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Tuesday, September 20, 2016

magaldrate

Generic Name: magaldrate (MAG al drate)

Brand names: Ron Acid, Riopan, Lowsium, Maoson, Ri-Mag, Losospan

What is magaldrate?

Magaldrate is an aluminum-containing antacid.

Magaldrate is used to treat heartburn, indigestion, or stomach upset.

Magaldrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about magaldrate?

You should not use this medication if you are allergic to magaldrate.

Before you take magaldrate, tell your doctor if you have kidney disease, Alzheimer's dementia, severe constipation or diarrhea, stomach ulcer or intestinal bleeding, a blockage in your stomach or intestines, or a colostomy or ileostomy.

Do not take this medication for longer than 2 weeks without your doctor's advice. Call your doctor if your symptoms do not improve, or if they get worse while taking magaldrate. This medication can cause you to have unusual results with certain medical tests such as an x-ray, CT scan, or MRI taken using a radioactive dye. Be sure any doctor who treats you knows ahead of time that you are taking magaldrate.

Stop taking magaldrate and call your doctor if you have severe stomach pain or cramps, severe nausea or vomiting, bone pain or muscle weakness, mood changes, or swelling in your hands or feet.

What should I discuss with my health care provider before taking magaldrate?

You should not use this medication if you are allergic to magaldrate.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take magaldrate, tell your doctor if you have:

kidney disease;

Alzheimer's dementia;

severe constipation or diarrhea;

stomach ulcer or intestinal bleeding;

a blockage in your stomach or intestines; or

a colostomy or ileostomy.

FDA pregnancy category C. It is not known whether magaldrate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Magaldrate may pass into breast milk. Although it is not expected to cause harm to a nursing baby, do not use magaldrate without telling your doctor if you are breast-feeding a baby.

How should I take magaldrate?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Magaldrate is usually taken 20 to 60 minutes after a meal and at bedtime. Follow your doctor's instructions.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Do not take this medication for longer than 2 weeks without your doctor's advice. Call your doctor if your symptoms do not improve, or if they get worse while taking magaldrate. This medication can cause you to have unusual results with certain medical tests such as an x-ray, CT scan, or MRI taken using a radioactive dye. Be sure any doctor who treats you knows ahead of time that you are taking magaldrate. Store magaldrate at room temperature away from moisture and heat. Do not freeze.

See also: Magaldrate dosage (in more detail)

What happens if I miss a dose?

Since magaldrate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe constipation, diarrhea, cramps, or other stomach problems.

What should I avoid while taking magaldrate?

Avoid taking any other medications within 2 hours before or after you take magaldrate. Either magaldrate or the other medications may be less effective when taken at the same time.

Magaldrate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using magaldrate and call your doctor at once if you have a serious side effect such as:

severe stomach pain, cramps, or bloating;

severe nausea or vomiting;

ongoing loss of appetite, weight loss;

severe constipation;

painful or difficult urination;

bone pain or muscle weakness;

mood changes; or

swelling in your hands or feet.

Less serious side effects may include:

mild constipation or diarrhea;

mild loss of appetite; or

light-colored stools.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Magaldrate Dosing Information

Usual Adult Dose for Dyspepsia:

Dose: 1 to 2 teaspoons after meals and at bedtime

What other drugs will affect magaldrate?

Tell your doctor about all other medications you use, especially:

ursodiol (Actigall, Urso);

ethambutol (Myambutol);

isoniazid;

ketoconazole (Nizoral);

mecamylamine (Inversine);

sodium polystyrene sulfonate (Kayexalate, Kionex);

tacrolimus (Prograf);

vitamin or mineral supplements that contain aluminum, calcium, or iron;

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others;

drugs to treat Paget's disease or osteoporosis, such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), or tiludronate (Skelid);

medicines containing phosphates, such as K-Phos, Neutra-Phos, and others;

methenamine (Hiprex, Mandelamine, Urex);

thyroid medications such as levothyroxine (Synthroid) or liothyronine (Cytomel); or

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap, Helidac).

This list is not complete and there may be other drugs that can interact with magaldrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More magaldrate resources

Magaldrate Side Effects (in more detail)
Magaldrate Dosage
Magaldrate Use in Pregnancy & Breastfeeding
Magaldrate Drug Interactions
Magaldrate Support Group
0 Reviews for Magaldrate - Add your own review/rating

Magaldrate Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare magaldrate with other medications

Indigestion

Where can I get more information?

Your pharmacist can provide more information about magaldrate.

See also: magaldrate side effects (in more detail)

Mometasone Lotion

Dosage Form: topical solution (lotion)
Mometasone Furoate Topical Solution USP, 0.1% (Lotion)

For Dermatologic Use Only

Not for Ophthalmic Use

Mometasone Lotion Description

Mometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate, USP for dermatologic use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity.

Chemically, mometasone furoate USP is 9α, 21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

Mometasone furoate USP is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.

Each gram of mometasone furoate topical solution USP, 0.1% (lotion) contains: 1 mg mometasone furoate, USP in a lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, sodium phosphate monobasic monohydrate and purified water. Also contains phosphoric acid used to adjust the pH to approximately 4.5.

Mometasone Lotion - Clinical Pharmacology

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate ointment USP, 0.1% enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with mometasone furoate topical solution USP, 0.1% (lotion) indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of mometasone furoate lotion on the hypothalamic-pituitary-adrenal (HPA) axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to four adult patients with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the four patients remained within the normal range and changed little from baseline.

Sixty-five pediatric patients ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Mometasone furoate topical solution USP, 0.1% (lotion) was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). In approximately 29% of patients who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate topical solution USP, 0.1% (lotion). The criteria for suppression were: basal cortosol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria.

Indications and Usage for Mometasone Lotion

Mometasone furoate topical solution USP, 0.1% (lotion) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of mometasone furoate topical solution USP, 0.1% (lotion) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended, (see PRECAUTIONS – Pediatric Use).

Contraindications

Mometasone furoate topical solution USP, 0.1% (lotion) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

In a study evaluating the effects of mometasone furoate topical solution USP, 0.1% (lotion) on the hypothalamic-pituitary-adrenal (HPA) axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to four adult patients with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the four patients remained within the normal range and changed little from baseline.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see Prescribing Information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS - Pediatric Use).

If irritation develops, mometasone furoate topical solution USP, 0.1% (lotion) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate topical solution USP, 0.1% (lotion) should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive, unless directed by the physician.

Patients should report to their physician any signs of local adverse reactions.

Parents of pediatric patients should be advised not to use mometasone furoate topical solution USP, 0.1% (lotion) in the treatment of diaper dermatitis. Mometasone furoate topical solution USP, 0.1% (lotion) should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).

This medication should not be used on the face, underarms, or groin areas unless directed by the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Other corticosteroid-containing products should not be used with mometasone furoate topical solution USP, 0.1% (lotion) without first consulting with the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate topical solution USP, 0.1% (lotion). Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague-Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis).

Pregnancy

Teratogenic Effects: Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis.)

In rabbits, mometasone furoate caused multiple malformations (eg, flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate topical solution USP, 0.1% (lotion) on a mcg/m2 basis.)

There are no adequate and well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate topical solution USP, 0.1% (lotion) is administered to a nursing woman.

Pediatric Use

Since safety and efficacy of mometasone furoate topical solution USP, 0.1% (lotion) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.

Mometasone furoate topical solution USP, 0.1% (lotion) caused HPA axis suppression in approximately 29% of pediatric patients ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population (see CLINICAL PHARMACOLOGY – Pharmacokinetics).

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone furoate topical solution USP, 0.1% (lotion) should not be used in the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of mometasone furoate topical solution USP, 0.1% (lotion) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of mometasone furoate topical solution USP, 0.1% (lotion) was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).

The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate topical solution USP, 0.1% (lotion) during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth, 1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder,1. The following signs of skin atrophy were also observed among 65 patients treated with mometasone furoate topical solution USP, 0.1% (lotion) in a clinical study: shininess 4, telangiectasia 2, loss of elasticity 2, and loss of normal skin markings 3. Striae, thinness and bruising were not observed in this study.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied mometasone furoate topical solution USP, 0.1% (lotion) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Mometasone Lotion Dosage and Administration

Apply a few drops of mometasone furoate topical solution USP, 0.1% (lotion) to the affected skin areas once daily and massage lightly until it disappears. For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze. Since safety and efficacy of mometasone furoate topical solution USP, 0.1% (lotion) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Mometasone furoate topical solution USP, 0.1% (lotion) should not be used with occlusive dressings unless directed by a physician. Mometasone furoate topical solution USP, 0.1% (lotion) should not be applied in the diaper area if the patient still requires diapers or plastic pants as these garments may constitute occlusive dressing.

How is Mometasone Lotion Supplied

Mometasone furoate topical solution USP, 0.1% (lotion) is supplied in 30 mL (NDC 68462-385-37) and 60 mL (NDC 68462-385-02) bottles, boxes of one.

Store mometasone furoate topical solution USP, 0.1% (lotion) at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured:

Glenmark Generics Ltd.

Village: Kishanpura, Baddi Nalagarh Road

District: Solan, Himachal Pradesh - 174101

India

Manufactured for:

Glenmark Generics Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

August 2010

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

MOMETASONE FUROATE
mometasone furoate lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68462-385
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOMETASONE FUROATE (MOMETASONE)	MOMETASONE FUROATE	1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
WATER
PHOSPHORIC ACID

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68462-385-37	30 mL In 1 TUBE	None
2	68462-385-02	60 mL In 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090506	08/09/2010

Labeler - Glenmark Generics Inc., USA (835917282)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		676115028	ANALYSIS, MANUFACTURE

Revised: 01/2011Glenmark Generics Inc., USA

More Mometasone Lotion resources

Mometasone Lotion Use in Pregnancy & Breastfeeding
Mometasone Lotion Drug Interactions
Mometasone Lotion Support Group
21 Reviews for Mometasone - Add your own review/rating

Compare Mometasone Lotion with other medications

Atopic Dermatitis
Dermatitis
Eczema
Psoriasis

Minoxidil topical

Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: C02DC01
VA Class: DE900
Chemical Name: 3-oxide 6-(1-piperidinyl)-2,4-pyrimidinediamine
Molecular Formula: C₉H₁₅N₅O
CAS Number: 38304-91-5
Brands: Hair Regrowth, Rogaine, Theroxidil

Introduction

Hair stimulant; a piperidinopyrimidine-derivative vasodilator.⁵ ¹⁹ ²⁰ ³⁷ ⁴³ ⁴⁴ ⁷³ ⁴ ⁹ ¹⁴ ¹⁵ ²⁰ ⁴⁰ ⁴³ ⁵⁶

Uses for Minoxidil

Androgenetic Alopecia

Stimulates regrowth of hair in men and women with androgenetic alopecia (male-pattern alopecia, hereditary alopecia, common male baldness).¹ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁵ ¹⁶ ²² ²³ ²⁴ ²⁵ ²⁶ ²⁷ ²⁸ ²⁹ ³⁰ ³¹ ³² ³³ ³⁴ ³⁵ ³⁶ ³⁹ ⁴⁰ ⁵⁹ ⁸³ ⁸⁵

Recommended for use in men who have general thinning of hair at the vertex of the scalp ¹¹⁵ ¹¹⁶ ¹²¹ ¹²² ¹²³ ¹²⁶ and in women who have general thinning of hair in frontoparietal areas.¹¹⁵ ¹¹⁷ May be ineffective in men or women with more extensive hair loss.¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶

Not recommended for patients without a family history of hair loss or for those with hair loss associated with childbirth, or for those who have hair loss that occurs suddenly or for unknown reasons.¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶

Generally most effective in men <40 years of age,⁵ ¹¹⁵ ¹¹⁶ ¹⁰⁰ ¹⁰¹ with <10 years duration of hair loss,⁶ ²³ ³⁹ ¹⁰⁰ ¹⁰¹ ¹¹⁵ ¹¹⁶ <10 cm diameter of baldness, ⁵ ⁶ ²³ ³⁹ ¹⁰⁰ ¹⁰¹ ¹¹⁵ ¹¹⁶ and with large number of terminal or intermediate hairs before initiation of therapy.⁵ ²³ ³⁹ ¹⁰⁰ ¹⁰¹

Alopecia Areata

Has been used to promote hair regrowth in males and females with alopecia areata†, including alopecia totalis or universalis.⁹ ⁴⁴ ⁴⁵ ⁴⁶ ⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰ ⁵¹ ⁵² ⁵³

Hair Transplantation

Has been used as an adjunct to hair transplantation†; may promote better evolution of hair grafts by reducing postoperative shedding of hair and hastening the onset of postsheddng hair regrowth.⁶⁴ ⁶⁵

Minoxidil Dosage and Administration

Administration

Topical Administration

Apply topically to the scalp as a 2 or 5% solution or as a 5% foam.¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b ^c ^d

For dermatologic use only;¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ avoid contact with eyes, mucous membranes, or sensitive or abraded skin areas.¹ ⁴⁰ ⁸⁵ ¹⁰¹ (See Dermatologic Effects under Cautions.) If contact with any of these areas occurs, flush area with large amounts of cool water.¹ ⁸⁵ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³

Apply to the scalp only; do not apply to other areas of the body because of risk of systemic adverse effects.¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ (See Systemic Effects under Cautions.)

In men, apply 2 or 5% solution or 5% foam to total affected (balding and anticipated balding) areas of the scalp twice daily, usually in the morning and evening.¹ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁵ ¹⁶ ²² ²³ ²⁴ ²⁵ ²⁶ ²⁷ ²⁸ ²⁹ ³⁰ ³¹ ³² ³³ ³⁴ ³⁵ ³⁶ ³⁹ ⁴⁰ ⁵⁹ ⁸³ ¹⁰¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^c

In women, apply 2% solution to total affected areas of the scalp twice daily, usually in the morning and evening;¹¹⁷ ^d 5% solution and 5% foam should not be used in women.¹²⁶ ^b ^c

Apply solution and foam to dry scalp.¹ ⁸⁵ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b ^c ^d

To apply solution, use applicator provided by the manufacturer and apply evenly over total affected areas of the scalp.⁸⁵ ^a ^b ^d

To apply foam, part hair into ≥1 rows to expose scalp.^c Rinse hands with cold water and dry thoroughly to minimize foam melting on warm skin.^c Hold container upside down and press nozzle to dispense ½ capful of foam onto fingers; apply foam to affected areas and gently massage into scalp.^c

Wash hands thoroughly after application using fingertips.¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b ^c ^d

Dosage

Adults

Androgenetic Alopecia

Treatment in Men

Topical

Apply 1 mL of 2 or 5% solution to affected areas of the scalp twice daily.¹ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁵ ¹⁶ ²² ²³ ²⁴ ²⁵ ²⁶ ²⁷ ²⁸ ²⁹ ³⁰ ³¹ ³² ³³ ³⁴ ³⁵ ³⁶ ³⁹ ⁴⁰ ⁵⁹ ⁸³ ¹⁰¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b

Apply ½ capful of 5% foam to affected areas of the scalp twice daily.^c

≥4 months of use may be necessary before regrowth observed.¹ ⁵ ⁶ ⁷ ⁶⁷ ¹⁰¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b ^c ^d Therapy must be continued indefinitely for maintenance of hair growth.¹ ⁶ ⁷ ⁹ ²⁴ ⁴⁰ ⁶⁷ ⁸³ ¹⁰⁰ ¹⁰¹ ¹⁰⁹ ¹¹⁵ ¹¹⁶ ¹²¹ ¹²² ¹²³ ¹²⁶

Treatment in Women

Topical

Apply 1 mL of 2% solution to affected areas of the scalp twice daily.¹¹⁷ ^d

Alopecia Areata†

Topical

Apply 1 mL of 5% solution to affected areas of the scalp twice daily.⁴⁵ ⁴⁶ ⁴⁹ ⁵² ⁵³ ¹⁰⁰ ¹⁰¹

Prescribing Limits

Adults

Androgenetic Alopecia

Treatment in Men

Topical

Maximum 2 mL of 2 or 5% solution daily.¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^b ^d

Maximum ½ capful of 5% foam per application.^c

Treatment in Women

Topical

Maximum 2 mL of 2% solution daily.¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶ ^a ^d

Special Populations

No special population dosage recommendations at this time.^a ^b ^c ^d

Cautions for Minoxidil

Contraindications

Known hypersensitivity to minoxidil or any ingredient in the formulation.¹

Warnings/Precautions

General Precautions

Dermatologic Effects

Possible adverse local dermatologic effects (e.g., pruritus, dryness, scaling/flaking, local irritation or burning);¹ ⁵ ⁸ ⁹ ¹⁵ ¹⁶ ²² ²³ ²⁶ ²⁷ ²⁹ ³⁰ ³² ⁴⁰ ⁴⁶ ⁵⁶ ⁸³ ⁸⁵ ⁹⁶ may occur more frequently with the 5 than the 2% topical solution¹²⁶ and may result from alcohol contained in formulation¹ ⁸⁵ and the wearing of a wig or hairpiece.⁵³ Local irritation usually is mild¹ ⁵ ⁹ ¹⁵ ¹⁶ ²⁶ ²⁹ ³⁸ ³⁹ ⁴⁶ ⁵¹ ⁵³ ⁵⁶ ⁸³ ⁸⁵ ⁹⁶ and rarely requires discontinuance of therapy.⁴⁶ ⁵¹ ⁵⁶

If irritation occurs, flush area with large amounts of cool water; contact clinician if irritation persists.¹ ⁸⁵ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³

Increased hair growth outside area of drug application (e.g., face, beard, eyebrows, ear, arm) reported; possibly due to inadvertent transfer of drug solution.¹ ⁵ ²² ³² ⁴⁶ ⁵⁰ ⁵¹ ⁵² ⁸³

Systemic Effects

Potential systemic adverse effects (e.g., weight gain, edema, tachycardia, hypotension),¹ ⁹ ²² ³² ⁴⁰ ⁸⁶ ⁹³ ¹⁰⁰ ¹¹⁰ ¹¹¹ especially in individuals with propensity for greater percutaneous absorption or with increased sensitivity to the drug.¹ ⁹ ⁹³ ¹⁰¹ Excessive doses, local abrasion or inflammation, or severe sunburn also may increase risk of systemic effects.¹ ¹⁰¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ^a ^b ^d

Use not recommended on inflamed, erythematous, infected, irritated, or painful scalp.¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ^a ^b ^c ^d

Exposure to UV Light

Severe UV light-induced skin injury (e.g., severe sunburn) may enhance percutaneous absorption and increase risk of systemic effects.¹ ¹⁰¹ (See Systemic Effects under Cautions.)

Specific Populations

Pregnancy

Category C.^e

Lactation

Distributed into milk after oral administration;⁷² ¹¹⁵ however, not known whether topical minoxidil is distributed into milk.^d AAP classifies minoxidil as compatible with breast-feeding.^e

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Women

Prior to initiating therapy for androgenetic alopecia, consider possibility of an underlying endocrine abnormality (e.g., polycystic ovary [Stein-Leventhal] syndrome, Cushing’s syndrome, androgen-secreting tumors, hypothyroidism).⁹ ⁸⁴ ¹⁰⁰ ¹⁰¹

Severe, diffuse hypertrichosis involving the face and limbs reported in women after 2–3 months of therapy with 5% solution for treatment of androgenetic alopecia; resolved within 4–5 months following discontinuance of therapy.¹³²

Common Adverse Effects

Pruritus, ¹ ⁵ ⁸ ⁹ ¹⁵ ¹⁶ ²² ²³ ²⁶ ²⁷ ²⁹ ³⁰ ³² ⁴⁰ ⁴⁶ ⁵⁶ ⁸³ ⁸⁵ ⁹⁶ dryness, ⁵ ²² ⁴⁰ ⁸³ scaling/flaking, ¹ ⁵ ⁹ ²⁶ ⁴⁶ ⁸³ local irritation or burning.¹ ⁵ ⁹ ¹⁵ ¹⁶ ²⁶ ²⁹ ³⁸ ³⁹ ⁴⁶ ⁵¹ ⁵³ ⁵⁶ ⁸³ ⁸⁵ ⁹⁶

Interactions for Minoxidil

Topical Preparations

Possible pharmacokinetic interaction (increased percutaneous absorption of minoxidil).¹⁰¹ ¹²⁹ ¹³⁰ Safety and efficacy of combined therapy with other topical drugs not established.¹³¹ Concomitant use with other topical drugs on the scalp is not recommended.^a ^b ^c ^d

Specific Drugs

Drug	Interaction	Comments
Hypotensive agents (guanethidine)	Possible increased risk of orthostatic hypotension if systemic absorption of minoxidil occurs¹	Use concomitantly with caution¹
Tretinoin, topical	Potential increased percutaneous absorption of minoxidil¹⁰¹ ¹²⁹ ¹³⁰	Safety and efficacy of combined use requires further evaluation¹³¹

Minoxidil Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application to intact scalp;¹ ¹⁵ ¹⁶ ⁴³ ⁶¹ 1.4% of a 2% topical solution may be absorbed.⁷⁰

Onset

Onset of hair regrowth is variable; however, 2 or ≥4 months usually required before evidence of regrowth is observed following topical administration with 2 or 5% topical solutions, respectively.¹ ²³ ²⁵ ²⁷ ³⁰ ³⁴ ³⁶ ⁵⁹ ¹⁰¹ ¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ ¹²⁶

Distribution

Extent

Not fully determined following topical administration;¹⁰⁰ ¹⁰¹ however, intact stratum corneum may serve as a barrier that inhibits substantial diffusion of topically applied minoxidil into systemic circulation.⁶⁸ ⁷¹ ¹⁰¹

Not known whether topical minoxidil crosses the placenta or is distributed into milk.¹ ⁷² ^e

Elimination

Metabolism

Not fully determined following topical administration;¹ however, appears to be converted in the hair follicle to an active metabolite, minoxidil sulfate, by minoxidil sulfotransferase.¹⁷

Elimination Route

Excreted principally in urine.⁶¹

Stability

Storage

Topical

Solution

20–25°C.¹²⁶ ¹³² Keep away from heat and flame.^a ^b ^d

Foam

20–25°C.^c Keep away from heat and flame; do not puncture or incinerate container.^c

ActionsActions

Exact mechanism of action not fully elucidated; however, appears to act at the level of the hair follicle,⁴ ⁵ ⁶ ⁷ ⁹ ¹⁰ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ³¹ ⁶² ⁸¹ possibly directly stimulating hair follicle epithelial growth.⁴ ⁶ ⁹ ¹⁰ ¹⁴ ¹⁵ ¹⁷ ¹⁸ ¹⁹ ²⁰ ⁸¹ ¹⁰⁰

May induce follicle hypertrophy and a return to more normal hair follicle diameter and depth in existing small follicles (i.e., regrowth) rather than stimulation of new follicle formation.⁴ ⁵ ⁶ ⁷ ⁹ ¹⁷ ¹⁹ ²⁰ ⁵⁹

Appears to prolong the anagen phase of the hair follicle, and accelerate the cyclic turnover of vellus hair follicles, enabling these follicles to produce thick, terminal hair⁴ ⁶ ⁹ ¹⁹ ²⁰ ¹⁰⁶

May directly induce proliferation of hair epithelial cells near the base of the hair follicle and increase incorporation of cysteine and glycine into the follicle;¹⁴ cysteine residues cross-link to form cystine, which provides strength to the hair shaft.⁵⁹

Advice to Patients

Product is flammable; importance of keeping product and area of application away from open flame and heat.^a ^b ^c ^d

Importance of using only as directed, only for the indicated types of hair loss, and for at least 2–4 months in order to see results; continuous use required to maintain hair regrowth.^a ^b ^c ^d (See Topical Administration under Dosage and Administration.)

Importance of applying only to healthy, normal scalp and not using topical minoxidil if scalp is inflamed, erythematous, infected, irritated, or painful.¹¹⁶ ¹¹⁷ ¹²¹ ¹²² ¹²³ Importance of avoiding contact with the eyes.^a ^b ^c ^d

Importance of washing hands after application.^a ^b ^c ^d

Importance of women using only 2% solution; 5% solution and 5% foam should not be used in women.^a ^b ^c ^d

Importance of reporting any local or systemic adverse reactions, especially chest pain, tachycardia, dizziness, unexplained weight gain, or peripheral edema, to a clinician.^a ^b ^c ^d

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.^a ^b ^c ^d

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^b ^c ^d

Importance of informing patients of other important precautionary information.^a ^b ^c ^d (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Minoxidil
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Solution	2%*	Hair Regrowth (with alcohol 60% and propylene glycol)	Eckerd, Rite Aid
			Rogaine Hair Regrowth Treatment for Men (with alcohol 60% and propylene glycol)	Pfizer
			Rogaine Hair Regrowth Treatment for Women (with alcohol 60% and propylene glycol)	Pfizer
		5%*	Rogaine for Men Extra Strength (with alcohol 30% and propylene glycol)	Pfizer
			Theroxidil (with alcohol 30% and propylene glycol)	Harmony
	Foam	5%*	Rogaine Hair Regrowth Treatment for Men (with alcohol SD 40-B, butane, butylated hydroxytoluene, isobutane, and propane)	Pfizer

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. The Upjohn Company. Rogaine (minoxidil topical solution) prescribing information. Kalamazoo, MI; 1990 Feb.

2. The Upjohn Company. Rogaine (minoxidil topical solution) product information. Kalamazoo, MI; 1988 Aug.

3. Dawber RPR. Aetiology and pathophysiology of hair loss. Dermatologica. 1987; 175(Suppl 2):23-8.

4. Headington JT. Hair follicle biology and topical minoxidil: possible mechanisms of action. Dermatologica. 1987; 175(Suppl 2):19-22. [PubMed 3319729]

5. Katz HI. Topical minoxidil: review of efficacy and safety. Cutis. 1989; 43:94-8. [PubMed 2644080]

6. Voorhees JJ. Editor’s summary. Dermatologica. 1987; 175(Suppl 2):54-6.

7. Katz HI. Topical minoxidil: review of efficacy. Clin Dermatol. 1988; 6:195-9. [PubMed 3063371]

8. Shupack JL, Kassimir JJ, Thirumoorthy T et al. Dose-response study of topical minoxidil in male pattern alopecia. J Am Acad Dermatol. 1987; 16:673-6. [PubMed 3549801]

9. Clissold SP, Heel RC. Topical minoxidil: preliminary review of its pharmacodynamic properties and therapeutic efficacy in alopecia areata and alopecia androgenetica. Drugs. 1987; 33:107-22. [IDIS 228948] [PubMed 3552591]

10. Fiedler-Weiss VC. Potential mechanisms of minoxidil-induced hair growth in alopecia areata. J Am Acad Dermatol. 1987; 16:653-6. [PubMed 3558910]

11. Bunker CB, Dowd PM. Topical minoxidil, scalp hair, and vasodilatation. Lancet. 1987; 1:1266.

12. Bunker CB, Dowd PM. Alterations in scalp blood flow after the epicutaneous application of 3% minoxidil and 0.1% hexyl nicotinate in alopecia. Br J Dermatol. 1987; 117:668-9. [IDIS 237238] [PubMed 3689690]

13. Fiedler-Weiss VC, Buys CM. Response to minoxidil in severe alopecia areata correlates with T lymphocyte stimulation. Br J Dermatol. 1987; 117:759- 63. [PubMed 3501310]

14. Buhl AE, Waldon DJ, Kawabe TT et al. Minoxidil stimulates mouse vibrissae follicles in organ culture. J Invest Dermatol. 1989; 92:315-20. [PubMed 2465357]

15. Fiedler VC. Minoxidil: clinical and basic research in perspective. Semin Dermatol. 1987; 6:101- 7.

16. Fiedler-Weiss VC. Minoxidil. Dermatol Clin. 1987; 5:627-35. [PubMed 3301118]

17. Uno H, Cappas A, Brigham P. Action of topical minoxidil in the bald stump-tailed macaque. J Am Acad Dermatol. 1987; 16:657-68. [PubMed 3558911]

18. Fiedler VC, Buys CM. Immunohistochemical characterization of the cellular infiltrate in severe alopecia areata before and after minoxidil treatment. Dermatologica. 1987; 175(Suppl 2):29-35. [PubMed 2961630]

19. Headington JT, Novak E. Clinical and histologic studies of male pattern baldness treated with topical minoxidil. Curr Ther Res Clin Exp. 1984; 36:1098-106.

20. Uno H, Cappas A, Schlagel C. Cyclic dynamics of hair follicles and the effect of minoxidil on the bald scalps of stumptailed macaques. Am J Dermatopathol. 1985; 7:283-97. [PubMed 4051135]

21. Eller MG, Szpunar GJ, Della-Coletta AA. Absorption of minoxidil after topical application: effect of frequency and site of application. Clin Pharmacol Ther. 1989; 45:396-402. [IDIS 253526] [PubMed 2702797]

22. Olsen EA, Weiner MS, Delong ER et al. Topical minoxidil in early male pattern baldness. J Am Acad Dermatol. 1985; 13:185-92. [PubMed 3900155]

23. De Villez RL. Topical minoxidil therapy in hereditary androgenetic alopecia. Arch Dermatol. 1985; 121:197-202. [IDIS 196318] [PubMed 3883902]

24. Tosti A. Topical minoxidil useful in 18% of patients with androgenetic alopecia: a study of 430 cases. Dermatologica. 1986; 173:136-8. [PubMed 3770260]

25. Storer JS, Brzuskiewicz J, Floyd H et al. Review: topical minoxidil for male pattern baldness. Am J Med Sci. 1986; 291:328-33. [IDIS 215989] [PubMed 3518451]

26. Civatte J, Laux B, Simpson NB et al. 2% topical minoxidil solution in androgenetic baldness: preliminary European results. Dermatologica. 1987; 175(Suppl 2):42-9. [PubMed 3319731]

27. Rietschel RL, Duncan SH. Safety and efficacy of topical minoxidil in the management of androgenetic alopecia. J Am Acad Dermatol. 1987; 16:677-85. [PubMed 3549802]

28. Kreindler TG. Topical minoxidil in early androgenetic alopecia. J Am Acad Dermatol. 1987; 16:718-24. [PubMed 3549807]

29. Roberts JL. Androgenetic alopecia: treatment results with topical minoxidil. J Am Acad Dermatol. 1987; 16:705-10. [PubMed 3549805]

30. Savin RC. Use of topical minoxidil in the treatment of male pattern baldness. J Am Acad Dermatol. 1987; 16:696-704. [PubMed 3549804]

31. Katz HI, Hien NT, Prawer SE et al. Long-term efficacy of topical minoxidil in male pattern baldness. J Am Acad Dermatol. 1987; 16:711-8. [PubMed 3549806]

32. Olsen EA, DeLong ER, Weiner MS. Long-term follow-up of men with male pattern baldness treated with topical minoxidil. J Am Acad Dermatol. 1987; 16:688-95. [PubMed 3549803]

33. Olsen EA, DeLong ER, Weiner MS. Dose-response study of topical minoxidil in male pattern baldness. J Am Acad Dermatol. 1986; 15:30-7. [PubMed 3722507]

34. De Villez RL. Androgenetic alopecia treated with topical minoxidil. J Am Acad Dermatol. 1987; 16:669-72. [PubMed 3549800]

35. De Villez RL. Topical minoxidil for androgenetic alopecia: optimizing the chance for success by appropriate patient selection. Dermatologica. 1987; 175(Suppl 2):50-3.

36. Koperski JA, Orenberg EK, Wilkinson DI. Topical minoxidil therapy for androgenetic alopecia. Arch Dermatol. 1987; 123:1483-7. [IDIS 235936] [PubMed 3314717]

37. Vanderveen EE, Ellis CN, Kang S et al. Topical minoxidil for hair regrowth. J Am Acad Dermatol. 1984; 11:416-21. [PubMed 6384289]

38. Weiss VC, West DP. Topical minoxidil therapy and hair regrowth. Arch Dermatol. 1985; 121:191-2. [IDIS 196316] [PubMed 3977331]

39. Rumsfield JA, West DP, Fiedler-Weiss VC. Topical minoxidil therapy for hair regrowth. Clin Pharm. 1987; 6:386-92. [IDIS 229037] [PubMed 3311578]

40. de Groot AC, Nater JP, Herxheimer A. Minoxidil: hope for the bald? Lancet. 1987; 1:1019-21. Editorial.

41. Mitchell AD, De Villez R. Minoxidil for male- pattern baldness. Lancet. 1987; 1:1436. [PubMed 2884528]

42. de Groot AC, Nater JP, Herxheimer A. Minoxidil for male-pattern baldness. Lancet. 1987; 2:563. [PubMed 2887848]

43. Novak E, Franz TJ, Headington JT et al. Topically applied minoxidil in baldness. Int J Dermatol. 1985; 24:82-7. [PubMed 3886571]

44. Fenton DA, Wilkinson JD. Topical minoxidil in the treatment of alopecia areata. BMJ. 1983; 287:1015-7. [IDIS 177632] [PubMed 6412929]

45. Weiss VC, West DP, Fu TS et al. Alopecia areata treated with topical minoxidil. Arch Dermatol. 1984; 120:457-63. [IDIS 185288] [PubMed 6703751]

46. Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987; 16:730-6. [PubMed 3549809]

47. King CM, Harrop B, Dave VK. Topical minoxidil in the treatment of alopecia areata. BMJ. 1983; 287:1380. [IDIS 178404] [PubMed 6416428]

48. Maitland JM, Aldridge RD, Main RA et al. Topical minoxidil in the treatment of alopecia areata. BMJ. 1984; 288:794. [IDIS 183293] [PubMed 6423083]

49. Fiedler-Weiss VC, West DP, Buys CM et al. Topical minoxidil dose-response effect in alopecia areata. Arch Dermatol. 1986; 122:180-2. [IDIS 211658] [PubMed 3947124]

50. White SI, Friedmann PS. Topical minoxidil lacks efficacy in alopecia areata. Arch Dermatol. 1985; 121:591. [IDIS 199275] [PubMed 3994404]

51. Price VH. Topical minoxidil in extensive alopecia areata, including 3-year follow-up. Dermatologica. 1987; 175(Suppl 2):36-41. [PubMed 3691913]

52. Price VH. Topical minoxidil (3%) in extensive alopecia areata, including long-term efficacy. J Am Acad Dermatol. 1987; 16:737-44. [PubMed 3549810]

53. Fiedler-Weiss VC. Topical minoxidil solution (1% and 5%) in the treatment of alopecia areata. J Am Acad Dermatol. 1987; 16:745-8. [PubMed 3549811]

54. Hamilton JB. Patterned loss of hair in man: types and incidence. Ann NY Acad Sci. 1951; 53:708- 28. [PubMed 14819896]

55. Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975; 68:1359-65. [PubMed 1188424]

56. Roenigk HH Jr, Pepper E, Kuruvilla S. Topical minoxidil therapy for hereditary male pattern alopecia. Cutis. 1987; 39:337-42. [PubM

minoxidil Topical

min-OX-i-dil

Commonly used brand name(s)

In the U.S.

Men's Rogaine

Rogaine

Rogaine For Men Extra Strength

Women's Rogaine

In Canada

Apo-Gain

Gen-Minoxidol

Hairgro

Hair Regrowth Treatment

Med Minoxidil

Minox

Available Dosage Forms:

Solution

Foam

Therapeutic Class: Alopecia Agent

Uses For minoxidil

Minoxidil applied to the scalp is used to stimulate hair growth in adult men and women with a certain type of baldness. The exact way that minoxidil works is not known.

If hair growth is going to occur with the use of minoxidil, it usually occurs after the medicine has been used for several months and lasts only as long as the medicine continues to be used. Hair loss will begin again within a few months after minoxidil treatment is stopped.

In the U.S., minoxidil is available without a prescription.

Before Using minoxidil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For minoxidil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to minoxidil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of topical minoxidil in children. Safety and efficacy have not been established ..

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of topical minoxidil in the elderly. However, studies have shown that the medicine works best in younger patients who have a short history of hair loss. Minoxidil has not been studied in patients older than 65 years of age .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of minoxidil

minoxidil usually comes with patient instructions. It is important that you read the instructions carefully.

It is very important that you use minoxidil only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of it being absorbed through the skin. For the same reason, do not apply minoxidil to other parts of your body. Absorption into the body may affect the heart and blood vessels and cause unwanted effects.

Do not use any other skin products on the same skin area on which you use minoxidil. Hair coloring, hair permanents, and hair relaxers may be used during minoxidil therapy as long as the scalp is washed just before applying the hair coloring, permanent, or relaxer. Minoxidil should not be used 24 hours before and after the hair treatment procedure. Be sure to not double your doses of minoxidil to make up for any missed doses.

To apply minoxidil topical solution:

Make sure your hair and scalp are completely dry before applying minoxidil.

Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Follow your doctor's instructions on how to apply the solution, using the applicator provided.

Do not shampoo your hair for 4 hours after applying minoxidil.

Immediately after using minoxidil, wash your hands to remove any medicine that may be on them.

Do not use a hairdryer to dry the scalp after you apply minoxidil solution. Blowing with a hairdryer on the scalp may make the treatment less effective.

Allow the minoxidil to completely dry for 2 to 4 hours after applying it, including before going to bed. Minoxidil can stain clothing, hats, or bed linen if your hair or scalp is not fully dry after using the medicine.

Avoid transferring the medicine while wet to other parts of the body. This can occur if the medicine gets on your pillowcase or bed linens or if your hands are not washed after applying minoxidil.

To apply minoxidil topical foam:

Open the container by matching the arrow on can ring with the arrow on cap. Pull off the cap.

Part the hair into one or more rows to expose the hair thinning area on the scalp.

Hold the can upside down and press the nozzle to put foam on your fingers.

Use your fingers to spread the foam over the hair loss area and gently massage into your scalp.

Immediately after using minoxidil, wash your hands to remove any medicine that may be on them .

If your scalp becomes abraded, irritated, or sunburned, check with your doctor before applying minoxidil.

Minoxidil topical foam or solution is for use on the scalp only. Keep minoxidil away from the eyes, nose, and mouth. If you should accidentally get some in your eyes, nose, or mouth, flush the area thoroughly with cool tap water. If you are using the pump spray, be careful not to breathe in the spray .

Do not use the foam near heat or open flame, or while smoking. Do not puncture, break, or burn the aerosol can .

Dosing

The dose of minoxidil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of minoxidil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For hair growth:
- For topical solution dosage form:
  - Adults—Apply 1 milliliter (mL) to the scalp two times a day.
  - Children—Use and dose must be determined by the doctor.
- For topical foam dosage form:
  - Adults—Apply half a capful to the scalp two times a day.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of minoxidil, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Flammable: Keep away from fire or flame.

Precautions While Using minoxidil

It is important that your doctor check your progress at regular visits to make sure that minoxidil is working properly and to check for unwanted effects.

Tell your doctor if you notice continued itching, redness, or burning of your scalp after you apply minoxidil. If the itching, redness, or burning is severe, wash the medicine off and check with your doctor before using it again.

Hair loss may continue for 2 weeks after you start using minoxidil. Tell your doctor if your hair loss continues after 2 weeks. Also, tell your doctor if your hair growth does not increase after using minoxidil for 4 months.

minoxidil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Itching or skin rash (continued)

Rare

Acne at site of application

burning of scalp

facial hair growth

increased hair loss

inflammation or soreness at root of hair

reddened skin

swelling of face

Signs and symptoms of too much medicine being absorbed into the body—Rare

Blurred vision or other changes in vision

chest pain

dizziness

fainting

fast or irregular heartbeat

flushing

headache

lightheadedness

numbness or tingling of hands, feet, or face

swelling of face, hands, feet, or lower legs

weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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