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Makena
Overview
What is Makena?
The active pharmaceutical ingredient in Makena is hydroxyprogesterone caproate, a progestin.
The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy]. It has an empirical formula of CHO and a molecular weight of 428.60. Hydroxyprogesterone caproate exists as white to practically white crystals or powder with a melting point of 120°-124°C.
The structural formula is:
Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular (vials) or subcutaneous (auto-injector) injection. Each 1.1 mL Makena auto-injector for subcutaneous use and each 1 mL single-dose vial for intramuscular use contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in a preservative-free solution containing castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v). Each 5 mL multi-dose vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6%) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).
What does Makena look like?
What are the available doses of Makena?
1.1 mL single-use auto-injector for subcutaneous use contains 275 mg of hydroxyprogesterone caproate (250 mg/mL) ()
1 mL single-dose vial for intramuscular use contains 250 mg of
hydroxyprogesterone caproate. ()
5 mL multi-dose vial for intramuscular use contains 1250 mg of
hydroxyprogesterone caproate (250 mg/mL). ()
What should I talk to my health care provider before I take Makena?
How should I use Makena?
Makena is a progestin indicated to reduce the risk of preterm
birth in women with a singleton pregnancy who have a history of
singleton spontaneous preterm birth. The effectiveness of Makena is
based on improvement in the proportion of women who delivered < 37
weeks of gestation. There are no controlled trials demonstrating a
direct clinical benefit, such as improvement in neonatal mortality and
morbidity.
Limitation of use
It is not intended
for use in women with multiple gestations or other risk factors for
preterm birth.
Makena auto-injector: Administer subcutaneously using Makena auto-injector at a dose of 275 mg (1.1 mL) once weekly, in the back of either upper arm ()
Makena (single- and multi-dose vials): Administer intramuscularly at a dose of 250 mg (1 mL) once weekly in the upper outer quadrant of the gluteus maximus ()
Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation ()
Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first ()
What interacts with Makena?
Sorry No Records found
What are the warnings of Makena?
Sorry No Records found
What are the precautions of Makena?
Sorry No Records found
What are the side effects of Makena?
Sorry No records found
What should I look out for while using Makena?
Do not use Makena in women with any of the following conditions:
What might happen if I take too much Makena?
There have been no reports of adverse events associated with
overdosage of Makena in clinical trials. In the case of overdosage, the
patient should be treated symptomatically.
How should I store and handle Makena?
Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.Makena auto-injector (for subcutaneous injection) Makena auto-injector (NDC 64011-301-03) is supplied as 1.1 mL of a clear yellow sterile preservative-free solution in an auto-injector containing a pre-filled syringe. Each 1.1 mL auto-injector contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1.1 mL single-patient-use auto-injector of Makena containing 275 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.Caution: Protect auto-injector from light. Store auto-injector in its box. Makena single- and multi-dose vials (for intramuscular injection)Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).Single unit carton: Contains one 1 mL single-dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial.Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).Single unit carton: Contains one 5 mL multi-dose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use.Caution: Protect vial from light. Store vial in its box. Store upright.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydroxyprogesterone caproate is a synthetic progestin.
The mechanism by which hydroxyprogesterone caproate reduces the
risk of recurrent preterm birth is not known.
Non-Clinical Toxicology
Do not use Makena in women with any of the following conditions:Discontinue Makena if an arterial or deep venous thrombotic or thromboembolic event occurs.
For the most serious adverse reactions to the use of progestins, see
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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