TOLISCRIN ®
Capsules, Inhalation powder
Colistimethate Sodium 1.662.500 UI

 

                     Argentine Industry                                                              Dispense under prescription

 

Quali-Quantitative Formula

Each TOLISCRIN ® capsule of inhalation powder contains:

Colistimethate sodium      1.662.50

Therapeutic Action

Antibacterial, antibiotic polymyxin group derivative from Bacillus polymyxa var derivative. colistinus.

Indication

TOLISCRIN® capsules, inhalation powder is indicated for inhalation therapy of pulmonary Pseudomonas aeruginosa infection in adult patients or children over 6 years of age with cystic fibrosis (CF).

Pharmacological Properties

Colistimethate sodium is a cyclic polypeptide antibacterial derivative from Bacillus polymyxa var. colistinus and belongs to the polymyxin group. Polymyxins act by damaging the cell membrane and the resulting physiological effects are lethal to bacteria. Polymyxins are selective for Gram negative bacteria, having a hydrophobic outer membrane.

Dosage and administration

Dosage

The first dose should be administered under medical supervision.
The efficiency of colistimethate sodium capsules, inhalation powder has been demonstrated in a study of 24 weeks duration. Treatment should be continued for as long as the physician considers the patient is gaining clinical benefit.

Adults and children over 6 years of age:

One capsule of TOLISCRIN® CAPSULES, INHALATION POWDER should be inhaled two times per day.
The dose interval should be as close as possible to 12 hours.

Administration Method

For use only by inhalation. TOLISCRIN® CAPSULES, INHALATION POWDER should only be used with a suitable inhaler.

Special precautions for storage

Store below 25 ° C.
Store in the primary packaging until use to protect from humidity.

Presentation:

Package containing 60 capsules and dry powder inhaler device.
The capsules are packed in aluminum blisters as primary packaging.

Each kit contains 6 blisters of 10 capsules each, sufficient for 30 days of treatment. 

KEEP OUT OF THE REACH OF CHILDREN

Information for the patient

"If any inconvenience is presented with the product, the patient can fill the sheet provided on the website of ANMAT: http://www.anmat.gov.ar/farmacovigilancia/Notificar.asp or call ANMAT, which responds to 0800-333 -1234 ".

Medicinal product authorized by the Ministry of Health.
Certificate Nº  55.633

Manufactured in Laboratorio DOSA S.A.
1369 Girardot St. – (C1427AKC) Buenos Aires
Pharmaceutical director: María Cecilia Terzo, Pharmacist