Talc

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

• 1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax.

• 4. CONTRAINDICATIONS Due to lead content, STERITALC® is contraindicated in pregnant women and can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].contraindicated

2. DOSAGE AND ADMINISTRATION 2.1 Important Use Information STERITALC is for pleurodesis only - Do NOT administer STERITALC intravenously. Administer STERITALC after adequate drainage of the pleural effusion or air. 2.2 Recommended Dose for Malignant Pleural Effusion The recommended dose for malignant pleural effusion is 2 to 5 grams administered intrapleurally. According to the physician’s discretion, and in consideration of diagnosis and patient’s condition, different dosages may be applied, but a total dosage of 10 grams should not be exceeded. 2.3 Recommended Dose for Pneumothorax The recommended dose for pneumothorax 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. 2.4 Preparation Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Do not prepare the slurry in advance. Use the slurry immediately after preparation. Prepare the talc suspension using aseptic technique in an appropriate laminar flow hood as follows: Step 1 : Fully bend or remove the flap into the direction of the arrow. The top can now be punctured to mix the slurry. Step 2 : Using a 16 gauge needle attached to a 60-mL Luer Lok syringe, draw up 50 mL of 0.9 % Sodium Chloride injection, USP. Vent the talc bottle using a needle. Slowly inject the 50 mL of 0.9% Sodium Chloride Injection, USP into the glass vial. Step 3: Swirl the glass vial to disperse the talc powder.

5. WARNINGS AND PRECAUTIONS 5.1 Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) Acute Pneumonitis and ARDS, including fatal cases, have been reported with intrapleural use of various talc products. Systemic exposure of talc could be affected by the integrity of the visceral pleura and could be increased if talc is administered immediately after mechanical abrasion or biopsy of the pleura. The literature also suggests a possible correlation between talc particle size distribution and risk of toxicity. There are published reports of two large, prospective trials conducted to evaluate the safety of STERITALC administered intrapleurally. One trial evaluated 558 patients treated with STERITALC 4g by poudrage for MPE. The second trial evaluated 418 patients with recurrent primary spontaneous pneumothorax treated with STERITALC 2 g by poudrage. No cases of ARDS or talc-related lung injury were reported. 5.2 Interference with Future Procedures Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. Consider the possible effects of the use of STERITALC on future diagnostic and therapeutic procedures prior to administration. 5.3 Lead Content Lead is present in STERITALC as an impurity. The main target organ for lead toxicity is the nervous system, but effects of lead exposure also include increased blood pressure, anemia, decreased sperm production, and damage to the kidneys in children and adults.

6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) [see Warnings and Precautions (5.1)] Lead Content [see Warnings and Precautions (5.3)] Asbestos Content [see Warnings and Precautions (5.4)] Common adverse reactions observed with intrapleural use of various talc products are fever and pain. Other adverse reactions include dyspnea, arrhythmia, empyema, pneumonitis and acute respiratory distress syndrome (ARDS). Procedure related adverse reactions such as bleeding, hemothorax, wound infections, atelectasis and pneumonia may occur. _____________ ADVERSE REACTIONS _____________ Common adverse reactions are fever and pain. (6) To report suspected adverse reactions contact Boston Medical Product Inc., at 508-898-9300 and FDA at 1-800-332-1088 or www.fda.gov/medwatch.

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary STERITALC is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3)] . There are no human data on the use of STERITALC in pregnant women. In an animal reproduction study, oral administration of talc in pregnant rabbits during organogenesis revealed no evidence of teratogenicity at dose up to approximately 5 times the human dose [see Data] . Data Animal Data In an embryo-fetal developmental toxicity study in rabbits, talc was administered to rabbits by oral gavage daily during the period of organogenesis at doses up to 900 mg/kg (approximately 5 times the human dose on a mg/m2 basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered talc was not absorbed systemically. 8.2 Lactation Risk Summary There is no information regarding the presence of talc in human milk, the effects on the breastfed infants, or the effects on milk production. STERITALC contains lead, which is known to have adverse effects on health and development in neonates, infants and children [see Warnings and Precautions (5.3)] .

• May 1, 2017NDANDA205555Novatech Sa

1. 1Pain38114%
2. 2Exposure To Chemical Pollution32012%
3. 3Anxiety27410.0%
4. 4Drug Ineffective2258.2%
5. 5Injury2258.2%
6. 6Mesothelioma1846.7%
7. 7Vulvovaginal Burning Sensation1746.3%
8. 8Off Label Use1666.0%
9. 9Dyspnoea1445.2%
10. 10Disability1385.0%
11. 11Fatigue1234.5%
12. 12Pruritus1144.1%
13. 13Condition Aggravated1104.0%
14. 14Emotional Distress1094.0%
15. 15Diarrhoea1073.9%

Recent PubMed references pinned to Talc as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Particles, fragments, fibers: what IARC missed in its assessment of talc mineralogy. (Authors' reply to Comment on ["The IARC re-classification of talc carcinogenicity: a move in the wrong direction?"]).
  Critical reviews in toxicology · 2026 · Korchevskiy AA, Wylie AG
  PMID 41920094DOI 10.1080/10408444.2026.2641747
• Insight into simultaneous destabilization of oleosomes during aqueous enzymatic extraction of Idesia polycarpa fruit oil by short-chain alcohol with talc.
  Food chemistry · 2026 · Nie X, Zhou X, Hua L, et al.
  PMID 41895111DOI 10.1016/j.foodchem.2026.148941
• Indocyanine green-guided video-assisted thoracoscopic surgery thoracic duct ligation and talc pleurodesis for refractory chylothorax after Ivor Lewis oesophagectomy.
  Multimedia manual of cardiothoracic surgery : MMCTS · 2026 · Montero J, Medina J, Carmignani P, et al.
  PMID 41891682DOI 10.1510/mmcts.2026.012
• Development and validation of a predictive model for pleural effusion control following talc pleurodesis in malignant pleural effusion.
  International journal of clinical oncology · 2026 · Hanawa S, Ejima M, Sugawara M, et al.
  PMID 41843055DOI 10.1007/s10147-026-03007-0
• Malignant Pleural Mesothelioma (MPM) Evaluation with [(11)C]-Methionine PET/CT Before and After Talc Pleurodesis.
  Molecular imaging and biology · 2026 · Lopci E, Castello A, Testori A, et al.
  PMID 41801610DOI 10.1007/s11307-026-02093-w
• Medical thoracoscopy with talc poudrage and indwelling pleural catheter insertion versus medical thoracoscopy with talc poudrage alone for patients with symptomatic malignant pleural effusion (TACTIC): a randomised, controlled phase 3 trial.
  The Lancet. Respiratory medicine · 2026 · Dipper A, Sundaralingam A, Hedley E, et al.
  PMID 41763237DOI 10.1016/S2213-2600(25)00409-6
• Talc fits the framework of poorly soluble low-toxicity particles - implications for hazard classification.
  Regulatory toxicology and pharmacology : RTP · 2026 · Driscoll KE, Everitt JI, Borm PJA, et al.
  PMID 41687805DOI 10.1016/j.yrtph.2026.106060
• Efficacy of Modified Talc Powder in Experimental Rat Model of Pleurodesis.
  Biomolecules · 2026 · Kilic M, Ozhan O, Yildiz A, et al.
  PMID 41594645DOI 10.3390/biom16010104

The 10 most recently updated of 100 ClinicalTrials.gov registrations naming Talc as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Initial Investigation Into the Effects of β-Alanine on Performance and Physiological Responses During Simulated Wrestling Matches
  Active not recruiting · Interventional · 16 enrolled · China Medical University Hospital
  NCT07641907updated 2026-06-11
• Fezolinetant and Vascular Health and Brain Health
  Not yet recruiting · Phase 3 · Interventional · 220 enrolled · Rebecca Thurston
  NCT07606664updated 2026-05-26
• AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion
  Completed · Interventional · 158 enrolled · The University of Western Australia
  NCT04322136updated 2026-05-05
• Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis
  Completed · Phase 3 · Interventional · 111 enrolled · Lille Catholic University
  NCT03128905updated 2026-04-17
• A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial
  Completed · Phase 3 · Interventional · 399 enrolled · Cardresearch
  NCT06128967updated 2026-04-13
• Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance
  Completed · Interventional · 12 enrolled · China Medical University Hospital
  NCT07518355updated 2026-04-08
• Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression
  Recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Federal University of Latin American Integration
  NCT06898606updated 2026-03-27
• Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties
  Completed · Interventional · 14 enrolled · China Medical University Hospital
  NCT07440394updated 2026-02-27
• Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsules for Improving Skin Health and Reducing Signs of Aging on Healthy Adult Male and Female Subjects.
  Not yet recruiting · Interventional · 50 enrolled · NovoBliss Research Pvt Ltd
  NCT07324759updated 2026-01-07
• Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
  Not yet recruiting · Interventional · 160 enrolled · University of Health Sciences Lahore
  NCT07167992updated 2026-01-06

Frequently asked questions

How does Talc work?

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

What is Talc used for?

According to FDA labeling, Talc carries indications including: 1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Talc?

Talc is classified as Unknown Cellular or Molecular Interaction, Vascular Sclerosing Activity.

What are the brand names for Talc?

Talc is marketed under brand names including Sclerosol, Steritalc.

What are the contraindications for Talc?

Talc labeling lists contraindications including: 4. CONTRAINDICATIONS Due to lead content, STERITALC® is contraindicated in pregnant women and can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].. Always consult the full prescribing information and a clinician.