MICOTIX

Miconazole Nitrate and Chlorhexidine Gluconate Shampoo

COMPOSITION:

Each ml contains:                                       

Miconazole Nitrate IP       20 mg          

Chlorhexidine Gluconate   20 mg

PHARMACOLOGY

PHARMACODYNAMICS:

i) Chlorhexidine gluconate

Chlorhexidine gluconate is a bisbiguanide antimicrobial agent against Gram-positive and Gram-negative bacteria. It is both bactericidal and bacteriostatic depending on the concentration used. Growth inhibition is achieved by a direct effect on ATP-ase so interfering with the energy transport mechanisms.  The bactericidal effect of chlorhexidine results from coagulation of the bacterial cell contents. Chlorhexidine gluconate is incorporated in Miconazole Nitrate and Chlorhexidine Gluconate Shampoo for its activity against Staphylococcus intermedius. Staphylococcus intermedius resistance to chlorhexidine has not been reported.

ii) Miconazole nitrate

Miconazole nitrate is an imidazole antifungal agent with activity against yeasts such as Malassezia pachydermatis. It is both fungicidal and fungistatic depending on the concentration used. Miconazole inhibits ergosterol incorporation into cell membranes so increasing concentrations of cytotoxic hydrogen peroxide within the fungal cell wall. Miconazole nitrate has been incorporated Miconazole Nitrate and Chlorhexidine Gluconate Shampoo for its activity against Malassezia pachydermatis.

iii) Chlorhexidine and miconazole in combination

In vitro studies have reported synergistic activity against Microsporum canis between chlorhexidine and miconazole.

PHARMACOKINETICS: 

Chlorhexidine gluconate

High concentrations of chlorhexidine gluconate are achieved in the hair coat and on the skin for the 10 minute period following shampooing. These concentrations are well in excess of the MICs for Staphylococcus intermedius. Chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract on ingestion. There is little or no percutaneous absorption. In humans it has been shown that 26% remains on the skin at 29 hours after application.

 Miconazole nitrate

High concentrations of miconazole nitrate are achieved in the hair coat and on the skin for the 10 minute period following shampooing. These concentrations are well in excess of the MICs for Malassezia pachydermatis Miconazole nitrate is poorly absorbed from the skin and gastrointestinal tract.

 INDICATIONS:

Dog: For the treatment and control of seborrhoeic dermatitis associated with Malassezia pachydermatis and Staphylococcus intermedius.

DOSAGE AND ADMINISTRATION:

Dog: As a general rule, shampoo twice weekly until the symptoms subside and weekly thereafter or as necessary to keep the condition under control.

Wet the animal thoroughly with clean water and apply Miconazole Nitrate and Chlorhexidine Gluconate Shampoo to the animal at several points and massage into the coat. Use sufficient to raise lather on the coat and skin. Ensure that the shampoo is applied around the lips, under the tail and between the toes. Allow the animal to stand for 10 minutes, and then rinse off with clean water and leave to dry naturally in a warm, draught-free environment.

The 250 ml bottle, for example, provides approximately 8-16 treatments for a 15 kg dog, or 5-10 treatments for a 25 kg dog treatment, depending on coat thickness.

CONTRAINDICATIONS:

Contraindicated in sick or convalescing animals. Contraindicated in animals that have shown previous hypersensitivity.

WARNINGS AND PREACAUTIONS:

Make sure that the dog does not lick his coat while the shampoo is applied, as this may lead to gastrointestinal or respiratory complications. Also, it is important to avoid contact with eyes, in order to avoid irritations. Flushing the eyes with clean water upon contact should resolve the problem. If the irritation persists, a veterinarian must be contacted urgently.

Puppies should not come into contact with nursing females respectively, after treatment until the coat has dried.

Special precautions for use in animals

For external use only.

In case of accidental contact with eyes, rinse with plenty of water.

Do not allow the animal to lick itself during shampooing and rinsing, or before it is dried. Take care to avoid the animal inhaling the product or getting it into the nose or mouth during shampooing.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

If known hypersensitivity to Chlorhexidine exists, handle product with care.

The product can cause eye irritation. Avoid contact with the eyes. In case of accidental contacts with eyes, rinse with plenty of water. If irritation persists consult your doctor.

Avoid excessive handling and stroking of treated animals immediately following treatment.

INTERACTIONS:

None known.

PREGNANCY AND LACTATION:

Pregnancy:

Always discuss whether the Miconazole Nitrate and Chlorhexidine Gluconate Shampoo is safe if your pet is pregnant.

Lactation:

Puppies should not come into with nursing females respectively, after treatment is contraindicated in pregnancy.

ADVERSE DRUG REACTIONS:

Side effects to this type of shampoo are only observed if the dog is hypersensitive or allergic to one or more of the ingredients.

Exceptionally a dog with the atopy or with allergic skin disease may develop a pruritic and / or erythematous reaction after treatment.

OVERDOSAGE:

Not applicable

PRESENTATION:

250ml pet Bottle 

For the use only of a Veterinary Medical Practitioner only, Hospital or Laboratory or a Farm