Lokson-400 - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose, potato starch, silicon dioxide colloid, methylparaben, propylparaben, magnesium stearate, talc, hydroxypropylmethylcellulose, titanium dioxide, dye-yellow, propylene glycol, talc.

Description:Oval tablets of red-orange color, film-coated with a dividing risk on one side.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone

ATX: & nbsp

S.01.A.E.02 Norfloxacin

Pharmacodynamics:

Antimicrobial drug from the group of fluoroquinolones, which has a wide spectrum of action. It is bactericidal. Norfloxacin is active against most gram-negative microorganisms: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia marcescens, Citrobacter spp., Yersinia enterocolitica, Providencia stuartii, Haemophilus influenza, Pseudomonas aeruginosa. Also active against certain Gram-positive microorganisms (in particular Staphylococcus spp.), for microorganisms producing beta-lactamases. Norfloxacin is less effective in Acinetobacter spp. and Enterococcus spp. and is ineffective against anaerobic bacteria and streptococci.

Pharmacokinetics:

Suction

After ingestion, the drug is quickly, but not completely (30-40%) absorbed from the digestive tract. The maximum concentrations in the serum are observed after 1 -2 h.

Distribution

Up to 67% of norfloxacin penetrates from the blood plasma into the peripheral tissues. Concentrations exceeding plasma are noted in the bile duct, gall bladder, liver, kidney and prostate gland. The drug does not penetrate the BBB. Binding to plasma proteins is about 14%.

Excretion

Half-life is 3.5-6.5 hours. About 80% is excreted by the kidneys, 20% is excreted unchanged through the intestine.

Indications:

Treatment of infectious-inflammatory diseases caused by sensitive microorganisms, including:

- urinary tract infections;

- infection of the genitals;

- gonococcal infection;

- infections of the digestive tract;

- prevention of sepsis in patients with neutropenia;

- travelers diarrhea.

Contraindications:

- Pregnancy;

- lactation (breastfeeding);

- children and adolescents under 18;

- increased sensitivity to norfloxacin or other drugs from the group of fluoroquinolones.

Carefully:

With caution appoint the drug to patients with epilepsy, seizures in the anamnesis, with severe impairment of kidney function.

Dosing and Administration:

Norfloxacin is taken orally on an empty stomach (at least 1 hour before or 2 hours after eating) and drink plenty of fluids.

When acute uncomplicated cystitis prescribe 200-400 mg 2 times / day for 3-5 days.

When acute urinary tract infections - 400 mg 2 times / day for 7-10 days.

When recurrent or chronic recurrent urinary tract infections - 400 mg 2 times / day for 4 weeks and 400 mg / day for up to 12 weeks in case of relapse. When infections of the genitals - 400-600 mg 2 times / day for 7 days.

When acute uncomplicated gonococcal infection - prescribe 800 mg once.

For prevention sepsis in patients with neutropenia - 400 mg 3 times / day for 8 weeks.

With infections GIT- 400 mg 2 times / day for 3-5 days.

For prevention of bacterial diarrhea at epidemically unfavorable areas - 400 mg 1 time / day.

Patients with hepatic impairment and creatinine clearance of 10-30 ml / min is prescribed 400 mg 1 time / day.

Side effects:

From the digestive tract, liver: nausea, anorexia, diarrhea; a transient increase in the activity of hepatic transaminases, alkaline phosphatase, lactate dehydrogenase is possible.

From the side of the central nervous system, the psyche: headache, dizziness, fatigue, drowsiness, anxiety, irritability, fear, confusion, hallucinations, depression, tinnitus.

From the musculoskeletal system: in some cases - tendonitis, rupture of tendons.

From the side of laboratory testimony: possibly a decrease in hematocrit, eosinophilia, leukopenia, an increase in the concentration of creatinine in the plasma.

Allergic reactions: rarely - hives, rash, itching, anaphylactic shock.

Overdose:

Symptoms: dyspeptic disorders (nausea, vomiting, diarrhea), in more severe cases - dizziness, fatigue, confusion, convulsions.

Treatment: gastric lavage, careful observation of the patient, symptomatic therapy. It is necessary to ensure a sufficient supply of fluid in the body while maintaining the appropriate diuresis.

Interaction:

With the simultaneous use of norfloxacin with theophylline and cyclosporin, an increase in the concentrations of theophylline and cyclosporine in plasma is possible.

With the simultaneous use of norfloxacin with warfarin, the therapeutic effect of the latter may be enhanced.

Simultaneous reception of norfloxacin and antacid agents reduces the intensity of absorption of norfloxacin. In this regard, the drug should be taken 1-2 hours before or no less than 4 hours after taking these drugs.

Special instructions:

If it is necessary to prescribe norfloxacin during lactation, the question of stopping breastfeeding should be solved.

With caution appoint the drug to patients with epilepsy, seizures in the anamnesis, with severe impairment of kidney function.

During treatment with the drug, patients should receive a sufficient amount of fluid (under the control of diuresis).

During the treatment of norfloxacin, an increase in the prothrombin index was noted.When performing surgical interventions, the condition of the blood coagulation system should be monitored.

During treatment with norfloxacin, exposure to direct sunlight should be avoided.

When pain occurs in the tendons or at the first signs of tendovaginitis, it is recommended to cancel the drug.

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

In connection with the possible occurrence of dizziness, patients receiving norfloxacin, caution should be exercised when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions (especially with simultaneous use of alcohol).

Form release / dosage:

The tablets covered with a film cover, on 400 mg.

Packaging:For 10 tablets in AL / PVC blisters, one by one and ten blisters in a cardboard box, along with instructions for medical use.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:П N013521 / 01

Date of registration:19.12.2007

Expiration Date:Unlimited

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp03.04.2018

Illustrated instructions

Instructions

Loxon-400 (Loxone-400)