Antibacterial agents / Antiparasitics / Antiprotozoal / Internal Use

Naksodzhin 500 mg (6 tablets)

Brands: Pfizer Italia S.r.L. (Italy)

$31.20

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Naksodzhin 500 mg (6 tablets) quantity

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1d0c48fbf84b

Brands:: Pfizer Italia S.r.L. (Italy)

Description

The instruction for medical use

of Naksodzhin® medicine

the Trade name
of Naksodzhin®

the International unlicensed

name Nimorazol Lekarstvennaya a form
of the Tablet of 500 mg

Structure
One tablet contains
active agent – nimorazol 500 mg,
excipients: microcrystalline cellulose, starch corn, methyl cellulose 400, stearic acid

the Description
Round convex tablets from white till slightly yellowish color with risky on one party

Pharmacotherapeutic group
Anti-protozoan drugs. Drugs for treatment of an amebiasis and other protozoan infections. Nitroimidazole derivatives. Nimorazol.
The ATX P01AB06 code

the Pharmacological

Nimorazol Pharmacokinetics properties is well soaked up in digestive tract. After reception of a dose equal of 2 g (with meal) higher concentration in blood in comparison with the minimum overwhelming concentration of 1.6 mkg/ml (from 0.3 to 3 mkg/ml) in 30 minutes and till 24-48 o’clock after administration of drug was found.
The maximum concentration in blood plasma is reached in 1-2 h, and elimination half-life makes 3.15 hours.
Nimorazol is metabolized in a liver with formation of active metabolites. In 24 hours of 15% of the accepted dose it is removed by kidneys (in not changed look and in the form of metabolites). High concentrations are also found in vaginal and salivary secrets.
A pharmacodynamics
of Naksodzhin® – the antiprotozoan means derivative of a nitroimidazole. The mechanism of action is connected with recovery of amine group of a nitroimidazolny ring the systems of transfer of electrons with very low redox potential. The Nitroimidazolny ring restored thus changes the DNA functions and the reproductive system of bacteria. This effect amplifies and extended with active metabolites of Naksodzhina®. Spectrum of action: Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia and sensitive gram-negative anaerobic bacteria (Fusobacteria, Bacteroides, Clostridia, etc.). Candida albicans is resistant to drug.

Indications
– the infections caused by Trichomonas vaginalis
– a giardiasis
– an amebiasis of intestines or liver
– an acute ulcer and necrotic ulitis (Vincent’s ulitis)

the Route of administration and doses
Trichomoniasis
Adults: a single dose – 2 g (4 tablets) in one step after the main meal, therapy within 24 hours: the divided dose on 1 g (2 tablets) is accepted 3 times with an interval between receptions of 12 hours (on 2 tablets before going to bed, next day in the morning 2 tablets and 2 tablets before going to bed), or 250 mg (1/2 tablets) three times a day within 5-7 days.
Children are more senior than 12 years: a dose 15мг/кг/сутки, divided into three receptions within 5-7 days
the Amebiasis of intestines or liver
Adults: 1 g (2 tablets) twice a day within 5-10 days.
Children are more senior than 12 years: a dose 20mg/kg/day, divided into 2 receptions within 5-10 days
the Giardiasis
Adults: 500 mg (1 tablet) twice a day within 5-7 days
Children are more senior than 12 years: a dose 15mg/kg/day, divided into 2 receptions within 5-7 days
the Acute ulcer and necrotic ulitis (Vincent’s ulitis)
Adults: 500 mg (1 tablet) twice a day within two days.

Side effects
Usually Naksogin ® is well had.
– drowsiness, a headache, dizziness, a taste perversion / metal smack
– a leukopenia
– dryness in a mouth, a coated tongue, a glossitis, stomatitis, dyspepsia, nausea, vomiting, diarrhea, pain in epigastriums, anorexia
– anaphylactic reactions, urticaria, skin rash, an itching
– an urethralgia, a chromaturia, urethral discomfort
– an abnormal liver function
– paresthesias, an ataxy and spasms
– exacerbation of mental diseases (irritability, a depression, insomnia)
– vulvovaginal candidiasis
Are available rare messages about pseudomembranous colitis at intake of metronidazole (initial component). Also at intake of metronidazole it was reported about cases of the peripheral neuropathy which is shown in the form of numbness, pricking of extremities, epileptic seizures, generally in connection with use of high dosages.

Contraindications
– hypersensitivity to derivatives of a nitroimidazole and auxiliary components of drug
– organic lesions of the central nervous system, including epilepsy
– disturbances of a hemopoiesis with the expressed leukopenia
– a heavy liver and renal failure
– pregnancy, the lactation period
– the children’s and teenage age up to 12 years

Medicinal interactions
At a concomitant use with Naksodzhin® alcohol can cause disulfirampodobny reaction.
At a concomitant use the anti-coagulating effect of warfarin and coumarin can amplify, the clearance of Phenytoinum and a lity can decrease. If therapy is at the same time performed by anticoagulants, then it is necessary to check often INR (the international normalized relation).
Phenobarbital can lower, and Cimetidinum to increase concentration of a nimorazol in plasma.

Special instructions
At treatment of trichomoniasis for avoidance of a reinfitsirovaniye, treatment of both sexual partners, even has to be carried out at the same time in case one of them has no disease symptoms.
It is necessary to avoid intake of alcoholic beverages during and 48 hours later after reception of Naksodzhina®.
Patients with acute neurologic diseases have to undergo treatment under strict observation of the doctor.
At patients with abnormal liver functions or kidneys the dose has to be selected individually depending on weight of disturbance.
Considering a possibility of development of a leukopenia, at long therapy (especially at therapy in connection with a recurrence) it is necessary to define quantity of leukocytes.
In case of candidiasis, it is necessary to begin the corresponding accompanying treatment.
Pregnancy and a lactation
Drug is contraindicated at pregnancy (especially in the first trimester) and lactations because of possible manifestation of mutagen properties.
Features of influence of medicine on ability to drive the car or potentially dangerous mechanisms
no researches on studying impact of drug on ability of control of transport or use of the equipment were conducted. However, considering side effects of drug (drowsiness, dizziness, etc.), it is necessary to refrain from control of motor transport and other potentially dangerous mechanisms.

Overdose
Symptoms: gastrointestinal disturbances which are followed by vomiting, dizziness, neurologic manifestations (numbness, pricking, paresthesia, ataxy or spasms).
Treatment: gastric lavage, symptomatic therapy.

A form of release and packing
On 6 tablets in a bottle of amber ΙII glass with the screw-on aluminum cover, from outer side white varnished, and polyethylene laying.
On 1 bottle together with the instruction for use in the state and Russian languages place in a cardboard pack.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

Not to use a period of storage of 5 years after the expiration date specified on packing.

Prescription status
According to the prescription

the Producer and the packer
Pfizer Italy Neuter of l.,
Lokalita Marino del Tronto
63100 Askoli Picheno, Italy

the Owner of the registration certificate
of Pfizer HCP Corporation, the USA

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of this product: Representative office of Pfizer HCP Corporation (USA) Almaty, Abylay Ave. of the khan, 141 ph. (727) 272-27-01факс (727) 272-04-06

Additional information