METROBACTIN 250MG 10 TABLETS | ANTIBACTERIAL DOGS AND CATS

METROBACTIN

Tablets for Dogs and Cats Systemic antibacterial in tablets

Pharmaceutical form

Oral tablet (Comp.o.)

Composition by tablet:

Metrobactin 250 mg: Metronidazole 250 mg.

Metrobactin 500 mg: Metronidazole 500 mg.

Pharmacological properties

Pharmacotherapeutic group: Derivatives of (nitro) imidazole.

ATC code: QP51AA01, QJ01X D01.

Pharmacodynamic Properties: After metronidazole enters bacteria, the molecule is reduced by sensitive (anaerobic) bacteria. The metabolites that are formed have a toxic effect on bacteria by binding to bacterial DNA. In general, metronidazole is bactericidal to susceptible bacteria at concentrations equal to or slightly higher than the minimum inhibitory concentration (MIC). Clinically, metronidazole has no relevant effect on facultative anaerobes, obligate aerobes, or microaerophilic bacteria.

Pharmacokinetic data: Metronidazole is well absorbed and immediately after oral administration. After 1 hour, a plasma concentration of 10 micrograms/ml is reached with a single 50 mg dose. The bioavailability of metronidazole is almost 100% and the plasma half-life is approximately 8-10 hours. Metronidazole penetrates well into tissues and body fluids such as saliva, milk, vaginal secretions, and semen. Metronidazole is mainly metabolized in the liver. 35-65% of the administered dose (metronidazole and its metabolites) is excreted in the urine within 24 hours after oral administration.

Interactions and incompatibilities

Metronidazole may have an inhibitory effect on the breakdown of other drugs in the liver, such as phenytoin, cyclosporine, and warfarin.

Cimetidine may reduce the hepatic metabolism of metronidazole, leading to an increased serum concentration of metronidazole.

Phenobarbital may increase the hepatic metabolism of metronidazole, leading to a decreased serum concentration of metronidazole.

Indications

Dogs and cats:

Treatment of gastrointestinal tract infections caused by Giardia spp. and Clostridium spp. (eg: C. perfringens or C. difficile).

Treatment of infections of the urogenital tract, oral cavity, throat and skin caused by obligate anaerobic bacteria (eg Clostridium spp.) sensitive to metronidazole.

Contraindications

Do not use in case of liver disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Adverse reactions

The following adverse reactions may occur after metronidazole administration: vomiting, hepatotoxicity, neutropenia, and neurological signs.

Route of administration

Orally.

Posology

Dogs and Cats: The recommended dose is 50 mg metronidazole/kg bw/day for 5-7 days. The daily dose can be divided equally for twice daily administration (ie 25 mg/kg bw/2 times daily).

To ensure administration of the correct dose, body weight should be determined as accurately as possible. The following table is intended as a guide for dispensing the product with the recommended dosage regimen of 50 mg/kg bw/day.

Body weight (kg) for Dogs and Cats

1 1,25: ¼ Metrobactin 250mg

>1,25 2,5: ½ Metrobactin 250mg

>2,5 3,75: ¾ Metrobactin 250 mg

>3,75 5 : 1 Metrobactin 250 mg or ½ Metrobactin 500 mg

>5 7,5: 1 ½ Metrobactin 250 mg or ¾ Metrobactin 500 mg

>7,5 10: 2 Metrobactin 250 mg or 1 Metrobactin 500 mg

>10 15: 3 Metrobactin 250 mg or 1 ½ Metrobactin 500 mg

>15 20: 4 Metrobactin 250 mg or 2 Metrobactin 500 mg

>20 25: 2 Metrobactin 250mg ½ Metrobactin 500mg

>25 30:3 Metrobactin 500mg

>30 35: 3 ½ Metrobactin 500 mg

>35 40:4 Metrobactin 500mg

The tablets can be divided into 2 or 4 equal parts to ensure an exact dosage. Place the tablet on a flat surface, with the scored side facing up and the convex (rounded) side facing the surface.

Halves: Press down with your thumbs on both sides of the tablet.

Quarters: Press down with your thumb on the center of the tablet.

Special precautions

Special precautions for use in animals:

Due to the likely variability (temporal, geographic) in the emergence of metronidazole-resistant bacteria, bacteriological sampling and susceptibility testing is recommended. Whenever possible, the product should only be used on the basis of susceptibility testing.

Official, national and regional policies should be taken into account when using the veterinary medicinal product.

In very rare cases neurological signs may appear after prolonged treatment with metronidazole.

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

Metronidazole has been confirmed to have mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has possible carcinogenic effects in humans. However, there are insufficient human data on the carcinogenicity of metronidazole. During the administration of the product, impervious gloves should be worn to avoid skin contact with the product.

To avoid accidental ingestion, especially by children, the unused parts of the tablets should be returned to the open space of the blister pack and inserted back into the carton. In case of accidental ingestion, consult a doctor immediately and show him the package leaflet.

Wash your hands thoroughly after handling the tablets.

Use during pregnancy and lactation:

Studies in laboratory animals have shown conflicting results regarding the teratogenic and embryotoxic effects of metronidazole. Therefore, the use of this product during pregnancy is not recommended. Metronidazole is excreted in milk and therefore its use during lactation is not recommended.

Wait time

Not applicable.

conservation mode

This veterinary medicinal product does not require special storage conditions.

Comments

Medicine subject to a veterinary prescription.

METROBACTIN