Minscalp Plus

Uses

Azelaic acid is used for acne vulgaris, rosacea.

Minoxidil is used for the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Minscalp Plus is also used to associated treatment for these conditions: Acne Vulgaris, Inflammatory lesions caused by rosacea, Susceptible Bacterial Infections, Nutritional supplementationAndrogenetic Alopecia, Severe, symptomatic HypertensionB Vitamin Deficiency, Dysuria, Urination impaired

How Minscalp Plus works

The exact mechanism of action of azelaic acid is not known. It is thought that azelaic acid manifests its antibacterial effects by inhibiting the synthesis of cellular protein in anaerobic and aerobic bacteria, especially Staphylococcus epidermidis and Propionibacterium acnes. In aerobic bacteria, azelaic acid reversibly inhibits several oxidoreductive enzymes including tyrosinase, mitochondrial enzymes of the respiratory chain, thioredoxin reductase, 5-alpha-reductase, and DNA polymerases. In anaerobic bacteria, azelaic acid impedes glycolysis. Along with these actions, azelaic acid also improves acne vulgaris by normalizing the keratin process and decreasing microcomedo formation. Azelaic acid may be effective against both inflamed and noninflamed lesions. Specifically, azelaic acid reduces the thickness of the stratum corneum, shrinks keratohyalin granules by reducing the amount and distribution of filaggrin (a component of keratohyalin) in epidermal layers, and lowers the number of keratohyalin granules.

Minoxidil is thought to promote the survival of human dermal papillary cells (DPCs) or hair cells by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of BCl^-2/Bax. Minoxidil may stimulate the growth of human hairs by prolonging anagen through these proliferative and anti-apoptotic effects on DPCs. Minoxidil, when used as a vasodilator, acts by opening adenosine triphosphate-sensitive potassium channels in vascular smooth muscle cells. This vasodilation may also improve the viability of hair cells or hair follicles.

Dosage

Minscalp Plus dosage

Acne vulgaris:

• Adult: As 20% cream or 15% gel: Apply thinly into the affected areas bid (morning and evening) after cleansing. Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth.
• Child: ≥12 yr Same as adult dose.

Rosacea:

• Adult: As 15% gel: Apply thinly into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk.
• Child: ≥12 yr Same as adult dose.

Minoxidil 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 Minoxidil 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, Minoxidil 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. Minoxidil 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. Minoxidil 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 Minoxidil 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 Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arresthair fall, Minoxidil 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 Minoxidil topical solution may be selected.

Side Effects

Burning, erythema, stinging, pruritus, dryness and scaling, peeling, irritation, dermatitis, hypopigmentation, rash, and photosensitivity. Rarely, exacerbation of asthma.

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.

Toxicity

Oral LD50 in rat: >5 g/kg

Oral LD₅₀ in rats has ranged from 1321-3492 mg/kg; in mice, 2456-2648 mg/kg. Side effects include cardiovascular effects associated with hypotension such as sudden weight gain, rapid heart beat, faintness or dizziness.

Precaution

Patient with sensitive skin. Not intended for application to broken, sunburnt or eczematous skin. Avoid use of occlusive dressing or wrappings. Pregnancy and lactation.

Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.

Interaction

Avoid spicy foods, alcoholic beverages and hot drinks that might provoke erythema, flushing and blushing during treatment of rosacea.

Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Elimination Route

Approximately 4% of the topically applied azelaic acid is systemically absorbed.

Minoxidil is at least 90% absorbed from the GI tract in experimental animals and man.

Half Life

The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics.

4.2 hours

Elimination Route

Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Minoxidil topical solution should not be used during pregnancy and lactation.

Contraindication

azelaic acid cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

• 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)

Acute Overdose

Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.

Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Storage Condition

Store between 15-30° C.

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

Innovators Monograph

You find simplified version here Minscalp Plus