Drug Interaction:
Peripheral Vasodilators-
Isoxsuprine hcl, Papaverine hcl, Hydralazine hcl, Minodoxil, Epoprostenol sodium,
Tresprostinil sodium,
Guanethidine-
Use in patients on guanerthidine can result in profound orthostic effects.
If possible discontinue guanithidine well before minoxidil is instituted
If not possible, start minoxidil in the hospital and institutionalize the patient until severity effects are
no longer present .
Indication:
Male pattern baldness
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Minoxidil Male pattern baldness April 1988
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Each ml contains: 07-02-2014
Minoxidil IP 5% +
Finasteride IP 0.1% Lipid solution for topical
Application
For the treatment of androgenic alopecia in males
Peripheral Vasodilators-
Isoxsuprine hcl, Papaverine hcl, Hydralazine hcl, Minodoxil, Epoprostenol sodium,
Tresprostinil sodium,
Adverse Reaction:
Cardiovascular- pericardial effusion and occasionally with tamponade (3%) . Changes in direction
and magnitude of T waves occur (app. 60%)
GI - nausea, vomiting
Haemotolgic- initially hematocrit , haemoglobin and erythrocyte count usually fall about 7% and
then recover to pretreatment levels.
Thrombocytopenia and leucopenia
Hypersensitivity- rashes, including bullous eruptions (rare) ansd Stevens- Johnson syndrome
Miscellaneous- temporary edema (7%) , breast tenderness fewer than ( 1%)
Hypertrichosis- elongation thickening and enhanced pigmentation of fine body hair develops within 3 to 6 weeks of startingtherapy in approx. (80%)
Contra-Indications:
Hypersensitivity to any component of the product.
Pheochromocytoma - because the drug may stimulate secretion of catecholamines from the tumor
through its antihypertensive action.
Warnings-
Mild hypertension- becasuse of serious adverse efects use in mild degrees of hypertension is not
recommended, the benefit -risk ratio in such patients is not defined
Animal toxicity-
Minoxidil has produced cardiac lesions in animals including grossly visible hemorrhagic lesions of
the atrium , epicardium, and walls of small arteries and arterioles
Fluid and electrolyte balance-
Monitor fluid and electrolyte balance andbody weight. Give with a diuuretic to prevent fluid retension
and possible CHF, a loop diuretic is usally required
Tachcardia/Angina-
Minoxidil increases heart rate. This can be prevented by co-administeration of a Beta adfrenergic
blocking drug or other sympathetic nervous system suppresants eg. clonidine, methyldopa.
Hazard of rapid control of blood pressure-
Too rapid control of very severe blood pressure elevation can precipitate syncope, cerbrovascular
accidents, MI and ischemia of special sense organs with resulting decrease or loss of vision or
hearing.
Hospitalize any patient with malignant hypertension during initial tretment to assure that blood pressure
is not falling rapidly than intended
Hypertrichosis- elongation, thickening and enhanced pigmentationof fine hair developds within
3to 6 weeks after starting therapy in approximately 80% of patients. Upon discontinuation of the drug
new hair growth stops, but 1 to 6 months may be required for restoration to pretreatment appearance
Hypersensitivity reactions-
Manifested as a skin rash, and rare reports of bullous eruptions and Stevens-Johnson syndrome.
These reactions occur in fewer than 1% of patients
Dosages/ Overdosage Etc:
Severe hypertension
Alopecia and androgenetica (topical use ) Treatment of male pattern baldness
Adults- and children over 12 years of age-
Initial dose is 5mg /day as a single dose.
Daily dose can be increased to 10, 20, and then to 40mg in single or divided dose if required
Maximum dose is 100mg per day
Other Information:
Peripheral Vasodilators-
Isoxsuprine hcl, Papaverine hcl, Hydralazine hcl, Minodoxil, Epoprostenol sodium,
Tresprostinil sodium,
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Minoxidil. Also tell your healthcare care professional if you are allergic to
any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Minoxidil has not been studied in pregnant women. However, there are
reports of babies born with thick or dark hair on their bodies after the
mothers took minoxidil during their pregnancy. Discuss this possible
effect with your doctor.
3. Breast-feeding-
Although minoxidil passes into breast milk, it has been reported to cause
problems in nursing babies.
4.Children-
Although there is no specific information comparing use of minoxidil
in children with use in other age groups, this medicine is not expected
to cause different side effects or problems than it does in adults.
5.Older adults-
Elderly patients are more sensitive to the effects of minoxidil, In addition,
Minoxidil may reduce the tolerance to cold temperature in elderly patients.
6. Other medicines-
Tell your doctor if you are using any of the following -
Guanethidine or
Nitrates -severe lowered blood pressure may occur
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Angina -minoxidil may make the condition worse
Heart attack or stroke - lowering of blood pressure may make problems
resulting from heart attack or stroke worse.
Heart or blood vessel disease- minoxidil can cause fluid buildup,
which can cause problems
Kidney disease- effects may be increased bcause of slower removal
from the body
Pheochromocytoma- minoxidil may cause the tumor to be more active.
Pharmacology/ Pharmacokinetics:
Peripheral Vasodilators-
Isoxsuprine hcl, Papaverine hcl, Hydralazine hcl, Minodoxil, Epoprostenol sodium,
Tresprostinil sodium,
Pharmacology-
Minodixil is direct acting peripheral vasodilator. Itb does not interfere with vasomotor reflux, therefore
it does not produce orthostatic hypotension. Drug does not affect ther CNS system.
Minoxidil elicts a reduction of peripheral arteriolar resistence. This action with the associated fall in
blood pressure, triggers sympathetic, vagal inhibitory , and renal hemostatic mechanisms, including
an increase in renin secretion, which leads to increase in cardiac rate and output, and salt and water
retention. These adverse effects can usually be minimized by coadministration of a diuretic and a
beta blocking agent or other sympathetic nervous suppressant.
Pharmacokinetics-
Minoxidil is not protein bound and is at least 90% absorbed from the GI tract. Plasma levels of the
parent drug reach a maximum within the first hour and decline rapidly thereafter. The metabolites
are all exceted principally in the urine. Minoxidil and its metabolites are hemodialazable.
Average plasma half life is 4.2 hours.
Pregnancy and lactation:
Pregnancy-
No adequate or well controlled studies in pregnant women
Use only when clearly needed.
Lactation-
safety for use in breast feeding mother has ot been established. Do not breast feed while taking minoxidil
Manufacturer Details