Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duphamox Palatable Tablets 200 mg are presented as off-white circular tablets scored on one face. Each tablet contains 200 mg Amoxicillin as Amoxicillin Trihydrate BP in a highly palatable base.

Chemically, Amoxicillin is 6-[D(-)-α-amino-p- hydroxyphenylacetamido] penicillanic acid.

Uses

Duphamox Palatable Tablets 200 mg are indicated for use only in cats and dogs for the treatment of infections of the alimentary tract, respiratory tract and urogenital tract, eye, ear, skin and wound infections caused by susceptible organisms.

Duphamox 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 cats and dogs which include: Bacillus cereus, Bordetella bronchiseptica, Corynebacterium spp, Citrobacter freundii, Chromobacter spp, Escherichia coli, Flavobacter spp, Proteus mirabilis, Pasteurella spp, including P. multocida, Salmonella spp, Staphylococci (penicillin-sensitive strains) and Streptococci.

Dosage and administration

To be administered orally at a dose rate of 10 mg/kg bodyweight twice daily for seven days.

The following is intended as a guide: dogs per 20 kg: 1×200 mg tablet twice daily for 7 days.

As high blood levels are achieved rapidly after oral dosing parenteral antibiotic treatment may not be necessary. However, where parenteral treatment is required, Duphamox injection is indicated and the tablets are valuable for use as follow-up therapy.

Duphamox Palatable Tablets 200 mg are normally accepted from the hand. However for the treatment of fastidious animals the tablets may be crushed and added to a little food.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

In common with all penicillins, Duphamox Palatable Tablets 200 mg should not be given to penicillin-sensitive animals.

Duphamox Palatable Tablets 200 mg should not be used in rabbits, guinea pigs, gerbils and hamsters.

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 precautions.

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.

4. Wash hands after use.

Pharmaceutical precautions

Keep out of the reach of children.

Do not store above 25°C. Store in a dry place.

Legal category

POM-V

Packaging Quantities

Duphamox Palatable Tablets 200 mg are supplied in plastic containers of 250 tablets.

Further information

After absorption, high levels of amoxicillin are found throughout the tissues especially in kidney, urine, liver and bile.

Amoxicillin provides rapid bactericidal action and due to its mode of action normally prevents recrudescence of sensitive respiratory infections.

In common with other penicillins an absence of toxicity has been demonstrated even at very high dose levels.

Dispose of any unused product or containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 01596/4118.