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This is indicated in-

• Patients with essential hypertension
• Patients with angina pectoris & hypertension as co-existing diseases
• ln post Ml patients
• ln patients with refractory angina pectoris where nitrate therapy has failed.

Combined antihypertensive preparations

This is a fixed-dose combination of Amlodipine and Atenolol. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle; it has a greater effect on vascular smooth muscle than on cardiac muscle. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Amlodipine reduces tone, decreases coronary vasoreactivity and lowers cardiac demand by reducing afterload.

Atenolol is a cardioselective beta-blocker. The cardio-selectivity is dose-related. Atenolol causes a reduction in blood pressure by lowering cardiac output, decreasing the plasma renin activity and sympathetic outflow from CNS. Atenolol also causes a reduction in myocardial oxygen demand by virtue of its negative inotropic and negative chronotropic effects.

The recommended dosage is Amlodipine and Atenolol 5/25 mg tablet once daily. If necessary, the dosage may be increased to 5/25 mg two tablets daily or as advised by the physicians. The dosage however should be individualized.

The combination of Amlodipine and Atenolol is well tolerated. Overall side-effects include
fatigue, headache, edema, nausea, drowsiness, anxiety and depression.

Hypersensitivity to either component, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.

Bronchospasm: The combination should be used with caution in patients with airway obstruction.

Renal impairment: The combination can be used in patients with renal impairment. However, caution may be necessary if the creatinine clearance is less than 30 ml/min because of possible reduction in the excretion of unchanged Atenolol.

Hepatic impairment: Caution may be necessary in the use of the combination in patients with severe liver damage because of prolongation of the elimination half-life of Amlodipine.

Drug withdrawal: Since coronary heart disease may exist without being recognized, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.

Disopyramide: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced.

Ampicillin: at doses of 1 gm and above may reduce Atenolol levels.

Oral antidiabetics and insulin: Beta-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion e.g. in response to oral antidiabetics. Atenolol has less potential for these actions.

The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk. The combination should not be used by nursing mothers. If its use is considered necessary, breast-feeding should be stopped.

Though not documented, hypotension and less frequently congestive cardiac failure may occur in cases of overdosage. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

Keep below 30°C temperature, away from light & moisture. 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

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.

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 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

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.

Prevention and treatment of calcium and vitamin D deficiency. Calcium and vitamin D supplement as an adjunct to specific therapy in the prevention and treatment of Osteoporosis for patients who are at risk of calcium and vitamin D deficiency

Specific mineral & vitamin combined preparations

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. Clinical evidence suggests that Calcium is useful for the prevention and treatment of Osteoporosis and associated fractures. 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 also show that Calcium and Vitamin D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.

1-2 tablets per day, preferably one tablet each morning and evening or as directed by the physician

Pour a tablet in a glass of water. The tablet will be dissolved within 1-2 minutes in the water. Drink the solution immediately.

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcemia is rarely produced by administration of Calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite dry mouth and drowsiness, skin rash.

Hypercalcemia and hyperparathyroidism, Hypercalciuria and nephrolithiasis, Hypersensitivity to the component of this preparation, Severe renal insufficiencies

When hypercalcemia 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. Patients with a history of stone formation should also be recommended to increase their fluid intake.

It has possible interaction with Digoxin, Antacids containing Calcium, Aluminum or Magnesium, other Calcium supplements, Calcitriol, Tetracycline, Doxycycline, Aminocycline or Oxytetracycline etc. So while taking this suppliment with any of these drugs consultations of the physicians is needed.

This can be used during pregnancy, in case of a calcium and vitamin D deficiency. However, for supplementation starting during the third trimester of pregnancy, the daily intake should not exceed 1500 mg calcium and 1000 IU vitamin D. This preparation can be used during breast-feeding.

Symptoms of over dose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, Metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability. The most serious consequence of acute chronic overdose is hypocalcaemia due to Vitamin D toxicity

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

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

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

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.

This combination is indicated to maintain strong bones and teeth as well as the health of the muscles and nerves. It is also indicated for the prevention & treatment of osteoporosis & post-menopausal osteoporosis. It is needed for bone development and constant regeneration of bone as well.

Specific mineral & vitamin combined preparations

This medicine is an absolute bone health formula with more than half a dozen key nutrients. Calcium decreases the rate of bone loss from the femoral neck, the spine and the total body. Since calcium is a nutrient, not a drug, the positive effects of supplemental calcium are most pronounced among women with low to moderate calcium intake. Vitamin D3 helps the body to absorb calcium which helps to reduce age-related bone loss and bone fractures related to osteoporosis. Magnesium helps the body to absorb both calcium and vitamin D3. It also helps to synthesize proteins. Low magnesium status has been associated with postmenopausal osteoporosis. The trace minerals Zinc, Copper and Manganese all play a role in bone development. Zinc is a part of an antioxidant enzyme that helps to prevent cellular destruction, which can cause problems with bone growth and maturation. Copper keeps bones free from thinning. Fifty percent of the total copper content in the body is in the bones and muscles. Manganese, in combination with other trace minerals, helps to prevent bone loss and osteoporosis. Boron works with magnesium and vitamin D3 to enhance calcium absorption and helps to maintain calcium levels in the body. Vitamin C works as an antioxidant. It is also essential for the formation of collagen and aids in iron absorption. Vitamin E serves as an antioxidant, protects biological membranes and stabilizes cellular functions.

2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening or as directed by the physician.

Calcium salts may cause mild gastrointestinal side effects such as constipation, flatulence, nausea, abdominal pain & bloating. Hypercalcaemia & in rare cases hypercalciuria have been seen with long term intake of calcium at high doses. Side effects from micronutrients are rare.

Hypersensitivity to any of the ingredients. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.

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

The risk of hypercalcaemia is increased if calcium salts are given with thiazide diuretics as these drugs reduce urinary calcium excretion. The effects of digitalis glycosides on the heart are enhanced by calcium. Calcium salts may reduce the absorption of fluoride, some fluoroquinolones, tetracyclines and iron.

Recommended in pregnancy and lactation.

Data is insufficient regarding use in children.

Symptoms of overdose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metalic taste, stomach cramps, unconsciousness, diarrhoea, weakness, headache, constipation, dizziness or irritability.

Store in a dry and cool place, away from direct light.

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.

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.

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.

Calcitriol & Calcium combination is indicated for Osteoporosis, Hypoparathyroidism, Hypocalcaemia, Osteomalacia rickets, Renal osteodystrophy.

Specific mineral & vitamin combined preparations

Calcium salt can be used in the prevention and treatment of calcium deficiency states or negative calcium balance. It is also used as an adjunct in the prevention and treatment of osteoporosis.

Calcitriol promotes calcium absorption in the intestines and retention at the kidneys thus increasing serum calcium levels. It also increases renal tubule phosphate resorption consequently decreasing serum phosphatase levels, PTH levels and bone resorption.

Hyperparathyroidism in renal failure: 0.25 mcg/day or alternate day. May increase slowly.

Hypoparathyroidism or pseudohypoparathyroidism: 0.5-2 mcg once daily.

Vitamin D dependent rickets: 0.015-0.02 mcg/kg/day. Maintenance: 0.03-0.06 mcg/kg/day. Max: 2 mcg/day.

Hyperparathyroidism in dialysis patients: 0.5-4 mcg 3 times/wk. Max: 8 mcg 3 times/wk.

Hyperparathyroidism in renal failure: 0.5 mcg 3 times/wk, may increase by 0.25-0.5 mcg at 2-4 wk intervals. Maintenance: 0.5-3 mcg 3 times/wk.

Weakness; headache; somnolence; nausea; vomiting; dry mouth; constipation; muscle pain; bone pain; metallic taste; polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild acidosis; reversible azotemia; generalized vascular calcification; nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia; rhinorrhoea; pruritus; hyperthermia; decreased libido; elevated BUN; albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic calcification; hypertension; cardiac arrhythmias.

Hypercalcaemia; evidence of vitamin D toxicity, pregnancy & lactation.

Idiopathic hypercalcaemia. Pediatric doses must be individualised and monitored under close medical supervision. Coronary disease, renal function impairment and arteriosclerosis, especially in the elderly. Hypoparathyroidism.

Calcium: 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.

Calcitriol: Hypermagnesaemia may develop in patients on chronic renal dialysis. Hypercalcaemia in patients on digitalis may precipitate cardiac arrhythmias. Intestinal absorption of calcitriol may be reduced by cholestyramine and colestipol. Phenytoin, barbiturates may decrease the T1/2 of calcitriol. May develop hypercalcaemia with thiazide diuretics.

Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

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.

Acalabrutinib is a kinase inhibitor indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy
• This indication is approved under accelerated approval based on overall response rate Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Tyrosine Kinase Inhibitor

Acalabrutinib is a small-molecule inhibitor of BTK. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.

The recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food. Advise patients not to break, open, or chew capsules. Manage toxicities using treatment interruption, dose reduction, or discontinuation. Avoid Acalabrutinib in patients with severe hepatic impairment.

Most common adverse reactions (incidence ≥30%) were: anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

Based on findings in animals, Acalabrutinib may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. No data are available regarding the presence of Acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production.

Do not store above 30⁰C. Keep away from light and out of the reach of children.

Calcium-channel blockers

Amlodipine is a dihydropyridine calcium-channel blocker, with a long duration of action, used for the treatment of hypertension and angina pectoris. Amlodipine influences the myocardial cells, the cells within the specialized conducting system of the heart, and the cells of vascular smooth muscle. Administration of Amlodipine results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in coronary heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.

Hypertension: Usual dose is 5 mg once daily. The maximum dose is 10 mg once daily. Elderly patients with hepatic insufficiency may be started on 2.5 mg once daily; this dose may also be used when adding Amlodipine to other antihypertensive therapy.

Angina (Chronic stable or Vasospastic): 5 to 10 mg, using the lower dose for elderly and in patients with hepatic insufficiency. Most patients require 10 mg.

Administrations: May be taken without regard to meals.

The most common adverse effects of amlodipine are associated with vasodilatory action, such as dizziness, flushing, headache, hypotension and peripheral edema. Gastrointestinal disturbances, increased micturition frequency, lethargy, eye pain and mental depression may also occur. A paradoxical increase in ischaemic chest pain may occur at the start of the treatment and in a few patients excessive fall in blood pressure has led to cerebral or myocardial ischaemia or transient blindness. Rashes, fever and abnormalities in liver function due to hypersensitivity reaction of Amlodipine may occur.

Hypersensitivity to dihydropyridine derivatives. Pregnant woman.

Precaution should be taken in patients with hepatic impairment and during pregnancy and breast feeding.

Drug Interactions-

• Potentially hazardous interactions: Little or no data are available in patients with markedly impaired cardiac left ventricular function; however, as with other calcium antagonist drugs, the combination of Amlodipine and p-blockers should be avoided in such patients.

Other Significant Interactions-

• Digoxin: Absence of any interaction between Amlodipine and Digoxin in healthy volunteers has been documented in a controlled clinical study.
• Cimetidine: An unpublished clinical study indicated no interaction between, Amlodipine and Cimetidine in healthy volunteers.
• Warfarin: An unpublished clinical study in healthy volunteers indicates that Amlodipine did not significantly alter the effect of Warfarin on prothrombin time.
• Food: Food does not alter the rate or extent of absorption of Amlodipine.

Pregnancy Category C. There are no adequate and well-controlled studies of Amlodipine in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while Amlodipine is administered.

Children with hypertension from 6 years to 17 years of age: 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients.

Children under 6 years old:  The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

Elderly: Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care.

Renal impairment: Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.

Hepatic impairment: Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautions and should start at the lower end of the dosing range. The pharmacokinetics of Amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose (2.5 mg once daily) and titrated slowly in patients with severe hepatic impairment.

Symptoms: Available data suggest that large overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.

Management: Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. 

A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.

Keep all medicines out of reach of children. Store in a cool & dry place, protected from light.