Medicines
Find Medicines
Search 21,000+ medicines by brand, generic, indication, or drug class
Ossi D
Calcium Carbonate [Elemental source] + Vitamin D3
Ossi D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
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.
DosageView
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.
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.
Side effectsView
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.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
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.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ostacid
Calcium Carbonate
Ostacid
Calcium Carbonate
Indication detailsView
250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
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.
DosageView
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.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
Side effectsView
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.
ContraindicationsView
- Hypercalcaemia and hyperparathyroidism
- Hypercalciuria and nephrolithiasis
- Zollinger-Ellison syndrome
- Concomitant digoxin therapy (requires careful monitoring of serum calcium level)
InteractionsView
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.
Pregnancy & lactationView
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.
Pediatric usageView
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.
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.
StorageView
Store in a cool, dry place in controlled room temperature.
Ostacid-D
Calcium Carbonate [Elemental source] + Vitamin D3
Ostacid-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
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.
DosageView
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.
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.
Side effectsView
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.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
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.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ostan
Losartan Potassium
Ostan
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Ostan
Losartan Potassium
Ostan
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Ostan Plus
Losartan Potassium + Hydrochlorothiazide
Ostan Plus
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Ostan Plus
Losartan Potassium + Hydrochlorothiazide
Ostan Plus
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Ostel-D
Alendronic Acid + Vitamin D3
Ostel-D
Alendronic Acid + Vitamin D3
Indications
Post-menopausal osteoporosis
Indication detailsView
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.
Therapeutic classView
Combined preparations: Inhibiting bone resorption
PharmacologyView
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.
DosageView
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.
- 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.
AdministrationView
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.
Side effectsView
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.
ContraindicationsView
- Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Hypersensitivity to any component of this product.
- Hypocalcaemia.
PrecautionsView
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.
InteractionsView
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 & lactationView
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.
Pediatric usageView
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.
Overdose effectsView
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.
StorageView
Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.
Ostelac
Ketorolac Tromethamine
Ostelac
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ostelin-D
Calcium Carbonate [Elemental source] + Vitamin D3
Ostelin-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
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.
DosageView
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.
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.
Side effectsView
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.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
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.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Osteo-D
Colecalciferol [Vitamin D3]
Osteo-D
Colecalciferol [Vitamin D3]
Indications
Rickets
Indication detailsView
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
Therapeutic classView
Vitamin in bone formation, Vitamin-D preparations
PharmacologyView
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.
DosageView
For capsule: Adults:
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:
- 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.
- 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 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)
- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- 1 -18 yrs: 2000 IU/ day for 6 weeks.
- 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.
- 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.
Side effectsView
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
PrecautionsView
It should be used with caution in patients with impaired renal function.
InteractionsView
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
Pregnancy & lactationView
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.
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.
Pediatric usageView
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Overdose effectsView
It can lead to hypervitaminosis D.
StorageView
Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
Osteo-D
Colecalciferol [Vitamin D3]
Osteo-D
Colecalciferol [Vitamin D3]
Indications
Rickets
Indication detailsView
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
Therapeutic classView
Vitamin in bone formation, Vitamin-D preparations
PharmacologyView
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.
DosageView
For capsule: Adults:
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:
- 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.
- 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 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)
- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- 1 -18 yrs: 2000 IU/ day for 6 weeks.
- 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.
- 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.
Side effectsView
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
PrecautionsView
It should be used with caution in patients with impaired renal function.
InteractionsView
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
Pregnancy & lactationView
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.
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.
Pediatric usageView
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Overdose effectsView
It can lead to hypervitaminosis D.
StorageView
Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
Osteo-D
Colecalciferol [Vitamin D3]
Osteo-D
Colecalciferol [Vitamin D3]
Indications
Rickets
Indication detailsView
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
Therapeutic classView
Vitamin in bone formation, Vitamin-D preparations
PharmacologyView
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.
DosageView
For capsule: Adults:
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:
- 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.
- 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 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)
- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- 1 -18 yrs: 2000 IU/ day for 6 weeks.
- 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.
- 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.
Side effectsView
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
PrecautionsView
It should be used with caution in patients with impaired renal function.
InteractionsView
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
Pregnancy & lactationView
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.
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.
Pediatric usageView
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Overdose effectsView
It can lead to hypervitaminosis D.
StorageView
Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
Osteo-D
Colecalciferol [Vitamin D3]
Osteo-D
Colecalciferol [Vitamin D3]
Indications
Rickets
Indication detailsView
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
Therapeutic classView
Vitamin in bone formation, Vitamin-D preparations
PharmacologyView
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.
DosageView
For capsule: Adults:
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:
- 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.
- 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 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)
- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- 1 -18 yrs: 2000 IU/ day for 6 weeks.
- 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.
- 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.
Side effectsView
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
PrecautionsView
It should be used with caution in patients with impaired renal function.
InteractionsView
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
Pregnancy & lactationView
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.
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.
Pediatric usageView
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Overdose effectsView
It can lead to hypervitaminosis D.
StorageView
Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
Osteo-D
Colecalciferol [Vitamin D3]
Osteo-D
Colecalciferol [Vitamin D3]
Indications
Rickets
Indication detailsView
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
Therapeutic classView
Vitamin in bone formation, Vitamin-D preparations
PharmacologyView
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.
DosageView
For capsule: Adults:
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:
- 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.
- 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 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)
- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- 1 -18 yrs: 2000 IU/ day for 6 weeks.
- 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.
- 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.
Side effectsView
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
PrecautionsView
It should be used with caution in patients with impaired renal function.
InteractionsView
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
Pregnancy & lactationView
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.
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.
Pediatric usageView
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Overdose effectsView
It can lead to hypervitaminosis D.
StorageView
Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
Osteonil
Ibandronic Acid
Osteonil
Ibandronic Acid
Indications
Hypercalcaemia of malignancy
Indication detailsView
Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.
Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.
Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.
Therapeutic classView
Bisphosphonate preparations
PharmacologyView
The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.
DosageView
The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):
- Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
- Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.
Side effectsView
The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.
ContraindicationsView
Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.
PrecautionsView
Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.
InteractionsView
It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.
In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.
In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.
Pregnancy & lactationView
Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.
Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
Pediatric usageView
Patients with renal impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is ≥30 ml/min. Below 30 ml/min creatinine clearance, the decision to administer Ibandronic Acid should be based on an individual risk-benefit assessment.
Patients with hepatic impairment: No dosage adjustment is necessary.
Patients with hepatic impairment: No dosage adjustment is necessary.
Elderly: No dosage adjustment is necessary.
Children: Safety and efficacy have not been established in patients less than 18 years old.
Overdose effectsView
No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Ostiban
Ibandronic Acid
Ostiban
Ibandronic Acid
Indications
Hypercalcaemia of malignancy
Indication detailsView
Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.
Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.
Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.
Therapeutic classView
Bisphosphonate preparations
PharmacologyView
The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.
DosageView
The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):
- Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
- Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.
Side effectsView
The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.
ContraindicationsView
Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.
PrecautionsView
Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.
InteractionsView
It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.
In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.
In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.
Pregnancy & lactationView
Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.
Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
Pediatric usageView
Patients with renal impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is ≥30 ml/min. Below 30 ml/min creatinine clearance, the decision to administer Ibandronic Acid should be based on an individual risk-benefit assessment.
Patients with hepatic impairment: No dosage adjustment is necessary.
Patients with hepatic impairment: No dosage adjustment is necessary.
Elderly: No dosage adjustment is necessary.
Children: Safety and efficacy have not been established in patients less than 18 years old.
Overdose effectsView
No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Osticare
Glucosamine Sulfate + Diacerein
Osticare
Glucosamine Sulfate + Diacerein
Indications
Rheumatoid arthritis
Indication detailsView
This tablet is indicated in-
- Osteoarthritis
- Rheumatoid arthritis
- Bone and Joint injuries
Therapeutic classView
Stimulation of Cartilage formation
PharmacologyView
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%.
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%.
DosageView
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.
Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.
Side effectsView
No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.
ContraindicationsView
Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.
PrecautionsView
Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.
InteractionsView
Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.
Pregnancy & lactationView
This tablet is contraindicated during pregnancy and breastfeeding.
Overdose effectsView
There is no data available regarding overdose of this combination.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.
Ostim
Calcium Carbonate
Ostim
Calcium Carbonate
Indication detailsView
250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
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.
DosageView
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.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
Side effectsView
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.
ContraindicationsView
- Hypercalcaemia and hyperparathyroidism
- Hypercalciuria and nephrolithiasis
- Zollinger-Ellison syndrome
- Concomitant digoxin therapy (requires careful monitoring of serum calcium level)
InteractionsView
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.
Pregnancy & lactationView
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.
Pediatric usageView
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.
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.
StorageView
Store in a cool, dry place in controlled room temperature.
Ostim-D
Calcium Carbonate [Elemental source] + Vitamin D3
Ostim-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
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.
DosageView
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.
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.
Side effectsView
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.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
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.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.