Metronidazole-Asteria 500mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metronidazole

Available from:

Hankook Korus Pharm Co.

ATC code:

P01AB01

INN (International Name):

metronidazole

Dosage:

500mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) and (100/10x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-10-28

Summary of Product characteristics

Summary of Product Characteristics insert company logo
1. NAME OF THE MEDICINAL PRODUCT
Metronidazole-Asteria Tab. 500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/g
Use
1
Metronidazole
500mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Magnesium stearate
5.0mg
Lubricant
2
Sodium
carboxylmethylstarch
5.0mg
Disintegrant
3
20% starch dextrin
36mg
Adherent
4
Pregelatinized starch
20 mg
Diluent/Dinste
grant
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic Trichomoniasis: Metronidazole is indicated for the
treatment of symptomatic
trichomoniasis in females and males when the presence of the
trichomonad has been confirmed
by appropriate laboratory procedures (wet smears and/or cultures).
Summary of Product Characteristics insert company logo
Asymptomatic Trichomoniasis: Metronidazole is indicated in the
treatment of asymptomatic
females when the organism is associated with endocervicitis,
cervicitis, or cervical erosion.
Since there is evidence that presence of the trichomonad can interfere
with accurate assessment
of abnormal cytological smears, additional smears should be performed
after eradication of the
parasite.
Treatment of Asymptomatic Consorts: T. vaginalis infection is a
venereal disease. Therefore,
asymptomatic sexual partners of treated patients should be treated
simultaneously if the
organism has been found to be present, in the order to prevent
reinfection of the partner. The
decision as to whether to treat an asymptomatic male partner who has a
negative culture or one
for whom no culture has been attempted is an individual one. In making
this decision, it should
be noted that there is evidence that a woman may become reinfected if
her consort is not
treated. Also, since there can be considerable difficulty in isolating
the organism from the
asymptomatic male carrier, negative smears and cultures cannot be
relied upon in this regard.
In any event, the consort should be treated with Metronida