Duphamox is an off-white oily suspension for injection containing 150 mg of amoxicillin (as Amoxicillin Trihydrate) per ml. Each ml also contains Butylhydroxyanisole 0.08 mg and Butylhydroxytoluene 0.08 mg as antioxidants.

Duphamox is indicated in the treatment and control of infections caused by organisms sensitive to amoxicillin.

Amoxicillin is a broad-spectrum semi-synthetic penicillin bactericidal in action. In vitro it is effective against a wide range of Gram-positive and Gram-negative bacteria which include:

Actinomyces bovis, Actinobacillus equuli, Actinobacillus lignieresi, Bacillus anthracis, Bordetella bronchiseptica, Clostridium spp, Corynebacterium spp, Erysipelothrix rhusiopathiae, Escherichia coli, Fusiformis spp, Haemophilus spp, Moraxella spp, Pasteurella spp, Proteus mirabilis, Salmonella spp, Staphylococci and Streptococci (non-penicillinase producing) in cattle, sheep, pigs, dogs and cats.

Shake well before use.

Administration is by the intramuscular route for cattle, sheep and pigs and by the intramuscular or subcutaneous route in dogs and cats. The dosage rate is 7mg/kg bodyweight daily for up to 5 days (equivalent to 0.25ml per 5kg daily). Massage the injection site after injection.

The suggested dosage rates are

Normal aseptic precautions should be observed. Use a dry syringe for extraction of suspension to avoid hydrolysis of amoxicillin.

If dose volume exceeds 20 ml in cattle or 10 ml in sheep and pigs, it should be divided and injected into two sites.

A separate injection site should be used for each administration.

An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

Do not use in cases of known hypersensitivity.

Not suitable for intravenous or intrathecal administration.

Do not use in small herbivores such as rabbits, hamsters, gerbils and guinea pigs.

Not effective against beta-lactamase producing organisms.

Occasional local tissue reaction may result from the use of this product.

Penicillins and cephalosporins may cause hypersensitivity (allergy, allergic skin reactions) after use. Allergic reactions may occasionally be serious (anaphylaxis).

Complete cross-resistance has been shown between amoxicillin and other penicillins, in particular amino-penicillins.

Use of the product/amoxicillin should be carefully considered when antimicrobial susceptibility testing has shown resistance to penicillins because its effectiveness may be reduced.

Cattle: meat and offal: 18 days. Milk: 24 hours.

Sheep: meat and offal: 10 days. Not for use in sheep producing milk for human consumption.

Pigs: meat and offal: 16 days.

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure, taking all recommended precautions.

If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.

Wash hands after use.

Do not store above 25°C. Protect from light.

This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Keep out of the sight and reach of children.

For animal treatment only.

Multidose vials of 50 or 100 ml. Not all pack sizes may be marketed.

After the administration of Duphamox, amoxicillin is absorbed and widely distributed in the body and high levels are found in kidney, urine, liver and bile. Amoxicillin has a rapid bactericidal action which normally prevents the recrudescence of respiratory infections. As with other penicillins, absence of toxicity is normally encountered. Animals with functional rumens should only be treated parenterally.

It is not generally recommended to use bactericidal and bacteriostatic antibiotics at the same time.

Beta-lactam antibiotics are known to interact with antibiotics with bacteriostatic action such as chloramphenicol, macrolides, sulfonamides and tetracyclines. There is also synergic action of penicillins with aminoglycosides.