STERITALC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STERITALC (STERITALC).
Sterile talc (STERITALC) induces pleural inflammation and fibrosis, leading to adhesion of the pleural layers. This mechanism is mediated by activation of mesothelial cells and fibroblasts, resulting in release of inflammatory cytokines and growth factors.
| Metabolism | Talc is an inert mineral; not metabolized. Systemic absorption may lead to deposition in tissues, but no specific metabolic pathway exists. |
| Excretion | Sterile talc (STERITALC) is not absorbed systemically following intrapleural administration. Excretion occurs locally via phagocytosis and clearance by pleural lymphatics; no significant renal, biliary, or fecal elimination applies. |
| Half-life | Not applicable; talc particles are not metabolized and remain in the pleural space indefinitely, with gradual clearance over months to years via macrophage uptake and lymphatic drainage. |
| Protein binding | Not applicable; talc is an inorganic silicate, does not bind to plasma proteins. |
| Volume of Distribution | Not applicable; talc remains at the site of administration (pleural space) with negligible systemic distribution. |
| Bioavailability | Not applicable; administered via intrapleural instillation and acts locally. No systemic absorption is intended or occurs. |
| Onset of Action | Intrapleural: Pleurodesis begins within 24–72 hours; maximal effect is observed at 4–6 weeks. |
| Duration of Action | Long-term; pleurodesis is permanent once fibrosis occurs. Clinical effect persists indefinitely unless recurrence of pleural effusion or pneumothorax. |
Sterile talc powder for intrapleural administration: 4-8 g mixed with 50-250 mL normal saline, instilled via chest tube for pleurodesis. Single dose typically used.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients; use not recommended. |
| Geriatric use | No specific dose adjustment; consider general precautions for elderly due to potential comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STERITALC (STERITALC).
| Breastfeeding | No data on excretion into breast milk. Due to lack of systemic absorption after pleural administration, transfer into milk is unlikely. Caution advised; consider risk-benefit. |
| Teratogenic Risk | Insufficient human data; animal studies not conducted. Sterile talc is not absorbed systemically when used for pleurodesis, thus minimal fetal exposure. However, talc may cause maternal inflammation and fever, which could theoretically increase risk of preterm labor or fetal distress in third trimester. Use in pregnancy only if clearly needed. |
■ FDA Black Box Warning
Risk of acute respiratory distress syndrome (ARDS), pneumonitis, and granulomatous inflammation secondary to talc particle absorption. Use only as a sterile, asbestos-free talc slurry or poudrage. Avoid systemic absorption.
| Serious Effects |
["Hypersensitivity to talc","Pleural infection or empyema","Severe respiratory insufficiency","Pregnancy and lactation (relative contraindication)","Uncontrolled bronchopleural fistula"]
| Precautions | ["Use only sterile, asbestos-free talc","Monitor for respiratory distress, pneumothorax, or re-expansion pulmonary edema","Avoid in patients with empyema or active pleural infection","Caution in patients with compromised pulmonary function","Risk of fever, chest pain, and pleural effusion recurrence"] |
Loading safety data…
| Fetal Monitoring |
| Monitor for signs of systemic inflammation (fever, hypoxia), respiratory distress, and preterm labor. Fetal heart rate monitoring recommended during and after procedure if gestational age ≥24 weeks. |
| Fertility Effects | No known effects on fertility. Talc is not absorbed systemically; reproductive toxicity unlikely. |