Alclav Neo/Alclav DS 457/Alclav Hospi

Alclav Neo/Alclav DS 457/Alclav Hospi

amoxicillin + clavulanic acid

Manufacturer:

Alkem Lab

Distributor:

Alkem Lab
Concise Prescribing Info
Contents
Per Alclav Neo 625 mg tab Amoxicillin trihydrate 500 mg, clavulanic acid 125 mg. Per Alclav Neo 1 g tab Amoxicillin trihydrate 875 mg, clavulanic acid 125 mg. Per 5 mL of Alclav DS 457 457 mg/5 mL powd for oral susp Amoxicillin trihydrate 400 mg, clavulanic acid 57 mg. Per Alclav Hospi 1.2 g powd for inj Amoxicillin 1,000 mg (equiv to 1,060.21 mg amoxicillin Na), clavulanic acid 200 mg (equiv to 238.25 mg of K clavulanate)
Indications/Uses
URTI including ENT (eg, tonsilitis, sinusitis, otitis media). Lower resp infections (eg, acute & chronic bronchitis, lobar & bronchopneumonia). GUT infection (eg, cystitis, urethritis, pyelonephritis, female genital infections). Skin & soft tissue infections. Bone & joint infections (eg, osteomyelitis) & other infections (eg, septic abortion, puerperal/intraabdominal sepsis, septicemia, peritonitis & post-surgical infections). Major surgical procedures eg, GI, pelvic, head & neck, cardiac, renal, joint replacement & biliary tract. Alclav Hospi Severe infections of the ENT (eg, mastoiditis, peritonsillar infections, epiglottitis & sinusitis. Cystitis. Pyelonephritis. Cellulitis, animal bites, severe dental abscess w/ spreading cellulitis. Female genital infections.
Dosage/Direction for Use
Alclav Neo 625 mg Adult & childn ≥40 kg 1 tab tid; childn <40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day in 3 divided doses. Alclav Neo 1 g 500 mg/125 mg every 12 hrs or 250 mg/125 mg every 8 hrs. Severe infections & infections of the resp tract 875 mg/125 mg every 12 hrs or 500 mg/125 mg every 8 hrs. Alclav DS 457 Childn >6 yr (18-40 kg) 5 mL tid, may be increased up to 50 mg/kg/day every 8 hr; <12 mth 2 mL tid. Alclav Hospi Surgical prophylaxis in adult & childn ≥40 kg 1,000 mg/200 mg-2,000 mg/200 mg given at induction anesth in <1 hr duration; 1,000 mg/200 mg-2,000 mg/200 mg given at induction anesth w/ up to 3 doses of 1,000 mg/200 mg in 24 hr in procedures >1 hr. Childn ≥3 mth 25 mg/5 mg/kg every 8 hr; <3 mth or <4 kg 25 mg/5 mg/kg every 12 hr. Renal impairment in adult & childn ≥40 kg CrCl 10-30 mL/min Initially 1,000 mg/200 mg & then 500 mg/100 mg bid; CrCl <10 mL/min Initially 1,000 mg/200 mg & 500 mg/100 mg every 24 hr; haemodialysis Initially 1,000 mg/200 mg followed by 500 mg/100 mg every 24 hr + 500 mg/100 mg at the end of dialysis. Childn <40 kg CrCl 10-30 mL/min 25 mg/5 mg every 12 hr; <10 mL/min 25 mg/5 mg every 24 hr; haemodialysis 25 mg/5 mg every 24 hr followed by 500 mg/100 mg every 24 hf + 500 mg/100 at the end of dialysis.
Administration
May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Hypersensitivity to penicillins, cephalosporins or other β-lactam antibiotics. Penicillin-associated jaundice or hepatic dysfunction.
Special Precautions
Anaphylactoid reactions. History of penicillin hypersensitivity. Maintain adequate fluid intake & urinary output. Periodic assessment of renal, hepatic & hematopoietic functions during prolonged use. Infectious mononucleosis, hypersensitivity reactions, superinfections. Overgrowth of nonsusceptible organisms w/ prolonged use. False +ve result for urine glucose tests. Hepatic impairment. Pregnancy (especially 1st trimester) & lactation. Alclav DS 457 Phenylketonuria. Concomitant use w/ drugs that delay peristalsis eg, opiates & diphenoxylate w/ atropine. Alclav Hospi Patients on Na-restricted diet.
Adverse Reactions
Diarrhoea, indigestion, nausea, vomiting, mucocutaneous candidiasis; vag itching, soreness & discharge; moderate & asymptomatic rises in AST &/or ALT & alkaline phosphatase; urticarial & erythematous skin rashes. Erythema multiforme, SJS, TENS, bullous exfoliative dermatitis, acute generalised exanthematous pustulosis, serum sickness-like syndrome, hypersensitivity vasculitis. Gastritis, stomatitis, glossitis, black "hair" tongue, enterocolitis, pseudomembranous colitis; anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia & agranulocytosis.
Drug Interactions
Alclav Neo/Alclav Hospi Increased INR w/ acenocoumarol or warfarin; increased MTX toxicity; probenecid; mycophenolate mofetil. Alclav DS 457 Decreased in plasma conc w/ conjugated estriol & estradiol. Disulfiram-like reaction w/ alcohol.
MIMS Class
Penicillins
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
Form
Alclav Neo 1 g FC tab
Packing/Price
14's
Form
Alclav Neo 625 mg FC tab
Packing/Price
14's;21's
Form
Alclav Hospi 1.2 g powd for inj
Packing/Price
1's
Form
Alclav DS 457 457 mg/5 mL powd for oral susp
Packing/Price
30 mL x 1's;70 mL x 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in