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This is indicated in-

• Increased demand for Calcium and Vitamin-C, e.g. pregnancy, lactation, periods of rapid growth (childhood, adolescence), in old age
• During infectious disease and convalescence
• Treatment of calcium and vitamin-C deficiency
• Osteoporosis
• Premenstrual syndrome
• Postmenopausal problems
• Adjuvant in colds and influenza.

Specific mineral & vitamin combined preparations

Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.

Vitamin-C is an essential component of the diet as man can not synthesize vitamin-C. It is a very powerful reducing agent. Vitamin-C plays an important part in the response of the body to stress. It is important in the defense against infection.

Adults and children above 7 years: 1 effervescent tablet daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants: As prescribed by the physician

Dissolve one tablet in half glass (100 ml) of water.

In rare cases, mild gastrointestinal disturbances (bloating, diarrhoea) can occur. In predisposed patients prolonged treatment with high doses may promote the formation of calculi in the urinary tract.

Hypercalcemia (e.g. in hyperparathyroidism, vitamin-D overdosage, decalcifying tumors such as plasmocytoma, bone metastases); severe hypercalciuria; severe renal failure.

Patients with hyperoxalauria, glucose-6- phosphate dehydrogenase deficiency, or iron overload. Larger doses may lead to gastrointestinal tract upset.

For patients with mild hypercalciuria (exceeding 300 mg = 7.5 mmol/24 hours), with mild or moderate impairment of renal function or with a history of urinary concrements, monitoring of calcium excretion in the urine is required. If necessary, the dosage should be reduced or therapy should be discontinued. High doses of vitamin-D and derivatives should be avoided during treatment with this preparation unless especially indicated.

Since citrate salts have been reported to increase aluminium absorption, this medicine  should be used with caution in patients with severely impaired renal function, especially those receiving aluminium-containing preparations. The sugar content should be taken into account by diabetic patients.

Calcium Gluconate: Co-admin of high calcium doses with thiazide diuretics may result in milk-alkali syndrome and hypercalcaemia. May potentiate digoxin toxicity. Decreases effects of calcium channel blockers. Enhanced absorption with calcitriol (a vitamin D metabolite).

Calcium Carbonate: Co-administration with thiazide diuretics or vit D may lead to milk-alkali syndrome and hypercalcaemia. Decreased absorption with corticosteroids. Decreases absorption of tetracyclines, atenolol, iron, quinolones, alendronate, Na fluoride, Zn and calcium-channel blockers. Enhances cardiac effects of digitalis glycosides and may precipitate digitalis intoxication.

Vitamin C: Deferroxamine, hormonal contraceptives, flufenazine, warfarin, elemental iron, salicylates, warfarin, fluphenazine, disulfiram, mexiletine, vitamin B12.

Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be safely used inlactating women. Vitamin-C may be taken safely during pregnancy and lactation

Acute overdosage has not been reported. It would be expected to cause gastrointestinal disturbances but not to result in hypercalcemia, except in patients treated with a very high dosage of vitamin-D and derivatives.

Store at a cool and dry place and protected from light and moisture.

Specific mineral & vitamin combined preparations

Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.

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).

Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.

Vitamin-C is an essential component of the diet as humans cannot synthesize Vitamin-C. It is a very powerful reducing agent and plays an important part in the response of the body to stress. It is important in the defense against infections.

Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in osteoporosis and fracture prevention.

Adults and children of school age: 1 effervescent tablet daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants: As prescribed by the physician

Dissolve one tablet in half glass (100 ml) of water.

The use of Calcium supplements has rarely given rise to mild gastrointestinal disturbances, such as constipation, flatulence, nausea, gastric pain and diarrhoea. Following administration of Vitamin-D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen in long-term treatment with Vitamin-D at high doses.

Absolute contraindications are hypercalcaemia resulting from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and Vitamin-D overdosage. It is also contraindicated in severe renal failure and hypersensitivity to any of the tablet ingredients.

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma Calcium levels and urinary Calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. In patients with a history of renal stones urinary Calcium excretion should be measured to exclude hypercalciuria. With long-term treatment it is advisable to monitor serum and urinary Calcium levels and kidney function, and reduce or stop treatment temporarily if urinary Calcium exceeds 7.5 mmol/24 hours. Allowances should be made for Calcium and Vitamin-D supplements from other sources.

The risk of hypercalcemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcemia must be avoided in digitalised patients. Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium. Concomitant therapy with phenytoin or barbiturates can decrease the effect of vitamin-D because of metabolic activation. The effect of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with vitamin-D. Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of 4 hours before taking the
calcium.

During pregnancy and lactation treatment with this supplements should always be under the direction of a physician.

During pregnancy and lactation, requirements for calcium and vitamin-D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources.

Overdoses of vitamin-D have shown teratogenic effects in pregnant animals. Vitamin-D and its metabolites pass into the breast milk.

The most serious consequence of acute or chronic overdose is hypercalcaemia due to Vitamin-D toxicity. Symptoms include nausea, vomiting, polyuria, and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intakes of calcium and Vitamin-D and rehydration.

Store at a cool and dry place. Protect from light and moisture. Keep out of reach of children. Keep the container tightly closed.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Minerals in bone formation, Specific mineral preparations

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. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.

250 mg or 500 mg tablet: 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 the recommended 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.

1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.

• Hypercalcaemia and hyperparathyroidism
• Hypercalciuria and nephrolithiasis
• Zollinger-Ellison syndrome
• Concomitant digoxin therapy (requires careful monitoring of serum calcium level)

When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides.

Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.

Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.

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.

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

Specific mineral & vitamin combined preparations

Nutrition is the most important to prevent osteoporosis and other bone related diseases. Calcium, Magnesium & Vitamin D3 are the macronutrients for bone. Without Vitamin D3 very little Calcium is absorbed. Like Calcium, Magnesium increases bone strength and rigidity. Recent epidemiological studies showed that some micronutrients like Copper, Manganese, Zinc & Boron play an important role in bone health. Deficiency of the micronutrients is noticed in patients with osteoporosis.

2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Side effects from micronutrient are rare.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with Calcium, Aluminium or Magnesium containing Antacids & other Calcium supplements, Calcitriol & other Vitamin D3 supplements; Digoxin, Tetracycline, Doxycycline, Minocycline or Oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Bisphosphonate preparations

Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [3H] alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [3H] alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.

Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.

Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is one 35 mg tablet once weekly or one 5 mg tablet once daily.

Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.

Treatment of Glucocorticoid-Induced Osteoporosis: The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone: The recommended treatment regimen is 40 mg once a day for six months.

The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.

Alendronic acid is contraindicated in patients with the following conditions: 

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 30 minutes.
• Do not administer Alendronic acid oral solution to patients at increased risk of aspiration.
• Hypocalcemia.
• Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported.

The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements.

Alendronic acid should not be given to pregnant women or nursing mother.

Pediatric Use: Alendronic acid is not indicated for use in pediatric patients.

Renal Impairment: Alendronic acid is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min.

Hepatic Impairment: As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary.

Store in a well-closed container at room temperature, 15-30°C

Bisphosphonate preparations

Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [3H] alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [3H] alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.

Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.

Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is one 35 mg tablet once weekly or one 5 mg tablet once daily.

Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.

Treatment of Glucocorticoid-Induced Osteoporosis: The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone: The recommended treatment regimen is 40 mg once a day for six months.

The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.

Alendronic acid is contraindicated in patients with the following conditions: 

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 30 minutes.
• Do not administer Alendronic acid oral solution to patients at increased risk of aspiration.
• Hypocalcemia.
• Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported.

The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements.

Alendronic acid should not be given to pregnant women or nursing mother.

Pediatric Use: Alendronic acid is not indicated for use in pediatric patients.

Renal Impairment: Alendronic acid is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min.

Hepatic Impairment: As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary.

Store in a well-closed container at room temperature, 15-30°C

Alendronic Acid & Vitamin D3 is indicated in:

• Treatment of osteoporosis in postmenopausal women.
• Treatment of osteoporosis in men.
• Treatment of osteoporosis as it increases the bone mass and reduces the incidence of fractures, including those of the hip and spine.

Combined preparations: Inhibiting bone resorption

Alendronate Sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Alendronate is effective when administered at least 30 minutes before breakfast. It transiently distributes to soft tissues following administration but is then rapidly distributed to bone or excreted in the urine. Protein binding in human plasma is approximately 78%. There is no evidence that Alendronate is metabolised in animals or humans. At the cellular level, Alendronate shows preferential localization to sites of bone resorption, specially under osteoclasts. It inhibits osteoclast activity. In addition, bone formation exceeds bone resorption, leading to progressive gains in bone mass. Vitamin D is required for normal bone formation. Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture.

Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is-

• 70 mg alendronate and 2800 IU vitamin D3 or
• 70 mg alendronate and 5600 IU vitamin D3 tablet once weekly.
• For most osteoporotic women, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.

Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is-

• 70 mg alendronate and 2800 IU vitamin D3 or
• 70 mg alendronate and 5600 IU D3 tablet once weekly.
• For most osteoporotic men, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.

To permit adequate absorption, Alendronate & Colecalciferol must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of Alendronate. To facilitate delivery to the stomach and thus to reduce the potential for esophageal irritation, Alendronate & Colecalciferol tablet should only be swallowed upon rising for the day with a full glass of water. Patients should not lie down for at least 30 minutes after taking Alendronate until after their first food of the day. Alendronate & Colecalciferol should not be taken at bed time.

Usually mild and generally do not require discontinuation of therapy. Side effects include esophageal reactions, abdominal pain and distension, diarrhoea or constipation, flatulence, musculoskeletal pain, headache, rash, erythema and transient decreases in serum calcium and phosphate.

Hypocalcaemia and other disturbances of mineral metabolism should be corrected before initiation of therapy. Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Caution should be used when Alendronate is given to patients with active upper gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis or ulcers. Patients should stop taking medicine and consult their physician if they develop esophageal diseases.

Calcium supplement, antacids and some oral medications will interfere with absorption of Alendronate if taken at the same time. Intravenous ranitidine makes the bioavailability of oral Alendronate double. Incidence of upper gastro-intestinal adverse events associated with NSAID and aspirin appears to be greater with concomitant administration of Alendronate. Mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D.

Pregnancy category C. Overdoses of vitamin D have shown teratogenic effects in pregnant animals. Alendronic Acid & Vitamin D3 (Colecalciferol) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Cholecalciferol and some of its active metabolites pass into breast milk. It is not known whether alendronate is excreted in human milk. Caution should be exercised when administered to lactating women.

Dosing in elderly and renal insufficiency: No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronic Acid + Vitamin D3 (Colecalciferol) is not recommended for patients with more severe renal insufficiency (creatinine clearance<35 mL/min) due to lack of experience.

Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage.  Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy.

Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.

Zoledronic Acid is indicated in:

• Hypercalcaemia of malignancy, 
• Bone metastases associated with solid tumours, Osteolytic lesions associated with multiple myeloma, 
• Corticosteroid-induced osteoporosis, Increase bone mass in men with osteoporosis, Osteoporosis in postmenopausal women
• Paget's disease of bone
• Prophylaxis of postmenopausal osteoporosis

Bisphosphonate preparations

Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone. The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. Clinical studies in tumour-induced hypercalcemia demonstrated that the effect of Zoledronic acid is characterized by decreases in serum calcium and urinary calcium excretion. In addition to its inhibitory activity against bone resorption, Zoledronic acid also possesses anti-tumour activity, anti-angiogenic activity, anti-pain activity, cytostatic and pro-apoptotic activity on tumour cells and synergistic cytostatic effect with other anti-cancer drugs. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.

Hypercalcemia of malignancy: The maximum recommended dose of Zoledronic Acid in hypercalcemia of malignancy (serum calcium 12 mg/dl or 3.0 mmol/l) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion. Dose adjustment of Zoledronic Acid is not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment. Re-treatment with Zoledronic Acid may be considered if serum calcium does not return to normal after initial treatment. It is recommended that a minimum of 7 days elapse before re-treatment, to allow for full response to the initial dose. 

Multiple myeloma and bone metastases of solid tumors: The recommended dose of Zoledronic Acid in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused every 3-4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU of Vitamin-D daily.

Prior to administration, the required amount of concentrate from one vial must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution). The duration of infusion must not be less than 15 minutes. After addition of the solution to the infusion media, the infusion solution should be used as soon as possible. If storage of the infusion solution is necessary, hold at 2-8º C for not more than 24 hours. If refrigerated, the solution must be allowed to reach room temperature before administration.

Zoledronic Acid must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer's solution, and should be administered as a single intravenous solution in a line separate from all other drugs.

The post-dose side-effects are headache, nausea, anorexia, fatigue, osteonecrosis of jaw, anemia, bone pain, constipation, fever, vomiting, flu-like syndrome, hypocalcemia, myalgia, arthralgia and hypophosphataemia.

The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; severe renal impairment (Creatinine clearance <30 ml/min); pregnancy and lactation.

Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Serum levels of calcium, phosphate, magnesium and potassium, as well as serum creatinine should be carefully monitored after initiating Zoledronic Acid therapy. If hypocalcemia, hypophosphatemia or hypomagnesemia occurs, short-term supplemental therapy may be necessary. Moreover, careful renal function monitoring should be considered.

In clinical studies, Zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without interactions. Caution is advised when Zoledronic acid are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods. In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid is used in combination with thalidomide. Concomitant use of loop diuretics with Zoledronic acid increases the risk of hypocalcemia. Caution is indicated when Zoledronic acid is used with other potentially nephrotoxic drugs.

Zoledronic acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.

Patients with renal impairment: The use of Zoledronic Acid is not recommended in patients with severe renal impairment (Creatinine clearance <30 ml/min). No dose adjustment is necessary in patients with creatinine clearance >60 ml/min. Based on creatinine clearance the following dose should be used in patient with impaired renal function:

• CrCl > 60 ml/min: 4 mg (5 ml)
• CrCl 50-60 ml/min: 3.5 mg (4.4 ml)
• CrCl 40-49 ml/min: 3.3 mg (4.1 ml)
• CrCl 30-39 ml/min: 3 mg (3.8 ml)

Clinical experience with acute over dosage is limited. Over dosage may cause hypocalcemia, hypophosphatemia, and hypomagnesemia. In such case, reduction in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate and magnesium sulfate respectively.

Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.

Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.

Minerals in bone formation, Specific mineral preparations

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. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.

250 mg or 500 mg tablet: 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 the recommended 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.

1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.

• Hypercalcaemia and hyperparathyroidism
• Hypercalciuria and nephrolithiasis
• Zollinger-Ellison syndrome
• Concomitant digoxin therapy (requires careful monitoring of serum calcium level)

When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides.

Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.

Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.

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.

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

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Minerals in bone formation, Specific mineral preparations

This contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand- orotic acid. Orotic acid assists the transport of calcium through cellular membrane structures, thus facilitating the intracellular uptake of calcium, particularly in bone. Calcium Orotate also helps in the maintenance of healthy cartilage. Furthermore, Orotate is involved in the synthesis of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) of the various calcium supplements on the market, Calcium Orotate gets high marks because of the compound's ability to penetrate complex cell membranes so that it can be metabolized in cartilage.

Calcium Orotate 400 mg: As an addition to the daily diet, 2-3 tablets are usually recommended with meal or as directed by a physician.

Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.

Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.

Calcium Orotate is contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.

Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. This drug may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this drug in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis difficulty absorbing nutrition from food (malabsorption syndrome).

Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum- and magnesium-containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin, Ibuprofen deplete calcium. Corticosteroids deplete calcium.

Women who are pregnant and breast-feeding need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help to reduce this risk.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

Minerals in bone formation, Specific mineral preparations

This contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand- orotic acid. Orotic acid assists the transport of calcium through cellular membrane structures, thus facilitating the intracellular uptake of calcium, particularly in bone. Calcium Orotate also helps in the maintenance of healthy cartilage. Furthermore, Orotate is involved in the synthesis of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) of the various calcium supplements on the market, Calcium Orotate gets high marks because of the compound's ability to penetrate complex cell membranes so that it can be metabolized in cartilage.

Calcium Orotate 400 mg: As an addition to the daily diet, 2-3 tablets are usually recommended with meal or as directed by a physician.

Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.

Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.

Calcium Orotate is contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.

Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. This drug may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this drug in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis difficulty absorbing nutrition from food (malabsorption syndrome).

Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum- and magnesium-containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin, Ibuprofen deplete calcium. Corticosteroids deplete calcium.

Women who are pregnant and breast-feeding need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help to reduce this risk.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

This tablet is indicated in-

• Osteoarthritis
• Rheumatoid arthritis
• Bone and Joint injuries

Stimulation of Cartilage formation

Glucosamine: Glucosamine (2-amino-2-deoxy-alpha-D-glucose) is a natural amino sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates, Osteoarthritis develops. It also helps to form ligaments, tendon, nails and various other connective tissues. When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.

Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.

Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.

Use in adults: One tablet twice daily with food.

Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.

No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.

Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.

Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.

Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.

This tablet is contraindicated during pregnancy and breastfeeding.

Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.

Specific mineral & vitamin combined preparations

Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.

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).

Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.

Vitamin-C is an essential component of the diet as humans cannot synthesize Vitamin-C. It is a very powerful reducing agent and plays an important part in the response of the body to stress. It is important in the defense against infections.

Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in osteoporosis and fracture prevention.

Adults and children of school age: 1 effervescent tablet daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants: As prescribed by the physician

Dissolve one tablet in half glass (100 ml) of water.

The use of Calcium supplements has rarely given rise to mild gastrointestinal disturbances, such as constipation, flatulence, nausea, gastric pain and diarrhoea. Following administration of Vitamin-D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen in long-term treatment with Vitamin-D at high doses.

Absolute contraindications are hypercalcaemia resulting from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and Vitamin-D overdosage. It is also contraindicated in severe renal failure and hypersensitivity to any of the tablet ingredients.

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma Calcium levels and urinary Calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. In patients with a history of renal stones urinary Calcium excretion should be measured to exclude hypercalciuria. With long-term treatment it is advisable to monitor serum and urinary Calcium levels and kidney function, and reduce or stop treatment temporarily if urinary Calcium exceeds 7.5 mmol/24 hours. Allowances should be made for Calcium and Vitamin-D supplements from other sources.

The risk of hypercalcemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcemia must be avoided in digitalised patients. Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium. Concomitant therapy with phenytoin or barbiturates can decrease the effect of vitamin-D because of metabolic activation. The effect of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with vitamin-D. Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of 4 hours before taking the
calcium.

During pregnancy and lactation treatment with this supplements should always be under the direction of a physician.

During pregnancy and lactation, requirements for calcium and vitamin-D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources.

Overdoses of vitamin-D have shown teratogenic effects in pregnant animals. Vitamin-D and its metabolites pass into the breast milk.

The most serious consequence of acute or chronic overdose is hypercalcaemia due to Vitamin-D toxicity. Symptoms include nausea, vomiting, polyuria, and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intakes of calcium and Vitamin-D and rehydration.

Store at a cool and dry place. Protect from light and moisture. Keep out of reach of children. Keep the container tightly closed.

Vitamin in bone formation, Vitamin-D preparations

Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.

For capsule: Adults:

• Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.
• Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.
• Addition to specific therapy for osteoporosis: 20000 IU once a month.

For capsule: Children (12-18 years):

• Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.
• Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.

For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.

For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.

For Syrup:
For patients with risk of Cholecalciferol deficiency:

• 0-1 yr: 400 IU/ day (2 ml)
• >1 Yr: 600 lU/ day (3 ml)

For Cholecalciferol deficient patients:

• 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
• 1 -18 yrs: 2000 IU/ day for 6 weeks.

Injection: Prevention: 

• Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.
• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.
• Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.
• Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.
• Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.

Injection: Vitamin D deficiency:

• 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.

It is contraindicated in patients with known hypersensitivity to Vitamin D3.

It should be used with caution in patients with impaired renal function.

It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.

Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment

Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.

The safety & efficacy of Vitamin D3 in children under 12 years have not been established.

It can lead to hypervitaminosis D.

Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.