Remedia - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline 74.0 mg / 81.0 mg / 228.0 mg; Povidone K-30 5.0 mg / 9.0 mg / 22.0 mg; crospovidone 12.0 mg / 27.0 mg / 45.0 mg; Silica colloidal dioxide 4,0 mg / 6.0 mg / 11.0 mg; magnesium stearate 2,0 mg / 5.0 mg / 11.0 mg; sodium lauryl sulfate 7,0 mg / 10.0 mg / 15.0 mg.

Film coating composition: film coating agent Yellow (hypromellose, talc, titanium dioxide, iron oxide yellow oxide) 9.0 mg / 15.0 mg / 30.0 mg; propylene glycol 1.0 mg / 2.0 mg / 3.0 mg.

Description:

Oblong biconvex tablets, covered with a film coating of yellow color, with a risk on one side.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Remedia is a broad-spectrum antimicrobial bactericide from the group of fluoroquinolones. As the active substance contains levofloxacin - the left-handed isomer of ofloxacin. It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis,causes morphological changes in the cytoplasm, cell wall and bacterial membranes.

It is active against a wide range of the following clinically significant microorganisms:

- Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (at t. h. Enterococcus faecalis), Listeria monocytogenes. Staphylococcus spp. Coagulase-negative and methicillin-sensitive (incl. moderately sensitive). Staphylococcus aureus (methicillin-sensitive), Staphylococcus epidermidis (methicillin-sensitive). Streptococcus spp. (groups C and G). Streptococcus agalactiae. Streptococcus pneumoniae (penicillin susceptible, moderately sensitive, resistant), Streptococcus pyogenes (penicillin-sensitive, moderately sensitive, resistant), Streptococcus groups viridans;

- Gram-negative microorganisms: Acinetobacter spp. (at t. h. Acinetobacter baumannii), Actinobacillus actinomycetemcomitans. Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (at t. 4. Enterobacter aerogenes. Enterobacter agglomerates, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive and resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (at t. h. Klebsiella pneumoniae, Klebsiella oxytoca), Moraxella catarrhal is (producing and non-producing beta-lactamase), Morganella morganii. Neisseria gonorrhoeae (penicillin-sensitive, moderately sensitive, resistant), Neisseria meningitidis, Pasteurella spp. (at t. h. Pasteur el la can is, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (at t. h. Pseudomonas aeruginosa). Salmonella spp., Serratia spp. (at t. h. Serratia marcescens);

- anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp.;

- other microorganisms: Bartonella spp.. Chlamydia pneumoniae. Chlamydia psittaci, Chlamydia trachomatis, Legionella spp, (at t. h. Legionella pneumonia), Mycobacterium spp. (at t. h. Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Pharmacokinetics:

After oral administration, quickly and almost completely absorbed from gastrointestinal tract. Bioavailability is 99%. Food intake has little effect on the speed and completeness of absorption.

The maximum concentration (Cmah) in blood plasma with the intake of 250 mg and 500 mg is achieved after 1-2 hours and is 2.8 μg / ml and 5.2 μg / ml, respectively. The connection with plasma proteins is 30-40%.

It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, bone tissue. cerebrospinal fluid, polymorphonuclear leukocytes, alveolar macrophages. The average volume of distribution is from 89 to 112 liters after a single and repeated intake of 500 mg of the drug.

In the liver, a small portion is oxidized and / or deacetylated.

The half-life (T1 / 2) is 6-8 hours. About 70% of levofloxacin is excreted unchanged by the kidneys for 24 hours (about 87% for 48 hours) and less than 5% in the form of metabolites for 48 hours. Intestinal decretes less than 4% accepted dose for 72 hours.

Kidney clearance is 70% of the total clearance.

It is not excreted from the body by hemodialysis or chronic outpatient peritoneal dialysis.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infections of the ENT organs (including acute sinusitis);

- infections of the lower respiratory tract (including chronic bronchitis in the acute stage, pneumonia);

- infections of the urinary tract and kidneys (including acute pyelonephritis);

- chronic bacterial prostatitis;

- infections of the skin and soft tissues (including festering atheromas, abscess, furunculosis);

- intra-abdominal infections (in combination with antibacterial drugs acting on anaerobic flora);

- tuberculosis (complex therapy of drug-resistant forms).

Contraindications:

- hypersensitivity to levofloxacin, other fluoroquinolones or other components of the drug;

- epilepsy;

- the defeat of the tendons during the previous treatment with quinolones;

- children and adolescence (up to 18 years);

- pregnancy;

- lactation period.

Carefully:

Elderly age (high probability of concomitant decrease in kidney function), deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Inside, before meals or in the interval between meals, without chewing, squeezed with enough liquid (0.5 to 1 cup).

Adult patients with normal renal function (creatinine clearance is more than 50 ml / min)

The dose and duration of treatment depend on the type and severity of the course of the disease:

Indication	Daily dose, mg	Multiplicity of reception per day	Duration of treatment, din
Acute Sinusitis	500	1	10-14
Acute Sinusitis	750	1	5
Chronic bronchitis in the acute phase	500	1	7
Hospital pneumonia	750	1	7-14
Community-acquired pneumonia	500	1-2	7-14
Community-acquired pneumonia	750 *	1	5
Uncomplicated urinary tract infections	250	1	3
Complicated urinary tract infections, including acute pyelonephritis	250	1	10
	750 **	1	5
Chronic bacterial prostatitis	500	1	28
Uncomplicated skin and soft tissue infections	500	1	7-10
Complicated skin and soft tissue infections	750	1	7-14
Intra-abdominal infections (in combination with antibacterial drugs acting on anaerobic flora)	500	1	7-14
Tuberculosis (complex therapy of drug-resistant forms of tuberculosis)	500	1-2	up to 3 months

* Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-sensitive, moderately sensitive, resistant), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae. Chlamydia pneumoniae.

** Complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pyelonephritis caused by Escherichia coli, including cases of concomitant bacteremia.

Application for renal dysfunction

In patients with impaired renal function, the dose is reduced in accordance with the degree of impaired function:

Clearance creatinine, ml / min	The initial dose is 250 mg	Initial dose - 500 >11		The initial dose is 750 mg
50-20	The initial dose is 250 mg / 24 h, then 125 mg / 24 h	The initial dose is 500 mg / 24 h, then 250 mg / 24 h	The initial dose is 500 mg / 12 h, then 250 mg / 12 h	750 mg / 48 h
19-10	The initial dose is 250 mg / 24 h, then 125 mg / 48 h	The initial dose is 500 mg / 24 h, then 125 mg / 24 h	The initial dose is 500 mg / 12 h, then 125 mg / 12 h	The initial dose is 750 mg / 48 h, then 250 mg / 24 h
less than 10 (including hemodialysis and chronic outpatient peritoneal dialysis)	The initial dose is 250 mg / 24 h, then 125 mg / 48 h	The initial dose is 500 mg / 24 h, then 125 mg / 24 h	The initial dose is 500 mg / 12 h, then 125 mg / 24 h	The initial dose is 750 mg / 48 h, then 250 mg / 24 h

After conducting hemodialysis or chronic outpatient peritoneal dialysis, no additional doses are required.

Application for violations of liver function

Correction of the dose in patients with impaired liver function is not required, since levofloxacin slightly metabolized in the liver.

Use in elderly patients

Correction of dose in elderly patients with normal renal function is not required.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, decreased appetite, indigestion, abdominal pain, pseudomembranous colitis; increased activity of "hepatic" transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

From the cardiovascular system: decrease in arterial pressure, vascular collapse, tachycardia, lengthening of the interval Q-T, extremely rare - atrial fibrillation.

From the side of metabolism: hypoglycemia (increased appetite, sweating, nervousness, trembling).

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesia, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions.

From the sense organs: impaired vision, hearing, smell, taste and tactile sensitivity.

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, rhabdomyolysis, tendonitis.

From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.

From the hematopoiesis: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions: itching, redness of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, anaphylactic shock, severe choking, allergic pneumonitis, vasculitis.

Other: photosensitivity, asthenia (general weakness), exacerbation of porphyria, persistent fever, development of superinfection.

Overdose:

Symptoms: nausea, erosive lesions of the mucous membrane of the gastrointestinal tract, lengthening of the interval Q-T, confusion, dizziness, convulsions.

Treatment: symptomatic.

Dialysis is ineffective. The specific antidote is not known.

Interaction:

Increases the half-life of cyclosporine.

Drugs that depress intestinal motility, sucralfate, aluminum- and magnesium-containing antacid drugs, as well as preparations containing iron and zinc salts, reduce the effect of levofloxacin.The drug should be taken within 2 hours or 2 hours after taking these medications.

Cimetidine and drugs that block tubular secretion, slow the withdrawal of levofloxacin.

Non-steroidal anti-inflammatory drugs and theophylline increase the risk of seizures.

Glucocorticosteroids increase the risk of rupture of the tendon.

Hypoglycemic drugs increase the likelihood of hyper- and hypoglycemia, so strict monitoring of blood glucose levels is necessary.

When used simultaneously with antagonists of vitamin K, monitoring of blood clotting indices is necessary.

Special instructions:

After reducing the symptoms of acute inflammation and normalizing body temperature, taking levofloxacin is recommended to continue for another 48-72 hours.

During treatment it is necessary to avoid sunlight and artificial Ultraviolet irradiation to avoid damage to the skin (photosensitization).

In the treatment of elderly patients, it should be borne in mind that patients of this group often have impaired renal function.

When there is an allergic reaction, the drug should be stopped.

When there are signs of pseudomembranous colitis, the drug should be immediately withdrawn and appropriate treatment started. In such cases, it is not recommended to take medications that depress the bowel motility

If suspected of tendonitis, treatment with levofloxacin should also be stopped immediately and appropriate treatment started. The risk of tendonitis is higher in elderly people.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), convulsions may develop, in patients with a deficiency of glucose-6-phosphate dehydrogenase - the development of hemolysis.

Hospital infections caused by certain pathogens (for example, Pseudomonas aeruginosa), may require combined treatment.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, as dizziness, drowsiness, and visual impairment are possible when taking levofloxacin.

Form release / dosage:Tablets, film-coated, 250 mg, 500 mg, 750 mg.

Packaging:

For 5 or 10 tablets in a contour cell pack of PVDC film and aluminum foil. 1 circuit cell pack together with instructions for use in a cardboard box.

Storage conditions:

Store in a dry, protected from summer place at a temperature of no higher than 25 ° C,

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001307/10

Date of registration:24.02.2010

The owner of the registration certificate: Simpex Pharma Pvt Ltd. Simpex Pharma Pvt Ltd. India

Manufacturer: & nbsp

SIMPEX PHARMA, Pvt. Ltd. India

Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC

Information update date: & nbsp09.10.2015

Illustrated instructions

Instructions

Remedy (Remedia)