Pharmacodynamics and pharmacokinetics
Oxytetracycline hydrochloride is an antibiotic from the tetracycline , which has a wide spectrum of action and is active against both gram+ and gram-bacteria, rickettsia , spirochetes , chlamydia and mycoplasmas .
The mechanism of action is based on preventing the proliferation of bacteria, that is, bacteriostatically: when the active substance gets inside the cell, it binds to the receptors of 30S subunits in the bacterial ribosome, blocks the aminoacyl-transp.RNA , which does not allow new amino acids to be included in the following peptide chains under construction and, as a result, – protein synthesis processes are completely disrupted. The action is selective, since microorganisms have a low ability to concentrate tetracyclines in mammalian cells.
Indications for use
The drug is effective for various bacterial infections: pneumonia , bronchitis , pleural empyema , tonsillitis , cholecystitis , endometritis , prostatitis , as well as purulent complications after surgical interventions.
Oxytetracycline is used in veterinary medicine in the form of the drug Oxytetracycline-100. It is used to treat various diseases of the gastrointestinal tract, respiratory and genitourinary systems, skin in cattle, goats, calves, sheep, pigs, cats and dogs. Pathogens must be sensitive to oxytetracycline, for example: microorganisms that cause pneumonia , bronchitis , bronchopneumonia , enteritis , salmonellosis , dysentery , endometritis , etc.
I. General information
1. Trade name of the drug: Oxytetracyclinum 100 (Oxytetracyclinum 100).
International nonproprietary name: oxytetracycline.
2. Dosage form: solution for injection.
Oxytetracycline 100 as an active ingredient in 1 ml contains 100 mg of oxytetracycline (in the form of hydrochloride), as well as auxiliary components: 1 mg of methyl 4-hydroxybenzoate, 5 mg of sodium formaldehyde sulfoxylate, 200 mg of magnesium chloride 6-water, 20 mg of povidone K 12 , ethanolamine in the amount necessary to bring the pH to 8.0 – 9.0 and water for injection to 1 ml.
In appearance, Oxytetracycline 100 is a clear, light yellow solution.
3. Oxytetracycline 100 is produced packaged in 100 ml bottles made of dark glass, sealed with stoppers reinforced with aluminum caps. The bottles are placed in individual cardboard boxes and provided with instructions for use.
4. Store the medicinal product in the manufacturer’s sealed packaging, in a dry place, protected from direct sunlight, separately from food and feed at a temperature of 5°C to 25°C.
Shelf life, subject to storage conditions, is 3 years from the date of production. After opening the bottle - no more than 28 days, subject to aseptic rules. Oxytetracycline 100 should not be used after the expiration date.
5. The drug should be stored out of the reach of children.
6. Unused medicinal product is disposed of in accordance with legal requirements.
II. Pharmacological properties
7. Oxytetracycline 100 is an antibacterial drug from the tetracycline group.
Oxytetracycline hydrochloride, which is part of the drug, has a wide spectrum of antibacterial action. Active against most gram-positive and gram-negative microorganisms, including Escherichia, Salmonella, staphylococci, streptococci, as well as rickettsia and some types of mycoplasmas; does not affect Pseudomonas aeruginosa, Proteus, as well as most fungi and viruses.
By binding to the 30S subunit on the ribosomes of the microorganism, oxytetracycline disrupts the access of tRNA to the mRNA-ribosomal complex, which leads to blockade of protein synthesis and death of the microbial cell.
After intramuscular administration of the drug, oxytetracycline is quickly absorbed into the blood and penetrates into most organs and tissues of the body. The maximum concentration of the antibiotic in the blood is reached within 30-60 minutes and is maintained at a therapeutic level for 48 hours after administration of the drug. The antibiotic is excreted from the body mainly with urine and bile, and in lactating animals - partly with milk.
In terms of the degree of impact on the body, Oxytetracycline 100 is classified as a moderately hazardous substance (hazard class 3 according to GOST 12.1.007-76).
III. Application procedure
8. Oxytetracycline 100 is used in pigs, cattle, sheep and goats for the treatment of acute and chronic diseases of the respiratory system, genitourinary system, gastrointestinal tract, skin, musculoskeletal system, colibacillosis, salmonellosis, pasteurellosis, gastroenterocolitis, mastitis, operating rooms, wound, postpartum complications and other primary and secondary infections of bacterial etiology, the pathogens of which are sensitive to tetracyclines.
9. Contraindication for use is the individual hypersensitivity of the animal to the components of the drug. The drug should not be used by animals with severe liver and kidney dysfunction, young animals during the period of dental development, females in the last months of pregnancy, as well as dogs, cats and horses.
10. Oxytetracycline 100 is administered to animals deeply intramuscularly once a day for 3-5 days: cattle, sheep, and goats at a dose of 0.5 ml per 10 kg of animal weight (5 mg of oxytetracycline hydrochloride per 1 kg of animal weight), pigs – 1 ml per 10 kg of animal weight (10 mg of oxytetracycline hydrochloride per 10 kg of animal weight).
In order to obtain a prolonged effect, the drug is administered to cattle twice at a dose of 1 ml per 10 kg of animal weight with an interval of 48 hours.
When administering the drug in a volume exceeding 20 ml for cattle, 10 ml for pigs, 5 ml for sheep, goats and calves, injections should be made at several points and the injection site should be thoroughly massaged.
11. Symptoms of overdose in animals may include depression, dysfunction of the gastrointestinal tract, and swelling at the injection site. In this case, Oxytetracycline 100 should be discontinued and symptomatic treatment performed.
12. The specific effects of the drug upon first taking the drug and upon its withdrawal have not been established.
13. Omissions should be avoided when administering the next dose of the drug, as this may lead to a decrease in therapeutic effectiveness. If one dose is missed, the use of the drug is resumed at the same dosage and according to the same regimen.
14. As a rule, there are no side effects or complications when using Oxytetracycline 100 in accordance with these instructions.
In some animals, a local reaction in the form of swelling may occur at the injection site, which spontaneously disappears within a few days without the use of therapeutic agents. If the animal is hypersensitive to tetracyclines and allergic reactions develop, the use of the drug is stopped and desensitizing therapy is carried out. In case of anaphylactic shock, animals are prescribed adrenaline, corticosteroids and antihistamines in accordance with the instructions for their use.
15. Oxytetracycline 100 should not be used simultaneously with corticosteroids and estrogens, as well as together with bactericidal drugs, due to a possible decrease in the antibacterial effect of oxytetracycline.
16. Slaughter of pigs, cattle, sheep and goats for meat is permitted no earlier than 21 days after the last use of the medicinal product.
The meat of animals forcedly killed before the expiration of the specified period can be used as feed for fur-bearing animals.
Milk from dairy animals must not be used for food purposes during the treatment period and for 7 days after the last administration of Oxytetracycline 100. This milk can be used as animal feed.
IV. Personal prevention measures
17. When working with Oxytetracycline 100, you should follow the general rules of personal hygiene and safety precautions provided for when working with medicines. After finishing work, wash your hands with warm water and soap.
18. In case of accidental contact of the medicinal product with the skin or mucous membranes of the eye, they must be rinsed with plenty of water. People with hypersensitivity to the components of the drug should avoid direct contact with Oxytetracycline 100. In case of allergic reactions or if the drug accidentally enters the human body, you should immediately contact a medical facility (have instructions for use of the drug or label with you).
19. Empty drug bottles must not be used for household purposes; they must be disposed of with household waste.
The instructions were developed by Gordonos, 7B, Agios Georgios Chavouzas, PC 3070, Limassol, Cyprus.
Side effects
- anorexia , nausea , vomiting , abdominal pain, glossitis , stomatitis , proctitis , diarrhea;
- long-term use leads to increased activity of liver enzymes - transaminases and alkaline phosphatases, increased urea content, candidiasis , deficiency of vitamin K and group B, as well as hyperbilirubinemia , hypoprothrombinemia ;
- staining of teeth yellow-brown, enamel hypoplasia;
- skin rash, itching, photosensitivity , eosinophilia , even angioedema ;
- hemolytic anemia , thrombocytopenia ;
- increased intracranial pressure , which can cause vomiting, headache, diplopia , papilledema.
Oxytetracycline, instructions for use (Method and dosage)
The drug can be used internally and externally, intramuscularly and locally.
Before prescribing the drug, the sensitivity of the microflora and pathogen to the drug and the severity of the infectious process are first determined.
Dosage depending on the severity of the disease
If the infectious process is mild, then 7.5-1 g is prescribed in 3-4 doses, while a moderate course requires large doses - 1.5-2 g in 3-4 doses.
In case of renal failure and/or functional liver disorders
Prescribe smaller doses or a longer interval, individually changing the treatment regimen.
Instructions for use in veterinary medicine
Oral dosage forms are intended for use in large animals. The use of long-acting injectable forms has not been studied in small animals. The use of tetracyclines in small animals is mainly based on doxycycline or minocycline. For large animals, there is both a regular and long-acting formula. The extended-release formulation contains a viscosity excipient used to prolong absorption at the injection site. One such excipient is 2-pyrrolidone. When using long-acting veterinary drugs, long-acting properties apply only to intramuscular use and not to intravenous administration. When long-acting products are compared to conventional injectable products, long-acting products generally allow for longer dosing intervals. However, in pigs there was no difference in the duration of plasma concentrations when administered at equivalent doses.
Interaction
In combination with the following drugs, drug interaction reactions or changes in pharmacokinetics are possible:
- With magnesium-, aluminum-, calcium-, and iron-containing antacids , absorption deteriorates.
- With anticoagulants, of hypoprothrombinemia increases .
- With bactericidal antibiotics ( penicillins and cephalosporins ), a decrease in their effectiveness is observed.
- With Streptomycin , Gentamicin , activity against intracellular pathogens increases (for example, Brucella , Pasteurella ).
- With Chymotrypsin, the concentration and circulation time of oxytetracycline increases.
- With estrogen-containing oral contraceptives, their effectiveness decreases and the risk of breakthrough bleeding .
- With Retinol intracranial pressure increases .
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special instructions
In order to prevent hypovitaminosis, you should take vitamin K and group B , brewer's yeast .
There is a risk of developing photosensitivity , which requires limiting insolation .
Long-term treatment involves periodic monitoring of the functional state of the liver, kidneys and hematopoietic organs.
Since the drug can mask the symptoms of syphilis and possible mixed infection , a monthly serological test is performed for 4 months.
Reviews of Oxytetracycline
There are a lot of comments and questions on the forums - people are interested in where to get this inexpensive and effective antibiotic. However, the problem of the lack of the drug in pharmacies is acute; experts recommend oxytetracycline containing ointment - Hyoxysone - .
Oxytetracycline, like Doxycycline , due to its wide spectrum of action, can be used for various infections in humans and animals, ranging from cattle to pets.
Precautionary measures. Adverse reactions and side effects
Tetracyclines can cause renal tubular necrosis at high doses, but this is rare at recommended doses. Tetracyclines may affect bone and tooth formation in young animals. (Note that no side effects were observed in the young foal treatment studies mentioned above.) These have been associated with drug fever in cats. Hepatotoxicity may occur at high doses in highly hypersensitive individuals. Administration of oxytetracycline to horses has been associated with colic and diarrhea.
