Tetracycline

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TETRACYCLINE

Composition:

Active substance: tetracycline hydrochloride;

1 g of ointment contains 10.82 mg tetracycline hydrochloride (equivalent to 10 mg tetracycline);

Excipients: lanolin, white soft paraffin.

Pharmaceutical form. Eye ointment.

Main physicochemical properties: ointment of uniform consistency, ranging in color from yellowish to yellow.

Pharmacotherapeutic group. Agents acting on sensory organs. Ophthalmological agents. Antimicrobial agents. Antibiotics. ATC code S01A A09.

Pharmacological properties.

Pharmacodynamics.

Bacteriostatic antibiotic from the tetracycline group. Disrupts the formation of the complex between transfer RNA and the ribosome, leading to inhibition of protein synthesis.

Active against Gram-positive and Gram-negative microorganisms – Staphylococcus aureus, Streptococcus epidemicus (Streptococcus pyogenes), Streptococcus pneumoniae (Diplococcus pneumoniae), Neisseria gonorrhoeae, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella pneumoniae, Francisella tularensis (Pasteurella tularensis), Yersinia pestis (Pasteurella pestis), Escherichia coli, Bacillus anthracis, as well as Chlamydia trachomatis.

Ineffective against some strains of Haemophilus influenzae, Klebsiella spp., Aerobacter spp., Pseudomonas aeruginosa, Serratia marcescens.

Pharmacokinetics.

When applied topically, systemic absorption is low.

Clinical characteristics.

Indications.

Infectious eye diseases: conjunctivitis, keratitis, blepharitis, trachoma.

Laboratory confirmation of microbial susceptibility in samples collected prior to initiation of treatment is required.

To minimize the development of resistant bacteria and maintain the effectiveness of tetracycline and other antibacterial agents, the medicinal product Tetracycline should be used only for treatment of infections proven or suspected to be caused by tetracycline-susceptible bacteria.

Contraindications.

Hypersensitivity to tetracycline or to related antibiotics (doxycycline, metacycline, oxytetracycline) and to excipients listed in the section "Composition". Fungal infections, systemic lupus erythematosus, deep or puncture wounds, severe burns, prolonged use in patients with liver or kidney disease, leukopenia. Pregnancy and lactation. Children under 8 years of age.

Interaction with other medicinal products and other types of interactions.

When applying tetracycline topically in ophthalmology, it should be noted that its bacteriostatic effect may interfere with the bactericidal action of penicillins, cephalosporins, and aminoglycosides. Their concomitant use, both topical and systemic, should be avoided.

Use of tetracycline by patients using contact lens solutions containing 0.004% thimerosal has been associated with ocular reactions of varying severity (eye redness, irritation, blepharitis). In some patients who used tetracycline concurrently with ophthalmic preparations containing thimerosal, eye inflammation occurred. Concomitant use of tetracycline with medicinal products and/or contact lens solutions containing thimerosal should be avoided.

Concomitant ophthalmic use of tetracycline and topical corticosteroids should be avoided (see section "Special precautions for use").

For enhanced efficacy, combined use with erythromycin, oleandomycin, or nitrofuran derivatives may be considered.

Cosmetics containing retinoids should not be used during tetracycline therapy.

Special precautions for use

If the patient's condition does not improve within a few days of treatment, medical advice should be sought regarding further use of the medicinal product.

Concomitant ophthalmic use of tetracycline and local corticosteroids (dexamethasone, prednisolone, hydrocortisone) should be avoided due to the potential for masking clinical signs of bacterial, viral, or fungal infections. Corticosteroids may suppress hypersensitivity reactions to tetracycline.

As with other antibacterial medicinal products, prolonged or repeated use, as well as concomitant use with other antibacterial agents, may lead to overgrowth of resistant bacterial strains or fungi. If superinfection occurs, treatment with the medicinal product should be discontinued and appropriate therapy initiated.

Due to the potential development of photodermatoses (increased photosensitivity associated with tetracycline-class antibiotics), the medicinal product should not be used during exposure to sunlight or ultraviolet (UV) radiation.

Treatment with tetracycline should be discontinued at the first sign of skin rash or other signs of hypersensitivity.

Patients with active eye infections should not wear contact lenses.

Since the medicinal product contains lanolin as an excipient, it may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

The efficacy and safety of the medicinal product during pregnancy or breastfeeding have not been sufficiently studied; therefore, it should not be used in these patient groups.

Ability to influence reaction rate while driving or operating machinery

As with all ophthalmic preparations, temporary blurred vision or other visual disturbances may occur, which could impair the ability to drive or operate machinery. Patients should refrain from driving or operating machinery until visual acuity is fully restored.

Method of Administration and Dosage.

Dosage.

Depending on the severity of the condition, a strip of ophthalmic ointment 1–1.5 cm in length is applied into the conjunctival sac of the lower eyelid 3–4 times daily; in more severe cases, up to 6 times daily.

The duration of treatment is determined by the physician and usually lasts from 5 to 7 days. After symptom relief, treatment should be continued for another 2–3 days. In more severe eye infections, acute or chronic trachoma, the treatment course may last up to 1–2 months, during which tetracycline may be combined with oral administration of the antibiotic.

When using simultaneously with other ophthalmic preparations, the interval between applications should be at least 10 minutes, and the ophthalmic ointment should be applied last.

It is very important to maintain hygiene when applying the ophthalmic ointment; therefore, the tip of the tube should not touch the eyes or surrounding surfaces.

Method of Administration.

1. A strip of ophthalmic ointment (1–1.5 cm) is carefully applied into the conjunctival sac of the affected eye, ensuring that the tip of the tube does not touch the eyelids or surrounding areas.
2. The eyelids are closed for 1–2 minutes, and the eye is moved in different directions to distribute the medication over the entire surface.
3. Excess ointment on the eyelids and eyelashes is removed with a clean tissue. The tube tip is wiped with another clean tissue and the tube is tightly closed.
4. If tetracycline needs to be applied to the other eye, repeat all the steps described above.

Children.

Do not use for treatment of children under 8 years of age.

Overdose.

Cases of overdose with topical application have not been reported.

Side effects.

The following moderate side effects have been reported, which rapidly resolve after discontinuation of treatment.

Eye disorders: blurred vision, acute pain, eye or eyelid itching, conjunctival hyperemia, irritation of the eyelid mucosa, eyelid edema, increased lacrimation, and eye pain. Myopia in patients receiving tetracyclines may be due to transient lens hydration.

Immune system disorders: local allergic reactions – dermatitis, rash, itching, burning sensation, inflammation, photodermatitis (increased sensitivity to sunlight and UV radiation); generalized allergic reactions, including rash, fixed drug eruption, exfoliative dermatitis, angioedema, itching and swelling of the face, tongue, or throat, dizziness, dyspnea. In such cases, the use of the ointment should be discontinued.

Gastrointestinal disorders: decreased appetite, nausea, vomiting, diarrhea, possible inflammatory processes in the tongue area, stomatitis, gastritis, proctitis.

Infections and infestations: possible development of candidiasis (growth of Candida albicans), overgrowth of resistant coliform organisms (Pseudomonas, Proteus).

General disorders: cases of increased muscle weakness in patients with myasthenia gravis and exacerbation of systemic lupus erythematosus have been reported during prolonged use of tetracycline.

Reporting of suspected side effects.

Reporting of suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of reach and sight of children.

Packaging.

3 g or 10 g in tubes, 1 tube per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

LLC "Arpimed".

Address of the manufacturer and location of its business activity.

Building 19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.