Posted by Bob P (129.65.46.87) on April 19, 2001 at 12:50:58:
I went and bugged Glaxo to see if they would come out with a 3mg injection for us 'heads'. Here's the response and one of the attachments. I'll post all three attachments in the 'medications' page of the OUCH Library when I get a chance.
Bob,
I am responding to your inquiry from Allan Pharr regarding dosing/packaging
of Imitrex injection. Attached is information relating to administration of
doses less than 6 mg of Imitrex, use in cluster headaches and opened or
repackaging of Imitrex Injection.
There are no definitive plans to market a dose less than the approved 6 mg
dose in the US.
Please let us know if you need more information.
< Shelly Lener Shelly Lener, B.S.; Pharm.D. (attachment)
CNS Therapeutic area
North American Medical Affairs
GlaxoSmithKline
Telephone: 1800-545-2965 Ext 34748
Fax (919) 315-0203
Email: MEL1890@GlaxoWellcome.com
RE: OPENED OR REPACKAGED IMITREX® INJECTION
SUMMARY
Imitrex® (sumatriptan succinate) Injection is a preservative-free product, therefore the sterility of either single-dose VIALS or single-dose syringe cartridges once the original container has been opened and partially used can not be assured.
Imitrex Injection is commercially available in single-dose syringe cartridges and single-dose VIALS. Both the syringe cartridges and the VIALS contain 6 mg of sumatriptan (as the succinate salt) and 3.5 mg of sodium chloride in 0.5 mL of sterile solution. Unopened syringes and VIALS of Imitrex Injection are stable for 24 months from the date of manufacture, when stored between 2° and 30°C (36° and 86°F) and protected from light. The product expiration date is stamped on the package and label of each vial and prefilled syringe cartridge ( ).
Nil et al ( ) published a study assessing the stability of Imitrex Injection when repackaged in polypropylene tuberculin syringes. Sumatriptan succinate 12 mg/mL was stable when exposed to fluorescent light or kept in the dark for 72 hours at 2–5°C and for at least 24 hours at 25°C.
Some of the information contained in this letter may be outside the product labeling for Imitrex. This letter is not intended to offer an opinion on the advisability of administering Imitrex in a manner inconsistent with product labeling. In order to allow GlaxoSmithKline to monitor the safety of Imitrex we encourage clinicians to report suspected overdoses or adverse effects to our Product Surveillance Department (888-825-5249). Please consult the enclosed product information for full prescribing details.