Amoxicillin-Asteria Cap. 500mg capsules hard

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

amoxicillin (amoxicillin trihydrate)

Доступна с:

Hankook Korus Pharm Co.

код АТС:

J01CA04

ИНН (Международная Имя):

amoxicillin (amoxicillin trihydrate)

дозировка:

500mg

Фармацевтическая форма:

capsules hard

Штук в упаковке:

(100/10x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2020-11-18

Характеристики продукта

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Amoxicillin-Asteria Cap. 500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/ vial
Use
1
Amoxicillin
500.0mg(potency)
Active ingredient
Excipient(s)
No.
Chemical Name
Quantity/vial
Use
1
Anhydrous Lactose
23.0mg
Inactive
ingredient
2
Magnesium stearate
9.3mg
Inactive
ingredient
3. PHARMACEUTICAL FORM
Hard capsule
Red cap and yellow body containing white powder
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Amoxicillin is indicated for the treatment of the following infections
in adults and children :
• Acute bacterial sinusitis
• Acute otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic bacteriuria in pregnancy
• Acute pyelonephritis
• Typhoid and paratyphoid fever
• Dental abscess with spreading cellulitis
• Prosthetic joint infections
• Helicobacter pylori eradication
• Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dose of Amoxicillin that is selected to treat an individual
infection should take into
account:
• The expected pathogens and their likely susceptibility to
antibacterial agents
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection
and the response of the
patient, and should generally be as short as possible. Some infections
require longer periods of
treatment.
Adults and children ≥40 kg
Indication*
Dose*
Acute bacterial sinusitis
250 mg to 500 mg every 8 hours or 750 mg to 1 g
every 12 hours
For severe infections 750 mg to 1 g every 8 hours
Acute cystitis may be treated with 3 g twice
daily for one day
Asymptomatic bacteriuria