BIOCLAVID Co-Amoxiclav 625mg Film-Coated Tablet 1's
RXDRUG-DRP-1291-3-15-1pc
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Features
Brand
Bioclavid
Full Details
Dosage Strength
625 mg
Drug Ingredients
- Co-Amoxiclav
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Co-Amoxiclav
Dosage Form
Film-Coated Tablet
Registration Number
DRP-1291
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Treatment of common bacterial infections where oral therapy is indicated including: Upper respiratory tract infections (including ENT), sinusitis, tonsillitis, otitis media. Skin and soft tissue infections eg, boils/abscesses, cellulitis, wound infection, intra-abdominal sepsis. Lower respiratory tract infections eg, acute and chronic bronchitis, pneumonia and lung abscess. Genitourinary tract infections eg, cystitis, urethritis, pyelonephritis, septic abortion, pelvic infection, gonorrhea. Other infections eg, osteomyelitis, septicemia, peritonitis, postoperative infections.
Dosage/Direction for Use
Bioclavid oral dosage recommendations for children <12 years are based on 25-50 mg/kg body weight/day (based on amoxicillin component), depending on the severity of infection.
Adults and Children >12 years: Mild and Moderate Infections: One 375 mg tablet 3 times daily. More Severe Infections and Respiratory Tract Infections: One 625 mg tablet 3 times daily; 7-12 years: 10 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily or 5 mL Bioclavid 250 mg/62.5 mg/5 mL suspension 3 times daily; 2-7 years: 5 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily; 9 months to 2 years: 2.5 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily; 0-9 months: No suitable oral presentation is currently available for this age group.
Treatment with Bioclavid should not be extended beyond 14 days without review.
Renal Impairment: Adults: Creatinine Clearance: Mild impairment (CrCl >30 mL/ min): No change of dosage; Moderate Impairment (CrCl 10-30 mL/ min): Bioclavid 375 mg or 625 mg 12 hourly; Severe Impairment (CrCl <10 mL/ min): Not more than Bioclavid 375 mg 12 hourly or Bioclavid 625 mg 24 hourly.
Children: Similar reductions in dosage should be made for children.
Hepatic Functional Impairment: Liver function parameters should be checked on regular intervals in patients with signs of hepatic lesions. The dosage should be adjusted if indicated.
Bioclavid is well absorbed whether taken with or before meals.
Adults and Children >12 years: Mild and Moderate Infections: One 375 mg tablet 3 times daily. More Severe Infections and Respiratory Tract Infections: One 625 mg tablet 3 times daily; 7-12 years: 10 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily or 5 mL Bioclavid 250 mg/62.5 mg/5 mL suspension 3 times daily; 2-7 years: 5 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily; 9 months to 2 years: 2.5 mL Bioclavid 125 mg/31.25 mg/5 mL suspension 3 times daily; 0-9 months: No suitable oral presentation is currently available for this age group.
Treatment with Bioclavid should not be extended beyond 14 days without review.
Renal Impairment: Adults: Creatinine Clearance: Mild impairment (CrCl >30 mL/ min): No change of dosage; Moderate Impairment (CrCl 10-30 mL/ min): Bioclavid 375 mg or 625 mg 12 hourly; Severe Impairment (CrCl <10 mL/ min): Not more than Bioclavid 375 mg 12 hourly or Bioclavid 625 mg 24 hourly.
Children: Similar reductions in dosage should be made for children.
Hepatic Functional Impairment: Liver function parameters should be checked on regular intervals in patients with signs of hepatic lesions. The dosage should be adjusted if indicated.
Bioclavid is well absorbed whether taken with or before meals.
Administration
May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Amoxicillin may not be administered to patients with verified penicillin allergy owing to the danger of anaphylactic shock. Cross-allergy with other penicillin derivatives and cephalosporins should be borne in mind. Patients with infectious mononucleosis or lymphatic leukemia should not be treated with amoxicillin since such patients tend to respond with maculopapular cutaneous reactions.
Warnings
The dose should be adjusted in patients with renal insufficiency depending on the severity of the functional impairment. Checks of hepatic and renal function and hematological studies are indicated on long-term treatment.
Bioclavid therapy should be discontinued if allergic reactions occur (see Side Effects). Hypersensitivity reactions respond favorably to antihistamines and corticosteroids and they mostly regress immediately after discontinuation of the preparation. Immediate emergency is necessary in severe anaphylactoid reactions. It has been reported that patients suffering from infectious mononucleosis tend to respond more frequently with erythematous skin rash on treatment with amoxicillin. The same as with all broad-spectrum antibiotics, due attention should be paid to development of resistant bacteria and fungi during prolonged therapy. Antibiotic-induced pseudomembranous colitis which can be life threatening should be borne in mind in patients with severe and persistent diarrhea. In such cases, treatment with Bioclavid should be discontinued at once and corresponding therapy instituted (eg, with oral vancomycin). Sensitivity tests to identify the causative agent are necessary. Antiperistaltics are contraindicated.
Dark-field examinations should be carried out before instituting treatment in patients with gonorrhea and suspected primary syphilitic lesions. Serological studies are advisable over at least 4 months in all other cases in which syphilis is also suspected. Symptomatic treatment should be instituted in the event of overdose in renal functional impairment (gastrointestinal symptoms and disturbances of electrolyte and fluid balance). Bioclavid can be eliminated from the circulation by hemodialysis.
Bioclavid therapy should be discontinued if allergic reactions occur (see Side Effects). Hypersensitivity reactions respond favorably to antihistamines and corticosteroids and they mostly regress immediately after discontinuation of the preparation. Immediate emergency is necessary in severe anaphylactoid reactions. It has been reported that patients suffering from infectious mononucleosis tend to respond more frequently with erythematous skin rash on treatment with amoxicillin. The same as with all broad-spectrum antibiotics, due attention should be paid to development of resistant bacteria and fungi during prolonged therapy. Antibiotic-induced pseudomembranous colitis which can be life threatening should be borne in mind in patients with severe and persistent diarrhea. In such cases, treatment with Bioclavid should be discontinued at once and corresponding therapy instituted (eg, with oral vancomycin). Sensitivity tests to identify the causative agent are necessary. Antiperistaltics are contraindicated.
Dark-field examinations should be carried out before instituting treatment in patients with gonorrhea and suspected primary syphilitic lesions. Serological studies are advisable over at least 4 months in all other cases in which syphilis is also suspected. Symptomatic treatment should be instituted in the event of overdose in renal functional impairment (gastrointestinal symptoms and disturbances of electrolyte and fluid balance). Bioclavid can be eliminated from the circulation by hemodialysis.
Special Precautions
Caution is necessary in patients with allergic diathesis, bronchial asthma, urticaria or hay fever.
Caution is advised if Bioclavid is given to babies born of mothers hypersensitive to penicillin.
Use in pregnancy & lactation: Animal studies with orally and parenterally administered amoxicillin and clavulanic acid have shown teratogenic effects. The product has been used in human pregnancy in a limited number of cases with no untoward effect, however, use of Bioclavid in pregnancy is not recommended unless considered essential by the physician. As with all drugs, therapy with co-amoxiclav during pregnancy should be avoided if at all possible, especially during the 1st trimester.
During lactation, trace quantities of amoxicillin can be detected in breast milk.
Caution is advised if Bioclavid is given to babies born of mothers hypersensitive to penicillin.
Use in pregnancy & lactation: Animal studies with orally and parenterally administered amoxicillin and clavulanic acid have shown teratogenic effects. The product has been used in human pregnancy in a limited number of cases with no untoward effect, however, use of Bioclavid in pregnancy is not recommended unless considered essential by the physician. As with all drugs, therapy with co-amoxiclav during pregnancy should be avoided if at all possible, especially during the 1st trimester.
During lactation, trace quantities of amoxicillin can be detected in breast milk.
Use In Pregnancy & Lactation
Animal studies with orally and parenterally administered amoxicillin and clavulanic acid have shown teratogenic effects. The product has been used in human pregnancy in a limited number of cases with no untoward effect, however, use of Bioclavid in pregnancy is not recommended unless considered essential by the physician. As with all drugs, therapy with co-amoxiclav during pregnancy should be avoided if at all possible, especially during the 1st trimester.
During lactation, trace quantities of amoxicillin can be detected in breast milk.
During lactation, trace quantities of amoxicillin can be detected in breast milk.
Adverse Reactions
GI effects, hypersensitivity reactions, hematologic & hepatic function changes, mucocutaneous candidosis, dizziness, headache, diarrhoea, nausea, vomiting.
Drug Interactions
Concurrent intake of allopurinol during amoxicillin therapy can promote the occurrence of cutaneous reactions but the cause of this is still unclear. Concomitant administration of probenecid results in a prolonged increase of amoxicillin concentrations but not of clavulanic acid concentrations. The same as with other antibiotic aminopenicillins eg, amoxicillin can attenuate the effect of oral contraceptives. Concomitant administration of antacids reduces the absorption of amoxicillin. Nonenzymatic methods for determination of urinary sugar can furnish falsely positive results. Urobilinogen tests can be affected and positive direct antiglobulin tests can result. The occurrence of diarrhea can adversely affect the absorption of other medicaments and consequently impair their efficacy. Consumption of alcohol should be avoided during and for some days after treatment with Bioclavid. An antabuse-like syndrome has been reported in isolated patients after intake of antibiotics together with alcohol. Consequently, Bioclavid should not be administered concomitantly with disulfiram.
Storage
Store below 25°C. Protect from light and moisture.
Action
Co-amoxiclav is a combination preparation consisting of a broad-spectrum antibiotic (amoxicillin) and a β-lactamase inhibitor (clavulanic acid).
Amoxicillin has a bactericidal action, it inhibits synthesis of the bacterial cell wall during the growth phase by competitive inhibition of transpeptidases. Clavulanic acid itself possesses only slight antibacterial activity but it binds β-lactamases irreversibly, thus inhibiting the breakdown of amoxicillin. The antibacterial spectrum of co-amoxiclav includes the following clinically important microorganisms: Staphylococci (penicillin-sensitive and penicillin-resistant), streptococci, Neisseriae, Branhamella catarrhalis, Enterobacteria (E. coli, Salmonellae, Shigellae, Proteus mirabilis, Proteus vulgaris, Klebsiella pneumoniae), Haemophilus influenzae, anaerobic cocci. The following microorganisms are resistant or partly resistant: Pseudomonas aeruginosa, Enterobacter, Serratia, Proteus rettgeri, Proteus morganii, Providencia, methicillin-resistant staphylococci, Mycoplasma, Chlamydiae and Rickettsiae.
Pharmacokinetics: Peak serum concentrations of both components are present about 1 hr after oral administration. Concomitant intake of food does not affect absorption, co-amoxiclav readily penetrates into tissues, it diffuses through the placenta and only small quantities are transferred into breast milk. The bioavailability of amoxicillin is approximately 90% and that of clavulanic acid is approximately 60%, however, the latter is subject to marked fluctuations. The elimination half-life of the 2 components which are eliminated in practically unchanged form in the urine is about 1 hr. Urine recovery of amoxicillin ranges between 60 and 80% and that of clavulanic acid between 30 and 50%.
Amoxicillin has a bactericidal action, it inhibits synthesis of the bacterial cell wall during the growth phase by competitive inhibition of transpeptidases. Clavulanic acid itself possesses only slight antibacterial activity but it binds β-lactamases irreversibly, thus inhibiting the breakdown of amoxicillin. The antibacterial spectrum of co-amoxiclav includes the following clinically important microorganisms: Staphylococci (penicillin-sensitive and penicillin-resistant), streptococci, Neisseriae, Branhamella catarrhalis, Enterobacteria (E. coli, Salmonellae, Shigellae, Proteus mirabilis, Proteus vulgaris, Klebsiella pneumoniae), Haemophilus influenzae, anaerobic cocci. The following microorganisms are resistant or partly resistant: Pseudomonas aeruginosa, Enterobacter, Serratia, Proteus rettgeri, Proteus morganii, Providencia, methicillin-resistant staphylococci, Mycoplasma, Chlamydiae and Rickettsiae.
Pharmacokinetics: Peak serum concentrations of both components are present about 1 hr after oral administration. Concomitant intake of food does not affect absorption, co-amoxiclav readily penetrates into tissues, it diffuses through the placenta and only small quantities are transferred into breast milk. The bioavailability of amoxicillin is approximately 90% and that of clavulanic acid is approximately 60%, however, the latter is subject to marked fluctuations. The elimination half-life of the 2 components which are eliminated in practically unchanged form in the urine is about 1 hr. Urine recovery of amoxicillin ranges between 60 and 80% and that of clavulanic acid between 30 and 50%.
MedsGo Class
Penicillins
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