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Merotic

Meropenem Trihydrate
IV Injection or Infusion 1 gm/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia
  • Pulmonary infections in cystic fibrosis
  • Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:
  • The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
  • Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
  • Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
  • Cystic fibrosis: Upto 2 gm every 8 hours.
  • Meningitis: 2 gm IV every 8 hours.
Children:
  • 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
  • Intra-abdominal infections: 20 mg/kg every 8 hours.
  • Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
  • Meningitis: 40 mg/kg IV every 8 hours.
  • Febrile neutropenia: 20 mg/kg every 8 hours.
  • Children over 50 kg weight: use adult dosage.
  • There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.

Merotrax

Meropenem Trihydrate
IV Injection or Infusion 1 gm/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia
  • Pulmonary infections in cystic fibrosis
  • Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:
  • The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
  • Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
  • Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
  • Cystic fibrosis: Upto 2 gm every 8 hours.
  • Meningitis: 2 gm IV every 8 hours.
Children:
  • 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
  • Intra-abdominal infections: 20 mg/kg every 8 hours.
  • Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
  • Meningitis: 40 mg/kg IV every 8 hours.
  • Febrile neutropenia: 20 mg/kg every 8 hours.
  • Children over 50 kg weight: use adult dosage.
  • There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.

Merotrax

Meropenem Trihydrate
IV Injection or Infusion 500 mg/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia
  • Pulmonary infections in cystic fibrosis
  • Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:
  • The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
  • Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
  • Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
  • Cystic fibrosis: Upto 2 gm every 8 hours.
  • Meningitis: 2 gm IV every 8 hours.
Children:
  • 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
  • Intra-abdominal infections: 20 mg/kg every 8 hours.
  • Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
  • Meningitis: 40 mg/kg IV every 8 hours.
  • Febrile neutropenia: 20 mg/kg every 8 hours.
  • Children over 50 kg weight: use adult dosage.
  • There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.

Meroxin

Meropenem Trihydrate
IV Injection or Infusion 1 gm/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia
  • Pulmonary infections in cystic fibrosis
  • Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:
  • The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
  • Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
  • Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
  • Cystic fibrosis: Upto 2 gm every 8 hours.
  • Meningitis: 2 gm IV every 8 hours.
Children:
  • 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
  • Intra-abdominal infections: 20 mg/kg every 8 hours.
  • Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
  • Meningitis: 40 mg/kg IV every 8 hours.
  • Febrile neutropenia: 20 mg/kg every 8 hours.
  • Children over 50 kg weight: use adult dosage.
  • There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.

Meroxin

Meropenem Trihydrate
IV Injection or Infusion 500 mg/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia
  • Pulmonary infections in cystic fibrosis
  • Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:
  • The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
  • Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
  • Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
  • Cystic fibrosis: Upto 2 gm every 8 hours.
  • Meningitis: 2 gm IV every 8 hours.
Children:
  • 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
  • Intra-abdominal infections: 20 mg/kg every 8 hours.
  • Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
  • Meningitis: 40 mg/kg IV every 8 hours.
  • Febrile neutropenia: 20 mg/kg every 8 hours.
  • Children over 50 kg weight: use adult dosage.
  • There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.

Merozolyn

Metolazone
Tablet 5 mg Allopathic Thiazide diuretics & related drugs

Indications

Oedema

Indication detailsView
Metolazone is indicated for the treatment of salt and water retention including:
  • Edema accompanying congestive heart failure
  • Edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
Therapeutic classView
Thiazide diuretics & related drugs
PharmacologyView
Metolazone is a thiazide-like diuretic. It inhibits reabsorption of sodium in the distal tubules resulting in increased excretion of sodium and water, as well as potassium and hydrogen ions.
DosageView
Effective dosage of Metolazone tablets should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with Metolazone tablets should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.

Usual Single Daily Dosage Schedules: Suitable initial dosages will usually fall in the ranges given.

Edema of Cardiac Failure: Metolazone tablets 5 to 20 mg once daily.

Edema of Renal Disease: Metolazone tablets 5 to 20 mg once daily.

Mild to Moderate Essential Hypertension: Metolazone tablets 2.5 to 5 mg once daily.

New patients- If considered desirable to switch patients currently on Zaroxolyn tablets and other formulations of Metolazone that share its slow and incomplete bioavailability to Mykrox , the dose should be determined by titration starting at one tablet (0.5 mg) once daily and increasing to two tablets (1 mg) once daily if needed.

Treatment Of Edematous States: The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient's condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with Metolazone tablets, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.

Treatment Of Hypertension: The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.
Side effectsView
Chest pain, palpitation, necrotising angiitis, orthostatic hypotension, syncope, venous thrombosis, vertigo, volume depletion; depression, dizziness, chills, drowsiness, fatigue, restlessness, headache, lightheadedness; petechiae, photosensitivity, hypersensitivity reactions; gout attacks, electrolyte disturbances; abdominal bloating, diarrhoea, abdominal pain, anorexia, constipation, epigastric distress, nausea, xerostomia, pancreatitis, vomiting; impotence; aplastic anaemia, thrombocytopenia, haemoconcentration, leukopenia; cholestatic jaundice, hepatitis; joint pain, muscle cramps, weakness, neuropathy, paraesthesia; blurred vision; increased BUN, glucosuria.
ContraindicationsView
Anuria; hepatic coma or pre-coma. Pregnancy.
PrecautionsView
Pre-diabetes or DM; gout; SLE; hepatic and renal impairment; hypercholesterolaemia. Correct electrolyte disturbances prior to therapy. Risk of cross-sensitivity with sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides and loop diuretics. Lactation.
InteractionsView
Hypotensive and nephrotoxic effects of ACE inhibitors may be enhanced. Absorption may be reduced with bile acid sequestrants. Hyperglycaemic effect may be enhanced with diazoxide. May increase serum concentration and QTc-prolonging effect of dofetilide. May reduce lithium excretion. Hypotensive effect may be increased with alcohol.
Pregnancy & lactationView
Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

If used in gestational HTN: Pregnancy Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Orthostatic hypotension, dizziness, drowsiness, syncope, haemoconcentration and haemodynamic changes due to plasma volume depletion.

Management: Symptomatic and supportive.

Mervan

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.

Mervan SR

Aceclofenac
Tablet (Sustained Release) 200 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.

Mes-D

Mesna
IV Injection 400 mg/4 ml Allopathic Antidote preparations

Indications

Urothelial toxicity

Indication detailsView
Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Therapeutic classView
Antidote preparations
PharmacologyView
Mesna is used to prevent urothelial toxicity associated with oxazaphosphorine, ifosfamide or cyclophosphamide. It acts in the kidney; reacting with thiol groups of urotoxic metabolites (e.g. acrolein) of ifosfamide and cyclophosphamide. It is used as a mucolytic in the management of some respiratory tract conditions e.g. cystic fibrosis where other mucolytics have failed. It acts by reducing the viscosity of pulmonary secretions; the drug's free sulfhydryl group is thought to reduce disulfide linkages of mucoproteins.
DosageView
Intravenous-
Prophylaxis against urothelial toxicity:
  • Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall. Administered either by short (15-30 minutes) or continuous (24 hr) infusion.
  • Child: Refer to individual and local protocol. Has been used in children >4 mth.
Oral-
Prophylaxis against urothelial toxicity:
  • Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall.
  • Child: Refer to individual and local protocol.
Side effectsView
Nausea, vomiting, colic, diarrhoea, anorexia, dyspepsia, unpleasant taste, constipation; headache, malaise, fatigue, depression, irritability, somnolence, hyperaesthesia, dizziness, confusion; rash, pruritus, generalised urticaria, alopecia, inj site reactions, flushing; leucopenia, thrombocytopenia, anaemia, granulocytopenia, chest pain, oedema (peripheral, facial and periorbital), hypotension, tachycardia, hypertension, increased heart rate, ST-segment elevation; dyspnoea, coughing, pneumonia, tachypnea; fever; hypocalcaemia; increased sweating; back pain, limb pain, myalgia; increased hepatic enzyme concentrations; pharyngitis; ulceration of mucous membranes. In patients receiving oral and/or IV mesna and were specifically not treated with concurrent cytotoxic therapy: flatulence; rhinitis; rigors; back pain; rash; conjunctivitis; arthralgia. Inhalation: bronchospasm.
ContraindicationsView
Hypersensitivity to thiol-containing compounds.
PrecautionsView
Protective effect applies only to the urinary tract; pregnancy, lactation. Patients with auto-immune disorders. IV formulation may contain benzyl alcohol as a preservative; avoid in neonates or infants. Instruct patients to seek medical attention if discolouration of urine occurs. During treatment, monitor urine for erythrocytes and haematuria. Maintain adequate hydration in all patients. Patients who vomit within 2 hr of oral dose should repeat dose or receive IV dose.
Pregnancy & lactationView
Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
ReconstitutionView
Dilute in 50-1000 ml normal saline, 5% dextrose or lactated Ringer's.
StorageView
Should be stored at 15-30° C.

Mesacol

Mesalazine [5-aminosalicylic acid]
Tablet (Delayed Release) 400 mg Allopathic Aminosalicylates

Indications

Ulcerative colitis

Indication detailsView
Mesalazine is indicated for
  • Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease
  • Maintenance of remission of Ulcerative Colitis
  • Maintenance of remission of Crohn’s disease
Therapeutic classView
Aminosalicylates
PharmacologyView

The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of Arachidonic Acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic infammatory bowel disease. Mesalamine diminishes infammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

DosageView
Ulcerative colitis-
Adults:
  • Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
  • Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:
  • Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
  • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
  • It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
AdministrationView
The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.
Side effectsView

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

ContraindicationsView

Hypersensitivity to salicylates or to any other component of the formulation.

PrecautionsView
Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.
InteractionsView
Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.
Pregnancy & lactationView

It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.

Pediatric usageView
Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.

Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy.

Paediatric: Safety and effectiveness have not been established.
Overdose effectsView
There is no specifc antidote for Mesalamine overdose. Treatment for suspected acute severe toxicity should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fuid electrolyte imbalance and maintenance of adequate renal function. This is a pH dependent delayed-release product and this factor should be considered when treating a suspected over dose.
StorageView

Store below 30 0 C. Protect from light and moisture. Keep all medicines out of the reach of children.

Mesagut

Mesalazine [5-aminosalicylic acid]
Tablet (Delayed Release) 400 mg Allopathic Aminosalicylates

Indications

Ulcerative colitis

Indication detailsView
Mesalazine is indicated for
  • Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease
  • Maintenance of remission of Ulcerative Colitis
  • Maintenance of remission of Crohn’s disease
Therapeutic classView
Aminosalicylates
PharmacologyView

The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of Arachidonic Acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic infammatory bowel disease. Mesalamine diminishes infammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

DosageView
Ulcerative colitis-
Adults:
  • Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
  • Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:
  • Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
  • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
  • It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
AdministrationView
The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.
Side effectsView

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

ContraindicationsView

Hypersensitivity to salicylates or to any other component of the formulation.

PrecautionsView
Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.
InteractionsView
Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.
Pregnancy & lactationView

It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.

Pediatric usageView
Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.

Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy.

Paediatric: Safety and effectiveness have not been established.
Overdose effectsView
There is no specifc antidote for Mesalamine overdose. Treatment for suspected acute severe toxicity should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fuid electrolyte imbalance and maintenance of adequate renal function. This is a pH dependent delayed-release product and this factor should be considered when treating a suspected over dose.
StorageView

Store below 30 0 C. Protect from light and moisture. Keep all medicines out of the reach of children.

Mesala

Mesalazine [5-aminosalicylic acid]
Tablet (Delayed Release) 400 mg Allopathic Aminosalicylates

Indications

Ulcerative colitis

Indication detailsView
Mesalazine is indicated for
  • Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease
  • Maintenance of remission of Ulcerative Colitis
  • Maintenance of remission of Crohn’s disease
Therapeutic classView
Aminosalicylates
PharmacologyView

The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of Arachidonic Acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic infammatory bowel disease. Mesalamine diminishes infammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

DosageView
Ulcerative colitis-
Adults:
  • Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
  • Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:
  • Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
  • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
  • It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
AdministrationView
The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.
Side effectsView

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

ContraindicationsView

Hypersensitivity to salicylates or to any other component of the formulation.

PrecautionsView
Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.
InteractionsView
Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.
Pregnancy & lactationView

It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.

Pediatric usageView
Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.

Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy.

Paediatric: Safety and effectiveness have not been established.
Overdose effectsView
There is no specifc antidote for Mesalamine overdose. Treatment for suspected acute severe toxicity should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fuid electrolyte imbalance and maintenance of adequate renal function. This is a pH dependent delayed-release product and this factor should be considered when treating a suspected over dose.
StorageView

Store below 30 0 C. Protect from light and moisture. Keep all medicines out of the reach of children.

Mesartin

Olmesartan Medoxomil
Tablet 20 mg Allopathic Angiotensin-ll receptor blocker

Indications

Hypertension

Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
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. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.

Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Pediatric usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.

Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.

Mesartin Plus

Amlodipine Besilate + Olmesartan Medoxomil
Tablet 5 mg+20 mg Allopathic Combined antihypertensive preparations

Indications

Hypertension

Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

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.

Olmesartan Medoxomil blocks 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 Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.

Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
  • Hypotension in volume- or salt depleted patients.
  • Vasodilation in patients with severe aortic stenosis.
  • Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. 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.
Pediatric usageView

Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.

Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.

Meslamin DR

Mesalazine [5-aminosalicylic acid]
Tablet (Delayed Release) 400 mg Allopathic Aminosalicylates

Indications

Ulcerative colitis

Indication detailsView
Mesalazine is indicated for
  • Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease
  • Maintenance of remission of Ulcerative Colitis
  • Maintenance of remission of Crohn’s disease
Therapeutic classView
Aminosalicylates
PharmacologyView

The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of Arachidonic Acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic infammatory bowel disease. Mesalamine diminishes infammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

DosageView
Ulcerative colitis-
Adults:
  • Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
  • Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:
  • Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
  • Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
  • It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
AdministrationView
The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.
Side effectsView

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

ContraindicationsView

Hypersensitivity to salicylates or to any other component of the formulation.

PrecautionsView
Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.
InteractionsView
Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.
Pregnancy & lactationView

It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.

Pediatric usageView
Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.

Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy.

Paediatric: Safety and effectiveness have not been established.
Overdose effectsView
There is no specifc antidote for Mesalamine overdose. Treatment for suspected acute severe toxicity should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fuid electrolyte imbalance and maintenance of adequate renal function. This is a pH dependent delayed-release product and this factor should be considered when treating a suspected over dose.
StorageView

Store below 30 0 C. Protect from light and moisture. Keep all medicines out of the reach of children.

Mesna

Mesna
IV Injection 400 mg/4 ml Allopathic Antidote preparations

Indications

Urothelial toxicity

Indication detailsView
Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Therapeutic classView
Antidote preparations
PharmacologyView
Mesna is used to prevent urothelial toxicity associated with oxazaphosphorine, ifosfamide or cyclophosphamide. It acts in the kidney; reacting with thiol groups of urotoxic metabolites (e.g. acrolein) of ifosfamide and cyclophosphamide. It is used as a mucolytic in the management of some respiratory tract conditions e.g. cystic fibrosis where other mucolytics have failed. It acts by reducing the viscosity of pulmonary secretions; the drug's free sulfhydryl group is thought to reduce disulfide linkages of mucoproteins.
DosageView
Intravenous-
Prophylaxis against urothelial toxicity:
  • Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall. Administered either by short (15-30 minutes) or continuous (24 hr) infusion.
  • Child: Refer to individual and local protocol. Has been used in children >4 mth.
Oral-
Prophylaxis against urothelial toxicity:
  • Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall.
  • Child: Refer to individual and local protocol.
Side effectsView
Nausea, vomiting, colic, diarrhoea, anorexia, dyspepsia, unpleasant taste, constipation; headache, malaise, fatigue, depression, irritability, somnolence, hyperaesthesia, dizziness, confusion; rash, pruritus, generalised urticaria, alopecia, inj site reactions, flushing; leucopenia, thrombocytopenia, anaemia, granulocytopenia, chest pain, oedema (peripheral, facial and periorbital), hypotension, tachycardia, hypertension, increased heart rate, ST-segment elevation; dyspnoea, coughing, pneumonia, tachypnea; fever; hypocalcaemia; increased sweating; back pain, limb pain, myalgia; increased hepatic enzyme concentrations; pharyngitis; ulceration of mucous membranes. In patients receiving oral and/or IV mesna and were specifically not treated with concurrent cytotoxic therapy: flatulence; rhinitis; rigors; back pain; rash; conjunctivitis; arthralgia. Inhalation: bronchospasm.
ContraindicationsView
Hypersensitivity to thiol-containing compounds.
PrecautionsView
Protective effect applies only to the urinary tract; pregnancy, lactation. Patients with auto-immune disorders. IV formulation may contain benzyl alcohol as a preservative; avoid in neonates or infants. Instruct patients to seek medical attention if discolouration of urine occurs. During treatment, monitor urine for erythrocytes and haematuria. Maintain adequate hydration in all patients. Patients who vomit within 2 hr of oral dose should repeat dose or receive IV dose.
Pregnancy & lactationView
Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
ReconstitutionView
Dilute in 50-1000 ml normal saline, 5% dextrose or lactated Ringer's.
StorageView
Should be stored at 15-30° C.

Mesta Care

Fluocinolone Acetonide + Hydroquinone + Tretinoin
Cream 0.01%+4%+0.05% Allopathic Hydroquinone Preparations

Indications

Melasma

Indication detailsView
This cream is indicated for the short-term treatment of moderate to severe melasma of the face, after starting the treatment avoid presence of sun. Use a sunscreen of at least SPF 30 or more.
Therapeutic classView
Hydroquinone Preparations
PharmacologyView
This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in This cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.
DosageView
This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.

Pediatric Use: The safety and effectiveness of this cream in pediatric patients have not been established.
Side effectsView
A very few patients may get severe allergic reactions from this cream. They may have trouble breathing or severe asthma attacks. While patients use this cream, skin may develop mild to moderate redness, peeling, burning, dryness or itching.
ContraindicationsView
This cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.
PrecautionsView
This cream contains Hydroquinone and Tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. This cream also contains the corticosteroid Fluocinolone Acetonide. Systemic absorption of topical corticosteroids can produce reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of this cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.
InteractionsView
Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.
Pregnancy & lactationView
Pregnancy Category C. This cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with this cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well controlled studies in pregnant women. This cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of this cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when this cream is administered to nursing women.
StorageView
Store in a cool & dry place, protected from light. Do not freeze. Keep out of reach of children.

Mestiza

Black Cohosh [Cimicifuga Racemosa]
Capsule 40 mg Herbal Herbal and Nutraceuticals

Indications

Vertigo

Indication detailsView
Black Cohosh is indicated in Premenstrual discomfort, Dysmenorrhea, Menopausal complaints such as hot flashes, heart palpitations, nervousness, irritability, sleep disturbances, tinnitus, vertigo, perspiration and depression.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Black cohosh (Cimicifuga racemosa) is popular as an alternative to hormonal therapy in the treatment of menopausal (climacteric) symptoms such as hot flashes, mood disturbances, diaphoresis, palpitations and vaginal dryness.
DosageView
1-2 capsules daily or as directed by the physician. Duration of treatment should be maximum six months at a time.
Side effectsView
Black cohosh is safe for most people. It might cause some mild side effects such as stomach upset, cramping, headache, rash, a feeling of heaviness, and weight gain. Occasional gastrointestinal discomfort may occur.
ContraindicationsView
No significant contraindication is observed.
PrecautionsView
Black cohosh should be used cautiously in patients with liver disease, kidney disease and seizure disorders.
InteractionsView
Black cohosh may interact with birth control pills, hormone replacement therapy, sedatives or antihypertensive.
Pregnancy & lactationView
Not recommended during pregnancy due to an increased risk of spontaneous abortion. Not recommended during lactation.
StorageView
Store in a cool and dry place, away from light & moisture. Keep out of reach of children.

Met

Metformin Hydrochloride
Tablet 850 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
  • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
  • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
  • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
  • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
  • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
  • Children: Metformin extended release tablet has not been studied in children.
  • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
  • Hypersensitivity to the active substance or to any of the excipients.
  • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
  • Severe renal failure (GFR <30 mL/min).
  • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
  • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
  • At least annually in patients with normal renal function,
  • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Met

Metformin Hydrochloride
Tablet 500 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
  • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
  • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
  • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
  • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
  • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
  • Children: Metformin extended release tablet has not been studied in children.
  • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
  • Hypersensitivity to the active substance or to any of the excipients.
  • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
  • Severe renal failure (GFR <30 mL/min).
  • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
  • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
  • At least annually in patients with normal renal function,
  • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.