Spirsol 120 mg for dogs and cats, 20 tablets (Stomorgyl analog)

Description

Round tablets, from white to yellow or brown with marbling, with a specific smell of the ingredients.

Composition

1 gram of the drug contains active ingredients:

• spiramycin adipate – 1,250,000 IU;
• metronidazole — 208.33 mg.

Excipients: microcrystalline cellulose, calcium stearate, talc, povidone, sorbitol, glucose, lactose, methylparaben, propylparaben, flavoring, flavor enhancer.

The drug is available in the following forms:

• SPIROZOL-BC (120 mg tablet) — spiramycin adipate 150,000 IU and metronidazole 25 mg;
• SPIROZOL-BC (600 mg tablet) — spiramycin adipate 750,000 IU and metronidazole 125 mg;
• SPIROZOL-BC (tablet weighing 1.2 g) – spiramycin adipate 1,500,000 IU and metronidazole 250 mg.

Pharmacological properties

ATS vet classification code QJ01 — antibacterial veterinary drugs for systemic use.

The drug SPIROZOL-BC is a combined drug that includes spiramycin and metronidazole. The combination of active ingredients of the drug has a wide spectrum of action against gram-positive and gram-negative microorganisms, as well as protozoa and mycoplasmas.

Spiramycin is a macrolide antibiotic with bacteriostatic activity. Reversibly binding to the 50S ribosomal subunit, it inhibits protein synthesis in the microbial cell, which leads to general bacteriostatic antibacterial activity with a post-antibiotic effect and a decrease in the formation of exotoxins. Unlike 14-membered macrolides, spiramycin is able to bind not to one, but simultaneously to three domains (I-III) of the 50S ribosomal subunit, which provides more stable binding and a long-lasting antibacterial effect. The activity increases at alkaline pH. Active against gram-positive, gram-negative, intracellular microorganisms, protozoa and mycoplasmas, including Actinomyces spp., Bacteroides spp., Bordetella pertussis spp., Campylobacter spp., Clostridium spp., Corynebacterium spp., Chlamydia spp. , Haemophilus spp., Legionella spp., Leptospira spp., Leishmania spp., Listeria spp., Mycoplasma spp., Neisseria spp., Rickettsia spp., Staphylococcus spp., Streptococcus spp., Toxoplasma spp., Treponema spp. Spiramycin retains activity against a number of strains of gram-positive cocci with acquired resistance to 14- and 15-membered macrolides. This property refers to the M-phenotype of resistance associated with active removal of the drug from the microbial cell (efflux), which is most often found in strains of S. pneumoniae and S. pyogenes.

When administered orally, spiramycin is rapidly absorbed in the gastrointestinal tract and penetrates well into biological fluids (including saliva), organs, and tissues.

Metronidazole is an antiprotozoal agent of the nitro-5-imidazole group. It is active against gram-positive, gram-negative microorganisms and protozoa, including Entamoeba spp., Gardnerelia spp., Giardia spp., Trichomonas spp., Bacteroides spp., Coccidia spp., Clostridium spp., Eubacter spp., Fusobacterium spp. Peptococcus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella spp., Spirochaete spp., Veillonella spp.

After oral administration, metronidazole is rapidly and almost completely absorbed from the gastrointestinal tract, reaching peak plasma and saliva concentrations within 1 hour.

Metronidazole is an inactive molecule that enters the cell cytoplasm by passive diffusion, where it is converted into a reduced intermediate that can cause oxidative damage to DNA strands. Oral bioavailability is 100% and is not significantly reduced by concomitant food intake. It has a rapid bactericidal effect that is concentration-dependent and independent of the size of the inoculum and the growth phase of the bacterial population. Metronidazole is metabolized in the liver by oxidation and conjugation with glucuronic acid.

The active components of the drug and their metabolites are excreted from the body mainly with urine and partly with feces. Metronidazole passes through the placental barrier and is excreted in lactating animals into milk.

SPIROZOL-VS, in terms of its degree of effect on the body, belongs to moderately hazardous substances (3rd toxicity class); in recommended doses, it does not have a sensitizing, teratogenic, or embryotoxic effect.

Application

Treatment of dogs and cats for oral diseases (stomatitis, gingivitis, pyorrhea, periodontitis), otitis, respiratory tract infections, canine leishmaniasis caused by Leishmania infantum, secondary and other infections caused by microorganisms sensitive to spiramycin and metronidazole, especially in the acute and subacute period of the disease.

Dosage

SPIROZOL-BC is administered to dogs and cats individually orally once a day at a dose of 75,000 IU spiramycin and 12.5 mg metronidazole per 1 kg of animal weight, which corresponds to:

• 1 tablet of SPIROZOL-BC, weighing 120 mg – per 2 kg of animal body weight;
• 1 tablet of SPIROZOL-BC, weighing 600 mg – per 10 kg of animal body weight;
• 1 tablet of SPIROZOL-VS, weighing 1.2 g – per 20 kg of animal body weight.

The duration of the course of treatment, depending on the condition of the animal, is on average 5-10 days and is determined by the attending veterinarian. The dosage and duration of use may be increased by the veterinarian’s prescription. When using the drug, the tablets should not be crushed.

*Kilograms to Pounds conversion table

Reservation

The drug should be used with caution under the supervision of a veterinarian in animals with severe heart, kidney, and liver diseases.

The drug is not recommended for use in pregnant and lactating females.

The drug should be used in animals younger than 2 months only as prescribed and under the supervision of a veterinarian.

Skipping a dose of the drug may lead to a decrease in the effectiveness of treatment. When skipping a dose of the drug, the drug should be resumed as soon as possible at the same dose and according to the same regimen.

SPIROZOL-BC should not be used simultaneously with other antibiotics of the macrolide and nitroimidazole groups, and with drugs containing ethyl alcohol. Metronidazole enhances the effect of indirect anticoagulants.

Due to the presence of glucose and lactose in the composition of the drug, the use of the drug in animals with hyperglycemia, diabetes mellitus, and allergies to dairy products is possible only after consultation with a veterinarian.

A contraindication for the use of the drug is hypersensitivity of the animal to the components of the drug (including a history).

Overdose

In case of overdose, animals may experience excessive salivation, digestive tract disorders, and depression.

Side effects

Side effects and complications in animals when using the drug according to this instruction are usually not observed. In case of hypersensitivity reactions to the components of the drug in the animal, such as skin reactions (erythema, pustular rash), nervous system disorders, damage to the intestinal mucosa, cholestatic hepatitis, etc., its use is discontinued and antihistamines and symptomatic agents are prescribed.

Personal prevention measures

When working with the drug, you should follow the general rules of personal hygiene and safety precautions that are provided for when working with medicines. People with hypersensitivity to the components of the drug SPIROZOL-VS should avoid direct contact with the tablets. In case of allergic reactions and/or accidental ingestion of the drug SPIROZOL-VS, you should contact a medical institution, having with you the instructions for use of the drug or the label.

Release form

Blisters of 10 tablets. Secondary packaging – cardboard box containing 1, 2, 3 or 5 blisters with an insert leaflet.

Polymer containers of 10, 20 or 30 tablets, packed together with an insert leaflet in a cardboard box.

Storage

Store the drug in the manufacturer’s closed packaging, separately from food and feed, in a dry place, protected from direct sunlight, at a temperature of 5 °C to 25 °C, out of the reach of children.

Expiration date

3 years.

For use in veterinary medicine!