"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(hydrocortisone sodium succinate) for Injection, USP
For Intravenous or Intramuscular Administration
SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid, which contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.
100 mg Plain - Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions).
ACT-O-VIAL® System (Single-Dose Vial) in four strengths:
Each 2 mL contains:
Each 2 mL contains:
Each 4 mL contains:
Each 8 mL contains:
|Hydrocortisone sodium succinate||equiv. to 100 mg Hydrocortisone||equiv. to 250 mg Hydrocortisone||equiv. to 500 mg Hydrocortisone||equiv. to 1000 mg Hydrocortisone|
|Monobasic sodium phosphate anhydrous||0.8 mg||2 mg||4 mg||8 mg|
|Dibasic sodium phosphate dried||8.73 mg||21.8 mg||44 mg||87.32 mg|
When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.
The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52.
The structural formula is represented below:
Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone and insoluble in chloroform.
What are the precautions when taking hydrocortisone sodium succinate (Solu Cortef)?
Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current fungal infections.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other infections (e.g., tuberculosis, threadworm), bleeding problems, blood clots, brittle bones (osteoporosis), high blood pressure, certain heart problems (e.g., congestive heart failure,...
Last reviewed on RxList: 7/12/2010
This monograph has been modified to include the generic and brand name in many instances.
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