sterile talc powder

Sterile talc powder is administered as an aerosol spray or slurry through a chest tube into the pleural cavity to prevent the recurrence of malignant pleural effusion. Pleura is a two-layered membrane surrounding the lungs and malignant pleural effusion is a collection of fluid and cancer cells in the pleural space that can occur in certain cancers. Sterile talc powder is administered after fluid drainage, to make the two layers of pleura stick together and prevent further fluid accumulation.

Talc is a mineral composed primarily of magnesium, silicon and oxygen and has been widely used in body, facial and baby powders. Sterile talc powder instilled into the pleural cavity induces an inflammatory reaction, which is believed to thicken the pleura and make the outer pleural layer (parietal pleura) and the inner pleural layer (visceral pleura) adhere to each other, eliminating the space between the layers where fluid can collect.

• Do not use sterile talc powder to treat patients with hypersensitivity to any of its components.
• Thickening (sclerosis) and adhesion of the pleural layers may preclude subsequent diagnostic or therapeutic procedures on the treated side, including partial or complete removal of the pleura and lung on the same side.
• Sterile talc powder does not have any anti-cancer activity and should not be used for malignant pleural effusions associated with potentially curable malignancies that can be treated with systemic therapy.
• There are rare reports of lung inflammation (pneumonitis) or acute respiratory distress syndrome (ARDS) after intrapleural administration of sterile talc powder, but it is not known to cause pulmonary hypertension or lung disease that intravenous administration can cause. Talc inhalation can cause lung diseases such as silicosis, asbestosis-like disease, chronic bronchitis, pleural plaques and bronchogenic carcinoma.
• Sterile talc powder canister contents are under pressure. The canister should not be punctured or kept near heat or flame.

Common side effects of sterile talc powder include:

• Pain
• Fever

Side effects from talc powder delivery procedure include:

• Infection at thoracostomy/thoracoscopy site
• Localized bleeding
• Collection of pus in the tissue beneath the skin (subcutaneous empyema)

Less common side effects of talc powder, sterile include:

• Pneumonia
• Acute respiratory distress syndrome (ARDS)
• Shortness of breath (dyspnea)
• Abnormal connection between airway and the membrane around the lung (bronchopleural fistula)
• Blood clots in lung (pulmonary emboli)
• Coughing up blood (hemoptysis)
• Empyema in the pleura
• Rapid heart rate (tachycardia)
• Irregular heartbeat (arrhythmia)
• Heart attack (myocardial infarction)
• Low blood pressure (hypotension)
• Low blood volume (hypovolemia)
• Cardiac flatline (asystolic arrest) with surgery and/or anesthesia

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Aerosol powder

• 4 g

Suspension reconstituted

• 5 g

Adult:

Malignant Pleural Effusion

• Indicated as a sclerosing agent to decrease malignant pleural effusion recurrence in symptomatic patients
• Administered intrapleurally via chest tube after adequate drainage of the effusion
• Aerosol: 4-8 g (1-2 canisters); deliver by manually pressing actuator button; distal end of the delivery tube should be pointed in several different directions, while short bursts are administered to distribute talc powder equally and extensively on all visceral and parietal pleural surfaces
• Powder: 5 g as single dose dispersed in sodium chloride injection 50 to 100 mL; doses range from 2 to 10.5 g shown to be effective

Pediatric:

• Safety and efficacy not established

Overdose

• No overdose has been reported. Sterile talc powder is administered in hospital settings in the pleural space around the lungs and overdose is unlikely.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Sterile talc powder has no known severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Animal reproductive studies do not show fetal harm from the use of sterile talc powder, however, there are no adequate and well-controlled studies in pregnant women. Sterile talc powder should be used in pregnant women only when it is clearly needed.
• There is no information on the use of sterile talc powder in breastfeeding women, no studies have been conducted.