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    Rovantin

    Cefpodoxime Proxetil
    Tablet 100 mg Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
    • Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
    • Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
    • Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
    • Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
    • Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
    • Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
    • Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
    • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
    • Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
    DosageView
    Adults and Adolescents (13 years and older)
    • Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
    • Community acquired pneumonia: 200 mg 12 hourly, 14 days
    • Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
    • Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
    • Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
    • Uncomplicated gonorrhea: single dose of 200 mg
    • Rectal gonococcal infections in women: single dose of 200 mg
    Infants and Pediatric Patients (2 months to 12 years)
    • Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
    • Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
    Side effectsView
    Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
    ContraindicationsView
    Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
    PrecautionsView
    In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
    InteractionsView
    Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
    Pregnancy & lactationView
    US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
    Pediatric usageView
    Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
    ReconstitutionView
    Step 1: Shake the bottle well to loosen the powder.
    Step 2    : Add boiled and cooled water in the bottle.
    Step 3    : Shake until powder is completely mixed with water.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Rovantin

    Cefpodoxime Proxetil
    Pediatric Drops 20 mg/ml Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
    • Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
    • Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
    • Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
    • Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
    • Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
    • Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
    • Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
    • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
    • Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
    DosageView
    Adults and Adolescents (13 years and older)
    • Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
    • Community acquired pneumonia: 200 mg 12 hourly, 14 days
    • Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
    • Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
    • Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
    • Uncomplicated gonorrhea: single dose of 200 mg
    • Rectal gonococcal infections in women: single dose of 200 mg
    Infants and Pediatric Patients (2 months to 12 years)
    • Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
    • Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
    Side effectsView
    Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
    ContraindicationsView
    Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
    PrecautionsView
    In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
    InteractionsView
    Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
    Pregnancy & lactationView
    US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
    Pediatric usageView
    Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
    ReconstitutionView
    Step 1: Shake the bottle well to loosen the powder.
    Step 2    : Add boiled and cooled water in the bottle.
    Step 3    : Shake until powder is completely mixed with water.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Rovantin

    Cefpodoxime Proxetil
    Powder for Suspension 40 mg/5 ml Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
    • Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
    • Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
    • Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
    • Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
    • Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
    • Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
    • Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
    • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
    • Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
    DosageView
    Adults and Adolescents (13 years and older)
    • Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
    • Community acquired pneumonia: 200 mg 12 hourly, 14 days
    • Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
    • Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
    • Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
    • Uncomplicated gonorrhea: single dose of 200 mg
    • Rectal gonococcal infections in women: single dose of 200 mg
    Infants and Pediatric Patients (2 months to 12 years)
    • Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
    • Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
    Side effectsView
    Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
    ContraindicationsView
    Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
    PrecautionsView
    In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
    InteractionsView
    Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
    Pregnancy & lactationView
    US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
    Pediatric usageView
    Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
    ReconstitutionView
    Step 1: Shake the bottle well to loosen the powder.
    Step 2    : Add boiled and cooled water in the bottle.
    Step 3    : Shake until powder is completely mixed with water.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Rovantin DS

    Cefpodoxime Proxetil
    Powder for Suspension 80 mg/5 ml Allopathic Third generation Cephalosporins

    Indications

    Urinary tract infection

    Indication detailsView
    Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
    • Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
    • Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
    • Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
    • Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
    • Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
    • Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
    • Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
    • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
    • Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
    DosageView
    Adults and Adolescents (13 years and older)
    • Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
    • Community acquired pneumonia: 200 mg 12 hourly, 14 days
    • Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
    • Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
    • Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
    • Uncomplicated gonorrhea: single dose of 200 mg
    • Rectal gonococcal infections in women: single dose of 200 mg
    Infants and Pediatric Patients (2 months to 12 years)
    • Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
    • Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
    • Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
    Side effectsView
    Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
    ContraindicationsView
    Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
    PrecautionsView
    In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
    InteractionsView
    Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
    Pregnancy & lactationView
    US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
    Pediatric usageView
    Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
    ReconstitutionView
    Step 1: Shake the bottle well to loosen the powder.
    Step 2    : Add boiled and cooled water in the bottle.
    Step 3    : Shake until powder is completely mixed with water.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Rovast

    Rosuvastatin
    Tablet 20 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovast

    Rosuvastatin
    Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovast

    Rosuvastatin
    Tablet 5 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovator

    Rosuvastatin
    Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovator

    Rosuvastatin
    Tablet 5 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovedilol

    Carvedilol
    Tablet 6.25 mg Allopathic Alpha adrenoceptor blocking drugs

    Indications

    Myocardial infarction

    Indication detailsView
    Carvedilol is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications. Carvedilol may be used in patients unable to tolerate an ACE inhibitor. Carvedilol may be used in patients who are not receiving digitalis, hydralazine or nitrate therapy.
    Therapeutic classView
    Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers
    PharmacologyView
    Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.
    DosageView
    In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

    In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

    In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.
    Side effectsView
    Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.
    ContraindicationsView
    Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.
    PrecautionsView
    Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating
    InteractionsView
    Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

    Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

    Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

    Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.
    Pregnancy & lactationView
    Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.
    StorageView
    Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

    Rovedilol

    Carvedilol
    Tablet 12.5 mg Allopathic Alpha adrenoceptor blocking drugs

    Indications

    Myocardial infarction

    Indication detailsView
    Carvedilol is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications. Carvedilol may be used in patients unable to tolerate an ACE inhibitor. Carvedilol may be used in patients who are not receiving digitalis, hydralazine or nitrate therapy.
    Therapeutic classView
    Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers
    PharmacologyView
    Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.
    DosageView
    In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

    In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

    In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.
    Side effectsView
    Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.
    ContraindicationsView
    Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.
    PrecautionsView
    Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating
    InteractionsView
    Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

    Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

    Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

    Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.
    Pregnancy & lactationView
    Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.
    StorageView
    Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

    Rovex

    Rosuvastatin
    Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Rovex

    Rosuvastatin
    Tablet 5 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

    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.
    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
    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.

    Roxadex

    Dexamethasone
    IM/IV Injection 6 mg/ml Allopathic
    Indication detailsView
    Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
    Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
    Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
    Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
    Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
    Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
    Neoplastic diseases: Leukemias and lymphomas.
    Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
    Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
    Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
    Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
    Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
    Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
    PharmacologyView
    Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
    DosageView
    In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

    For tablet:
    • In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
    • In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
    • For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
    • Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
    • for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.
    For injection:
    • Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
    • Intravenous injections of massive doses should be given slowly, over a period of several minutes.
    • Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
    • Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
    • The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
    • For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.
    For local therapy, the following doses are recommended:
    • Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
    • Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
    • The frequency of these injections may vary from every 3-5 days to every 2-3 weeks
    Side effectsView
    The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

    Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

    Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

    Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

    Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

    Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

    Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

    Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

    Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
    ContraindicationsView
    • Gastric and duodenal ulcers.
    • Systemic and ophthalmic fungal infections.
    • Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
    • Glaucoma.
    • Hypersensitivity to corticosteroids
    PrecautionsView
    General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

    Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

    Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

    Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

    Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

    Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
    InteractionsView
    • Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
    • Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
    • Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
    • Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
    • Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
    • If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
    • Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.
    Pregnancy & lactationView
    Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed
    Pediatric usageView
    In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
    Overdose effectsView
    Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy
    StorageView
    Tablet: Store in a cool & dry place, protected from light & moisture.
    Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

    Roxadex

    Dexamethasone
    Tablet 6 mg Allopathic
    Indication detailsView
    Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
    Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
    Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
    Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
    Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
    Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
    Neoplastic diseases: Leukemias and lymphomas.
    Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
    Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
    Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
    Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
    Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
    Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
    PharmacologyView
    Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
    DosageView
    In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

    For tablet:
    • In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
    • In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
    • For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
    • Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
    • for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.
    For injection:
    • Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
    • Intravenous injections of massive doses should be given slowly, over a period of several minutes.
    • Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
    • Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
    • The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
    • For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.
    For local therapy, the following doses are recommended:
    • Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
    • Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
    • The frequency of these injections may vary from every 3-5 days to every 2-3 weeks
    Side effectsView
    The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

    Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

    Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

    Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

    Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

    Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

    Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

    Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

    Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
    ContraindicationsView
    • Gastric and duodenal ulcers.
    • Systemic and ophthalmic fungal infections.
    • Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
    • Glaucoma.
    • Hypersensitivity to corticosteroids
    PrecautionsView
    General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

    Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

    Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

    Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

    Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

    Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
    InteractionsView
    • Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
    • Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
    • Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
    • Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
    • Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
    • If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
    • Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.
    Pregnancy & lactationView
    Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed
    Pediatric usageView
    In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
    Overdose effectsView
    Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy
    StorageView
    Tablet: Store in a cool & dry place, protected from light & moisture.
    Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

    Roxadex

    Dexamethasone
    IM/IV Injection 5 mg/ml Allopathic
    Indication detailsView
    Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
    Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
    Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
    Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
    Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
    Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
    Neoplastic diseases: Leukemias and lymphomas.
    Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
    Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
    Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
    Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
    Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
    Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
    PharmacologyView
    Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
    DosageView
    In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

    For tablet:
    • In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
    • In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
    • For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
    • Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
    • for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.
    For injection:
    • Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
    • Intravenous injections of massive doses should be given slowly, over a period of several minutes.
    • Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
    • Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
    • The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
    • For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.
    For local therapy, the following doses are recommended:
    • Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
    • Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
    • The frequency of these injections may vary from every 3-5 days to every 2-3 weeks
    Side effectsView
    The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

    Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

    Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

    Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

    Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

    Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

    Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

    Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

    Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
    ContraindicationsView
    • Gastric and duodenal ulcers.
    • Systemic and ophthalmic fungal infections.
    • Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
    • Glaucoma.
    • Hypersensitivity to corticosteroids
    PrecautionsView
    General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

    Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

    Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

    Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

    Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

    Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
    InteractionsView
    • Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
    • Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
    • Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
    • Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
    • Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
    • If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
    • Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.
    Pregnancy & lactationView
    Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed
    Pediatric usageView
    In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
    Overdose effectsView
    Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy
    StorageView
    Tablet: Store in a cool & dry place, protected from light & moisture.
    Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

    Roxair

    Roflumilast
    Tablet 500 mcg Allopathic Antihistamines anti-allergies & hypo-sensitisation

    Indications

    COPD

    Indication detailsView
    Roflumilast is indicated:
    • As add-on therapy to bronchodilator treatment.
    • For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.
    Roflumilast should not be used as a rescue medication.
    Therapeutic classView
    Antihistamines anti-allergies & hypo-sensitisation
    PharmacologyView
    Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
    DosageView
    The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.
    Side effectsView
    General disorders: Fatigue.
    Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
    Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
    Nervous system disorders: Dizziness, Headache, Tremor.
    Psychiatric disorders: Anxiety, Depression, Insomnia.
    ContraindicationsView
    Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
    PrecautionsView
    Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.
    InteractionsView
    A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
    Pregnancy & lactationView
    Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
    Pediatric usageView
    Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.

    Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.

    Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.

    Renal impairment: No dosage adjustment is necessary for patients with renal impairment
    Overdose effectsView
    No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,

    The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.

    Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
    StorageView
    Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

    Roxal

    Ambroxol Hydrochloride
    Pediatric Drops 6 mg/ml Allopathic Cough expectorants & mucolytics

    Indications

    Sore throat

    Indication detailsView
    This is indicated in-
    • Productive cough
    • Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
    • Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
    • Asthmatic bronchitis bronchial asthma with thick expectoration
    • Bronchiectasis
    • Chronic pneumonia etc.
    Therapeutic classView
    Cough expectorants & mucolytics
    PharmacologyView
    Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
    DosageView
    Average daily dose (preferably after meal):

    Pediatric Drops:
    • 0-6 months: 0.5 ml 2 times a day
    • 6-12 months: 1 ml 2 times a day
    • 1-2 years: 1.25 ml 2 times a day
    Syrup:
    • 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
    • 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
    • 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
    Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.
    Side effectsView
    Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
    ContraindicationsView
    Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
    PrecautionsView
    Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
    InteractionsView
    Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
    Pregnancy & lactationView
    Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
    StorageView
    Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

    Roxal

    Ambroxol Hydrochloride
    Syrup 15 mg/5 ml Allopathic Cough expectorants & mucolytics

    Indications

    Sore throat

    Indication detailsView
    This is indicated in-
    • Productive cough
    • Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
    • Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
    • Asthmatic bronchitis bronchial asthma with thick expectoration
    • Bronchiectasis
    • Chronic pneumonia etc.
    Therapeutic classView
    Cough expectorants & mucolytics
    PharmacologyView
    Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
    DosageView
    Average daily dose (preferably after meal):

    Pediatric Drops:
    • 0-6 months: 0.5 ml 2 times a day
    • 6-12 months: 1 ml 2 times a day
    • 1-2 years: 1.25 ml 2 times a day
    Syrup:
    • 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
    • 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
    • 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
    Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.
    Side effectsView
    Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
    ContraindicationsView
    Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
    PrecautionsView
    Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
    InteractionsView
    Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
    Pregnancy & lactationView
    Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
    StorageView
    Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

    Roxarel

    Rivaroxaban
    Tablet 15 mg Allopathic Oral Anti-coagulants

    Indications

    Stroke

    Indication detailsView
    Rivaroxaban 2.5 mg:
    • For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.
    Rivaroxaban 10-20 mg:
    • To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
    • Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
    • For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
    Therapeutic classView
    Oral Anti-coagulants
    PharmacologyView
    Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
    DosageView
    Rivaroxaban 2.5 mg:
    • The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
    Rivaroxaban 10-20 mg:
    • Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
    • Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
    • Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
    • Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
    • Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.
    May be taken with or without food.
    Side effectsView
    The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.
    ContraindicationsView
    It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.
    PrecautionsView
    Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
    InteractionsView
    Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.
    Pregnancy & lactationView
    Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.
    Overdose effectsView
    Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
    StorageView
    Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.