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Pleurodesis (chemical) - Sclerosant agents

Disclaimer - Please see package insert if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK
Background
Doxycycline Sterile Talc (powder) 5gm
Sclerosol® Intrapleural [Aerosol ] (sterile talc powder) --





Background

Source: http://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:
  • Malignant pleural effusions
  • Refractory nonmalignant pleural effusions
  • Pneumothorax

 Sterile Talc: top of page

Talc use in pleurodesis:
  • Most commonly used agent.
  • Patients treated with talc have effective and successful pleurodesis in greater than 90 percent of cases.
  • Mechanism: irritation between the parietal and the visceral layers of the pleura which closes off the space between them and prevents further fluid from accumulating.
Usual dose:  (Sterile powder used to prepare a slurry): 
  • 5 grams dissolved in 50 to 100 mL of NS.
  • Route:  intrapleurally via chest tube following adequate drainage of the effusion.
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Preparation:
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1] Dissolve 5 grams sterile talc powder (vial) with 50 mL NS.
2] Swirl vial to disperse powder (prevent talc from settling) to create a slurry.
3] Divide the reconstituted contents as follows:
       -Obtain two 60 mL syringes and withdraw 25 mL of the slurry into each syringe.
       -Add an additional 25ml NS to each syringe (total volume: 50 mL -  25mL NS + 25 mL slurry).
       -Final concentration in each syringe: 2.5 grams/50mL.
       -Pull back syringe plunger to the 60mL mark to create a 10ml open space to facilitate mixing.
       -LABELINTRAPLEURAL administration ONLY
4] Use talc slurry within 12 hours of preparation.
5] Shake well before installation.
6] Vent the 10ml of open space in the syringe just prior to administration through the chest tube.

Additional actions:
1]  Consider flushing the chest tube with 10-25mL of NS after administration of the slurry.
2]  Clamp the chest tube ~2 hours.
3]  Patient should be repositioned at 15-20 minute intervals.
4]  Drain excess saline from chest tube (suction).


Overview (source: http://en.wikipedia.org/wiki/Sterile_talc_powder\):

"Sterile Talc Powder is a sclerosing agent intended for intrapleural administration supplied in a single use 100 ml brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal. Each bottle contains a minimum of 5.0 g of Talc USP (Ultra 2000 Talc), either white or off-white to light gray, asbestos-free and brucite-free grade of talc of controlled particle size. The composition of the talc is geq 95% talc as hydrated magnesium silicate. The empirical formula of talc is Mg3Si4O10(OH)2 with a molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate.), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water and in dilute solutions of acids and alkali hydroxides. The finished product has been sterilized by gamma irradiation.

Sterile Talc Powder, administered intrapleurally via a chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients."


 Doxycycline: top of page

Doxycycline use in pleurodesis:
Key points:
  • Not as effective as talc.
  • Recurrence rates of 13 to 35 percent
  • Mechanism: irritation between the parietal and the visceral layers of the pleura which closes off the space between them and prevents further fluid from accumulating.
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Dosing
:
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The typical dose of doxycycline used for intrapleural instillation is 500 mg dissolved in a total volume of 50 mL of normal saline.

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Alt: Pleurodesis:  Intrapleural instillation of 10 mL 1% lidocaine and doxycycline, 500 mg in 30 mL 0.9% saline solution. Chest tube clamped 2 hours with patient repositioned every 15 minutes.

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): top of page

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:
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.

INDICATIONS AND USAGE
Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.

CONTRAINDICATIONS
None known.

WARNINGS
None.


PRECAUTIONS
General:
1) Future procedures. The possibility of future diagnostic and therapeutic procedures involving the hemithorax to be treated must be considered prior to administering Sclerosol® Intrapleural Aerosol. Sclerosis of the pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side. Talc sclerosis may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.

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.

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DOSAGE AND ADMINISTRATION
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Sclerosol® Intrapleural Aerosol (sterile talc powder) is administered after adequate drainage of the effusion. It has been suggested that success of the pleurodesis is related to the completeness of the drainage of the pleural fluid, as well as full reexpansion of the lung, both of which will promote symphysis of the pleural surfaces.

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
Shake canister well before usage. Remove protective cap and securely attach actuator button with its delivery nozzle (either 15 cm or 25 cm) to the valve stem of canister.

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
NDC 63256-100-30: Sclerosol® Intrapleural Aerosol (sterile talc powder) contains 4 g of talc suspended in 25 g of inert propellant in a single-use aluminum canister. The canister is fitted with a continuous spray valve which delivers approximately 1.2 g of talc per second. This canister, attached to an actuator button, and two delivery nozzles of 15 cm and 25 cm length, are supplied in a sterile, flexible plastic peel pack.

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
DISTRIBUTED BY: Bryan Corporation, Woburn MA 01801
October 2012
Principal Display Panel – Pouch Label
Sclerosol® Intrapleural Aerosol
(Sterile Talc Powder)
NDC 63256-100-30 Reorder No. 1680
 
 
 
 

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.

Disclaimer

Listed dosages are for - Adult patients ONLY. if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK
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