Tetracycline nextpharm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Tetracyclin Nextpharm (Tetracyclin Nextpharm)

Composition:

Active substance: tetracycline hydrochloride;

1 g of ointment contains tetracycline hydrochloride 10 mg;

Excipients: methylparaben (E 218), propylparaben (E 216), mineral oil, paraffin, lanolin, white soft paraffin.

Pharmaceutical form. Ophthalmic ointment.

Main physicochemical properties: homogeneous ointment of yellow to dark yellow color.

Pharmacotherapeutic group. Agents acting on sensory organs. Medicinal products used in ophthalmology. Antimicrobial agents. Antibiotics.

ATC code S01A A09.

Pharmacological Properties

Pharmacodynamics

Tetracycline is a bacteriostatic antibiotic (at high doses it also exerts bactericidal activity) of the tetracycline group with a broad spectrum of activity, effective against microorganisms located both extracellularly and intracellularly. Tetracycline inhibits protein synthesis in microorganisms by interfering with the binding of aminoacyl-tRNA to the 30S ribosomal subunit. Tetracycline is active against a wide range of bacteria, including Gram-positive and Gram-negative, aerobic and anaerobic microorganisms. It is also active against spirochetes, mycoplasmas, rickettsiae, chlamydiae, and certain protozoa that are common pathogens causing ocular infections.

The antibiotic is also used to treat infections caused by Streptococcus pyogenes and certain anaerobic streptococci, Bacillus anthracis, Listeria monocytogenes, Actinomyces israelii, Shigella, Escherichia coli, Haemophilus influenzae.

Among the Gram-negative anaerobic microorganisms sensitive to the drug are Fusobacterium and some strains of Bacteroides. However, most strains of B. fragilis are resistant to tetracycline.

Tetracyclines are included in the group of drugs of choice for infections caused by Mycoplasma pneumoniae and Ureaplasma urealyticum, chlamydiae (C. trachomatis, C. psittaci, C. pneumoniae) and rickettsiae (R. akari, R. rickettsii, R. prowazekii, Coxiella burnetii). With local application, activity is also demonstrated against Proteus spp. and Pseudomonas aeruginosa. Tetracycline usually inhibits susceptible microorganisms at a concentration of 4 µg/mL. Staphylococci exhibit cross-resistance to all tetracyclines except minocycline. Bacterial resistance to tetracyclines used in clinical practice is mostly acquired. The following mechanisms of bacterial resistance to tetracyclines are known:

1. Production of a cytoplasmic protein that protects ribosomes and renders them insensitive to the drug;
2. Secretion of enzyme(s) that modify the antibiotic;
3. Altered permeability of bacterial cells to the agent.

The second and third mechanisms are the most common for tetracyclines. Genetic information responsible for this resistance is often located on extrachromosomal DNA elements (plasmids).

Synergism has been demonstrated with combined use of tetracycline and macrolides (erythromycin, oleandomycin), as well as streptomycin.

Pharmacokinetics

When applied locally, tetracyclines are absorbed through the conjunctiva and achieve adequate concentrations to suppress the most common etiological agents of superficial ocular infections: conjunctivitis, blepharitis, rosacea, trachoma, and other chlamydia-induced diseases, dacryocystitis, corneal ulcers.

Clinical characteristics.

Indications.

Topical treatment of superficial ocular infections caused by microorganisms sensitive to tetracycline: Streptococcus spp., Haemophilus influenzae, Escherichia coli, Neisseria gonorrhoeae, Chlamydia trachomatis.

Used for the treatment of blepharitis, conjunctivitis, keratitis, dacryocystitis, hordeolum, trachoma, as well as for pre- and postoperative prophylaxis in ophthalmic surgery.

The medicinal product is also used for the prevention of neonatal ophthalmia (Neisseria gonorrhoeae).

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product, or to other tetracycline-class antibacterial agents.

Interaction with other medicinal products and other forms of interaction.

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. Therefore, simultaneous use, both topical and systemic, should be avoided.

Use of tetracycline in patients who use contact lens solutions containing 0.004% thimerosal has been associated with ocular reactions of varying severity (eye redness, irritation, blepharitis); therefore, simultaneous use should be avoided.

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

Cosmetic products containing retinoids should not be used during tetracycline application.

In some patients using tetracycline, eye inflammation has occurred after simultaneous use of ophthalmic preparations containing the preservative thimerosal.

Special precautions for use

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

As with other antibacterial medicinal products, prolonged use of tetracycline may lead to overgrowth of resistant strains or fungi. If superinfection occurs, appropriate therapy should be initiated.

Laboratory confirmation of microbial sensitivity to the active substance, including in vitro culture, should be performed using samples collected prior to the start of treatment.

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

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

Patients with ocular infections should not wear contact lenses.

Since the medicinal product contains the excipients propylparahydroxybenzoate (E 216) and methylparahydroxybenzoate (E 218), it may cause allergic reactions (possibly delayed).

The excipient lanolin may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

Pregnancy

There are no adequate and well-controlled studies on the ophthalmic use of tetracycline during pregnancy. For this reason, the product should be used with particular caution during the second and third trimesters of pregnancy and only after careful assessment by a physician of the benefit-risk ratio, as it may adversely affect fetal skeletal development and bone growth. A serious effect on dentin and tooth enamel is also possible, potentially leading to permanent yellow-brown discoloration of teeth and enamel hypoplasia.

Breastfeeding period

Tetracycline is excreted in breast milk following oral administration. Data on the penetration of ophthalmically administered tetracycline into breast milk are lacking. Therefore, during breastfeeding, the product should be used only after a physician has evaluated the benefit-risk ratio.

Ability to influence reaction speed while driving or operating machinery

As with all ophthalmic medicinal products, temporary blurred vision or other visual disturbances may occur, which could affect the ability to drive or operate machinery. Patients should refrain from driving or operating machinery until visual acuity is 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 ocular infections, acute or chronic trachoma, the treatment course may last up to 1–2 months, during which tetracycline may be combined with oral antibiotic therapy.

For the prevention of neonatal ophthalmia neonatorum, a strip of ophthalmic ointment 0.5–1 cm in length is applied into the conjunctival sac of the lower eyelid of the newborn within 1 hour after birth.

A new tube of ointment must be used for each newborn.

When used concomitantly with other ophthalmic agents, 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 during ointment application; therefore, the tip of the tube should not touch the eyes or surrounding surfaces.

Method of Administration

1. Prior to first use, the protective seal between the cap and the tube must remain intact.
2. 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.
3. The eyelids should be kept closed for 1–2 minutes, and the eye should be moved in different directions to distribute the ointment over the entire surface.
4. Excess ointment on the eyelids and eyelashes should be removed with a clean tissue. The tube tip should then be wiped with another clean tissue and the cap tightly replaced.
5. If tetracycline needs to be applied to the other eye, repeat all the steps described above.

Children

The medicinal product is used in newborns only for the prevention of ophthalmia neonatorum. The drug must not be administered to children under 8 years of age.

Overdose

There are no data on cases of tetracycline overdose following topical application.

There are no data on overdose resulting from accidental or intentional ingestion of the medicinal product.

Adverse Reactions

The following moderate adverse reactions, which rapidly resolve after discontinuation of treatment, have been reported:

Ocular disorders: blurred vision, burning sensation, acute pain, itching of the eyes or eyelids, conjunctival hyperemia, eyelid edema, increased lacrimation, and eye pain.

Immune system disorders: local allergic reactions — dermatitis, rash, pruritus, photoallergic dermatitis (increased sensitivity to sunlight and UV radiation); generalized allergic reactions — rash, pruritus/edema of the face, tongue, or throat, dizziness, dyspnea.

Tetracycline Nextpharm, ophthalmic ointment for topical use, has no systemic effect; in individual cases, it may cause irritation of the eyelid mucosa. Candidiasis may occur, primarily due to overgrowth of Candida albicans; overgrowth of resistant coliform organisms such as Pseudomonas and Proteus species may also be observed.

Myopia in patients receiving tetracyclines may be caused by transient hydration of the lens.

Exacerbation of muscle weakness in patients with myasthenia gravis and exacerbation of systemic lupus erythematosus have been reported during prolonged use of tetracycline.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

After first opening, store for up to 28 days at a temperature not exceeding 25 °C.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 5 g in a tube; 1 tube per carton.

Prescription status. Prescription only.

Manufacturer.

BALKANPHARMA-RAZGRAD AD / BALKANPHARMA-RAZGRAD AD.

Manufacturer's address and place of business.

68 Aprilsko vastanie Blvd., Razgrad 7200, Bulgaria / Blvd. Aprilsko vastanie 68, Razgrad 7200, Bulgaria.