Tetracycline Hydrochloride - Instructions For Use Of Tablets, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Tetracycline hydrochloride

Tetracycline hydrochloride: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Tetracycline hydrochloride

ATX code: J01AA07

Active ingredient: tetracycline (Tetracycline)

Manufacturer: PJSC (Public Joint Stock Company) Scientific and Production Center Borshagovskiy Chemical and Pharmaceutical Plant (Ukraine); PJSC "Vitamins" (Ukraine)

Description and photo updated: 2020-13-02

Tetracycline hydrochloride is a broad-spectrum antibacterial drug.

Release form and composition

The drug is available in the form of film-coated tablets: from red to red-brown color, round, biconvex (in blisters: 20 pcs., In a cardboard box 1 blister; 10 pcs., In a cardboard box 1 or 2 blisters. each pack also contains instructions for the use of Tetracycline Hydrochloride).

1 tablet contains:

• active substance: tetracycline hydrochloride (in terms of 100% dry matter) - 100 mg;
• auxiliary components: sodium croscarmellose, microcrystalline cellulose, calcium stearate, talc;
• composition of the film-forming coating: polyvinyl alcohol, macrogol (polyethylene glycol) 3350, special red AG (E129) dye, titanium dioxide (E171), sunset yellow FCF (E110), talc (E553b).

Pharmacological properties

Pharmacodynamics

Tetracycline hydrochloride is an antibacterial drug of the tetracyclines group with a wide spectrum of bacteriostatic activity. The mechanism of action of the drug is due to the property of tetracycline to inhibit protein synthesis by blocking the binding of aminoacyl-transport RNA (ribonucleic acid) to the "informational RNA - ribosome" complex.

The following bacteria are susceptible to tetracycline hydrochloride:

• gram-positive microorganisms: Streptococcus pneumoniae and other Streptococcus speciales (), Staphylococcus spp. (including producing penicillinase species), Haemophilus influenzae, Listeria spp., Bacillus anthracis;
• gram-negative microorganisms: Enterobacter spp., Neisseria gonorrhoeae, Klebsiella spp., Bordetella pertussis, Salmonella spp., Escherichia coli, Shigella spp., Treponema spp., Rickettsia spp., Mycoplasma spp., Chlamydia spp.

Small viruses, Pseudomonas aeruginosa, Serratia spp., Proteus spp., As well as a significant part of Bacteroides spp. Strains are resistant to the drug. and mushrooms.

Pharmacokinetics

After taking the drug inside, 75–80% of the dose taken is absorbed. The maximum concentration in the blood is reached after 2-3 hours, it can range from 1.5 to 3.5 mg / l. Over the next 8 hours, the level of concentration of tetracycline hydrochloride in the blood gradually decreases.

Plasma protein binding - 55–65%.

The distribution of the substance in the body is uneven. The maximum concentration of tetracycline hydrochloride is observed in the kidneys (determined in urine 2 hours after administration and persists for 6-12 hours), liver, lungs and organs rich in elements of the reticuloendothelial system (spleen, lymph nodes). The level of tetracycline in bile exceeds its concentration in serum by 5-10 times. The content of the drug in blood plasma, thyroid or prostate tissues is the same. In saliva, pleural and ascitic fluids, breast milk, it can be 60–100% of the plasma concentration. It accumulates in bone tissue in large quantities. Overcoming the placental barrier, it enters the fetal bloodstream. It penetrates the blood-brain barrier poorly.

It is metabolized in the liver (30-50% of the dose taken). Long-term stay of the drug in the body is facilitated by the intestinal-hepatic circulation of the active substance, which is exposed to 5-10% of the total dose.

The half-life is 8 hours. About 10–20% is excreted through the kidneys during the first 12 hours, and from 20 to 50% is excreted through the intestines.

Indications for use

The use of Tetracycline hydrochloride is indicated in the treatment of the following infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• angina, scarlet fever;
• whooping cough, bronchitis, pneumonia, purulent pleurisy;
• purulent infections of the skin and soft tissues;
• infections of the urinary and biliary tract;
• subacute septic endocarditis;
• bacterial and amoebic dysentery;
• purulent meningitis;
• brucellosis;
• tularemia;
• psittacosis, psittacosis;
• gonorrhea;
• typhus and relapsing fever;
• cholera.

In addition, Tetracycline hydrochloride is prescribed for the prevention of postoperative infections.

Contraindications

Absolute:

• fungal diseases;
• chronic hepatic dysfunction;
• renal failure, including chronic;
• systemic lupus erythematosus, porphyria;
• combined intake with retinoids or vitamin A;
• During pregnancy and breastfeeding;
• age up to 12 years;
• hypersensitivity to the components of the drug.

Tetracycline hydrochloride should be used with caution to treat patients with gastroesophageal reflux, myasthenia gravis, impaired liver function, leukopenia, hypersensitivity to acetylsalicylic acid, in old age.

Tetracycline hydrochloride, instructions for use: method and dosage

Tetracycline hydrochloride tablets are taken orally 1 hour before or 2 hours after a meal with plenty of water.

It should be borne in mind that the simultaneous use of milk and other dairy products or food intake significantly disrupts the absorption of the drug.

After taking the drug, the patient should be in an upright position (sitting or standing).

Do not take tetracycline hydrochloride before going to bed, as this increases the risk of developing esophagitis.

The doctor prescribes the dose and duration of the course of treatment individually, taking into account the clinical indications and the nature of the course of the disease.

Recommended dosage for patients over the age of 12 years: the usual single dose is 200 mg (2 pcs.) 4 times a day, observing the same interval between doses of the drug. In the treatment of severe infections, it is possible to use Tetracycline hydrochloride in a dose of up to 500 mg 4 times a day. The maximum daily dose is 2000 mg. After the disappearance of the symptoms of the disease, treatment must be continued for another three days.

The duration of the course of therapy for all infections caused by group A beta hemolytic streptococci should be at least 10 days.

If you accidentally skip the next dose, you can take it a little later, if this does not mean doubling the single dose the next time you take it.

For elderly patients, dose adjustment of tetracycline hydrochloride is not required.

In cases where the administration of this class of antibiotics is absolutely necessary in patients with renal insufficiency, the usual daily dose should be reduced and / or the interval between pills should be increased.

Side effects

• from the immune system: urticaria, angioedema (including the face and tongue), anaphylaxis, pericarditis, bronchospasm and other hypersensitivity reactions; anaphylactoid reactions, including fixed drug erythema, exacerbation of systemic lupus erythematosus, anaphylactoid purpura, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome; allergic reactions, bronchial asthma;
• on the part of the skin and subcutaneous tissue: itching, hyperemia, skin rashes (including maculopapular, erythematous), pigmentation disorders of mucous membranes and skin, bullous dermatoses, photosensitization reactions;
• from the lymphatic system and blood: thrombocytopenia, hemolytic anemia, aplastic anemia, eosinophilia, agranulocytosis, neutropenia, Moshkovich's disease;
• on the part of the endocrine system: after prolonged use, microscopic areas of brown-black color can be observed in the tissues of the thyroid gland, which do not affect the function of the thyroid gland;
• from the nervous system: in infants - bulging fontanelle; in adolescents and adults - benign intracranial hypertension with symptoms such as tinnitus, nausea, vomiting, headache, hearing impairment, dizziness, unsteady gait, visual impairment (including blurred vision, optic nerve edema, photophobia, scotomas, diplopia, complete temporary or permanent loss of vision);
• from the digestive system: dry mouth, nausea, vomiting, anorexia, discomfort (pain) in the abdomen, dysphagia, dyspepsia, heartburn, gastritis, pancreatitis, intestinal dysbiosis, diarrhea, constipation, esophageal ulcers, esophagitis, gastric ulcer and duodenal ulcer;
• from the hepatobiliary system: hepatotoxicity, a transient increase in the level of alkaline phosphatase, liver transaminases and bilirubin in the blood, impaired liver function, fatty liver disease, hepatitis, jaundice, hepatic failure (the first symptoms of liver damage include poor general health, pain in the right hypochondrium and / or fever, nausea, vomiting, stomach pain, sclera subicterus);
• on the part of the musculoskeletal system: in the presence of myasthenia gravis - muscle weakness;
• from the urinary system: nephritis, acute renal failure (more often in patients with impaired renal function), azotemia, hypercreatininemia;
• development of superinfections: stomatitis, candidiasis, glossitis with papillary hypertrophy, glossophytosis, CDAD (Clostridium difficile), staphylococcal enterocolitis, pseudomembranous colitis, balanitis, inflammatory lesion of the anogenital zone (due to candidiasis), itching in the anal area, vulvovaginitis;
• others: hypovitaminosis, hoarse voice, sore throat, pharyngitis, permanent discoloration of teeth (yellow, brown, gray), impaired bone formation; in children - hypoplasia of tooth enamel and / or slowing of the linear growth of bones.

Overdose

Symptoms: nausea, vomiting, crystalluria, hematuria, increased manifestation of side effects, hypersensitivity reactions.

Treatment: there is no specific antidote to tetracycline hydrochloride, therefore, careful medical monitoring of the patient's condition and the appointment of symptomatic therapy are required.

special instructions

During the period of treatment with tetracycline hydrochloride, it is necessary to strictly follow the doctor's recommendations regarding the dosage regimen and the method of using the drug. It should be borne in mind that an insufficient amount of water when swallowing a tablet, taking the drug while lying down or before bedtime increases the risk of developing esophagitis and esophageal ulcers. If dysphagia or chest pain occurs, discontinuation of the drug should be considered.

It is recommended to avoid exposure to direct sunlight or artificial ultraviolet radiation on exposed areas of the body. Patients should be informed about the existing risk of photosensitivity and the immediate discontinuation of tetracyclines when the first signs of erythema appear on the skin.

In order to prevent candidiasis, it is necessary to prescribe antifungal agents and vitamins simultaneously with Tetracycline hydrochloride. It should be borne in mind that the development of superinfection can be observed not only during treatment, but also several weeks after the withdrawal of the antibiotic. Therefore, if a patient develops severe, persistent and / or bloody diarrhea and suspected CDAD during (or after) treatment, it is necessary to immediately stop taking the tablets and conduct appropriate studies. The use of drugs that inhibit peristalsis is contraindicated in this clinical situation. It is inappropriate to prescribe the drug in a daily dose of less than 800 mg for the treatment of adult patients due to the possible development of tetracycline-resistant forms of microorganisms and insufficient therapeutic effect.

Treatment of sexually transmitted diseases with suspected concomitant syphilis should be accompanied by appropriate diagnostic procedures, including monthly serological tests for at least 16 weeks. This is due to the fact that tetracycline hydrochloride can mask the manifestations of syphilis.

The use of the drug in severe renal impairment can lead to an increase in the level of urea in the blood, azotemia, hyperphosphatemia and acidosis.

Do not allow the appointment of high doses of tetracycline hydrochloride in case of liver dysfunction or patients taking potentially hepatotoxic drugs, due to the increased risk of developing fatty liver and pancreatitis. With a long course of treatment, the function of the kidneys, liver and hematopoietic organs should be monitored periodically.

In order to prevent the development of adverse events, it is advisable to use the drug in combination with hepatoprotectors, choleretic and antimycotic agents, probiotics and vitamins. When treating any type of staphylococcal infection, tetracycline hydrochloride is not the drug of choice.

Patients with hypersensitivity to acetylsalicylic acid are at increased risk of developing allergic reactions.

Influence on the ability to drive vehicles and complex mechanisms

There are no data on the effect of Tetracycline hydrochloride on the rate of human psychomotor reactions when driving vehicles and complex mechanisms, but during the period of use of the drug, patients should take into account the possibility of developing adverse events from the nervous system and be careful when carrying out potentially hazardous activities.

Application during pregnancy and lactation

The use of Tetracycline hydrochloride during pregnancy and breastfeeding is contraindicated.

Pediatric use

The use of tetracycline hydrochloride for the treatment of children under the age of 12 is contraindicated.

With impaired renal function

It is contraindicated to use Tetracycline hydrochloride tablets for renal failure, including chronic.

If, according to the doctor, the appointment of the drug to patients with renal insufficiency is absolutely necessary, a reduced usual daily dose should be used and / or the interval between pills should be increased.

For violations of liver function

It is contraindicated to use tetracycline hydrochloride in chronic hepatic dysfunction.

The tablets should be taken with caution in patients with impaired liver function.

Use in the elderly

Tetracycline hydrochloride should be used with caution to treat elderly patients. No dose adjustment is required.

Drug interactions

• vitamin A, acitretin, tretinoin, isotretinoin and other retinoids: combined use with the drug increases the risk of developing benign intracranial hypertension;
• iron salts, cholestyramine, kaolin pectin, colestipol, sodium bicarbonate, oral forms of bismuth preparations (including bismuth subsalicylate), zinc, calcium, aluminum, magnesium (including magnesium-containing laxatives, quinapril, sucralfate, antacids), didanosine (due to the content of calcium and magnesium-containing auxiliary components): the interaction of any of the listed drugs with tetracycline contributes to the formation of inactive chelates and a decrease in its absorption; it is recommended to avoid such a combination, and if necessary, concomitant therapy with these drugs, take tetracycline 2 hours before or 4-6 hours after taking them;
• strontium ranelate: it is recommended to interrupt treatment with strontium ranelate for the period of antibiotic therapy due to the fact that it can lower the level of tetracycline concentration in blood serum;
• digoxin, lithium preparations: tetracycline hydrochloride can increase the concentration of these substances in the blood serum;
• penicillins, beta-lactam antibiotics, cephalosporins: a combination with each of these antibiotics should be avoided due to the fact that the bacteriostatic effect of tetracycline may interfere with their bactericidal activity;
• oleandomycin, erythromycin: a combination with each of these drugs may be accompanied by a synergistic action;
• indirect anticoagulants, including antithrombotic agents, warfarin, phenindione: a clinically significant increase in the effect of indirect anticoagulants and the need to reduce their dose is possible;
• atovaquone: the concentration of atovaquone in blood plasma decreases;
• methotrexate: the combination with methotrexate may be accompanied by an increase in its toxicity, therefore, caution should be exercised;
• methoxyflurane: a combination with methoxyflurane increases the risk of toxic effects on the kidneys, an increase in urea nitrogen and serum creatinine, the development of acute renal failure (including fatal);
• hormonal contraceptives: the incidence of breakthrough bleeding increases and the effectiveness of hormonal contraceptives decreases. In order to prevent unplanned conception during the entire period of tetracycline treatment and 7 days after its completion, it is recommended to use non-hormonal methods of contraception;
• diuretics: when combined with diuretics, the risk of nephrotoxicity due to dehydration increases;
• insulin, sulfonylurea derivatives (including glibenclamide, gliclazide): the hypoglycemic effect of antidiabetic agents is enhanced;
• chymotrypsin: helps to increase the concentration level and duration of circulation of tetracycline hydrochloride in the blood;
• ergotamine, methysergide: concomitant therapy with ergotamine or methysergide increases the risk of developing ergotism;
• oral typhoid vaccine, BCG (bacillus Calmette - Guerin): vaccination should be avoided during tetracycline treatment, as antibiotics can reduce the therapeutic effect of vaccines.

Analogs

Tetracycline hydrochloride analogs are Tetracycline, Tetracycline-AKOS, Doxycycline, Bassado, Vibramycin, Vidoccin, Doxibene, Rondomycin, Minolexin, Minocycline hydrochloride, Minocycline hydrochloride dihydrate, Innolir, Oxyridtetracycline hydrochloride, and Dzhigligline

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Tetracycline hydrochloride

Reviews of Tetracycline hydrochloride are positive. Patients point to the high efficiency of the drug in the treatment of infectious and inflammatory diseases. The advantages of the drug include a wide range of clinical indications.

The price of Tetracycline hydrochloride in pharmacies

The price of Tetracycline hydrochloride has not been established due to its absence in the pharmacy chain.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!