Vidokcine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

PFC Prebend, LLC (Russia)

ATC Code

J01AA02 (Doxycycline)

Active Substance

Doxycycline (Rec.INN registered by WHO)

Dosage Form

Vidokcine

Lyophilizate for preparation of solution for intravenous administration 100 mg: vial 1 pc.

Dosage Form, Packaging, and Composition

100 mg – vials (1) – carton packs.

Clinical-Pharmacological Group

Antibiotic of the tetracycline group

Pharmacotherapeutic Group

Antibiotic-tetracycline

Pharmacological Action

A broad-spectrum semisynthetic antibiotic of the tetracycline group. It exerts a bacteriostatic effect by inhibiting protein synthesis of pathogens.

It is active against aerobic gram-positive bacteria: Staphylococcus spp. (including penicillinase-producing strains), Streptococcus spp. (including Streptococcus pneumoniae), Bacillus anthracis, Listeria monocytogenes; anaerobic bacteria: Clostridium spp.

Doxycycline is also active against aerobic gram-negative bacteria: Neisseria gonorrhoeae, Escherichia coli, Shigella spp., Salmonella spp., Enterobacter spp., Klebsiella spp., Bordetella pertussis, as well as against Rickettsia spp., Treponema spp., Mycoplasma spp. and Chlamydia spp.

Pseudomonas aeruginosa, Proteus spp., Serratia spp., and most strains of Bacteroides fragilis are resistant to doxycycline.

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the absorption of doxycycline. It is widely distributed in body tissues and fluids. Plasma protein binding is 80-95%. The elimination half-life (T_1/2) is 12-22 hours.

It is excreted unchanged in the urine (40%), but the main part of the dose is excreted unchanged in the feces due to biliary secretion.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to doxycycline, including infections of the respiratory tract and ENT organs; gastrointestinal infections; purulent infections of the skin and soft tissues (including acne); infections of the genitourinary system (including gonorrhea, primary and secondary syphilis); typhus, brucellosis, rickettsioses, osteomyelitis, trachoma, chlamydia.

ICD codes

Dosage Regimen

Adults are prescribed 200 mg/day orally or intravenously (drip) on the first day of treatment, and 100-200 mg/day on subsequent days. The frequency of administration (or IV infusions) is 1-2 times/day.

For children over 8 years of age and weighing more than 50 kg, the daily dose for oral administration or intravenous (drip) administration is 4 mg/kg on the first day of treatment. On subsequent days – 2-4 mg/kg/day, depending on the severity of the clinical course of the disease. The frequency of administration (or IV infusion) is 1-2 times/day.

The recommended minimum time for intravenous infusion of 100 mg of doxycycline (at an infusion solution concentration of 0.5 mg/ml) is 1 hour.

Maximum doses for adults: for oral administration – 300 mg/day or 600 mg/day (depending on the etiology of the pathogen); for intravenous administration – 300 mg/day.

Adverse Reactions

From the digestive system nausea, vomiting, anorexia, abdominal pain, diarrhea, constipation, dysphagia, glossitis, esophagitis, transient increase in blood levels of hepatic transaminases, alkaline phosphatase, bilirubin.

From the hematopoietic system neutropenia, thrombocytopenia, hemolytic anemia.

Allergic reactions skin rash, itching, eosinophilia; rarely – angioedema, photosensitivity.

Other increased residual nitrogen, candidiasis, intestinal dysbiosis, discoloration of teeth in children.

Contraindications

Pregnancy, children under 8 years of age (possibility of forming insoluble complexes with calcium in the bone skeleton, enamel and dentin of teeth), hypersensitivity to tetracyclines, porphyria, severe hepatic insufficiency, leukopenia, lactation period, myasthenia gravis (for intravenous administration).

Use in Pregnancy and Lactation

Doxycycline is contraindicated for use during pregnancy and lactation. Doxycycline crosses the placental barrier.

It can cause long-term discoloration of teeth, enamel hypoplasia, suppression of fetal skeletal bone growth, and the development of fatty liver infiltration.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency. Doxycycline should be used with caution in patients with impaired liver function.

Use in Renal Impairment

No dose adjustment is required in patients with impaired renal function.

Pediatric Use

Doxycycline is not used in children under 8 years of age, because tetracyclines (including Doxycycline) cause long-term discoloration of teeth, enamel hypoplasia, and slowing of longitudinal bone growth in this category of patients.

Special Precautions

Doxycycline should be used with caution in patients with impaired liver function. No dose adjustment is required in patients with impaired renal function.

To prevent local irritant effects (esophagitis, gastritis, gastrointestinal ulceration), it is recommended to take it during the day with plenty of fluid, food, or milk.

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

Doxycycline is not used in children under 8 years of age, because tetracyclines (including Doxycycline) cause long-term discoloration of teeth, enamel hypoplasia, and slowing of longitudinal bone growth in this category of patients.

The doxycycline solution for intravenous administration should be used no later than 72 hours after its preparation.

Drug Interactions

Drugs containing metal ions (antacids, drugs containing iron, magnesium, calcium) form inactive chelates with doxycycline, so their simultaneous administration should be avoided.

With simultaneous use with barbiturates, carbamazepine, phenytoin, the concentration of doxycycline in blood plasma decreases due to the induction of liver microsomal enzymes, which may cause a decrease in its antibacterial effect.

Combination with penicillins and cephalosporins, which have a bactericidal effect and are antagonists of bacteriostatic antibiotics (including doxycycline), should be avoided.

Cholestyramine and colestipol reduce the absorption of doxycycline (maintain an interval of at least 3 hours between doses).

Due to the suppression of intestinal microflora, Doxycycline reduces the prothrombin index, which requires adjustment of the dose of indirect anticoagulants.

Taking doxycycline reduces the reliability of contraception and increases the frequency of breakthrough bleeding while taking estrogen-containing oral contraceptives.

Simultaneous use of retinol promotes an increase in intracranial pressure.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.