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Loniten (Minoxidil) - Summary

 
 



WARNINGS

LONITEN 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. LONITEN 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).

LONITEN 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 LONITEN is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.

 

LONITEN SUMMARY

Loniten®
minoxidil tablets, USP

LONITEN Tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white or off-white, odorless, crystalline solid that is soluble in water to the extent of approximately 2 mg/mL, is readily soluble in propylene glycol or ethanol, and is almost insoluble in acetone, chloroform or ethyl acetate.

Because of the potential for serious adverse effects, LONITEN 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.

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


See all Loniten indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Loniten (Minoxidil)

High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Source: MedicineNet Facial Nerve Problems Specialty [2017.09.19]
Title: High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Category: MedicineNet Quiz
Created: 2/9/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 6:02:11 PM

Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Source: MedicineNet Congenital Heart Disease Specialty [2017.07.26]
Title: Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/26/2017 12:00:00 AM

High Blood Pressure (Hypertension)
Source: MedicineNet Polycystic Ovary Specialty [2017.03.31]
Title: High Blood Pressure (Hypertension)
Category: Symptoms and Signs
Created: 1/15/2014 12:00:00 AM
Last Editorial Review: 3/31/2017 12:00:00 AM

Portal Hypertension
Source: MedicineNet nitroglycerin Specialty [2016.09.06]
Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 9/6/2016 12:00:00 AM

Picture of Hypertension
Source: MedicineNet betaxolol ophthalmic Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

more news >>

Published Studies Related to Loniten (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.

more studies >>

Clinical Trials Related to Loniten (Minoxidil)

Minoxidil Response Testing in Males With Androgenetic Alopecia [Active, not recruiting]
Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i. e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous. Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker. Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam. The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Minoxidil Response Testing in Females With Female Pattern Hair Loss [Active, not recruiting]

Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia [Recruiting]
5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5. 7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81. 8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil [Not yet recruiting]
5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i. e., 30-40% re-grow hair. The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia [Not yet recruiting]
The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).

more trials >>


Page last updated: 2017-09-19

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