Famcet Da

Uses

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.

Famotidine is used for-

• Short term treatment of active duodenal ulcer and benign gastric ulcer
• Maintenance therapy for prevention of relapses of duodenal ulceration
• Gastro-oesophageal reflux disease
• Zollinger Ellison Syndrome

Famcet Da is also used to associated treatment for these conditions: Acid 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 supplementationChronic Back Pain, Duodenal Ulcer, Erosive Esophagitis, Extra-Articular Rheumatism, Gastritis, Heartburn, Helicobacter Pylori Infection, Multiple Endocrine Neoplasia, Muscle Spasms, Nonspecific Pain Post Traumatic Injury, Osteoarthritis (OA), Postoperative pain, Stress Ulcers, Zollinger-Ellison Syndrome, Active Gastric ulcer, Acute Duodenal Ulcers, Gastrointestinal ulceration, Pathological hypersecretory conditions, Symptomatic non-erosive gastroesphageal reflux disease

How Famcet Da works

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).

Histamine acts as a local hormone that stimulates the acid output by parietal cells via a paracrine mechanism. Neuroendocrine cells called enterochromaffin-like (ECL) cells lie close to the parietal cells and regulate the basal secretion of histamine. Histamine release is also promoted from stimulation by acetylcholine and gastrin, a peptide hormone. Gastrin (G) cells release gastrin, which works on CCK₂ receptors on ECL cells. This action promotes the release of histamine from ECL cells. Upon release, histamine acts on H₂ receptors expressed on the basolateral membrane of parietal cells, leading to increased intracellular cAMP levels and activated proton pumps on parietal cells. Proton pump releases more protons into the stomach, thereby increasing the secretion of acid. In conditions that are associated with acid hypersecretion such as ulcers, there is a loss of regulation of acid secretion. Famotidine works on H₂ receptors and blocks the actions of histamine.

Dosage

Famcet Da dosage

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.

Duodenal ulcer: 40 mg at night for 4 to 8 weeks

Benign gastric ulcer: 40 mg at night for 4 to 8 weeks; Maintenance therapy: 20 mg at night for preventing the recurrences of duodenal ulceration

Gastro-oesophageal reflux disease: 20 mg twice daily for 6 to 12 weeks

Zollinger Ellison syndrome: The recommended starting dose is 20 mg every six hours. Dosage should then be adjusted to individual response. Doses up to 160 mg every six hours have been administered to some patients without the development of significant adverse effects.

Dosage can be administered irrespective of meals. Antacids may be given concomitantly if needed.

Side Effects

In rare cases, flatulence, diarrhoea or constipation.

Famotidine is generally well tolerated and side effects are uncommon. Dizziness, headache, constipation and diarrhoea have been reported rarely. Other side effects reported less frequently include dry mouth, nausea and/or vomiting, rash, abdominal discomfort, anorexia and fatigue.

Toxicity

The oral LD₅₀ is 4049 mg/kg in rats and 4686 mg/kg in mice. The subcutaneous LD₅₀ is 800 mg/kg in rats and mice. The lowest published toxic dose (TDLo) in man following oral administration is 4 mg/kg/7D.

Symptoms of overdose resemble the adverse events seen with the use of recommended doses, and they should be responded with supportive and symptomatic treatment. Any unabsorbed drug should be removed from the gastrointestinal tract, and the patient should be monitored accordingly. The use of hemodialysis to eliminate the drug from the systemic circulation is effective, but the experience of using hemodialysis in response to famotidine overdose is limited in clinical settings.

Precaution

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.

Dosage reduction should be considered or interval between doses should be prolonged if creatinine clearance falls to or below 30 ml/min.

Interaction

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).

Famotidine does not interact with the cytochrome P450 linked drug metabolising enzyme system. So, no interactions have been found in man with Warfarin, Theophylline, Phenytoin, Diazepam, Propranolol, Aminopyrine or antipyrine.

Volume of Distribution

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.

The steady-state volume of distribution ranges from 1.0 to 1.3 L/kg. Famotidine is found in breast milk; however, it is found in breast milk at the lowest concentrations compared to other H₂ receptor antagonists.

Elimination Route

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.

Following oral administration, the absorption of famotidine is dose-dependent and incomplete. The oral bioavailability ranges from 40-50%, and the Cmax is reached in 1-4 hours post-dosing. While the bioavailability can be slightly increased with the intake of food and decreased by antacids, there is no clinical significance.

Half Life

The elimination half-life is about 2 to 4 hours. The half-life is expected to increase nonlinearly in patients with decreased renal function.

Clearance

Renal clearance is 250-450 mL/min, indicating some tubular excretion. Because the renal clearance rate exceeds the glomerular filtration rate, famotidine is thought to be mainly eliminated via both glomerular filtration and renal tubular secretion.

Elimination Route

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.

About 65-70% of the total administered dose of famotidine undergoes renal elimination, and 30-35% of the dose is cleared by metabolism. Following intravenous administration, about 70% of the drug is eliminated in the urine as an unchanged drug.

Pregnancy & Breastfeeding use

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.

Pregnancy: There are no adequate, well controlled studies on Famotidine in pregnancy, but it is known to cross the placenta and should be prescribed only if clearly needed.

Lactation: It is not known whether Famotidine is secreted into human milk, nursing mothers should either stop nursing or stop taking the drug.

Contraindication

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.

There are no known contraindication to Famotidine. If any evidence of hypersensitivity appear, the therapy should be discontinued and consultation with physician is required.

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.

Storage Condition

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

Tablet: Store between 15-30° C. Concentrate for injection: Store between 2-8° C.

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