Mometasone Furoate

Class: Adrenals
VA Class: RE101
Chemical Name: (11β,16α) - 9,21 - Dichloro - 17 - [(2 - furanylcarbonyl)oxy] - 11 - hydroxy - 16 - methyl - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C₂₇H₃₀Cl₂O₆
CAS Number: 83919-23-7
Brands: Asmanex

REMS:

FDA approved a REMS for mometasone furoate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of mometasone furoate and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Synthetic nonfluorinated glucocorticoid.^{1 2 4}

Uses for Mometasone Furoate

Asthma

Long-term prevention of bronchospasm in patients with asthma.^{1 2}

In corticosteroid-dependent patients, may permit a substantial reduction in the daily maintenance dosage or discontinuance of the systemic corticosteroid.^{1 6}

Do not use for rapid relief of bronchospasm.^{1 2 8}

Mometasone Furoate Dosage and Administration

General

• 
  

  Adjust dosage carefully according to individual requirements and response.¹

  
  


• 
  

  After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.¹ Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)¹

  
  


• 
  

  Base initial and maximum dosages in adults and children ≥12 years of age on previous asthma therapy.¹

  
  

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• 
  

  When switching from systemic corticosteroids to orally inhaled mometasone furoate, asthma should be reasonably stable before initiating treatment with oral inhalation.^{13 14}

  
  


• 
  

  Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid.¹ After at least 1 week, gradually withdraw the systemic corticosteroid.¹

  
  


• 
  

  Decrements usually should not exceed 2.5 mg daily of prednisone (or its equivalent) each week in patients receiving the oral inhalation.¹ Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.¹

  
  


• 
  

  Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.¹ (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

  
  

Administration

Oral Inhalation

Administer by oral inhalation using the Twisthaler breath-actuated dry powder inhalation device.^{1 2 8}

When administered once daily, use at the same time each day, preferably in the evening for optimal efficacy.^{1 2 5}

Removal of the cap of the device (by twisting in a counterclockwise direction) releases a single 220-mcg dose of drug from the drug storage unit into the inhalation channel, making the dose available for administration via inhalation through the mouthpiece.^{1 8} A dose counter will decrement by 1 each time the cap is removed.⁸

Remove the cap with the inhaler in an upright position.¹ Before inhaling the dose, exhale as completely as possible, but not into the Twisthaler device.^{1 8} Place the mouthpiece of the inhaler between the lips and inhale quickly and deeply through the inhaler.⁸ Do not cover the ventilation holes on either side of the inhaler while inhaling the dose.⁸ Remove the inhaler from the mouth, hold breath for about 10 seconds, then exhale slowly.⁸ Do not take extra doses despite not being able to taste, smell, or feel the released powder, unless otherwise instructed by a clinician.⁸

After inhalation, rinse mouth to minimize potential systemic or local adverse effects.^{1 8} Wipe the mouthpiece dry with a dry cloth or tissue.^{1 8} Close and reload the Twisthaler device for the next dose by twisting the cap in a clockwise direction until a click is heard.^{1 8}

Do not wash the inhaler; store in a dry place.⁸ Discard the inhaler when every inhalation has been used (when the dose indicator reads “00”) or 45 days after removal from its foil overwrap pouch, whichever comes first.^{1 8}

Dosage

Available as mometasone furoate; dosage expressed in terms of the salt.¹

Dose of mometasone furoate administered as an oral inhalation powder is expressed as the nominal (labeled) dose contained in the Twisthaler device.¹ The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.¹

Each actuation of the Twisthaler inhaler contains 110 or 220 mcg of mometasone furoate inhalation powder and delivers approximately 100 or 200 mcg of mometasone furoate, respectively, per activation from the mouthpiece.¹

Pediatric Patients

Asthma

Oral Inhalation

Children 4–11 years of age: Initial and maximum dosage is 110 mcg once daily in the evening, regardless of prior therapy.¹

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.¹ If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.¹ If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.¹

Children ≥12 years of age previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.¹

Adults

Asthma

Oral Inhalation

Previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.¹ If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.¹ If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.¹

Previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.¹

Prescribing Limits

Pediatric Patients

Asthma

Oral Inhalation

Children 4–11 years of age: Maximum 110 mcg daily.¹

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.¹

Children ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg daily.¹

Adults

Asthma

Oral Inhalation

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.¹

Previously receiving oral corticosteroids: Maximum 880 mcg daily.¹

Special Populations

No special population dosage recommendations at this time.¹

Cautions for Mometasone Furoate

Contraindications

• 
  

  Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids⁹ ) are required.¹

  
  


• 
  

  Known hypersensitivity to mometasone furoate or any ingredient (e.g., lactose) in the formulation.¹

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled mometasone furoate.¹

Withdraw systemic corticosteroid therapy gradually ¹ and monitor for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy.¹ Lung function (FEV₁ or PEFR), adjunctive β₂-adrenergic agonist use, and asthma symptoms also should be carefully monitored.¹ In most patients, several months are required for total recovery of HPA function following withdrawal of systemic corticosteroid therapy.¹ Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer.¹

Monitor for corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression).¹

Monitor for acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with acute electrolyte loss.¹

Possible unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).¹

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.¹ Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.¹

Take particular care to avoid exposure in susceptible patients.¹ If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immunoglobulin (IG), respectively.¹ Consider treatment with an antiviral agent if varicella develops.¹

Respiratory Effects

Bronchospasm and/or wheezing may occur.¹

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, discontinue treatment with mometasone furoate, and institute alternative therapy.^{1 8}

Acute Exacerbations of Asthma

Treat acute asthma symptoms with a short-acting β₂-agonist bronchodilator.^{1 8 12} If symptoms persist, promptly reevaluate and consider initiation of systemic corticosteroids.^{1 12}

Galactose Intolerance

Oral inhalation powder contains lactose and should not be used in those with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.^{1 2}

Sensitivity Reactions

Allergic reaction, facial edema, urticaria, hypersensitivity, and throat tightness reported.¹

General Precautions

Ocular Effects

Glaucoma, increased intraocular pressure, and cataracts reported rarely.¹ Carefully monitor patients who have a change in vision or those with a history of increased IOP, glaucoma and/or cataracts.¹

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of inhaled mometasone furoate over prolonged periods of time, or in particularly sensitive individuals, may result in manifestations of hypercorticism and suppression of HPA function.¹ If such changes occur, reduce the dosage of mometasone furoate slowly, consistent with accepted procedures for reducing systemic corticosteroid dosage and management of asthma symptoms.¹

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.¹

Musculoskeletal Effects

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).¹

Monitor patients with major risk factors for decreased BMD (e.g., family history of osteoporosis, prolonged immobilization, chronic use of drugs that can reduce bone mass [e.g., anticonvulsants, corticosteroids]) and treat with established standards of care.¹

Infections

Localized candidal infections of the mouth and pharynx reported.¹ If infection occurs, appropriate local or systemic treatment and/or discontinuance of therapy may be required.¹

Use with extreme caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether mometasone is distributed into milk;¹ however, other corticosteroids are distributed into milk.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy of mometasone oral inhalation powder not established in children <4 years of age.¹

With prolonged use, may slow growth rate in children and adolescents.¹ Monitor routinely (e.g., via stadiometry) the growth and development of pediatric patients receiving corticosteroid therapy.¹ Weigh benefits of corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies.¹ Use the lowest possible dosage that effectively controls asthma.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Common Adverse Effects

Adults and children ≥12 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Headache,^{1 3 4 7 8} allergic rhinitis,^{1 8} pharyngitis,^{1 3 4 5 7} upper respiratory tract infection,^{1 8} sinusitis,¹ oral candidiasis,^{1 3 4 5 7} dysmenorrhea,^{1 8} musculoskeletal pain,^{1 8} back pain,^{1 8} dyspepsia.^{1 7}

Adults and children ≥12 years of age previously receiving oral corticosteroids: Musculoskeletal pain, oral candidiasis, sinusitis, allergic rhinitis, upper respiratory infection, arthralgia, fatigue, depression, sinus congestion.¹

Children 4–11 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Fever,¹ headache,¹¹ allergic rhinitis,¹ pharyngitis,¹¹ upper respiratory tract infection,¹¹ abdominal pain.^{1 11}

Interactions for Mometasone Furoate

Metabolized by CYP3A4 isoenzyme.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potent inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma mometasone furoate concentrations).¹

Specific Drugs

Drug	Interaction	Comments
Ketoconazole	Increased plasma mometasone furoate concentrations1

Mometasone Furoate Pharmacokinetics

Absorption

Bioavailability

<1% following oral inhalation of a single 440-mcg dose.^{1 2}

Onset

≥1–2 weeks of continuous therapy required to achieve optimum symptomatic relief.¹

Duration

When corticosteroids are discontinued, asthma control remains stable for several days or longer.¹

Distribution

Extent

Not known whether mometasone is distributed into milk;¹ however, other corticosteroids are distributed into milk.¹

Does not accumulate in red blood cells.¹

Plasma Protein Binding

98–99%.¹

Elimination

Metabolism

Extensively metabolized in the liver principally by CYP3A4 isoenzyme.^{1 2}

Elimination Route

Excreted principally in feces and to a lesser extent in urine.^{1 2}

Half-life

Following IV administration, approximately 5 hours.¹

Special Populations

In patients with hepatic impairment, plasma concentrations of the drug may be increased.¹

Stability

Storage

Oral Inhalation

Powder

25°C (may be exposed to 15–30°C) in a dry place.¹ Discard the inhaler 45 days after opening the foil pouch or when dose counter reads ‘00’, whichever comes first.¹

Actions

• 
  

  Reduces the inflammatory asthmatic response by inhibiting multiple cell types (e.g., mast cells, eosinophils, lymphocytes, neutrophils, macrophages).¹

  
  


• 
  

  Inhibits mediator production or secretion (e.g., eicosanoids, leukotrienes, cytokines, histamine) involved in the asthmatic response.¹

  
  


• 
  

  Improves lung function (e.g., forced expiratory volume in 1 second [FEV₁], morning and evening peak expiratory flow rate).^{1 3 4}

  
  

Advice to Patients

• 
  

  Importance of providing the patient a copy of the manufacturer's patient information.¹

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the Twisthaler device.^{1 8}

  
  


• 
  

  Importance of pediatric patients receiving oral inhalation therapy under adult supervision.⁸

  
  


• 
  

  Importance of rinsing the mouth after oral inhalation.^{1 2 8}

  
  


• 
  

  Importance of advising patients that mometasone furoate oral inhalation must be used at regular intervals to be therapeutically effective.^{1 8}

  
  


• 
  

  Importance of adherence to prescribed dosage regimen; do not increase the frequency of administration without consulting a clinician.⁸

  
  


• 
  

  Importance of advising patients that at least 1–2 weeks of continuous therapy may be required for optimum effects to be achieved.^{1 8} Importance of contacting a clinician if asthma symptoms do not improve in such a time frame.^{1 8}

  
  


• 
  

  Importance of advising patients that orally inhaled mometasone should not be used as a bronchodilator and that the drug is not indicated for emergency use (e.g., relief of acute bronchospasm).^{1 8}

  
  


• 
  

  Importance of availability and use of a short-acting β₂-adrenergic agonist for relief of acute asthma symptoms.^{1 8 12}

  
  


• 
  

  Importance of contacting a clinician immediately if asthmatic attacks that are not controlled by bronchodilator therapy occur.¹

  
  


• 
  

  Importance of gradual withdrawal from systemic corticosteroids during transfer to orally inhaled mometasone and of monitoring by a clinician during such transfer of therapy.⁸ (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)

  
  


• 
  

  Importance of advising patients being transferred from systemic corticosteroid to mometasone oral inhalation therapy to carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress or severe exacerbation of asthma.¹ Importance of advising patients to immediately resume therapy with large doses¹ of systemic corticosteroids and contact their clinician for further instructions during stressful periods (e.g., stress, severe asthmatic attack, surgery, trauma, infection).^{1 8}

  
  


• 
  

  Importance of informing patients that corticosteroids may decrease bone mineral density.^{1 8} (See Musculoskeletal Effects under Cautions.)

  
  


• 
  

  Risk of localized candidal infections of mouth and pharynx.^{1 8} (See Infections under Cautions.)

  
  


• 
  

  Risk of systemic corticosteroid effects (e.g., hypercorticism, potentially life-threatening adrenal suppression).¹ Importance of informing a clinician of fatigue, weakness, nausea, vomiting, dizziness, or fainting.^{1 8} (See Systemic Corticosteroid Effects under Cautions.)

  
  


• 
  

  Risk of reduction in growth velocity with orally inhaled corticosteroids.¹ (See Pediatric Use under Cautions.)

  
  


• 
  

  Importance of informing patients that long-term use of inhaled corticosteroids may increase the risk for development of some eye problems (e.g., cataracts, glaucoma).¹ (See Ocular Effects under Cautions.)

  
  


• 
  

  Importance of immunosuppressed patients avoiding exposure to chickenpox or measles, and, if exposed, of immediately consulting a clinician.^{1 8} (See Immunosuppressed Patients under Cautions.)

  
  


• 
  

  Importance of advising immunosuppressed patients of potential worsening of existing tuberculosis, fungal, bacterial, parasitic, or viral infections, or ocular herpes simplex.¹ Importance of immunosuppressed patients informing clinician of a history of infections.⁸

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., infections).^{1 8}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Mometasone Furoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Powder for inhalation	110 mcg/inhalation (delivers 100 mcg/inhalation)	Asmanex Twisthaler	Schering
		220 mcg/inhalation (delivers 200 mcg/inhalation)	Asmanex Twisthaler	Schering

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Asmanex 120 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$233.99 or 1/$650.00

Asmanex 30 Metered Doses 110MCG/INH Aerosol (SCHERING): 0/$130.99 or 0/$362.96

Asmanex 30 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$148.00 or 1/$405.98

Asmanex 60 Metered Doses 220MCG/INH Aerosol (SCHERING): 0/$167.99 or 1/$462.97

Dulera 100-5MCG/ACT Aerosol (SCHERING): 13/$219.00 or 39/$636.94

Dulera 200-5MCG/ACT Aerosol (SCHERING): 13/$229.99 or 39/$659.98

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Schering Corporation. Asmanex Twisthaler (mometasone furoate) inhalation powder prescribing information. Kenilworth, NJ; 2008 Jan.

2. Sharpe M, Jarvis B. Inhaled mometasone furoate: a review of its uses in adults and adolescents with persistent asthma. Drugs. 2001; 61:1325-50. [PubMed 11511026]

3. Nayak AS, Banov C, Corren J et al. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Ann Allergy Asthma Immunol. 2000; 84:417-24. [IDIS 445793] [PubMed 10795650]

4. Kemp JP, Berkowitz RB, Miller SD et al. Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma. J Allergy Clin Immunol. 2000; 106:485-92. [IDIS 453105] [PubMed 10984368]

5. Noonan M, Karpel JP, Bensch GW et al. Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler. Ann Allergy Asthma Immunol. 2001; 86:36-43. [IDIS 458309] [PubMed 11206236]

6. Fish JE, Karpel JP, Craig TJ et al. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. J Allergy Clin Immunol. 2000; 106:852-60. [IDIS 456665] [PubMed 11080706]

7. Bernstein DI, Berkowitz RB, Chervinsky P et al. Dose-ranging study of new steroid for asthma: mometasone furoate dry powder inhaler. Respir Med. 1999; 93:603-12. [PubMed 10542973]

8. Schering Corporation. Asmanex Twisthaler(mometasone furoate) inhalation powder patient instructions for use. Kenilworth, NJ; 2008 Jan.

9. National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma update on selected topics—2002. J Allergy Clin Immunol. 2002; 110 (Suppl 5):S141-219.

10. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2005 Oct. NIH/NHLBI Publication No. 02-3659. Available at . Accessed Jan. 5, 2006.

11. Berger WE, Milgrom H, Chervinsky P et al. Effects of treatment with mometasone furoate dry powder in children with persistent asthma. Ann Allergy Asthma Immunol. 2006; 97:672-80. [PubMed 17165278]

12. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health, National Heart, Lung and Blood Institute. Aug 28. 2007. Available at .

13. IVAX Laboratories. Qvar (beclomethasone dipropronate) HFA inhalation aerosol prescribing information. Miami, FL; 2005 Nov.

14. Schering Plough, Kenilworth, NJ: Personal communication.

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Lamisil AT Continuous Spray

terbinafine hydrochloride

Dosage Form: liquid
Drug Facts

Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses

• cures most jock itch (tinea cruris)


• relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

For external use only

Do Not Use

• on nails or scalp


• in or near the mouth or the eyes


• for vaginal yeast infections

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

if too much irritation occurs or gets worse.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control

Center right away.  

Directions

• adults and children 12 years and over
  
  • wash the affected area with soap and water and dry completely before applying
  
  
  • to open remove clear cap.
  
  
  • hold can 4" to 6" from skin.  Press and hold to spray a thin layer over affected area
  
  
  • spray affected area once a day (morning or night) for 1 week or as directed by a doctor
  
  
  • release to stop spray
  
  
  • wipe excess from spray opening after each use
  
  
  • return cap to can
  
  
  • wash hands after each use
  
  


• children under 12 years: ask a doctor

Other information

store at 8° - 25° C (46° - 77° F)

Additional Information

Full Prescription Strength

Continuous Spray Action

Cures Most Jock Itch

For Effective Relief of Itching & Burning

Distr. By:  

 

Novartis Consumer Health, Inc.

 

Parsippany, NJ 07054-0622 ©2009

Inactive ingredients

Ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

Questions

call 1-800-452-0051 or visit us at www.lamisilat.com

Principal Display

LAMISIL  AT CONTINUOUS SPRAY terbinafine hydrochloride  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-6293 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 1.25 mL  in 125 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   POLYOXYL 20 CETOSTEARYL ETHER   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-6293-83 125 mL In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021124	07/23/2009

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010Novartis Consumer Health, Inc.

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• Lamisil AT Continuous Spray Side Effects (in more detail)
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• Tinea Corporis
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Vidaza

Pronunciation: AY-za-SYE-ti-deen
Generic Name: Azacitidine
Brand Name: Vidaza

Vidaza is used for:

Treating certain blood problems, including chronic myelomonocytic leukemia. It may also be used for other conditions as determined by your doctor.

Vidaza is an antineoplastic. It works by causing the death of abnormal, rapidly dividing cells in the bone marrow.

Do NOT use Vidaza if:

• you are allergic to any ingredient in Vidaza or to mannitol


• you have advanced liver cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vidaza:

Some medical conditions may interact with Vidaza. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are able to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney or liver problems

Some MEDICINES MAY INTERACT with Vidaza. However, no specific interactions with Vidaza are known at this time.

Ask your health care provider if Vidaza may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vidaza:

Use Vidaza as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Vidaza is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Vidaza at home, a health care provider will teach you how to use it. Be sure you understand how to use Vidaza. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Vidaza if it contains particles, is discolored, or if the vial is cracked or damaged.


• You may receive certain other medicines before Vidaza to help decrease the risk of nausea and vomiting. Discuss any questions with your doctor.


• If Vidaza comes into contact with the skin, immediately and thoroughly wash it off with soap and water. If it comes into contact with mucous membranes (eg, eyes, nose, mouth, vagina), flush thoroughly with water.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Vidaza, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Vidaza.

Important safety information:

• Vidaza may cause dizziness, fainting, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Vidaza with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Vidaza may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Tell your doctor or dentist that you take Vidaza before you receive any medical or dental care, emergency care, or surgery.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Vidaza may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Vidaza may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Men should not father a child while using Vidaza. Talk with your doctor about using effective methods of birth control while using Vidaza.


• Lab tests, including liver function tests, kidney function tests, and blood cell counts, may be performed while you use Vidaza. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Vidaza with caution in the ELDERLY; they may be more sensitive to its effects.


• Vidaza should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Vidaza may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vidaza while you are pregnant. It is not known if Vidaza is found in breast milk. Do not breast-feed while taking Vidaza.

Possible side effects of Vidaza:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; cough; diarrhea; dizziness; dry skin; headache; indigestion; joint pain; loss of appetite; mild muscle pain; nausea; pain, swelling, or redness at the injection site; stomach tenderness; tiredness or weakness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding at the injection site; blood in the urine; chest pain; confusion; dark urine; decreased or painful urination; fainting; fever, chills, or persistent sore throat; irregular heartbeat; mouth or tongue swelling or soreness; muscle pain, weakness, or cramping; numbness of an arm or leg; one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; stomach or leg pain; swelling of the hands, arms, ankles, feet, or legs; unusual bruising or bleeding; unusual or severe tiredness or weakness; vision changes; weight loss; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vidaza side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; vomiting.

Proper storage of Vidaza:

Vidaza is usually handled and stored by a health care provider. If you are using Vidaza at home, store Vidaza as directed by your pharmacist or health care provider. Keep Vidaza out of the reach of children and away from pets.

General information:

• If you have any questions about Vidaza, please talk with your doctor, pharmacist, or other health care provider.


• Vidaza is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vidaza. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Vidaza resources

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

• Vidaza Prescribing Information (FDA)


• Vidaza Consumer Overview


• Vidaza Monograph (AHFS DI)


• Azacitidine Professional Patient Advice (Wolters Kluwer)


• azacitidine Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Vidaza with other medications

• Myelodysplastic Syndrome

Myozyme

Generic Name: alglucosidase alfa (Intravenous route)

al-gloo-KOE-si-dase AL-fa

Intravenous route(Powder for Solution)

Myozyme(R): Life-threatening anaphylactic reactions have been observed in patients during alglucosidase alfa infusion. Appropriate supportive measures should be readily available during treatment. Patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation due to infusion reactions, and require additional monitoring .

Intravenous route(Powder for Solution)

Lumizyme(TM): Life-threatening anaphylactic reactions, severe allergic reactions, and immune-mediated reactions have been observed in some patients during alglucosidase alfa infusions. Appropriate medical support should be readily available when alglucosidase alfa is administered. Because of the potential risk of rapid disease progression in Pompe disease patients less than 8 years of age, alglucosidase alfa is available only through a restricted distribution program called the LUMIZYME ACE Program. Only prescribers and healthcare facilities enrolled in the program may prescribe, dispense, or administer alglucosidase alfa. Alglucosidase alfa may be administered only to patients who are enrolled in and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME ACE Program call 1-800-745-4447 .

Commonly used brand name(s)

In the U.S.

• Lumizyme


• Myozyme

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

Uses For Myozyme

Alglucosidase alfa injection is an enzyme that treats Pompe disease, which is also called glycogen storage disease type II. Alglucosidase alfa contains a human enzyme called acid alpha-glucosidase. This enzyme helps with the digestion and absorption of glycogen. People with Pompe disease are not able to make enough of this enzyme.

The Lumizyme™ form of this medicine is only available under a special restricted distribution program called Lumizyme™ ACE (Alglucosidase alfa Control and Education) program.

This medicine is available only with your doctor's prescription.

Before Using Myozyme

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.

Geriatric

No information is available on the relationship of age to the effects of alglucosidase alfa injection in the geriatric population.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or


• Cardiac hypertrophy (heart is larger than normal) or


• Heart rhythm problems (e.g., arrhythmia) or


• Lung disease—Use with caution. May make these conditions worse.

Proper Use of alglucosidase alfa

This section provides information on the proper use of a number of products that contain alglucosidase alfa. It may not be specific to Myozyme. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

Precautions While Using Myozyme

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause chest pain; fever; chills; itching; hives or a rash; a fast heartbeat; flushing of the face; dizziness, fainting, or lightheadedness; trouble with breathing; or swelling of the face, tongue, and throat within a few hours after it is given. Check with your doctor or nurse right away if you or your child have any of these symptoms.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Myozyme 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 or nurse immediately if any of the following side effects occur:

More common

• Blue lips, fingernails, or skin


• body aches or pain


• chest discomfort or pain


• chills


• cough


• difficult or labored breathing


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dry, red, hot, or irritated skin


• ear congestion


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth


• fever


• headache


• hives


• increased sweating


• irregular, fast, slow, or shallow breathing


• itching


• lightheadedness, dizziness, or fainting


• loss of voice


• nasal congestion


• pain


• pale skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid shallow breathing


• redness of the face, neck, arms, and occasionally, upper chest


• redness or pain at the catheter site


• runny nose


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• slow or irregular heartbeat


• sneezing


• sore throat


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tightness in the chest


• trembling or shaking of the hands or feet


• troubled breathing


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Less common

• Blood in the urine


• convulsions


• decreased urine


• dry mouth


• increased thirst


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• pain in the groin or genitals


• sharp back pain just below the ribs

Incidence not known

• Blue-green to black skin discoloration


• blurred vision


• confusion


• dilated neck veins


• extreme fatigue


• heart stops


• inability to speak


• no breathing


• no pulse or blood pressure


• pain, redness, swelling, or sloughing of the skin at the place of injection


• seizures


• severe or sudden headache


• severe pain in the chest


• slurred speech


• sudden and severe weakness in the arm or leg on one side of the body


• sudden onset of severe breathing difficulty


• swelling of the face, fingers, feet, or lower legs


• temporary blindness


• unconscious


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• acid or sour stomach


• belching


• body aches or pain


• change in hearing


• congestion


• constipation


• dryness or soreness of the throat


• ear discomfort or pain


• ear drainage


• earache


• feeling of constant movement of self or surroundings


• general feeling of discomfort or illness


• heartburn


• hives or welts


• hoarseness


• indigestion


• muscle or bone pain, stiffness, or tightness


• muscle twitching


• redness of the skin


• redness or swelling in the ear


• sensation of spinning


• sore mouth or tongue


• stomach discomfort, upset, or pain


• stuffy nose


• tender, swollen glands in the neck


• trouble with swallowing


• upper abdominal or stomach pain


• voice changes


• white patches in the mouth or on the tongue

Less common

• Bloody nose


• sleepiness or unusual drowsiness

Incidence not known

• Burning, dry, or itching eyes


• discharge, excessive tearing


• muscle spasm


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

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.

See also: Myozyme side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Myozyme resources

• Myozyme Side Effects (in more detail)
• Myozyme Use in Pregnancy & Breastfeeding
• Myozyme Support Group
• 0 Reviews for Myozyme - Add your own review/rating

• Myozyme Prescribing Information (FDA)


• Myozyme MedFacts Consumer Leaflet (Wolters Kluwer)


• Myozyme Monograph (AHFS DI)


• Myozyme Consumer Overview


• Alglucosidase Alfa Professional Patient Advice (Wolters Kluwer)


• Lumizyme Consumer Overview


• Lumizyme Prescribing Information (FDA)

Compare Myozyme with other medications

• Pompe disease

Minoxidil

Class: Direct Vasodilators
VA Class: CV490
CAS Number: 38304-91-5

• 
  

  Risk of developing potentially serious cardiac effects.^{110 b} (See Cardiovascular Effects under Cautions.) Pericardial effusion, progressing to tamponade may occur and angina pectoris may be exacerbated.^{110 b} Reserve for hypertensive patients who do not respond to maximum therapeutic doses of a diuretic and 2 other antihypertensive agents.^{110 b}

  
  


• 
  

  In animal studies, minoxidil caused myocardial lesions and other adverse cardiac effects.^{110 b}

  
  


• 
  

  Administer under close supervision, usually concomitantly with a β-adrenergic blocking agent and a diuretic, usually a loop diuretic, to prevent adverse effects.^{110 b}

  
  


• 
  

  Hospitalize and monitor patients with malignant hypertension or those already receiving concomitant guanethidine therapy to prevent too rapid or severe orthostatic decreases in BP.^{110 b}

  
  

Introduction

Vasodilating agent.^b

Uses for Minoxidil

Hypertension

Management of severe symptomatic hypertension or hypertension associated with end-organ damage in patients with uncontrolled hypertension not manageable with maximal therapeutic dosages of a diuretic and 2 other antihypertensive agents.^{110 158 b}

Not recommended for mild or moderate hypertension or severe hypertension controllable with other drugs.^{110 143 b}

Often effective in management of hypertension resistant to other drugs.^b

May be used in combination with other antihypertensive therapies (e.g., a diuretic and a β-adrenergic blocking agent, an ACE inhibitor, a calcium-channel blocking agent, and/or an angiotensin II receptor antagonist).^{110 158 b}

Do not use for the treatment of hypertension in patients with left ventricular hypertrophy.^{158 b}

Androgenetic Alopecia

Used topically to stimulate regrowth of hair in patients with androgenetic alopecia^{106 107 108 109 116 117 118 119 122 123 124 128 129 130 131 132 133 134 135 137 b} (male pattern alopecia, hereditary alopecia, common male baldness) or alopecia areata†.^{102 103 104 105 106 107 116 117 118 125 126 127 b} Safety and efficacy of extemporaneously prepared formulations of topical minoxidil in promoting hair growth not fully evaluated and such preparations may vary in strength and efficacy.^{110 b} FDA requests that physicians and pharmacists refrain from preparing extemporaneous topical formulations using the commercially available tablets.¹¹³

Minoxidil Dosage and Administration

General

• 
  

  A β-adrenergic blocking agent (equivalent to 80–160 mg of propranolol daily) must be given before initiation of minoxidil therapy and continued for duration of therapy, to minimize minoxidil-induced tachycardia and increased myocardial workload.^{110 b} If a β-adrenergic blocking agent is contraindicated, methyldopa (250–750 mg twice daily) should be initiated at least 24 hours prior to minoxidil therapy; clonidine (0.1–0.2 mg twice daily) may be used as an alternative.^{110 b}

  
  


• 
  

  A thiazide or loop diuretic must be used in patients dependent on renal function for maintenance of sodium and water balance.^{110 b}

  
  


• 
  

  Once therapy initiated, adjust dosage carefully according to individual requirements and BP response at approximately monthly intervals or more aggressively in high-risk patients.^{145 158 b}

  
  

Administration

Oral Administration

Administer orally once daily if patient’s supine DBP has been reduced by <30 mm Hg; administer twice daily (in equally divided doses) if patient’s supine DBP reduced >30 mm Hg.^{110 b}

If rapid control needed, may give dose every 6 hours; monitor BP closely.^{110 b}

Dosage

Pediatric Patients

Hypertension

Oral

Children <12 years of age: Initially, 0.2 mg/kg^{110 b} (not to exceed 5 mg) once daily.^b

Dosages may be increased at intervals of at least 3 days in increments of 50–100% until optimum BP response is achieved.^{110 b} If rapid control needed, adjust dosage every 6 hours; monitor BP closely.^{110 b}

Usual effective dosage is 0.25–1 mg/kg daily in 1 or 2 doses up to a maximum dosage of 50 mg daily.^{110 b}

Children >12 years of age: Initially, 2.5–5 mg once daily.^b Dosages may be increased at intervals of least 3 days to 10 mg, 20 mg, and then 40 mg daily in 1 or 2 divided doses until optimum BP response is achieved.^{110 b} If rapid control needed, adjust dosage every 6 hours; monitor BP closely.^{110 b}

Usual effective dosage is 10–40 mg daily in 1 or 2 doses up to maximum dosage of 100 mg daily.^{110 b}

Some experts (JNC 7) recommend a usual dosage of 2.5–80 mg daily given in 1 or 2 divided doses daily.¹⁵⁸

Severe Hypertension†

Oral

Pediatric patients 1–17 years of age: For rapid reduction of blood pressure, 0.1–0.2 mg/kg may be used.^{163 b}

Adults

Hypertension

Oral

Initially, 2.5–5 mg once daily.^b Dosages may be increased at intervals of least 3 days^b to 10 mg, 20 mg, and then 40 mg daily in 1 or 2 divided doses until optimum BP response is achieved.^{110 b} If rapid control needed, adjust dosage every 6 hours; monitor BP closely.^{110 b}

Usual effective dosage is 10–40 mg daily in 1 or 2 doses up to maximum dosage of 100 mg daily.^{110 b}

Some experts (JNC 7) recommend a usual dosage of 2.5–80 mg daily given in 1 or 2 divided doses.^{158 b}

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Children <12 years of age: maximum 50 mg daily.^{110 b}

Children >12 years of age: maximum 100 mg daily.^{110 b}

Adults

Hypertension

Oral

Maximum 100 mg daily.^{110 b}

Special Populations

Renal Impairment

Lower dosage may be required in renal failure or dialysis (about (1/3) less than in patients who are not receiving dialysis).^{110 b}

Removed during dialysis.^b Some clinicians recommend administering minoxidil immediately after dialysis (if dialysis is at 9 a.m.); if dialysis is after 3 p.m., the daily dose is given at 7 a.m. (i.e., 8 hours before dialysis). ^b

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.^{110 b}

Cautions for Minoxidil

Contraindications

• 
  

  Pheochromocytoma.^{110 b}

  
  


• 
  

  Known hypersensitivity to minoxidil or any ingredient in the formulation.^{110 b}

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Sodium and water retention occur frequently; may result in edema, weight gain, CHF, pulmonary edema, and refractoriness to the antihypertensive effects of minoxidil.^{110 b} Concomitant administration of a diuretic (usually a loop diuretic) generally required.^{110 b} (See General under Dosage and Administration.) Ascites also reported.^{110 b}

Tachycardia occurs commonly and angina pectoris may worsen or occur without previous angina; these effects may be minimized by concomitant administration of a β-adrenergic blocking agent.^{110 b} (See General under Dosage and Administration.)

Pericarditis and pericardial effusion (occasionally with tamponade) reported mainly in patients with connective tissue disease, uremic syndrome, CHF, or marked fluid retention; idiopathic cases also reported.^{110 b} Observe patients closely.^{110 b} (See Boxed Warning.)

Rapid or excessive BP reductions in patients with severe BP elevation may precipitate syncope, cerebrovascular accidents, MI, and ischemia of special sense organs resulting in decrease or loss of vision or hearing;^{110 b} hospitalize patients with malignant hypertension and those already receiving guanethidine (see Specific Drugs under Interactions) during initial minoxidil therapy and monitor closely to assure that BP is decreasing but not too rapidly.^{110 b}

Use with caution in patients with recent MI (within previous month); decreased arterial BP may further limit myocardial blood flow.^{110 b}

Sensitivity Reactions

Possible hypersensitivity (skin rash); may consider discontinuance depending on alternative therapies.^{110 b}

General Precautions

Patient Monitoring

Monitor fluid and electrolyte balance and body weight.^{110 b} Closely supervise patients with renal failure or those undergoing dialysis to prevent exacerbation of renal failure or precipitation of cardiac failure.^{110 b} Observe patients for signs and symptoms of pericardial effusion.^{110 b}

Repeat any abnormal laboratory test (e.g., urinalysis, renal function, ECG, chest radiograph, echocardiogram) occurring at initiation of therapy, initially at 1- to 3-month intervals and as stabilization occurs, at 6- to 12-month intervals.¹¹⁰

Specific Populations

Pregnancy

Category C.¹¹⁰

Lactation

Distributed into milk. ^{110 b} Use not recommended by manufacturers.¹¹⁰

Pediatric Use

Clinical experience with minoxidil for management of hypertension in children, especially infants, is limited.^{110 b} Careful titration of dosage required.^{110 b}

Geriatric Use

Insufficient experience in patients ≥ 65 years of age to determine whether geriatric patients respond differently than younger adults.^{110 b}

Select dosage with caution; because of greater frequency of hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in the elderly.^{110 b} (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Hypertrichosis,¹¹⁰ salt and water retention,^{110 b} pericardial effusion,^{110 b} nausea, ^{110 b} vomiting. ¹¹⁰

Interactions for Minoxidil

Specific Drugs

Drug	Interaction	Comments
Diuretics	Additive hypotensive effect.b Concomitant use may prevent sodium retention and increased plasma volume that may occur with minoxidil therapy110 b	Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reduction110 b
Guanethidine	Possibly profound orthostatic hypotensive effects110 b	Withdraw guanethidine110 b 1–3 weeks prior to initiating minoxidil therapy.b If not possible, initiate minoxidil in hospital setting and monitor until orthostasis no longer present110 b
Hypotensive agents	Additive hypotensive effect.b Concomitant use may prevent sodium retention and increased plasma volume that may occur with minoxidil therapy110 b	Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reduction110 b

Minoxidil Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; at least 90% of an oral dose is absorbed.¹¹⁰ Peak plasma concentrations of unchanged drug usually attained within 1 hour.^{110 b}

Onset

Following oral administration, antihypertensive effect occurs within 30 minutes and is maximum in 2–8 hours.^{110 b}

Duration

2–5 days.^{110 b}

Distribution

Extent

Readily distributed into body tissues.^b

Distributed into milk.^{110 b}

Plasma Protein Binding

Does not bind to plasma proteins.^{110 b}

Elimination

Metabolism

Approximately 90% of an oral dose is metabolized to less active metabolites than parent drug, principally by conjugation with glucuronic acid and by conversion to more polar metabolites.^{110 b}

Elimination Route

Excreted principally in urine by glomerular filtration.^{110 b}

Half-life

4.2 hours.^{110 b}

Special Populations

Clearance is directly affected by GFR.¹¹⁰

Stability

Storage

Oral

Tablets

20–25°C.^{110 b}

ActionsActions

• 
  

  Reduces peripheral vascular resistance and BP through direct vasodilation of vascular smooth muscle.^{110 b}

  
  


• 
  

  Reduces BP in both supine and standing patients; does not produce orthostatic hypotension.^b

  
  


• 
  

  Increases heart rate, cardiac output, and stroke volume.^{110 b}

  
  


• 
  

  Causes sodium and water retention and increased plasma volume.^{110 b}

  
  

Advice to Patients

• 
  

  Importance of informing patients about continuance of all antihypertensive drugs and taking only as prescribed.¹¹⁰

  
  


• 
  

  Do not discontinue minoxidil unless instructed by a clinician.¹¹⁰

  
  


• 
  

  Importance of informing patients of symptoms of fluid overload and cardiac effects.¹¹⁰ Importance of reporting these symptoms to a clinician.¹¹⁰

  
  


• 
  

  Importance of providing patient a copy of manufacturer's patient information.¹¹⁰

  
  


• 
  

  Inform patients of the likelihood of hair growth, which may develop within 3 to 6 weeks after starting therapy and may be especially disturbing to children and women.¹¹⁰ Inform patients about this effect before initiating therapy.¹¹⁰

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.¹¹⁰

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹¹⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information. (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
Oral	Tablets	2.5 mg*	Minoxidil Tablets	Mutual, Par, Watson
		10 mg*	Minoxidil Tablets	Mutual, Par, Watson

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Minoxidil 10MG Tablets (MUTUAL PHARMACEUTICAL): 90/$53.99 or 180/$86

Minoxidil 2.5MG Tablets (PAR): 60/$19.99 or 180/$50.99

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 July 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

Only references cited for selected revisions after 1984 are available electronically.

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101. Valdivieso A, Valdés G, Spiro TE et al. Minoxidil in breast milk. Ann Intern Med. 1985; 102:135. [IDIS 194820] [PubMed 3966734]

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