mg, three times a day, and may the same be increased when required. Patients with this syndrome had received doses increasing up to 6 grams per day, which were well tolerated. For patients with dyspepsia episodic chronic, the treatment recommended is 1 tablet of 150 mg two times a day, up to 6 weeks. Any patient who does not respond to therapy or relapse at this time, should be investigated. In patients with possibility of developing the syndrome of aspiration of acid, can be administered at a dose of 150 mg two hours before induction of anaesthesia and preferably also a 150 mg the previous evening.
In patients obstetric care, at the beginning of labour, can be administered a dose of 150 mg followed by 150 mg every 6 hours. As the gastric emptying and absorption of medicines are delayed during labour, in a situation of general anesthesia, emergency, in addition to the RANIDIN it is recommended to administer an antacid that does not form particles (for example, sodium citrate), before the induction of anesthesia. Should be taken also precautions usual to prevent aspiration of acid.
Slow intravenous (for 2 minutes): 50 mg (1 vial), diluted to a volume of 10 ml (see compatibility), every 6-8 hours.
intravenous Infusion: the reason of 25 mg for 1 or 2 hours, and as needed, be repeated at intervals of 6-8 hours.
intramuscular Injection of 50 mg (1 ampoule every 6-8 hours)
Parenteral solutions compatible: sodium Chloride 0,9%, glucose 5%, sodium bicarbonate 4.2% solution and Hartmann.
The dilute solutions of Ranidin not used within 24 hours should be discarded.
For the prevention of bleeding, in the case of ulcer of stress in severely ill patients or for prophylaxis of bleeding in patients with peptic ulcer, you should persist with the parenteral administration until it is possible to oral feeding, to continue, if necessary, with the medicine orally.
In patients prone to developing syndrome of aspiration of acid, advises the administration of 1 ampule (50mg) by intramuscular or slow intravenous, 40 to 60 minutes before the induction of anesthesia.
Warnings and Precautions
what should I know before using?
General: The treatment with H2 antagonists of histamine may mask symptoms associated with carcinoma of the stomach and, therefore, delay diagnosis of the disease. Consequently, when there is a suspicion of gastric ulcer, the possibility of malignancy should be excluded before it can be instituted therapy with RANIDIN. Ranitidine is excreted via the kidney, therefore plasma levels of the drug are increased in patients with severe renal impairment, therefore, it is recommended that the dosage of RANIDIN in such patients be 150 mg at night, for four to eight weeks.
The same dose should be used for maintenance treatment, when it deems it necessary. If the ulcer has not healed after treatment, the dose standard of 150 mg twice daily should be instituted, followed, if need be, by maintenance treatment of 150 mg at night.
The therapeutic doses administered to patients obstetric care in labor, or who would undergo cesarean section, have not exhibited any adverse effect during the work of delivery or subsequent neonatal period.
Pregnancy: studies in animals have not shown any effect teratogenic, but one should evaluate the benefit in relation to the potential risk to the fetus.
Breastfeeding: due to the passage of Ranidin for the breast milk, its use in infants can cause turmoil in the newly born, it being necessary to exchange the medicine or to stop breastfeeding during the treatment, so the risk/benefit should be evaluated.
Pediatrics: The safety and efficacy of the use of the product in children have not been established.
what to do if someone use a larger amount than is recommended?
RANIDIN and have very specific and for that reason not expected to occur particular problems after overdosage with the product.
Should be administered the adequate symptomatic therapy and support. If necessary, the drug should be removed from the plasma by hemodialysis.
This product is a new drug. Although the research carried out have shown efficiency 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.