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KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Before starting on Rogaine the patient should have a healthy, normal scalp.
Although extensive use of topical minoxidil has not revealed evidence that enough minoxidil is absorbed to
have systemic effects, greater absorption because of misuse or individual variability or unusual sensitivity
could lead, at least theoretically, to a systemic effect, and patients need to be aware of this.
Accidental ingestion of Rogaine could lead to serious adverse effects. The following adverse effects may be
observed as a result of systemic absorption:
-salt and water retention,
-generalized and local edema,
-pericardial effusion,
-pericarditis,
-tamponade,
-tachycardia,
-increased frequency of angina or new onset of angina, or
-the potentiation of the orthostatic hypotension produced by guanethidine.
Patients with known cardiovascular disease or cardiac arrhythmias should contact a physician before using Rogaine.
Rogaine is recommended for use only in healthy adults with normal cardiovascular status. The safety is unknown
in patients with cerebrovascular disease, ischemic heart disease, cardiac arrhythmias or congestive heart failure.
Patients with a history of underlying heart disease should be aware that adverse effects in them might be especially
serious. The consumer should stop using the product and see a doctor if hypotension is detected or if experiencing
chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet
or persistent redness or irritation of the scalp.
Patients treated with Rogaine should be monitored after starting therapy and periodically thereafter. If systemic
effects should occur, discontinue use of Rogaine. If necessary, fluid retention and edema can be managed with
diuretic treatment. Tachycardia and angina can be controlled by administration of beta-adrenergic blocking drugs
or other sympathetic nervous system suppressants.
Topical minoxidil therapy should be stopped if hair regrowth is not evident after 12 months of treatment.
Rogaine contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental
contact with sensitive surfaces ( eye, abraded skin, mucous membranes ), the area should be bathed with copious
amounts of cool tap water. Inhalation of the spray mist should be avoided.
The effects of Rogaine in patients with concomitant skin diseases, or in those using topical corticosteroids
or other dermatological preparations, are unknown. There is a possibility that an increase in bioavailability,
of topically administered minoxidil, may occur in the presence of inflammatory conditions of the scalp and such
situations are to be avoided.
If a patient wishes to wear any form of protective headgear, he should be instructed to allow 1 hour to elapse
after using Rogaine before covering the head.
Some patients have experienced changes in hair color and/or texture with Rogaine use.
There are currently no known drug interactions associated with the use of Rogaine. Although it has not been
clinically demonstrated, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic
hypotension in patients currently taking peripheral vasodilators. In vitro studies have shown that paracetamol
and diethylcarbamazine may inhibit the stimulation of hair growth by minoxidil.
Drugs for cutaneous use, e.g., tretinoin and anthralin/dithranol, which alter the stratum corneum barrier,
could result in increased absorption of cutaneously used minoxidil if applied concurrently.
Carcinogenic activity of minoxidil has been investigated following dietary administration to mice at 10-64mg/kg/day,
and following topical administration to mice and rats at 8-80mg/kg/day. Minoxidil treatment was associated with
the development of benign pituitary tumors and malignant mammary tumors in female mice, hepatic adenomas and
splenic hemangiosarcomas in male mice, and adrenal medullary and clitoral gland adenomas in female rats. The
hepatic tumors were only observed at high dose levels. The development of mammary adenocarcinomas in mice may
be related to stimulation of prolactin release. Tumor development in the pituitary, preputial and clitoral glands
may also involve endocrine mechanisms, while the vascular wall tumors in mouse spleen and adrenal medullary
tumors in rats may be related to the vasodilator activity of the drug.
In a 12-month photocarcinogenicity study in hairless mice, topical minoxidil did not accelerate the development
of dermal tumors initiated by ultraviolet light.
Genetic toxicology studies showed that minoxidil does not cause gene mutation in bacterial cells, but gene
mutation studies in mammalian cells have not been reported. Minoxidil had weak clastogenic activity in a cytogenetics
assay in Chinese hamster lung cells in vitro, but there was no evidence of similar effects in cultured human
lymphocytes, or in an in vivo assay ( micronucleus test in mice ). Minoxidil did not cause DNA damage in an
alkaline elution assay in Chinese hamster fibroblasts or unscheduled DNA synthesis in rat hepatocytes.
In fertility studies in rats, minoxidil decreased live litter size at oral doses of 3-10mg/kg/day and at 80mg/kg/day
SC.
Animal studies have shown a risk to the fetus at exposure levels that in comparison to levels obtained in humans
are very high and showing signs of maternal toxicity. The risk of fetal harm is low if topical minoxidil is
administered as directed during pregnancy.
There are no adequate and well-controlled studies in pregnant women. Minoxidil should be used during pregnancy
only if the potential benefit justifies the risk to the fetus.
Systemically-absorbed minoxidil is secreted in human milk. Rogaine should not be used by nursing women.
Subcutaneous administration of minoxidil at 80mg/kg/day to lactating rats suppressed postnatal growth and increased
postnatal mortality of the offspring. These effects may have been due to interference with nursing behavior
rather than to ingestion of drug-related material by the offspring.
Safety and efficacy of Rogaine in patients under 18 years of age have not been established.
Safety and efficacy of Rogaine in patients over 65 years of age have not been established.
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