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Amoxil

GlaxoSmithKline Nigeria
1 Industrial Avenue Ilipeju, P.M.B. 21218, Ikeja Lagos State, Nigeria
Email: Consumer: CustomerCare_ch_nigeria@gsk.com | Pharma: CustomerCare_ph_nigeria@gsk.com
Tel: 234-1- : 900220–10, 4979093, 4702111
Website: http://gsk.com.ng/

Brand Name

Amoxil

Manufacturer

SmithKline Beecham Pharmaceutique, France; Beecham Pharmaceutical Brentford, UK; Medreich Sterils Ltd, Bengalore, India.

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule 250 mg (NRN: 04-0179 & 04-2508): Amoxycillin (as trihydrate) BP 250 mg.

How to identify the Product: Maroon and yellow capsules.

Pack: Amoxil Capsules 250 mg in blisters and HDPE jars.

 

Capsule 500 mg (NRN: 04-2527 & 04-2481) Amoxycillin (as trihydrate) BP 500 mg.

How to identify the Product: Maroon and yellow capsules.

Pack: Amoxil Capsules 500 mg in blisters, Alu/Alu strips and HDPE jars.

 

Dry Syrup (NRN: 04- 0179): Amoxycillin BP 125 mg per 5 mL.

How to identify the Product: Powder for the preparation of oral suspension.

Pack size: 100 mL.

 

Dry Syrup (NRN: 04-2402): Amoxycillin BP 125 mg per 5 mL.

How to identify the Product: Powder for the preparation of oral suspension.

 

Injection (NRN: 04-0187): Amoxycillin (as sodium salt) BP 500 mg.

Pack size: 10 vials.

The amoxycillin content per unit dose is present as the trihydrate in Amoxil oral preparations and as the sodium salt in Amoxil injection. Each 1 g vial of amoxil contains approximately 3.3 mmol of sodium.

Pharmacology

Amoxil is well absorbed by the oral and parenteral routes.

Oral administration, usually at convenient t.d.s. dosage produced high serum levels independent of the time at which food is taken.

Amoxil gives food penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin.

Indications

Amoxil 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 Bronchopneumona; Cystitis, Urethritis, Pyelonephritis; Bacteriuria in Pregnancy;

Gynaecological Infections including Puerperal Sepsis and Septic Abortion; Gonorrhoea; Peritonitis; Intra-abdominal Sepsis; Septicaemia; Bacterial Endocarditis; Typhoid and Paratyphoid Fever; Skin and Soft Tissue Infections; Dental absess (as an adjunct to surgical management).

Contra-indications

Penicillin-hypertensive patients.

Use in pregnancy and lactation:

Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate. During lactation, trace quantities of Amoxil can be detected in breast milk.

Precautions/Warnings

Interactions

Adverse Effects

Side effects, as with other penicillins, are uncommon and mainly of a mild and transitory nature; they may include diarrhoea, indigestion, or occasionally a rash, either urticaria or erythematous. An urticaria suggests penicillin hypersensitivity and the erythemous type rash may arise if Amoxil is administered to patients with glandular fever.

In either case, treatment should be discontnued. In common with other beta-lactam antibiotics angioedema and anaphylaxis have been reported. Pseudomembranous colitis has been reported rarely.

Dosage & Administration

Treatment of infection:

Adult dosage (including elderly patients): Oral: Standard adult dosage:

250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High-dosage therapy (maximum recommended oral dosage 6g daily in divided doses):

A dosage of 3g 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 3g doses with 8 hours between the doses.

Gonorrhoea:

Single 3g dose.

Injectable:

500 mg IM eight hourly (or more frequently if necessary) in moderate infections (this dose may be given by slow IV injection if more convenient). 1g IV six hourly in severe infections.

Children's dosage (up to 10 years of age): Oral: Standard children's dosage:

125 mg three times daily, increasing to 250 mg three times daily for more severe infections. Amoxil Paediatric Suspension is recommended for children under six months of age.

In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Injectable:

50 - 100 mg/kg body weight a day, in divided doses.

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.

In renal impairment, the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

Administration: Oral: using capsules, syrups.

IV injection:

Dissove 250 mg in 5.0 mL Water for Injections B.P (Final volume = 5.2 mL).

Dissove 500 mg in 10.0 mL Water for Injections B.P (Final volume = 10.4 mL).

Dissove 1 g in 20.0 mL Water for Injections B.P (Final volume = 20.8 mL).

Amoxil injection, suitably diluted, may be injected directly into a vein or the infusion line over a period of 3 - 4 minutes.

IV Infusion: Solutions may be prepared as described for intravenous injections and then added to intravenous solution in a minibag or in-line burette and administered over a period of half to one hour. Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transfered from the infusion bag into the vial and then drawn back into the bag after dissolution.

IM: 250 mg: Add 1.5 mL Water for Injections BP* and shake vigorously (Final volume =1.7 mL).

500 mg: Add 2.5 mL Water for Injections BP* and shake vigorously (Final volume = 2.9 mL).

1g: Add 2.5 mL Water for Injections BP** and shake vigorously (Final volume = 3.3 mL).

* If pain is experienced on intramuscular injection, a sterile 1% solution of lignocaine hydrochloride or 0.5% solution of procaine hydrochloride may be used in place of Water for Injections.

** The 1 g vial will not dissolve in sterile 1% solution of lignocaine hydrochloride at the required concentration. To minimise pain on injection, 1g of Amoxil may be given as two separate injections of 500 mg dissolved in a sterile solution of 1% lignocaine hydrochloride (see above).

A transient pink colouration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.

Overdosage

Gross overdose will produce very high urinary concentrations, more so after parenteral administration. Problems are unlikely if adequate fluid intake and urinary output are maintained; however crystalluria is a possibility. More specific measures may be necessary in patients with impaired renal function. The antibiotic is removed by haemodialysis.

Storage/Handling Recommendations

Oral presentations of Amoxil should be stored in a dry place.

Once dispensed, Amoxil syrups should be stored at 25oC or below and used within 7 days. If dilution of the reconstituted product is required, cooled boiled water should be used.

When prepared for intramuscular or direct intravenous injection, Amoxil should be administered immediately after reconstitution. The stability of Amoxil in various infusion fluids is dependent upon the concentration and temperature.

Amoxil should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.

If Amoxil is prescribed concurrently with an aminoglycoside, the antibiotic should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.

Review Date

2016-10-21 09:31:53