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

Ingredient name	Amount in tablet, mg
Ingredient name	200 mg	400 mg
Active substance:
Norfloxacin	200,0	400,0
Excipients:
Starch	20	80
Lactose	5	30
Calcium phosphate disubstituted	7	54
Polyvinylpyrrolidone K-30	1,5	3
Croscarmellose sodium	10	20
Sodium starch glycolate	10	10
Talc	5	5
Magnesium stearate	3	3
Sodium lauryl sulfate	3	6
Film Sheath:
Thydroxypropylmethyl cellulose 15 cps	7,92	18,3
Polyethylene glycol-400	1,44	3,66
Talc	0,43	1,00
Titanium dioxide	1,84	4,27
Sunset yellow varnish	1,4	3,25
Total tablet weight:	277,7	641,48

Description:Orange colored round, biconvex tablets, covered with a film membrane.

Pharmacotherapeutic group:antimicrobial agent-fluoroquinolone

ATX: & nbsp

S.01.A.E.02 Norfloxacin

Pharmacodynamics:Antibacterial agent from the group of fluoroquinolones. Has a bactericidal effect. Affects the bacterial enzyme DNA-gyrase, which provides supercoiling and, thus, stability of bacterial DNA. The destabilization of the DNA chain leads to the death of bacteria.

Norfloxacin has a broad spectrum of antibacterial action and is active against most strains of microorganisms, as in conditions in vitro, and in vivo.

In vitro:

Gram-positive aerobic microorganisms are sensitive:

Enterococcus faecalis (3.13 - 6.25 μg / ml), Staphylococcus aureus (1.56 μg / ml), Staphylococcus epidermidis (0.78 - 1.56 μg / ml), Streptococcus pneumoniae (6.25 - 12.5 μg / ml), Staphylococcus pyogenes (0.78 - 3,13 μg / ml).

Gram-negative aerobic microorganisms are sensitive:

Citrobacter freundii (6.10 μg / ml), Enterobacter cloacae (0.20- μg / ml), Escherichia coli (0.10 μg / ml), Klebsiella pneumoniae (0.20 μg / ml), Neisseria gonorrhoeae (0.025 μg / ml), Shigella sp. (0.05-0.20 μg / ml), Haemophilus influenzae (05 μg / ml), Proteus mirabilis (0.10-0.20 μg / ml), Proteus vulgaris (0.10 μg / ml), Pseudomonas aeruginosa (0.78 - 1.56 μg / ml), Serratia marcescens (0.78 μg / ml).

Norfloxacin at concentrations ≤ 4 μg / ml in vitro is active against most strains (≥90%) of the following microorganisms:

Citrobacter diversus (0.10 μg / ml), Morganella morganii (0.05-0.10 μg / ml), Providencia alcalifaciens (0.39 μg / ml), Providencia rettgeri (0.39 μg / ml), Providencia stuartii (0.39 μg / ml), Pseudomonas fluorescens, Pseudomonas stutzeri, Edwardsiella tarda, Enterobacter agglomerans, Haemophilus ducreyi, Klebsiella oxytocai.

Norfloxacin is practically inactive with respect to obligate anaerobes.

To norfloxacin is stable Treponema pallidum.

The duration of the antimicrobial effect is about 12 hours.

Pharmacokinetics:

Norfloxacin quickly, but not completely (20-40%) is absorbed after ingestion, food slows the absorption of the drug.

The maximum concentrations in the blood plasma are achieved after 1-2 hours and range from 1 to 4 μg / ml depending on the dose. The low binding of norfloxacin to plasma proteins (10-15%) and high solubility in lipids cause a large volume of drug distribution and good penetration into organs and tissues (renal parenchyma, ovaries, seminal tubular fluid, prostate, uterus, abdominal cavity and small pelvis, bile, mother's milk). Penetrates through the hemato-encephalic barrier and the placenta. It is metabolized to an insignificant degree in the liver. It is excreted by the kidneys, by glomerular filtration and tubular secretion.

Within 24 hours after receiving 32% of the dose is excreted by the kidneys unchanged, 5-8% in the form of metabolites, about 30% of the dose is taken out with bile.

Indications:

- Infectious-inflammatory diseases caused by sensitive to norfloxacin by microorganisms;

- acute and chronic infectious diseases of urination(urethritis, cystitis);

- chronic bacterial prostatitis;

- gonorrhea uncomplicated;

- shigellosis;

- salmonellosis;

- prevention infectious diseases, u patients with granulocytopenia;

- prevention of travelers' diarrhea.

Contraindications:

- Hypersensitivity to norfloxacin, the components of the drug, other fluoroquinolones;

- deficiency of glucose-6-phosphate dehydrogenase,

- pregnancy,

- lactation,

- tendonitis, tendon rupture caused by the intake of fluoroquinolones (including in the anamnesis);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the presence of lactose in the composition);

- children and adolescence (up to 18 years).

Carefully:Atherosclerosis of cerebral vessels, cerebral circulation, epilepsy, epileptic syndrome, renal or hepatic insufficiency. Organic diseases of the central nervous system, predisposition to convulsive reactions, myasthenia gravis gravis, hepatic porphyria, diabetes mellitus, congenital lengthening interval syndrome Q-T, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg, hypokalemia, hypomagnesemia), elderly age, psychosis, etc.Mental disorders in the anamnesis, simultaneous reception of drugs that extend the interval Q-T (antiarrhythmic IA and III classes, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal, imidazole derivatives, some antihistamines, including. astemizole, terfenadine, ebastine), for general anesthesia from the barbiturate group; medicines that reduce blood pressure.

Dosing and Administration:

Inside.

In the absence of special doctor's instructions, the following doses are recommended: 1 tablet (400 mg) 2 times a day for 1 hour or 2 hours after a meal. Duration of treatment is from 7 to 14 days, if necessary, spend a longer treatment.

Treatment of chronic bacterial prostatitis is carried out within 4-6 weeks.

When chronic bacterial prostatitis - 28 days.

When gonorrhea the drug is prescribed once in a dose of 800 - 1200 mg or twice a day for 400 mg for 3-5 days.

When acute uncomplicated gonorrhea - once 800 mg.

For prevention of travelers' diarrhea it is recommended to take 400 mg daily for 1 day before departure and during the whole journey time (no more than 21 days).

For prevention of sepsis in neutropenia appoint 400 mg twice a day

When uncomplicated cystitis - 400 mg 2 times in a hurry for 3-7 days.

When infections of the gastrointestinal tract - 400 mg twice a day at for 5 days.

When acute infections of the urinary tract - 400 mg twice a day for 7-10 days.

For prevention of recurrence of urinary tract infections with frequent exacerbations (up to 4-5 times a year), the drug is prescribed 200 mg once a day for a long time.

When chronic recurrent urinary tract infection - by 400 mg per day up to 12 weeks.

Patients with impaired renal function when creatinine clearance of more than 20 ml / min correction dosing regime is not required.

If creatinine clearance less than 20 mL / min (or serum creatinine level above 5 mg / 100ml) and patients on hemodialysis, half the therapeutic dose administered norfloxacin 2 times a day, or one full dose once a day.

Side effects:

From the digestive system: decreased appetite, bitterness in the mouth, nausea, vomiting, abdominal pain, diarrhea, pseudomembranous colitis (with prolonged use), increasing, activity of "liver" enzymes, pain in the rectum or anus, constipation, dyspepsia, flatulence, dryness of the oral mucosa mouth, unformed stool, ulceration of the oral mucosa,itching of the anus, heartburn, stomatitis, dysphagia, hepatitis, jaundice (including cholestatic jaundice), hepatic insufficiency (including fatal outcome), liver necrosis.

From the urinary system: interstitial nephritis, renal failure, crystalluria, glomerulonephritis, dysuria, polyuria, candiduria, albuminuria, cylinduria, hematuria ,, urethral bleeding, hypercreatininemia, renal colic, proteinuria.

From the nervous system: depression, anxiety / nervousness, confusion, irritability, euphoria, nystagmus,disorientation, ringing in the ears, polyneuropathy, Guillain-Barre syndrome, psychotic reactions, convulsions, seizures, tremor, myoclonus, peripheral neuropathy (tingling in the fingers, paresthesia, hypoesthesia), ataxia, confusion, drowsiness, insomnia, headache, , dizziness, fainting, insomnia, hallucinations.

From the side of the heart-cardiovascular system: postural hypotension, myocardial infarction, palpitation, lengthening of the interval Q-T, ventricular arrhythmia, tachycardia such as "pirouette", tachycardia, arrhythmias, lowering of arterial pressure, vasculitis.

Allergic reactions: skin itching, urticaria, edema, malignant exudative erythema (Stevens-Johnson syndrome), anaphylaxis, angioedema, vasculitis, dyspnea, myalgia, photosensitivity, exfoliative dermatitis, erythema polymorph, rash, toxic epidermal necrolysis.

From the musculoskeletal system: arthralgia, myalgia, tendenitis, tendon ruptures, exacerbation of myasthenia gravis gravis, Bursitis, swelling of the hands and feet, arthritis.

From the side of the blood and lymphatic system: eosinophilia, leukopenia, decreased hematocrit, decreased hemoglobin, neutropenia, thrombocytopenia, hyperglycemia, hypercholesterolemia, hyperkalemia, hypertriglyceridemia, prolonged prothrombin time, hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase, agranulocytosis, rise activity creatinine phosphokinase, increased urea concentration in the blood.

From the sense organs: dysgeusia, vision disorders, blurred vision, hearing loss, tinnitus, dipload, increased separation of tear fluid (epiphora).

Other: candidiasis, hyperhidrosis, asthenia, back pain, fever, chills, pain in the chest, dysmenorrhea, edema, pancreatitis, hypoglycemia.

Overdose:

In case of an overdose, the following symptoms may occur:

dizziness, nausea, vomiting, drowsiness,, "cold" sweat, puffy face.

Treatment: gastric lavage, adequate hydration therapy with forced diuresis. It requires a survey and observation in the hospital for several days.

There is no specific antidote.

Interaction:

With the simultaneous use of norfloxacin and theophylline, the concentration of theophylline in the blood plasma should be monitored and its dose adjusted, since norfloxacin reduces the clearance of theophylline by 25%, and the development of corresponding undesirable side effects can occur.

Reduces the effect of nitrofurans.

Norfloxacin can enhance the therapeutic effect of cyclosporine and warfarin. In some cases, with the use of norfloxacin with cyclosporine, an increase in the serum creatinine concentration was observed, therefore, in such patients monitoring of this index is necessary.

The simultaneous use of norfloxacin and antacid agents containing aluminum or magnesium hydroxide, as well as preparations, containing iron, zinc, sucralfate, reduces the absorption of norfloxacin (the interval between their intake should be at least 4 hours).

Simultaneous use with drugs that reduce the convulsive threshold can lead to the development of epileptiform seizures.

Simultaneous reception of norfloxacin with drugs that have the potential to lower blood pressure can cause a sharp decrease in it. In this connection, in such cases, as well as with simultaneous administration with barbiturates and other drugs for general anesthesia should monitor heart rate, blood pressure and ECG parameters.

Norfloxacin reduces hepatic metabolism by inhibiting the isoenzyme CYP1A2, which can lead to an increase in the concentration of its substrates in the blood (including caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine).

Didanosine should be applied 2 hours before or 2 hours after the administration of any fluoroquinolone, because the parallel use of didanosine may reduce the absorption of fluoroquinolones. Simultaneous application of probenecid reduces renal tubular secretion of fluoroquinolones, leading to a decrease in urinary excretion of fluoroquinolones, prolonging the half-life and increasing the risk toxicity.With simultaneous use with hypoglycemic agents, both hypo- and hyperglycemia are possible, and therefore it is necessary to monitor the concentration of glucose in the blood plasma. With simultaneous applications with drugs that extend the interval Q-T, possibly lengthening the latter.

Special instructions:

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

During the period of therapy, an increase in the prothrombin index is possible (during surgical interventions, the state of the blood coagulation system should be monitored).

During treatment with norfloxacin, the effects of direct sunlight.

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

During treatment with norfloxacin, exposure to direct sunlight and other sources of ultraviolet radiation should be avoided. Norfloxacin, like other fluoroquinolones, can cause tendonitis and tendon rupture (risk factors: age over 60 years, glucocorticosteroids, kidney, heart or lung transplantation, increased physical activity, chronic renal failure, tendon damage in history, including rheumatoid arthritis).These phenomena can occur and a few months after completion of the drug. Norfloxacin can reduce the threshold of convulsive readiness and cause seizures, fluoroquinolones can also stimulate the CNS, causing tremors, toxic psychoses, anxiety, confusion and hallucinations, increased intracranial pressure. Norfloxacin may lead to the development of pseudomembranous colitis, caused by Clostridium difficile. In this case, it is necessary to cancel the drug and prescribe the appropriate treatment (use of vancomycin inwards or metronidazole). Norfloxacin can cause peripheral neuropathy (paresthesia, hypoesthesia, dysesthesia, muscle weakness). At the first signs of neuropathy (pain, tingling, numbness or weakness in the extremities, violation of other sensitivities), the drug should be discarded in order to avoid irreversible changes. To avoid the formation of crystals, norfloxacin in the kidney should not exceed the recommended dosage, it is necessary to take the tablets with a sufficient amount of liquid.

Effect on the ability to drive transp. cf. and fur:Care must be taken when driving a car and engaging in other potentially hazardous activities requiring increased concentration of attention and the speed of psychomotor reactions. During the treatment you can not drink alcohol.

Form release / dosage:Tablets, film-coated, 200 and 400 mg.

Packaging:For 10 tablets in a blister of PVC-aluminum foil. By 1, 2,3,4, 5 or 10 plisters together with the instruction for medical use are placed in a cardboard box.

Storage conditions:

In a dry 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 expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001057

Date of registration:24.08.2011

The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India

Manufacturer: & nbsp

SHREYA LIFE SCIENCES, Pvt.Ltd. India

Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Information update date: & nbsp09.08.2015

Illustrated instructions

Instructions

Norfacine (Norfacin)