Septrin

1. Name of the medicinal product :

Septrin 80 mg/400 mg Tablets

2. Qualitative and quantitative : composition

Each tablet contains 400 mg Sulfamethoxazole and 80 mg Trimethoprim

3. Pharmaceutical form :

Tablets

White, round, biconvex tablets, debossed with "S2" on one side with scoreline on the other side.

4. Clinical particulars :

4.1 Therapeutic indications

Septrin tablets are indicated for the treatment of the following infections when owing to sensitive organisms

Treatment and prevention of Pneumocystis jiroveci (P. carinii) pneumonitis.

Treatment and prophylaxis of toxoplasmosis

Treatment of nocardiosis.

The following infections may be treated with Septrin where there is bacterial evidence of sensitivity to Septrin and good reason to prefer the combination of antibiotics in Septrin to a single antibiotic:

1▪ Acute uncomplicated urinary tract infection

2▪ Acute otitis media

3▪ Acute exacerbation of chronic bronchitis

4▪ Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Method of administration: oral

It may be preferable to take Septrin with some food or drink to minimise the possibility of gastrointestinal disturbances.

Standard dosage recommendations for acute infections

Adults and children over 12 years:

Tablets

2 every 12 hours

This dosage approximates to 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per 24 hours.

Treatment should be continued until the patient has been symptom free for two days; the majority will require treatment for at least 5 days. If clinical improvement is not evident after 7 days therapy, the patient should be reassessed.

As an alternative to Standard Dosage for acute uncomplicated lower urinary tract infections, short-term therapy of 1 to 3 days duration has been shown to be effective.

The elderly:

See Special Warnings and Precautions for Use. Unless otherwise specified standard dosage applies.

☆☆Impaired hepatic function:

No data are available relating to dosage in patients with impaired hepatic function.

☆☆ Special Dosage Recommendations

(Standard dosage applies unless otherwise specified)

♧♧-Where dosage is expressed as "tablets" this refers to the adult tablet, i.e. 80 mg Trimethoprim BP and 400 mg Sulfamethoxazole BP. If other formulations are to be used appropriate adjustment should be made.

**Impaired renal function:

Adults and children over 12 years (no information is available for children under 12 years of age):

☆☆-Creatinine Clearance (ml/min)

●●-Recommended Dosage

>30

@@-STANDARD DOSAGE

15 to 30

@@-Half the STANDARD DOSAGE

<15

~~Not recommended

Measurements of plasma concentration of sulfamethoxazole at intervals of 2 to 3 days are recommended in samples obtained 12 hours after administration of Septrin. If the concentration of total sulfamethoxazole exceeds 150 microgram/ml then treatment should be interrupted until the value falls below 120 microgram/ml.

Pneumocystis jiroveci (P.carinii) pneumonitis:

~~Treatment:
        A higher dosage is recommended, using 20 mg trimethoprim and 100 mg sulfamethoxazole per kg of body weight per day in two or more divided doses for two weeks. The aim is to obtain peak plasma or serum levels of trimethoprim of greater than or equal to 5 microgram/ml (verified in patients receiving 1-hour infusions of intravenous Septrin). (See 4.8 Undesirable Effects).