Signicef
Signicef: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Signicef
ATX code: J01MA; J01MA12
Active ingredient: Levofloxacin (Levofloxacinum)
Manufacturer: Sentiss Pharma Pvt. Ltd. (India), Promed export (India)
Description and photo update: 2018-23-10
Prices in pharmacies: from 159 rubles.
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Signicef is a third-generation antimicrobial drug, second-generation trequinolone.
Release form and composition
- eye drops: clear solution, light yellow (5 ml each in plastic dropper bottles, 1 dropper bottle in a cardboard box);
- solution for infusion (100 ml in plastic bottles, 1 bottle in a polyethylene bag, 1 plastic bag in a cardboard box).
Composition of 1 ml eye drops:
- active substance: levofloxacin hemihydrate, equivalent to levofloxacin - 5 mg;
- auxiliary components: benzalkonium chloride, hypromellose, sodium chloride, hydrochloric acid qs, water for injection.
Composition of 1 ml solution for infusion: Levofloxacin - 5 mg.
Pharmacological properties
Pharmacodynamics
Levofloxacin - the active substance of the drug Signicef is the L-isomer of the racemic drug substance ofloxacin with pronounced antibacterial activity. By blocking gyrase and topoisomerase IV in deoxyribonucleic acid (DNA), as well as disrupting supercoiling and stitching of DNA breaks, levofloxacin inhibits the synthesis of a DNA molecule, causing deep morphological changes in the cell wall, cytoplasm, and bacterial membranes.
In vitro activity of levofloxacin against gram-positive microorganisms and representatives of Enterobacteriaceae, P. aeruginosa is approximately 2 times higher than that of ofloxacin.
Levofloxacin is highly active both in vitro and in vivo against most strains of microorganisms. The drug is effective against: Gram-negative aerobes, such as Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Gram-positive aerobes, such as Staphylococcus pylames aureus, Streptococcus pylamus, etc. trachomatis.
Resistance to levofoloksacin is shown by gram-positive aerobes (methicillin-resistant Staphylococcus aureus and Staphylococcus spp. Coagulase-negative; Corynebacterium jeikeium); gram-negative aerobes (Alcaligenes xylosoxidans); other microorganisms (Mycobacterium avium).
When applied topically in the form of eye drops, the maximum concentration of levofloxacin is more than 100 times higher than the value of its MIC (minimum inhibitory concentration) for sensitive microorganisms.
Pharmacokinetics
Eye drops
After instillation into the eye, levofloxacin persists for a long time in the tear film. With the introduction of a single dose of levofloxacin (1 drop), its concentration rapidly increases in the lacrimal fluid and is maintained for most sensitive eye pathogens at a MIC level of ≤ 2 μg / ml for at least 6 hours.
Studies carried out on healthy volunteers have shown that on average the concentration of levofloxacin in the tear film measured after topical application after 4 and 6 hours is 17.0 μg / ml and 6.6 μg / ml, respectively. After 4 hours from the time of application, in 5 out of 6 subjects, the levofloxacin value was 2 μg / ml and higher. In 4 out of 6 subjects, this concentration remained 6 hours after the instillation.
An hour after instillation of Signicef drops, the average plasma concentration of levofloxacin in the blood on the first day is from 0.86 to 2.05 ng / ml; the maximum concentration is 2.25 ng / ml (it was detected 4 days after the drug was used for 2 days with a frequency of 1 instillation every 2 hours, up to 8 times a day). The maximum concentrations of levofloxacin when applied topically, reached on the 15th day, are more than 1000 times lower than those observed after taking standard doses of levofloxacin inside.
Solution for infusion
After taking the drug inside, levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Joint food intake practically does not slow down the absorption of the drug. Bioavailability of levofloxacin is 99%. The maximum concentration of the substance (C max) is achieved after 1–2 hours when taking the drug at a dose of 250–500 mg, and is 2.8 and 5.2 μg / ml, respectively. Plasma protein binding is 30-40%. Levofloxacin penetrates well into the following organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. A small part of the drug is oxidized and / or deacetylated in the liver. Renal clearance is about 70% of the total clearance.
T 1/2 (half-life) of levofloxacin is 6-8 hours. Excretion of the drug by the kidneys occurs by glomerular filtration and secretion. Less than 5% of levofloxacin is excreted in the form of metabolites. In unchanged form, 70% is excreted in the urine during the day and 87% in 2 days; in feces for 3 days, 4% of the dose taken orally is found. After intravenous (iv) administration of the drug at a dose of 500 mg for 60 minutes, C max - 6.2 μg / ml. With intravenous single and multiple administration, the apparent Vd (volume of distribution) after the administration of an identical dose is 89–112 L, C max - 6.2 μg / ml, T 1/2 - 6.4 hours.
Indications for use
Eye drops
The drug is indicated for the treatment of infections of the anterior segment and the accessory apparatus of the eye caused by microorganisms sensitive to levofloxacin, as well as for the prevention of complications after laser and surgical operations on the eye.
Solution for infusion
According to the instructions, Signicef in the form of a solution for infusion is used in the treatment of infectious and inflammatory diseases of the following systems and organs:
- lower respiratory tract (pneumonia, chronic bronchitis);
- ENT organs (otitis media, sinusitis);
- kidneys and urinary tract (including acute pyelonephritis);
- genitals (including urogenital chlamydia);
- skin and soft tissues (boils, abscess, festering atheroma).
Contraindications
Eye drops
Absolute contraindications:
- pregnancy and lactation;
- age up to 1 year;
- hypersensitivity to any component of the drug or to other quinolones.
Caution should be exercised when using Signicef drops in patients under the age of 18 years.
Solution for infusion
- pregnancy and lactation;
- epilepsy;
- age up to 18 years;
- tendon lesions during previous therapy with quinolones;
- increased sensitivity to the drug.
Instructions for the use of Signicef: method and dosage
Eye drops
The drug is applied topically by instillation into the affected eye.
The recommended dosage of Signicef eye drops: for the first two days, 1-2 drops every 2 hours during wakefulness, up to 8 times a day. From 3 to 5 days of instillation, it is recommended to carry out 4 times a day.
The duration of the course of treatment is determined by the doctor and is usually 5 days.
Solution for infusion
Signicef is administered by intravenous slow infusion for at least 1 hour. The dose of the drug depends on the nature and severity of infection, as well as on the sensitivity of the alleged pathogen and is usually from 250 to 500 mg 1-2 times a day.
Recommended dosage according to indications for patients with normal renal function with CC (creatinine clearance)> 50 ml / min:
- acute sinusitis: once a day 500 mg, a course of 10 to 14 days;
- community-acquired pneumonia: 1–2 times a day, 500 mg, course from 7 to 14 days;
- chronic bronchitis in the exacerbation stage: once a day from 250 to 500 mg; course from 7 to 10 days;
- uncomplicated urinary tract infections: once a day, 250 mg, course for 3 days;
- complicated urinary tract infections (including pyelonephritis): 1 time per day, 250 mg, with an increase in dose in severe disease, a course of 7 to 10 days;
- chronic bacterial prostatitis: 1 time per day, 500 mg, course of 28 days;
- infections of the skin and soft tissues: 2 times a day, 500 mg, a course of 7 to 14 days;
- septicemia / bacteremia: 1–2 times a day, 500 mg, course from 7 to 14 days;
- intra-abdominal infections: once a day, 500 mg, a course of 7 to 14 days (as part of complex therapy with antibiotics acting on the anaerobic microflora);
- drug-resistant forms of tuberculosis (as part of complex therapy): 500 mg 1-2 times a day, for up to 3 months.
At the beginning of treatment, IV administration of Signicef is recommended, after a few days, you can switch to taking other preparations of levofloxacin for oral administration, dose adjustment is not required.
In case of impaired renal function, it is necessary to reduce the dose of the drug according to the CC indications:
- 20-50 ml / min: 125-250 mg 1-2 times a day;
- 10-19 ml / min: 125 mg once every 12-48 hours;
- <10 ml / min: 125 mg every 24 to 48 hours.
Side effects
Eye drops
- organ of vision: often (1-10%): decreased visual acuity, the appearance of mucous cords; rarely (0.1–1%): chemosis, eyelid edema, blepharitis, burning sensation, itching, pain, discomfort in the eye, papillary growths in the conjunctiva, blurred vision, folliculosis or conjunctival hyperemia, contact dermatitis, photophobia, dry eye syndrome, mucous discharge, erythema of the eyelids;
- other reactions: rarely - rhinitis, headache, allergic reactions.
Solution for infusion
- digestive system: nausea, vomiting, anorexia, diarrhea, pseudomembranous colitis, dysbiosis, abdominal pain, increased activity of hepatic transaminases, hepatitis, hyperbilirubinemia;
- cardiovascular system: lowering blood pressure, tachycardia, vascular collapse;
- metabolism: hypoglycemia (increased appetite, tremors, sweating);
- central and peripheral nervous system: dizziness, weakness, headache, drowsiness, insomnia, anxiety, fear, paresthesia, confusion, hallucinations, depression, convulsions, movement disorders;
- sense organs: impairment of hearing, vision, gustatory and tactile sensitivity;
- urinary system: interstitial nephritis, hypercreatininemia;
- musculoskeletal system: myalgia, arthralgia, tendon rupture, muscle weakness, tendonitis;
- hematopoietic system: hemolytic anemia, leukopenia, neutropenia, agranulocytosis, eosinophilia, pancytopenia, thrombocytopenia, hemorrhages;
- dermatological reactions: itching, edema of the skin and mucous membranes, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- allergic reactions: urticaria, dyspnea, bronchospasm, anaphylactic shock, vasculitis, allergic pneumonitis;
- other: rhabdomyolysis, development of superinfection, exacerbation of porphyria, persistent fever.
Overdose
The amount of the drug in one bottle is not enough to cause toxic reactions if unintentionally ingested. In the case of topical application of too large a dose of Signicef, it is recommended to rinse the eyes with clean water at room temperature.
Symptoms of a systemic overdose of levofloxacin are nausea, prolongation of the QT interval, erosion of the mucous membranes of the gastrointestinal tract (gastrointestinal tract), dizziness, confusion, convulsions.
For the treatment of the condition, relief of symptoms is recommended; dialysis is ineffective.
special instructions
Eye drops
Do not enter Signicef subconjunctivally or into the anterior chamber of the eye.
The interval between instillation of Signicef eye drops and other ophthalmic solutions, when applied topically, should be at least 15 minutes.
During therapy with Signicef, it is required to refrain from wearing hydrophilic (soft) contact lenses, since the preservative benzalkonium chloride contained in the preparation can be absorbed by the lenses, have a negative effect on the eye tissue and cause discoloration of contact lenses.
During instillation, the dropper tip should not touch the eye and other surfaces to avoid contamination of the dropper and solution.
Solution for infusion
During therapy with levofloxacin, it is important to take into account the possibility of developing superinfection.
With intravenous administration of 500 mg of the drug (100 ml of solution), the duration of the infusion should be at least 1 hour.
After normalization of body temperature, continue to use the drug for at least 48–78 hours.
During the period of therapy with Signicef, the sun and UV radiation should be avoided due to the risk of photosensitization (damage to the skin).
At the first sign of tendinitis, the levofloxacin infusion should be stopped immediately.
If you have a history of brain damage, such as stroke, severe trauma, there is a risk of seizures, and in the case of glucose-6-phosphate dehydrogenase deficiency, the risk of hemolysis.
Influence on the ability to drive vehicles and complex mechanisms
During the systemic use of levofloxacin (infusion), taking into account such adverse reactions as dizziness, impairment of hearing and vision, general weakness, etc., it is recommended to be careful when engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
After applying levofloxacin topically (drops), taking into account the transient deterioration of vision after instillation, before starting to perform types of work requiring increased concentration of attention and speed of psychomotor reactions, it is necessary to wait some time until it is completely restored.
Application during pregnancy and lactation
Signicef is contraindicated in pregnancy.
If necessary, treatment with the drug during lactation, breastfeeding is stopped.
Pediatric use
Signicef eye drops are contraindicated in children under 1 year of age; caution should be exercised when using them to treat children and adolescents from 1 to 18 years old.
The solution for infusion is contraindicated for use in pediatrics.
With impaired renal function
In case of kidney disease, the dose of Signicef infusion solution is reduced depending on the degree of impairment of their function.
Use in the elderly
Signicef should be used with caution in systemically elderly patients due to the high probability of age-related decline in renal function.
Drug interactions
Eye drops
There have been no studies on the interaction of Syngitsef with other drugs. Its concentration in blood plasma after topical application is negligible, which makes this interaction minimal.
Solution for infusion
When taken simultaneously, levofloxacin increases T 1/2 of cyclosporin.
The effectiveness of levofloxacin decreases when the following drugs are taken together: magnesium and aluminum-containing antacids, drugs that inhibit intestinal motility, sucralfate, iron salts (the interval between doses should be at least 2 hours).
Simultaneous reception with NSAIDs, theophylline increases convulsive readiness; with GCS - increases the risk of tendon rupture.
Drugs that block calcium secretion, as well as cimetidine, slow down the excretion of levofloxacin.
As solvents for levofloxacin solution, you can use 2.5% Ringer's solution with dextrose, 0.9% sodium chloride solution, 5% dextrose solution, combined solutions for parenteral nutrition (carbohydrates, amino acids, electrolytes).
Do not mix levofloxacin solution with heparin and alkaline solutions.
Analogs
Analogues of Signicef are Levo, Oftaquix, Abiflox, Glevo, Zevocin, Zolev, Lebel, Levasept, Levobax, Levocacin, Levofloxacin, Novox, Potant-Sanovel, Remedia, Tigeron, Floxium.
Terms and conditions of storage
Store away from light, at a temperature: drops - up to 30 ° C; solution - up to 25 ° C. Keep out of the reach of children. Do not freeze.
Shelf life is 2 years.
Drops after opening the bottle must be used within 30 days.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Signicef
Reviews of Signicef in the form of eye drops and solution for infusion indicate the high efficacy of the drug. Among the negative aspects, patients note the relatively high cost of both the solution and the drops, as well as the fact that the drug is contraindicated in pregnancy and lactation.
Price for Signicef in pharmacies
The approximate price of Signicef in the form of eye drops 0.5% is 235 rubles, solution for infusion is 770 rubles.
Signicef: prices in online pharmacies
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Drug name Price Pharmacy |
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Signicef eye drops 0.5% 5ml 159 r Buy |
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Signicef 0.5% eye drops 5 ml 1 pc. 159 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
