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Minoxidil (Minoxidil) - Summary

 



WARNINGS

Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents.

In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects (see Cardiac Lesions in Animals).

Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine (see Warnings) should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.

 

MINOXIDIL SUMMARY

MINOXIDIL TABLETS, USP

Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, crystalline powder, soluble in alcohol and propylene glycol; sparingly soluble in methanol; slightly soluble in water; practically insoluble in chloroform, acetone and ethyl acetate.

Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined.

Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of whom had hypertension that could not be controlled by other drugs.


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NEWS HIGHLIGHTS

Media Articles Related to Minoxidil

New Consortium Paves The Way For Improved Treatment Of Hypertension And Associated Vascular Complications
Source: Hypertension News From Medical News Today [2009.11.18]
Top Institute Pharma (TI Pharma) has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension (high blood pressure) and associated vascular complications such as heart and kidney failure, myocardial infarction and stroke.

Kids with CKD Often Have Masked Hypertension (CME/CE)
Source: MedPage Today Nephrology [2009.11.13]
Many children with chronic kidney disease may have undetected hypertension, placing them at risk for enlarged hearts and future cardiovascular disease, a cross-sectional study showed.

Key Player Identified In Cascade That Leads To Hypertension-Related Kidney Damage
Source: Hypertension News From Medical News Today [2009.11.06]
A key player in a cascade that likely begins with stress and leads to high blood pressure and kidney damage has been identified by researchers who say the finding may lead to better ways to control both. Medical College of Georgia researchers have found endothelin, a powerful blood vessel constrictor and inflammatory peptide, increases the number of T cells in the kidneys, which helps recruit other immune cells, causing inflammation and destruction.

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

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Published Studies Related to Minoxidil

Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men. [2009.08]
Minoxidil is efficacious in inducing hair growth in patients with androgenetic alopecia by inducing hair follicles to undergo transition from the early to late anagen phase... Our findings confirmed the superiority of 5% topical minoxidil to 1% topical minoxidil in treating Japanese men with androgenetic alopecia.

A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men. [2007.11]
BACKGROUND: An alternative to currently marketed topical minoxidil solutions is desirable. OBJECTIVE: To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol-free foam vehicle in men with androgenetic alopecia (AGA)... CONCLUSIONS: We believe that 5% MTF is a safe and effective treatment for men with AGA.

A randomized, placebo-controlled trial of 1% topical minoxidil solution in the treatment of androgenetic alopecia in Japanese women. [2007.01]
Minoxidil is effective in inducing hair growth in patients with androgenetic alopecia by stimulating hair follicles to undergo transition from early to late anagen phase. However, there have been no controlled studies of topical minoxidil in Asian women... The patients tolerated treatment with 1% topical minoxidil well without significant adverse effects.

K+ channel activation with minoxidil stimulates nasal-epithelial ion transport and blunts exaggerated hypoxic pulmonary hypertension. [2006.03]
Increased pulmonary capillary pressure and inhibition of alveolar Na+ transport putatively contribute to the formation of pulmonary edema in alveolar hypoxia such as at high altitude. Since both events might be linked to the inhibition of K+ channels, we studied whether in vivo application of minoxidil, a stimulator of ATP-gated K channels (K+ ATP channel activator) prevents both effects...

Treatment of anal fissures using a combination of minoxidil and lignocaine: a randomized, double-blind trial. [2005.07]
AIM : Anal fissures are associated with hypertonia of the internal anal sphincter and pain. We evaluated the efficacy of local application of a combination of minoxidil and lignocaine in healing anal fissures... CONCLUSION: Combination treatment with minoxidil and lignocaine helps in faster healing of anal fissures and provides better symptomatic relief than either drug alone.

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Clinical Trials Related to Minoxidil

A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss [Completed]
The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.

Efficacy of Minoxidil in Children With Williams-Beuren Syndrome [Recruiting]
The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11. 23 that encompasses loss of the elastin locus.

Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.

These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications.

Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis.

Working Hypothesis: If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children.

Objective: To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome.

Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion: variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension.

Total study duration: 30 months including a 12 month-recruitment period

Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss [Recruiting]
This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension [Recruiting]
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat VEGF inhibitor treatment induced hypertension.

Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension [Completed]
Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy. 2,3

The researchers hypothesize that:

1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by Clinical Hypertension Specialists.

2. Renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more medications, while under the care of a Clinical Hypertension Specialist.

3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Minoxidil has an overall score of 9.33. The effectiveness score is 10 and the side effect score is 8.67. The scores are on ten point scale: 10 - best, 1 - worst.
 

Minoxidil review by 38 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Hair loss
Dosage & duration:   1mL (dosage frequency: x2 daily) for the period of 12 months
Other conditions:   thinning hair on crown and temples
Other drugs taken:   none
  
Reported Results
Benefits:   The benefits of using minoxidil was the halting of DHT buildup in the scalp around hair follicles. It also improved circulation to the scalp. This encouraged the recovery of thinning hair to become thicker and fuller. This halted hair loss and restored hair to cover up signs of male pattern baldness.
Side effects:   There were no observed side effects with the use of this product.
Comments:   1mL Minoxidil was applied twice daily to the scalp until the entire dose and been absorbed. treatment was coupled with Low Light Laser Therapy - 650nm 5W lasers that served to biostimulate the scalp and help in the halting of the effects of DHT.

 

Minoxidil review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   hair loss
Dosage & duration:   Men's formulation, applied twice daily (dosage frequency: twice daily) for the period of two years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Even though I am a woman, my dermatologist recommended that I use the men's dose of Rogain. It definitely thickened my hair, after using the woman's dose for several years, which just kept me from losing hair.
Side effects:   Mild drying of the scalp
Comments:   Applied men's formulation of rogaine to my scalp twice a day.

 

Minoxidil review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   hair loss
Dosage & duration:   Men's formulation, applied twice daily (dosage frequency: twice daily) for the period of two years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Even though I am a woman, my dermatologist recommended that I use the men's dose of Rogain. It definitely thickened my hair, after using the woman's dose for several years, which just kept me from losing hair.
Side effects:   Mild drying of the scalp
Comments:   Applied men's formulation of rogaine to my scalp twice a day.

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Page last updated: 2009-11-18

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