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Drug overview for HOLIXIA (minoxidil/progesterone):
Generic name: MINOXIDIL/PROGESTERONE
Drug class:
Therapeutic class: Dermatological
Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Progesterone is a naturally occurring progestin secreted by the corpus hair growth stimulant properties. luteum and is the prototype of the progestins.
Progesterone is used orally to reduce the incidence of endometrial hyperplasia in postmenopausal women receiving estrogen replacement therapy. Progesterone is used orally or intravaginally for the management of secondary amenorrhea. Progesterone is used intravaginally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of assisted reproductive technology (ART) treatment of infertile women.
Efficacy of progesterone vaginal insert for this indication has not been established in women 35 years of age or older. Progesterone is used parenterally for the treatment of amenorrhea and for the treatment of abnormal uterine bleeding caused by hormonal imbalance in patients without underlying organic pathology such as fibroids or uterine cancer. Progesterone also is used parenterally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of ART treatment+ of infertile women.
Generic name: MINOXIDIL/PROGESTERONE
Drug class:
Therapeutic class: Dermatological
Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Progesterone is a naturally occurring progestin secreted by the corpus hair growth stimulant properties. luteum and is the prototype of the progestins.
Progesterone is used orally to reduce the incidence of endometrial hyperplasia in postmenopausal women receiving estrogen replacement therapy. Progesterone is used orally or intravaginally for the management of secondary amenorrhea. Progesterone is used intravaginally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of assisted reproductive technology (ART) treatment of infertile women.
Efficacy of progesterone vaginal insert for this indication has not been established in women 35 years of age or older. Progesterone is used parenterally for the treatment of amenorrhea and for the treatment of abnormal uterine bleeding caused by hormonal imbalance in patients without underlying organic pathology such as fibroids or uterine cancer. Progesterone also is used parenterally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of ART treatment+ of infertile women.
DRUG IMAGES
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The following indications for HOLIXIA (minoxidil/progesterone) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for HOLIXIA (minoxidil/progesterone):
When the dropper applicator is used as directed, the applicator delivers 1 mL of minoxidil topical solution (20 or 50 mg of minoxidil in the 2 or 5% solution, respectively). When the metered-spray or extender-spray applicator is used, delivery of a 1-mL dose requires pumping the spray attachment 6 times (i.e., with approximately 3.3 or 8.3 mg of drug per metered spray with the 2 or 5% solution, respectively). When used as directed, each bottle of minoxidil topical solution should last 25-30 days provided substantial amounts of solution are not lost during applicator changes.
Progesterone is administered by orally, intravaginally, and by IM injection. Progesterone capsules are administered orally once daily at bedtime. Women who have difficulty swallowing the capsules should be advised to swallow progesterone capsules while in an upright position and with adequate amounts of fluid (e.g., a glass of water).
Administration at bedtime may alleviate some of the adverse effects (e.g., dizziness, blurred vision) associated with the drug. Progesterone vaginal gel should not be administered concurrently with other intravaginal preparations. If therapy with another agent administered intravaginally is needed, such therapy should be administered 6 hours before or 6 hours after progesterone vaginal gel.
Concomitant use of progesterone vaginal inserts with other preparations that are administered intravaginally is not recommended. Although specific studies have not been undertaken, the possibility exists that concomitant administration of a progesterone vaginal insert with another preparation administered intravaginally may alter the release and absorption of progesterone from the vaginal insert. Minoxidil solution is applied topically to the scalp.
Twice-daily application appears to be necessary for optimum results. Individuals receiving topical minoxidil therapy should be carefully instructed regarding proper use of the solution. To obtain optimum results, these individuals should be given a copy of the instructions provided by the manufacturers.
Topical minoxidil solution is applied to the total affected areas of the scalp using one of the applicators provided by the manufacturers (i.e., metered-spray applicator, extender spray applicator, dropper applicator). The manufacturers' patient information should be consulted for specific methods of application. Individuals being treated for androgenetic alopecia should be advised that because of the risk of adverse systemic effects, the topical preparation is intended for application to the scalp only and should not be applied to other areas of the body.
Prior to application of minoxidil topical solution, the hair and scalp should be dry. Individuals applying minoxidil topical solution with their fingertips should be instructed to wash their hands thoroughly afterward. When the metered-spray or extender-spray applicator is used, inhalation of the spray mist should be avoided.
Administration at bedtime may alleviate some of the adverse effects (e.g., dizziness, blurred vision) associated with the drug. Progesterone vaginal gel should not be administered concurrently with other intravaginal preparations. If therapy with another agent administered intravaginally is needed, such therapy should be administered 6 hours before or 6 hours after progesterone vaginal gel.
Concomitant use of progesterone vaginal inserts with other preparations that are administered intravaginally is not recommended. Although specific studies have not been undertaken, the possibility exists that concomitant administration of a progesterone vaginal insert with another preparation administered intravaginally may alter the release and absorption of progesterone from the vaginal insert. Minoxidil solution is applied topically to the scalp.
Twice-daily application appears to be necessary for optimum results. Individuals receiving topical minoxidil therapy should be carefully instructed regarding proper use of the solution. To obtain optimum results, these individuals should be given a copy of the instructions provided by the manufacturers.
Topical minoxidil solution is applied to the total affected areas of the scalp using one of the applicators provided by the manufacturers (i.e., metered-spray applicator, extender spray applicator, dropper applicator). The manufacturers' patient information should be consulted for specific methods of application. Individuals being treated for androgenetic alopecia should be advised that because of the risk of adverse systemic effects, the topical preparation is intended for application to the scalp only and should not be applied to other areas of the body.
Prior to application of minoxidil topical solution, the hair and scalp should be dry. Individuals applying minoxidil topical solution with their fingertips should be instructed to wash their hands thoroughly afterward. When the metered-spray or extender-spray applicator is used, inhalation of the spray mist should be avoided.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for HOLIXIA (minoxidil/progesterone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for HOLIXIA (minoxidil/progesterone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Carcinoma of breast |
| Dermatosis of the scalp |
| Neoplasm of liver |
| Porphyria |
There are 14 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Bed-ridden |
| Cerebrovascular accident |
| Coronary artery disease |
| Deep venous thrombosis |
| Disease of liver |
| Migraine |
| Obesity |
| Predisposition to thrombosis |
| Pulmonary thromboembolism |
| Retinal thrombosis |
| Thromboembolic disorder |
| Thrombophlebitis |
| Tobacco smoker |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Depression |
| Diabetes mellitus |
| Edema |
| Hyperlipidemia |
| Hypertension |
The following adverse reaction information is available for HOLIXIA (minoxidil/progesterone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dermatitis due to topical drug Pruritus of skin Skin rash Urticaria |
| Rare/Very Rare |
|---|
|
Abnormal sexual function Alopecia Angioedema Body fluid retention Cardiac arrhythmia Chest pain Dizziness Eczema Edema Folliculitis Head sensation disturbance Headache disorder Hypotension Neuralgia Reduced visual acuity Tachycardia Visual changes |
There are 3 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dry skin Erythema |
| Rare/Very Rare |
|---|
|
Vasodilation of blood vessels |
The following precautions are available for HOLIXIA (minoxidil/progesterone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Progesterone is used to support embryo implantation and maintain pregnancy as a component of assisted reproductive technology (ART) treatment in infertile women. Such use is associated with increased ongoing pregnancy rates. Although progestins have been used beginning in the first trimester of pregnancy to prevent habitual abortion or to treat threatened abortion, there is no adequate evidence from well-controlled studies to substantiate the efficacy of progestins for these uses; however, there is evidence of potential adverse effects on the fetus when these drugs are administered during the first 4 months of pregnancy.
In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova. Masculinization of the female fetus has reportedly occurred when progestins were used during pregnancy.
Clitoral hypertrophy has been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy. An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) Use of progestins generally is not recommended during the first 4 months of pregnancy.
Progesterone should not be used to induce withdrawal bleeding as a test for pregnancy. Although there are no adequate and controlled studies to date in humans receiving oral or topical minoxidil, orally administered minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not rats, when given at dosages 5 times the maximum recommended human oral antihypertensive dosage. There was no evidence of teratogenic effects of orally administered minoxidil in rats or rabbits.
There was no evidence of teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved with daily administration of topical minoxidil); however, maternal toxicity was observed with this dosage. Evidence of developmental toxicity was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily. For additional information on the potential risks of oral minoxidil therapy during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in Minoxidil 24:08.20. The effects of the drug on labor and delivery are not known.
In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova. Masculinization of the female fetus has reportedly occurred when progestins were used during pregnancy.
Clitoral hypertrophy has been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy. An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) Use of progestins generally is not recommended during the first 4 months of pregnancy.
Progesterone should not be used to induce withdrawal bleeding as a test for pregnancy. Although there are no adequate and controlled studies to date in humans receiving oral or topical minoxidil, orally administered minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not rats, when given at dosages 5 times the maximum recommended human oral antihypertensive dosage. There was no evidence of teratogenic effects of orally administered minoxidil in rats or rabbits.
There was no evidence of teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved with daily administration of topical minoxidil); however, maternal toxicity was observed with this dosage. Evidence of developmental toxicity was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily. For additional information on the potential risks of oral minoxidil therapy during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in Minoxidil 24:08.20. The effects of the drug on labor and delivery are not known.
Progestins are reportedly distributed into milk. The manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined. Minoxidil is distributed into milk after oral administration. Because of the potential for serious adverse effects in nursing infants if topically applied drug were absorbed percutaneously and distributed into breast milk, the manufacturer recommends that minoxidil topical solution not be administered to nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for HOLIXIA (minoxidil/progesterone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HOLIXIA (minoxidil/progesterone)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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