Ranitidine bismuth citrate has been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections.

Mucosal penetration and absorption of bismuth are not affected by the degree of gastritis, the presence of Helicobacter Pylori, or an active ulcer.

 

Following ingestion, Ranitidine Bismuth Citrate dissociates in intragastric fluid, giving rise to ranitidine and soluble and insoluble forms of bismuth.

Absorption: Following a single oral 400 mg dose to healthy volunteers, mean (±SD) peak ranitidine plasma concentration of 455 (±145.3) ng/ml occurred at 0.5 to 5 hours. The rate and extent of absorption of ranitidine increased proportionally with increasing doses up to 1600 mg. Ranitidine plasma concentrations showed no evidence of accumulation during a 28 day dosing period.

Oral absorption of bismuth is variable. A mean (±SD) peak bismuth plasma concentration of 3.3 (±2.0) ng/ml occurs at 15 to 60 minutes after a 400 mg dose. The rate and extent of absorption of bismuth do not increase with increasing doses up to 800 mg. The rate of absorption of bismuth derived from an 800 mg dose is decreased by 50%, and the extent of absorption is decreased by 25% when taken 30 minutes after a meal as compared to 30 minutes before a meal. The absorption of bismuth from an 800 mg dose increased when gastric pH exceeded 6. The increased pH resulted from the administration of an 800 mg dose given 3 hours previously.

Excretion: The elimination half-life of ranitidine derived from Ranitidine Bismuth Citrate is 2.8 to 3.1 hours. The principal route of elimination for ranitidine is renal, accounting for 30% of the dose.

The terminal elimination half-life of bismuth is 11 to 28 days. Less than 1% of bismuth derived from Ranitidine Bismuth Citrate is recovered in urine after oral administration. Up to 28% of bismuth was recovered in the feces during a 6-day postdose period. Bismuth also undergoes minor excretion in the bile.

 

PYLOTAC is indicated for:

- The prevention of relapse of peptic ulcer disease when administered in co-prescription with appropriate antibiotics.

- Treatment of duodenal ulcer and benign gastric ulcer.

 

Ranitidine Bismuth Citrate is contraindicated in patients known to have hypersensitivity to ranitidine bismuth citrate or any of its ingredients.

 

The bismuth derived from Ranitidine Bismuth Citrate may cause a temporary and harmless darkening of the tongue and/or stool.

Ranitidine Bismuth Citrate in combination with clarithromycin should not be used in patients with a history of acute porphyria.

This combination therapy is not recommended in patients with creatinine clearance less than 25 ml/min.

Pregnancy and lactation: It is not recommended during pregnancy and lactation

 

- Coadministration of Ranitidine Bismuth Citrate with clarithromycin resulted in increased plasma ranitidine concentrations (57%), increased plasma bismuth trough concentrations (48%), and increased 14-hydroxy-clarithromycin plasma concentrations (31%).

- Coadministration with aspirin results in a slight decrease in the rate of salicylate absorption that is clinically unimportant.

- Coadministrations with a high dose of antacid (170 mEq) results in a 28% decrease in plasma concentrations of ranitidine and may decrease plasma concentrations of bismuth from Ranitidine Bismuth Citrate. These effects are clinically insignificant.

 

It may rarely cause:

Gastrointestinal: Abdominal discomfort, gastric pain.

Hepatic: Transient changes in the liver enzymes SGPT and SGOT.

Hypersensitivity: There have been rare reports of hypersensitivity reactions, including skin rash and anaphylaxis.

 

PYLOTAC should be taken twice daily (morning and evening), preferably with food.

The following dosage regimens have been shown to be clinically effective.

A) 7-Days triple regimens:

The recommended dose of PYLOTAC is 400 mg twice daily taken orally with antibiotics as below:

B) Alternatively, 14-days dual therapy regimen may be given as follows:

If symptoms recur and the patient is H.Pylori positive, a further course of Pylotac together with an alternative antibiotic regimen may be considered.

To facilitate ulcer healing, therapy with Pylotac 400 mg twice daily may be continued 28 days.

Duodenal Ulcer: Pylotac 400 mg twice daily for 4 weeks. Treatment may be extended for a further 4 weeks.

Benign Gastric Ulcer: Pylotac 400 mg twice daily for 8 weeks.

 

PYLOTAC - Film Coated Tablets: A Pack of 20 Film Coated Tablets. Each F.C. Tablet contains 400 mg of Ranitidine Bismutrex.

 

Store PYLOTAC - Film Coated Tablets at temperature below 30°C in a dry place. Protect from light.