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TETRACYCLINE HYDROCHLORIDE 100 mg film-coated tablets

Instruction manual

For medical use of the drug

Tetracycline hydrochloride

(tetracycline hydrochloride)

Structure:

Active substance: tetracycline hydrochloride;

1 tablet contains tetracycline hydrochloride 100 mg;

excipients: sugar, gelatin, calcium stearate, talc, potato starch, polysorbate, opadra II red 85F35289 (mixture of substances: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E 171), talc, carmine (E 120), charming red AC ( E 129), yellow sunset FCF (E 110)).

Dosage form.

Coated tablets.

Basic physical and chemical properties: round tablets, coated, from raspberry to red-brown in color, with a smooth biconvex surface.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. tetracyclines. code atx j01a a07.

Pharmacological properties.

Pharmacodynamics

An antibiotic of a broad-spectrum tetracycline group. It is active against gram-positive (staphylococci, including those that produce penicillinase; streptococci, pneumococci, clostridia, listeria, anthrax bacilli) and gram-negative bacteria (gonococci, bordetellum, Escherichia coli, enterobacteria, Klebsiella, salmon) also spirochetes, rickettsia, leptospira, pathogens of trachoma, ornithosis. Inactive or inactive against Pseudomonas aeruginosa, Proteus, sera, acid-resistant bacteria, most strains of the species Bacteroides fragilis, fungi, influenza viruses, polio, measles. There is evidence of the effectiveness of tetracycline in cholera.

The mechanism of the antibacterial action of tetracycline is based on the inhibition of ribosomal protein synthesis of the microbial cell.

At commonly used doses, tetracycline acts bacteriostatically.

Pharmacokinetics

After internal use, 75–77% is quickly absorbed in the digestive canal (food reduces absorption), it binds well to blood plasma proteins. It is rapidly distributed in most body fluids, including bile, secretion of the paranasal sinuses, pleural effusion, synovial, ascitic fluid. It accumulates in the cells of the liver, spleen, tumors, teeth; passes through the placenta and passes into breast milk. The therapeutic concentration is achieved after 2-3 days. It is excreted by the kidneys by glomerular filtration, with feces (kidneys and bile 60%), 65% binds to blood proteins; the elimination half-life is normal - 6–11 hours, with anuria - 57–108 hours.

Impaired renal excretory function can lead to an increase in the concentration of tetracycline in the blood.

Clinical characteristics.

Indications.

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug, such as bronchitis, pneumonia, bacterial and amoebic dysentery, gonorrhea, brucellosis, tularemia, typhus and relapsing fever, psittacosis, ornithosis, biliary and urinary tract infections, purulent meningitis and soft tissues, cholera.

Prevention of postoperative infections.

Contraindications

Hypersensitivity to the drug and to related antibiotics, to local anesthetics (lidocaine, procaine); fungal diseases, systemic lupus erythematosus. lactation period. children under 12 years old; patients with diseases of the liver and kidneys with severe functional impairment. cases of benign intracranial hypertension have been reported with the simultaneous use of tetracyclines with vitamin A or retinoids, so their simultaneous use should be contraindicated.

Interaction with other drugs and other types of interactions.

Salts of iron, oral preparations of zinc, calcium, bismuth (includingbismuth subsalicylate), aluminum, magnesium and other preparations containing these cations (including magnesium-containing laxatives, antacids, sucralfate), cholestyramine, colestipol, kaolin-pectin, sodium bicarbonate: formation of inactive chelates with tetracycline and a decrease in tetracycline absorption. combination with such drugs should be avoided, as well as with quinapril (contains magnesium carbonate), didanosine (contains calcium-containing and magnesium-containing excipients). if such a combination is necessary, the use of tetracycline should be maximally removed in time (2 hours before or 4-6 hours after their use).

Strontium ranelate: a decrease in the concentration of tetracycline in blood serum is possible. Co-administration should be avoided. It is recommended that treatment with strontium ranelate be interrupted during tetracycline therapy.

Digoxin, lithium preparations: an increase in their concentration in blood serum is possible. Ergotamine and metisergide: increased risk of ergotism.

Penicillins, cephalosporins, beta-lactam antibiotics: as a bacteriostatic antibiotic, tetracycline can interfere with the bactericidal activity of other antibiotics. This combination should be avoided.

The combination of tetracycline with oleandomycin and erythromycin is considered synergistic.

Indirect anticoagulants, including warfarin, phenindione, antithrombotic agents: tetracyclines can enhance the effect of indirect anticoagulants due to inhibition of their metabolism in the liver, reduce the level of plasma prothrombin, which requires careful monitoring of prothrombin time and, if necessary, a decrease in the dose of anticoagulants.

Atovaquone: a decrease in the concentration of atovaquone in blood plasma.

Methoxiflurane: a possible toxic effect on the kidneys (including an increase in urea nitrogen and serum creatinine), acute renal failure, sometimes fatal. Methotrexate: possibly increased toxicity of the latter; this combination should be used with caution. If necessary, the simultaneous administration of drugs, regular toxicity monitoring should be carried out.

Vitamin A and retinoids, such as acitretin, isotretionine and tretionin (for the treatment of acne), when used together with tetracyclines, can cause benign intracranial hypertension, so their simultaneous use should be contraindicated. To prevent this complication in the treatment of acne with retinoids, it is necessary to maintain the interval after therapy with tetracyclines.

Hormonal contraceptives: a decrease in their effectiveness (unplanned pregnancy) and an increase in the frequency of breakthrough bleeding when used with tetracyclines. In this regard, it is recommended to use non-hormonal methods of contraception during treatment with tetracycline and for another 7 days after completion of the course of treatment.

Diuretics: this combination requires caution, since against the background of dehydration, the risk of nephrotoxicity increases.

Antidiabetic drugs (insulin, sulfonylurea derivatives,

including glibenclamide, gliclazide): increased their hypoglycemic effect.

Chymotrypsin increases the concentration and duration of circulation of tetracycline in the blood.

Prescribe tetracycline with hepatotoxic drugs with caution.

Oral vaccine against typhoid fever, BCG: antibacterial drugs,

including tetracyclines may reduce the therapeutic effect of these vaccines. Vaccines should be avoided during antibiotic treatment.

The absorption of tetracycline is disturbed when used with food, with milk and dairy products.

Features of the application.

Esophagitis. cases of esophagitis and esophageal ulcers have been reported in patients receiving capsule or tablet forms of tetracyclines.the drug should be washed down with a sufficient amount of liquid and swallow in an upright position, sitting or standing, long before bedtime. if symptoms such as dysphagia or pain behind the sternum occur, consider the possibility of developing this complication and discontinuing the drug. tetracycline should be used with caution in patients with esophageal reflux.

Photosensitivity. Cases of photosensitivity reactions with clinical manifestations of severe sunburn in patients taking tetracyclines have been reported. During treatment, it is recommended to protect exposed areas of the body from direct sunlight and artificial UV radiation. Patients should be informed of the possibility of such a reaction and warned that treatment with tetracyclines should be stopped immediately at the first sign of erythema on the skin.

Microflora. The use of antibiotics can lead to excessive growth of insensitive microorganisms, in particular fungi, including Candida, and to the development of superinfection, which requires the abolition of the antibiotic and the adoption of appropriate measures.

To prevent the development of candidiasis simultaneously with tetracycline, it is recommended to use antifungal drugs and vitamins.

Diarrhea, especially severe, persistent and / or mixed with blood, during or after treatment (including several weeks after treatment) with tetracycline may be a symptom of Clostridium difficile-associated diarrhea (CDAD). The severity of the manifestations of CDAD can range from mild diarrhea to life-threatening pseudomembranous colitis. If CDAD is suspected, tetracycline should be discontinued immediately and appropriate therapy should be started immediately. Antiperistaltic drugs are contraindicated in this clinical situation.

CDAD should be considered in all patients who develop severe diarrhea during or after antibiotic use.

Tooth development. The use of tetracyclines during the period of development of teeth (II-III trimesters of pregnancy, the period of breast-feeding, the neonatal period, children under 12 years of age) can cause a permanent change in the color of the teeth (yellow-brown-gray). Such an adverse reaction often occurs with prolonged use, but can also be observed after repeated short courses of treatment. There have also been reports of enamel hypoplasia.

Sexually transmitted diseases. Tetracyclines can mask the manifestations of syphilis. In the treatment of sexually transmitted diseases with suspected concomitant syphilis, appropriate diagnostic procedures should be applied. In all such cases, monthly serological tests should be performed for at least 4 months.

Beta hemolytic streptococcus. For infections caused by beta-hemolytic group A streptococci, treatment should be carried out for at least 10 days.

Myasthenia gravis. The drug should be used with caution in patients with myasthenia gravis because of the possibility of a weak neuromuscular blockade.

Systemic lupus erythematosus, porphyria. Tetracyclines can cause an exacerbation of systemic lupus erythematosus. Cases of porphyria have occasionally been observed in patients receiving tetracyclines. Therefore, tetracycline should not be used in patients with porphyria or systemic lupus erythematosus.

Impaired renal function. The use of tetracycline is generally contraindicated in renal failure due to the possibility of excessive cumulation and an increased risk of side effects.

The anti-anabolic effect of tetracyclines can cause an increase in the level of residual urea nitrogen in the blood. Although this is not essential for patients with normal renal function, in patients with significantly impaired renal function, high serum tetracycline levels can lead to azotemia, hyperphosphatemia, and acidosis.

Impaired liver function.Tetracycline should be used with caution in patients with impaired liver function and in patients who receive potentially hepatotoxic drugs. High doses of the drug should be avoided. The use of high doses of tetracycline have been associated with the development of fatty liver and pancreatitis.

With caution, prescribe tetracycline hydrochloride for leukopenia.

Since tetracyclines reduce plasma prothrombin activity, patients who are on anticoagulation therapy may need to reduce the dose of anticoagulants.

With prolonged use of the drug should be periodically performed blood tests, functional renal and liver tests.

Tetracycline therapy should be carried out under the supervision of a physician. The appointment regimen should be strictly observed during the entire course of treatment, do not skip doses and take them at regular intervals. If you miss a dose, take it as soon as possible; do not take if it is almost time for the next dose; do not double the dose. Tetracycline hydrochloride should not be taken at the same time as milk or other dairy products, as this disrupts its absorption.

In case of signs of hypersensitivity to the drug and adverse reactions, stop taking the drug, if necessary, prescribe another antibiotic (not a group of tetracyclines). For the prevention of possible complications, the simultaneous use of hepatoprotectors, choleretic drugs, eubiotics, vitamins, antifungal drugs is advisable.

Tetracycline is not the drug of choice in the treatment of any type of staph infection.

It is not advisable to prescribe the drug to adults in doses of less than 800 mg per day, since in addition to the insufficient therapeutic effect, the development of forms of microorganisms resistant to tetracycline is possible.

The dye yellow sunset FCF (E 110), which is part of the tablet shell, can cause allergic reactions. The risk of allergies is higher in patients with hypersensitivity to acetylsalicylic acid.

The drug contains sugar, therefore, in case of intolerance to certain sugars, you should consult your doctor before taking this drug.

Use during pregnancy or lactation.

The drug is contraindicated for use during pregnancy or breastfeeding.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

There is no data on the negative effect of the drug on the ability to drive vehicles and service mobile mechanisms.

Dosage and administration.

Tetracycline should be taken 1 hour before or 2 hours after eating, as food and some dairy products interfere with absorption. tablets should be washed down with water.

The dosage and course of treatment is determined by the doctor individually, depending on the nature and course of the disease.

The course of treatment must be continued for three days after the disappearance of the clinical manifestations of the disease.

All infections caused by β-hemolytic streptococcus should be treated for at least 10 days.

Adults (including elderly patients) and children from 12 years old. Typically, a single dose is 200 mg (2 tablets) every 6 hours. In severe infections, the dose may be increased to 500 mg every 6 hours.

The maximum daily dose is 2 g.

Elderly patients. Use the usual dose for adults. With caution, the drug should be used for subclinical renal failure, as this can lead to the accumulation of the drug.

Renal failure. In general, the use of tetracyclines is contraindicated in renal failure, unless the use of this class of drugs is considered absolutely necessary.The daily dose should be reduced by reducing the recommended individual doses and / or by increasing the intervals between doses.

Children.

Children under 12 years old do not use the drug.

Overdose.

Symptoms: nausea, vomiting; when applying doses significantly higher than recommended - crystalluria, hematuria. may increase the manifestations of the described adverse reactions, including hypersensitivity reactions.

Treatment: symptomatic therapy. There is no specific antidote.

Adverse Reactions

The drug, as a rule, is well tolerated. in some cases, the following reactions may occur.

- Allergic and immunopathological reactions: hypersensitivity reactions, including urticaria, angioedema, including face and tongue, anaphylaxis, anaphylactoid reactions, including anaphylactoid purpura, exacerbation of systemic lupus erythematosus, fixed drug erythema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

The dye yellow sunset FCF (E 110), which is part of the tablet shell, can cause allergic reactions.

- On the part of the skin and subcutaneous tissue: itching, flushing of the skin, rashes, including maculopapular, erythematous, photosensitization reactions, bullous dermatoses, pigmentation disorders of the skin and mucous membranes.

- From the respiratory system: bronchospasm.

- From the cardiovascular system: pericarditis.

- From the digestive system: anorexia, nausea, vomiting, dry mouth, diarrhea, constipation, abdominal pain or discomfort, dyspepsia (including heartburn / gastritis), dysphagia, intestinal dysbiosis, pancreatitis. Cases of esophagitis and esophageal ulcers have been reported in patients taking capsules and tablets of tetracyclines, gastric and duodenal ulcers.

- From the hepatobiliary system: cases of hepatotoxicity with a transient increase in hepatic transaminases, alkaline phosphatase and bilirubin in the blood, impaired liver function; hepatitis, jaundice, fatty liver, liver failure. The first symptoms of liver damage can be feeling unwell, an increase in body temperature and / or pain in the right hypochondrium, pain in the stomach, nausea, vomiting, sclerotemia.

- From the nervous system: swelling of the fontanel in infants and benign intracranial hypertension in adolescents and adults, the first symptoms of which may be headache, dizziness, tinnitus / hearing impairment, visual impairment (including optic edema, blurred vision , scotomas, diplopia, photophobia), anorexia, nausea, vomiting, shaky gait. Cases of temporary / permanent loss of vision have been reported.

- From the hemopoietic organs: hemolytic anemia, thrombocytopenia, neutropenia, anemia, Moshkovich disease, eosinophilia, agranulocytosis, aplastic anemia.

- From the endocrine system: with prolonged use of tetracyclines, microscopic areas of brown-black color may appear in the thyroid gland tissue. Thyroid function is not impaired.

- From the urinary system: azotemia, hypercreatininemia, acute renal failure, nephritis, usually in patients with pre-existing renal impairment.

- From the musculoskeletal system: increased muscle weakness in patients with myasthenia gravis.

- Effects due to biological effects: with prolonged use of high doses of antibiotics, incl. tetracycline, the development of superinfection is possible, which can lead to the development of candidiasis, glossitis with papillary hypertrophy and blackening of the tongue, stomatitis, staphylococcal enterocolitis, CDAD, pseudomembranous colitis, itching in the anal area, inflammatory lesions of the anogenital zone (due to candidiasis), vulvovaginitis, balanitis, prognosis, .

- Others: hypovitaminosis, sore throat, hoarseness, pharyngitis, tooth enamel hypoplasia in children, permanent discoloration of teeth (yellow or gray-brown color), impaired bone formation, slowing down linear bone growth (in children); changes in laboratory parameters (levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, blood urea nitrogen may increase).

If signs of hypersensitivity and side effects appear, the course of treatment should be discontinued and consult a doctor.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ○ s.

Keep out of the reach of children.

Packaging.

10 tablets in blisters; No. 10x1 or No. 10x2 blisters in a pack of cardboard.

Vacation category.

On prescription.

Manufacturer.

Pao "vitamins."

The location of the manufacturer and the address of the location of his activity.

20300, Ukraine, Cherkasy region, Uman, st. Lenin spark, 31.

Applicant

Pao "vitamins."

Location of the applicant and / or representative of the applicant.

20300, Ukraine, Cherkasy region, Uman, st. Lenin spark, 31.

Tags: Tetracycline