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FDA Facts About Generics

A generic drug is the same as a brand-name drug in: dosage, safety, strength, quality, the way it works, the way it is taken, the way it should be used US FDA Office

Zantac

Drug Name: Generic Zantac (ranitidine ( zantac ) ® equivalent)

"Zantac" is used to treat duodenal ulcer. Histamine is a natural chemical that stimulates the stomach cells to produce acid. ranitidine ( zantac )  or ZANTAC belongs to a class of medications called H2-blockers, that block the action of histamine on stomach cells, thus reducing stomach acid production.

Drug Uses:
ranitidine ( zantac )  blocks the action of histamine on stomach cells, and reduces stomach acid production. ranitidine ( zantac )  is useful in promoting healing of stomach and duodenal ulcers, and in reducing ulcer pain. ranitidine ( zantac )  has been effective in preventing ulcer recurrence when given in low doses for prolonged periods of time. In doses higher than that used in ulcer treatment, ranitidine ( zantac )  has been helpful in treating heartburn and in healing ulcer and inflammation of the esophagus resulting from acid reflux (reflux esophagitis).

Drug Class Mechanism:
Zantac belongs to a class of medications called H2-blockers, that block the action of histamine on stomach cells, thus reducing stomach acid production.

Notes:
Treatment of duodenal ulcer and benign gastric ulcers, including ulcers caused by NSAIDs. Prevention of ulcers in patients using NSAIDs (including aspirin) and particularly in patients with a history of ulcer disease. Ulcer surgery. Reflux esophagitis. Zollinger-Ellison syndrome. Chronic episodic dyspepsia, characterized by pain (epigastric or retrosternal) which is related to diet or appear overnight but is not associated with earlier disease. Stress ulcer prophylaxis in severe disease. Bleeding recurrence after peptic ulcer prophylaxis. Mendelsohn syndrome prophylaxis.

Mode of action:
Zantac is a specific antagonist and histamine receptor type fast H2. Zantac inhibits basal and stimulated secretion of gastric acid, reducing the acid content and pepsin content of gastric secretion. Zantac has a relatively long duration of action and only a single 150 mg dose effectively suppresses gastric acid secretion for 12 hours.

Method of administration, dose:
Zantac effervescent tablets will be placed in a glass with at least 75 ml of water and will be mixed until completely dissolved. Be given only after complete dissolution. For doses of 300 mg is required a minimum volume of 150 ml of water. Effervescent forms contain aspartame.

Adults:

Duodenal ulcer and benign gastric ulcer:

Acute treatment: standard dosage for duodenal ulcer or benign gastric at 150 mg twice daily or 300 mg in the evening. In most cases of duodenal ulcer or benign gastric ulcer healing occurs within 4 weeks of treatment. Healing usually occurs after 4 weeks of treatment in those who were not healed after the first 4 weeks of treatment. In duodenal ulcer (DU) 300 mg twice daily for 4 weeks results in a higher proportion of healing than 150 mg twice daily or 300 mg at night in 4 weeks. Increasing the dose is not associated with increased unwanted effects.

Long-term: For long-term treatment of duodenal ulcer and benign gastric ulcers, the usual dose is 150 mg in the evening. Smoking is associated with an increased frequency of duodenal ulcer relapse and that these patients should be warned. Those who fail to follow this advice (warning) are recommended a dose of 300 mg in the evening, which would bring a benefit greater than 150 mg in the evening.

NSAID (NSAIDs) associated with peptic ulcer disease:

Acute Treatment: The ulcers occurred after treatment with NSAIDs or associated with continuous NSAID therapy are needed 8-12 weeks of treatment with 150 mg twice daily or 300 mg in the evening.

Prevention: Prevention of duodenal ulcers associated with NSAID treatment can be done with ranitidine ( zantac )  150 mg twice a day, which can be co-administered with NSAIDs.

Ulcer surgery: postoperative ulcers standard dosage is 150 mg twice a day. Most cases heal within four weeks. The incompletely healed may continue treatment 4 weeks for complete healing.

Reflux esophagitis (RE):

Acute Treatment: In ER 150 mg twice daily or 300 mg at night for a period of 8 weeks or as necessary to 12 weeks.

Long-term: For long-term treatment is recommended for adult ER 150 mg twice a day.

Zollinger: Ellison (Sze) Sze initial treatment starts with 150mg three times daily, but can be increased if necessary. Doses above 6 g / day are well tolerated.

Chronic episodic dyspepsia (DCE) for patients with DCE sandard dosage is 150 mg twice daily for at least 6 weeks. Patients not responding to this treatment or relapse occurs shortly after treatment should be investigated.

Prophylaxis of bleeding due to stress ulcers in patients with severe or recurrent bleeding prophylaxis in patients with bleeding due to ulcer disease: 150 mg twice a day can replace parenteral therapy once oral feeding is resumed.

Mendelsohn Syndrome Prevention (MS): 150 mg two hours before anesthesia and 150 mg preferably the night before. Alternatively you can use and parenteral. In obstetrics, during labor is recommended 150 mg every 6 hours, but if general anesthesia is required the combination with an antacid such as sodium citrate.

Children: The recommended oral dose in children tratementul ulcer disease is between 2 and 4 mg / kg twice daily to a maximum dose of 300 mg ranitidine ( zantac )  per day.

Renal insufficiency: Accumulation of ranitidine ( zantac )  with resulting elevated plasma concentrations can occur in patients with severe renal impairment (creatinine clearance below 50 ml / min), the recommended daily dose of 150 mg of Zantac. In patients on chronic hemodialysis or peritoneal dialysis, ranitidine ( zantac )  (150 mg) should be administered immediately after dialysis.

Contraindications:
Zantac is contraindicated in patients with known hypersensitivity.

Cautions:

Malignancy:
Possibility of malignant gastric diseases must be excluded before initiating therapy in patients with gastric ulcer (and if indications include dyspepsia, middle-aged patients with new or recent changes in symptoms) as treatment with ranitidine ( zantac )  may mask symptoms of gastric carcinoma.

Pregnancy and lactation:
ranitidine ( zantac )  crosses the placenta and is excreted in breast milk. Like other drugs should be used during pregnancy and lactation only if deemed necessary.

Renal disease:
ranitidine ( zantac )  is excreted via the kidneys and so plasma levels of drugs is increased in patients with renal impairment. Doses should be adjusted in accordance with paragraph "Dosage in renal impairment." Monitoring is recommended in patients who were administered NSAIDs (NSAIDs) and Zantac especially in elderly patients or those with a history of ulcer disease. Zantac effervescent tablets and granules contain sodium. The administration must be carefully controlled sodium diet. Zantac effervescent tablets and granules contain aspartame and should be used with caution in patients with phenylketonuria. The few reported cases suggest the possibility of triggering acute porphyria crises. ranitidine ( zantac )  should be avoided in patients with acute porphyria in history.


Side effects:
Side effects have been reported, the following side effects during clinical trials or routine therapy of patients with ranitidine ( zantac ) . In many cases could not be established a link between therapy and the occurrence of these side effects ranitidine ( zantac ) . For transient and reversible changes appearance of liver function tests. Occasionally there were reported cases of hepatitis (hepatocellular, hepatocanaliculară or mixed) with or without jaundice. Most were reversible. Have been reported rare cases of acute pancreatitis. Changes in blood picture (leukopenia, thrombocytopenia) were reported in a few patients, most reversible. Rare cases of pancytopenia granulocitoză and sometimes associated with bone marrow hypoplasia or aplasia have been reported. Hypersensitivity reactions (urticaria, angioedema, fever, bronchospasm, hypotension, anaphylactic shock, chest pain) were rarely the result of oral or parenteral ranitidine ( zantac ) . These reactions have occurred occasionally after a single dose. As with other H2 receptor antagonists have been reported in rare cases of bradycardia and block atriovetricular. Headache, sometimes severe and dizziness were reported in very few cases. Rare cases of mental confusion, depression and hallucinations have been reported predominantly reversible in elderly patients with severe disease. There have been few reports of visual disturbances, especially to accommodate changes. Rash have been reported, including rare cases of erythema multiforme. There have been reports of arthralgia and myalgia rare cases. No disturbances were reported in clinical endocrine and sexual functions. It was reported in very few cases the appearance of symptoms in the mammary glands in men who took ranitidine ( zantac ) .

Overdose:  

Ranitidine ( zantac )  has a very specific action or a particular problem may not arise from an overdose of ranitidine ( zantac )  tablets. If effervescent forms of clinically should be considered sodium content. Overdose should be initiated in symptomatic and supportive therapy. If necessary the product may be removed from plasma by hemodialysis.

Pharmaceutical Precautions: Zantac capsules should be stored below 25 degrees Celsius.

Drug Interactions: Zantac, the blood concentaţia reached after the recommended dosage does not inhibit hepatic cytochrome P4 50. Therefore, ranitidine ( zantac )  at therapeutic doses does not potentiate the action of drugs, which are inactivated by these enzymes, which include diazepam, lignocaine, fentoină,, propranolol theophylline and warfarin.

Pharmacokinetics:  

The bioavailability of ranitidine ( zantac )  is about 50%. Maximum plasma concentration is around 300-550 ng / ml and occurs 2-3 hours after an oral dose of 150 mg. When administered at high doses (2 g) of sucralfate, ranitidine ( zantac )  absorption may be reduced. This effect is not observed when sucralfate is administered after an interval of two hours. ranitidine ( zantac )  is not extensively metabolized. Elimination of the drug is predominantly by tubular secretion. The half-life is 2-3 hours. In comparative studies with 150 mg ranitidine ( zantac )  marked with tritium, 93% of intravenous dose was excreted in urine and 5% in faeces, 60-70% of an oral dose was excreted in urine and 26% in faeces. Analysis of urine excreted within 24 hours after administration indicates that 70% of intravenous dose and 35% of the orally administered dose was excreted unchanged. Metabolism ranitidine ( zantac )  is similar after oral and parenteral, about 6% of the dose was excreted in urine as N-oxide, 2% as S oxide, 2% and 1-2% as desmetilranitidină as furoic acid analogue.

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