Unimox     Film Coated Tablets

Amoxicillin 1gm

 

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.

  1. In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis

  • Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
  • Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. “Susceptibility of the causative organisms to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

Dosage and administration:

Treatment of Infection:

Adult dosage (including elderly patients):

  • High-dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
  • Short-course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses.
  • Dental abscess: two 3 g doses with 8 hours between the doses.
  • Gonorrhea: single 3 g dose.

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:

  • Glomerular filtration rate >30ml/min: No adjustment necessary
  • Glomerular filtration rate 10-30ml/min: Amoxicillin maximum 500mg b.d
  • Glomerular filtration rate <10ml/min: Amoxicillin maximum 500mg/day

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.

  1. Children weighing more than 40 kg should be given the usual adult dosage.

Dosage in children under 40 kg with renal impairment:

Creatinine clearance ml/min

Dose

Interval between administration

> 30

Usual dose

No adjustment necessary

10 - 30

Usual dose

12 h

(corresponding to 2/3 of the dose)

< 10

Usual dose

24 h

(corresponding to 1/3 of the dose)

 

Amoxicillin Pediatric Suspension is recommended for children under six months of age.

Special dosage recommendation:

  • Tonsillitis: 50 mg/kg/day in two divided doses.
  • Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.
  • Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21 days.

 

Prophylaxis of endocarditis:

Condition

 

Adults Dosage (including elderly)

Children's Dosage ( < 40 kg)

Notes

Dental Procedures: Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues, and who have not received penicillin in the previous month.

(N.B. Patients with prosthetic heart valves should be referred to hospital - see below.)

Patients not having general anesthetic.

3 g Amoxicillin orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.

50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.

Note 1.

If prophylaxis with Amoxicillin is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotic are recommended if more frequent prophylaxis, or if the patient has received a course of treatment with penicillin during the previous month.

Note 2.

To minimize pain on injection, Amoxicillin may be given as two injections of 500 mg dissolved in sterile 1% lignocaine solution.

 

Patient having general anesthetic: if oral antibiotics considered being appropriate.

Initially 3 g Amoxicillin orally 4 hours prior to anesthesia, followed by 3 g orally as soon as possible after the operation.

 

 

 

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.

Undesirable effects:

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.]

Gastrointestinal disorders:

Common: diarrhea and nausea.

Uncommon: vomiting.

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

Hepato-biliary disorder:

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.

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