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Drug overview for HENTIS HP (minoxidil/progesterone/tretinoin):
Generic name: MINOXIDIL/PROGESTERONE/TRETINOIN
Drug class:
Therapeutic class: Dermatological
Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Progesterone is a naturally occurring progestin secreted by the corpus Tretinoin, all trans-retinoic acid, is a retinoid. 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/TRETINOIN
Drug class:
Therapeutic class: Dermatological
Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Progesterone is a naturally occurring progestin secreted by the corpus Tretinoin, all trans-retinoic acid, is a retinoid. 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 HENTIS HP (minoxidil/progesterone/tretinoin) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for HENTIS HP (minoxidil/progesterone/tretinoin):
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.
Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.
Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.
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 Tretinoin is applied topically to the skin as a cream, gel, or solution. application appears to be necessary for optimum results. Individuals Patients should be instructed carefully in proper use of the drug, including associated precautions.
(See Cautions: Precautions and receiving topical minoxidil therapy should be carefully instructed Contraindications and also Drug Interactions.) 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 Tretinoin is applied topically to the skin as a cream, gel, or solution. application appears to be necessary for optimum results. Individuals Patients should be instructed carefully in proper use of the drug, including associated precautions.
(See Cautions: Precautions and receiving topical minoxidil therapy should be carefully instructed Contraindications and also Drug Interactions.) 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 HENTIS HP (minoxidil/progesterone/tretinoin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for HENTIS HP (minoxidil/progesterone/tretinoin):
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 16 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 |
| Eczema |
| Migraine |
| Obesity |
| Predisposition to thrombosis |
| Pulmonary thromboembolism |
| Retinal thrombosis |
| Sunburn |
| 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 HENTIS HP (minoxidil/progesterone/tretinoin):
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 25 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 Blistering skin Body fluid retention Cardiac arrhythmia Chest pain Dizziness Dyschromia Eczema Edema Folliculitis Head sensation disturbance Headache disorder Hypotension Neuralgia Reduced visual acuity Skin crusting Skin inflammation Tachycardia Visual changes |
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Erythema Skin photosensitivity |
Dry skin Erythema |
| Rare/Very Rare |
|---|
|
Edema Vasodilation of blood vessels |
The following precautions are available for HENTIS HP (minoxidil/progesterone/tretinoin):
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. Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates.
Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported.
Similar results also have been reported in pigtail macaques. Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area).
Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally. Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1%
tretinoin gel (microsphere formulation), normalized for total body surface area. In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages.
Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification. When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily.
These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult). With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported.
Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The relevance of these spontaneous reports in terms of risk to the fetus is unknown. To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known.
The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during 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. Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates.
Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported.
Similar results also have been reported in pigtail macaques. Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area).
Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally. Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1%
tretinoin gel (microsphere formulation), normalized for total body surface area. In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages.
Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification. When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily.
These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult). With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported.
Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The relevance of these spontaneous reports in terms of risk to the fetus is unknown. To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known.
The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during 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. It is not known whether topically applied tretinoin is excreted in human milk.
Caution should be exercised when topical tretinoin is administered to a nursing woman. 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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
Caution should be exercised when topical tretinoin is administered to a nursing woman. 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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Tretinoin (retinoic Or Vit A Acid-top) | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient human data available |
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Minoxidil (topical) | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Small amount absorbed systemically, unlikely to cause adverse effects |
| Progesterone | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Data suggest low amount excreted with no adverse effects on infants |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for HENTIS HP (minoxidil/progesterone/tretinoin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HENTIS HP (minoxidil/progesterone/tretinoin)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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