INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE HYDROCHLORIDE)

Composition:

Active substance: tetracycline hydrochloride;

One tablet contains 100 mg of tetracycline hydrochloride;

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

Pharmaceutical form. Coated tablets.

Main physicochemical characteristics: round, coated tablets, ranging in color from raspberry to reddish-brown, with a smooth, biconvex surface.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Tetracyclines. ATC code J01A A07.

Pharmacological Properties.

Pharmacodynamics.

A broad-spectrum tetracycline-group antibiotic. Active against Gram-positive bacteria (staphylococci, including penicillinase-producing strains; streptococci, pneumococci, clostridia, listeria, Bacillus anthracis) and Gram-negative bacteria (gonococci, Bordetella, Escherichia coli, enterobacteria, Klebsiella, Salmonella, Shigella), as well as spirochetes, rickettsiae, leptospira, and the causative agents of trachoma and psittacosis. It is weakly active or inactive against Pseudomonas aeruginosa, Proteus, Serratia, acid-fast bacteria, most strains of Bacteroides fragilis, fungi, influenza viruses, poliovirus, and measles virus. There is evidence of tetracycline's effectiveness in the treatment of cholera.

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

At normally administered doses, tetracycline exerts a bacteriostatic effect.

Pharmacokinetics.

After oral administration, tetracycline is rapidly absorbed (75–77%) in the gastrointestinal tract (food reduces absorption), and binds well to plasma proteins. It rapidly distributes into most body fluids, including bile, paranasal sinus secretions, pleural exudate, synovial, and ascitic fluids. It accumulates in liver and spleen cells, tumors, and teeth; crosses the placenta and penetrates into breast milk. Therapeutic concentrations are achieved within 2–3 days. It is excreted by the kidneys via glomerular filtration and in feces (60% via kidneys and bile); 65% is protein-bound in blood. The elimination half-life under normal conditions is 6–11 hours, and in cases of anuria, it extends to 57–108 hours.

Impaired renal excretory function may lead to increased tetracycline blood concentrations.

Clinical characteristics.

Indications.

Infectious-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, infections of biliary and urinary tracts, purulent meningitis, purulent skin and soft tissue infections, cholera.

Prevention of postoperative infections.

Contraindications.

Hypersensitivity to the drug and related antibiotics, local anesthetics (lidocaine, procaine); fungal infections, systemic lupus erythematosus. Breastfeeding period. Children under 12 years of age; patients with liver and kidney diseases accompanied by pronounced functional insufficiency. Cases of benign intracranial hypertension have been reported with concomitant use of tetracyclines and vitamin A or retinoids; therefore, their simultaneous use should be contraindicated.

Interaction with other medicinal products and other types of interactions.

Iron salts, oral zinc, calcium, bismuth (including bismuth 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 reduced absorption of tetracycline. Combinations with these agents should be avoided, as well as with quinapril (contains magnesium carbonate) and didanosine (contains calcium- and magnesium-containing excipients). If such combination is necessary, administration of tetracycline should be separated in time as much as possible (2 hours before or 4–6 hours after administration of these agents).

Strontium ranelate: possible reduction in tetracycline serum concentration. Concomitant use should be avoided. It is recommended to interrupt strontium ranelate treatment during tetracycline therapy.

Digoxin, lithium preparations: possible increase in their serum concentrations.

Ergotamine and methysergide: increased risk of ergotism.

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

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

Indirect anticoagulants, including warfarin, phenindione, antithrombotic agents: tetracyclines may enhance the effect of indirect anticoagulants due to inhibition of their metabolism in the liver, reduce plasma prothrombin levels, requiring careful monitoring of prothrombin time and, if necessary, reduction of anticoagulant doses.

Atovaquone: reduced plasma concentration of atovaquone.

Metoxiflurane: possible nephrotoxic effects (including increased blood urea nitrogen and serum creatinine), acute renal failure, sometimes fatal.

Methotrexate: possible increase in its toxicity; this combination should be used with caution. Regular monitoring of toxicity is required if concomitant administration is necessary.

Vitamin A and retinoids such as acitretin, isotretinoin, and tretinoin (for acne treatment), when used concomitantly with tetracyclines, may cause benign intracranial hypertension; therefore, their simultaneous use should be contraindicated. To prevent this complication during acne treatment with retinoids, an interval should be maintained after tetracycline therapy.

Hormonal contraceptives: reduced efficacy (unplanned pregnancy) and increased frequency of breakthrough bleeding when used with tetracyclines. Therefore, non-hormonal contraceptive methods are recommended during tetracycline treatment and for 7 days after completion of therapy.

Diuretics: such combination requires caution, as dehydration increases the risk of nephrotoxicity.

Antidiabetic agents (insulin, sulfonylurea derivatives, including glyburide, glipizide): enhanced hypoglycemic effect.

Chymotrypsin increases tetracycline concentration and prolongs its circulation in blood.

Tetracycline should be administered with caution together with hepatotoxic agents.

Oral typhoid vaccine, BCG: antibacterial agents, including tetracyclines, may reduce the therapeutic efficacy of these vaccines. Vaccination should be avoided during antibiotic treatment.

Tetracycline absorption is impaired when administered with food, milk, or dairy products.

Special precautions.

Esophagitis. Cases of esophagitis and esophageal ulcers have been reported in patients taking encapsulated or tablet forms of tetracyclines. The drug should be taken with sufficient fluid and swallowed in an upright position (sitting or standing), well before bedtime. If symptoms such as dysphagia or retrosternal pain occur, the possibility of this complication should be considered and discontinuation of the drug should be evaluated. Tetracycline should be used with caution in patients with esophageal reflux.

Photosensitization. Cases of photosensitivity reactions with clinical manifestations of severe sunburn have been reported in patients taking tetracyclines. During treatment, patients should protect exposed areas of skin from direct sunlight and artificial UV radiation. Patients should be informed about the possibility of such reactions and advised to discontinue tetracycline therapy immediately at the first signs of skin erythema.

Microflora. Antibiotic use may lead to overgrowth of non-susceptible microorganisms, including fungi such as Candida, and development of superinfection, which may require discontinuation of the antibiotic and appropriate interventions.

To prevent candidiasis, concomitant use of antifungal agents and vitamins is recommended during tetracycline therapy.

Diarrhea, especially severe, persistent, and/or bloody, occurring during or after treatment (including several weeks after therapy) with tetracycline may be a symptom of Clostridium difficile-associated diarrhea (CDAD). The severity of CDAD may range from mild diarrhea to life-threatening pseudomembranous colitis. If CDAD is suspected, tetracycline should be discontinued immediately and appropriate therapy initiated without delay. Antiperistaltic agents are contraindicated in this clinical situation.

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

Tooth development. Tetracycline use during tooth development (second and third trimesters of pregnancy, breastfeeding period, neonatal period, children under 12 years of age) may cause permanent tooth discoloration (yellow-gray-brown). This adverse reaction is more common with prolonged use but may also occur after repeated short courses. Hypoplasia of the enamel has also been reported.

Sexually transmitted diseases. Tetracyclines may mask the symptoms of syphilis. When treating sexually transmitted infections with suspected concomitant syphilis, appropriate diagnostic procedures should be performed. In all such cases, monthly serological testing should be conducted for at least 4 months.

Beta-hemolytic streptococci. For infections caused by group A beta-hemolytic streptococci, treatment should last at least 10 days.

Myasthenia gravis. The drug should be used with caution in patients with myasthenia gravis due to the possibility of inducing weak neuromuscular blockade.

Systemic lupus erythematosus, porphyria. Tetracyclines may exacerbate systemic lupus erythematosus. Rare cases of porphyria have been observed in patients receiving tetracyclines. Therefore, tetracycline should not be used in patients with porphyria or systemic lupus erythematosus.

Renal function impairment. The use of tetracycline is generally contraindicated in renal insufficiency due to the risk of excessive accumulation and increased likelihood of adverse effects.

Antianabolic effect of tetracyclines may lead to elevated blood urea nitrogen levels. While this is not significant in patients with normal renal function, high serum tetracycline levels in patients with severely impaired renal function may result in azotemia, hyperphosphatemia, and acidosis.

Hepatic function impairment. Tetracycline should be used with caution in patients with impaired liver function and in those receiving potentially hepatotoxic drugs. High doses should be avoided. High-dose tetracycline use has been associated with fatty infiltration of the liver and pancreatitis.

Tetracycline hydrochloride should be prescribed with caution in leukopenia.

Since tetracyclines reduce plasma prothrombin activity, patients on anticoagulant therapy may require a reduction in anticoagulant dosage.

During prolonged treatment, periodic blood tests, renal and liver function tests should be performed.

Tetracycline therapy should be administered under medical supervision. The prescribed dosing schedule must be strictly followed throughout the treatment course, without missing doses and taken at regular intervals. If a dose is missed, it should be taken as soon as possible; however, if it is almost time for the next dose, the missed dose should be skipped; doses should not be doubled. Tetracycline hydrochloride should not be taken simultaneously with milk or other dairy products, as this impairs its absorption.

If signs of hypersensitivity or adverse reactions occur, the drug should be discontinued and, if necessary, an alternative antibiotic (not from the tetracycline group) should be prescribed. To prevent possible complications, concomitant use of hepatoprotectors, choleretics, eubiotics, vitamins, and antifungal agents may be advisable.

Tetracycline is not the drug of choice for the treatment of any type of staphylococcal infection.

Prescribing the drug to adults in doses less than 800 mg per day is not recommended, as it may result in inadequate therapeutic effect and may promote the development of tetracycline-resistant microbial strains.

Yellow dye FCF (E 110), present in the tablet coating, may cause allergic reactions. The risk of allergy is higher in patients with hypersensitivity to acetylsalicylic acid.

The medicinal product contains sugar; therefore, if a sugar intolerance has been diagnosed, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

There are no data on the negative impact of the drug on the ability to drive or operate moving machinery.

Method of Administration and Dosage

Tetracycline should be taken 1 hour before or 2 hours after a meal, as food and certain dairy products interfere with its absorption. Tablets should be swallowed with water.

Dosage and duration of treatment are determined individually by a physician depending on the nature and course of the disease.

The treatment course should be continued for three days after the disappearance of clinical symptoms of the disease.

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

Adults (including elderly patients) and children aged 12 years and older. The usual dose is 200 mg (2 tablets) every 6 hours. In severe infections, the dose may be increased to 500 mg every 6 hours.

Maximum daily dose – 2 g.

Elderly patients. The usual adult dose should be used. The drug should be administered with caution in patients with subclinical renal insufficiency, as this may lead to drug accumulation.

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

Children.

The drug is not recommended for children under 12 years of age.

Overdose.

Symptoms: nausea, vomiting; when doses significantly exceeding the recommended ones are used – crystalluria, hematuria. Exacerbation of the described adverse effects, including hypersensitivity reactions, is possible.

Treatment: symptomatic therapy. There is no specific antidote.

Adverse Reactions.

The drug is generally well tolerated. In individual cases, the following reactions may occur.

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

The yellow sunset FCF dye (E 110) contained in the tablet coating may cause allergic reactions.

Skin and subcutaneous tissue disorders: pruritus, skin hyperemia, rashes (including maculopapular, erythematous), photosensitization reactions, bullous dermatoses, disturbances in skin and mucous membranes pigmentation.
Respiratory system disorders: bronchospasm.
Cardiovascular system disorders: pericarditis.
Gastrointestinal disorders: anorexia, nausea, vomiting, dry mouth, diarrhea, constipation, abdominal pain or discomfort, dyspepsia (including heartburn/gastritis), dysphagia, intestinal dysbiosis, pancreatitis. Cases of esophagitis and ulceration of the esophagus have been reported in patients taking tetracycline capsules and tablets, as well as gastric and duodenal ulcers.
Hepatobiliary system disorders: cases of hepatotoxicity with transient elevation of liver transaminases, alkaline phosphatase, and bilirubin in blood, impaired liver function; hepatitis, jaundice, fatty liver dystrophy, hepatic failure. Initial symptoms of liver damage may include malaise, fever and/or right upper quadrant pain, epigastric pain, nausea, vomiting, subicterus of the sclera.
Nervous system disorders: bulging of the fontanelle in infants and benign intracranial hypertension in adolescents and adults, whose initial symptoms may include headache, dizziness, tinnitus/hearing disturbances, visual disturbances (including optic nerve edema, blurred vision, scotomas, diplopia, photophobia), anorexia, nausea, vomiting, unsteady gait. Reports have been received of cases of temporary/permanent vision loss.
Blood and lymphatic system disorders: hemolytic anemia, thrombocytopenia, neutropenia, anemia, Moschowitz disease, eosinophilia, agranulocytosis, aplastic anemia.
Endocrine system disorders: prolonged use of tetracyclines may lead to appearance of microscopic areas of brown-black discoloration in thyroid tissue. Thyroid function remains unaffected.
Renal and urinary system disorders: azotemia, hypercreatininemia, acute renal failure, nephritis, usually in patients with pre-existing renal function impairment.
Musculoskeletal system disorders: increased muscle weakness in patients with myasthenia gravis.
Effects due to biological action: prolonged use of high doses of antibiotics, including tetracycline, may lead to superinfection, resulting in candidiasis, glossitis with papillary hypertrophy and black discoloration of the tongue, stomatitis, staphylococcal enterocolitis, CDAD, pseudomembranous colitis, anal itching, inflammatory lesions of the anogenital area (due to candidiasis), vulvovaginitis, balanitis, proctitis.
Other: hypovitaminosis, sore throat, hoarseness, pharyngitis, dental enamel hypoplasia in children, permanent tooth discoloration (yellow or gray-brown color), impaired bone tissue formation, slowed linear bone growth (in children); laboratory parameter changes (elevated levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, blood urea nitrogen).

If signs of hypersensitivity or adverse effects occur, treatment should be discontinued and medical advice sought.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister; 10x1 or 10x2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer.

PJSC "VITAMINS".

Manufacturer's address and location of manufacturing activities.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

PJSC "VITAMINS".

Address of the Marketing Authorization Holder and/or its representative.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

INSTRUCTION

for medical use of medicinal product

TETRACYCLINE HYDROCHLORIDE

(TETRACYCLINE HYDROCHLORIDE)

Composition:

Active ingredient: tetracycline hydrochloride;

1 tablet contains 100 mg of tetracycline hydrochloride;

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

Dosage form. Film-coated tablets.

Main physicochemical properties: round-shaped film-coated tablets ranging from raspberry to reddish-brown in color, with a smooth biconvex surface.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Tetracyclines. ATC code J01AA07.

Pharmacological properties.

Pharmacodynamics.

Broad-spectrum tetracycline-group antibiotic. Active against Gram-positive bacteria (staphylococci, including penicillinase-producing strains; streptococci, pneumococci, clostridia, listeria, Bacillus anthracis) and Gram-negative bacteria (gonococci, bordetellae, Escherichia coli, enterobacteria, klebsiellae, salmonellae, shigellae), as well as spirochetes, rickettsiae, leptospira, causative agents of trachoma and ornithosis. Weakly active or inactive against Pseudomonas aeruginosa, Proteus, Serratia, acid-resistant bacteria, most strains of Bacteroides fragilis, fungi, influenza, poliomyelitis, measles viruses. Data exist on tetracycline efficacy in cholera.

The mechanism of tetracycline's antibacterial action is based on inhibition of microbial ribosomal protein synthesis.

At usual therapeutic doses, tetracycline acts bacteriostatically.

Pharmacokinetics.

After oral administration, tetracycline is rapidly absorbed (75–77%) in the gastrointestinal tract (food reduces absorption) and binds well to plasma proteins. It is rapidly distributed into most body fluids, including bile, paranasal sinus secretions, pleural effusion, synovial, and ascitic fluids. It accumulates in liver and spleen cells, tumors, and teeth; crosses the placenta and enters breast milk. Therapeutic concentration is achieved within 2–3 days. Excreted via the kidneys by glomerular filtration and with feces (60% via kidneys and bile); 65% protein-bound in blood; elimination half-life is 6–11 hours under normal conditions and 57–108 hours in anuria.

Impaired renal excretory function may lead to increased tetracycline blood concentration.

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, infections of biliary and urinary tracts, purulent meningitis, purulent skin and soft tissue infections, cholera.

Prevention of postoperative infections.

Contraindications.

Hypersensitivity to the drug and related antibiotics, local anesthetics (lidocaine, procaine); fungal infections, systemic lupus erythematosus. Breastfeeding period. Children under 12 years of age; patients with severe hepatic or renal functional impairment. Cases of benign intracranial hypertension have been reported with concomitant use of tetracyclines and vitamin A or retinoids; therefore, their combined use is contraindicated.

Interaction with other medicinal products and other forms of interaction.

Iron salts, oral zinc preparations, calcium, bismuth (including bismuth subsalicylate), aluminum, magnesium, and other drugs containing these cations (including magnesium-containing laxatives, antacids, sucralfate), cholestyramine, colestipol, kaolin-pectin, sodium bicarbonate: form inactive chelates with tetracycline, reducing its absorption. Avoid combination with such drugs, as well as with quinapril (contains magnesium carbonate) and didanosine (contains calcium- and magnesium-containing excipients). If such combination is necessary, administration of tetracycline should be separated in time (at least 2 hours before or 4–6 hours after administration of these drugs).

Strontium ranelate: may reduce tetracycline serum concentration. Avoid concomitant use. Treatment with strontium ranelate should be interrupted during tetracycline therapy.

Digoxin, lithium preparations: may increase their serum concentrations. Ergotamine and methysergide: increased risk of ergotism.

Penicillins, cephalosporins, beta-lactam antibiotics: as a bacteriostatic antibiotic, tetracycline may interfere with the bactericidal activity of other antibiotics. Avoid such combinations.

Combination of tetracycline with oleandomycin and erythromycin is considered synergistic.

Indirect anticoagulants, including warfarin, phenindione, antithrombotic agents: tetracyclines may enhance the effect of indirect anticoagulants by inhibiting their hepatic metabolism, reduce plasma prothrombin levels, requiring careful monitoring of prothrombin time and, if necessary, dose reduction of anticoagulants.

Atovaquone: reduced plasma concentration of atovaquone.

Methoxyflurane: possible nephrotoxic effects (including increased blood urea nitrogen and serum creatinine), acute renal failure, sometimes fatal. Methotrexate: possible increased toxicity; this combination should be used with caution. Regular monitoring of toxicity is required if concomitant use is necessary.

Vitamin A and retinoids such as acitretin, isotretinoin, and tretinoin (for acne treatment), when used concomitantly with tetracyclines, may cause benign intracranial hypertension; therefore, their combined use is contraindicated. To prevent this complication during acne treatment with retinoids, an interval should be maintained after tetracycline therapy.

Hormonal contraceptives: reduced efficacy (unplanned pregnancy) and increased incidence of breakthrough bleeding when used with tetracyclines. Therefore, non-hormonal contraceptive methods are recommended during and for at least 7 days after completion of tetracycline treatment.

Diuretics: such combination requires caution due to increased risk of nephrotoxicity in the context of dehydration.

Antidiabetic agents (insulin, sulfonylurea derivatives, including glyburide, glipizide): enhanced hypoglycemic effect.

Chymotrypsin increases tetracycline concentration and prolongs its circulation in blood.

Tetracycline should be used cautiously with hepatotoxic drugs.

Oral typhoid vaccine, BCG vaccine: antibacterial agents, including tetracyclines, may reduce the therapeutic effect of these vaccines. Avoid vaccination during antibiotic treatment.

Tetracycline absorption is impaired when taken with food, milk, or dairy products.

Special precautions.

Esophagitis. Cases of esophagitis and esophageal ulcers have been reported in patients receiving encapsulated or tablet forms of tetracyclines. The drug should be taken with sufficient liquid while in an upright position (sitting or standing), well before bedtime. If symptoms such as dysphagia or retrosternal pain occur, consider the possibility of this complication and discontinue the drug. Use tetracycline cautiously in patients with esophageal reflux.

Photosensitization. Cases of photosensitivity reactions with clinical manifestations of severe sunburn have been reported in patients taking tetracyclines. During treatment, patients should protect exposed skin from direct sunlight and artificial UV radiation. Patients should be informed about the possibility of such reactions and advised to discontinue tetracycline treatment immediately at the first signs of skin erythema.

Microflora. Antibiotic use may lead to overgrowth of non-susceptible microorganisms, particularly fungi including Candida, and development of superinfection, requiring discontinuation of the antibiotic and appropriate management.

To prevent candidiasis, concomitant use of antifungal agents and vitamins is recommended.

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

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

Tooth development. Use of tetracyclines during tooth development (second and third trimesters of pregnancy, breastfeeding period, neonatal period, children under 12 years) may cause permanent tooth discoloration (yellow-brown-gray). This adverse reaction occurs more frequently with prolonged use but may also occur after repeated short courses. Hypoplasia of enamel has also been reported.

Venereal diseases. Tetracyclines may mask manifestations of syphilis. In treating venereal diseases with suspected concurrent syphilis, appropriate diagnostic procedures should be performed. Monthly serological tests should be conducted in all such cases for at least 4 months.

Beta-hemolytic streptococcus. Infections caused by group A beta-hemolytic streptococci should be treated for at least 10 days.

Myasthenia gravis. The drug should be used cautiously in patients with myasthenia gravis due to the possibility of inducing neuromuscular blockade.

Systemic lupus erythematosus, porphyria. Tetracyclines may exacerbate 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.

Renal function impairment. Tetracycline use is generally contraindicated in renal failure due to the risk of excessive accumulation and increased adverse effects.

Antianabolic effect of tetracyclines may lead to increased blood urea nitrogen levels. While this is not significant in patients with normal renal function, high serum tetracycline levels in patients with severely impaired renal function may lead to azotemia, hyperphosphatemia, and acidosis.

Hepatic function impairment. Tetracycline should be used cautiously in patients with hepatic dysfunction and those receiving potentially hepatotoxic drugs. High doses should be avoided. High-dose tetracycline use has been associated with fatty liver infiltration and pancreatitis.

Tetracycline hydrochloride should be prescribed cautiously in leukopenic patients.

Since tetracyclines reduce plasma prothrombin activity, patients on anticoagulant therapy may require dose reduction of anticoagulants.

During prolonged treatment, periodic blood tests, renal and liver function tests should be performed.

Tetracycline therapy should be administered under medical supervision. The dosing regimen must be strictly followed throughout the treatment course, without missing doses and taken at regular intervals. If a dose is missed, take it as soon as possible; do not take if the next dose is nearly due; do not double doses. Tetracycline hydrochloride should not be taken simultaneously with milk or other dairy products, as this impairs its absorption.

If signs of hypersensitivity or adverse reactions occur, discontinue the drug and, if necessary, prescribe another antibiotic (not from the tetracycline group). For prevention of possible complications, concomitant use of hepatoprotectors, choleretics, eubiotics, vitamins, and antifungal agents is advisable.

Tetracycline is not the drug of choice for treating any type of staphylococcal infection.

Administering the drug to adults at doses less than 800 mg daily is not advisable, as this may result in insufficient therapeutic effect and development of tetracycline-resistant microorganisms.

Sunset yellow FCF dye (E 110) contained in the tablet coating may cause allergic reactions. The risk of allergy is higher in patients with hypersensitivity to acetylsalicylic acid.

The medicinal product contains sugar; therefore, patients with known sugar intolerance should consult a physician before taking this drug.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

There are no data on negative effects of the drug on the ability to drive or operate machinery.

Administration and dosage.

Tetracycline should be taken 1 hour before or 2 hours after meals, as food and certain dairy products interfere with absorption. Tablets should be taken with water.

Dosage and duration of treatment are determined individually by a physician depending on the nature and course of the disease.

Treatment should continue for three days after disappearance of clinical symptoms.

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

Maximum daily dose – 2 g.

Elderly patients. Use the standard adult dose. Use the drug cautiously in subclinical renal insufficiency, as it may lead to drug accumulation.

Renal impairment. Generally, tetracycline use is contraindicated in renal failure except when use of this class of drugs is absolutely necessary. The daily dose should be reduced by decreasing individual doses and/or increasing intervals between doses.

Children.

Do not use in children under 12 years of age.

Overdose.

Symptoms: nausea, vomiting; when doses significantly exceeding recommended levels are used – crystalluria, hematuria. Possible intensification of described adverse reactions, including hypersensitivity reactions.

Treatment: symptomatic therapy. No specific antidote exists.

Adverse reactions.

The drug is generally well tolerated. In individual cases, the following reactions may occur.

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

The sunset yellow FCF dye (E 110) contained in the tablet coating may cause allergic reactions.

Skin and subcutaneous tissue disorders: pruritus, skin hyperemia, rashes (including maculopapular, erythematous), photosensitization reactions, bullous dermatoses, disturbances in skin and mucous membranes pigmentation.
Respiratory system disorders: bronchospasm.
Cardiovascular system disorders: pericarditis.
Gastrointestinal disorders: anorexia, nausea, vomiting, dry mouth, diarrhea, constipation, abdominal pain or discomfort, dyspepsia (including heartburn/gastritis), dysphagia, intestinal dysbiosis, pancreatitis. Cases of esophagitis and esophageal ulceration have been reported in patients taking tetracycline capsules and tablets, as well as gastric and duodenal ulcers.
Hepatobiliary system disorders: cases of hepatotoxicity with transient elevation of liver transaminases, alkaline phosphatase, and bilirubin in blood, impaired liver function; hepatitis, jaundice, fatty liver dystrophy, hepatic failure. Initial symptoms of liver damage may include malaise, fever and/or right upper quadrant pain, epigastric pain, nausea, vomiting, subicterus of the sclera.
Nervous system disorders: bulging of the fontanelle in infants and benign intracranial hypertension in adolescents and adults, whose initial symptoms may include headache, dizziness, tinnitus/hearing disturbances, visual disturbances (including optic nerve edema, blurred vision, scotomas, diplopia, photophobia), anorexia, nausea, vomiting, unsteady gait. Reports have been received of cases of temporary/permanent vision loss.
Blood and lymphatic system disorders: hemolytic anemia, thrombocytopenia, neutropenia, anemia, Moschowitz disease, eosinophilia, agranulocytosis, aplastic anemia.
Endocrine system disorders: prolonged use of tetracyclines may lead to appearance of microscopic areas of brown-black discoloration in thyroid tissue. Thyroid function remains unaffected.
Renal and urinary system disorders: azotemia, hypercreatininemia, acute renal failure, nephritis, usually in patients with pre-existing renal function impairment.
Musculoskeletal system disorders: increased muscle weakness in patients with myasthenia gravis.
Effects due to biological action: prolonged use of high doses of antibiotics, including tetracycline, may lead to superinfection, resulting in candidiasis, glossitis with papillary hypertrophy and black discoloration of the tongue, stomatitis, staphylococcal enterocolitis, CDAD, pseudomembranous colitis, anal itching, inflammatory lesions of the anogenital area (due to candidiasis), vulvovaginitis, balanitis, proctitis.
Other: hypovitaminosis, sore throat, hoarseness, pharyngitis, dental enamel hypoplasia in children, permanent tooth discoloration (yellow or gray-brown color), impaired bone tissue formation, slowed linear bone growth (in children); laboratory parameter changes (elevated levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, blood urea nitrogen).

If signs of hypersensitivity or adverse effects occur, treatment should be discontinued and medical advice sought.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister; 10x1 or 10x2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer.

PJSC "VITAMINS".

Manufacturer's address and location of manufacturing activities.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

PJSC "VITAMINS".

Address of the Marketing Authorization Holder and/or its representative.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.