Unimox Film Coated Tablets
Usage and indications:
Treatment of infection:
Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections; Otitis media; Acute and chronic bronchitis; Chronic bronchial sepsis; Lobar and bronchopneumonia; Cystitis, urethritis, pyelonephritis; Bacteriuria in pregnancy; Gynecological infections including puerperal sepsis and septic abortion; Gonorrhea; Peritonitis; Intra-abdominal sepsis; Septicemia; Bacterial endocarditis; Typhoid and paratyphoid fever; Skin and soft tissue infections; Dental abscess (as an adjunct to surgical management); and Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
Prophylaxis of endocarditis
Dosage and administration:
Treatment of Infection:
Adult dosage (including elderly patients):
Dosage in adults with impaired renal function:
The dose should be reduced in patients with severe renal function impairment.
In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended:
Helicobacter eradication in peptic (duodenal and gastric) ulcer disease: Amoxicillin is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below:
Omeprazole 40 mg daily, Amoxicillin 1g BID, Clarithromycin 500 mg BID x 7 days or
Omeprazole 40 mg daily, Amoxicillin 750 mg -1g BID, Metronidazole 400 mg TID x 7 days.
Children weighing < 40 kg:
The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen
* PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.
Dosage in children under 40 kg with renal impairment:
Amoxicillin Pediatric Suspension is recommended for children under six months of age.
Special dosage recommendation:
Prophylaxis of endocarditis:
Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-hemolytic streptococci in order to achieve eradication of the organism.
Blood and lymphatic system disorders:
Very rare: reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia.
Prolongation of bleeding time and prothrombin time.
Infections and infestations:
Very rare: mucocutaneous candidiasis.
Immune system disorders:
Very rare: as with other antibiotics, severe allergic reactions, including angioneurotic edema, anaphylaxis, serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).
Nervous system disorders:
Very rare: hyperkinesia, dizziness and convulsions. [Convulsions may occur in patients with impaired renal function or in those receiving high doses.]
Common: diarrhea and nausea.
Very rare: antibiotic associated colitis (including pseudomembraneous colitis and hemorrhagic colitis); Black hairy tongue; Superficial tooth discoloration has been reported in children. [Good oral hygiene may help to prevent tooth discoloration as it can usually be removed by brushing.]
Skin and subcutaneous tissue disorders:
Common: Skin rash
Uncommon: urticaria and pruritus
Very rare: skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalized exanthematous pustulosis (AGEP).
Renal and urinary tract disorders:
Very rare: Interstitial nephritis, Crystalluria
Very rare: hepatitis and cholestatic jaundice; A moderate rise in AST and/or ALT.
[The significance of a rise in AST and/or ALT is unclear.]
Warnings and precautions:
Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics.
Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.
In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation
Precaution should be taken in premature children and during the neonatal period: renal, hepatic and hematological functions should be monitored.
Pack: carton box containing one (AL-PVC) Strip of 8 film coated tablets.