Sclerosol

Sclerosing Agents

Intrapleural Administration
Sterile talc powder is indicated for pleurodesis only and is administered intrapleurally; it is NOT for IV administration.
Administer after adequate drainage of the pleural effusion or air.
Follow the manufacuturer's "Instructions for preparation and administration", depending on clinical indication for use.

acute respiratory distress syndrome (ARDS) / Early / Incidence not known

dyspnea / Early / 5.0-10.0
costovertebral pain / Delayed / 10.0
bleeding / Early / Incidence not known
pneumonitis / Delayed / Incidence not known

fever / Early / 10.0
infection / Delayed / Incidence not known

Sclerosol, STERITALC

Rx

Sterile intrapleural agent containing 95% or more of magnesium silicate; do not confuse sterile talc with 'talcum powder' which is a lay term that refers to various types of dusting powder
Primarily used to decrease the recurrence of malignant pleural effusions in symptomatic adults following maximal drainage of the pleural effusion; also used in adults to to decrease the recurrence of pneumothorax
Lead is present in sterile talc as an impurity and the product is contraindicated for use during pregnancy due to the potential for fetal harm and potential loss of pregnancy

The recommended dose is 2 to 5 grams administered intrapleurally. Do not exceed a total cumulative dosage of 10 grams per procedure.

The recommended dose is 2 grams administered intrapleurally. According to physician's discretion and in consideration of diagnosis and patient's condition, different dosages may be applied, but a cumulative dosage of 10 grams should not be exceeded.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Talc, Magnesium Silicate products.

Sclerosol Intrapleural Aer: 4g
STERITALC/Talc Intrapleural Pwd: 2g, 3g, 4g

Do not exceed 10 grams intrapleurally per procedure.

Do not exceed 10 grams intrapleurally per procedure.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Talc instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura to prevent reaccumulation of pleural air or fluid.

Talc, magnesium silicate is administered intrapleurally. The amount of systemic absorption after intrapleural administration is not known; however, the systemic exposure of talc could be affected by the integrity of the visceral pleura and could be increased if administered immediately following biopsy or lung resection. Data from animals indicated that the use of specific, size-calibrated talc products seems to correlate with the likeliness of systemic talc exposure and its potential risks; larger-size talc particles are less likely to induce systemic reactions. Additional pharmacokinetic data are not available.

Sterile talc intrapleural instillation is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy. Exposure of a pregnant woman to lead may cause miscarriage, premature birth, lower birth weights and slow or impaired mental development in the child. Administration of the SteriTalc product at the highest recommended dose of 10 grams may deliver up to 40 mcg of lead.

Breast-feeding should be avoided during treatment with sterile talc and for 5 months after the final intrapleural dose. There is no information regarding the presence of sterile talc in human milk, the effects on the breastfed infant, or the effects on milk production following intrapleural instillation of the drug. SteriTalc contains lead, which is known to have adverse effects on health and development in exposed pediatric patients.