hydroxyprogesterone caproate

Action and Spectrum

Actions and Spectrum: 

Hydroxyprogesterone caproate acts as a progestational agent and reduces the risk of preterm birth. Progesterone hormone plays an important role to maintain the pregnancy. It prepares the uterus for the implantation of fertilized egg and supports the development and growth of fetus.  

Hydroxyprogesterone caproate binds to progesterone receptor and mimic the action of natural progesterone. This helps to maintain pregnancy and prevent the preterm labor. 

The activity of hydroxyprogesterone caproate is limited. It reduces the risk of preterm birth in pregnant women. It is not effective in women who have history of preterm birth or cervical incompetence. It is also not effective to treat the preterm labor which is already started. 

Drug Interaction

Adverse Reaction

Adverse Reaction:

Frequency defined 

>10% 

Urticaria (12.3%) 

Swelling on injection area (17.1%) 

Pain on injection area (34.8%) 

1-10% 

Pruritus on injection area (5.8%) 

Diarrhea (2.3%) 

Pruritus (7.7%) 

Injection site nodule (4.5%) 

Nausea (5.8%) 

Frequency not defined 

Fluid retention 

Jaundice 

Depression 

Thromboembolic events 

Angioedema 

Vaginal bleeding 

Decreased glucose tolerance 

Hypertension 

Black Box Warning

Black Box Warning: 

The black box warning for hydroxyprogesterone caproate is associated with the risk of neonatal death and other adverse results. 

It is not for the use to prevent the preterm birth in women who have a multiple pregnancy. Research has observed that the usage of this medication in multiple pregnancy can be linked with an elevated risk of fetal and neonatal heath and adverse result.

Contraindication / Caution

Contraindication/Caution: 

Allergy: Females who are allergic to this medication or components which is used in it must not take it.  

Liver disease: Patients who have severe liver disease must not take it.  

Blood clots: Patients who have any history of blood clots DVT or pulmonary embolism must not use this medication.  

Undiagnosed vaginal bleeding: Women who have unexplained vaginal bleeding must not use this medication. 

Breast cancer: Patients who have any history of breast cancer must not use this medication. 

Active liver disease: Women who have active liver disease like hepatitis B or C must not use this medication. 

Known or suspected pregnancy: hydroxyprogesterone caproate must not be used during the pregnancy. 

Porphyria: Patients who have porphyria affect the production of a heme must not use this medication.  

Caution: 

Diabetes: Females who have diabetes mellitus must use this medication with curation because it affects the blood glucose level and may need adjustment to treat diabetes. 

Hypertension: hydroxyprogesterone caproate may elevate the blood pressure. So it must be used with caution.  

Asthma: Hydroxyprogesterone caproate may increase the symptoms of asthma in some females. It must be used with cautions when it is prescribes in this condition. 

Depression: females who have history of depression or other mental conditions must use this medications with cautions because it can cause mood changes. 

Thromboembolic disorders: Females who have any history of blood clots, DVT or pulmonary embolism must use his medication with cautions because it can increase the risk o blood clots. 

Renal impairment: Hydroxyprogesterone caproate is mainly eliminated by the kidneys. Precautions must be taken if it is used in females who have renal impairment. 

Pregnancy / Lactation

Pregnancy / Lactation:

Pregnancy consideration:  

Pregnancy Category: Not assigned. 

Lactation:   

Excreted into human milk is Not known.  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/later trimester.        
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women        
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.       
• Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.        
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.        
• Category N: There is no data available for the drug under this category.

Pharmacology

Pharmacology: 

Hydroxyprogesterone caproate, 17α-hydroxyprogesterone caproate or 17P is a synthetic form of the progesterone hormone. 

It is used to prevent the preterm birth in females who had an earlier preterm delivery. It is a progastrin and binds to the progesterone receptors and activates it. This can reduce the production of the prostaglandins.  

Pharmacodynamics: 

The mechanism of this medication to reduce the risk of preterm labor is not known. 

Pharmacokinetics: 

Absorption 

The peak plasma level is reached in 3 to 7 days after the single dose of IM injection and the time is about 4.6 to 6.3 days.  

Distribution 

It is highly protein bound medication. It binds to albumin and corticosteroid binding globulins. 

Metabolism 

The ½ life of hydroxyprogesterone caproate is about 7.8 to 10.8 days. It goes for hepatic metabolism mainly by the CYP3A5 and CYP3A4 enzymes.  

Elimination and Excretion 

hydroxyprogesterone caproate is eliminated by the feces and urine. About 50% of the drug is eliminated by the feces and 30% is by the urine. Conjugated and free form are excreted by this process.

Adminstartion

Administration: 

Intramuscular administration 

Hydroxyprogesterone caproate is administrated by IM injection by a helahcare provider. This injection is given into the muscle of buttocks or hip. The frequency and dosage can vary on the basis of condition and other factors. It must be determined by the healthcare provider.

Patient Information Leaflet

Patient information leaflet 

Generic Name: hydroxyprogesterone caproate 

Pronounced: [ hye-DROX-ee-pro-JES-te-rone ] 

Why do we use hydroxyprogesterone caproate? 

• Hydroxyprogesterone caproate is a synthetic form of progestin hormone. It is used in different medical conditions.  

  To prevent preterm birth: It is used to decrease the risk of preterm birth during the pregnancy.  

  Hormone replacement therapy: It is used as a hormone replacement therapy in females who have reduced levels of progesterone.  

  Menstrual diseases: It is sued to treat menstrual diseases like abnormal uterine bleeding. 

  Endometriosis: Hydroxyprogesterone caproate is used to treat endometriosis. 

  Breast cancer: Hydroxyprogesterone caproate is used to treat metastatic breast cancer.