THEOMOX-250 Tablets

Pays: Tanzanie

Langue: anglais

Source: Tanzania Medicinces & Medical Devices Authority

Ingrédients actifs:

Amoxicillin

Disponible depuis:

THEON PHARMACEUTICALS LIMITED, INDIA

Code ATC:

Antibacterials for systemic use, beta-lactam anti

DCI (Dénomination commune internationale):

Amoxicillin

Dosage:

250

forme pharmaceutique:

Tablets

Fabriqué par:

theon pharmaceuticals limited, INDIA

Descriptif du produit:

Physical description: Each hard gelatin capsule has maroon color cap and yellow color body; size ‘2’ having white granular powder; Local technical representative: Heko Pharmacy Limited (7718)

Statut de autorisation:

Registered/Compliant

Date de l'autorisation:

2021-08-20

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Amoxicillin Capsules USP 250 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains:
Amoxicillin Trihydrate USP
eq. to Amoxicillin.
250 mg
.........
Excipients
q.s.
.......................
Approved colour used in capsule shells
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solid Dosage form, hard gelatin capsules
Each hard gelatin capsule shell having maroon color cap and yellow
color body,
size “2” filled with off white powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The treatment of bacterial infections caused by
amoxicillin-susceptible organisms.
It is principally indicated for respiratory, middle ear and urinary
tract infections.
•
Respiratory tract - pneumonia, acute and chronic bronchitis, upper
respiratory tract infections
•
Chronic bronchial sepsis
•
Lobar and bronchopneumonia
•
ENT - otitis media
•
Urinary tract - cystitis, urethritis, pyelonephritis
•
Biliary and intra-abdominal infections
•
Bacteriuria in pregnancy
•
Gynaecological infections including puerperal sepsis and septic
abortion
•
Gonorrhoea
•
Peritonitis
•
Intra-abdominal sepsis
•
Septicaemia
•
Bacterial endocarditis
•
Skin and soft tissue infections
•
Osteomyelitis
•
Meningitis
•
Enteric fevers (typhoid and paratyphoid fevers)
•
Dental abscess (as an adjunct to surgical management)
•
In children with urinary tract infection the need for investigation
should
be considered.
Prophylaxis of endocarditis: The prevention of bacteraemia, associated
with
procedures (e.g. dental), in patients at risk of developing bacterial
endocarditis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment of Infection:
Adult dosage (including elderly patients):
Standard adult dosage: 250mg every 8 hours, increasing to 500mg every
8 hours in
severe infections.
High
dosage
therapy
(maximum
recommended
oral
dosage
6 g daily in
divided doses): A dosage of 3 g twice daily is recommended in
app