Pleurodesis (chemical)
Background
| Source: https://en.wikipedia.org/wiki/Pleurodesis (direct quotes) . Pleurodesis is a medical procedure in which the pleural space is artificially obliterated. It involves the adhesion of the two pleurae. Pleurodesis is performed to prevent recurrence of pneumothorax or recurrent pleural effusion. It can be done chemically or surgically. It is generally avoided in patients with cystic fibrosis, if possible, because lung transplantation becomes more difficult following this procedure.Previous pneumothorax with or without pleurodesis is not a contraindication to subsequent lung transplantation. Chemical Chemicals such as bleomycin, tetracycline e.g. minocycline, povidone iodine, or a slurry of talc can be introduced into the pleural space through a chest drain. The instilled chemicals cause irritation between the parietal and the visceral layers of the pleura which closes off the space between them and prevents further fluid from accumulating. Pharmacy-prepared chemicals for pleurodesis should be clearly labeled "NOT FOR IV ADMINISTRATION" to avoid potentially fatal wrong-site medication errors. Povidone iodine is equally effective and safe as talc, and may be preferred because of easy availability and low cost. Chemical pleurodesis is a painful procedure, and so patients are often premedicated with a sedative and analgesics. A local anesthetic may be instilled into the pleural space, or an epidural catheter may be placed for anesthesia. Used to manage:
|
sterile talc
Talc use in pleurodesis:
Usual dose: (Sterile powder used to prepare a slurry):
------------------------------- Additional actions:
|
doxycycline
| Doxycycline use in pleurodesis: Key points:
------------------------------ ------ Source: Robinson LA, Fleming WH, Galbraith TA. Intrapleural doxycycline control of malignant pleural effusions. Ann Thorac Surg. 1993 May;55(5):1115-21; discussion 1121-2. |
sclerosol® intrapleural aerosol (sterile talc powder 4 g)
| 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. Mechanism of Action: INDICATIONS AND USAGE CONTRAINDICATIONS WARNINGS PRECAUTIONS 2) Use in potentially curable disease. Talc has no known antineoplastic activity and should not be used for potentially curable malignancies where systemic therapy would be more appropriate, e.g., a malignant effusion secondary to a potentially curable lymphoma. 3) Potential pulmonary complications. Acute pneumonitis or acute respiratory distress syndrome (ARDS) have rarely been reported in association with intrapleural talc administration. Whether these were causally related to talc is unclear. In none of the reported cases was talc applied thoracoscopically or by insufflation. Three of four case reports of ARDS have occurred after treatment with 10 g of talc administered via intrapleural chest tube instillation. One patient died one month post treatment and two patients recovered without further sequelae. Intravenous administration of talc is a well-recognized cause of pulmonary hypertension and pulmonary lung parenchymal disease, but these complications have not been reported after intrapleural administration. Pulmonary diseases, e.g., silicosis or asbestosis-like diseases, chronic bronchitis, bronchogenic carcinoma, and pleural plaques have been reported in association with inhaled talc. 4) Contents under pressure. The contents of the Sclerosol® Intrapleural Aerosol (sterile talc powder) canister are under pressure. The canister must not be punctured and should not be used or stored near heat or open flame. Drug Interactions: It is not known whether the effectiveness of a second sclerosing agent after prior talc pleurodesis would be diminished by the absorptive properties of talc. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on the carcinogenicity of talc have been performed using non-standard designs in which talc and its asbestos content were not fully characterized, preventing firm conclusions on its carcinogenicity. Tumor incidence in rats was not increased following either a single 20 mg injection with a 6 month recovery period or weekly injections of 25 mg for 4 weeks with an 84-week recovery period. Genotoxicity was assessed in cultures of rat pleural mesothelial cells (RPMC), as unscheduled DNA syntheses (UDS) and sister chromatid exchanges (SCEs). Asbestos-free talc was negative for genotoxicity under the conditions tested. No information is available on impairment of fertility in animals by talc. Pregnancy: Pregnancy category B. An oral administration study has been performed in the rabbit at 900 mg/kg, approximately 5-fold higher than the human dose on mg/m² basis, and has revealed no evidence of teratogenicity due to talc. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless it is clearly needed. Pediatric Use: The safety and efficacy of Sclerosol Intrapleural Aerosol® (sterile talc powder) in pediatric patients have not been established. Geriatric Use: The mean and median ages of patients treated with talc in the clinical studies table were 50-62 years. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported. ---------------------------------------------------------------- The usual dosage of Sclerosol® Intrapleural Aerosol (sterile talc powder) is a single 4-8 g dose delivered intrapleurally from the spray canister (1-2 cans), which delivers talc at a rate of 1.2 g per second. ADMINISTRATION PROCEDURE Insert delivery nozzle through pleural trocar, taking care not to place the distal end of the delivery nozzle adjacent to the lung parenchyma or directly against the chest wall. While firmly holding the delivery nozzle and pleural trocar together in one hand, gently apply pressure to the actuator button on the canister. Sclerosol Intrapleural Aerosol® is not delivered by metered dose, but depends on the extent and duration of manual compression of the actuator button on the canister. The distal end of the delivery nozzle should be pointed in several different directions, while short bursts are administered in order to distribute the talc powder equally and extensively on all visceral and parietal pleural surfaces. For optimal distribution, always maintain the Sclerosol Intrapleural Aerosol® (sterile talc powder) canister in the upright position. After application, discard the canister and delivery nozzle. The duration of chest tube drainage following talc sclerosis is dictated by the clinical situation. HOW SUPPLIED STORAGE: Warning: Contents under pressure. Do not puncture or incinerate container. Store between 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) (see USP Controlled Room Temperature). Protect against sunlight and do not expose to a temperature above 49° C (120° F), or the canister may rupture. Avoid freezing. Shake well before using. Source: Package insert - accessed August 2, 2014 |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.
