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Reoplex Silver

Multivitamin & Multimineral [A-Z silver preparation]
Tablet Allopathic Multi-vitamin & Multi-mineral combined preparations

Indications

Vitamin deficiency

Indication detailsView
This is specially formulated for the prevention and treatment of vitamin and mineral deficiencies for adults over 45 years of age. This Silver is also indicated to meet the increase demands of vitamin and minerals for adults over 45 years of age.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations
PharmacologyView
This preparation is a comprehensive well-balanced multivitamin and multimineral preparation scientifically adjusted and designed to serve as the complete nutritional program for the elderly people. This preparation maintains a healthy body and active lifestyle and keeps proper nutrition covered for elderly people
DosageView
One tablet once daily with food or as indicated by the physician.
Side effectsView
Generally, this preparation is well tolerated. Allergic sensitization has been reported following oral administration of folic acid. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
ContraindicationsView
This product is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not take this product if taking other vitamin A supplements.
PrecautionsView
Long term intake of high levels of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Recommended by the consultation with physician.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Repace

Losartan Potassium
Tablet 50 mg Allopathic Angiotensin-ll receptor blocker

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.
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.

Repace

Losartan Potassium
Tablet 25 mg Allopathic Angiotensin-ll receptor blocker

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.
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.

Repace H

Losartan Potassium + Hydrochlorothiazide
Tablet 50 mg+12.5 mg Allopathic Combined antihypertensive preparations

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.
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.
Severe Hypertension:
  • 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
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.
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.
StorageView
Do not store above 30°C. Keep out of the reach of children.

Repaglid

Repaglinide
Tablet 2 mg Allopathic Meglitinide Analogues

Indications

Type 2 DM

Indication detailsView
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Therapeutic classView
Meglitinide Analogues
PharmacologyView
Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
DosageView
  • For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
  • For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
  • Repaglinide should be taken immediately or up to 30 minutes before each meal.
  • Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
Side effectsView
The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
ContraindicationsView
Repaglinide is contraindicated in patients with:
  • Diabetic ketoacidosis, with or without coma.
  • Type 1 diabetes mellitus and
  • Known hypersensitivity to the drug or its inactive ingredients.
PrecautionsView
Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
InteractionsView
The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
  • Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
  • Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
  • Cimetidine has no significant effect on Repaglinide absorption or clearance.
  • Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
  • Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
  • The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
Pregnancy & lactationView
Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.

Repaglid

Repaglinide
Tablet 1 mg Allopathic Meglitinide Analogues

Indications

Type 2 DM

Indication detailsView
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Therapeutic classView
Meglitinide Analogues
PharmacologyView
Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
DosageView
  • For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
  • For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
  • Repaglinide should be taken immediately or up to 30 minutes before each meal.
  • Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
Side effectsView
The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
ContraindicationsView
Repaglinide is contraindicated in patients with:
  • Diabetic ketoacidosis, with or without coma.
  • Type 1 diabetes mellitus and
  • Known hypersensitivity to the drug or its inactive ingredients.
PrecautionsView
Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
InteractionsView
The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
  • Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
  • Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
  • Cimetidine has no significant effect on Repaglinide absorption or clearance.
  • Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
  • Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
  • The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
Pregnancy & lactationView
Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.

Repanid

Repaglinide
Tablet 2 mg Allopathic Meglitinide Analogues

Indications

Type 2 DM

Indication detailsView
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Therapeutic classView
Meglitinide Analogues
PharmacologyView
Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
DosageView
  • For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
  • For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
  • Repaglinide should be taken immediately or up to 30 minutes before each meal.
  • Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
Side effectsView
The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
ContraindicationsView
Repaglinide is contraindicated in patients with:
  • Diabetic ketoacidosis, with or without coma.
  • Type 1 diabetes mellitus and
  • Known hypersensitivity to the drug or its inactive ingredients.
PrecautionsView
Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
InteractionsView
The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
  • Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
  • Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
  • Cimetidine has no significant effect on Repaglinide absorption or clearance.
  • Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
  • Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
  • The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
Pregnancy & lactationView
Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.

Repanid

Repaglinide
Tablet 1 mg Allopathic Meglitinide Analogues

Indications

Type 2 DM

Indication detailsView
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Therapeutic classView
Meglitinide Analogues
PharmacologyView
Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
DosageView
  • For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
  • For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
  • Repaglinide should be taken immediately or up to 30 minutes before each meal.
  • Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
Side effectsView
The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
ContraindicationsView
Repaglinide is contraindicated in patients with:
  • Diabetic ketoacidosis, with or without coma.
  • Type 1 diabetes mellitus and
  • Known hypersensitivity to the drug or its inactive ingredients.
PrecautionsView
Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
InteractionsView
The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
  • Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
  • Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
  • Cimetidine has no significant effect on Repaglinide absorption or clearance.
  • Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
  • Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
  • The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
Pregnancy & lactationView
Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.

Rephaston

Dydrogesterone
Tablet 10 mg Allopathic Female Sex hormones

Indications

Uterine bleeding

Indication detailsView
Progesterone deficiencies:
  • Treatment of threatened miscarriage
  • Treatment of habitual miscarriage
  • Treatment of dysmenorrhoea
  • Treatment of endometriosis
  • Treatment of secondary amenorrhoea
  • Treatment of irregular cycles
  • Treatment of dysfunctional uterine bleeding
  • Treatment of infertility due to luteal insufficiency
  • Luteal support as part of an Assisted Reproductive Technology (ART)
Hormone Replacement Therapy: To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus.
Therapeutic classView
Female Sex hormones
PharmacologyView
Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and carcinogenesis induced by oestrogens. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no oestrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.
DosageView
Always take Presentation 10 mg tablet exactly as your doctor has prescribed.

Presentationerone deficiencies:
  • Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit.
  • Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy.
  • Dysmenorrhoea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle.
  • Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously.
  • Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Presentation should be given with oestrogen.
  • Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Presentation should be given with oestrogen.
  • Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation twice daily from day 11 to day 25 of the cycle.
  • Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle.
  • Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage.
  • Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.
Hormone Replacement Therapy: In combination with continuous oestrogentherapy, take one tablet daily for 14 consecutive days of a 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy. For doctors: If endometrial biopsies or ultrasound reveal inadequate Presentationational response, 20 mg Dydrogesterone should be prescribed. For patients: If you are not sure what type of oestrogen therapy you are on, talk to your Doctor before taking Presentation. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.
Side effectsView
The most commonly reported adverse drug reactions of patients treated with Dydrogesterone in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.
ContraindicationsView
Known hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms (e.g. meningioma).
PrecautionsView
Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered.
  • Severe headache, migraine or symptoms that may indicate cerebral ischemia.
  • Marked increase in blood pressure.
  • Occurrence of venous thromboembolism (VTE)
In cases of habitual or threatened abortion, the viability of the foetus should be ascertained. It is also necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive. Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with dydrogesterone must be stopped
Pregnancy & lactationView
It is estimated that more than 10 million pregnancies have been exposed to Dydrogesterone. So far there were no indications of a harmful effect of Dydrogesterone use during pregnancy. No data exist on excretion of Dydrogesterone in mother's milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother's milk in small quantities. Whether there is a risk to the child is not known. Therefore Dydrogesterone should not be used during the lactation period.
Overdose effectsView
Dydrogesterone was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.
StorageView
Store at below 30°C in a dry place protected from light. Keep out of reach of children.

Repidor

Aceclofenac
Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
  • Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
  • Diuretics: may interact the activity of diuretics.
  • Anticoagulants: may enhance the activity of anticoagulant.
  • Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView

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

Replet

Clopidogrel Bisulphate
Tablet 75 mg Allopathic Anti-platelet drugs

Indications

Unstable angina

Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).

Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
DosageView
Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.
Side effectsView
Clopidogrel is generally well tolerated drug.
  • Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
  • Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
ContraindicationsView
Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
  • As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
  • As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
  • Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
  • Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
  • Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
InteractionsView
  • NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
  • CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
  • Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose effectsView
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
StorageView
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Replet Plus

Clopidogrel + Aspirin
Tablet 75 mg+75 mg Allopathic Anti-platelet drugs

Indications

Transient ischemic attack

Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial Infarction (STEMI)].

Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
DosageView
The recommended oral dose is one tablet daily.
Side effectsView
This combination is generally well tolerated.
ContraindicationsView
This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
  • This combination may prolongs the bleeding time.
  • Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of this combination.
  • Reye's syndrome: Reye's syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving this combination or history of hypersensitivity to other thienopyridines
InteractionsView
Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.
Pediatric usageView
It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.
Overdose effectsView
Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.
StorageView
Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

Replivir

Entecavir
Tablet 1 mg Allopathic Hepatic viral infections (Hepatitis B)

Indications

Chronic hepatitis B

Indication detailsView
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.
Therapeutic classView
Hepatic viral infections (Hepatitis B)
PharmacologyView
By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):
  • Base priming,
  • Reverse transcription of the negative strand from the pregenomic messenger RNA, and
  • Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.
DosageView
The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.
Side effectsView
The most common adverse events are headache, fatigue, dizziness and nausea.
ContraindicationsView
Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
PrecautionsView
Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.
InteractionsView
Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.
Pregnancy & lactationView
There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.
Pediatric usageView
Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:
  • CrCl ≥50 ml/min: 0.5 mg every 24 hours
  • CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
  • CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
  • CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days
Overdose effectsView
There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Replivir

Entecavir
Tablet 0.5 mg Allopathic Hepatic viral infections (Hepatitis B)

Indications

Chronic hepatitis B

Indication detailsView
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.
Therapeutic classView
Hepatic viral infections (Hepatitis B)
PharmacologyView
By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):
  • Base priming,
  • Reverse transcription of the negative strand from the pregenomic messenger RNA, and
  • Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.
DosageView
The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.
Side effectsView
The most common adverse events are headache, fatigue, dizziness and nausea.
ContraindicationsView
Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
PrecautionsView
Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.
InteractionsView
Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.
Pregnancy & lactationView
There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.
Pediatric usageView
Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:
  • CrCl ≥50 ml/min: 0.5 mg every 24 hours
  • CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
  • CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
  • CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days
Overdose effectsView
There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Repopain

Ketorolac Tromethamine
IM/IV Injection 30 mg/ml Allopathic Drugs used for Rheumatoid Arthritis

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.
IV Dosing (Adult):
  • 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.
IV or IM Dosing (2 to 16 years of age):
  • 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.
Multiple-Dose Treatment (IV or IM)-
  • 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.
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.

Repopain

Ketorolac Tromethamine
Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

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.
IV Dosing (Adult):
  • 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.
IV or IM Dosing (2 to 16 years of age):
  • 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.
Multiple-Dose Treatment (IV or IM)-
  • 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.
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.

Repose

Sertraline Hydrochloride
Tablet 100 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView
Sertraline is indicated for the treatment of-
  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Post-traumatic stress disorder (PTSD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
  • Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
  • Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.

Repose

Sertraline Hydrochloride
Tablet 50 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView
Sertraline is indicated for the treatment of-
  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Post-traumatic stress disorder (PTSD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
  • Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
  • Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.

Repose

Sertraline Hydrochloride
Tablet 25 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView
Sertraline is indicated for the treatment of-
  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Post-traumatic stress disorder (PTSD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD).
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
DosageView
Adults-
Major depressive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Obsessive-compulsive disorder:
  • Starting Dose: 50 mg
  • Therapeutic Range: 50-200 mg
Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:
  • Starting Dose: 25 mg
  • Therapeutic Range: 50-200 mg
The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
  • Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
  • Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
Side effectsView
Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
ContraindicationsView
Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
PrecautionsView
Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
InteractionsView
Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
Pregnancy & lactationView
Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
StorageView
Do not store above 30°C. Keep out of the reach of children.

Repotyn

Amino Acid + D-Sorbitol + Electrolytes
IV Infusion 5% Allopathic Parenteral nutritional preparations

Indications

Protein supply for peritoneal nutrition

Indication detailsView
Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
Therapeutic classView
Parenteral nutritional preparations
PharmacologyView
This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.
DosageView
The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).
  • No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day, 
  • Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day, 
  • Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day. 
The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day. 

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
Side effectsView
This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.
ContraindicationsView
This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.
PrecautionsView
IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.
InteractionsView
At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Pregnancy & lactationView
Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.
Overdose effectsView
If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.
StorageView
Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.