Hydroxyprogesterone Caproate

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Overview

What is Hydroxyprogesterone Caproate?

Hydroxyprogesterone Caproate Injection, USP is a sterile, long-acting preparation of the caproate ester of the naturally-occurring progestational hormone, hydroxyprogesterone, in an oil solution for intramuscular use.

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 creamy white crystalline powder.

The structural formula is:

Each 5 mL multiple-dose vial contains hydroxyprogesterone caproate, 250 mg/mL, in castor oil (28.6% v/v) and benzyl benzoate (46% v/v) with the preservative benzyl alcohol (2% v/v).

What does Hydroxyprogesterone Caproate look like?

What are the available doses of Hydroxyprogesterone Caproate?

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What should I talk to my health care provider before I take Hydroxyprogesterone Caproate?

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How should I use Hydroxyprogesterone Caproate?

Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.

Suggested dosages are presented in the therapy guide. Because of the low viscosity of the vehicle, Hydroxyprogesterone Caproate Injection may be administered with a small gauge needle. Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection. Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.

Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.

THERAPY GUIDE

CYCLIC THERAPY SCHEDULE: (28-day cycle; repeated every 4 weeks)

Day 1 of each cycle: 20 mg Estradiol Valerate Injection, USP

2 weeks after Day 1: 250 mg Hydroxyprogesterone Caproate Injection, USP and 5 mg Estradiol Valerate Injection, USP

4 weeks after Day 1: This is Day 1 of next cycle

What interacts with Hydroxyprogesterone Caproate?

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What are the warnings of Hydroxyprogesterone Caproate?

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What are the precautions of Hydroxyprogesterone Caproate?

Sorry No Records found

What are the side effects of Hydroxyprogesterone Caproate?

Sorry No records found

What should I look out for while using Hydroxyprogesterone Caproate?

Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

What might happen if I take too much Hydroxyprogesterone Caproate?

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How should I store and handle Hydroxyprogesterone Caproate?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05).StorageHydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water.Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.Manufactured for: Rockford, IL 61103 U.S.A.by: Santa Ana, CA 92704 U.S.A.MD381-0051aRevised: 1/2017MCG:HPCIJ:R1

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The effect of hepatic impairment on the pharmacokinetics of hydroxyprogesterone caproate has not been evaluated.

Hydroxyprogesterone caproate is extensively metabolized and hepatic impairment may reduce the elimination of hydroxyprogesterone caproate.

Non-Clinical Toxicology

Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone Hydrochloride and Acetaminophen Tablets.

If concomitant use is necessary, consider dosage reduction of Oxycodone Hydrochloride and Acetaminophen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider increasing the Oxycodone Hydrochloride and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride and Acetaminophen Tablets dosage reduction and monitor for signs of respiratory depression.

Benzodiazepines and Other CNS Depressants

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone Hydrochloride and Acetaminophen Tablets if serotonin syndrome is suspected.

The use of Oxycodone Hydrochloride and Acetaminophen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Advise patient to avoid concomitant use of these drugs.

Muscle Relaxants

If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone Hydrochloride and Acetaminophen Tablets and/or the muscle relaxant as necessary.

Diuretics

If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone Hydrochloride and Acetaminophen Tablets are used concomitantly with anticholinergic drugs.

Alcohol, ethyl

Oral Contraceptives

Charcoal (activated)

Beta Blockers (Propranolol)

Loop Diuretics

Lamotrigine

Probenecid

Zidovudine

Detectable amounts of progestins have been identified in the milk of mothers receiving the drug. Many studies have found no adverse effects of progestins on breastfeeding performance, or on the health, growth, or development of the infant.

Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this effect, such as asthma, migraine, epilepsy, or cardiac or renal dysfunction require careful observation.

The pretreatment physical examination should include examination of the breasts and pelvic organs and a Papanicolaou smear.

In relation to irregular bleeding which does not respond predictably to the hormone therapy, nonfunctional causes should be borne in mind and adequate diagnostic measures instituted.

Any influence of prolonged sex hormone medication on pituitary, ovarian, adrenal, hepatic, or uterine function awaits further study.

The pathologist should be advised of progesterone therapy when relevant specimens are submitted.

Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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A few instances of coughing, dyspnea, constriction of the chest, and/or allergic-like reactions have occurred following hydroxyprogesterone caproate therapy; the likelihood of these occurring may be increased at higher dosage levels.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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