Friday, 5 October 2012

Talc


Class: Sclerosing Agents
CAS Number: 14807-96-6
Brands: Sclerosol

Introduction

Sclerosing agent;1 2 sterile, asbestos- and brucite-free, controlled-granule-size talc powder.1


Uses for Talc


Pleural Effusions


Sclerosis of pleural serosal surfaces (pleurodesis) to decrease the risk of malignant pleural effusion recurrence in symptomatic patients with advanced stages of metastatic tumors.1 2 3 4 5 6 7 8 9 10


Safety and efficacy based on data from published literature.1 2 3 14


Absence of reaccumulation of the effusion (determined by clinical examination or chest radiograph) reported in about 93% of patients with recurrent, symptomatic malignant pleural effusions.3 14


Similar success rates with talc slurry or aerosol powder.3


May be at least as effective as intrapleural bleomycin,1 2 6 7 8 9 15 16 17 doxycycline,12 mustine,2 11 or tetracycline2 10 (no longer commercially available as a parenteral formulation in the US) and more effective than therapeutic thoracentesis.1 2 4 11


Talc Dosage and Administration


Administration


Administer intrapleurally as a slurry instilled via a chest tube1 or by aerosol during thoracoscopy or open thoracotomy.2


Intrapleural Instillation via Chest Tube


Preparation of Slurry

Prepare slurry in a laminar flow hood using aseptic technique.1


Attach 16-gauge needle to a 60-mL Leur-Lok syringe and draw up 50 mL of 0.9% sodium chloride injection into the syringe.1


Vent vial containing 5 g of talc with a needle; slowly inject syringe contents into the vial and swirl to disperse.1


Continue swirling vial to prevent settling; draw up 25 mL of slurry into each of 2 60-mL syringes.1


Draw up sufficient 0.9% sodium chloride injection into each syringe to total 50 mL; each syringe will contain a slurry of 2.5 g of talc per 50 mL of 0.9% sodium chloride injection.1


Draw air into each syringe to the 60-mL mark to provide 10 mL of space for mixing prior to administration.1


Appropriately label each syringe, including expiration date and time, identity of patient to receive the preparation, and the cautionary statements “For Pleurodesis Only–NOT FOR IV ADMINISTRATION” and “Shake Well Before Use.“ 1


Use slurry within 12 hours of preparation.1


Administration Procedure

Prior to administration, adequately drain the effusion from the pleural cavity.1 2 Success of treatment apparently is related to the completeness of pleural fluid drainage and to full reexpansion of the lung.1 2


Completely and continuously agitate the slurry-containing syringes to disperse and avoid settlement of the talc.1


Immediately prior to administration, vent the 10 mL of air (provided for mixing) from each syringe.1


Attach the adapter and place a syringe tip on the adapter; maintain continuous agitation of the syringes.1


Apply gentle pressure to syringe plunger to empty syringe contents through the chest tube into the chest cavity.1


Flush the chest tube with 10–25 mL of 0.9% sodium chloride solution to ensure complete dose delivery; clamp the drainage tube.1


Have the patient move from supine to alternating decubitus positions at 20- to 30-minute intervals over a period of about 2 hours to distribute the talc within the chest cavity;1 however, recent evidence suggests that this step may not be necessary.1


At the end of this period, unclamp the chest drainage tube and remove excess saline by routine continual external suction on the tube.1


Intrapleural Aerosol


Administration Procedure

Prior to administration, adequately drain the effusion from the pleural cavity.1 2 Success of treatment apparently is related to the completeness of pleural fluid drainage and to full reexpansion of the lung.1 2


Shake aerosol canister well before use; securely attach actuator button with delivery tube (15 or 25 cm) to canister valve stem.2


Insert delivery tube through the pleural trocar; avoid placing the distal end of the tube adjacent to lung parenchyma or directly against the chest wall.2


For optimal distribution, always maintain canister in an upright position.2


Firmly hold the delivery tube and pleural trocar together in one hand, and gently press the actuator button on the canister.2


While pointing the distal end of the delivery tube in several different directions, administer short bursts to distribute talc equally and extensively on all visceral and parietal pleural surfaces.2


Discard the canister and delivery tube after application.2


The duration of chest tube drainage following sclerosis is dictated by the clinical situation.2


Rate of Administration

Commercially available spray canister delivers talc at a rate of 0.4 g per second but is not considered to be a metered-dose delivery system; dose delivered depends on the extent and duration of manual compression of the actuator button.2


Dosage


Adults


Pleural Effusions

Intrapleural Instillation

5 g as slurry dispersed in 50–100 mL of 0.9% sodium chloride injection.1


Optimal dose is unknown; 5 g was most frequently reported dose in published literature.1


Intrapleural Aerosol

Usually 4–8 g (from 1–2 spray canisters) as a single dose.2


Special Populations


No special population dosage recommendations at this time.1 2


Cautions for Talc


Contraindications



  • No known contraindications.1 2



Warnings/Precautions


General Precautions


Future Procedures

Prior to administration, consider the possible need for future diagnostic and therapeutic procedures involving the hemithorax.1 2 Sclerosis of pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side and may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.1 2


Potentially Curable Malignancies

Talc has no known antineoplastic activity; do not use alone for potentially curable malignancies (e.g., a malignant effusion secondary to a potentially curable lymphoma) when systemic antineoplastic therapy would be more appropriate.1 2


Pulmonary Complications

Acute pneumonitis and ARDS reported; 3 of 4 reports of ARDS occurred following relatively large dose (10 g) instilled intrapleurally via chest tube.1 2


IV administration causes pulmonary hypertension and lung parenchymal disease; not reported following intrapleural administration.2


Inhaled talc associated with pulmonary diseases (e.g., silicosis or asbestos-like disease, chronic bronchitis, bronchogenic carcinoma, pleural plaques).2


Aerosol Canister Pressure

The contents of the aerosol canister are under pressure; do not puncture or use near heat or open flame.2


Specific Populations


Pregnancy

Category B.1 2


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2


Geriatric Use

Safety and efficacy in geriatric patients not specifically evaluated.1 2


Estimated mean and median ages of patients receiving intrapleural talc slurry in clinical studies were 60 and 62 years, respectively.1 Mean and median ages of patients receiving talc intrapleural aerosol were 50–62 years.2


Common Adverse Effects


Fever, pain.1 2


Interactions for Talc


Specific Drugs







Drug



Comments



Sclerosing agents



Unknown whether talc’s absorptive properties may diminish the effectiveness of subsequent therapy with a second sclerosing agent1 2


Talc Pharmacokinetics


Absorption


Bioavailability


Extent of absorption after intrapleural administration not determined; integrity of the pleural surface may affect systemic exposure.1 2


Special Populations


Systemic exposure may be increased when administered immediately following lung resection or biopsy.1 2


Stability


Storage


Intrapleural


Powder

18–25°C.1 Protect from sunlight.1


Use slurry within 12 hours following preparation.1


Aerosol

15–30°C.2 Do not expose to temperatures >49°C (canister may rupture).2 Avoid freezing.2 Protect from sunlight.2


ActionsActions



  • Following intrapleural administration, talc induces inflammation that results in fibrosis and adherence of visceral to parietal pleura (pleurodesis), thereby obliterating the pleural space and reducing the chance of fluid reaccumulation.1 2 18 19 20



Advice to Patients



  • Importance of describing the intrapleural procedure to patients prior to administration of talc.




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Talc

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Intrapleural



Aerosol



4 g



Sclerosol Intrapleural Aerosol (with dichlorodifluoromethane [CFC-12] propellants)



Bryan



Powder



5 g



Sterile Talc Powder



Bryan



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Bryan Corporation. Sterile talc powder prescribing information. Woburn, MA; undated.



2. Bryan Corporation. Sclerosol (sterile talc powder) intrapleural aerosol prescribing information. Woburn, MA; undated.



3. American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000; 162:1987-2001. [PubMed 11069845]



4. Sorensen PG, Svendsen TL, Enk B. Treatment of malignant pleural effusion with drainage, with and without instillation of talc. Eur J Respir Dis. 1984; 65:131-5. [PubMed 6365578]



5. Aelony Y, King R, Boutin C. Thoracoscopic talc poudrage pleurodesis for chronic recurrent pleural effusions. Ann Intern Med. 1991; 115:778-82. [IDIS 288492] [PubMed 1929026]



6. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]



7. Ong KC, Indumathi V, Raghuram J et.al. A comparative study of pleurodesis using talc slurry and bleomycin in the management of malignant pleural effusions. Respirology. 2000; 5:99-103. [PubMed 10894097]



8. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]



9. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]



10. Fentiman IS, Rubens RD, Hayward JL. A comparison of intracavitary talc and tetracycline for the control of pleural effusions secondary to breast cancer. Eur J Cancer Clin Oncol. 1986; 22:1079-81. [PubMed 3536525]



11. Fentiman IS, Rubens RD, Hayward JL. Control of pleural effusions in patients with breast cancer. A randomized trial. Cancer. 1983; 52:737-9. [IDIS 173650] [PubMed 6190551]



12. Kuzdzal J, Sladek K, Wasowski D et al. Talc powder vs doxycycline in the control of malignant pleural effusion: a prospective, randomized trial. Med Sci Monit. 2003; 9:PI72-9. [PubMed 12824959]



13. Yim AP, Chan AT, Lee TW et al. Thoracoscopic talc insufflation versus talc slurry for symptomatic malignant pleural effusion. Ann Thorac Surg. 1996; 62:1655-8. [IDIS 377654] [PubMed 8957368]



14. Walker-Renard PB, Vaughan LM, Sahn SA. Chemical pleurodesis for malignant pleural effusions. Ann Intern Med. 1994; 120:56-64. [IDIS 323067] [PubMed 8250457]



15. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]



16. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]



17. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]



18. Ruckdeschel JC. Management of malignant pleural effusion: an overview. Semin Oncol. 1988; 15(Suppl 3):24-8. [PubMed 3293215]



19. Andrews CO, Gora ML. Pleural effusions: pathophysiology and management. Ann Pharmacother. 1994; 28:894-903. [IDIS 334463] [PubMed 7524816]



20. Hausheer FH, Yarbro JW. Diagnosis and treatment of malignant pleural effusion. Semin Oncol. 1985; 12:54-75. [PubMed 2579439]



More Talc resources


  • Talc Side Effects (in more detail)
  • Talc Support Group
  • 0 Reviews · Be the first to review/rate this drug

Monday, 1 October 2012

Ampyra


Pronunciation: dal-FAM-pri-DEEN
Generic Name: Dalfampridine
Brand Name: Ampyra


Ampyra is used for:

Improvement of walking in patients with multiple sclerosis (MS).


Ampyra is a potassium channel blocker. Exactly how it works is not known. It is thought to increase nerve function that will improve walking in patients with MS.


Do NOT use Ampyra if:


  • you are allergic to any ingredient in Ampyra

  • you have moderate to severe kidney problems

  • you have a history of seizures

  • you take any other medicines that contain other aminopyridines (eg, 4-AP, fampridine)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Ampyra:


Some medical conditions may interact with Ampyra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of kidney problems, kidney or urinary tract infections, or an abnormal electroencephalogram (EEG)

Some MEDICINES MAY INTERACT with Ampyra. However, no specific interactions with Ampyra are known at this time.


Ask your health care provider if Ampyra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Ampyra:


Use Ampyra as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Ampyra comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ampyra refilled.

  • Take Ampyra by mouth with or without food.

  • Swallow Ampyra whole. Do not break, crush, chew, or dissolve before swallowing.

  • Ampyra works best if it is taken at the same time each day.

  • If you miss a dose of Ampyra, do not make up the missed dose. Take your next dose at your regular scheduled time. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ampyra.



Important safety information:


  • Ampyra may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ampyra with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do NOT take more than the recommended dose or take for longer than prescribed without talking with your doctor.

  • Ampyra may increase your risk of seizures. Contact your doctor right away if you experience a seizure while taking Ampyra.

  • Lab tests, including kidney function, may be performed while you take Ampyra. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Ampyra with caution in the ELDERLY; they may be more sensitive to its effects.

  • Ampyra should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Ampyra can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ampyra while you are pregnant. It is not known if Ampyra is found in breast milk. Do not breast-feed while taking Ampyra.


Possible side effects of Ampyra:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Back pain; constipation; dizziness; headache; nausea; sore throat; stuffy or runny nose; trouble sleeping; upset stomach; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); balance problems; burning, numbness, or tingling; confusion; seizure; symptoms of urinary tract infection (eg, burning or pain while urinating, difficulty urinating, inability to control urination).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Ampyra side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; memory loss; seizure; sweating; tremor.


Proper storage of Ampyra:

Store Ampyra at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ampyra out of the reach of children and away from pets.


General information:


  • If you have any questions about Ampyra, please talk with your doctor, pharmacist, or other health care provider.

  • Ampyra is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ampyra. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ampyra resources


  • Ampyra Side Effects (in more detail)
  • Ampyra Use in Pregnancy & Breastfeeding
  • Ampyra Drug Interactions
  • Ampyra Support Group
  • 17 Reviews for Ampyra - Add your own review/rating


  • Ampyra Prescribing Information (FDA)

  • Ampyra Consumer Overview

  • Ampyra Monograph (AHFS DI)

  • Ampyra Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dalfampridine Professional Patient Advice (Wolters Kluwer)



Compare Ampyra with other medications


  • Multiple Sclerosis