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Drug overview for HONISTA (minoxidil/finasteride/tretinoin):
Generic name: MINOXIDIL/FINASTERIDE/TRETINOIN
Drug class: Acne Products
Therapeutic class: Dermatological
Finasteride is a competitive and specific inhibitor of Type II Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Tretinoin, all trans-retinoic acid, is a retinoid. 5alpha-reductase, an intracellular enzyme that convertstestosteroneto hair growth stimulant properties. 5alpha-dihydrotestosterone (DHT).
No enhanced Uses information available for this drug.
Generic name: MINOXIDIL/FINASTERIDE/TRETINOIN
Drug class: Acne Products
Therapeutic class: Dermatological
Finasteride is a competitive and specific inhibitor of Type II Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses Tretinoin, all trans-retinoic acid, is a retinoid. 5alpha-reductase, an intracellular enzyme that convertstestosteroneto hair growth stimulant properties. 5alpha-dihydrotestosterone (DHT).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for HONISTA (minoxidil/finasteride/tretinoin) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for HONISTA (minoxidil/finasteride/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.
Finasteride is administered orallywithout regard to meals. 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.
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 HONISTA (minoxidil/finasteride/tretinoin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for HONISTA (minoxidil/finasteride/tretinoin):
Drug contraindication overview.
*Pregnancy. *Hypersensitivity to any component of the medication.
*Pregnancy. *Hypersensitivity to any component of the medication.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Dermatosis of the scalp |
| Lactation |
| Pregnancy |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Eczema |
| Suicidal ideation |
| Sunburn |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| High-grade prostate cancer |
| Malignant tumor of male breast |
The following adverse reaction information is available for HONISTA (minoxidil/finasteride/tretinoin):
Adverse reaction overview.
The most common adverse effects reported in >=1% of patients receiving finasteride inclinical studies and more frequentlythan in patients treated with placebo include decreased libido, erectile dysfunction, and ejaculation disorder.
The most common adverse effects reported in >=1% of patients receiving finasteride inclinical studies and more frequentlythan in patients treated with placebo include decreased libido, erectile dysfunction, and ejaculation disorder.
There are 22 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 Eczema Edema Folliculitis Head sensation disturbance Headache disorder Hypotension Neuralgia Reduced visual acuity Tachycardia Visual changes |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Pruritus of skin Skin inflammation Skin irritation Skin photosensitivity |
Dry skin Erythema Localized edema Stinging of skin |
| Rare/Very Rare |
|---|
|
Dyschromia Vasodilation of blood vessels |
The following precautions are available for HONISTA (minoxidil/finasteride/tretinoin):
Finasteride is not indicated for use in pediatric patients; safety and efficacy have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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 Finasteride is contraindicated in women who are or maybecome pregnant. receiving oral or topical minoxidil, orally administered minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not Because of the ability of Type II 5alpha-reductase inhibitors toinhibit the conversion of testosterone to 5alpha-dihydrotestosterone (DHT), rats, when given at dosages 5 times the maximum recommended human oral antihypertensive dosage. There was no evidence of teratogenic effects of finasteridemay cause abnormalities of the external genitalia of a male fetus.
If finasteride is used during pregnancy, or if the patient becomes orally administered minoxidil in rats or rabbits. There was no evidence of pregnant while taking the drug, the patient should be apprised of the teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved potential hazard to the male fetus. with daily administration of topical minoxidil); however, maternal toxicity In animal studies, finasteride caused abnormal development of external was observed with this dosage. Evidence of developmental toxicity was genitalia in male fetuses.
A dose-dependent increase in hypospadias was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily. For additional information on the potential risks of oral minoxidil therapy observed in 3.6 to 100% of male offspring in an embryo-fetal development during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in study where pregnant rats received oral finasteride at maternal doses of approximately 1 to 684 times the recommended human dose (RHD) of 1mg/day Minoxidil 24:08.20.
The effects of the drug on labor and delivery are not during theperiod of major organogenesis (gestation days 6 to 17); days 16 known. to 17 ofgestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.2
times the RHD (based on AUC at animal doseof 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicularweights, delayed preputial separation, and transient nipple development. Decreasedanogenital distance occurred in male offspring of pregnant rats that receivedapproximately 0.02 times the RHD.
No abnormalities were observed in female offspring exposed to any dose of finasteridein utero. In addition, no developmental abnormalities were observed in the offspring of untreated femalesmated with finasteride-treated male rats that received approximately 488 times the RHD. In another study in rhesus monkeys, administration of an oral dose of finasteride (2 mg/kg/day or approximately120,000 times the highest estimated blood levels of finasteride from semen of mentaking 1 mg/day) to pregnant monkeys resulted in external genital abnormalities in malefetuses.
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 Finasteride is contraindicated in women who are or maybecome pregnant. receiving oral or topical minoxidil, orally administered minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not Because of the ability of Type II 5alpha-reductase inhibitors toinhibit the conversion of testosterone to 5alpha-dihydrotestosterone (DHT), rats, when given at dosages 5 times the maximum recommended human oral antihypertensive dosage. There was no evidence of teratogenic effects of finasteridemay cause abnormalities of the external genitalia of a male fetus.
If finasteride is used during pregnancy, or if the patient becomes orally administered minoxidil in rats or rabbits. There was no evidence of pregnant while taking the drug, the patient should be apprised of the teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved potential hazard to the male fetus. with daily administration of topical minoxidil); however, maternal toxicity In animal studies, finasteride caused abnormal development of external was observed with this dosage. Evidence of developmental toxicity was genitalia in male fetuses.
A dose-dependent increase in hypospadias was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily. For additional information on the potential risks of oral minoxidil therapy observed in 3.6 to 100% of male offspring in an embryo-fetal development during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in study where pregnant rats received oral finasteride at maternal doses of approximately 1 to 684 times the recommended human dose (RHD) of 1mg/day Minoxidil 24:08.20.
The effects of the drug on labor and delivery are not during theperiod of major organogenesis (gestation days 6 to 17); days 16 known. to 17 ofgestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.2
times the RHD (based on AUC at animal doseof 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicularweights, delayed preputial separation, and transient nipple development. Decreasedanogenital distance occurred in male offspring of pregnant rats that receivedapproximately 0.02 times the RHD.
No abnormalities were observed in female offspring exposed to any dose of finasteridein utero. In addition, no developmental abnormalities were observed in the offspring of untreated femalesmated with finasteride-treated male rats that received approximately 488 times the RHD. In another study in rhesus monkeys, administration of an oral dose of finasteride (2 mg/kg/day or approximately120,000 times the highest estimated blood levels of finasteride from semen of mentaking 1 mg/day) to pregnant monkeys resulted in external genital abnormalities in malefetuses.
Finasteride is not indicated for use in women. It is not known whether the It is not known whether topically applied tretinoin is excreted in human drug is distributed into human milk. 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.
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.
Clinical studies of finasteridefor androgenetic alopeciadid not include patients 65 years of age and older. Basedon the pharmacokinetics of finasteride 5 mg, the manufacturer states that no dosage adjustment is necessary in theelderly; however, efficacy of the drug has not been established in this population. The elimination rate of finasteride decreases slightly with increasing age of the patient, with a half-liferanging from approximately 5-6 hours in men 18-60 years of age to 8 hours in men older than 70 years of age.
The following prioritized warning is available for HONISTA (minoxidil/finasteride/tretinoin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HONISTA (minoxidil/finasteride/tretinoin)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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