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Amoksiklav

Taylek Drugs Company Ltd
Plot 8, Block ‘M’, Abimbola Street, Isolo, P.O.Box, 3344, Mushin, Lagos State.
Email: taylekdrugs@yahoo.com
Tel: 234-1-2790918,

Brand Name

Amoksiklav

Manufacturer

Lek Pharma. & Chem. Co. d.d., Verovkova 57 Ljublijana, Slovenia.

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet(NRN: 04-2192): Amoxycillin (as trihydrate) BP 250 mg, Clavulanic acid (as potassium salt) BP 125 mg.

Pack size: 14; 20; 21.

 Amoksiklav Tablet500

Tablet(NRN: 04-2191): Amoxycillin (as trihydrate) BP 500 mg, Clavulanic acid (as Potassium salt) BP 125 mg.

Pack size: 15.

 Amoksiklav Tablet

Injection(NRN: 04-2517): Amoxycillin BP 500 mg, Clavulanic acid BP 100 mg.

Pack size: 5 x 100 mL vials.

Amoksiklav INJ 

Injection(NRN: 04-2518): Amoxycillin BP 1 g, Clavulanic acid BP 200 mg.

Pack size: 5 x 100 mL vials.

 Amoksiklav TabletINJ

Oral Suspension(NRN: 04-2626): Amoxycillin (as trihydrate) 125 mg, Clavulanic acid (as potassium salt) 312.5 mg per 5 mL.

Pack size: 100 mL.

 Amoksiklav

Oral Suspension forte(NRN: 04-2732): Amoxycillin (as trihydrate) 250 mg, Clavulanic acid (as potassium salt) 62.5 mg per 5 mL.

Pack size: 100 mL.

Amoksiklavv

Pharmacology

Amoksiklav is a combination of amoxycillin and clavulanic acid. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It has a weak antibacterial activity alone, but may prove to act as a potent irreversible beta-lactamase inhibitor. With the enzymes, it produces stable non-active complexes and protects amoxycillin from degradation.

Amoksiklav possesses a broad spectrum of activity. It is active against amoxycillin-susceptible microorganisms and microorganisms resistant to it, including S. aureus, S. epidermidis, N. gonorrhoea, H. influenzae, E. coli, and Klebsiella spp.

Amoksiklav is not active against Pseudomonas spp and majority of Enterobacter and Serratia species.

Both components of Amoksiklav are well absorbed after oral administration; food has no effect on the degree of absorption.

The basic pharmacokinetic properties of amoxycillin and clavulanic acid are similar. Peak serum concentration is achieved approximately 1 hour after dosing. The half-life of amoxycillin is 78 minutes and that of clavulanic acid 60-70 minutes.

In patients with impaired renal function excretion of Amoksiklav from the body is delayed and it accumulates in the blood proportionately to the degree of renal impairment.

Indications

Infections due to microorganisms susceptible to Amoksiklav:

  • Upper and lower respiratory tract infections;
  • Urinary tract infections;
  • Gynaecological infections;
  • Skin and soft tissue infections;
  • Gastro-intestinal infections.

Contra-indications

Hypersensitivity to penicillin group of antibiotics, infectious mononucleosis, lymphatic leukemia.

Precautions/Warnings

Amoksiklav should be used with caution in patients with a history of allergic reactions.

Safety for use of Amoksiklav in pregnancy has not been established although animal studies revealed no evidence of teratogenicity.

In patients with severely impaired liver or renal function the dose should be adequately reduced or the interval between two dosing prolonged.

Interactions

The concorrent administration of Amokssiklav and methotrexate increases methotrexate toxicity.

Concomitant use with allopurinol appears to increase the incidence of exanthema.

In some cases the medicinal product may prolong prothrombin time, therefore, caution is required when oral concomitant use with disulfiram should be avoided.

Amoksiklav should not be used in combination with beta-lactam antibiotics (penems, cephalosporines, monobactams), and bacteriostatic antibiotics (macrolides, tetracyclines) which reduce the efficiency of Amoksiklav.

Combination with rifampicin acts antagonistically.

Antibiotics have been reported to reduce the efficency of oral contraceptives.

Amoksiklav can be used in combination with chinolones.

Adverse Effects

Adverse reactions are usually of a mild nature. The most frequently reported are digestive disorders (nausea, vomiting, diarrhoea).

These reactions can be minimised if the drug is taken with meals.

Skin reactions may occur.

If skin rash occurs, Amoksiklav should be discontinued. A rise in hepatic enzymes may rarely occur.

Dosage & Administration

Children

7 to 12 years: 5 mL of Suspension forte or 10 mL of Suspension 3 times daily;

2 to 7 years: 2.5 mL of Suspension forte or 5 mL of Suspension 3 times daily;

9 months to 2 years: 2.5 mL of Suspension 3 times daily before or with meals

Or as prescribed by physicians.

The exact children's doses are based on body weight. Depending upon severity of infection, the usual dosage is 20-40 mg/kg body weight per day (based on the amoxycillin component), divided into three equal doses.

In severe renal insufficiency (creatinine clearance 10-30 mL/min), the dose should be reduced, or the dosage interval prolonged to 12 hours, respectively, and in anuria to 48 hours or longer.

Treatment with Amoksiklav must not exceed 14 days without medical re-examination.

Reconstitution:

Suspension forte:

Shake well the bottle containing the powder, add 85 mL of water in two portions (or first to 2/3 and then to the mark) each time shaking well.

Suspension:

Shake well the bottle containing the powder, add 86 mL of water in two portions (or first to 2/3 and then to the mark) each time shaking well. Shake well before use.

Store reconstituted suspension and drops in refrigirator and use within 7 days.

Storage/Handling Recommendations

Store the medicinal product below 25oC, protected from humidity.

The desiccant canister inserted in the bottle with tablets is not edible.

Close the bottle immediately after use.

Store reconstituted suspension and drops in refrigirator and use within 7 days.

Keep the medicinal product out of the reach of children.

Review Date

2016-05-25 06:05:13