NIKSON  1g

Trade name: NIKSON

International nonproprietary name: Cefotaxime

Dosage band:

Dry substance for injections in vials; ampoule with dissolvent.

Formula:

One vial contains 1g of cefotaxime for mixing solutions for intramuscular and intravenous injections;

1 ampoule of solution for intramuscular injections contains 3,5ml of 1% lidocaine solution.

Pharmacological action:

NIKSON- is a semi-synthetic antibiotic of III generation- cephalosporin group for parenteral administration. Nikson is bactericidal in its mode of action. It possesses a broad spectrum of activity.

Indications:

Nikson is effective in severe and moderate bacterial infections:

-         lower respiratory tract infections (pneumonia, lung abscess, empyema);

-         urinary tract infections;

-         septemia;

-         bacteremia;

-         intra-abdominal infections (including peritonitis);

-         central nervous system infections (including meningitis, except for listeric meningitis);

-         skin and soft tissues infections;

-         bones and joints infections;

-         prophylaxis of infectious complications after gastrointestinal, urological and obstetric-gynecologic operations.

Dosage and method of application:

NIKSON is injected intramuscularly or intravenously, depending on the severity of patient’s condition and preparation dosage.

Adults and children with body weight more than 50kg: in urinary tract infections and other uncomplicated infections 1g i/m or i/v every 12 hours. In moderate infections- 1-2g i/m or i/v every 12 hours. In severe infections (for e.g. bacterial meningitis) single and daily dose are increased: 2g intravenously every 6-8 hours in average. Maximal daily dose for adults comprises 12g, it is divided into 4 daily infections and is injected intravenously. The duration of treatment course is set individually.

For premature infants and newborns (under 1 week of age) daily dose comprises 50mg/kg and is divided in 2 i/v injections.

For infants of 2-4 weeks of age daily dose comprises 50-100 mg/kg and is divided in 3 i/v injections.

To children with body weight less than 50kg the preparation is injected i/v or i/m in the daily dose of 50-100 mg/kg and divided in 3-4 injections.

In bacterial meningitis and other severe infections in children, daily dose is doubled and divided in 4 daily injections. The duration of treatment course is set individually.

In gonorrhea (uncomplicated)- single i/m 500mg injection of NIKSON. In disseminated gonococcal infection 3 i/v injections daily: adults- 1g, children- 25-50mg/kg daily during not less than 7 days (in meningitis- 10-14 days).

For prophylaxis of post surgical complication 1 g of NIKSON is injected once before the operation during anesthetic induction. If necessary the injection is repeated in 6-12 hours.

In kidney insufficiency daily dose is reduced twice only in creatinine clearance of less than 10ml/min. 

Method and duration of application:

For i/v injections: dissolve 1g of preparation in 4ml, 2g in 10ml in water for injections. The solution is administered slowly during 3-5 minutes.

Higher doses of NIKSON are injected in the form of intravenous infusion: 2g of NIKSON is dissolved in 40-100 ml of water for injections or other solution for infusions (except for sodium bicarbonate).

Short infusion (2g in 40ml) is conducted during 20 minutes. Longer infusion (2g in 100ml of isotonic solution of sodium chloride or of 5% dextrose) is conducted during 50-60 minutes.

For i/m injections Nikson can be dissolved in the water for injections or in 1% lidocaine solution.

The duration of treatment course is set individually.

Side effects:

Hemocytogenesis- thrombocytopenia, leucopenia, neutropenia, agranulocytosis, eosinophilia, in single cases- hemolytic anemia.

Gastrointestinal tract and liver: sickness, vomiting, stomach aches, diarrhea, pseudomembranous colitis, increase of “liver” transaminases.

Allergic reactions: hives, allergic dermatitis, itching, bronchospasm, rarely- anaphylactic shock.

Central nervous system: encephalopathy (in injection of the preparation in high doses, especially in patients with liver insufficiency).

Local reactions: pain in the site of injection (in i/m administration).

Contraindications:

- hypersensitivity to cephalosporins;

For solution containing lidocaine (in intramuscular injection of Nikson):

-         hypersensitivity to lidocaine;

-         intracardial block without fixed pacemaker;

-         severe heart failure;

-         intravenous injection;

-         infancy under 2,5 years of age;

Warnings and precaution measures:

Patients with allergy to penicillin in history should use the preparation with care, as there is polyvalent allergy between penicillins and cephalosporins. During the first week of treatment there is a risk of pseudomembranous colitis, expressed by long-lasting diarrhea. The diagnosis is proved by colonoscopy. Such complication is treated as serious; the injection of NIKSON should be immediately cancelled and appropriate therapy is prescribed, including vancomycin and metronidazole.

In pregnancy NIKSON is prescribed only in cases of absolute necessity.

In necessity of prescription the preparation to a breast-feeding mother, lactation should be stopped as NIKSON penetrates into the breast milk.

In simultaneous administration of the preparation with aminoglycoside antibiotics and diuretics, kidney function should be controlled (danger of nephrotoxic action of the latter).

Development of a positive Coombs’test may occur during treatment.

In case of using lidocaine solution as a dissolvent, intravenous injection is strictly CONTRAINDICATED!

Overdosage:

Symptoms- there is a risk of reversible metabolic encephalopathy.

Treatment should be symptomatic. There is no specific antidote.

Drug interaction and other forms of interaction:

NIKSON solution is incompatible with another antibiotic in the same syringe or instillator.

In simultaneous administration NIKSON can potentiate toxic effect of preparations with nephrotoxic action.

Form of issue:

Powder for mixing solution for injections in vials, 1g.

1 ampoule, containing 3,5ml of 1% lidocaine solution.

Storage conditions:

Should be stored under the temperature of 25˚С and less, in the dark place.

Keep out of reach of children.

Conditions of delivery at chemistry stores:

Delivered according to prescription.

Expiry period: Printed on the package. Do not use the preparation after the expiry date!