Metronidazole-Asteria tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

metronidazole

Доступна с:

Hankook Korus Pharm Co.

код АТС:

J01XD01

ИНН (Международная Имя):

metronidazole

дозировка:

500mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(30/3x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2020-04-15

тонкая брошюра

&
120*256
DIC 433p
Store in hermetic container at temperature below 25℃. Protect from
moisture. Keep out of reach of children.
Known hypersensitivity to nitroimidazoles, metronidazole or to any of
the excipients.
• Pregnancy - metronidazole should not be used in the first
trimester in patients with trichomoniasis or bacterial vaginosis.
• Breast feeding should be discontinued for 12-24 hours when single
high dose (e.g. 2g) therapy is used.
Frequency type and severity of adverse reactions in children are the
same as in adults. The frequency of adverse events listed below is
defined using the following convention: very common (≥
1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <
1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not
known (cannot be estimated from the available data). Serious
adverse reactions occur rarely with standard recommended regimens.
Frequency, type and severity of adverse reactions in children are the
same as in adults. Clinicians who contemplate continuous
therapy for the relief of chronic conditions, for periods longer than
those recommended, are advised to consider the possible therapeutic
benefit against the risk of peripheral neuropathy.
Interactions to be used with caution:
•
_Lithium:_
Lithium retention accompanied by evidence of possible renal damage has
been reported in patients treated simultaneously with lithium and
metronidazole. Lithium treatment should be
tapered or withdrawn before administering metronidazole. Plasma
concentration of lithium, creatinine, and electrolytes should be
monitored in patients under treatment with lithium while they
receive metronidazole.
•
_Anticoagulants: _
Some potentiation of anticoagulant therapy has been reported when
metronidazole has been used with the warfarin type oral
anticoagulants. Dosage of the latter may require
reducing. Prothrombin times should be monitored. No interactions have
been reported with anticoagulants of the heparin type. However,
anticoagulant activity should be routinely monitored

Характеристики продукта

Summary of Product Characteristics
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).
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 Metronidazole in cases
of reinfection.
Amebiasis: Metronidazole is indicated in the