Instructions Tetracycline Nextpharm eye ointment 10 mg/g tube 5 g
Composition
active ingredient: tetracycline hydrochloride;
1 g of ointment contains tetracycline hydrochloride 10 mg;
excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), mineral oil, paraffin, lanolin, white soft paraffin.
Dosage form
Eye ointment.
Main physicochemical properties: ointment of uniform consistency from yellow to dark yellow.
Pharmacotherapeutic group
Means acting on the sensory organs. Means used in ophthalmology. Antimicrobial agents. Antibiotics.
ATX code S01A A09.
Pharmacological properties
Pharmacodynamics.
Tetracycline is a bacteriostatic antibiotic (at high doses it also has a bactericidal effect) of a broad spectrum of action from the tetracycline group and is active against microorganisms that are both outside and inside cells. Tetracycline inhibits protein synthesis in microorganisms by preventing the binding of aminoacyl-tRNA to the 30S subunit of ribosomes. Tetracycline is active against a large number of bacteria, including gram-positive and gram-negative, aerobic and anaerobic microorganisms. It is active against spirochetes, mycoplasmas, rickettsiae, chlamydia and some protozoa, which are often pathogens that cause eye infections.
The antibiotic is also used to treat infections caused by Streptococcus pyogenes and some anaerobic streptococci, Bacillus anthracis, Listeria monocytogenes, Actinomyces israelii, Shigella, Escherichia coli, Haemophilus influenzae.
Fusobacterium and some strains of Bacteroides are also susceptible to the drug, but most strains of B. fragilis are resistant to tetracycline.
Tetracyclines are the drugs of choice for infections caused by Mycoplasma pneumoniae and Ureaplasma urealyticum, chlamydia (C. trachomatis, C. psitacci, C. pneumoniae) and rickettsiae (R. akari, R. ricketsii, R. prowazeki, Coxiella burnetii). When applied topically, they are also active against Proteus spp. and Pseudomonas aeruginosa. Tetracycline usually inhibits sensitive microorganisms at a concentration of 4 μg/ml. Staphylococci have cross-resistance to all tetracyclines except minocycline. Bacterial resistance to tetracyclines used in clinical practice is in most cases acquired. The following mechanisms of bacterial resistance to tetracyclines are known:
1) formation of a cytoplasmic protein that protects ribosomes and makes them insensitive to the action of the drug;
2) release of enzyme(s) that modify the antibiotic;
3) change in the permeability of bacteria to the agent.
For tetracyclines, the second and third mechanisms are the most common. The genetic information for this resistance is often embedded in extrachromosomal DNA elements (plasmids).
Synergism has been established with the combined use of tetracycline and macrolides (erythromycin, oleandomycin), as well as streptomycin.
Pharmacokinetics.
When applied topically, tetracyclines are absorbed through the conjunctiva and reach adequate levels to suppress the most common etiological agents of superficial ocular infections: conjunctivitis, blepharitis, rosacea, trachoma and other diseases caused by chlamydia, dacryocystitis, corneal ulcers.
Indication
Topical treatment of superficial ocular infections caused by tetracycline-sensitive microorganisms: Streptococcus spp., Haemophilus influenzae, Escherichia coli, Neisseria gonorrhoeae, Chlamydia trachomatis.
It is used to treat blepharitis, conjunctivitis, keratitis, dacryocystitis, styes, trachoma, and as part of pre- and postoperative prophylaxis in eye surgery.
The drug is also used to prevent neonatal blenorrhea (Neisseria gonorrhoeae).
Contraindication
Hypersensitivity to the active substance and other components of the drug or to other antibacterial agents of the tetracycline series.
Interaction with other medicinal products and other types of interactions
When topically using tetracycline in ophthalmology, it should be borne in mind that its bacteriostatic action may interfere with the bactericidal action of penicillins, cephalosporins and aminoglycosides. It is recommended to avoid their simultaneous use, both topically and systemically.
The use of tetracycline in patients using contact lens solution containing 0.004% thiomersal has been associated with ocular reactions of varying severity (eye redness, irritation, blepharitis), so their concomitant use should be avoided.
The concomitant use of ophthalmic tetracycline and topical corticosteroids should be avoided (see section "Special warnings and precautions for use").
You should not use cosmetics containing retinoids while using tetracycline.
Some patients taking tetracycline have developed eye inflammation after concomitant use of ophthalmic preparations containing the preservative thiomersal.
Application features
As with other antibacterial drugs, prolonged use of tetracycline may result in overgrowth of non-susceptible strains or fungi. In the event of superinfection, appropriate treatment is recommended.
Laboratory confirmation of the susceptibility of microorganisms to the active substance, including in vitro cultivation, should be performed on samples collected before the start of treatment.
Due to the possible development of photodermatoses (increased photosensitivity when using tetracycline antibiotics), the drug should not be used in sunlight or under the influence of UV radiation.
Tetracycline should be discontinued at the first appearance of skin rashes or other signs of hypersensitivity reactions.
Patients should not wear contact lenses if they have an eye infection.
Since the medicinal product contains the excipients propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (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 of the ophthalmic use of tetracycline during pregnancy. For this reason, during the 2nd and 3rd trimesters of pregnancy, the drug should be used with extreme caution and only after a careful assessment of the benefit/risk ratio by the doctor, since there may be an undesirable effect on the development of the skeleton and bone growth of the fetus. There may also be a serious effect on the dentin and enamel of the teeth, which can lead to persistent yellow-brown discoloration of the teeth and enamel hypoplasia.
Breastfeeding period
Tetracycline is excreted in breast milk after oral administration. There are no data on the passage of tetracycline for ophthalmic use into breast milk, therefore, during breastfeeding, its use is recommended only after a physician has assessed the benefit/risk ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
As with all ophthalmic agents, temporary blurred vision or other visual disturbances may occur, which may affect the ability to drive or use machines. Patients should refrain from driving or using machines until visual acuity is restored.
Method of administration and doses
Dosage
Depending on the severity of the condition, a strip of eye ointment 1–1.5 cm long is applied to the conjunctival fold of the lower eyelid 3–4 times a day, in severe cases up to 6 times a day.
The duration of treatment is determined by the doctor, usually it is from 5 to 7 days. After the symptoms have subsided, the treatment should be continued for another 2–3 days. In more severe eye infections, acute or chronic trachoma, the course of treatment may last up to 1–2 months, and tetracycline can be combined with oral antibiotic use.
To prevent neonatal blenorrhea, a strip of eye ointment 0.5–1 cm long is applied to the conjunctival fold of the newborn's lower eyelid within 1 hour after birth.
A new tube of ointment is used for each newborn.
When used simultaneously with other ophthalmic drugs, the interval between applications should be at least 10 minutes, and the eye ointment should be applied last.
It is very important to practice hygiene when applying eye ointment, so you should not touch your eyes or surrounding surfaces with the tip of the tube.
Method of application
- Before the first opening, the protective tape between the cap and the tube must not be broken.
- A strip of eye ointment (1–1.5 cm) is carefully applied to the conjunctival sac of the affected eye so that the tip of the tube does not touch the eyelids or surrounding surfaces.
- The eyelids are closed for 1–2 minutes and the ointment is distributed over the entire surface by moving the eyeball in different directions.
- Use a clean tissue to remove excess ointment from the eyelids and eyelashes. Use another clean tissue to wipe the tip of the tube and close it tightly.
- If it is necessary to apply tetracycline to the other eye, repeat all the steps described.
Children.
The drug is used in newborns only for the prevention of blenorrhea. The drug should not be prescribed to children under 8 years of age.
Overdose
There are no reports of overdose with topical tetracycline.
There are no data on overdose as a result of accidental or intentional ingestion of the drug.
Adverse reactions
The following adverse reactions of moderate severity, which resolve rapidly after discontinuation of treatment, have been reported:
On the part of the organs of vision: blurred vision, burning sensation, sharp pain, itching of the eyes or eyelids, conjunctival hyperemia, eyelid swelling, increased tearing and eye pain.
Tetracycline Nextpharm, an ophthalmic ointment for topical use, has no systemic effect; in isolated cases, it may cause irritation of the mucous membrane of the eyelids. Candidiasis may occur, mainly due to overgrowth of Candida albicans; and overgrowth of resistant coliform organisms such as Pseudomonas and Proteus species may also occur.
Myopia in patients taking tetracyclines may be caused by temporary hydration of the lens.
Cases of increased muscle weakness in patients with myasthenia gravis and exacerbation of lupus erythematosus have been reported with prolonged use of tetracycline.
Reporting of suspected adverse reactions
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
After first opening, store for 28 days at a temperature not exceeding 25 ºС.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 g in a tube; 1 tube in a pack.
Vacation category
According to the recipe.
Producer
BALKANPHARMA-RAZGRAD AD / BALKANPHARMA-RAZGRAD AD.
Location of the manufacturer and address of its place of business.
Blvd. Aprilsko vastanie 68, Razgrad 7200, Bulgaria / 68 Aprilsko vastanie Blvd., Razgrad 7200, Bulgaria.
