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Doxycycline-TK 100 mg, 10 capsules




Instruction for medical use of medicine Doxycycline – Trade name Doxycycline – shopping Mall Mezhdunarodnoye the unlicensed name Doxycycline Dosage Form of the Capsule of 100 mg Structure One capsule contains active agent – doxycycline (in the form of hiklat doxycycline) – 100 mg excipients: lactoses monohydrate, magnesium stearate Structure of the capsule: a lid – crimson red (E 124), the titan dioxide (E 171), gelatin, the body – crimson red (E 124), the titan dioxide (E 171), gelatin. The description Solid gelatin capsules of No. in size 3 cylindrical forms with the body and a lid of pink color. Contents of capsules – powder of yellow color. Pharmacotherapeutic group Antibacterial drugs for system use. Tetracyclines. Doxycycline. The ATX J01AA02 code the Pharmacological Pharmacokinetics Docsitsiklin properties is quickly soaked up from a digestive tract in proportion to the accepted dose. Process of absorption can slow down the food contents, especially dairy products and drugs containing ions of metals. After intake of 200 mg of drug reaches the maximum concentration in plasma making 2.6 mkg/ml doxycycline in 2 hours. About 50% of doxycycline are metabolized in a liver. Doxycycline contacts proteins of serum for 80 – 90%. Biological elimination half-life of drug makes from 18 to 22 hours and is extended approximately till 25 o’clock at patients with a renal failure. Thanks to long elimination half-life it is possible to take the drug once a day. Doxycycline is well dissolved in fats. Easily gets into the majority of biological liquids and body tissues. Drug reaches high concentrations in watery moisture of an eye, in a prostate, ovaries, a uterus, a bladder, bile, a liver, muscles, rudiments of teeth and bones, in separated a bronchial tree, easy, lymph nodes, near-nasal bosoms, palatine tonsils. Passes through a placenta. Gets into maternal milk. At patients with the kept function of kidneys about 40% of drug it is removed in not changed view with urine, and the rest of drug is removed with a stake, mainly in the form of metabolites. Doxycycline is not exposed to considerable cumulation in an organism of patients with a renal failure. Biological elimination half-life and AUC value of doxycycline do not change. Correction of a dosage is not required from patients with a renal failure because at such patients the concentration of doxycycline in bile increases therefore its removal with a stake increases. The hemodialysis does not influence biological elimination half-life of drug from serum. The pharmacodynamics Doxycycline shopping mall is the antibiotic belonging to group of tetracyclines. Possesses a broad spectrum of activity concerning gram-negative and gram-positive bacteria and also protozoa. The bacteriostatic mechanism of effect of drug consists in slowing down of synthesis of protein at the ribosomalny level. Antibacterial activity. In vitro doxycycline possesses antibacterial action in the relation: – gram-negative bacteria of Neisseria gonorrhoeae, Campylobacter granulomatis, Haemophilus ducreyi, Haemophilus influenzae, Pasteurella pestis, Pasteurella tularensis, Vibrio cholerae, Bartonella bacilliformis, Brucella spp., the changeable sensitivity is shown: Escherichia coli, Klebsiella spp., Enterobacter aerogenes, Shigella spp., Mima spp., Herella spp., Bacteroides spp. – gram-positive bacteria of Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus faecalis, Streptococcus faecium, Staphylococcus aureus, α-hemolytic streptococci of the viridans group – Other microorganisms of Rickettsia, Chlamydia psittaci, Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia recurrentis, Treponema pallidum, Clostridium spp., Fusobacterium fusiforme, Actinomyces spp., Bacillus anthracis, Propinibacterium acnes, Entamoeba spp., Balantidium coli. Plasmodium falciparum. Doxycycline resistance is observed among many strains, especially among gram-positive bacteria. This phenomenon is characterized by heterogeneity since big differences of stability of bacteria of different regions of the world are often observed. The mechanism of stability to doxycycline is connected with decline in the ability of drug to penetrate in a bacterial cell. This stability is caused by presence at a cell of transferable R-plazmidov. Streptococcus pneumoniae strains resistant to doxycycline show also other tetracyclines resistance, and is frequent to penicillin and macroleads (cross stability). Synergism of action between doxycycline and macroleads is observed. Indications apply Doxycycline to treatment of various infections caused by sensitive strains of gram-positive and gram-negative bacteria and some other microorganisms. – Respiratory infections: pneumonia and others of lower respiratory tract infections, Streptococcus pneumoniae caused by sensitive strains, Haemophilus influenzae, Klebsiella pneumoniae and other organisms, mycoplasmal pneumonia, chronic bronchitis, sinusitis. – Infections of an urinogenital system: the infections caused by sensitive strains of Klebsiella species, Enterobacter species. Escherichia coli, Streptococcus faecalis and other organisms, including infection sexually transmitted: the infections caused by Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Not gonococcal urethritis, the caused Ureaplasma urealyticum (T-mycoplasma), a venereal ulcer, an inguinal granuloma and a venereal lymphogranuloma. Doxycycline is alternative drug in treatment of gonorrhea and syphilis. – Skin infections: severe forms of an acne disease (as a part of combination therapy). – Other diseases: a frambeziya, legionellosis, clamidiosis of various localization (including prostatitis and a proctitis), a rickettsial disease, Ku’s fever, spotty fever of the Rocky Mountains, typhus (including sypny, tick-borne returnable), Lyme’s disease (the I article – erythema migrans), a tularemia, plague, actinomycosis, malaria, infectious diseases of eyes, as a part of combination therapy – trachoma, leptospirosis, an ornithosis, ornithosis, anthrax (including a pulmonary form), a bartonellosis, granulotsitarny erlikhioz, whooping cough, a brucellosis, osteomyelitis, sepsis, a subacute septic endocarditis, peritonitis, – prevention of postoperative purulent complications, – the malaria caused by Plasmodium falciparum at short-term travel (less than 4 months) in the territory where the strains resistant to chloroquine and/or Pyrimethaminum-sulphadoxine are widespread. To Apply a route of administration and doses strictly on doctor’s orders in order to avoid complications. Doxycycline is appointed only in the presence of absolute indications. Capsules should be washed down with a large amount of liquid. It is recommended to take the drug in a prone position or standing before going to bed for the night for reduction of probability of esophageal irritation and its ulceration. At emergence of irritation of a stomach, it is recommended to accept Doxycycline during meal or with milk. Researches showed that intake of food or milk has no considerable impact on doxycycline absorption. Adults: In the first day of treatment appoint usually 200 mg of doxycycline in 1 reception or divide into 2 receptions – to 100 mg there are each 12 hours, and then pass to a maintenance dose – 100 mg a day. In heavy infections during the entire period of treatment appoint 200 mg of doxycycline a day. Course of treatment: at administration of drug inside depending on features of the course and severity of a disease the course of treatment makes 7-10 days. Exceeding the recommended dose can lead to increase in frequency of side effects. Side effects At the patients receiving tetracyclines, including doxycycline, were observed the following side reactions: Infections and invasions Superinfection: As well as in a case with other antibiotics, excessively rapid growth of insensitive organisms can lead to candidiasis, a glossitis, a staphylococcal coloenteritis, pseudomembranous colitis (can cause excessively rapid growth of Clostridia) and inflammatory defeats (urogenital candidiasis) of bodies of an urinogenital system. From blood and lymphatic system Hemolytic anemia, thrombocytopenia, a neutropenia, a porphyria and an eosinophilia. From the immune system Allergic reactions, including an acute anaphylaxis, anaphylactoid reactions, an anaphylactic purpura, hypotonia, a pericarditis, a Quincke’s disease, a small tortoiseshell, aggravation of a system lupus erythematosus, an asthma, a serum disease, peripheral swell, tachycardia. Disturbances from an endocrine system At prolonged use of tetracyclines the brown-black coloring of tissue of thyroid gland revealed at microscopic examination was observed. Dysfunction of a thyroid gland was not revealed. From nervous system the Headache, dizziness, benign intracranial hypertensia which can be shown by illegibility of sight, scotomas, a diplopia. From organs of hearing and a vestibular mechanism: sonitus. From a digestive tract the Gastrointestinal symptoms are usually mild and seldom demand the treatment termination. They include: abdominal pain, stomatitis, anorexia, nausea, vomiting, diarrhea, dyspepsia and seldom dysphagy. It was reported about developing of an esophagitis and formation of ulcers of a gullet. Tetracyclines can be the reason of discoloration of teeth or hypoplasias of enamel of teeth that is usually observed at long administration of drug. From digestive system: tranzitorny increase in level of hepatic transaminases, abnormal liver function, hepatitis, jaundice and pancreatitis. Isolated cases of hepatotoxicity, a liver failure were observed. Integuments: makulopapulezny and erythematic rash, skin photosensitization, fotoonikholizis, multiformny erythema, exfoliative dermatitis, Stephens-Johnson’s syndrome, toxic epidermal necrolysis. From bones and joints: arthralgia, myalgia. Renal failure and uric ways: increase in level of residual nitrogen of urea. Other: candidiasis. Contraindications – hypersensitivity to doxycycline, other tetracyclines or to any substance which is a part of drug – a heavy liver and renal failure – children’s age up to 18 years – pregnancy and the period of a lactation – the hereditary lactose intolerance, galactoses, a lactose intolerance Medicinal interactions Simultaneous use of iron preparations, the drugs containing aluminum, calcium, magnesium, zinc or bismuth breaks doxycycline absorption. It is recommended to avoid a concomitant use of these drugs. Ergotamine and metisergid Exists the increased risk of an ergotism at simultaneous use of doxycycline with ergotamine and metisergidy. The methotrexate Doxycycline increases risk of toxicity of a methotrexate. It is necessary to appoint with care to the patients who are on treatment by a methotrexate. A kaolin and sukralfat can reduce doxycycline absorption. Hinapril contains magnesium carbonate and can reduce doxycycline absorption. It is desirable to avoid simultaneous use of doxycycline in combination with penicillin owing to doxycycline absorption reduction. Use of doxycycline and warfarin causes lengthening of a prothrombin time. Tetracyclines suppress prothrombin activity of plasma in this connection it is necessary to lower a dose of the accompanying anticoagulants. Simultaneous use of barbiturates, carbamazepine, Phenytoinum or Primidonum causes reduction of elimination half-life of doxycycline. In such cases it is necessary to consider a question of increase in a daily dose of doxycycline. Alcohol can reduce a doxycycline half-life period. Doxycycline reduces efficiency of oral contraception and increases the frequency of ‘breakthrough’ bleedings at reception of estrogensoderzhashchy oral contraceptives. Doxycycline can increase concentration in cyclosporine plasma. Joint administration of these drugs should be carried out only under control of the doctor. The drugs inducing liver enzymes such as, rifampicin, can accelerate doxycycline removal, thereby reducing its half-life period that can result in subtherapeutic concentration of doxycycline in blood. In such cases the medical control is recommended and in case of need to consider a question of increase in a dose of doxycycline. It is necessary to avoid simultaneous use of doxycycline with retinoids in connection with the increased risk of developing benign intracranial hypertensia. Simultaneous use of tetracyclines and a metoksifluran increases risk of nephrotoxicity with possible death. It is necessary to avoid oral vaccination against typhus during treatment by doxycycline in connection with an inactivation an antibiotic. When carrying out the fluorescent test the false increase in level of catecholamines in urine can be observed. Special instructions Patients with abnormal liver functions. Doxycycline should be applied with care at patients with a liver failure and also at the persons receiving potentially hepatotoxic drugs. Abnormal liver functions, the tetracyclines connected with oral or parenteral administration, including doxycycline, were observed seldom. Patients with renal failures. Excretion of doxycycline through kidneys is about 40% in 72 hours at persons with the kept function of kidneys. This range can decrease to 1-5% in 72 hours at persons with a heavy renal failure (the clearance of creatinine is lower than 10 ml/min.). Researches did not reveal a considerable difference in elimination half-life of doxycycline from blood serum at persons from kept and impaired renal function. The hemodialysis does not influence elimination half-life of drug from blood serum. Antianabolichny effect of tetracyclines can lead to increase in urea level blood. The anti-anabolic effect was absent at use of doxycycline for patients with renal failures. Photosensitization. At some patients accepting tetracyclines, including doxycycline, reactions of photosensitivity are observed. During treatment by doxycycline and also after the end of therapy within 4-5 days it is recommended to protect open parts of the body from direct sunlight and artificial UF-radiation. Treatment by tetracyclines, including doxycycline, has to be immediately stopped at the first manifestations on erythema skin. Growth of resistant microflora. For prevention of development of candidiasis along with Doxycycline it is recommended to use antifungal drugs. Pseudomembranous colitis messages about development of pseudomembranous colitis at use of almost all antibacterial substances, including doxycycline Arrived. Weight of a complication fluctuated from easy to zhizneugrozhayushchy. It is necessary to make the decision concerning the therapy termination by doxycycline, and if necessary, to carry out the corresponding treatment (reception of specific antibiotics and chemotherapeutic means). Treatment by antibacterial drugs changes normal flora of a large intestine that leads to the excess growth of insensitive microorganisms, including Clostridium difficile. Cases of the diarrhea caused by Clostridium difficile at use of almost all antibacterial drugs are registered. The patients who are on treatment by antibacterial drugs have to be under careful observation in connection with risk of developing the diarrhea caused by Clostridium difficile within two months after the termination of a course of therapy. Esophagitis. Cases of an esophagitis and ulcers of a gullet at the patients applying the encapsulated or tableted forms of drugs of a class of tetracyclines including doxycycline are registered. Most of these patients took the drug just before a dream or with insufficient amount of liquid. Slight intracranial hypertensia was registered at the persons receiving drug in the maximum therapeutic dose. Quickly disappeared after drug withdrawal. A porphyria Exceptional cases of emergence of a porphyria were observed at the patients accepting tetracycline. Treatment of venereal diseases At treatment of venereal diseases with suspicion of the accompanying syphilis the corresponding diagnostic procedures, including microscopy in the dark field and other analyses have to be used. In such cases
serological tests an extent not less than four months have to be spent ezhemesyachn e. The beta and hemolytic streptococcus the Course of treatment at patients with the infections caused by beta and hemolytic streptococci of group A has to make not less than 10 days. A myasthenia gravis Drugs of group of tetracyclines can cause neuromuscular blockade therefore it is necessary to be careful at use of doxycycline for patients with a myasthenia gravis. A system lupus erythematosus Tetracyclines can cause aggravation of a system lupus erythematosus. Metoksifluran Sleduyet to be careful at simultaneous use of a metoksifluran with tetracyclines in connection with increase in nephrotoxicity. Ability to influence speed of response at control of motor transport and work with mechanisms. Individual reaction of the patient to drug will not be found out yet, it is necessary to refrain from control of motor transport or other mechanisms, considering that during treatment by doxycycline loss of sight, the illegibility of sight, dizziness can be observed. Overdose overdose Symptoms doxycycline are fever, face reddening, dizziness, collapse can sometimes develop. Treatment: drug withdrawal, gastric lavage, control of the main vital functions (pulse, breath) and in case of need – symptomatic treatment. Use of a hemodialysis for elimination of drug from blood is inefficient. A form of release and packing On 10 capsules in blister strip packaging from a film of the polyvinylchloride brand and/or printing aluminum foil varnished. On 1 blister strip packaging together with the instruction for use in the state and Russian languages place in a pack from cardboard for a retail container. Storage conditions In the dry, protected from light place, at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Shopping Mall Pharm Aktobe LLP manufacturing Organization, the Republic of Kazakhstan, Aktobe New of the village of the lake, uch. No. 467, phone number / fax 8 (7132) 21 72 15, e-mail: the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine: Shopping Mall Pharm Aktobe LLP, Republic of Kazakhstan, Aktobe New of the village of the lake.
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