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Clacef
Cefuroxime Axetil + Clavulanic Acid
Clacef
Cefuroxime Axetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
- Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.
Clacef
Cefuroxime Axetil + Clavulanic Acid
Clacef
Cefuroxime Axetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
- Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.
Clacido
Amoxicillin + Clavulanic Acid
Clacido
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacido
Amoxicillin + Clavulanic Acid
Clacido
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacido
Amoxicillin + Clavulanic Acid
Clacido
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacido
Amoxicillin + Clavulanic Acid
Clacido
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacido
Amoxicillin + Clavulanic Acid
Clacido
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacido BID
Amoxicillin + Clavulanic Acid
Clacido BID
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clacin
Clarithromycin
Clacin
Clarithromycin
Indications
Tonsillitis
Indication detailsView
Clarithromycin is indicated in-
- Streptococcal pharyngitis
- Sinusitis
- Infective exacerbations of chronic bronchitis
- Community-acquired pneumonia
- Atypical pneumonia
- Skin and soft tissue infection
- Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.
Therapeutic classView
Macrolides
PharmacologyView
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.
DosageView
Adults:
- Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
- Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
- Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
- Pneumonia 250 mg every 12 hours for 7-14 days.
- Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
- Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.
- Bodyweight under 8 kg: 7.5 mg/kg twice daily.
- Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
- Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
- Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
- Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.
AdministrationView
Clarithromycin may be given with or without meals.
Side effectsView
Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.
ContraindicationsView
Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
PrecautionsView
Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.
Pregnancy & lactationView
The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.
Overdose effectsView
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
StorageView
Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.
Cladin
Loratadine
Cladin
Loratadine
Indications
Urticaria
Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.
Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.
Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.
Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Claim
Aceclofenac
Claim
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Claim ER
Aceclofenac
Claim ER
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox
Amoxicillin + Clavulanic Acid
Clamox
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamox DS
Amoxicillin + Clavulanic Acid
Clamox DS
Amoxicillin + Clavulanic Acid
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.
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:
Mild to moderate infections:
Adults-
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.
- 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.
- 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).
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
- 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
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.
- 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.
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:
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.
- 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.
Clamycin
Clarithromycin
Clamycin
Clarithromycin
Indications
Tonsillitis
Indication detailsView
Clarithromycin is indicated in-
- Streptococcal pharyngitis
- Sinusitis
- Infective exacerbations of chronic bronchitis
- Community-acquired pneumonia
- Atypical pneumonia
- Skin and soft tissue infection
- Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.
Therapeutic classView
Macrolides
PharmacologyView
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.
DosageView
Adults:
- Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
- Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
- Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
- Pneumonia 250 mg every 12 hours for 7-14 days.
- Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
- Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.
- Bodyweight under 8 kg: 7.5 mg/kg twice daily.
- Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
- Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
- Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
- Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.
AdministrationView
Clarithromycin may be given with or without meals.
Side effectsView
Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.
ContraindicationsView
Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
PrecautionsView
Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.
Pregnancy & lactationView
The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.
Overdose effectsView
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
StorageView
Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.