Splendora 5%

PHARMACOLOGY
Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the
hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair
follicles.
Following topical application, an average of about 1.4% of the total applied dose is
absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by
increasing the dose applied, increasing the frequency of dosing and decreasing the barrier
function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting
from the administration of topical Minoxidil are governed by the drug’s absorption rate
through the skin. Following cessation of topical dosing, approximately 95% of the
systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are
excreted principally in the urine.
INDICATION
Splendora™ is indicated for the treatment of alopecia androgenetica (hair loss) in males
and females between 18 to 65 years of age.
DOSAGE AND ADMINISTRATION
Splendora™ topical solution is for external use only and should be applied when the hair
and scalp are clean and dry. Apply 1 ml (7 sprays) of Splendora™ topical solution twice
daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and
spreading the solution out to cover the entire affected area. The total daily application
dose should not exceed 2 ml.
For the best results, Splendora™ topical solution should be allowed to remain on the
scalp for about 4 hours before washing. The night-time application should be done 2–4
hours before going to bed to allow the solution to dry out. Splendora™ topical solution
should not be massaged into the scalp, but applied lightly. A hair dryer should not be
used to speed up the drying of the solution as it may decrease the effectiveness.
Splendora™ topical solution should not be mixed with any hair oil. The drug should not
be used more than two times a day, or be taken orally or applied to any other part of the
body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or
longer application time have no effect on hair growth. In case of missing any daily
applications of Splendora™ topical solution, the patient should continue with the next
application.
Hands should be washed immediately if Minoxidil topical solution is applied with the
fingertips. Clinical experience with Splendora™ indicates that twice-daily applications
for 4 months or more may be required before there is evidence of hair growth. To arrest
hair fall, Splendora™ topical solution should be used for not less than 45 days.
Depending upon the severity of hair loss or type and extent of baldness, particular
strength of Splendora™ topical solution may be selected.
CONTRAINDICATION
• Patients with cardiac abnormalities
• Children below 18 years of age
• Patients using occlusive dressings or other medicines on the scalp
• Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis
& sunburn)
SIDE EFFECT
Commonly encountered side effects in clinical trials with Minoxidil topical solution were
minor dermatological reactions. Dermatitis or hypertrichosis may occur. These
incidences may occur in 0.1–5% of patients.