Steritalc 2g 2 g/50mL
Talc · POWDER · Novatech SA
Steritalc 2g is a powder containing talc at 2 g/50mL, taken intrapleural. Manufactured by Novatech SA.
Key Facts
- Brand Name
- Steritalc 2g
- Generic Name
- Talc
- NDC Code (Product)
62327-222- Manufacturer
- Novatech SA
- Strength
- 2 g/50mL
- Dosage Form
- POWDER
- Route
- INTRAPLEURAL
- Marketing Status
- Application #
- NDA205555
- Marketing Start
- 11/01/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)
Dosage & Administration
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…
Contraindications
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)]. _____________ CONTRAINDICATIONS_ ____________ Pregnancy. (4, 5.3, 8.1)
Adverse Reactions
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.
Frequently Asked Questions
What is Steritalc 2g used for?
Steritalc 2g contains Talc. It is a powder taken intrapleural. Consult your doctor for specific uses.
Is Steritalc 2g a controlled substance?
Steritalc 2g is not classified as a controlled substance by the DEA.
What is the generic name for Steritalc 2g?
The generic name for Steritalc 2g is Talc. There are 2 other brand versions of Talc.
What is the NDC code for Steritalc 2g 2 g/50mL?
The NDC (National Drug Code) for Steritalc 2g 2 g/50mL is 62327-222, listed by Novatech SA.