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You are now leaving makena. AMAG Pharmaceuticals is not responsible for the information contained in any of the linked third-party sites. If you have any questions or concerns about receiving your therapy as prescribed, we encourage you to talk directly with your healthcare provider about options that may be available to you.

Because Makena auto-injector is preservative-free, once the cap is removed the device should be used immediately or discarded. Rotate the injection site to the alternate arm from the previous week.

Do not use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard. Avoid areas with scars, tattoos, or stretch marks.

The solution is viscous and oily. The auto-injector takes approximately 15 seconds to deliver the dose; when the viewing window is fully blocked completely orange , the full dose has been administered.

For subcutaneous injection. Single Use. Administer one injection weekly. Administration by Healthcare Professionals only.

Record the location of the injection site in the patient's record to ensure rotation of the injection site each week.

Discontinue Makena if an arterial or deep venous thrombotic or thromboembolic event occurs. Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil.

Consider discontinuing the drug if such reactions occur. A decrease in glucose tolerance has been observed in some patients on progestin treatment.

The mechanism of this decrease is not known. Carefully monitor prediabetic and diabetic women while they are receiving Makena.

Because progestational drugs may cause some degree of fluid retention, carefully monitor women with conditions that might be influenced by this effect e.

Monitor women who have a history of clinical depression and discontinue Makena if clinical depression recurs. Carefully monitor women who develop jaundice while receiving Makena and consider whether the benefit of use warrants continuation.

Carefully monitor women who develop hypertension while receiving Makena and consider whether the benefit of use warrants continuation.

For the most serious adverse reactions to the use of progestins, see Warnings and Precautions 5. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a vehicle placebo -controlled clinical trial of pregnant women at risk for spontaneous preterm delivery based on obstetrical history, received mg of Makena and received a vehicle formulation containing no drug by a weekly intramuscular injection beginning at 16 to 20 weeks of gestation and continuing until 37 weeks of gestation or delivery, whichever occurred first.

Certain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena-treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios Tables 1 and 2.

The most common adverse reaction with intramuscular injection was injection site pain, which was reported after at least one injection by In the clinical trial using intramuscular injection, 2.

Pulmonary embolus in one subject and injection site cellulitis in another subject were reported as serious adverse reactions in Makena-treated subjects.

Two clinical studies were conducted in healthy post-menopausal women, comparing Makena administered via subcutaneous auto-injector to Makena administered as an intramuscular injection.

The following adverse reactions have been identified during postapproval use of Makena. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In vitro drug-drug interaction studies were conducted with Makena. Makena is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Fetal, neonatal, and maternal risks are discussed throughout labeling. Data from the placebo-controlled clinical trial and the infant follow-up safety study [ see Clinical Studies However, these data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the Makena-treated women received the drug during the first trimester of pregnancy.

In animal reproduction studies, intramuscular administration of hydroxyprogesterone caproate to pregnant rats during gestation at doses 5 times the human dose equivalent based on a kg human was not associated with adverse developmental outcomes.

In the U. Reproduction studies of hydroxyprogesterone caproate administered to various animal species have been reported in the literature.

In nonhuman primates, embryolethality was reported in rhesus monkeys administered hydroxyprogesterone caproate up to 2.

There were no teratogenic effects in either strain of monkey. Reproduction studies have been performed in mice and rats at doses up to 95 and 5, respectively, times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to hydroxyprogesterone caproate.

Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate.

Published studies have reported no adverse effects of progestins on the breastfed child or on milk production. Makena is not indicated for use in women under 16 years of age.

Safety and effectiveness in patients less than 16 years of age have not been established. A small number of women under age 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older [ See Clinical Studies 14 ].

No studies have been conducted to examine the pharmacokinetics of Makena in patients with hepatic impairment. Makena is extensively metabolized and hepatic impairment may reduce the elimination of 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.

The active pharmaceutical ingredient in Makena is hydroxyprogesterone caproate, a progestin. The chemical name for hydroxyprogesterone caproate is pregnene-3,dione, 17[ 1-oxohexyl oxy].

It has an empirical formula of C 27 H 40 O 4 and a molecular weight of Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular vials or subcutaneous auto-injector injection.

Each 1. Hydroxyprogesterone caproate is a synthetic progestin. The mechanism by which hydroxyprogesterone caproate reduces the risk of recurrent preterm birth is not known.

Absorption: Female patients with a singleton pregnancy received intramuscular doses of mg hydroxyprogesterone caproate for the reduction of preterm birth starting between 16 weeks 0 days and 20 weeks 6 days.

All patients had blood drawn daily for 7 days to evaluate pharmacokinetics. Blood was drawn daily for 7 days 1 starting 24 hours after the first dose between Weeks Group 1 , 2 after a dose between Weeks Group 2 , or 3 after a dose between Weeks Group 3.

For all three groups, peak concentration C max and area under the curve AUC days of the mono-hydroxylated metabolites were approximately fold lower than the respective parameters for the parent drug, hydroxyprogesterone caproate.

While di-hydroxylated and tri-hydroxylated metabolites were also detected in human plasma to a lesser extent, no meaningful quantitative results could be derived due to the absence of reference standards for these multiple hydroxylated metabolites.

The relative activity and significance of these metabolites are not known. The elimination half-life of hydroxyprogesterone caproate, as evaluated from 4 patients in the study who reached full-term in their pregnancies, was The elimination half-life of the mono-hydroxylated metabolites was In a single-dose, open-label, randomized, parallel design bioavailability study in healthy post-menopausal women, comparable systemic exposure of hydroxyprogesterone caproate was seen when Makena was administered subcutaneously with the auto-injector 1.

Distribution: Hydroxyprogesterone caproate binds extensively to plasma proteins including albumin and corticosteroid binding globulins.

Metabolism: In vitro studies have shown that hydroxyprogesterone caproate can be metabolized by human hepatocytes, both by phase I and phase II reactions.

Hydroxyprogesterone caproate undergoes extensive reduction, hydroxylation and conjugation. The conjugated metabolites include sulfated, glucuronidated and acetylated products.

The in vitro data indicate that the caproate group is retained during metabolism of hydroxyprogesterone caproate. Excretion: Both conjugated metabolites and free steroids are excreted in the urine and feces, with the conjugated metabolites being prominent.

However, in another in vitro study using human hepatocytes under conditions where the prototypical inducers or inhibitors caused the anticipated increases or decreases in CYP enzyme activities, hydroxyprogesterone caproate did not induce or inhibit CYP1A2, CYP2A6, or CYP2B6 activity.

Hydroxyprogesterone caproate has not been adequately evaluated for carcinogenicity. No reproductive or developmental toxicity or impaired fertility was observed in a multigenerational study in rats.

Hydroxyprogesterone caproate administered intramuscularly, at gestational exposures up to 5 times the recommended human dose, had no adverse effects on the parental F 0 dams, their developing offspring F 1 , or the latter offspring's ability to produce a viable, normal second F 2 generation.

In a multicenter, randomized, double-blind, vehicle placebo -controlled clinical trial, the safety and effectiveness of Makena for the reduction of the risk of spontaneous preterm birth was studied in women with a singleton pregnancy age 16 to 43 years who had a documented history of singleton spontaneous preterm birth defined as delivery at less than 37 weeks of gestation following spontaneous preterm labor or premature rupture of membranes.

At the time of randomization between 16 weeks, 0 days and 20 weeks, 6 days of gestation , an ultrasound examination had confirmed gestational age and no known fetal anomaly.

Demographics of the Makena-treated women were similar to those in the control group, and included: The mean body mass index was Do not refrigerate or freeze.

Store upright, protected from light, in the original carton. Discard any unused product within 5 weeks of first use. Inject deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for IM injection.

The injection provides a high concentration in a small volume; particular care should be taken to administer the full dose. Storage of multiple-dose vials: Storage instructions may vary between products; refer to the product label for specific storage information.

Hydroxyprogesterone auto-injector is a single-use, pre-filled, disposable device containing a gauge, 0. For subcutaneous use only.

The device is intended for use by a health-care professional to administer to a patient. The patient should not self-administer the injection.

Read the Instructions for Use before administration. Subcutaneous injection Makena auto-injector : Inspect the auto-injector for any damage; do not use if it appears damaged or broken, or if cap is missing or not secure.

Inspect the liquid through the viewing window;an air bubble may be noticed, this is normal. Wash hands with soap and water and wipe the injection site with an alcohol swab; allow the site to dry on its own.

Do not fan or blow on the injection site. Do not touch the site again before injecting. Only use the back of either upper arm for the injection site.

Do not use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard. Avoid areas with scars, tattoos, or stretch marks.

Rotate the injection site to the alternate arm from the previous week. To remove the cap, twist the cap counter clockwise this will break the red safety seal , and pull straight off.

After the cap is removed, a few drops of the liquid may appear - this is normal. The auto-injector should be used or discarded once the cap is removed.

Do not recap for later use. Do not use the auto-injector if the device is dropped. To inject, support the upper arm with the opposite hand.

On the relaxed outstretched arm to be injected, gently place the auto-injector at a 90 degree angle to the injection site back of upper arm.

Check that the viewing window is seen clearly. It will take approximately 15 seconds for the full dose to be delivered. Push down while supporting the upper arm with the opposite hand.

A click will occur when the injections begins. Hold the auto-injector against the arm. While holding against the arm, watch the viewing window until it turns completely orange before removing the injector from the injection site.

It is normal if there is slight bleeding after injection. If this occurs, hold a cotton ball or gauze on the area with light pressure for a few seconds.

Do not rub the area. After completing injection, dispose of auto-injector and cap in a sharps disposal container immediately after use.

Makena: - Discard unused portion. Do not store for later use. Hydroxyprogesterone caproate injection is for intramuscular or subcutaneous use only.

Do not administer via intravenous administration. Hydroxyprogesterone caproate injection contains castor oil.

Allergic reactions, including urticaria, pruritus, and angioedema have been reported with use of hydroxyprogesterone and other products containing castor oil.

Therefore, use caution when administering to patients with polyoxyethylated castor oil hypersensitivity and discontinue use if allergic reactions occur.

In addition, hydroxyprogesterone caproate multi-dose vials contain the preservative benzyl alcohol, which can cause adverse effects in patients with a benzyl alcohol hypersensitivity and should be avoided in these patients.

Hydroxyprogesterone is contraindicated in patients with current or history of thromboembolism or thromboembolic disease. If a thromboembolic event occurs, including thrombophlebitis or deep venous thrombus, discontinue hydroxyprogesterone immediately.

Hydroxyprogesterone is contraindicated in patients with known or suspected breast cancer or other hormone-sensitive cancer, such as cervical cancer, uterine cancer, or vaginal cancer.

A history of any of these conditions also contraindicates the use of hydroxyprogesterone. Hydroxyprogesterone is contraindicated in patients with undiagnosed abnormal vaginal bleeding unrelated to being pregnant.

Hydroxyprogesterone is contraindicated in patients with uncontrolled hypertension. Close monitoring of patients who develop hypertension while receiving therapy is recommended; careful consideration should be given to whether the benefit of use warrants continuation of therapy.

Progestational drugs may cause some degree of fluid retention. Therefore, use hydroxyprogesterone cautiously in patients with preeclampsia, cardiac disease, or any other condition that might be influenced by this effect.

Carefully monitor women with these conditions. Hydroxyprogesterone should be used cautiously in patients with diabetes mellitus.

Although the effects appear to be minimal during therapy with progestins, decreased glucose tolerance has been observed in some patients on progestin treatment.

The mechanism of this decrease is unknown. Carefully monitor prediabetic and diabetic patients while on hydroxyprogesterone therapy. Hydroxyprogesterone should be used cautiously in patients with a history of depression.

Progestins may exacerbate this condition in some patients. Monitor women who have a history of clinical depression and discontinue therapy if clinical depression recurs.

In addition, progestational drugs may cause some degree of fluid retention. Therefore, use hydroxyprogesterone cautiously in patients with a history of migraine or seizure disorder or other condition that might be influenced by this effect.

Therefore, use hydroxyprogesterone cautiously in patients with renal disease, asthma, or any other condition that might be influenced by this effect.

Hydroxyprogesterone is intended for use during pregnancy in order to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show a difference in adverse developmental outcomes between children of hydroxyprogesterone-treated women and children of control subjects.

The data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the hydroxyprogesterone-treated women received the drug during the first trimester of pregnancy.

Hydroxyprogesterone administration produced embryolethality in rhesus monkeys but not in cynomolgus monkeys exposed to 1 and 10 times the human dose equivalent every 7 days between days 20 and of gestation.

There were no teratogenic effects in either monkey species. Hydroxyprogesterone is not intended for use to stop active preterm labor; its effect in active labor is unknown.

Hydroxyprogesterone is contraindicated in patients with hepatocellular cancer, benign liver tumors, or active hepatic disease. Hydroxyprogesterone is extensively metabolized and hepatic impairment may reduce its elimination.

In addition, hydroxyprogesterone is contraindicated in patients with symptomatic Intrahepatic Cholestasis of Pregnancy ICP. Patients who develop jaundice while receiving therapy should be closely monitored; careful consideration should be given to whether the benefit of use warrants continuation of therapy.

Hydroxyprogesterone is considered compatible with breast-feeding. Detectable amounts of progestins have been identified in the milk of mothers receiving progestin treatment.

Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate. Published studies have reported no adverse effects of progestins on the breast-fed child or on milk production.

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This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Skip to Content.

Instructions for Use: Read this carefully before each use. Protect from light. Keep away from children. DO NOT use if it appears damaged or broken, or if cap is missing or not secure.

DO NOT use if expired. See Figure 1. DO NOT use if the liquid is cloudy or if particles are present. You may notice an air bubble, this is normal.

See Figure 2. DO NOT fan or blow on the injection site. DO NOT touch the site again before injecting. DO NOT use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard.

See Figure 3. After the cap is removed, a few drops of liquid may appear - this is normal. Auto-Injector should be used or discarded once cap is removed.

DO NOT recap for later use. DO NOT use if device is dropped. See Figure 4. Push down while supporting the upper arm with the opposite hand.

A click will occur when the injection begins. See Figure 5. Hold the Auto-Injector against the arm. If this occurs, hold a cotton ball or gauze on the area with light pressure for a few seconds.

DO NOT rub the area. Call for assistance. Waltham, MA rev They were counted as deliveries at their gestational ages at time of last contact 18 4 , 22 0 , 34 3 and 36 4 weeks.

This Patient Information has been approved by the U. What is Makena? Makena is for women who: Are pregnant with one baby.

Have had a preterm delivery of one baby in the past. Makena is not intended for use to stop active preterm labor.

Makena is not for use in women under 16 years of age. Who should not receive Makena? Makena should not be used if you have: blood clots or other blood clotting problems now or in the past breast cancer or other hormone-sensitive cancers now or in the past unusual vaginal bleeding not related to your current pregnancy yellowing of your skin due to liver problems during your pregnancy liver problems, including liver tumors high blood pressure that is not controlled What should I tell my healthcare provider before receiving Makena?

Before you receive Makena, tell your healthcare provider about all of your medical conditions, including if you have: a history of allergic reaction to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena.

See the end of this Patient Information leaflet for a complete list of ingredients in Makena. Makena may affect the way other medicines work, and other medicines may affect how Makena works.

How should I receive Makena? Do not give yourself Makena injections. A healthcare provider will give you the Makena injection 1 time each week every 7 days either: in the back of your upper arm as an injection under the skin subcutaneous , or in the upper outer area of the buttocks as an injection into the muscle intramuscular.

You will start receiving Makena injections anytime from 16 weeks and 0 days of your pregnancy, up to 20 weeks and 6 days of your pregnancy.

You will continue to receive Makena injections 1 time each week until week 37 through 36 weeks and 6 days of your pregnancy or when your baby is delivered, whichever comes first.

What are the possible side effects of Makena? Makena may cause serious side effects, including: Blood clots. Symptoms of a blood clot may include; leg swelling redness in your leg a spot on your leg that is warm to the touch leg pain that gets worse when you bend your foot Call your healthcare provider right away if you get any of the symptoms above during treatment with Makena.

Allergic reactions. Symptoms of an allergic reaction may include: hives itching swelling of the face Call your healthcare provider right away if you get any of the symptoms above during treatment with Makena.

Decrease in glucose blood sugar tolerance. Your healthcare provider will need to monitor your blood sugar while taking Makena if you have diabetes or pre-diabetes.

Your body may hold too much fluid fluid retention. Yellowing of your skin and the whites of your eyes jaundice.

High blood pressure. The most common side effects of Makena include: pain, swelling, itching or a hard bump at the injection site hives itching nausea diarrhea Call your healthcare provider if you have the following at your injection site: increased pain over time oozing of blood or fluid swelling Other side effects that may happen more often in women who receive Makena include: Miscarriage pregnancy loss before 20 weeks of pregnancy Stillbirth fetal death occurring during or after the 20th week of pregnancy Hospital admission for preterm labor Preeclampsia high blood pressure and too much protein in your urine Gestational hypertension high blood pressure caused by pregnancy Gestational diabetes Oligohydramnios low amniotic fluid levels Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

How should I store Makena? Do not refrigerate or freeze. Protect the auto-injector from light. Store the auto-injector in its box.

Protect the vial from light. Store the vial in its box in an upright position. Keep Makena and all medicines out of the reach of children.

What are the ingredients in Makena? Active ingredient : hydroxyprogesterone caproate Inactive ingredients : castor oil and benzyl benzoate.

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Email address. Cancel Send. Long description: Injection, hydroxyprogesterone caproate, makena , 10 mg Short description: Makena, 10 mg.

Do not touch the site again before injecting. Only use the back of either upper arm for the injection site.

Do not use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard. Avoid areas with scars, tattoos, or stretch marks.

Rotate the injection site to the alternate arm from the previous week. To remove the cap, twist the cap counter clockwise this will break the red safety seal , and pull straight off.

After the cap is removed, a few drops of the liquid may appear - this is normal. The auto-injector should be used or discarded once the cap is removed.

Do not recap for later use. Do not use the auto-injector if the device is dropped. To inject, support the upper arm with the opposite hand.

On the relaxed outstretched arm to be injected, gently place the auto-injector at a 90 degree angle to the injection site back of upper arm. Check that the viewing window is seen clearly.

It will take approximately 15 seconds for the full dose to be delivered. Push down while supporting the upper arm with the opposite hand.

A click will occur when the injections begins. Hold the auto-injector against the arm. While holding against the arm, watch the viewing window until it turns completely orange before removing the injector from the injection site.

It is normal if there is slight bleeding after injection. If this occurs, hold a cotton ball or gauze on the area with light pressure for a few seconds.

Do not rub the area. After completing injection, dispose of auto-injector and cap in a sharps disposal container immediately after use.

Makena: - Discard unused portion. Do not store for later use. Hydroxyprogesterone caproate injection is for intramuscular or subcutaneous use only.

Do not administer via intravenous administration. Hydroxyprogesterone caproate injection contains castor oil.

Allergic reactions, including urticaria, pruritus, and angioedema have been reported with use of hydroxyprogesterone and other products containing castor oil.

Therefore, use caution when administering to patients with polyoxyethylated castor oil hypersensitivity and discontinue use if allergic reactions occur.

In addition, hydroxyprogesterone caproate multi-dose vials contain the preservative benzyl alcohol, which can cause adverse effects in patients with a benzyl alcohol hypersensitivity and should be avoided in these patients.

Hydroxyprogesterone is contraindicated in patients with current or history of thromboembolism or thromboembolic disease. If a thromboembolic event occurs, including thrombophlebitis or deep venous thrombus, discontinue hydroxyprogesterone immediately.

Hydroxyprogesterone is contraindicated in patients with known or suspected breast cancer or other hormone-sensitive cancer, such as cervical cancer, uterine cancer, or vaginal cancer.

A history of any of these conditions also contraindicates the use of hydroxyprogesterone. Hydroxyprogesterone is contraindicated in patients with undiagnosed abnormal vaginal bleeding unrelated to being pregnant.

Hydroxyprogesterone is contraindicated in patients with uncontrolled hypertension. Close monitoring of patients who develop hypertension while receiving therapy is recommended; careful consideration should be given to whether the benefit of use warrants continuation of therapy.

Progestational drugs may cause some degree of fluid retention. Therefore, use hydroxyprogesterone cautiously in patients with preeclampsia, cardiac disease, or any other condition that might be influenced by this effect.

Carefully monitor women with these conditions. Hydroxyprogesterone should be used cautiously in patients with diabetes mellitus. Although the effects appear to be minimal during therapy with progestins, decreased glucose tolerance has been observed in some patients on progestin treatment.

The mechanism of this decrease is unknown. Carefully monitor prediabetic and diabetic patients while on hydroxyprogesterone therapy.

Hydroxyprogesterone should be used cautiously in patients with a history of depression. Progestins may exacerbate this condition in some patients.

Monitor women who have a history of clinical depression and discontinue therapy if clinical depression recurs. In addition, progestational drugs may cause some degree of fluid retention.

Therefore, use hydroxyprogesterone cautiously in patients with a history of migraine or seizure disorder or other condition that might be influenced by this effect.

Therefore, use hydroxyprogesterone cautiously in patients with renal disease, asthma, or any other condition that might be influenced by this effect.

Hydroxyprogesterone is intended for use during pregnancy in order to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show a difference in adverse developmental outcomes between children of hydroxyprogesterone-treated women and children of control subjects.

The data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the hydroxyprogesterone-treated women received the drug during the first trimester of pregnancy.

Hydroxyprogesterone administration produced embryolethality in rhesus monkeys but not in cynomolgus monkeys exposed to 1 and 10 times the human dose equivalent every 7 days between days 20 and of gestation.

There were no teratogenic effects in either monkey species. Hydroxyprogesterone is not intended for use to stop active preterm labor; its effect in active labor is unknown.

Hydroxyprogesterone is contraindicated in patients with hepatocellular cancer, benign liver tumors, or active hepatic disease.

Hydroxyprogesterone is extensively metabolized and hepatic impairment may reduce its elimination. In addition, hydroxyprogesterone is contraindicated in patients with symptomatic Intrahepatic Cholestasis of Pregnancy ICP.

Patients who develop jaundice while receiving therapy should be closely monitored; careful consideration should be given to whether the benefit of use warrants continuation of therapy.

Hydroxyprogesterone is considered compatible with breast-feeding. Detectable amounts of progestins have been identified in the milk of mothers receiving progestin treatment.

Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate. Published studies have reported no adverse effects of progestins on the breast-fed child or on milk production.

Safety and effectiveness in children less than 16 years of age have not been established. Studies included a small number of pregnant women between the ages of 16 and 18; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older.

Hydroxyprogesterone is not indicated for use in neonates or infants, and studies continue to study the effect of hydroxyprogesterone on neonatal outcomes following maternal use.

Acarbose: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance. Patients receiving antidiabetic agents should be closely monitored for signs indicating changes in diabetic control when therapy with progestins is instituted or discontinued.

Acetohexamide: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance. Albiglutide: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance.

Alogliptin: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance. Alogliptin; Metformin: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance.

Alogliptin; Pioglitazone: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance. Antidiabetic Agents: Minor Progestins, like hydroxyprogesterone, can impair glucose tolerance.

Atazanavir; Cobicistat: Major Consider the benefits and risk of administering antiretroviral regimens containing cobicistat with hydroxyprogesterone caproate.

Insufficient data are available to make dosage recommendations, particularly when cobicistat is combined in other antiviral regimens.

It is not clear how cobicistat alters various progestin-only agents used for contraception, fertility or luteal support, or for hormone replacement therapy HRT.

Instruct women to report any breakthrough bleeding or other adverse effects e.

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