"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
(Generic versions may still be available.)
ARAMINE (metaraminol) is indicated for prevention and treatment of the acute hypotensive state occurring with spinal anesthesia. It is also indicated as adjunctive treatment of hypotension due to hemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to trauma or tumor.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Allow at least 10 minutes to elapse before increasing the dose because the maximum effect is not immediately apparent. When the vasopressor is discontinued, observe the patient carefully as the effect of the drug tapers off, so that therapy can be reinitiated promptly if the blood pressure falls too rapidly. The response to vasopressors may be p.o. in patients with coexistent shock and acidosis. When indicated, established methods of shock management should be used, such as blood or fluid replacement.
Intramuscular or Subcutaneous Injection (for prevention of hypotension — see INDICATIONS): The recommended dose is 2 to 10 mg (0.2 to 1mL). As with other agents given subcutaneously, only the preferred sites of injection, as set forth in standard texts, should be used.
Intravenous Infusion (for adjunctive treatment of hypotension — see INDICATIONS): The recommended dose is 15 to 100 mg (1.5 to 10 mL) in 500 mL of Sodium Chloride Injection or 5% Dextrose Injection, adjusting the rate of infusion to maintain the blood pressure at the desired level. Higher concentrations of ARAMINE (metaraminol) , 150 to 500 mg per 500 mL of infusion fluid, have been used.
If the patient needs more saline or dextrose solution at a rate of flow that would provide an excessive dose of the vasopressor, the recommended volume of infusion fluid (500 mL) should be increased accordingly. ARAMINE (metaraminol) may also be added to less than 500 mL of infusion fluid if a smaller volume is desired.
In addition to Sodium Chloride Injection and Dextrose Injection 5%, the following infusion solutions were found physically and chemically compatible with Injection ARAMINE when 5 mL of Injection ARAMINE, 10 mg/mL (metaraminol equivalent), was added to 500 mL of infusion solution: Ringer's Injection, Lactated Ringer's Injection Dextran 6% in Saline †, Normosol®-R pH 7.4†, and Normosol®-M in D5-W† .
When Injection ARAMINE (metaraminol) is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.
Direct Intravenous Injection: In severe shock, when time is of great importance, this agent should be given by direct intravenous injection. The suggested dose is 0.5 to 5 mg (0.05 to 0.5 mL), followed by an infusion of 15 to 100 mg (1.5 to 10 mL) in 500 mL of infusion fluid as described previously.
Vials may be sterilized by autoclaving or by immersion in a sterilizing solution.
No. 3222X — Injection ARAMINE 1%, containing metaraminol bitartrate equivalent to 10 mg of metaraminol per mL, is a clear, colorless solution and is supplied as follows:
NDC 0006-3222-10 in 10 mL vials
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store container in carton until contents have been used. Protect from light. Protect from freezing.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Aramine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.