Bioclavid/Bioclavid Forte

Bioclavid/Bioclavid Forte

amoxicillin + clavulanic acid

Manufacturer:

Sandoz

Distributor:

Zuellig
Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin & clavulanic acid.
Description
Tablet: Bioclavid 375 mg: Each tablet contains amoxicillin (as trihydrate) 250 mg and clavulanic acid (as potassium salt) 125 mg. Bioclavid 625-mg: Each tablet contains amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium salt) 125 mg . Bioclavid 1000-mg: Each tablet contains amoxicillin 875 mg and clavulanic acid 125 mg.
Suspension: Bioclavid 125 mg/31.25 mg Powder for Oral Suspension: Each 5-mL (1 tsp) of the reconstituted suspension contains 125 mg amoxicillin (as trihydrate) and 31.25 mg clavulanic acid (as potassium salt). Bioclavid Forte 250 mg/62.5 mg Powder for Oral Suspension: Each 5-mL (1 tsp) of the reconstituted suspension contains amoxicillin (as trihydrate) 250 mg and clavulanic acid (as potassium salt) 62.5 mg.
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%.
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.
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.
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.
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.
Side Effects
Side effects occurring on co-amoxiclav therapy are generally mild and they rarely result in discontinuation of therapy. The following side effects are possible: Gastrointestinal: Diarrhea, nausea, vomiting and digestive disturbances may occur occasionally but they are of transient nature. They can be attenuated by intake of the preparation at mealtime. Colonization of the intestine by candida and isolated cases of pseudomembranous colitis have been described after amoxicillin therapy. Studies of effects on the intestinal flora have reported promotion of colonization by resistant enterobacteria and a reduction in staphylococci.
Hypersensitivity Reactions: Skin rash, pruritus, urticaria, fever and joint pain can occur occasionally. Further reactions eg, angioneurotic edema, anaphylaxis, erythema multiforme exudativum, Stevens-Johnson syndrome, exfoliative dermatitis have been observed in rare cases. Treatment with co-amoxiclav should be discontinued if skin rashes occur. Patients with viral infections tend to respond more frequently with cutaneous reactions. Rare cases of interstitial nephritis have been reported.
Hematological Changes: Leukopenia, thrombocytopenia, agranulocytosis and eosinophilia have been reported. Likewise, prolongation of the bleeding and prothrombin time has been observed. The development of positive Coombs' test has been reported. Isolated cases of behavioral changes (aggression, irritability) have been observed in pediatric patients and elevated urea nitrogen or creatinine levels have been reported.
Liver: Changes of hepatic function parameters (SGOT and SGPT) have been observed in isolated cases. Transient hepatitis and cholestatic jaundice have been reported in rare cases.
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.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Bioclavid: FC tab 250 mg/125 mg x 100's. 500 mg/125 mg x 100's. 875 mg/125 mg x 14's. Powd for susp 125 mg/31.25 mg/5 mL x 60 mL.
Bioclavid Forte: Powd for susp 250 mg/62. 5 mg/5 mL x 60 mL.
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