Unidox Solutab Dispersible pills 100mg, 10pcs

Composition

Active ingredient:

doxycycline monohydrate, in terms of doxycycline 100 mg.

Auxiliary substances:

microcrystalline cellulose – 45 mg,

saccharin – 10 mg,

hyprolose (low-substituted) – 18.75 mg,

hypromellose-3.75 mg,

colloidal silicon dioxide (anhydrous) – 0.625 mg,

magnesium stearate-2 mg,

lactose monohydrate-up to 250 mg

Pharmacological action

of Unidox-bacteriostatic, antibacterial.

Inhibits protein synthesis in the microbial cell, disrupting the connection of transport RNAs of the ribosomal membrane.

Pharmacodynamics

A broad-spectrum antibiotic from the tetracycline group. It acts bacteriostatically, suppresses protein synthesis in the microbial cell by interacting with the 30S subunit of ribosomes. Active against many gram-positive and gram-negative microorganisms:  Streptococcus spp., Treponema spp., Staphylococcus spp., Klebsiella spp., Enterobacter spp.  (including E. aerugenes), Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Chlamydia spp., Mycoplasma spp., Ureaplasma urealyticum, Listeria monocytogenes, Rickettsia spp., Typhus exanthematicus, Escherichia coli, Shigella spp., Campylobacter fetus, Vibrio cholerae, Yersinia spp.  (including Yersinia pestis), Brucella spp., Francisella tularensis, Bacillus anthracis, Bartonella bacilliformis, Pasteurella multocida, Borrelia recurrentis, Clostridium spp.  (except Clostridium difficile), Actinomyces spp., Fusobacterium fusiforme, Calymmatobacterium granulomatis, Propionibacterium acnes,  some of the protozoa (Entamoeba spp., Plasmodium falciparum).

As a rule, it does not act on Acinetobacter spp., Proteus spp., Pseudomonas spp., Serratia spp., Providencia spp., Enterococcus spp.

It is necessary to take into account the possibility of acquired resistance to doxycycline in a number of pathogens, which is often cross-linked within the group (i. e., strains resistant to doxycycline will simultaneously be resistant to the entire group of tetracyclines).

Pharmacokinetics

Suction

Absorption is fast and high (about 100%). Food intake does not significantly affect the absorption of the drug.

_{Cmax of}doxycycline in blood plasma (2.6–3 mcg/ml) is reached 2 hours after taking 200 mg, after 24 hours the concentration of the Active ingredient in blood plasma decreases to 1.5 mcg / ml.

After taking 200 mg on the first day of treatment and 100 mg / day on subsequent days, the concentration of doxycycline in blood plasma is 1.5-3 mcg / ml.

Distribution

Doxycycline reversibly binds to plasma proteins (80-90%), penetrates well into organs and tissues, and poorly into the cerebrospinal fluid (10-20% of the level in blood plasma), but the concentration of doxycycline in the cerebrospinal fluid increases with inflammation of the spinal cord.

The volume of distribution is 1.58 l / kg. In 30-45 minutes after oral use, doxycycline is detected in therapeutic concentrations in the liver, kidneys, lungs, spleen, bones, teeth, prostate gland, eye tissues, pleural and ascitic fluids, bile, synovial exudate, maxillary and frontal sinus exudate, and gingival sulcus fluid.

With normal liver function, the level of the drug in bile is 5-10 times higher than in plasma.

In saliva,5-27% of the concentration of doxycycline in blood plasma is determined.

Doxycycline penetrates the placental barrier and is secreted in small amounts into breast milk.

It accumulates in dentin and bone tissue.

Metabolism

A small part of doxycycline is metabolized.

Elimination

of T_1/2 after a single oral dose is 16-18 hours, after repeated doses — 22-23 hours.

Approximately 40% of the drug taken is excreted by the kidneys and 20-40% is excreted through the intestine in the form of inactive forms (chelates).

Pharmacokinetics in special clinical cases

The half-life of the drug in patients with impaired renal function does not change, because its excretion through the intestine increases.

Hemodialysis and peritoneal dialysis do not affect the concentration of doxycycline in blood plasma.

Indications

-osteomyelitis;

– sepsis;

– subacute septic endocarditis

— – peritonitis.

— respiratory tract infections (including pharyngitis, acute bronchitis, exacerbation of chronic obstructive pulmonary disease, bronchitis, bronchopneumonia, lobar pneumonia, community-acquired pneumonia, lung abscess, empyema);

infections of ENT organs (including otitis media, sinusitis, tonsillitis);

infection of the genitourinary system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, sharp orhiepididimita; endometritis, endocervicitis and oophoritis /combination therapy/);

infection, sexually transmitted diseases (urogenital chlamydia, syphilis in patients with intolerance to penicillins, uncomplicated gonorrhea /as an alternative therapy, inguinal granuloma, lymphogranuloma venereum);

— infections of the gastrointestinal tract and biliary tract diseases (cholera, yersiniosis, cholecystitis, cholangitis, gastroenterocolitis, bacillary and amoebic dysentery, diarrhea travelers);

infections of skin and soft tissue (including wound infection after an animal bite), severe acne (as part of combination therapy);

— other diseases: yaws, legionellosis, chlamydia various locations (including prostatitis and proctitis), rickettsiosis, the fever, Rocky mountain spotted fever, typhus (including typhus, tick), Lyme disease (stage I) – erythema migrans/, tularemia, anthrax, actinomycosis, malaria, leptospirosis, psittacosis, ornithosis, anthrax (including pneumonic form), bartonellosis, granulocyte arlais, pertussis, Brucella;

— infectious eye diseases (in combination therapy) – trachoma;

Prevention of postoperative purulent complications and malaria caused by Plasmodium falciparum during short-term travel (less than 4 months) in areas where strains resistant to chloroquine and/or pyrimethamine-sulfadoxine are common.

Contraindications

: hypersensitivity to tetracycline antibiotics.

— severe liver and/or kidney function disorders

— – porphyria;

– children under 8 years of age;

Side effects

From the digestive system: anorexia, nausea, vomiting, dysphagia, diarrhea, enterocolitis, pseudomembranous colitis, esophagitis, esophageal ulcer, dark staining of the tongue, liver damage (during prolonged use or in patients with renal or hepatic insufficiency), cholestasis.

Dermatological reactions: photosensitization, maculopapular and erythematous rash, exfoliative dermatitis.

Allergic reactions: urticaria, angioedema, anaphylactic reactions, exacerbation of systemic lupus erythematosus, pericarditis, a syndrome similar to serum sickness, erythema multiforme.

From the hematopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity.

Endocrine system disorders: reversible dark brown staining of thyroid tissue may occur in patients treated with doxycycline for a long time.

From the central nervous system: benign increase in intracranial pressure (anorexia, vomiting, headache, edema of the optic nerve), vestibular disorders (dizziness or instability), blurred vision, double vision.

From the urinary system: increased residual urea nitrogen (due to the antianabolic effect).

From the musculoskeletal system: doxycycline slows down osteogenesis, disrupts the normal development of teeth in children (irreversibly changes the color of teeth, enamel hypoplasia develops).

Other: candidiasis (glossitis, stomatitis, proctitis, vaginitis) as a manifestation of superinfection.

Interaction

Antacids containing aluminum, magnesium, calcium, iron preparations, sodium bicarbonate, magnesium-containing laxatives reduce the absorption of doxycycline, so their use should be separated by a 3-hour interval.

Due to the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants.

When doxicillin is combined with bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter decreases, which should be taken into account in the treatment of meningitis and tonsillopharyngitis caused by Streptococcus pyogenes.

Doxycycline reduces the reliability of contraception and increases the frequency of acyclic bleeding when taking estrogen-containing hormonal contraceptives.

Ethanol, barbiturates, rifampicin, carbamazepine, phenytoin, accelerating the metabolism of doxycycline, reduce its concentration in blood plasma.

Simultaneous use of doxycycline and retinol increases intracranial pressure.

How to take it, course of use and dosage

Tablets are dispersed (dissolved) in a small amount of water (about 20 ml) to obtain a suspension. Tablets can also be swallowed whole, divided into parts, or chewed with water.

The drug should preferably be taken with a meal. Take pills sitting or standing, which reduces the likelihood of developing esophagitis and esophageal ulcers. The drug should not be taken immediately before bedtime.

Usually, the duration of treatment is 5-10 days.

Adults and children over 8 years of age with a body weight of more than 50 kg on the first day of treatment are prescribed 200 mg/day in 1 or 2 doses, on subsequent days of treatment-100 mg / day in 1 dose.In case of severe infections,200 mg/day is prescribed for the entire treatment period.

For children aged 8-12 years with a body weight of less than 50 kg, the average daily dose is 4 mg / kg on the first day, then 2 mg / kg / day (in 1-2 doses). In cases of severe infections, the drug is prescribed at a dose of 4 mg/kg daily for the duration of treatment.

For Streptococcus pyogenes infection, the duration of treatment is at least 10 days.

For uncomplicated gonorrhea (with the exception of anorectal infections in men), adults are prescribed 100 mg 2 times a day until complete cure (on average for 7 days), or 600 mg – 300 mg in 2 doses (the second dose is 1 hour after the first).

For primary syphilis,100 mg is prescribed 2 times/day for 14 days, for secondary syphilis-100 mg 2 times/day for 28 days.

For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum,100 mg is prescribed 2 times a day for 7 days.

For acne,100 mg/day is prescribed, the course of treatment is 6-12 weeks.

For the prevention of malaria,100 mg 1 time/day is prescribed 1-2 days before the trip, then daily during the trip and for 4 weeks after returning; children over 8 years of age – 2 mg / kg 1 time/day. The duration of prevention should not exceed 4 months.

To prevent travelers ‘ diarrhea-200 mg on the first day of the trip in 1 or 2 doses, then-100 mg 1 time/day during the entire stay in the region (no more than 3 weeks).

For the treatment of leptospirosis-100 mg orally 2 times / day for 7 days; for the prevention of leptospirosis-200 mg 1 time / week during your stay in a poor area and 200 mg at the end of the trip.

In order to prevent infections during medical abortion,100 mg is prescribed 1 hour before and 200 mg after the intervention.

The maximum daily dose for adults is up to 300 mg / day or up to 600 mg / day for 5 days for severe gonococcal infections. For children over 8 years of age with a body weight of more than 50 kg – up to 200 mg, for children 8-12 years of age with a body weight of less than 50 kg-4 mg / kg daily during the entire treatment.

With renal (creatinine clearance less than 60 ml / min) and / or hepatic insufficiency, a reduction in the daily dose of doxycycline is required, since it gradually accumulates in the body (risk of hepatotoxic effects).

Overdose

Symptoms: increased adverse reactions caused by liver damage-vomiting, fever, jaundice, azotemia, increased transaminase levels, increased prothrombin time.

Treatment: immediately after taking large doses, gastric lavage, heavy drinking, and, if necessary, inducing vomiting are recommended. Take activated charcoal and osmotic laxatives. Hemodialysis and peritoneal dialysis are not recommended due to low efficacy.

Special instructions

There is a possibility of cross-resistance and hypersensitivity with other tetracycline drugs.

Tetracyclines may increase prothrombin time, and tetracycline use in patients with coagulopathy should be carefully monitored.

The antianabolic effect of tetracyclines can lead to an increase in the level of residual urea nitrogen in the blood. As a rule, this is not significant for patients with normal renal function. However, patients with renal insufficiency may experience an increase in azotemia. The use of tetracyclines in patients with impaired renal function requires medical supervision.

With prolonged use of the drug, periodic monitoring of laboratory parameters of blood, liver and kidney function is required.

Due to the possible development of photodermatitis, it is necessary to limit sun exposure during treatment and for 4-5 days after it.

When using the drug, both against the background of taking it, and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium dificile may develop. In mild cases, it is sufficient to cancel treatment and use ion exchange resins (colestyramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein,

the appointment of vancomycin or metronidazole is indicated.

Do not use medications that inhibit intestinal motility.

Prolonged use of the drug can cause dysbiosis and, as a result, the development of hypovitaminosis (especially B vitamins).

To prevent dyspeptic symptoms, it is recommended to take the drug with meals.

To avoid the development of esophagitis or esophageal ulcers, it is necessary to take the drug with plenty of water and avoid using the drug immediately before bedtime.

Influence on the ability to drive motor vehicles and manage mechanisms

The effect on the ability to drive vehicles, machines and mechanisms is unknown. In case of dizziness, blurred vision, or double vision, driving vehicles or mechanisms is not recommended.

Form of production

Dispersible tablets.

Storage conditions

At a temperature of 15-25 °C

Shelf life

5 years

Active ingredient

Doxycycline

Conditions of release from pharmacies

By prescription

Dosage form

soluble tablets

Purpose

Children as prescribed by a doctor, Children over 8 years of age, Adults as prescribed by a doctor

Indications

Skin Infections, Respiratory Tract Infections, Chlamydia, Prostatitis, Urinary Tract Infections, Acne, Intestinal Infections, Tracheitis, Sinusitis, Sinusitis, Bronchitis, Diarrhea, Whooping Cough, Osteomyelitis, Pharyngitis, Cholecystitis, Otitis media, Inflammation of the female genital organs, Urethritis, Pneumonia, Sore throat