Hydroxyprogesterone Brand Name– Makena
What is Hydroxyprogesterone
Hydroxyprogesterone caproate (also known as 17-alpha hydroxyprogesterone caproate) is an injectable progestin.
One product (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; the drug is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Studies have shown progestational agents to be ineffective in preventing preterm delivery in women carrying multiple fetuses (e.g., twins, triplets), in women at low-risk for preterm delivery (e.g., no history of preterm delivery in previous pregnancies), in the prevention of early pregnancy loss or threatened abortion, or in prolonging pregnancy once labor has started.
A meta-analysis of studies demonstrated that progestational agents reduce the risk of delivery before 37 weeks gestation (RR 0.57, 95% CI 0.36 to 0.9).
There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Hydroxyprogesterone caproate injections have long been used for other female hormonal conditions, including amenorrhea, dysfunctional uterine bleeding, and the palliation of advanced endometrial cancer.
The initial FDA approval of hydroxyprogesterone was in 1956.
Indications
- amenorrhea
- dysfunctional uterine bleeding
- endometrial cancer
- preterm delivery prophylaxis
- test for endogenous estrogen production
For preterm delivery prophylaxis in females with a singleton pregnancy who have a history of singleton spontaneous preterm birth
Side Effects
- anxiety
- breast discharge
- depression
- diabetes mellitus
- diarrhea
- dizziness
- dyspnea
- edema
- emotional lability
- erythema
- fatigue
- fetal death
- fever
- fluid retention
- galactorrhea
- headache
- hot flashes
- hyperglycemia
- hypertension
- infection
- injection site reaction
- irritability
- jaundice
- mastalgia
- nausea
- premature labor
- pruritus
- pulmonary embolism
- rash
- retinal thrombosis
- skin irritation
- spontaneous fetal abortion
- stroke
- thromboembolism
- urticaria
- vaginal bleeding
- vomiting
Monitoring Parameters
- pelvic exam
- pelvic ultrasound
Contraindications
- asthma
- benzyl alcohol hypersensitivity
- breast cancer
- breast-feeding
- cardiac disease
- cervical cancer
- children
- cholestasis
- depression
- diabetes mellitus
- hepatic disease
- hepatocellular cancer
- hypertension
- infants
- intravenous administration
- jaundice
- labor
- migraine
- neonates
- polyoxyethylated castor oil hypersensitivity
- preeclampsia
- pregnancy
- renal disease
- seizure disorder
- thromboembolic disease
- thromboembolism
- thrombophlebitis
- uterine cancer
- vaginal bleeding
- vaginal cancer
Interactions
- Acetaminophen
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
- Acetaminophen; Dextromethorphan; Phenylephrine
- Acetaminophen; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Dichloralphenazone; Isometheptene
- Acetaminophen; Diphenhydramine
- Acetaminophen; Guaifenesin; Phenylephrine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Propoxyphene
- Acetaminophen; Pseudoephedrine
- Acetaminophen; Tramadol
- Acetohexamide
- Alogliptin
- Alogliptin; Metformin
- Alogliptin; Pioglitazone
- Alpha-glucosidase Inhibitors
- Amobarbital
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Apalutamide
- Aprepitant, Fosaprepitant
- Armodafinil
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Atazanavir; Cobicistat
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Barbiturates
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Benzhydrocodone; Acetaminophen
- Bexarotene
- Bosentan
- Bromocriptine
- Bupropion
- Bupropion; Naltrexone
- Butabarbital
- Canagliflozin; Metformin
- Carbamazepine
- Cenobamate
- Chlorpropamide
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Clobazam
- Clozapine
- Cobicistat
- Danazol
- Dapagliflozin
- Dapagliflozin; Metformin
- Dapagliflozin; Saxagliptin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Diltiazem
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elbasvir; Grazoprevir
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Empagliflozin
- Empagliflozin; Linagliptin
- Empagliflozin; Linagliptin; Metformin
- Empagliflozin; Metformin
- Enzalutamide
- Ertugliflozin; Metformin
- Ertugliflozin; Sitagliptin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Felbamate
- Fluconazole
- Fosamprenavir
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Glipizide
- Glipizide; Metformin
- Glyburide
- Glyburide; Metformin
- Griseofulvin
- Halothane
- Hydantoins
- Idelalisib
- Incretin Mimetics
- Insulins
- Isavuconazonium
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ketoconazole
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Linagliptin
- Linagliptin; Metformin
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lorlatinib
- Meglitinides
- Mephobarbital
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methadone
- Methohexital
- Mitotane
- Modafinil
- Netupitant, Fosnetupitant; Palonosetron
- Nevirapine
- Nicotine
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Oritavancin
- Oxcarbazepine
- Pentobarbital
- Phenobarbital
- Phentermine; Topiramate
- Pramlintide
- Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements)
- Prasterone, Dehydroepiandrosterone, DHEA (FDA-approved)
- Primidone
- Rifabutin
- Rifampin
- Rifamycins
- Rifapentine
- Ritonavir
- Saquinavir
- Saxagliptin
- Secobarbital
- Simvastatin; Sitagliptin
- Sitagliptin
- Sofosbuvir; Velpatasvir
- Sofosbuvir; Velpatasvir; Voxilaprevir
- St. John’s Wort, Hypericum perforatum
- Sulfonylureas
- Tazemetostat
- Telotristat Ethyl
- Terbinafine
- Theophylline, Aminophylline
- Thiopental
- Tizanidine
- Tolazamide
- Tolbutamide
- Topiramate
- Trandolapril; Verapamil
- Ulipristal
- Vemurafenib
- Verapamil
- Voriconazole
