Remedia

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Remedia: 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. Drug interactions
13. Analogs
14. Terms and conditions of storage
15. Terms of dispensing from pharmacies
16. Reviews
17. Price in pharmacies

Latin name: Remedia

ATX code: J01MA12

Active ingredient: levofloxacin (levofloxacin)

Manufacturer: Simpex Pharma Pvt. Ltd. (Simpex Pharma, Pvt. Ltd.) (India)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 270 rubles.

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Remedia is an antimicrobial drug with bactericidal effectiveness.

Release form and composition

Dosage forms of Remedia:

film-coated tablets: biconvex, oblong, yellow, with a line on one side (in blister strip packs of 5 or 10 pcs., 1 pack in a cardboard box);
solution for infusion: transparent, greenish-yellow (in plastic bottles of 100 ml, in a cardboard box 1 bottle).

Composition of 1 tablet:

active substance: levofloxacin hemihydrate - 0.256 / 0.512 / 0.768 g (corresponds to the content of levofloxacin - 0.25 / 0.5 / 0.75 g);
auxiliary components: sodium lauryl sulfate - 0.007 / 0.01 / 0.015 g; magnesium stearate - 0.002 / 0.005 / 0.011 g; colloidal silicon dioxide - 0.004 / 0.006 / 0.011 g; crospovidone - 0.012 / 0.027 / 0.045 g; povidone K-30 - 0.005 / 0.009 / 0.022 g; microcrystalline cellulose - 0.074 / 0.081 / 0.228g;
film shell: propylene glycol - 0.001 / 0.002 / 0.003 g; yellow substance for film coating (iron dye yellow oxide, titanium dioxide, talc, hypromellose) - 0.009 / 0.015 / 0.03 g.

Composition of 100 ml solution:

active substance: levofloxacin hemihydrate - 0.523 28 g (corresponds to the content of levofloxacin - 0.5 g);
auxiliary components: water for injection - up to 100 ml; hydrochloric acid - 0.126 ml; sodium hydroxide - 0.002 8 g, disodium edetate - 0.1 g; sodium chloride - 0.9 g

Pharmacological properties

Pharmacodynamics

Remedia is a broad-spectrum antimicrobial bactericidal drug from the group of fluoroquinolones. The active substance of the drug is levofloxacin (levorotatory isomer of ofloxacin). Levofloxacin causes morphological changes in the membranes, cell wall and cytoplasm of bacteria, inhibits the synthesis of deoxyribonucleic acid (DNA), disrupts supercoiling and stitching of DNA breaks, blocks DNA gyrase (topoisomerase II) and topoisomerase IV.

The drug is active against a wide range of clinically significant microorganisms, namely:

gram-positive microorganisms: Streptococcus viridans, Streptococcus pyogenes (resistant, moderately sensitive, penicillin-sensitive), Streptococcus pneumoniae (resistant, moderately sensitive, penicillin-sensitive), Streptococcus agalactiae, Streptococcus spp. (groups C and G), Staphylococcus epidermidis (methicillin-susceptible), Staphylococcus aureus (methicillin-susceptible), Staphylococcus spp. coagulase-negative and methicillin-sensitive (including moderately sensitive), Listeria monocytogenes, Enterococcus spp. (including Enterococcus faecalis), Corynebacterium diphtheriae;
gram-negative microorganisms: Serratia spp. (including Serratia marcescens), Salmonella spp., Pseudomonas spp. (including Pseudomonas aeruginosa), Providencia spp. (Providencia stuartii, Providencia rettgeri), Proteus vulgaris, Proteus mirabilis, Pasteurella spp. (including Pasteurella multocida, Pasteurella dagmatis, Pasteurella canis), Neisseria meningitidis, Neisseria gonorrhoeae (resistant, moderately sensitive, penicillin-susceptible), Morganella morganii, Moraxella catarrhalis (producing and non-producing) spplebsella spplebsella. (including Klebsiella oxytoca, Klebsiella pneumoniae), Helicobacter pylori, Haemophilus parainfluenzae, Haemophilus influenzae (resistant and ampicillin susceptible), Haemophilus ducreyi, Gardnerella vaginalis, Escherichia coli, Enterobacter spp. (including Enterobacter cloacae,Enterobacter agglomerates, Enterobacter aerogenes), Eikenella corrodens, Citrobacter freundii, Actinobacillus actinomycetemcomitans, Acinetobacter spp. (including Acinetobacter baumannii);
anaerobic microorganisms: Veillonella spp., Propionibacterium spp., Peptostreptococcus spp., Fusobacterium spp., Clostridium perfringens, Bifidobacterium spp., Bacteroides fragilis;
other microorganisms: Ureaplasma urealyticum, Rickettsia spp., Mycoplasma pneumoniae, Mycoplasma hominis, Mycobacterium spp. (including Mycobacterium tuberculosis, Mycobacterium leprae), Legionella spp, (including Legionella pneumonia), Chlamydia trachomatis, Chlamydia psittaci, Chlamydia pneumoniae, Bartonella spp.

Pharmacokinetics

The main pharmacokinetic characteristics of levofloxacin:

absorption: after oral administration, the substance is rapidly and almost completely absorbed from the gastrointestinal tract; bioavailability - 99%; food has little effect on the speed and completeness of its absorption; With _max (maximum concentration in blood plasma) when taking 0.25 and 0.5 g is achieved after 1-2 hours and is, respectively, 2.8 and 5.2 μg per 1 ml;
distribution and metabolism: the connection with plasma proteins varies from 30 to 40%; well penetrates organs and tissues (alveolar macrophages, polymorphonuclear leukocytes, cerebrospinal fluid, bone tissue, organs of the genitourinary system, sputum, bronchial mucosa, lungs); Vd (average volume of distribution) is 89-112 liters after a single and multiple intake of 0.5 g; a small part of the substance is deacetylated and / or oxidized in the liver;
Excretion: T _1/2 (half-life) is from 6 to 8 hours; approximately 70% of the substance is excreted unchanged by the kidneys within 24 hours (about 87% within 48 hours) and less than 5% as metabolites within 48 hours; less than 4% of the dose taken is excreted by the intestines in 72 hours; 70% of the total clearance is renal clearance; by chronic outpatient peritoneal dialysis or hemodialysis, levofloxacin is not excreted from the body.

Indications for use

According to the instructions, Remedia is prescribed for the treatment of infectious and inflammatory pathologies caused by microorganisms sensitive to levofloxacin.

Film-coated tablets

ENT infections, including acute sinusitis;
lower respiratory tract infections, including pneumonia, chronic bronchitis in the acute stage;
urinary tract and kidney infections, including acute pyelonephritis;
chronic bacterial prostatitis;
infections of the skin and soft tissues, including furunculosis, abscess, suppurative atheroma;
intra-abdominal infections (as part of combination therapy with antibiotics that are active against the anaerobic flora);
tuberculosis (as part of the complex treatment of drug-resistant forms).

Solution for infusion

acute maxillary sinusitis;
community-acquired pneumonia, exacerbation of chronic bronchitis (lower respiratory tract infection);
uncomplicated and complicated urinary tract infections, including acute pyelonephritis;
bacteremia, septicemia;
boils, abscess, suppurating atheromas (infections of the skin and soft tissues);
chronic bacterial prostatitis;
intra-abdominal infection;
drug-resistant forms of tuberculosis (as part of complex treatment).

Contraindications

Absolute:

epilepsy;
damage to the tendons against the background of previous therapy with quinolones;
age under 18;
pregnancy;
period of breastfeeding;
individual intolerance to the components contained in the preparation.

Relative (diseases / conditions in the presence of which the appointment of Remedia requires caution): deficiency of glucose-6-phosphate dehydrogenase; elderly age.

Additional relative contraindications for the solution:

a history of brain damage (severe trauma or stroke);
combined use of drugs that reduce the threshold of convulsive readiness of the brain;
pseudoparalytic myasthenia gravis;
the presence of known risk factors for prolongation of the QT interval.

Instructions for use of Remedia: method and dosage

Film-coated tablets

Remedia tablets are taken orally, without chewing, before meals or between meals, with a liquid (½ to 1 glass).

Recommended dosing regimen for adult patients with normal renal function [CC (creatinine clearance)> 50 ml / min]:

acute sinusitis: 1 pc. (0.5 g) per day for 10-14 days or 1 pc. (0.75 g) per day for 5 days;
chronic bronchitis in the exacerbation phase: 1 pc. (0.5 g) per day for 7 days;
hospital pneumonia: 1 pc. (0.75 g) per day for 7-14 days;
community-acquired pneumonia: 1 pc. (0.5 g) 1-2 times a day for 5 days; for community-acquired pneumonia caused by Chlamydia pneumoniae, Mycoplasma pneumoniae, Haemophilus parainfluenzae, Haemophilus influenzae or Streptococcus pneumoniae (resistant, moderately sensitive, penicillin-sensitive) - 1 pc. (0.75 g) per day for 5 days;
uncomplicated urinary tract infections: 1 pc. (0.25 g) per day for 3 days;
complicated urinary tract infections, including acute pyelonephritis: 1 pc. (0.25 g) per day for 10 days; for complicated urinary tract infections caused by Proteus mirabilis, Klebsiella pneumoniae or Escherichia coli and acute pyelonephritis caused by Escherichia coli, including in cases of concomitant bacteremia - 1 pc. (0.75 g) per day for 5 days;
chronic bacterial prostatitis: 1 pc. (0.5 g) per day for 28 days;
uncomplicated infections of the skin and soft tissues: 1 pc. (0.5 g) per day for 7-10 days;
complicated infections of the skin and soft tissues: 1 pc. (0.75 g) per day for 7-14 days;
intra-abdominal infections (in combination with antibiotics acting on the anaerobic flora): 1 pc. (0.5 g) per day for 7-14 days;
tuberculosis (as part of complex treatment of drug-resistant forms): 1 pc. (0.5 g) 1-2 times a day for 3 months (no more).

In case of impaired renal function, the dose of Remedia is reduced in accordance with the degree of impaired organ function:

tablets 0.25 g: dose with normal renal function - 0.25 g; initial dose with CC 50–20 ml / min - 0.25 g / 24 h, then at 0.125 g / 24 h; the initial dose with CC 19–10 ml / min - 0.25 g / 24 h, then - 0.125 g / 48 h; initial dose for CC <10 ml / min (including hemodialysis and chronic outpatient peritoneal dialysis) - 0.25 g / 24 h, then - 0.125 g / 48 h;
tablets 0.5 g: dose with normal renal function - 0.5 g; initial dose with CC 50–20 ml / min - 0.5 g / 24 h or 0.5 g / 12 h, then - 0.25 g / 24 h or 0.25 g / 12 h; the initial dose with CC 19-10 ml / min - 0.5 g / 24 h or 0.5 g / 12 h, then - at 0.125 g / 24 h or 0.125 g / 12 h; initial dose for CC <10 ml / min (including hemodialysis and chronic ambulatory peritoneal dialysis) - 0.5 g / 24 h or 0.5 g / 12 h, then - 0.125 g / 24 h;
tablets 0.75 g: dose with normal renal function - 0.75 g; dose at CC 50–20 ml / min - 0.75 g / 48 h; initial dose with CC 19–10 ml / min - 0.75 g / 48 h, then - 0.25 g / 24 h; initial dose for CC <10 ml / min (including hemodialysis and chronic ambulatory peritoneal dialysis) - 0.75 g / 48 h, then - 0.25 g / 24 h.

Solution for infusion

Remedia solution is injected intravenously at a rate of 0.5 g of levofloxacin for 60 minutes (at least).

The dosage is set individually, depending on the nature of the disease, the severity of the infection and the sensitivity of the alleged pathogen.

The recommended dosage regimen of Remedia for patients with normal renal function (CC> 50 ml / min):

exacerbation of chronic bronchitis: 0.25–0.5 g 1 time per day for 7–10 days;
community-acquired pneumonia: 0.5 g 1–2 times a day for 7–14 days;
acute maxillary sinusitis: 0.5 g 1 time per day for 10-14 days;
uncomplicated urinary tract infections: 0.25 g once a day for 3 days;
complicated urinary tract infections (including acute pyelonephritis): 0.25 g 1 time per day for 7-10 days;
infections of the skin and soft tissues: 0.5 g 2 times a day for 7-14 days;
bacteremia, septicemia: 0.5 g 1–2 times a day for 10–14 days;
chronic bacterial prostatitis: 0.5 g 1 time per day for 28 days;
intra-abdominal infection: 0.5 g 1 time per day for 7-14 days (combined with antibiotics acting on the anaerobic flora);
drug-resistant forms of tuberculosis (as part of complex treatment): 0.5 g 1-2 times a day for up to 90 days.

In case of impaired renal function (CC <50 ml / min), the following dosage regimen of Remedia is recommended:

dose for normal renal function - 0.25 g: initial dose with CC 50–20 ml / min - 0.25 g / 24 h, then at 0.125 g / 24 h; the initial dose with CC 19–10 ml / min - 0.25 g / 24 h, then - 0.125 g / 48 h; initial dose for CC <10 ml / min (including hemodialysis and chronic outpatient peritoneal dialysis) - 0.25 g / 24 h, then - 0.125 g / 48 h;
dose with normal renal function - 0.5 g: initial dose with CC 50-20 ml / min - 0.5 g / 24 h or 0.5 g / 12 h, then - 0.25 g / 24 h or 0, 25 g / 12 h; the initial dose with CC 19-10 ml / min - 0.5 g / 24 h or 0.5 g / 12 h, then - at 0.125 g / 24 h or 0.125 g / 12 h; the initial dose for CC <10 ml / min (including hemodialysis and chronic ambulatory peritoneal dialysis) is 0.5 g / 24 h or 0.5 g / 12 h, then - 0.125 g / 24 h.

Solutions compatible with Remedia solution for infusion: 5% dextrose solution; 0.9% sodium chloride solution; combined solutions for parenteral nutrition (electrolytes, carbohydrates, amino acids); 2.5% Ringer's solution with dextrose.

The drug should not be mixed with solutions that have an alkaline reaction (for example, sodium bicarbonate solution) and heparin.

After several days of therapy, depending on the patient's condition, it is possible to transfer from parenteral administration of the drug to oral forms of Remedia in the same doses.

Additional doses of the drug (tablets, solution) after chronic outpatient peritoneal dialysis or hemodialysis are not required.

Due to the fact that the metabolism of levofloxacin in the liver is insignificant, there is no need to correct the dosage regimen in case of impaired liver function.

Side effects

digestive system: dysbiosis, hepatitis, hyperbilirubinemia, increased activity of hepatic transaminases, pseudomembranous colitis, abdominal pain, decreased appetite, indigestion, diarrhea (including blood), vomiting, nausea;
cardiovascular system: atrial fibrillation, an increase in the QT interval on the cardiogram, tachycardia, vascular collapse, a decrease in blood pressure;
metabolism: hypoglycemia (tremors, nervousness, sweating, increased appetite); solution - hyperglycemia;
nervous system: convulsions, movement disorders, depression, confusion, hallucinations, fear, anxiety, paresthesia, insomnia, drowsiness, weakness, dizziness, headache; tablets - paresthesia in the hands; solution - peripheral sensory-motor neuropathy, peripheral sensory neuropathy, mental disorders with self-destructive auto-aggressive behavior (up to suicidal thoughts and suicidal attempts);
sense organs: violations of tactile and gustatory sensitivity, smell, hearing, vision;
musculoskeletal system: tendonitis, rhabdomyolysis, tendon rupture, myalgia, muscle weakness, arthralgia;
urinary system: acute renal failure, interstitial nephritis, hypercreatininemia;
hematopoietic organs: hemorrhage, pancytopenia, thrombocytopenia, agranulocytosis, neutropenia, leukopenia, hemolytic anemia, eosinophilia;
allergic reactions: vasculitis, allergic pneumonitis, anaphylactic shock, bronchospasm, Lyell's syndrome, Stevens-Johnson, urticaria, edema of the skin and mucous membranes, flushing and itching of the skin; pills - severe suffocation;
others: the development of superinfection, persistent fever, photosensitivity, exacerbation of porphyria, asthenia; solution - leukocytoclastic vasculitis;
local reactions: solution - phlebitis, redness, pain at the injection site.

Overdose

The main symptoms: convulsions, dizziness, confusion, prolongation of the QT interval, erosive lesions of the mucous membrane of the gastrointestinal tract, nausea; solution - impaired consciousness.

Symptomatic treatment is recommended.

special instructions

The use of Remedia continues for another 2-3 days after the normalization of body temperature and a decrease in symptoms of acute inflammation.

In order to avoid the development of photosensitization during the period of therapy, it is important to avoid solar and artificial ultraviolet radiation.

When prescribing the drug to elderly patients, it should be borne in mind that they often have impaired renal function.

Cancellation of the drug is carried out with the development of allergic reactions.

In cases of the appearance of symptoms of pseudomembranous colitis, Remedia is immediately canceled and appropriate therapy is started. It is not recommended in such cases to use drugs that inhibit intestinal motility.

If a patient is suspected of having tendonitis, the drug is immediately discontinued and appropriate treatment initiated. Elderly patients are at increased risk of developing tendonitis.

With a history of brain damage (severe trauma, stroke) against the background of Remedia therapy, convulsions may develop; with a deficiency of glucose-6-phosphate dehydrogenase - hemolysis.

Combined treatment may be required for hospital infections caused by certain pathogens (for example, Pseudomonas aeruginosa).

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of use of Remedia should be careful when driving and conducting potentially hazardous activities, since the potential side effects of the drug include visual impairment, drowsiness and dizziness.

Application during pregnancy and lactation

Remedia is contraindicated for use during pregnancy and lactation.

Pediatric use

For children and adolescents under the age of 18, the use of Remedia is contraindicated.

With impaired renal function

In case of impaired renal function, the dose of the drug is reduced.

Drug interactions

cimetidine, drugs that block tubular secretion: slow down the excretion of levofloxacin;
alcohol: may increase the side effects of levofloxacin from the central nervous system (drowsiness, numbness, dizziness);
cyclosporine: its half-life increases;
warfarin: its anticoagulant activity increases;
theophylline, nonsteroidal anti-inflammatory drugs: increased risk of seizures;
glucocorticosteroids: the risk of tendon rupture increases (especially in elderly patients);
insulin or oral hypoglycemic agents (against the background of diabetes mellitus): the risk of developing hypo- and hyperglycemic conditions increases (control of blood glucose concentration is recommended).

Analogs

Analogs of Remedia are Eleflox, Haileflox, Floracid, Tanflomed, Signicef, Oftaquix, OD-Levox, Lufy, Lefsan, Levoximed, Ivatsin, Glevo, Ashlev.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life: film-coated tablets - 3 years; solution for infusion - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Remedia

According to reviews, Remedia is an effective antibacterial drug with a wide spectrum of action. As disadvantages, it is generally noted that its cost is too high.

Price for Remedia in pharmacies

The approximate price of Remedia film-coated tablets, 0.5 g each (5 pcs. In a package) - 252 rubles; 0.5 g each (10 pcs. in a package) - 624 rubles; 0.75 g each (10 pcs. in a package) - 1700 rubles.

Remedia: prices in online pharmacies

Drug name

Price

Pharmacy

Remedia tablets p.p. 500mg 5 pcs.

270 RUB

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Remedia 500 mg film-coated tablets 5 pcs.

270 RUB

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Remedia 500 mg film-coated tablets 10 pcs.

505 RUB

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Remedia tablets p.p. 500mg 10 pcs.

RUB 520

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!