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Emparol

Empagliflozin

Tablet 25 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Emparol

Empagliflozin

Tablet 10 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Emparol-M

Empagliflozin + Metformin Hydrochloride

Tablet 5 mg+500 mg Allopathic Combination Oral hypoglycemic preparations

Indications

Type 2 DM

Indication detailsView

This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:

In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.

Therapeutic classView

Combination Oral hypoglycemic preparations

PharmacologyView

Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.

Recommended individualized starting dose:

In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.

Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m² is contraindicated.

Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Side effectsView

Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:

Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
Rare: Diabetic ketoacidosis.

ContraindicationsView

Hypersensitivity to Empagliflozin and Metformin
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Diabetic pre-coma
Severe renal failure (GFR <30 ml/min)
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
Hepatic impairment, acute alcohol intoxication, alcoholism

PrecautionsView

Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.

Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.

Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.

Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.

Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.

Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.

Increased LDL-C: Monitor and treat as appropriate.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.

Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.

Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.

Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.

Pregnancy & lactationView

Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.

Overdose effectsView

In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied

StorageView

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

Empatab

Empagliflozin

Tablet 10 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empatab

Empagliflozin

Tablet 25 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empatab M

Empagliflozin + Metformin Hydrochloride

Tablet 5 mg+500 mg Allopathic Combination Oral hypoglycemic preparations

Indications

Type 2 DM

Indication detailsView

This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:

In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.

Therapeutic classView

Combination Oral hypoglycemic preparations

PharmacologyView

Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.

Recommended individualized starting dose:

In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.

Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m² is contraindicated.

Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Side effectsView

Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:

Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
Rare: Diabetic ketoacidosis.

ContraindicationsView

Hypersensitivity to Empagliflozin and Metformin
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Diabetic pre-coma
Severe renal failure (GFR <30 ml/min)
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
Hepatic impairment, acute alcohol intoxication, alcoholism

PrecautionsView

Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.

Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.

Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.

Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.

Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.

Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.

Increased LDL-C: Monitor and treat as appropriate.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.

Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.

Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.

Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.

Pregnancy & lactationView

Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.

Overdose effectsView

In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied

StorageView

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

Empavic

Empagliflozin

Tablet 25 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empavic

Empagliflozin

Tablet 10 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empazin

Empagliflozin

Tablet 25 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empazin

Empagliflozin

Tablet 10 mg Allopathic Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Indications

Type 2 DM

Indication detailsView

Empagliflozin is indicated in:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Therapeutic classView

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

PharmacologyView

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

DosageView

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

Side effectsView

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

ContraindicationsView

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

PrecautionsView

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Pregnancy & lactationView

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

Overdose effectsView

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

StorageView

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empazin L

Empagliflozin + Linagliptin

Tablet 10 mg+5 mg Allopathic

Indication detailsView

This is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

PharmacologyView

Empagliflozin: Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increasing urinary glucose excretion.

Linagliptin: Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

DosageView

Assess renal function before initiating and as clinically indicated. The recommended dose of this is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.

Pediatric Patients: The safety and effectiveness in pediatric patients have not been established.

Geriatric Patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function.

Renal Impairment: Higher incidence of adverse reactions related to reduced renal function.

Side effectsView

The most common side effects are:

urinary tract infection
stuffy or runny nose and sore throat
upper respiratory tract infection

PrecautionsView

Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this tablet, evaluate and treat promptly. Before initiating this tablet, consider risk factors for ketoacidosis. Patients on this tablet may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Volume Depletion: Before initiating this tablet, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.

Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this tablet.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.

Genital Mycotic Infections: Monitor and treat as appropriate.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with empagliflozin and linagliptin. If hypersensitivity reactions occur, discontinue this tablet, treat promptly, and monitor until signs and symptoms resolve.

Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.

Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report the development of blisters or erosions. If bullous pemphigoid is suspected, discontinue this tablet.

Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of this tablet in patients who have known risk factors for heart failure. Monitor for signs and symptoms.

Pregnancy & lactationView

Advise females of the potential risk to a fetus, especially during the second and third trimesters. This is not recommended when breastfeeding.

StorageView

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

Empazin L

Empagliflozin + Linagliptin

Tablet 25 mg+5 mg Allopathic

Indication detailsView

This is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

PharmacologyView

Empagliflozin: Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increasing urinary glucose excretion.

Linagliptin: Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

DosageView

Assess renal function before initiating and as clinically indicated. The recommended dose of this is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.

Pediatric Patients: The safety and effectiveness in pediatric patients have not been established.

Geriatric Patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function.

Renal Impairment: Higher incidence of adverse reactions related to reduced renal function.

Side effectsView

The most common side effects are:

urinary tract infection
stuffy or runny nose and sore throat
upper respiratory tract infection

PrecautionsView

Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this tablet, evaluate and treat promptly. Before initiating this tablet, consider risk factors for ketoacidosis. Patients on this tablet may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Volume Depletion: Before initiating this tablet, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.

Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this tablet.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.

Genital Mycotic Infections: Monitor and treat as appropriate.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with empagliflozin and linagliptin. If hypersensitivity reactions occur, discontinue this tablet, treat promptly, and monitor until signs and symptoms resolve.

Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.

Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report the development of blisters or erosions. If bullous pemphigoid is suspected, discontinue this tablet.

Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of this tablet in patients who have known risk factors for heart failure. Monitor for signs and symptoms.

Pregnancy & lactationView

Advise females of the potential risk to a fetus, especially during the second and third trimesters. This is not recommended when breastfeeding.

StorageView

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

Empazin M

Empagliflozin + Metformin Hydrochloride

Tablet 5 mg+500 mg Allopathic Combination Oral hypoglycemic preparations

Indications

Type 2 DM

Indication detailsView

This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:

In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.

Therapeutic classView

Combination Oral hypoglycemic preparations

PharmacologyView

Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

DosageView

The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.

Recommended individualized starting dose:

In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.

Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m² is contraindicated.

Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Side effectsView

Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:

Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
Rare: Diabetic ketoacidosis.

ContraindicationsView

Hypersensitivity to Empagliflozin and Metformin
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Diabetic pre-coma
Severe renal failure (GFR <30 ml/min)
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
Hepatic impairment, acute alcohol intoxication, alcoholism

PrecautionsView

Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.

Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.

Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.

Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.

Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.

Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.

Increased LDL-C: Monitor and treat as appropriate.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.

InteractionsView

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.

Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.

Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.

Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.

Pregnancy & lactationView

Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.

Overdose effectsView

In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied

StorageView

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

Emprila

Lidocaine + Prilocaine

Cream 2.5%+2.5% Allopathic Local & Surface anesthesia

Indication detailsView

Indicated as a topical anesthetic for use on normal intact skin for local analgesia, genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia

Therapeutic classView

Local & Surface anesthesia, Topical Local Anesthetics

PharmacologyView

Lidocaine and prilocaine are local anaesthetic agents of the amide type. Both work by stabilising the neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby giving rise to the anaesthetic action.

DosageView

A thick layer of Lidocaine & Prilocaine cream is applied to intact skin and covered with an occlusive dressing.

Minor Dermal Procedures: For intravenous cannulation and venipuncture, apply 2.5 grams of Lidocaine & Prilocaine cream over 20-25 cm² of skin surface for at least 1 hour.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area, apply 2 grams of Lidocaine & Prilocaine cream per 10 cm² of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of Lidocaine & Prilocaine cream to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Lidocaine & Prilocaine cream.

Adult Female Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of Lidocaine & Prilocaine cream for 5 to 10 minutes. Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the Lidocaine & Prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of Lidocaine & Prilocaine cream.

Pediatric Patients: The following are the maximum recommended doses, application areas and application times for Lidocaine & Prilocaine cream based on a child’s age and weight:

0 to 3 months or <5 kg: Maximum Total Dose 1 gm, Maximum Application Time: 1 hour
3 to 12 months and >5 kg: Maximum Total Dose 2 gm, Maximum Application Time 4 hour
1 to 6 years and >10 kg: Maximum Total Dose 10 gm, Maximum Application Time 4 hour
7 to 12 years and >20 kg: Maximum Total Dose 20 gm, Maximum Application Time 4 hour

Side effectsView

Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactoid reactions (cutaneous lesion, urticaria, oedema).

ContraindicationsView

Hypersensitivity to local anaesthetics of the amide type or to any other component of the product.

PrecautionsView

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. This cream should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, cream should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock. The use of oropharyngeal topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.

InteractionsView

Cream should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since the toxic effects are additive.

Pregnancy & lactationView

There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Cream enters the mothers milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

Overdose effectsView

Toxic levels of lidocaine (>5 µg/ml) and/or prilocaine (>6 µg/ml) may decrease cardiac output, total peripheral resistance and mean arterial pressure. These changes are due to direct depressant effects of these local anaesthetic agents on the CVS.

StorageView

Store in a cool and dry place, protected from light

Emulyt

Ambroxol Hydrochloride

Syrup 15 mg/5 ml Allopathic Cough expectorants & mucolytics

Indications

Sore throat

Indication detailsView

This is indicated in-

Productive cough
Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
Asthmatic bronchitis bronchial asthma with thick expectoration
Bronchiectasis
Chronic pneumonia etc.

Therapeutic classView

Cough expectorants & mucolytics

PharmacologyView

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

DosageView

Average daily dose (preferably after meal):

Pediatric Drops:

0-6 months: 0.5 ml 2 times a day
6-12 months: 1 ml 2 times a day
1-2 years: 1.25 ml 2 times a day

Syrup:

2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Side effectsView

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

ContraindicationsView

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

PrecautionsView

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

InteractionsView

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Pregnancy & lactationView

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

StorageView

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Emurea

Urea (25%)

Cream 25% w/w Allopathic Topical urea preparations

Indications

Hyperkeratosis

Indication detailsView

Adults & children over 12 years: It is intended to be used for the symptomatic treatment of heels & feet anhydrosis including in consumers and diabetics.

Therapeutic classView

Topical urea preparations

PharmacologyView

Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose-dependent. Most of its therapeutic application depends on its hygroscopic properties. The hygroscopic property is due to its ability to cause a configurational change in proteins in the stratum corneum. Urea gently dissolves the intracellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.

DosageView

Apply enough Urea 25% Cream to cover affected area, once or twice daily or as directed by the physician. For external use only.

Side effectsView

No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.

ContraindicationsView

Allergy to any of the ingredients of this product.

PrecautionsView

Avoid contact with eyes. Do not use, if sensitive to any of the ingredients, on genitals or other areas of sensitive skin, on skin that is badly cracked, infected or bleeding and at the same time as other skin care products. Stop use if skin irritation or rash occurs during use.

InteractionsView

No hazardous drug interaction has been reported.

Pregnancy & lactationView

There are no adequate & well-controlled studies in pregnant women. Urea should only be used if the anticipated benefits outweigh the risks.

StorageView

Store in a cool & dry place, protect from light. Do not freeze.

Emurea

Urea (10%)

Cream 10% w/w Allopathic Topical urea preparations

Indications

Psoriasis

Indication detailsView

Urea 10% cream is indicated for-

Ichthyosis and dry skin conditions
Management of eczemas
Management of psoriasis

Therapeutic classView

Topical urea preparations

PharmacologyView

Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.

DosageView

Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.

Use in children: Urea 10% cream can be used in all age groups.

Side effectsView

No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.

ContraindicationsView

This is contraindicated in any other ingredient of this preaparation.

PrecautionsView

In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.

InteractionsView

No hazardous drug interaction has been reported.

Pregnancy & lactationView

Urea cream can be used during pregnancy and lactation.

StorageView

Keep out of the reach of children. Do not freeze. Keep at cool and dry place.

Emycin

Erythromycin (Oral)

Tablet 250 mg Allopathic Macrolides

Indications

Susceptible infections

Indication detailsView

Erythromycin is highly effective in the treatment of a wide variety of clinical infections.

Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
Ear infections: Otitis media, otitis externa, mastoiditis.
Eye infections: Blepharitis, established trachoma.
Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.

Therapeutic classView

Anti-diarrhoeal Antimicrobial drugs, Macrolides

PharmacologyView

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

DosageView

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Side effectsView

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

ContraindicationsView

Known hypersensitivity to Erythromycin.

PrecautionsView

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

InteractionsView

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Pregnancy & lactationView

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

Overdose effectsView

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

ReconstitutionView

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

StorageView

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Emycin

Erythromycin (Oral)

Powder for Suspension 125 mg/5 ml Allopathic Macrolides

Indications

Susceptible infections

Indication detailsView

Erythromycin is highly effective in the treatment of a wide variety of clinical infections.

Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
Ear infections: Otitis media, otitis externa, mastoiditis.
Eye infections: Blepharitis, established trachoma.
Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.

Therapeutic classView

Anti-diarrhoeal Antimicrobial drugs, Macrolides

PharmacologyView

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

DosageView

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Side effectsView

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

ContraindicationsView

Known hypersensitivity to Erythromycin.

PrecautionsView

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

InteractionsView

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Pregnancy & lactationView

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

Overdose effectsView

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

ReconstitutionView

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

StorageView

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Ena

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.