Chewable Bismuth s with Calcium Carbonate

Chewable Bismuth s with Calcium Carbonate Uses, Dosage, Side Effects, Food Interaction and all others data.

Antacid action: Peptocid coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, producing bismuth oxychloride and salicylic acid. Thus it reduces HCl.

Anti-diarrheal action: Bismuth Subsalicylate stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli and disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.

Anti-inflammatory action: Salicylic acid from hydrolyzed Bismuth Subsalicylate inhibits prostaglandin G/H synthase. Thus reduces inflammation and coats irritated tissue to retard the expulsion of fluid.

Bismuth subsalicylate is an antacid and antimicrobial, gastroprotective, anti-secretory, and anti-inflammatory actions. It works to reduce the severity and incidence of flatulence and diarrhea, and consequently relieving gastrointestinal discomfort. In one study, bismuth subsalicylate was prevented traveler's diarrhea with a protection rate >60%.

Organobismuth compounds, formed by the breakdown of bismuth subsalicylate in the gastrointestinal tract, inhibit the growth of Helicobacter pylori and other bacteria implicated in gastrointestinal disorders, and some fungi. In one study, bismuth subsalicylate was shown to eradicate up to 90% of H. pylori infection when used as part of a quadruple therapy regimen containing a proton pump inhibitor, tetracycline, and metronidazole. Bismuth subsalicylate exhibited antimicrobial activity against Clostridium difficile, enterotoxigenic Escherichia coli O157:H7, norovirus, and other common enteric pathogens such as Salmonella and Shigella.

Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is:

CaCO3 + 2HCl = CaCl2 + H2O + CO2

Indicated in raised calcium requirement e.g. during pregnancy and lactation, and in children and adolescents at time of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation, latent tetany.

Gastric-peptic disease occurs as a result of an imbalance between protective factors, such as mucus, bicarbonate, and prostaglandin secretion, and aggressive factors, such as hydrochloric acid, pepsin, and Helicobacter pylori (H. pylori). Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion. The acid-neutralizing capacity of calcium carbonate is 58 mEq/15 ml.When used as a nutritional supplement, calcium carbonate acts by directly increasing calcium stores within the body.

Trade Name Chewable Bismuth s with Calcium Carbonate
Generic bismuth subsalicylate + calcium carbonate
Type
Therapeutic Class
Manufacturer
Available Country Canada, United States
Last Updated: September 19, 2023 at 7:00 am
Chewable Bismuth s with Calcium Carbonate
Chewable Bismuth s with Calcium Carbonate

Uses

Peptocid is used for indigestion, gastric fullness, bloating, belching, growling stomach, sour stomach and diarrhea.

Adult: One Calcium Carbonate 500 tablet or as directed by the physician. For the prevention of osteoporosis, 1-3 Calcium Carbonate 500 tablet is recommended generally as a dietary supplement . Doses for children is half of those for adults. A large dose should not be taken without physician\'s advice.

Adolescent: One to two Calcium Carbonate tablet daily.

Children: One Calcium Carbonate tablet daily.

Chewable Bismuth s with Calcium Carbonate is also used to associated treatment for these conditions: Diarrhoea, Dyspepsia, Flatulence, Heartburn, Helicobacter Pylori Infection, Nausea, Traveler's Diarrhea, Upset stomach, Belching, Gastrointestinal fullnessAcid Reflux, Acid indigestion, Bloating, Calcium Deficiency, Calcium Metabolism Disorders, Calcium and Vitamin D Deficiencies, Colic, Dyspepsia, Gastric Ulcer, Gastroesophageal Reflux, Heartburn, Hemorrhoids, Hot Flushes, Hyperacidity, Hyperphosphataemia, Hypovitaminosis D, Low Bone Density, Osteodystrophy, Osteomalacia, Osteoporosis, Postmenopausal Osteoporosis, Postoperative Gas, Proctitis, Vertebral Fractures, Calcium loss, Gastrointestinal ulceration, Dietary supplementation

How Chewable Bismuth s with Calcium Carbonate works

The exact mechanism of bismuth subsalicylate is not fully understood. Bismuth subsalicylate is an insoluble complex that constitutes salicylic acid and trivalent bismuth. Once orally administered, bismuth subsalicylate hydrolyzes in the stomach into bismuth oxychloride, which is minimally absorbed into the bloodstream, and salicylic acid, which is almost completely absorbed. Bismuth interacts with other anions and compounds, such as hydrochloric acid, bicarbonate, phosphate, and hydrogen sulfide, in the gastrointestinal tract to form bismuth salts such as bismuth oxychloride, bismuth subcarbonate, bismuth phosphate, and bismuth sulfide. Bismuth salts possess bactericidal and antimicrobial activity, mainly by preventing bacteria from binding and growing on the mucosal cells of the stomach. It has no effects on normal gut flora. By preventing bacteria from binding to mucosal cells, bismuth subsalicylate prevents intestinal secretion and fluid loss, promotes fluid and electrolyte reabsorption, reduces gastrointestinal inflammation, and promotes the healing of pre-existing ulcer in the stomach. Salicylic acid from dissociated bismuth subsalicylate adds to the anti-inflammatory actions of bismuth salts by inhibiting the cyclooxygenase enzyme and limiting the formation of prostaglandin, a pro-inflammatory mediator. Bismuth subsalicylate exhibits cytoprotective and demulcent activity, which makes it an effective drug in peptic ulcer disease. It blocks the adhesion of H. pylori to the gastric epithelial cells and blocks the bacteria's enzyme activities, including phospholipase, protease, and urease.

Calcium carbonate is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions. It also inhibits the action of pepsin by increasing the pH and via adsorption. Cytoprotective effects may occur through increases in bicarbonate ion (HCO3-) and prostaglandins. Neutralization of hydrochloric acid results in the formation of calcium chloride, carbon dioxide and water. Approximately 90% of calcium chloride is converted to insoluble calcium salts (e.g. calcium carbonate and calcium phosphate).

Dosage

Chewable Bismuth s with Calcium Carbonate dosage

12 years and above: 30 ml at a time.Dose can be repeated after 1-2 hours if necessary. Daily maximum intake should not exceed 8 doses.Less than 12 years: Please contact with physician.

Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation therecommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5 - 9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.

Side Effects

Black stool and black tongue are common with use of Peptocid. Peptocid should not be used if black stool and black tongue are severe or persist for more than 2 days.

In rare cases, flatulence, diarrhoea or constipation.

Toxicity

Lowest Lethal Dose (LDLo) in humans is 700 mg/kg. LD50 in rats is 1200 mg/kg via oral route, 542 mg/kg via intraperitoneal route, and 980 mg/kg via subcutaneous route.

Overdose of bismuth subsalicylate over an extended period of time and consequently, bismuth toxicity, can lead to blackening of the tongue and teeth, fatigue, mood changes, deterioration of mental status, and neurotoxicity. Other signs and symptoms include impaired cognition, tremors, lethargy, somnolence, insomnia, delirium, myoclonus, seizures, depressed mood, anxiety, and a depressed mood. Salicylate toxicity can occur from chronic bismuth subsalicylate use : it mostly occurs from ingestion of more than 150 mg/kg of salicylates (or >6.5 g of aspirin equivalent). As there are no specific antidotes for bismuth salicylate toxicity, overdose should be managed with supportive care, with or without decontamination with activated charcoal. Hemodialysis may be considered in more severe cases and with the presence of altered mental status and metabolic acidosis.

Precaution

Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation, diabetes or gout.For elderly patients suffering from renal insufficiency, caution should be taken.

In the presence of mild hypercalciuria, excretion levels must be carefully monitored and where necessary the dose of calcium carbonate should be reduced or treatment should be stopped. Patients with a history of stone formation should also be recommended to increase their fluid intake. High dosage of vitamin D should be avoided during Calcium therapy unless specifically indicated.

Interaction

There are no known drug interactions and none well documented.

Oral calcium can reduce internal absorption of tetracycline and fluoride prepa-rations and an interval of at least 3 hours should therefore be allowed between ingestion of these medications. Vitamin D increases internal absorption of calcium. The intestinal uptake of calcium may be reduced by concomitant ingestion of certain foods (e.g. spinach, milk and milk products).

Volume of Distribution

There is no information available.

Calcium is rapidly distributed taken up by skeletal tissues following absorption and distribution into extracellular fluids. Bone contains 99% of the body's calcium and the remaining 1% is approximately equally distributed between intracellular and extracellular fluids.

Elimination Route

Following oral administration, bismuth subsalicylate hydrolyzes into bismuth and salicylic acid in the stomach. Salicylic acid is almost completely absorbed in the small intestine and reaches plasma peak levels one to two hours after dosing. In one study involving healthy male subjects, oral administration of 60 mL Pepto-Bismol, a common over-the-counter product of bismuth subsalicylate, equivalent to 1050 mg of bismuth subsalicylate, resulted in the peak plasma concentration of salicylate of 40.1 μg/mL, with a time to peak concentration (Tmax) of 1.8 hours.

Less than 1% of bismuth from bismuth subsalicylate is absorbed from the gastrointestinal tract into the systemic circulation. In one study, oral administration of 787 mg bismuth subsalicylate in the chewable tablet form for two weeks resulted in the mean trough blood bismuth concentration was 5.1 ± 3.1 ng/mL. In another study, the mean trough blood bismuth concentration ranged from five to 32 ng/mL following oral administration of 525 mg bismuth subsalicylate in the liquid suspension form.

Maximal absorption occurs at doses of 500 mg or less taken with food. Oral bioavailability depends on intestinal pH, the presence of food and dosage.

Half Life

The terminal half-life of salicylic acid following a single oral dose of 525 mg bismuth subsalicylate is ranges from two to five hours. Bismuth has an intermediate half-life of 5 to 11 days and a terminal half-life of 21 to 72 days.

Clearance

The renal clearance of bismuth is 50 ± 18 mL/min.

Elimination Route

Following oral administration, salicylate dissociated from bismuth subsalicylate is excreted in the urine. Bismuth is primarily eliminated via urinary and biliary routes.

Excreted mainly in the feces. The majority of renally filtered calcium is reabsorbed in the ascending limb of the loop of Henle and the proximal and distal convoluted tubules. Also secreted by sweat glands.

Pregnancy & Breastfeeding use

There are no adequate data concerning the use of Peptocid in pregnant women. Peptocid should be avoided during pregnancy and lactation.

Pregnant women : Calcium containing drugs are used widely in pregnancy by way of calcium supplement or antacid therapy. No relationship between malformation in general and calcium exposure has been noted.

Lactating mother : There is no contraindication to the use of calcium carbonate in lactating mother.

Contraindication

Hypersensitivity to bismuth, aspirin, other salicylates, Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or Gl bleeding with black or bloody stool, hemophilia, chicken pox or influenza (risk of Reye syndrome); changes in behavior with nausea and vomiting may be early sign of Reye syndrome.

Hypersensitivity to the Calcium Carbonate or any inactive ingredient of the medication. Hypercalcemia (e.g. in hyperparathyroidism, overdosage of vitamin D, demineralizing tumours such as plasmacytomas and bone metastases), severe hypercalcuria, several renal insufficiency.

Special Warning

USE IN CHILDREN: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.

USE IN ELDERLY: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.

Acute Overdose

Bismuth intoxication may be present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbance, skin reactions, discoloration of mucus membranes and renal dysfunction as a result of acute tubular necrosis. Treatments include gastric lavage, purgation and hydration. Overdose of Peptocid may also give symptoms of salicylate intoxication e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Peptocid should be avoided.

Storage Condition

Store in a cool (25 o C) and dry place.Keep out of the reach of children.Shake well before use.

Store in a cool, dry place in controlled room temperature.

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