Loading…
WOMEN'S GLN-MINOXIDIL is a brand name for Minoxidil, supplied as a aerosol, foam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Women’s GLN-MINOXIDIL (5% minoxidil topical foam) is indicated for: • the treatment of female androgenetic alopecia (female pattern hair loss) on the top of the scalp. The effectiveness of Women’s GLN-MINOXIDIL in the treatment of receding hairlines has not been demonstrated in clinical trials. Persistence of effect…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • FOR EXTERNAL USE ONLY. Do not ingest. Use Women’s GLN-MINOXIDIL (5% minoxidil topical foam) only as directed. Apply Women’s GLN-MINOXIDIL when the hair and scalp are thoroughly dry. Women’s GLN-MINOXIDIL has been found to be safe and effective in women from 18 up to 87 years of age.
2 Recommended Dose and Dosage Adjustment Women’s GLN-MINOXIDIL Apply half (½) capful foam (50 mg minoxidil) on a clean non-absorbent surface such as a dish. Make a centre part within the hair thinning areas to help maximize scalp exposure.
Part the hair at least 2 more times on each side of the centre part around the thinning area. Spread the foam with the fingertips over the hair loss scalp areas and gently massage foam into the scalp starting from the back to front (forehead) direction.
Massage until all the foam dose is gone. After each use, thoroughly clean and dry the non-absorbent surface to which the foam was placed before applying to the scalp. The hands should be washed well with soap and water after the application.
Allow Women’s GLN- MINOXIDIL to remain on scalp for at least 4 hours for best results. Health Canada has not authorized an indication for pediatric use. 4 Administration Women’s GLN-MINOXIDIL 1) To open container: Match arrow on can ring with arrow on cap.
Pull off cap. 2) Hold the can upside down and press nozzle to dispense the foam. The total amount of foam applied should not exceed half (½) capful (equivalent to one gram of foam). 3) The foam may begin to melt on contact with warm skin.
If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam. 4) The foam should be massaged lightly into the affected areas of the scalp. 5 Missed Dose Women’s GLN-MINOXIDIL If one or two applications are missed, the missed application(s) should be skipped, and treatment should be resumed with the next scheduled application/dose.
Do not use twice as much, or twice as Women’s GLN-MINOXIDIL Page 6 of 43 Minoxidil Foam often, the prescribed dose.
1 Adverse Reaction Overview Women’s GLN-MINOXIDIL Page 9 of 43 Minoxidil Foam Women’s GLN-MINOXIDIL The clinical trial safety database comprises a total of 942 subjects, of whom 576 were treated with one or more formulations of 5% Minoxidil Topical Foam (MTF).
In the placebo-controlled phase 3 study of efficacy and safety (MINALO3005), patterns of adverse events indicated that both 5% MTF once daily and foam vehicle were well tolerated by the subjects. No difference in the overall incidence of adverse events between treatment groups (approximately 50% of subjects in each group) was observed.
The incidence of specific adverse events was generally similar between the treatment groups. 5%, respectively). In the active-controlled phase 3 study of efficacy and safety (MINALO3004), patterns of adverse events indicated that both 5% MTF once daily and 2% Minoxidil Topical Solution (MTS) applied twice daily were well tolerated by the subjects.
3% in 2% MTS twice daily). 0%). 0%). In MINOB-9140-004, because subjects received all study medications simultaneously via skin patches, no comparison of adverse event incidences between treatments is possible. In MINOB- 9140-001, the numbers of subjects receiving 2% MTS or 5% MTS were too small to allow meaningful comparison of adverse event rates between treatments.
In addition, in the phase 3 studies, serum minoxidil concentrations were to be determined at the investigator’s discretion for any subject having a cardiovascular adverse event during the study. Serum minoxidil levels from such testing were found to be below the threshold associated with hemodynamic events.
The timing of the collection of these samples varied depending on when the subject had the cardiovascular event. If the event occurred in-between study visits, then the subject was required to come to the office as soon as possible for an unscheduled visit.
General • Women’s GLN-MINOXIDIL is for external use only. Apply only to scalp. Do not ingest. • Before applying Women’s GLN-MINOXIDIL, the user should determine that the scalp is normal and healthy. • Hands should be washed thoroughly after use.
• Inhalation of the spray should be avoided. • Women’s GLN-MINOXIDIL contain ethanol (alcohol) 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 large amounts of cool tap water.
• Women’s GLN-MINOXIDIL also contain butylated hydroxytoluene, cetyl alcohol, and stearyl alcohol. , contact dermatitis), or irritation to the eyes or mucous membranes. , contact dermatitis). • Some patients have experienced changes in hair colour and/or texture with Women’s GLN- MINOXIDIL use.
• Shedding of hair may occur within two to six weeks after initiating therapy, likely due to minoxidil’s action on shifting hairs from the resting telogen phase to the growing anagen phase. If shedding persists for more than two weeks, users should stop applying Women’s GLN-MINOXIDIL and consult their doctor.
• Women’s GLN-MINOXIDIL should not be used when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown. • Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application site of patients (caregivers) using topical minoxidil.
Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil. Contact between children and minoxidil application sites should be avoided. Women’s GLN-MINOXIDIL Page 8 of 43 Minoxidil Foam Cardiovascular • Accidental ingestion may cause serious cardiac adverse events.
• Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Women’s GLN-MINOXIDIL. • Although the following systemic effects have not been associated with the topical use of Women’s GLN-MINOXIDIL, there is some absorption of minoxidil from the skin and the potential exists for systemic effects such as salt and water retention, hypertension, tachycardia, angina, and edema.
Women’s GLN-MINOXIDIL is contraindicated: • in Women who are pregnant or breastfeeding or have hair loss associated with childbirth. • in individuals with a history of hypersensitivity to minoxidil or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • in individuals with treated or untreated hypertension. • in individuals whose baldness is not due to hereditary factors. Women’s GLN-MINOXIDIL is only effective for the treatment of hair loss on the top of the scalp (female pattern hair loss).
• in individuals with any scalp abnormality (including psoriasis and sunburn). • in individuals with a shaved scalp or whose scalp’s skin is broken, inflamed, irritated, infected, or severely sunburned. • if occlusive dressings or other topical therapeutic medications for treating disorders of the skin of the scalp are being used.
, cornrowing, tight ponytails), may also cause temporary hair loss which should not be treated with Women’s GLN-MINOXIDIL.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Minoxidil in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In MINALO3005, 2 subjects in the 5% MTF once daily group died within 30 days after the last dose of investigational product (IP) due to non-investigational-product-related causes (cardiovascular disorder in 1 subject and dehydration and renal failure in 1 subject).
No deaths occurred during MINALO3004 within 30 days after the last dose of IP. However, 1 subject in the 2% MTS BID group experienced a serious adverse event of metastatic neoplasm that led to death 140 days after the last dose of IP.
This serious adverse event was considered to be not IP related. The percentage of subjects experiencing serious adverse events in the phase 3 studies was low. All serious adverse events were considered by the investigator to have a doubtful relationship or to be not related to IP.
In the 4 clinical studies, the incidence of drug-related adverse events was low overall. 0% of the subjects across the 4 studies. Women’s GLN-MINOXIDIL Page 10 of 43 Minoxidil Foam The incidence of adverse events leading to study withdrawal was low overall.
Headache (2 subjects overall) and pruritus (2 subjects overall) were the only adverse events causing subjects to discontinue that were reported in more than 1 subject across the 4 studies. Data from the phase 3 studies indicated a low incidence of hypertrichosis.
In MINALO3005, hypertrichosis was recorded as an adverse event for one subject in both the 5% MTF once daily and foam vehicle groups. In MINALO3004, hypertrichosis was recorded as an adverse event for 3 subjects in the 5% MTF once daily group.
Analysis of clinical laboratory test results, vital signs, and physical examination findings revealed no new or unexpected safety issues relevant to the intended use of 5% MTF once daily. Overall safety analyses in the 4 clinical trials have shown 5% MTF once daily to be well tolerated in healthy subjects and in women with FPHL who were treated for up to 52 weeks.
The safety profile of 5% MTF in females was generally similar to that observed in clinical trials of 5% MTF BID in males and 5% Minoxidil Topical Solution applied twice daily in males. No new or unusual findings were reported in the phase 3 studies.
In general, the overall post-marketing safety experience to date has been consistent with that observed in the clinical trial program. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 0% of Subjects in the Foam Vehicle, 2% MTS Twice Daily, or 5% MTF Once Daily Groups in MINALO3004 or MINALO3005 (Intent-to Treat Subjects) Number (%) of Subjects MINALO3004 MINALO3005 System Organ Class Preferred Term 2% MTS Twice Daily 52 weeks (N=161) 5% MTF Once Daily 52 weeks (N=161) Foam Vehicle Once Daily 24 weeks (N=201) 5% MTF Once Daily 24 weeks (N=203) […]
• The patient should stop using Women’s GLN-MINOXIDIL and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, or persistent redness.
Monitoring and Laboratory Tests Patients should be monitored for signs of systemic effects of minoxidil such as hypotension, chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp.
The use of Women’s GLN-MINOXIDIL should be discontinued in the event of systemic effects and/or severe dermatologic reactions. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women using Women’s GLN- MINOXIDIL.
This product should not be used in pregnant women. 2 Breast-feeding There are no adequate and well controlled studies in breastfeeding women. Systemically absorbed minoxidil is secreted in human milk. Women’s GLN-MINOXIDIL should not be used in nursing women.
3 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Women’s GLN-MINOXIDIL in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
1 Pediatrics. Accidental ingestion may cause serious cardiac adverse events. Therefore, this product has to be kept out of the reach of children. See 7 Warnings and Precautions, Cardiovascular.