Haileflox - Instructions For Use, Price, Analogues, 500 Mg, 750 Mg

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

Haileflox

Haileflox: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Use in the elderly
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Hileflox

ATX code: J01MA12

Active ingredient: levofloxacin (levofloxacin)

Manufacturer: HiGlance Laboratories Pvt. Ltd. (India)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 318 rubles.

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Haileflox is an antimicrobial drug - fluoroquinolone.

Release form and composition

The dosage form of Haileflox is film-coated tablets:

• 250 mg each: from orange to light orange, biconvex, round (in blisters of 3, 5, 7 or 10 pcs., in a cardboard box 1 blister of 3, 5, 7 or 10 pcs., 2 blisters of 5 pcs.., 5 blisters of 5 pcs., 10 blisters of 3, 5, 7 or 10 pcs.);
• 500 and 750 mg each: from orange to light orange, biconvex, oval, with a line on one side (in blisters of 5, 7 or 10 pcs., in a cardboard box 1 blister of 5, 7 or 10 pcs., 2 blisters of 5 pcs., 10 blisters of 5, 7 or 10 pcs.).

Composition of 1 tablet (250/500/750 mg each, respectively):

• active substance: levofloxacin hemihydrate - 260 / 520.15 / 780.26 (corresponds to the content of levofloxacin 250/500/750 mg);
• auxiliary components: sodium carboxymethyl starch, magnesium stearate, purified talc, propyl parahydroxybenzoate, methyl parahydroxybenzoate, povidone K 30, microcrystalline cellulose, corn starch;
• film shell: sunset yellow dye, titanium dioxide; macrogol 6000; talcum powder; hypromellose.

Pharmacological properties

Pharmacodynamics

Levofloxacin is a synthetic broad-spectrum fluoroquinolone. The substance inhibits the synthesis of deoxyribonucleic acid (DNA), disrupts the stitching and supercoiling of DNA breaks, inhibits topoisomerase II (DNA gyrase) and topoisomerase IV, promotes profound morphological changes in the membranes, cell wall and cytoplasm of sensitive microorganisms.

Levofloxacin is active against most strains of microorganisms, which include:

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

Microorganisms resistant to levofloxacin are:

• aerobic gram-positive microorganisms: Staphylococcus spp. (coagulase-negative methicillin-resistant strains, including methicillin-resistant strains of Staphylococcus aureus), Corynebacterium jeikeium;
• aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;
• other microorganisms: Mycobacterium avium.

Pharmacokinetics

Characteristics of levofloxacin:

• absorption: quickly and almost completely absorbed after oral administration from the gastrointestinal tract; food intake has little effect on the rate and completeness of absorption; bioavailability is 99%; the maximum concentration in blood plasma (Cmax) is reached after 1–2 hours and for a dose of levofloxacin 250/500/750 mg is respectively 2.8 / 5.2 / 8 μg per 1 ml;
• distribution: the amount of absorbed substance is directly proportional to the accepted single or multiple dose; after 48 hours after administration, an equilibrium plasma concentration is achieved; the average volume of distribution (Vd) varies from 74 to 112 liters; binding to plasma proteins is 30-40%; it penetrates well into tissues and organs: polymorphonuclear leukocytes, organs of the genitourinary system, alveolar macrophages (concentration in lung tissues exceeds that in plasma by 2-5 times), phlegm, bronchial mucosa, lungs;
• metabolism: undergoes limited metabolism in the liver (deacetylation and / or oxidation);
• excretion: excreted mainly by the kidneys through tubular secretion and glomerular filtration; half-life (T1 / 2) is 6 to 8 hours; in the form of desmethyl- and N-oxide-metabolites, less than 5% of the dose taken is excreted; 70% of the dose taken orally within 24 hours is excreted unchanged through the kidneys and 87% in 48 hours; within 72 hours, 4% of the dose is excreted by the intestines.

Indications for use

According to the instructions, Haileflox is used to treat the following infectious and inflammatory pathologies of mild and moderate severity caused by microorganisms sensitive to levofloxacin:

• acute bacterial sinusitis;
• exacerbation of chronic bronchitis, pneumonia (lower respiratory tract infections);
• kidney and urinary tract infections, including acute pyelonephritis;
• boils, abscess, suppurating atheromas (infections of the skin and soft tissues);
• chronic bacterial prostatitis;
• intra-abdominal infection (combined treatment with antibiotics that have an effect on the anaerobic microflora);
• tuberculosis (complex therapy of drug-resistant forms).

Contraindications

Absolute:

• epilepsy;
• a history of tendon damage, the development of which was the use of quinolones;
• age under 18;
• pregnancy;
• lactation period;
• individual intolerance to the components contained in the drug, other fluoroquinolones (including a history).

Relative (diseases / conditions in the presence of which the appointment of Haileflox requires caution):

• deficiency of glucose-6-phosphate dehydrogenase;
• elderly age.

Instructions for the use of Haileflox: method and dosage

Haileflox tablets are taken orally, without chewing, before meals or in between meals, with water (sufficient amount).

Recommended doses for adults with normal renal function [creatinine clearance (CC)> 50 ml in 1 min]:

• hospital pneumonia: Haileflox 750 mg once a day for 7-14 days;
• community-acquired pneumonia: 500 mg 1–2 times a day for 7–14 days; for community-acquired pneumonia caused by Chlamydia pneumoniae, Mycoplasma pneumoniae, Haemophilus parainfluenzae, Haemophilus influenzae, Streptococcus pneumonia - 750 mg per day for 5 days;
• acute bacterial exacerbation of chronic bronchitis: Haileflox 500 mg once a day for 7 days;
• acute bacterial sinusitis: 500 mg per day for 10-14 days or 750 mg per day for 5 days;
• uncomplicated urinary tract infections: 250 mg per day for 3 days;
• complicated urinary tract infections, including acute pyelonephritis: 750 mg per day; in the treatment of urinary tract infections caused by Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumonia, Enterococcus cloacae, Enterococcus faecalis, and acute pyelonephritis caused by Escherichia coli - 250 mg per day for 10 days;
• uncomplicated infections of the skin and subcutaneous tissues: 500 mg per day for 7-10 days;
• complicated infections of the skin and subcutaneous tissues: Haileflox 750 mg once a day for 7-14 days;
• chronic bacterial prostatitis: 500 mg per day for 28 days;
• intra-abdominal infection (in combination with antibacterial drugs acting on the anaerobic microflora): Haileflox 500 mg once a day for 7-14 days;
• tuberculosis (as part of the complex therapy of drug-resistant forms): 500 mg 1-2 times a day for a period of up to 3 months.

Correction of the Haileflox dose in adult patients with impaired renal function (CC <50 ml per minute):

• dose for normal renal function - 750 mg every 24 hours; CC from 20 to 49 ml in 1 minute - 750 mg every 48 hours; the initial dose with QC from 10 to 19 ml in 1 minute - 750 mg, then - 500 mg every 48 hours; the initial dose for CC <10 ml in 1 minute, including chronic ambulatory peritoneal dialysis or hemodialysis - 750 mg, then - 500 mg every 48 hours;
• dose for normal renal function - 500 mg every 24 hours; the initial dose for QC from 20 to 49 ml per minute is 500 mg, then 250 mg every 24 hours; the initial dose for QC is from 10 to 19 ml per minute - 500 mg, then - 250 mg every 48 hours; the initial dose for CC <10 ml in 1 minute, including chronic ambulatory peritoneal dialysis or hemodialysis - 500 mg, then - 250 mg every 48 hours;
• dose for normal renal function - 250 mg every 24 hours; QC from 20 to 49 ml in 1 minute - no dosage adjustment is required; CC from 10 to 19 ml in 1 minute - 250 mg every 48 hours; correction of the dosage regimen is not required in cases of uncomplicated urinary tract infections; CC <10 ml in 1 minute, including chronic ambulatory peritoneal dialysis or hemodialysis - there is no information on the correction of the dosage regimen.

Doses of Haileflox in patients with impaired liver function are not adjusted, since the degree of metabolism of levofloxacin in the liver is limited.

Side effects

• nervous system: convulsions, movement disorders, depression, confusion, hallucinations, fear, paresthesia, anxiety, tremors, insomnia, drowsiness, weakness, dizziness, headache;
• sense organs: violation of tactile and gustatory sensitivity, smell, hearing, vision;
• cardiovascular system: atrial fibrillation, prolongation of the QT interval, tachycardia, vascular collapse, decreased blood pressure;
• digestive system: dysbiosis, hepatitis, hyperbilirubinemia, increased activity of hepatic transaminases, pseudomembranous colitis, abdominal pain, decreased appetite, indigestion, diarrhea (including blood), nausea, vomiting;
• metabolism: hypoglycemia (nervousness, tremors, increased sweating, increased appetite);
• musculoskeletal system: tendonitis, tendon rupture, rhabdomyolysis, myalgia, muscle weakness, arthralgia;
• urinary system: acute renal failure, interstitial nephritis, hypercreatininemia;
• hematopoietic organs: hemorrhages, pancytopenia, thrombocytopenia, agranulocytosis, neutropenia, leukopenia, hemolytic anemia, eosinophilia;
• allergic reactions: vasculitis, allergic pneumonitis, anaphylactic shock, dyspnea, bronchospasm, Lyell's syndrome, urticaria, Stevens-Johnson syndrome, edema of mucous membranes and skin, hyperemia and itching of the skin;
• others: the development of superinfection, persistent fever, exacerbation of porphyria, asthenia, photosensitivity.

Overdose

The main symptoms: convulsions, dizziness, confusion, prolongation of the QT interval, erosive lesions of the mucous membranes of the gastrointestinal tract, nausea.

Therapy: gastric lavage, symptomatic treatment (if necessary).

special instructions

It is recommended to continue Haileflox therapy for 2-3 days (at least) after the normalization of body temperature.

In case of combined treatment with sucralfate, magnesium-containing or aluminum-containing antacids, and other agents that include zinc, iron or calcium, levofloxacin is taken at least 2 hours before or after 2 hours after taking them.

In connection with the possible development of photosensitization, during the period of taking the drug and for 5 days after its cancellation, it is important to avoid solar and artificial ultraviolet radiation. In cases of phototoxicity, treatment with Haileflox is discontinued.

Immediate withdrawal of therapy is required when symptoms of pseudomembranous colitis and tendinitis appear.

It should be borne in mind that with a history of brain damage (severe trauma, stroke), seizures may develop; with deficiency of glucose-6-phosphate dehydrogenase - hemolytic reactions.

Careful monitoring of blood glucose concentration during the period of taking Haileflox is necessary in patients with diabetes mellitus.

In cases of combined use of warfarin, monitoring for signs of bleeding, prothrombin time, international normalized ratio and other anticoagulation tests is indicated.

Influence on the ability to drive vehicles and complex mechanisms

Patients should be careful when driving and conducting potentially hazardous activities, since during the period of taking Haileflox, the ability to concentrate and psychomotor speed may be impaired.

Application during pregnancy and lactation

Haileflox is contraindicated for use during pregnancy and lactation.

Pediatric use

The use of the drug is contraindicated in children and adolescents under the age of 18.

Use in the elderly

With caution, Haileflox is prescribed to elderly patients, since while taking the drug, they have an increased risk of a concomitant decrease in renal function.

Drug interactions

Effect of levofloxacin on drugs / substances in combination therapy:

• cyclosporine: increases its half-life;
• warfarin: enhances its anticoagulant effect.

The effect of drugs / substances on levofloxacin in combination treatment:

• sucralfate, iron preparations, magnesium-containing and aluminum-containing antacids, suppressing intestinal motility drugs: reduce its effects;
• drugs that block tubular secretion, cimetidine: slow down its excretion.

With the simultaneous use of levofloxacin with theophylline or non-steroidal anti-inflammatory drugs, the risk of seizures in predisposed patients increases; with glucocorticosteroids - the risk of tendon rupture; with hypoglycemic agents - changes in the concentration of glucose in the blood are possible, including hypoglycemia and hyperglycemia.

Analogs

The analogues of Haileflox are Eleflox, Fleksid, Tavanik, Signicef, Roflox-Scan, Oftaquix, MAKLEVO, Lefsan, Levofloxacin, Levotek, Ivatsin, Glevo, Ashlev.

Terms and conditions of storage

Store in a place protected from light and moisture at a temperature of 8 to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Haileflox

According to reviews, Haileflox is an effective drug in the treatment of bronchitis and bilateral sinusitis, as well as in the complex treatment of prostatitis. Among the disadvantages, many note the development of side effects in the form of pain in the tendons and joints, tremors, body aches, and exacerbation of existing symptoms.

Price for Haileflox in pharmacies

The approximate price of Haileflox 500 mg (5 tablets per pack) is 439 rubles. The cost of Haileflox 750 mg tablets (5 pieces per package) is 689 rubles.

Haileflox: prices in online pharmacies

Drug name Price Pharmacy

Haileflox 500 mg film-coated tablets 5 pcs. RUB 318 Buy

Haileflox tablets p.p. 500mg 5 pcs. 366 r Buy

Haileflox 750 mg film-coated tablets 5 pcs. RUB 550 Buy

Haileflox tablets p.p. 750mg 5 pcs. 695 RUB 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!