Skip directly to search Skip directly to A to Z list Skip directly to site content
CDC Home

Notice to Readers U.S.-Manufactured Pentamidine Isethionate Cleared for Investigational Use

A U.S.-manufactured preparation of pentamidine isethionate has undergone satisfactory completion of chemical and biologic tests, and CDC is now able to include this preparation in its claimed investigational exemption for a new drug for treatment of Pneumocystis carinii pneumonia. The Investigational New Drug status for the U.S.-manufactured preparation makes it unnecessary for CDC to distribute the foreign-produced product (pentamidine methanesulfonate) described in the May 4, 1984, issue of the MMWR (33:225-6). The U.S. preparation is being synthesized by Aldrich Chemical Company, Milwaukee, Wisconsin, and packaged for pharmaceutical use by LyphoMed, Inc., Melrose Park, Illinois.

There are two minor differences between the LyphoMed-manufactured product and the previously used May & Baker preparation of pentamidine isethionate. First, the LyphoMed product contains more pentamidine per vial than the May & Baker product (300 mg, compared with 200 mg). Second, the two preparations differ in their physical appearance. May & Baker uses a "dry fill" manufacturing process that leaves a fluffy white powder in the vial, whereas LyphoMed uses a "wet fill" process, followed by lyophilization, leaving a dry "plug" of white powder at the bottom of the vial.

The dosage of the LyphoMed product is the same as for the May & Baker product (4 mg (salt)/kg body weight). Reported by Div of Parasitic Diseases, Div of Host Factors, Center for Infectious Diseases, CDC.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.


All MMWR HTML versions of articles are electronic conversions from typeset documents. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (http://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

 
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention   1600 Clifton Road Atlanta, GA 30329-4027, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348 - Contact CDC–INFO
A-Z Index
  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
  27. #