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Drug overview for HARVIVA HP (minoxidil/finasteride):
Generic name: MINOXIDIL/FINASTERIDE
Drug class:
Therapeutic class: Dermatological
Finasteride is a competitive and specific inhibitor of Type II Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses 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
Drug class:
Therapeutic class: Dermatological
Finasteride is a competitive and specific inhibitor of Type II Minoxidil is a piperidinopyrimidine-derivative vasodilator that possesses 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 HARVIVA HP (minoxidil/finasteride) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for HARVIVA HP (minoxidil/finasteride):
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.
Finasteride is administered orallywithout regard to meals. 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.
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 HARVIVA HP (minoxidil/finasteride):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for HARVIVA HP (minoxidil/finasteride):
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 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Suicidal ideation |
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 HARVIVA HP (minoxidil/finasteride):
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 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 HARVIVA HP (minoxidil/finasteride):
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 |
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.
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 drug is distributed into human milk. 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 HARVIVA HP (minoxidil/finasteride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HARVIVA HP (minoxidil/finasteride)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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