SURAXIM Capsules 400 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Cefixime

Available from:

UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY, JORDAN

ATC code:

Other beta-lactam antibacterials

INN (International Name):

Cefixime

Dosage:

400 mg

Pharmaceutical form:

Capsules

Manufactured by:

The United Pharmaceuticals Mfg. Co. Ltd., JORDAN

Product summary:

Physical description: Purple opaque cap and white opaque body size 0 hard gelatin capsules containing off white to yellowish powder; Local technical representative: Gama Pharmaceutical Company Ltd (7245)

Authorization status:

Registered/Compliant

Authorization date:

2022-01-10

Summary of Product characteristics

1
. NAME OF THE MEDICINAL PRODUCT
Suraxim® 400 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cefixime Trihydrate 448.0 mg equivalent to
Cefixime 400 mg.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Dosage Form: Capsules
Suraxim® 400 mg Capsules Description: Purple Opaque cap and white
opaque body,
size 0’ hard gelatin capsules, containing off-white to yellowish
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
SURAXIM® is indicated in the treatment of the following:
Pharyngitis, tonsillitis and sinusitis.
Acute bronchitis and acute exacerbations of chronic bronchitis.
Otitis media.
Uncomplicated urinary tract infections.
Uncomplicated urethral or cervical gonorrhea.
Bacterial gastroenteritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The recommended dose of SURAXIM® is 400 mg daily. This may be given
as a 400 mg
capsule once daily, or as a 200 mg capsule every 1 2 hours.
For the treatment of uncomplicated urethral or cervical gonococcal
infections, a single
oral dose of 400 mg is recommended.
The usual course of treatment is 7 days. This may be continued for up
to 14 days if
required.
Children:
Cefixime 400 mg is not recommended for use in children under 10 years
old. The safety
and efficacy of Cefixime has not been established in children less
than 6 months.
Children weight more than 50 kg or older than 12 years should be
treated with the
recommended adult dose.
Renal impairment
SURAXIM® may be administered in the presence of impaired renal
function as follows:
Creatinine clearance
Dose
≥ 60 ml/min Standard dose (400 mg daily)
21 -60 ml/mm
75% of the standard dose (300 mg daily)
≤ 20 ml/min Half the standard dose (200 mg daily)
4.3 CONTRAINDICATIONS
Cefixime is contraindicated in patients with known allergy to
cephalosporin group of
antibiotics.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before therapy with cefixime is instituted, careful inquiry should be
made to determine
whether the patient has had previous hypersensitivity