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  • CLASSES

    Sclerosing Agents

    DEA CLASS

    Rx

    DESCRIPTION

    Agent containing >= 95% magnesium silicate; do not confuse sterile talc with 'talcum powder' which is a lay term that refers to various types of dusting powder.
    Used for the treatment of recurrent malignant pleural effusions in symptomatic patients.
    Talc must be carefully sterilized prior to clinical intrapleural use; sterile products are marketed.

    COMMON BRAND NAMES

    Sclerosol

    HOW SUPPLIED

    Sclerosol Intrapleural Aer: 4g
    Talc Intrapleural Pwd

    DOSAGE & INDICATIONS

    For the treatment of recurrent malignant pleural effusion in symptomatic patients.
    NOTE: Talc, magnesium silicate is not an antineoplastic agent and should not be used for potentially curable malignancies in which systemic therapy would be more appropriate.
    NOTE: Administer talc, magnesium silicate after adequate drainage of the effusion. Pleurodesis success is related to complete drainage of pleural fluid and full reexpansion of the lung, both of which promote symphysis of the pleural surfaces.
    Intrapleural dosage (Sclerosol)
    Adults

    4—8 g (1 to 2 cans) as a single dose. Sclerosol is not delivered by metered dose, but depends upon the extent and duration of manual compression of the actuator button on the canister; delivered from the spray canister at a rate of 0.4 g/second. Clamp for 2 hours, then continue suction and drainage.

    Intrapleural dosage (sterile talc slurry)
    Adults

    5 g dissolved in 50—100 ml 0.9% Sodium Chloride Injection (see Administration). Although the optimal dose for effective pleurodesis is not known, a 5 g dosage has been most frequently reported in the literature.

    MAXIMUM DOSAGE

    Adults

    8 g intrapleurally for Sclerosol; 5 g intrapleurally for sterile talc slurry is usual dose, but up to 10 g described in literature and optimal unknown.

    Geriatric

    8 g intrapleurally for Sclerosol; 5 g intrapleurally for sterile talc slurry is usual dose, but up to 10 g described in literature and optimal unknown.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

    Other Administration Route(s)

    Intrapleural Administration
    Sterile talc powder is indicated for intrapleural administration following adequate drainage of the pleural effusion; not for IV administration.
    Rotation of the patient following intrapleural administration of a sclerosing agent is described in most pleurodesis studies in order to achieve adequate distribution of the agent over the pleura.
    Intrapleural aerosol (Sclerosol):
    Contents of the aerosol can are under pressure. Do not puncture the canister or store near heat or an open flame.
    Shake canister well prior to use.
    Use aseptic techniques.
    Remove the protective cap and securely attach the actuator button with its delivery tube (either 15 cm or 25 cm) to the valve stem of the canister.
    Insert delivery tube through pleural trocar, taking care not to place the distal end of the delivery tube next to the lung parenchyma or directly against the chest wall.
    While firmly holding the delivery tube and pleural trocar in one hand, gently apply pressure to the actuator button on the canister.
    The canister delivers talc at a rate of 0.4 g/second.
    The distal end of the delivery tube should be pointed in several different directions, while short bursts are administered in order to distribute the talc powder equally and extensively on the visceral and parietal pleural surfaces.
    For optimal distribution, always maintain the canister in an upright position.
    The duration of chest tube drainage following talc sclerosis is dependent on the clinical situation.
     
    Preparation of sterile talc powder (for talc slurry):
    The talc slurry should be prepared in an appropriate laminar flow hood using aseptic technique.
    Using a 16 gauge needle attached to a 60 ml Luer-Lok syringe measure and draw up 50 ml of sodium chloride injection.
    Vent the talc bottle using a needle.
    Slowly inject the 50 ml of sodium chloride injection into the bottle. For doses > 5 g, repeat the procedure with another bottle.
    Swirl the bottle to disperse the talc and continue to swirl to avoid settling of the talc in the slurry.
    While swirling continuously, withdraw 25 ml of the slurry into 2, 60 ml irrigation syringes.
    Add sodium chloride injection to each syringe for a total of 50 ml per syringe. Draw air into each syringe to the 60 ml mark to serve as space for mixing prior to administration. Each syringe will contain 2.5 g of Sterile Talc in 50 ml of sodium chloride injection.
    Use slurry within 12 hours or discard and prepare fresh slurry.
    Label syringes with the statement: 'For Pleurodesis Only - NOT FOR IV ADMINSISTRATION'. In addition, syringes should also have the message: 'SHAKE WELL prior to use.'
     
    Intrapleural Administration (talc slurry):
    Prior to administration, completely and continuously agitate the syringes to evenly redisperse the talc and avoid settlement.
    Immediately prior to administration, vent the 10 ml of air from each syringe.
    Attach the adapter and place a syringe tip on the adapter. Maintain continuous agitation of the syringes until administration through the chest tube.
    After talc slurry has been administered, the chest tube may be flushed with 10—25 ml of sodium chloride solution to ensure the complete dose of talc was delivered.
    Following administration, the chest tube is clamped, and the patient is asked to move every 20—30 minutes from supine to alternating decubitus positions, so that over a period of 2 hours the talc is distributed within the chest cavity; although, recent evidence suggests that this step may not be necessary. 
    After 2 hours, the chest tube is unclamped, and the excess saline is removed by routine continual suction on the tube.

    STORAGE

    Generic:
    - Protect from direct sunlight
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Sclerosol:
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Protect from direct sunlight
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Sclerosis of the pleural space using talc, magnesium silicate may preclude diagnostic procedures of the pleura on the treated side and also may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes. The possibility of future diagnostic and therapeutic procedures involving the thorax must be considered prior to the administration of talc.
     
    The mean age of patients treated with talc, magnesium silicate during clinical trials was 50 years.

    Children, infants, neonates

    The safety and efficacy of talc, magnesium silicate have not been established in neonates, infants, children, or adolescents.

    Pregnancy

    Talc, magnesium silicate is classified as FDA pregnancy category B and should only be used in pregnancy if clearly needed.

    Breast-feeding

    Breast-feeding information for talc, magnesium silicate is not available from the manufacturer. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Intravenous administration

    Talc, magnesium silicate is approved for intrapleural administration and should not be given via intravenous administration. Pulmonary hypertension, pulmonary lung parenchymal disease, and other complications can occur when talc is administered intravenously.

    ADVERSE REACTIONS

    Severe

    acute respiratory distress syndrome (ARDS) / Early / 0-1.0
    bronchopleural fistula / Delayed / Incidence not known
    pulmonary embolism / Delayed / Incidence not known
    myocardial infarction / Delayed / Incidence not known
    asystole / Rapid / Incidence not known

    Moderate

    dyspnea / Early / 8.5-8.5
    pneumonitis / Delayed / 2.8-2.8
    hemoptysis / Delayed / 0-1.0
    costovertebral pain / Delayed / 10.0
    bleeding / Early / Incidence not known
    hypotension / Rapid / Incidence not known
    sinus tachycardia / Rapid / Incidence not known
    hypovolemia / Early / Incidence not known

    Mild

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

    DRUG INTERACTIONS

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

    PREGNANCY AND LACTATION

    Pregnancy

    Talc, magnesium silicate is classified as FDA pregnancy category B and should only be used in pregnancy if clearly needed.

    Breast-feeding information for talc, magnesium silicate is not available from the manufacturer. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    After instillation into the pleural cavity, talc initiates an inflammatory reaction. The resulting development of scar tissue interrupts the communication between the intravascular space and the pleural space, eliminating the pleural space and preventing the reaccumulation of fluid.

    PHARMACOKINETICS

    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.