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Ronem
Meropenem Trihydrate
Ronem
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Ronem
Meropenem Trihydrate
Ronem
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Ronem
Meropenem Trihydrate
Ronem
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Ropenem
Meropenem Trihydrate
Ropenem
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Ropenem
Meropenem Trihydrate
Ropenem
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Ropenia
Filgrastim
Ropenia
Filgrastim
Indications
Peripheral blood progenitor cell collection and therapy
Indication detailsView
Filgrastim is indicated to those:
- Cancer patients receiving myelosuppressive chemotherapy
- Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy
- Cancer patients receiving bone marrow transplant
- Patients with severe neutropenia
- Peripheral blood progenitor cell collection and therapy
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Filgrastim is a granulocyte-colony stimulating factor which binds to cell surface receptors on haemetopoietic cells thus stimulating the development of granulocytes to increase their migration and cytotoxicity.
Filgrastim is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. Elevations of neutrophil counts are dose-dependent at recommended doses. Following termination of Filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Filgrastim is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. Elevations of neutrophil counts are dose-dependent at recommended doses. Following termination of Filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
DosageView
Parenteral-
Chemotherapy-induced neutropenia: 5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting notBone marrow transplantation: 10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response.
Subcutaneous-
Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation: 10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed.Congenital neutropenia: 12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response.
HIV infection and persistent neutropenia: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.
Side effectsView
Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.
ContraindicationsView
Filgrastim is contraindicated in patients hypersensitive to the drug, any ingredient in the formulation, or proteins derived from Escherichia coli.
PrecautionsView
Filgrastim should not be administered within 24 hours before and after chemotherapy The possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded. To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment. Filgrastim is given by subcutaneous or intravenous infusion as required
InteractionsView
Drug interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium should be used with caution.
Pregnancy & lactationView
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Pediatric usageView
Pediatric precautions: Filgrastim has been used in children 3 months to 18 years of age without unusual adverse effect. However, safety and efficacy of the drug in neonates or patients with autoimmune neutropenia of infancy have not been established.
Overdose effectsView
The possibility of Filgrastim acting as a growth factor for any tumor type and adverse effects of excessive neutrophils may occur in overdose of Filgrastim.
ReconstitutionView
Dilution of Filgrastim conc less than 5 mcg/ml is not recommended at any time. Filgrastim may be diluted in 5% dextrose as required
StorageView
Refrigerate at 2-8° C. Do not freeze.
Ropinol
Ropinirole
Ropinol
Ropinirole
Indications
Tourette syndrome
Indication detailsView
Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. It is also indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Therapeutic classView
Antiparkinson drugs
PharmacologyView
Ropinirole is a non-ergoline dopamine agonist. Ropinirole has the highest affinity at the D3 receptors, which are concentrated in the limbic areas of the brain and may be responsible for some of the neuropsychiatric effects. The exact mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, however, it is believed to be related to its ability to selectively stimulate dopamine D2 receptors within the caudate-putamen system in the brain. This system affects body movement. Negligible affinity is seen for ropinirole at α2 adrenoreceptors in the periphery and 5HT-1 receptor. Ropinirole has no affinity at the D1-like receptors, benzodiazepine or GABA receptors. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, however, it is believed to be related to its ability to stimulate dopamine receptors.
DosageView
Dosing for Parkinson's disease: The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described below. Maximum recommended total daily dose of 24 mg (8 mg three times daily).
- Week 1: 0.25 mg 3 times daily. Total Daily Dose 0.75 mg
- Week 2: 0.5 mg 3 times daily. Total Daily Dose 1.50 mg
- Week 3: 0.75 mg 3 times daily. Total Daily Dose 2.25 mg
- Week 4: 1 mg 3 times daily. Total Daily Dose 3 mg
- Days 1 and 2: 0.25 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3-7: 0.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 2: 1 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3: 1.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 4: 2 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 5: 2.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 6: 3 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 7: 4 mg, 1 to 3 hours before bedtime, to be taken once daily
Side effectsView
The most common side effects of Ropinirole include fainting, drowsiness, hallucinations, dizziness, nausea or vomiting, uncontrolled sudden movements, leg swelling, fatigue, confusion, headache, upset stomach, abdominal pain or discomfort, increased sweating etc.
ContraindicationsView
It is contraindicated in patients known to have a hypersensitivity to Ropinirole.
PrecautionsView
Patients treated with Ropinirole have reported falling asleep while engaged in activities of daily living. Dopamine agonists in clinical trials and clinical experience appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension.
InteractionsView
Because Ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metodopramide may reduce the efficacy of Ropinirole.
Pregnancy & lactationView
Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Ropinirole inhibits prolactin secretion in human and could potentially inhibit lactation.
StorageView
Protect from light and moisture, store below 25°C. Keep out of the reach of children.
Ropinol
Ropinirole
Ropinol
Ropinirole
Indications
Tourette syndrome
Indication detailsView
Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. It is also indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Therapeutic classView
Antiparkinson drugs
PharmacologyView
Ropinirole is a non-ergoline dopamine agonist. Ropinirole has the highest affinity at the D3 receptors, which are concentrated in the limbic areas of the brain and may be responsible for some of the neuropsychiatric effects. The exact mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, however, it is believed to be related to its ability to selectively stimulate dopamine D2 receptors within the caudate-putamen system in the brain. This system affects body movement. Negligible affinity is seen for ropinirole at α2 adrenoreceptors in the periphery and 5HT-1 receptor. Ropinirole has no affinity at the D1-like receptors, benzodiazepine or GABA receptors. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, however, it is believed to be related to its ability to stimulate dopamine receptors.
DosageView
Dosing for Parkinson's disease: The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described below. Maximum recommended total daily dose of 24 mg (8 mg three times daily).
- Week 1: 0.25 mg 3 times daily. Total Daily Dose 0.75 mg
- Week 2: 0.5 mg 3 times daily. Total Daily Dose 1.50 mg
- Week 3: 0.75 mg 3 times daily. Total Daily Dose 2.25 mg
- Week 4: 1 mg 3 times daily. Total Daily Dose 3 mg
- Days 1 and 2: 0.25 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3-7: 0.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 2: 1 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3: 1.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 4: 2 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 5: 2.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 6: 3 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 7: 4 mg, 1 to 3 hours before bedtime, to be taken once daily
Side effectsView
The most common side effects of Ropinirole include fainting, drowsiness, hallucinations, dizziness, nausea or vomiting, uncontrolled sudden movements, leg swelling, fatigue, confusion, headache, upset stomach, abdominal pain or discomfort, increased sweating etc.
ContraindicationsView
It is contraindicated in patients known to have a hypersensitivity to Ropinirole.
PrecautionsView
Patients treated with Ropinirole have reported falling asleep while engaged in activities of daily living. Dopamine agonists in clinical trials and clinical experience appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension.
InteractionsView
Because Ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metodopramide may reduce the efficacy of Ropinirole.
Pregnancy & lactationView
Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Ropinirole inhibits prolactin secretion in human and could potentially inhibit lactation.
StorageView
Protect from light and moisture, store below 25°C. Keep out of the reach of children.
Ropinol
Ropinirole
Ropinol
Ropinirole
Indications
Tourette syndrome
Indication detailsView
Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. It is also indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Therapeutic classView
Antiparkinson drugs
PharmacologyView
Ropinirole is a non-ergoline dopamine agonist. Ropinirole has the highest affinity at the D3 receptors, which are concentrated in the limbic areas of the brain and may be responsible for some of the neuropsychiatric effects. The exact mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, however, it is believed to be related to its ability to selectively stimulate dopamine D2 receptors within the caudate-putamen system in the brain. This system affects body movement. Negligible affinity is seen for ropinirole at α2 adrenoreceptors in the periphery and 5HT-1 receptor. Ropinirole has no affinity at the D1-like receptors, benzodiazepine or GABA receptors. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, however, it is believed to be related to its ability to stimulate dopamine receptors.
DosageView
Dosing for Parkinson's disease: The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described below. Maximum recommended total daily dose of 24 mg (8 mg three times daily).
- Week 1: 0.25 mg 3 times daily. Total Daily Dose 0.75 mg
- Week 2: 0.5 mg 3 times daily. Total Daily Dose 1.50 mg
- Week 3: 0.75 mg 3 times daily. Total Daily Dose 2.25 mg
- Week 4: 1 mg 3 times daily. Total Daily Dose 3 mg
- Days 1 and 2: 0.25 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3-7: 0.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 2: 1 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 3: 1.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 4: 2 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 5: 2.5 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 6: 3 mg, 1 to 3 hours before bedtime, to be taken once daily
- Days 7: 4 mg, 1 to 3 hours before bedtime, to be taken once daily
Side effectsView
The most common side effects of Ropinirole include fainting, drowsiness, hallucinations, dizziness, nausea or vomiting, uncontrolled sudden movements, leg swelling, fatigue, confusion, headache, upset stomach, abdominal pain or discomfort, increased sweating etc.
ContraindicationsView
It is contraindicated in patients known to have a hypersensitivity to Ropinirole.
PrecautionsView
Patients treated with Ropinirole have reported falling asleep while engaged in activities of daily living. Dopamine agonists in clinical trials and clinical experience appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension.
InteractionsView
Because Ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metodopramide may reduce the efficacy of Ropinirole.
Pregnancy & lactationView
Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Ropinirole inhibits prolactin secretion in human and could potentially inhibit lactation.
StorageView
Protect from light and moisture, store below 25°C. Keep out of the reach of children.
Ropitor
Rosuvastatin
Ropitor
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Ropitor
Rosuvastatin
Ropitor
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Ropitor
Rosuvastatin
Ropitor
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Roquin
Hydroxychloroquine Sulphate
Roquin
Hydroxychloroquine Sulphate
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Hydroxychloroquine Sulphate is indicated in-
- Acute and chronic rheumatoid arthritis
- Systemic Lupus Erythematosus (SLE)
- Malaria
Therapeutic classView
Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis
PharmacologyView
Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.
DosageView
Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.
Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.
Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.
Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.
Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.
Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.
Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.
- First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
- Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
- Third dose: 5 mg base/kg 18 hours after second dose.
- Fourth dose: 5 mg base/kg 24 hours after third dose.
Side effectsView
Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.
PrecautionsView
Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.
Pregnancy & lactationView
During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.
Overdose effectsView
Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.
StorageView
Store below 30° C.
Rosalin
Oxymetazoline Hydrochloride (Cream)
Rosalin
Oxymetazoline Hydrochloride (Cream)
Indications
Rosacea
Indication detailsView
Oxymetazoline Hydrochloride cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Therapeutic classView
Vasoconstrictor/Venotonic
PharmacologyView
Oxymetazoline is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.
DosageView
For topical use only, it is not for oral, ophthalmic or intravaginal use. Apply a little amount of the cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek and chin) avoiding eyes and lips. Wash hands immediately after applying the cream.
Side effectsView
Most common side effects are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema and application site pain.
PrecautionsView
Alpha-adrenergic agonists may impact blood pressure. Advise patients with ardiovascular disese, orthostatic hypotension and/or uncontolled hypertension or hypotension to seek medical care if their condition worsens. Use with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma or Sjögren’s syndrome and advisepatients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
Pregnancy & lactationView
The safety of oxymetazoline during pregnancy and lactation has not been established, but use during this period is not considered to constitute a hazard.
Overdose effectsView
Oxymetazoline is not for oral use. If oral ingestion occurs, seek medical advice. Monitor patient closely and administer appropriate supportive measures as necessary
StorageView
Do not store above 30° C. Keep away from light and out of the reach of children.
Rosatan H
Losartan Potassium + Hydrochlorothiazide
Rosatan H
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Rose
Evening primrose oil
Rose
Evening primrose oil
Indications
Premenstrual syndrome
Indication detailsView
Evening primrose oil is indicated in:
- Premenstrual syndrome symptoms (PMS)
- Benign breast disease & cyclical mastalgia
- Lactation
- Atopic, allergic & neurodermatitis
- Psoriasis
- Hypertension
- Rheumatoid arthritis
- Thrombosis
- Atopic eczema
- Dietary aid
- Promotes healthy skin, nourishes brittle nails & hair.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Improves EFA composition of plasma, erythrocytes, platelet lipids and atocopherol levels in non-diabetic persons and Type 1 diabetic patients; increase total fat and EFA contents of mother's milk; affects fatty acid composition of serum lipids and adipose tissue in men with low dihoma-gamma-linolenic acid (DGLA) levels; helps maintain normal cellular structures and in the precursor of DGLA, which is the parent of the 1-series prostanoids and as a precursor of arachidonic acid, the parent of the 2-series prostanoids.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
DosageView
Atopic & Allergic Dermatitis:
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
- Adult dosage: 1 capsule 2 times daily.
- Children dosage: 1 capsule 1/2 times daily.
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
Side effectsView
Side effects are rare at recommended dosages. Overdose may cause loose stool and abdominal pain.
ContraindicationsView
Previously it was not recommended for patients diagnosed with schizophrenia. However, a recently published analysis of clinical trials involving polyunsaturated fatty acids in the treatment of schizophrenia did not indicate a clear therapeutic or adverse effect of evening primrose oil supplements on schizophrenic patients.
Pregnancy & lactationView
Linolenic acid, GLA and DGLA are important components of human breast milk, so it is responsible to assure that evening primrose oil may be taken while nursing. According to World Health Organization (WHO), pregnant or lactating women should get 5% of their total daily caloric intake from EFAs.
StorageView
Keep out of reach of children. Keep away from direct sunlight. Store below 25°C in a dry place.
Rosebac
Meropenem Trihydrate
Rosebac
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Rosebac
Meropenem Trihydrate
Rosebac
Meropenem Trihydrate
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:
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.
- 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.
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
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.
Rosela
Rupatadine Fumarate
Rosela
Rupatadine Fumarate
Indication detailsView
Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.
DosageView
Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.
Children aged 2 to 11 years:
Children aged 2 to 11 years:
- Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
- Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
Side effectsView
Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.
ContraindicationsView
Hypersensitivity to Rupatadine or to any of the excipients.
PrecautionsView
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
InteractionsView
With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
Pregnancy & lactationView
There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.
Pediatric usageView
Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Overdose effectsView
The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Rosela
Rupatadine Fumarate
Rosela
Rupatadine Fumarate
Indication detailsView
Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.
DosageView
Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.
Children aged 2 to 11 years:
Children aged 2 to 11 years:
- Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
- Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
Side effectsView
Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.
ContraindicationsView
Hypersensitivity to Rupatadine or to any of the excipients.
PrecautionsView
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
InteractionsView
With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
Pregnancy & lactationView
There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.
Pediatric usageView
Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Overdose effectsView
The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.