Antibacterial agents / Antiparasitics / Antiprotozoal / Internal Use

Ornikap 10s 500 mg film-coated tablets

Brands: Nobel AFF (Kazakhstan)

$17.10

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Ornikap 10s 500 mg film-coated tablets quantity

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072f3118a115

Brands:: Nobel AFF (Kazakhstan)

Description

ornikap 250
ornikap 500

Trade name
ornikap 250
ornikap 500

International unlicensed

name Ornidazol Lekarstvennaya
the Tablet form, film coated, 250 mg and 500 mg

Structure
One tablet contains
active agent – ornidazol 250 mg and 500 mg,
excipients: methylhydroxyethylcellulose, starch corn, cellulose microcrystalline PH 102, magnesium stearate.
structure of a cover: Opadry White 02A28361: Gipromelloza (E 464), talc (E 553b), titan dioxide (E 171).

The description
Round tablets, film coated almost white color, with a biconvex surface (for ORNIKAP 250).
Round tablets, film coated white color, with a biconvex surface (for ORNIKAP 500).

Pharmacotherapeutic group
Anti-protozoan drugs. Nitroimidazole derivatives.
The code of automatic telephone exchange P01AB03

the Pharmacological

Ornidazol Pharmacokinetics properties is easily absorbed from digestive tract. Bioavailability – 90%. The maximum concentration in plasma is reached within 2 hours after reception. After oral administration of the maximum daily dose of drug of 1.5 g the concentration of an ornidazol in blood plasma makes 30mg/ml, on the expiration of 24 hours the plasma concentration goes down to 9mg/ml. Linking with blood proteins makes less than 15%.
Ornidazol well gets into all fabrics and liquids of an organism, including cerebrospinal liquid. Biotransformation of an ornidazol occurs in a liver. Elimination half-life of an ornidazol makes 12-14 hours. After single dose of 85% of a dose it is brought out of an organism within 5 days in the form of metabolites. Ornidazol is brought, generally in the form of metabolites by kidneys (63%) and with excrement (22%). Elimination of an ornidazol is possible also with bile.
The pharmacodynamics
of ORNIKAP possesses antibacterial and antiprotozoan action. Interacting with DNA of a microbic cell, causes disturbance of its helical structure, a rupture of threads, suppresses synthesis of nucleic acids and causes death of microbic cells and cells of protozoa.
ORNIKAP is active concerning protozoa:
Trichomonas vaginalis, Entamoeba histolitica, Gardnerella vaginalis. Giardia intestinalis, Lambilia,
concerning anaerobe bacterias: Bacteroides, Clostridium spp., Fusobacterium spp., and also concerning anaerobic cocci: Peptostrepococcus, Peptococcus.

Indications
– trichomoniasis: urinogenital infections women and at men have caused Trichomonas vaginalis (vulvovaginitis, a bartholinitis, a cervicitis, an adnexitis, an urethritis, prostatitis)
– an amebiasis (all intestinal infections, the caused Entamoeba histolytica, including amoebic dysentery and also all not intestinal forms of an amebiasis, in particular, amoebic abscess of a liver)
– a giardiasis (giardiaz)
– the nonspecific vaginitis caused by Gardnerella vaginalis
– prevention of mephitic gangrenes at surgical interventions, especially on a large intestine or bodies of a small pelvis

the Route of administration and doses
the Pill is taken after a meal.
Acute trichomoniasis
the Adult – on 1500 mg (6 tablets ORNIKAPA 250 mg or 3 tablets ORNIKAPA of 500 mg) once in the evening.
Chronic trichomoniasis
the Adult – on 500 mg (on 2 tablets ORNIKAPA of 250 mg or on 1 tablet ORNIKAPA of 500 mg) 2 times a day. A course of treatment – 5 days.
In all cases the sexual partners have to be treated at the same time, accepting an identical dosage, for prevention of reinfection.
Children are more senior than 6 years and teenagers – a therapeutic dose of treatment of acute or chronic trichomoniasis establish at the rate of 25 mg/kg of body weight a day.
Amoebic dysentery
the Adult – at body weight less than 60 kg appoint inside on 1500 mg (6 tablets ORNIKAPA 250 mg or 3 tablets ORNIKAPA of 500 mg) once in the evening. A course of treatment – 3 days,
the Adult – at body weight more than 60 kg 2 times a day appoint inside 1000 mg (on 4 tablets ORNIKAPA of 250 mg or on the 2nd tablet ORNIKAPA of 500 mg). The course of treatment – 3 days,
Children is more senior than 6 years and teenagers – a therapeutic dose establish at the rate of 40 mg/kg of body weight once. Course of treatment – 3 days.
Other forms of an amebiasis:
The adult – on 500 mg (on 2 tablets ORNIKAPA of 250 mg or on 1 tablet ORNIKAPA of 500 mg) 2 times a day. The course of treatment – 5-10 days,
Children is more senior than 6 years and teenagers – a therapeutic dose establish at the rate of 25 mg/kg of body weight once. A course of treatment – 5-10 days.
A giardiasis
the Adult – on 1500 mg (6 tablets ORNIKAPA 250 mg or 3 tablets ORNIKAPA of 500 mg) once in the evening. The course of treatment – 1-2 days,
Children is more senior than 6 years and teenagers – a therapeutic dose establish at the rate of 40 mg/kg of body weight once. A course of treatment – 1-2 days.
A nonspecific vaginitis
the Adult – on 500 mg (2 tablets ORNIKAPA 250 mg or 1 tablet ORNIKAPA of 500 mg) 2 times a day. A course of treatment – 7 days.
Prevention of mephitic gangrenes
by the Adult – before operation inside on 500-1000 mg (2-4 tablets ORNIKAPA 250 mg or 1-2 tablets ORNIKAPA of 500 mg) once, in the postoperative period – inside on 1000 mg (on 4 tablets ORNIKAPA 250 mg or 2 tablets ORNIKAPA of 500 mg) 2 times a day.
A course of treatment – 1-5 days.
Children are more senior than 6 years and teenagers – before operation establish a dose at the rate of 25 mg/kg of body weight once, in the postoperative period – the dose is established at the rate of 25 mg/kg of body weight by 2 times a day.
A course of treatment – 1-5 days.

Side effects
– a headache, drowsiness
– nausea, vomiting
Seldom
– dizziness, a tremor, an ataxy, rigidity, an incoordination of movements, spasms, fatigue, a temporary loss of consciousness
– burning sensation, numbness of extremities, paresthesia, peripheral neuropathy
– disturbances of taste
– skin rash, an itching
– a polyuria (as can partially block receptors to angiotensin II)
– oppression of a leukopoiesis
– increase in activity of liver enzymes (an alaninaminotrasferaza – AlAT and aspartate aminotransferases – AsAT)

Contraindications
– hypersensitivity to drug components
– organic diseases of central nervous system
– pregnancy and the period of a lactation
– children’s age up to 6 years

Medicinal interactions
At combined use ORNIKAPA with other derivatives
5 nitroimidazoles can be observed peripheral neuropathy, a depression and epileptiform spasms.
ORNIKAP does not cause braking of an aldegiddegidrogenaza and therefore does not interact with alcohol.
Simultaneous use of phenobarbital or other drugs which are microsomal fermental drugs reduces a half-life period of an ornidazol in serum.
Inhibitors of microsomal enzymes (Cimetidinum, macroleads, etc.) are increased by a half-life period of an ornidazol in plasma.
Ornidazol strengthens action of anticoagulative means that demands dose adjustment of anticoagulative drugs. The combination of an ornidazol with neurotoxic and gematotoksichny drugs is not recommended.

Special instructions
In trichomoniasis it is necessary to carry out simultaneous treatment of the sexual partner in order to avoid repeated infection.
The feature of influence of medicine on ability to run vehicles and other mechanisms
to the Patients accepting ORNIKAP should show care at management of mechanical means, including the car as ORNIKAP can cause drowsiness, a lack of coordination of movements.

Overdose
Symptoms: strengthening of manifestations of side effects.
Treatment: antidote does not exist, carry out symptomatic therapy, in spasms appoint diazepam.

The form of release and packing
On 10 (for a dosage of 250 mg) or 5 (for a dosage of 500 mg) tablets place in blister strip packaging from an opaque film of polyvinylchloride and printing aluminum foil.
On 1 or 2 (for a dosage of 250 mg) or 2 or 4 (for a dosage of 500 mg) planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.

To Store storage conditions at a temperature not over 25 of 0C, in the dry, protected from light place.
To store out of children’s reach!

A period of storage
2 years
not to apply after the storage expiration

Prescription status
According to the prescription

Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,
Almaty, Shevchenko St. 162 E.

The owner of the registration certificate
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
the Republic of Kazakhstan

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Additional information