Loxof (levofloxacin) coated tablets 500 mg. №5

Description

Loxof composition
active substance: levofloxacin;
1 film-coated tablet contains levofloxacin hemihydrate equivalent to 500 mg of levofloxacin;
Excipients: microcrystalline cellulose, hypromellose, polysorbate 80, crospovidone, magnesium stearate, opadry yellow 0ZV52874 (hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172), iron oxide red).

Dosage form
Film-coated tablets.

Pharmacological properties
This drug Loxof belongs to the group of antibacterial drugs of the group of quinolones, fluoroquinolones.
The effect of the application is due to the properties of the main active ingredient of the drug – levofloxacin, which is a synthetic antibacterial agent. Also levofloxacin is the S-enantiometer of the racemic mixture of ofloxacin.
Able to affect DNA-DNA gyrase and topoisomerase IV.
The level of antibacterial activity of the drug depends on its concentration in the blood serum.
There is a risk of cross-resistance with other fluoroquinolones and no cross-resistance with other antibiotic groups.

Indications
This drug Loxof is intended for the treatment of bacterial inflammatory processes caused by bacteria sensitive to levofloxacin. In particular, when:

• pneumonia;
• complicated urinary tract infections, including pyelonephritis;
• infections of the skin and soft tissues;
• chronic bacterial prostatitis.

Contraindications
Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Also contraindicated for:

• epilepsy;
• problems with tendons with a history of quinolones.

Use in pediatrics is contraindicated (articular cartilage may be impaired).

Children
It is contraindicated to use Loxof in children, as damage to the articular cartilage is not excluded.

Application during pregnancy and lactation
Treatment of pregnant women with this drug is contraindicated.
During treatment, lactation (breastfeeding) should be suspended.

Method of administration and dosage                                                                                                            Loxof tablets should be taken 1 or 2 times a day. The dose and duration of treatment depend on the type, severity of the infection and the susceptibility of the probable pathogen. It is recommended to continue treatment with Loxof for at least 48 – 72 hours after normalization of body temperature or confirmed by microbiological tests in the absence of pathogens.
The drug can be used to complete the course of therapy in patients who have shown improvement in the initial treatment with levofloxacin in the form of a solution for infusion, using the same dosage.
Loxof tablets should be swallowed without chewing, drinking plenty of fluids. They can be taken with food or in between meals.

• Acute bacterial sinusitis 500 mg 1 time – 10-14 days;
• Exacerbation of chronic bronchitis 500 mg 1 time – 7-10 days;
• Nosocomial pneumonia 500 mg 1-2 times – 7-14 days;
• Pyelonephritis 500 mg 1 time – 7-10 days;
• Complicated urinary tract infections, including pyelonephritis 500 mg 1 time – 10-14 days;
• Chronic bacterial prostatitis 500 mg 1 time – 28 days;
• Infections of the skin and soft tissues 500 mg 1-2 times – 7-14 days;
• Pulmonary anthrax 500 mg 1 time – 8 weeks.

Overdose
In case of an overdose, symptoms such as:

• dizziness, loss of consciousness;
• convulsions;
• lengthening of the QT interval.

In case of an overdose, it is necessary to monitor the patient’s condition, primarily the ECG.
Dialysis is ineffective. There is no antidote.
Treatment is symptomatic.

Side effects
In particular, the patient may experience:

• mycoses;
• tendinitis, arthralgia, myalgia, damage to the ligaments, up to their ruptures, damage to the cartilage tissue of the joints;
• leukopenia, eosinophilia, thrombocytopenia, agranulocytosis, pancytopenia;
• anaphylactic shock;
• anorexia, hypoglycemia;
• insomnia, nervousness, anxiety, agitation, hallucinations;
• convulsions, tremors, paresthesia, dysgeusia, ageusia, anosmia;
• vertigo, ringing in the ears;
• tachycardia, arterial hypotension, prolongation of the QT interval;
• bronchospasm, dyspnea, allergic pneumonitis;
• nausea, vomiting, dyspepsia, diarrhea;
• hepatitis, jaundice;
• rash, itching, angioedema, hyperhidrosis;
• deterioration of kidney function, up to acute renal failure (due to interstitial neuritis);
• asthenia, pyrexia, pain in the chest, back, limbs;
• attacks of porphyria.

Storage conditions and periods
The shelf life of the drug Loxof is no more than 2 years from the production date indicated on the package.
This medicinal product should be stored in a dry place out of direct sunlight, at a temperature not exceeding 25 ° C.