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Product Name
:
PYLOTAC
Chemical Name
:
Ranitidine Bismutrex
Therapeutic Category
:
Gastro-intestinal drugs
Pharmacologic Category
:
Histamine H2 Antagonist
Pharmaceutical Form
:
Tablets
Composition
:
Ranitidine Bismutrex 400mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Eradication of H. pylori Infection in Patients With an Active Duodenal Ulcer: The recommended dosage of PYLOTAC(ranitidine bismuth citrate) is 400 mg b.i.d. for 4 weeks (28 days) in conjunction with clarithromycin 500 mg b.i.d. t.i.d. for the first 2 weeks (14 days). PYLOTAC(ranitidine bismuth citrate) and clarithromycin can be taken with or without food.

Dosing: Geriatric

No dosage adjustment is necessary in elderly patients.

Dosing: Renal Impairment
Because the principal route of excretion is renal, care should be exercised when administering this combination therapy to renally impaired patients. This combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min.
Use
 
PYLOTAC(ranitidine bismuth citrate) in combination with clarithromycin is indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Most patients not eradicated of H. pylori following PYLOTAC(ranitidine bismuth citrate) plus clarithromycin treatment will have clarithromycin resistant H. pylori isolates. Therefore, for those patients who fail therapy, clarithromycin susceptibility testing should be done when possible. Patients with clarithromycin resistant H. pylori should not be treated with PYLOTAC(ranitidine bismuth citrate) plus clarithromycin or with regimens which include clarithromycin as the sole antimicrobial agent.
The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.
Adverse Reactions
 
Stop taking ranitidine bismuth citrate if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take ranitidine bismuth citrate and talk to your doctor if you experience
•    changes in taste;
•    headache or dizziness;
•    diarrhea, nausea, or constipation; or
•    tremor (shaking).
Contraindications
 
PYLOTAC(ranitidine bismuth citrate) is contraindicated in patients known to have hypersensitivity to ranitidine bismuth citrate or any of its ingredients.
Warnings / Precautions Drug
 
General
The bismuth derived from PYLOTAC(ranitidine bismuth citrate) may cause a temporary and harmless darkening of the tongue and/or stool. Stool darkening should not be confused with melena (blood in the stool).
PYLOTAC(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. \
Interactions
 
Coadministration of PYLOTAC(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. Coadministration 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 PYLOTAC(ranitidine bismuth citrate) . These effects are clinically insignificant.
Pregnancy
 
C
Lactation
 
It is not known whether ranitidine bismuth citrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ranitidine bismuth citrate is administered to a nursing woman. It is known that both ranitidine and bismuth are excreted in rat milk. 
Mechanism of Action
 
Competitive inhibition of histamine at H2-receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume, and hydrogen ion concentration are reduced. Does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin
Pharmacodynamics / Kinetics
 
Absorption: Oral: 50%
Distribution: Normal renal function: Vd: ~1.4 L/kg; Clcr 25-35 mL/minute: 1.76 L/kg minimally penetrates the blood-brain barrier
Protein binding: 15%
Metabolism: Hepatic to N-oxide, S-oxide, and N-desmethyl metabolites
Bioavailability: Oral: 48% to 50%; I.M.: 90% to 100%
Half-life elimination:
Oral: Normal renal function: 2.5-3 hours; Clcr 25-35 mL/minute: 4.8 hours
I.V.: Normal renal function: 2-2.5 hours
Time to peak, serum: Oral: 2-3 hours; I.M.: ≤15 minutes
Excretion: Urine: Oral: 30%, I.V.: 70% (as unchanged drug); feces (as metabolites)
 
   
 
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