Pharmacological properties
The active component of this ointment belongs to the tetracycline group of antibiotics. It has a wide spectrum of antibacterial action, with bacteriostatic properties. Tetracycline exhibits bacteriostatic activity against gram-positive and gram-negative microorganisms, including most types of streptococci and staphylococci. In addition, it is effective against gonococci, salmonella, pneumococci, shigella, E. coli, clostridium, chlamydia, mycoplasma and rickettsia.
The effect of tetracycline does not apply to viruses, fungi, as well as Proteus and Pseudomonas aeruginosa.
special instructions
It is necessary to remember the ability of tetracycline to change the color of tooth enamel in children during teething; this effect is explained by the ability of tetracycline to be deposited in tooth enamel and dentin.
Like any ophthalmic drug, tetracycline ointment can cause temporary blurred vision, so immediately after applying the drug it is better to refrain from driving a car or working with moving mechanisms.
Store tubes with tetracycline ointment at a temperature of 8 -15 oC. Keep away from children.
Shelf life – 3 years.
Tetracycline
Trade name: Tetracycline International name: Tetracycline
Pharmacological group: tetracycline antibiotic Pharmacological action: antibacterial Pharmacodynamics: Bacteriostatic antibiotic from the tetracycline group. It disrupts the formation of the complex between transfer RNA and the ribosome, which leads to the suppression of protein synthesis. Active against gram-positive microorganisms: Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-producing strains), Streptococcus spp. (including Streptococcus pneumoniae), Listeria spp., Bacillus anthracis, Clostridium spp., Actinomyces israelii, gram-negative microorganisms: Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, most enterobacteria: Escherichia coli, Enterobacter spp., including Enterobacter aerogenes, Klebsiella spp., Salmonella spp., Shigella spp., Yersinia pestis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia spp., Borrelia burgdorferi, Brucella spp. (in combination with streptomycin), with contraindications to the use of penicillins - Clostridium spp., Neisseria gonorrhoeae, Actinomyces spp., is also active against pathogens of venereal and inguinal lymphogranuloma, Treponema spp. Microorganisms resistant to tetracycline: Pseudomonas aeruginosa, Proteus spp., Serratia spp., most strains of Bacteroides spp. and fungi, viruses, group A beta-hemolytic streptococci (including 44% of Streptococcus pyogenes strains and 74% of Streptococcus faecalis strains).
Pharmacokinetics: When taken orally: Absorption - 75-77%, decreases with food intake, binding to plasma proteins - 55-65%. TCmax for oral administration is 2-3 hours (2-3 days may be required to achieve therapeutic concentrations). Over the next 8 hours, the concentration gradually decreases. Cmax - 1.5-3.5 mg/l (a concentration of 1 mg/l is sufficient to achieve a therapeutic effect). It is distributed unevenly in the body: Cmax is determined in the liver, kidneys, lungs and in organs with well-developed RES - the spleen, lymph nodes. The concentration in bile is 5-10 times higher than in blood serum. In the tissues of the thyroid and prostate glands, the concentration of tetracycline corresponds to that found in plasma, in pleural, ascitic fluid, saliva, and milk of lactating women - 60-100% of the concentration in plasma. It accumulates in large quantities in bone tissue, tumor tissue, dentin and enamel of baby teeth. Poorly penetrates the BBB. With intact meninges, it is not detected in the CSF or is detected in small quantities (5-10% of the plasma concentration). In patients with diseases of the central nervous system, especially with inflammatory processes in the meninges, the concentration in the CSF is 8-36% of the concentration in plasma. Penetrates through the placental barrier and into breast milk. Volume of distribution - 1.3-1.6 l/kg. Slightly metabolized in the liver. T1/2 - 6-11 hours, with anuria - 57-108 hours. It is found in urine in high concentration 2 hours after administration and persists for 6-12 hours; in the first 12 hours, up to 10-20% of the dose is excreted by the kidneys. In smaller quantities (5-10% of the total dose) it is excreted with bile into the intestine, where partial reabsorption occurs, which promotes long-term circulation of the active substance in the body (enterohepatic circulation). Excretion through the intestines is 20-50%. During hemodialysis it is removed slowly.
When applied to intact skin, it is practically not absorbed.
Indications for use: When taken orally: Infectious diseases caused by sensitive pathogens: pneumonia and respiratory tract infections caused by Mycoplasma pneumoniae, respiratory tract infections caused by Haemophilus influenzae and Klebsiella spp., bacterial infections of the genitourinary organs, skin and soft tissue infections, ulcerative necrotizing gingivostomatitis, conjunctivitis, acne, actinomycosis, intestinal amoebiasis, anthrax, brucellosis, bartonellosis, chancroid, cholera, chlamydia, uncomplicated gonorrhea, granuloma inguinale, lymphogranuloma venereum, listeriosis, plague, psittacosis, vesicular rickettsiosis, macular Rocky Mountain fever, spotted fever typhus, relapsing fever, syphilis, trachoma, tularemia, yaws.
For external use: Acne vulgaris, bacterial skin infections.
For topical use: Bacterial and chlamydial eye infections - blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, meibomitis (styre), trachoma, eye damage due to rosacea.
Contraindications: For oral administration: Hypersensitivity, pregnancy (II-III trimesters), lactation period, children (up to 8 years), leukopenia.
For external use: Hypersensitivity, children's age (up to 11 years).
For local use: Hypersensitivity.
With caution: For oral forms: Renal failure.
Dosage regimen: Orally, with plenty of liquid, adults - 0.25-0.5 g 4 times a day or 0.5-1 g every 12 hours. Maximum daily dose - 4 g. For acne: 0.5-2 g / day in divided doses doses If the condition improves (usually after 3 weeks), the dose is gradually reduced to a maintenance dose of 0.125-1 g. Adequate remission of acne can be achieved by using the drug every other day or intermittent therapy. Brucellosis - 0.5 g every 6 hours for 3 weeks, simultaneously with intramuscular administration of streptomycin at a dose of 1 g every 12 hours for 1 week and 1 time per day for 2 weeks. Uncomplicated gonorrhea: initial single dose - 1.5 g, then 0.5 g every 6 hours for 4 days (total dose 9 g). Syphilis - 0.5 g every 6 hours for 15 days (early syphilis) or 30 days (late syphilis). Uncomplicated urethral, endocervical and rectal infections caused by Chlamydia trachomatis - 0.5 g 4 times a day for at least 7 days. Children over 8 years old - 6.25-12.5 mg/kg every 6 hours or 12.5-25 mg/kg every 12 hours.
Externally. The ointment is applied to the affected areas of the skin 1-2 times a day (a gauze bandage may be applied).
Locally. The ointment is applied behind the eyelid every 2-4 hours or more often. The duration of use depends on the form of the disease: for trachoma - 1-2 months or longer (combination with systemic drugs is possible).
Side effects: From the digestive system: loss of appetite, vomiting, diarrhea, nausea, glossitis, esophagitis, gastritis, ulceration of the stomach and duodenum, hypertrophy of the papillae of the tongue, dysphagia, hepatotoxic effect, increased activity of liver transaminases, pancreatitis, intestinal dysbiosis. From the nervous system: increased intracranial pressure, dizziness or unsteadiness. From the hematopoietic organs: hemolytic anemia, thrombocytopenia, neutropenia. From the urinary system: azotemia, hypercreatininemia. Allergic and immunopathological reactions: maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug-induced SLE, photosensitivity. Other: superinfection, candidiasis, hypovitaminosis B, hyperbilirubinemia, discoloration of tooth enamel in children.
For external use: Allergic reactions: burning, skin flushing, swelling or other signs of irritation.
When applied topically: Allergic reactions.
Interaction: When taken orally: Due to the suppression of intestinal microflora, it reduces the prothrombin index (requires a reduction in the dose of indirect anticoagulants). Reduces the effectiveness of bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins). Reduces the effectiveness of estrogen-containing oral contraceptives and increases the risk of breakthrough bleeding; retinol increases the risk of increased intracranial pressure. Absorption is reduced by antacids containing Al3+, Mg2+ and Ca2+, Fe preparations and cholestyramine. Chymotrypsin increases the concentration and duration of circulation.
Special instructions: When taken orally: Due to the possible development of photosensitivity, it is necessary to limit exposure to insolation. With long-term use, periodic monitoring of the function of the kidneys, liver, and hematopoietic organs is necessary. It can mask the manifestations of syphilis, and therefore, if a mixed infection is possible, monthly serological analysis is necessary for 4 months. All tetracyclines form stable complexes with Ca2+ in any bone-forming tissue. In this regard, intake during the period of tooth development can cause long-term staining of teeth in a yellow-gray-brown color, as well as enamel hypoplasia. To prevent hypovitaminosis, vitamins B and K and brewer's yeast should be prescribed.
For external use: It is not recommended for use on deep or puncture wounds, severe burns, or in ophthalmology (use 1% eye ointment). It should be borne in mind that the use of antibacterial drugs for external use can lead to sensitization of the body, accompanied by the development of hypersensitivity reactions. If the condition does not improve within 2 weeks, you should consult your doctor. Adequate and strictly controlled studies have not been conducted in children under 11 years of age; doses for this category of patients have not been determined.
For topical use: Blurred vision may occur after applying the eye ointment. If the condition does not improve within a few days, you should consult your doctor.
Manufacturer: Biosintez JSC, Russia Registration certificate holder: Biosintez JSC, Russia Forms of release: ointment for external use 3%, aluminum tubes, ointment for external use 3%, Aluminum tube, ointment for external use 3%, polymer tube Composition: tetracycline hydrochloride 3.226 g - 100 g Preferential release: DLO Conditions of release: without a prescription Shelf life: 3 years Registration data: LS-002178 dated 12/23/2011, 11/03/2006 Registration certificate status: valid Pharmaceutical article number: LS-002178-231211, FS 42 -3-89, FS 42-3-97, FS 42-3VS-91, FSP 42-0152-7600-06
Manufacturer: Biokhimik OAO, Russia Registration certificate holder: Biokhimik OAO, Russia Release form: ointment for external use 3%, aluminum tubes Composition: tetracycline hydrochloride 3.226 g [activity 930 mcg/mg] - 100 g Preferential release: DLO Release conditions: without prescription Shelf life: 3 years Registration data: LS-001079 dated December 30, 2005 Status of the registration certificate: valid (until 2010) Pharmaceutical article number: FS 42-3-89, FS 42-3-97, FS 42-3ВС- 91, FSP 42-0048-5458-04
Manufacturer: Murom Instrument-Making Plant Federal State Unitary Enterprise, Russia Registration certificate holder: Murom Instrument-Making Plant Federal State Unitary Enterprise, Russia Forms of release: eye ointment 1%, Aluminum tube Belongs to the Vital and Essential Drugs Minimum pharmacy assortment Preferential dispensing: DLO Dispensing conditions: without a prescription Registration data: LP-000920 dated 10/18/2011 Registration certificate status: valid (until 2021) Pharmaceutical article number: LP 000920-181011
Manufacturer: Nizhpharm OAO, Russia Registration certificate holder: Nizhpharm OAO, Russia Forms of release: ointment for external use 3%, aluminum or polyethylene laminated tubes Preferential release: DLO Conditions of release: without a prescription Registration data: P N001903/01 dated 08/14/2008 Status of the registration certificate: valid Pharmaceutical article number: P N001903/01-260509
Manufacturer: Nizhpharm OJSC, Russia Registration certificate holder: Nizhpharm OJSC, Russia Release form: ointment for external use 3%, aluminum tubes Ingredients: tetracycline hydrochloride [with activity 1 mg/mg] 30 mg - 1 g Preferential release: DLO Release conditions: without prescription Shelf life: 3 years Registration data: P N001903/01 dated 08/14/2008 Status of the registration certificate: valid Pharmaceutical article number: P N001903/01-260509, FS 42-3-89, FS 42-3-97, FS 42- 3ВС-91, FSP 42-0079-3219-02
Manufacturer: Tatkhimfarmpreparaty OJSC, Russia Registration certificate holder: Tatkhimfarmpreparaty OJSC, Russia Forms of release: eye ointment 1%, aluminum tubes, ophthalmic ointment 1%, aluminum tube Ingredients: tetracycline 1 g, excipients (vaseline, lanolin 40 g) - 100 g Belongs to the Vital and Essential Drugs Minimum pharmacy assortment Preferential dispensing: DLO Dispensing conditions: without a prescription Expiration date: 3 years Registration data: P N003442/01 dated May 29, 2009 Status of the registration certificate: valid Pharmaceutical article number: P N003442/01-281210, FS 42- 1207-78, FS 42-1207-98, FSP 42-0015-4589-03
Owner of the registration certificate: Aspharma OJSC, Russia Forms of release: substance-powder, dark glass jars, substance-powder, two-layer plastic bags Registration data: 74/331/11 dated 04/12/1974 Status of the registration certificate: valid
Manufacturer: Biosintez OJSC, Russia Registration certificate holder: Biosintez OJSC, Russia Release form: substance-powder, packages Registration data: LS-001801 dated 07/28/2006 Registration certificate status: valid Pharmaceutical article number: LS-001801-150312, FS 42- 2672-97, FSP 42-0152-6418-05
Manufacturer: Belmedpreparaty RUP, Belarus Registration certificate holder: Omela LLC, Russia Release forms: film-coated tablets 100 mg, blister packs, film-coated tablets 100 mg, blister packs Ingredients: tetracycline 100 mg Preferential release: DLO Shelf life: 3 years Registration data: LS-000868 dated 08/04/2010, 12/29/2006 Registration certificate status: valid Pharmaceutical article number: LS-000868-051011, ND 42-9802-04, ND 42-9802-06, ND 42-9802-99
Manufacturer: Biosintez JSC, Russia Registration certificate holder: Biosintez JSC, Russia Release forms: film-coated tablets 100 mg, cellular contour packs, film-coated tablets 100 mg, plastic bags, film-coated tablets 100 mg, polymer jars, film-coated tablets 100 mg, polymer jar, film-coated tablets 100 mg, double bags made of polyethylene film, film-coated tablets 100 mg, contour cell packaging [alfoil/PVC], film-coated tablets 100 mg, contour cell packaging [paper with poly. coating/PVC] Composition: tetracycline hydrochloride 100 mg [in terms of tetracycline] Preferential release: DLO Conditions of release: prescription Expiration date: 3 years Registration data: LS-001800 dated 07/11/2011, 07/21/2006 Registration certificate status: valid Pharmaceutical article number: LS-001800-110711, FS 42-3455-97, FSP 42-0152-6087-04
Manufacturer: Biokhimik OJSC, Russia Registration certificate holder: Biokhimik OJSC, Russia Release forms: film-coated tablets 100 mg, dark glass jars, film-coated tablets 100 mg, contour blister packaging, film-coated tablets 100 mg, contour blister packaging made of polyvinyl chloride film and printed varnished aluminum foil Composition: tetracycline hydrochloride 100 mg Preferential release: DLO Dispensation conditions: by prescription Expiration date: 3 years Registration data: LS-001413 dated 01/23/2012, 03/17/2006 Status of the registration certificate: valid Pharmaceutical article number: LS- 001413-230112, FS 42-3455-97, FSP 42-0048-6611-05
Manufacturer: Valenta Pharmaceuticals OJSC, Russia Registration certificate holder: Valenta Pharmaceuticals OJSC, Russia Release forms: film-coated tablets 100 mg, blister packs, film-coated tablets 250 mg, blister packs, film-coated tablets 250 mg, polymer jars, coated tablets shell 100 mg, polymer cans Composition: tetracycline hydrochloride 100/250 mg Preferential release: DLO Shelf life: 3 years Registration data: LS-000993 dated 08/14/2008 Status of the registration certificate: valid (until 2010) Pharmaceutical article number: FS 42 -3455-97, FSP 42-0055-6618-05
