pressure caused by pregnancy)
Gestational diabetes
Oligohydramnios (low amniotic fluid levels)
Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Makena?
Store Makena at room temperature (59° to 86°F or 15° to 30°C)
Store Makena in the original box to protect it from light
Store the Makena box upright
Makena should be used within 5 weeks after first use.
Keep Makena out of the reach of children
General information about the safe and effective use of Makena.
Medicines are sometimes prescribed for purposes other than those mentioned in the Patient Information Leaflets. Do not take Makena for conditions for which it was not prescribed. Do not give Makena to other people, even if they have the same condition you have. It may harm them.
This leaflet summarizes the most important information about Makena. If you would like more information, talk with your healthcare provider. You can ask for information about Makena that is written for healthcare professionals.
For more information, go to www.Makena.com or call Ther-Rx Corporation Customer Service at the toll free number 1-877-567-7676.
To refill a prescription or to check on prescription status, call the Makena Care Connection at the toll free number 1-800-847-3418.
What are the ingredients in Makena?
Active ingredient: hydroxyprogesterone caproate
Inactive ingredients: castor oil, benzyl benzoate, and benzyl alcohol (a preservative)
PRINCIPAL DISPLAY PANEL - CARTON
Carton Label
NDC 64011-243-01
MakenaTM
hydroxyprogesterone
caproate injection
1250 mg/5 mL
(250 mg/mL)
FOR INTRAMUSCULAR USE
5 mL multidose vial
Rx ONLY
Store at controlled room temperature
15°-30°C (59°-86°F).
Caution: Protect vial from light.
Store vial in its box. Store upright. Use within
5 weeks after first use.
Each mL contains:
hydroxyprogesterone caproate
250 mg, benzyl benzoate 46%,
castor oil 28.6%, and benzyl
alcohol 2%, as preservative.
See package insert for
full prescribing and
patient information.
Ther-Rx Corporation
P10071 - 1 4/12
Makena
hydroxyprogesterone caproate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64011-243
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroxyprogesterone Caproate (HYDROXYPROGESTERONE) Hydroxyprogesterone Caproate 250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL 277.8 mg in 1 mL
BENZYL BENZOATE 514.3 mg in 1 mL
BENZYL ALCOHOL 21.92 mg in 1 mL
Packaging
# Item Code Package Description
1 NDC:64011-243-01 1 VIAL, GLASS in 1 CARTON
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021945 02/03/2011
Labeler - Ther-Rx Corporation (055041706)
Registrant - KV Pharmaceutical Co. (006291405)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 MA |
