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    Demoxiclave

    Amoxicillin + Clavulanic Acid
    Tablet 500 mg+125 mg Allopathic Broad spectrum penicillins

    Indications

    Severe or recurrent respiratory tract infections

    Indication detailsView
    Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
    • Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
    • Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
    • Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
    • Skin and soft tissue infections.
    • Bone and joint infections e.g.osteomyelitis.
    • Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

    Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
    DosageView
    Adults and children over 12 years:

    Tablet:
    • The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
    • For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
    Suspension:
    • Children 6-12 years: 2 teaspoonful every 8 hours.
    • Children 1-6years: 1 teaspoonful every 8 hours.
    • Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
    Forte suspension:
    • The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
    • For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
    Children of 2 to 12 years:
    Mild to moderate infections:
    • 25/3.6 mg/kg/day (Suspension)
    • 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
    • 7-12years (22-40kg) 5 ml suspension b.i.d
    Serious infections:
    • 45/6.4 mg/kg/day (Forte Suspension)
    • 2-6 years (13-21 kg) 5 ml suspension b.i.d
    • 7-12 years (22-40 kg) 10 ml suspension b.i.d
    IV Injection

    Adults-
    • Usually, 1.2 gm every 8 hours
    • Increased in more serious infections to 1.2 gm every 6 hours
    • For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
    Children-
    • 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
    • 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
    AdministrationView
    Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

    IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
    Side effectsView
    Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
    ContraindicationsView
    History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
    PrecautionsView
    Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
    InteractionsView
    Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
    Pregnancy & lactationView
    Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
    Pediatric usageView
    The dose should be adjusted in case of patients with renal impairment

    Adult:
    • Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
    • Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
    • Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
    Children:
    • A similar reduction in dosage should be made for children.
    • Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
    Overdose effectsView
    Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
    ReconstitutionView
    IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
    StorageView
    This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.

    Demoxiclave

    Amoxicillin + Clavulanic Acid
    Tablet 250 mg+125 mg Allopathic Broad spectrum penicillins

    Indications

    Severe or recurrent respiratory tract infections

    Indication detailsView
    Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
    • Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
    • Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
    • Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
    • Skin and soft tissue infections.
    • Bone and joint infections e.g.osteomyelitis.
    • Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

    Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
    DosageView
    Adults and children over 12 years:

    Tablet:
    • The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
    • For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
    Suspension:
    • Children 6-12 years: 2 teaspoonful every 8 hours.
    • Children 1-6years: 1 teaspoonful every 8 hours.
    • Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
    Forte suspension:
    • The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
    • For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
    Children of 2 to 12 years:
    Mild to moderate infections:
    • 25/3.6 mg/kg/day (Suspension)
    • 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
    • 7-12years (22-40kg) 5 ml suspension b.i.d
    Serious infections:
    • 45/6.4 mg/kg/day (Forte Suspension)
    • 2-6 years (13-21 kg) 5 ml suspension b.i.d
    • 7-12 years (22-40 kg) 10 ml suspension b.i.d
    IV Injection

    Adults-
    • Usually, 1.2 gm every 8 hours
    • Increased in more serious infections to 1.2 gm every 6 hours
    • For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
    Children-
    • 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
    • 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
    AdministrationView
    Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

    IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
    Side effectsView
    Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
    ContraindicationsView
    History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
    PrecautionsView
    Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
    InteractionsView
    Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
    Pregnancy & lactationView
    Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
    Pediatric usageView
    The dose should be adjusted in case of patients with renal impairment

    Adult:
    • Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
    • Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
    • Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
    Children:
    • A similar reduction in dosage should be made for children.
    • Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
    Overdose effectsView
    Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
    ReconstitutionView
    IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
    StorageView
    This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.

    Demoxiclave

    Amoxicillin + Clavulanic Acid
    Powder for Suspension (125 mg+31.25 mg)/5 ml Allopathic Broad spectrum penicillins

    Indications

    Severe or recurrent respiratory tract infections

    Indication detailsView
    Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
    • Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
    • Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
    • Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
    • Skin and soft tissue infections.
    • Bone and joint infections e.g.osteomyelitis.
    • Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

    Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
    DosageView
    Adults and children over 12 years:

    Tablet:
    • The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
    • For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
    Suspension:
    • Children 6-12 years: 2 teaspoonful every 8 hours.
    • Children 1-6years: 1 teaspoonful every 8 hours.
    • Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
    Forte suspension:
    • The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
    • For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
    Children of 2 to 12 years:
    Mild to moderate infections:
    • 25/3.6 mg/kg/day (Suspension)
    • 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
    • 7-12years (22-40kg) 5 ml suspension b.i.d
    Serious infections:
    • 45/6.4 mg/kg/day (Forte Suspension)
    • 2-6 years (13-21 kg) 5 ml suspension b.i.d
    • 7-12 years (22-40 kg) 10 ml suspension b.i.d
    IV Injection

    Adults-
    • Usually, 1.2 gm every 8 hours
    • Increased in more serious infections to 1.2 gm every 6 hours
    • For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
    Children-
    • 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
    • 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
    AdministrationView
    Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

    IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
    Side effectsView
    Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
    ContraindicationsView
    History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
    PrecautionsView
    Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
    InteractionsView
    Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
    Pregnancy & lactationView
    Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
    Pediatric usageView
    The dose should be adjusted in case of patients with renal impairment

    Adult:
    • Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
    • Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
    • Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
    Children:
    • A similar reduction in dosage should be made for children.
    • Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
    Overdose effectsView
    Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
    ReconstitutionView
    IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
    StorageView
    This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.

    Demoxiclave Forte

    Amoxicillin + Clavulanic Acid
    Powder for Suspension (400 mg+57.50 mg)/5 ml Allopathic Broad spectrum penicillins

    Indications

    Severe or recurrent respiratory tract infections

    Indication detailsView
    Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
    • Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
    • Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
    • Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
    • Skin and soft tissue infections.
    • Bone and joint infections e.g.osteomyelitis.
    • Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

    Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
    DosageView
    Adults and children over 12 years:

    Tablet:
    • The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
    • For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
    Suspension:
    • Children 6-12 years: 2 teaspoonful every 8 hours.
    • Children 1-6years: 1 teaspoonful every 8 hours.
    • Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
    Forte suspension:
    • The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
    • For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
    Children of 2 to 12 years:
    Mild to moderate infections:
    • 25/3.6 mg/kg/day (Suspension)
    • 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
    • 7-12years (22-40kg) 5 ml suspension b.i.d
    Serious infections:
    • 45/6.4 mg/kg/day (Forte Suspension)
    • 2-6 years (13-21 kg) 5 ml suspension b.i.d
    • 7-12 years (22-40 kg) 10 ml suspension b.i.d
    IV Injection

    Adults-
    • Usually, 1.2 gm every 8 hours
    • Increased in more serious infections to 1.2 gm every 6 hours
    • For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
    Children-
    • 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
    • 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
    AdministrationView
    Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

    IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
    Side effectsView
    Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
    ContraindicationsView
    History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
    PrecautionsView
    Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
    InteractionsView
    Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
    Pregnancy & lactationView
    Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
    Pediatric usageView
    The dose should be adjusted in case of patients with renal impairment

    Adult:
    • Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
    • Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
    • Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
    Children:
    • A similar reduction in dosage should be made for children.
    • Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
    Overdose effectsView
    Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
    ReconstitutionView
    IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
    StorageView
    This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.

    Demoxil

    Amoxicillin Trihydrate
    IM/IV Injection 1 gm/vial Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Demoxil

    Amoxicillin Trihydrate
    Powder for Suspension 125 mg/5 ml Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Demoxil

    Amoxicillin Trihydrate
    Capsule 500 mg Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Demoxil

    Amoxicillin Trihydrate
    Capsule 250 mg Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Demoxil DS

    Amoxicillin Trihydrate
    Powder for Suspension 250 mg/5 ml Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Denamine

    Chlorpheniramine Maleate
    Tablet 4 mg Allopathic Sedating Anti-histamine

    Indications

    Watery eye

    Indication detailsView
    Chlorpheniramine Maleate is indicated in the following indications-
    • Urticaria
    • Sensitivity reactions
    • Angioneurotic edema
    • Vasomotor rhinitis
    • Cough
    • Common cold
    • Motion sickness and
    • Other allergic conditions.
    Therapeutic classView
    Sedating Anti-histamine
    PharmacologyView
    Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.
    DosageView
    Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

    Child-
    • 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
    • 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
    • 1-2 years: 1 mg twice daily.
    Below 1 year the use of Chlorpheniramine Maleate is not recommended.
    Side effectsView
    Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.
    ContraindicationsView
    Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.
    PrecautionsView
    Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.
    InteractionsView
    Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.
    Pregnancy & lactationView
    This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.
    Overdose effectsView
    CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.
    StorageView
    Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

    Denazit

    Flupentixol + Melitracen
    Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

    Indications

    Psychosis

    Indication detailsView
    Flupentixol and Melitracen tablet is indicated in-
    • Anxiety
    • Depression
    • Apathy
    • Psychogenic depression.
    • Depressive neurosses.
    • Masked depression.
    • Psychosomatic affections accompanied by anxiety and apathy.
    • Menopausal depressions.
    • Dysphoria and depression in alcoholics and drug addicts.
    Therapeutic classView
    Combined anxiolytics & anti-depressant drugs
    PharmacologyView
    This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
    DosageView
    Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

    Elderly patients: 1 tablet in the morning.

    Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
    Side effectsView
    In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
    ContraindicationsView
    • The immediate recovery phase after myocardial infarction.
    • Defects in bundle-branch conduction.
    • Untreated narrow-angle glaucoma.
    • Acute alcohol, barbiturate and opiate intoxications.
    • This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
    • Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
    PrecautionsView
    If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
    InteractionsView
    This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
    Pregnancy & lactationView
    This tablet should preferably not be given during pregnancy and lactation.
    Overdose effectsView
    In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
    StorageView
    Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

    Denicol

    Dexamethasone + Chloramphenicol
    Ophthalmic Solution 0.1%+0.5% Allopathic Ophthalmic steroid - antibiotic combined preparations

    Indications

    Post-herpetic keratitis

    Indication detailsView
    Eye: This combination is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The combination is used in steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or arisk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

    Ear: This combination is indicated in otitis externa, otitis media and chronic suppurative otitis media.
    Therapeutic classView
    Ophthalmic steroid - antibiotic combined preparations
    PharmacologyView
    Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

    Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage
    DosageView
    Eye:
    • Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
    • Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
    Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
    Side effectsView
    Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.
    ContraindicationsView
    The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.
    PrecautionsView
    The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.
    InteractionsView
    If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.
    Pregnancy & lactationView
    There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.
    StorageView
    Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

    Denitine

    Ranitidine Hydrochloride
    Tablet 150 mg Allopathic H2 receptor antagonist

    Indications

    Zollinger-Ellison syndrome

    Indication detailsView
    Ranitidine is indicated in:
    • Treatment of active duodenal ulcer
    • Benign gastric ulcer
    • Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
    • Post operative stress ulcer.
    • Zollinger-Ellison Syndrome.
    • Gastroesophageal reflux disease (GERD).
    • Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
    • Recurrent haemorrhage in patients with bleeding peptic ulcer.
    • Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
    Therapeutic classView
    H2 receptor antagonist
    PharmacologyView
    Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
    DosageView

    Ranitidine Tablet & Syrup:

    Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

    Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

    Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

    Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

    Maintenance: 150 mg at night for preventing recurrences.

    Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.


    Ranitidine IV injection & IV Infusion:

    Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

    In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

    Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
    Side effectsView
    Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
    ContraindicationsView
    Patients hypersensitive to Ranitidine
    PrecautionsView
    Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
    InteractionsView
    Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
    Pregnancy & lactationView
    Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

    Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
    Pediatric usageView
    Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
    Overdose effectsView
    Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
    ReconstitutionView
    Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

    Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

    Continuous IV infusion:     Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

    Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
    StorageView
    Store in a cool and dry place. protect from light.

    Denixil

    Clonazepam
    Tablet 0.25 mg Allopathic Adjunct anti-epileptic drugs
    Indication detailsView
    It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.

    It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.

    The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
    Therapeutic classView
    Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
    PharmacologyView
    Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

    There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
    DosageView
    Oral:
    • Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
    • The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
    • Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

    Injection:
    • Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
    • Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
    Side effectsView
    The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
    ContraindicationsView
    It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
    PrecautionsView
    When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
    InteractionsView
    Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
    Pregnancy & lactationView
    Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

    Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
    Pediatric usageView
    Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

    Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

    Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

    Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
    Overdose effectsView
    Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

    Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
    ReconstitutionView
    Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

    Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

    Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Denixil

    Clonazepam
    Tablet 1 mg Allopathic Adjunct anti-epileptic drugs
    Indication detailsView
    It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.

    It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.

    The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
    Therapeutic classView
    Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
    PharmacologyView
    Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

    There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
    DosageView
    Oral:
    • Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
    • The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
    • Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

    Injection:
    • Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
    • Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
    Side effectsView
    The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
    ContraindicationsView
    It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
    PrecautionsView
    When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
    InteractionsView
    Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
    Pregnancy & lactationView
    Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

    Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
    Pediatric usageView
    Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

    Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

    Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

    Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
    Overdose effectsView
    Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

    Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
    ReconstitutionView
    Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

    Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

    Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Denixil

    Clonazepam
    Tablet 0.5 mg Allopathic Adjunct anti-epileptic drugs
    Indication detailsView
    It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.

    It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.

    The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
    Therapeutic classView
    Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
    PharmacologyView
    Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

    There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
    DosageView
    Oral:
    • Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
    • The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
    • Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

    Injection:
    • Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
    • Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
    Side effectsView
    The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
    ContraindicationsView
    It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
    PrecautionsView
    When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
    InteractionsView
    Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
    Pregnancy & lactationView
    Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

    Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
    Pediatric usageView
    Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

    Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

    Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

    Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
    Overdose effectsView
    Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

    Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
    ReconstitutionView
    Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

    Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

    Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Denixil

    Clonazepam
    Tablet 2 mg Allopathic Adjunct anti-epileptic drugs
    Indication detailsView
    It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.

    It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.

    The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
    Therapeutic classView
    Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
    PharmacologyView
    Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

    There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
    DosageView
    Oral:
    • Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
    • The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
    • Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

    Injection:
    • Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
    • Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
    Side effectsView
    The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
    ContraindicationsView
    It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
    PrecautionsView
    When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
    InteractionsView
    Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
    Pregnancy & lactationView
    Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

    Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
    Pediatric usageView
    Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

    Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

    Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

    Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
    Overdose effectsView
    Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

    Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
    ReconstitutionView
    Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

    Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

    Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Denosis

    Denosumab
    SC Injection 120 mg/1.7 ml Allopathic Inhibiting bone resorption

    Indications

    Prostate carcinoma

    Indication detailsView
    Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or bone surgery) in patients with bone metastases from solid tumours.
    Therapeutic classView
    Inhibiting bone resorption
    PharmacologyView
    Denosumab binds to Receptor activator of nuclear factor kappa-B ligand (RANKL), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
    DosageView
    Subcutaneous Injection: 120 mg once every 4 wk into thigh, abdomen or upper arm. Ca & vitamin D supplements should be given whilst undergoing treatment.
    Side effectsView
    Dyspnoea, Hypocalcaemia, hypophosphataemia, Osteonecrosis of the Jaw (ONJ).
    ContraindicationsView
    Hypersensitivity to denosumab or to any of the excipients.
    PrecautionsView
    Correct preexisting hypocalcaemia prior to therapy. Osteonecrosis of the jaw (ONJ). Perform oral & dental exam with preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene while on treatment. Atypical femoral fractures. Severe renal impairment (CrCl <30 ml/min) or in patients receiving dialysis. Concomitant use with other denosumab-containing prep. Pregnancy & lactation. Children.
    InteractionsView
    In subjects with postmenopausal osteoporosis, Denosumab (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
    Overdose effectsView
    There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
    StorageView
    Should be stored in cool and dry place.

    Denosis

    Denosumab
    SC Injection 60 mg/ml Allopathic Inhibiting bone resorption

    Indications

    Prostate carcinoma

    Indication detailsView
    Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or bone surgery) in patients with bone metastases from solid tumours.
    Therapeutic classView
    Inhibiting bone resorption
    PharmacologyView
    Denosumab binds to Receptor activator of nuclear factor kappa-B ligand (RANKL), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
    DosageView
    Subcutaneous Injection: 120 mg once every 4 wk into thigh, abdomen or upper arm. Ca & vitamin D supplements should be given whilst undergoing treatment.
    Side effectsView
    Dyspnoea, Hypocalcaemia, hypophosphataemia, Osteonecrosis of the Jaw (ONJ).
    ContraindicationsView
    Hypersensitivity to denosumab or to any of the excipients.
    PrecautionsView
    Correct preexisting hypocalcaemia prior to therapy. Osteonecrosis of the jaw (ONJ). Perform oral & dental exam with preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene while on treatment. Atypical femoral fractures. Severe renal impairment (CrCl <30 ml/min) or in patients receiving dialysis. Concomitant use with other denosumab-containing prep. Pregnancy & lactation. Children.
    InteractionsView
    In subjects with postmenopausal osteoporosis, Denosumab (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
    Overdose effectsView
    There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
    StorageView
    Should be stored in cool and dry place.

    Denvar

    Cefixime Trihydrate
    Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

    Indications

    Urethritis

    Indication detailsView
    Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
    • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
    • Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
    • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
    • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
    • Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
    Therapeutic classView
    Third generation Cephalosporins
    PharmacologyView
    Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
    DosageView
    The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

    Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

    Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
    • ½-1 year: 75 mg daily.
    • 1-4 years: 100 mg daily.
    • 5-10 years: 200 mg daily.
    • 11-12 years: 300 mg daily
    • In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
    Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
    Side effectsView
    The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
    ContraindicationsView
    It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
    PrecautionsView
    The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
    InteractionsView
    Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
    Pregnancy & lactationView
    There are, however, no adequate and well-controlled studies 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. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
    Overdose effectsView
    Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
    StorageView
    Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.