Cool Joint

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.

Indicated for the treatment of osteoarthritis of knee, hip, spine, and other locations. Also used as dietary supplement

Cool Joint 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 supplementationArthritis, Backache, Joint Pain, Osteoarthritis (OA), Osteoarthritis of the Knee

How Cool Joint 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).

The mechanism of action of glucosamine in joint health is unclear, however there are several possible mechanisms that contribute to its therapeutic effects. Because glucosamine is a precursor for glycosaminoglycans, and glycosaminoglycans are a major component of joint cartilage, glucosamine supplements may help to rebuild cartilage and treat the symptoms of arthritis. Some in vitro studies show evidence that glucosamine reduces inflammation via inhibition of interferon gamma and Nuclear factor kappa B subunit 65 (NF-κB p65), improving the symptoms of arthritis and joint pain. Clinical relevance is unknown at this time.

Dosage

Cool Joint 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.

500 mg tablet three times daily or as directed by the physician. A single dose of 1500 mg daily may also be effective. Obese individuals may need higher doses, based on body weight.

Side Effects

In rare cases, flatulence, diarrhoea or constipation.

Safety studies with Glucosamine show no demonstrable toxicity. Rarely occurring side effects like mild & reversible intestinal flatulence are almost like placebo.

Toxicity

The oral LD50 of glucosamine in rats is >5000 mg/kg. Symptoms of an overdose with glucosamine may include nausea, vomiting, abdominal pain, and diarrhea (common side effects of this drug). Severe and life-threatening hypersensitivity reactions to glucosamine may occur in patients with a shellfish allergy or asthma.

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.

Diabetics are advised to monitor blood glucose levels regularly while taking Glucosamine. No special studies were formed in patients with renal and/or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitations for these patients. However, administration to these patients with severe hepatic or renal insufficiency should be under appropriate medical supervision.

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).

There have been no reports of significant drug interactions ofGlucosamine with antibiotics, antidepressants, antihypertensives, nitrates, antiarrhythmics, anxiolytic, hypoglycaemic agents, anti-secretives.

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.

Results of a pharmacokinetic study of 12 healthy volunteers receiving three daily consecutive oral administrations of glucosamine sulfate soluble powder demonstrated glucosamine distribution to extravascular compartments. Human pharmacokinetic data for glucosamine is limited in the literature, however, a large animal model study of horses revealed a mean apparent volume of distribution of 15.4 L/kg. Concentrations of glucosamine ranged from 9-15 microM after an intravenous dose, and 0.3-0.7 microM after nasogastric dosing. These concentrations remained in the range of 0.1-0.7 microM in the majority of horses 12 hours after dosing, suggesting effectiveness of a once-daily dose. In rats and dogs, radioactivity from a C-14 labeled dose of glucosamine is detected in the liver, kidneys, articular cartilage, and other areas.

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.

In a pharmacokinetic study, glucosamine was 88.7% absorption by the gastrointestinal tract. Absolute oral bioavailability was 44%, likely due to the hepatic first-pass effect. In a pharmacokinetic study of 12 healthy adults receiving oral crystalline glucosamine, plasma levels increased up to 30 times the baseline levels and Cmax was 10 microM with a 1,500 mg once-daily dose. Tmax was about 3 hours. AUC was 20,216 ± 5021 after a 15,000 mg dose.

Half Life

The estimated half-life for glucosamine is 15 hours after an oral dose. After a bolus intravenous injection of 1005 mg crystalline glucosamine sulfate, the parent drug has an apparent half life of 1.11 hours.

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.

Fecal excretion of glucosamine in a pharmacokinetic study was 11.3% within 120 hours after administration. Urinary elimination was found to be 1.19% within the first 8 hours post-administration.

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.

Women who are pregnant or who could become pregnant should not supplement with glucosamine. Glucosamine has not been studied enough to determine their effects on a developing fetus. And no studies have evaluated the use of Glucosamine during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.

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 contraindications for Glucosamine. But proven hypersensitivity to Glucosamine is a contraindication.

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.

Should be stored in cool and dry place.

Innovators Monograph

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