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

Excipients: cellulose microcrystalline, talc purified, starch glycolate sodium salt, silicon dioxide colloid, sodium lauryl sulfate, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide.

Description:

White or almost white capsule capsules coated

film shell, with a 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, possessing 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 influenzae. 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

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 hours

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:

Infectious-inflammatory diseases caused by sensitive microorganisms, incl .:

- 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;

- Hypersensitivity 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.

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

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

With 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.

With infections of the genitals - 400-600 mg 2 times / day for 7 days.

In acute uncomplicated gonococcal infection - appoint 800 mg once. For the prevention of sepsis in patients with neutropenia - 400 mg 3 times / day for 8 weeks.

With infections of the gastrointestinal tract - 400 mg 2 times / day for 3-5 days.

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

Patients with renal insufficiency 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 laboratory indicators: possibly reducing the hematocrit, eosinophilia, leukopenia, increased creatinine concentration in plasma

Allergic reactions: rarely - hives, rashes, itching, anaphylactic shock!

Overdose:

Symptoms: dyspeptic disorders (nausea vomiting diarrhea), in more severe cases - dizziness, fatigue, confusion, convulsions. Treatment: gastric lavage, careful monitoring of the patient, symptomatic therapy.It is necessary to ensure sufficient the flow of fluid into 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:film-coated tablets

Packaging:

For 6 or 10 tablets in a contour non-cellular package (strip) of aluminum foil.

1 strip package with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature below 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 N013963 / 01

Date of registration:18.07.2008

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp10.08.2015

Illustrated instructions

Instructions

Normox® (Normax®)