Sclerosol

Generic name:sterile talc
Dosage form: aerosol, powder
Drug class:Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

For Intrapleural Administration Only

Shake Well Immediately Before Using

DESCRIPTION

Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery nozzles of 15 cm and 25 cm in length. Each canister contains 4 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate. The empirical formula is Mg3Si4O10(OH)2 with molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonite), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water, and in dilute solutions of acids and alkali hydroxides. The canister and delivery nozzles have been sterilized by gamma irradiation. The aerosol propellant contained in Sclerosol® Intrapleural Aerosol is 1,1,1,2-Tetrafluoroethane (HFA-134a) with 25 g present per canister. The canister delivers 1.2 g of talc per second through the valve and the product contains no other excipients.

CLINICAL PHARMACOLOGY

Mechanism of Action:

The therapeutic action of talc instilled into the pleural cavity is thought to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral to the parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. The extent of talc systemically absorbed after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the visceral pleura, and therefore could be increased if talc is administered immediately following lung resection or biopsy.

CLINICAL STUDIES

The data demonstrating safety and efficacy of talc in the treatment of malignant pleural effusions are de...