Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A pale red powder containing Amoxicillin Trihydrate PhEur equivalent to 750 mg amoxcillin. The powder is contained within a bottle and should be reconstituted with 12 ml water to give 15 ml suspension containing 50 mg amoxicillin per ml. Chemically, amoxicillin is 6[D(-)-α-amino-p-hydroxyphenylacetamido] penicillanic acid.

Uses

Duphamox Palatable Drops are indicated in the treatment and control of infections caused by organisms sensitive to amoxicillin in dogs and cats.

Amoxicillin is a broad-spectrum, semi-synthetic penicillin, bactericidal in action. In vitro activity has been demonstrated against a wide range of Gram-positive and Gram-negative bacteria found in dogs and cats including Bacillus cereus, Bordetella bronchiseptica, Corynebacterium spp, Citrobacter freundii, Chromobacter spp, Escherichia coli, Flavobacter spp, Pasteurella spp, including Pasteurella multocida, Proteus mirabilis, Salmonella spp, Staphylococci (penicillin-sensitive strains) and Streptococci.

Where the causative organism is susceptible to amoxicillin, Duphamox Palatable Drops are particularly indicated for infections of: Alimentary tract; respiratory tract; urogenital tract; eye and ear infections; skin and wound infections.

Dosage and administration

To be administered orally using the graduated pipette provided, at a dose rate of 10 mg per kg bodyweight twice daily for up to 7 days. This is achieved by administering 1 ml of reconstituted product per 5 kg bodyweight twice daily for up to 7 days.

Duphamox Palatable Drops provide a particularly useful means of dosing small dogs and cats and those which are unwilling to accept tablets.

As high blood levels are achieved immediately after oral administration of Duphamox Palatable Drops, parenteral antibiotic treatment may not be necessary, even in the presence of systemic diseases. However, where parenteral treatment is required, Duphamox injection is indicated and Duphamox Palatable Drops are recommended for follow-up therapy.

Contra-indications, warnings, etc

Duphamox Palatable Drops should not be given to penicillin sensitive animals.

As with other penicillins, amoxicillin should not be used orally or parentally in rabbits, guinea pigs, hamsters or gerbils.

Caution is advised when used in any other very small herbivores.

Operator warning

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.

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

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

3. 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 of the product.

Pharmaceutical precautions

FOR ANIMAL TREATMENT ONLY

Do not store the powder or reconstituted product above 25°C. After the product is reconstituted, using the in-use shelf-life which is specified on this package insert, the date on which any reconstituted product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the carton. Any reconstituted product remaining after 7 days should be discarded. Shake bottle before use. Keep out of the reach of children.

Disposal Advice

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

Legal category

POM-V

Packaging Quantities

Duphamox Palatable Drops are packaged in bottles containing Amoxicillin Trihydrate BP equivalent to 750 mg amoxicillin. To enable convenient and accurate dosing a graduated pipette is provided with each pack.

Further information

After absorption, high levels of amoxicillin are found throughout the body, especially in kidney, urine, liver and bile. Amoxicillin provides rapid bactericidal action and due to its mode of action normally prevents recrudescence of respiratory infections. In common with other penicillins an absence of toxicity has been demonstrated at very high dose levels.