Xandrox 15 Plus- More Information
Directions:
Apply up to 1mL of Xandrox15-PLUS to moisten the areas of the scalp affected by male pattern baldness no more frequently than once daily. The same affected areas should be followed up with a lower concentration minoxidil formula at least 8 hours later. The scalp can be dry or hydrated, but the scalp should not be wet to the degree of diluting or washing off the minoxidil/azelaic acid. Each bottle of Xandrox15-PLUS is accompanied with a medicine dropper calibrated at 1mL.
Xandrox15-PLUS should be used in conjunction with 5% Xandrox. Apply 1mL of each solution once/day. The applications should be at least 8 hours apart. If a Xandrox solution containing 0.025% retinoic acid is used, it should be applied at night and Xandrox15-PLUS should be applied in the morning.
Xandrox15-PLUS can also be used in conjunction with the 5% Minoxidil Solution. Apply 1mL of each solution once/day. The applications should be at least 8 hours apart.
It is important to apply the topical Xandrox15-PLUS directly to your scalp, where the medicine will be most effective. In solution form, it is the alcohol that allows for penetration of minoxidil into the scalp, so massaging the scalp has no appreciable additional benefit. Even though the Xandrox15-PLUS may not be evenly distributed on the scalp, there is diffusion in the layers under the surface of the skin to allow for effective coverage. Although it is desirable to leave minoxidil on the scalp all day before the next application, most of the absorption occurs within the first 1 hour. If you desire to swim, blow dry, or shampoo your hair after applying minoxidil, wait from 1½ hour to 2 hours before doing so.
As a rule, patients should not initiate topical minoxidil treatment for male pattern baldness with Xandrox15-PLUS. Most patients will have a satisfactory response to Xandrox 5% solutions or to the combination of a 5% Minoxidil solution with the use of the 5% Spironolactone Lotion or 12.5% Minoxidil Solution. If, after at least six months of treatment with either of these regimens, the improvement is not satisfactory, then the patient should consider the use of Xandrox15-PLUS on those areas of the scalp with inadequate restoration of hair.
When you use the dropper, place the tip of the dropper onto the scalp and squeeze the rubber bulb to release a small amount of Xandrox15-PLUS. Divide the total 1mL quantity into as many doses as are required to moisten/wet the scalp in all the areas affected by male pattern baldness. The fingertips can be used to spread the liquid within the desired areas or to restrict the flow to other areas. Wash hands thereafter.
If you use a blow dryer, do so before the application of Xandrox15-PLUS. Otherwise, blow-drying will cause most of the alcohol in the Xandrox15-PLUS to evaporate, preventing absorption of the medicines.
Warnings:
Initial Shedding: Topical minoxidil can cause an initial mild increase in shedding of follicles that were going to shed within 100 days anyway. However, it's important to realize that the sustained use of topical minoxidil will result in an improvement in the number and quality of the hairs on your scalp.
Minoxidil allows hair that is already in the telogen phase to shed. Normally, the hair shaft sheds at the end of the telogen phase. 10% of normal hair is in the telogen phase, but in areas affected by male pattern baldness, up to 20% of thinning, miniaturized follicles are in the telogen phase. This is why minoxidil induced shedding may appear so dramatic when it affects thinning hair. The hair shafts, which are shed, will be replaced at the end of the telogen phase with healthier hair. On the other hand, untreated male pattern baldness will result in progressive miniaturization of the hair follicles.
Tolerance: There are misconceptions about minoxidil and finasteride in regards to 'tolerance'. Minoxidil and finasteride will help to recruit atrophic follicles to grow thicker hair again for about two years (sometimes as long as three years). Beyond that time, they continue to support mature hair shafts, but do not stimulate appreciably more atrophic hair follicles to mature.
But, because most patients do not see any significant continued improvement after a few years, they might assume that the minoxidil or the finasteride has caused a tolerance and is no longer working. If they are unfortunately convinced to stop minoxidil/finasteride treatment, the hair that they have regrown will shed again in 3-4 months.
Side Effects:
Patients with any history of heart disease should not use Xandrox15-PLUS. Also patients who have a known adverse reaction to minoxidil or finasteride should avoid using Xandrox15-PLUS. Although rare, patients who are sensitive to minoxidil can experience a rapid heart rate, a drop in blood pressure and water retention. As a result, they may experience headaches, dizziness, chest pain and/or edema of the ankles. If that happens, the patients should discontinue any formulas containing minoxidil. In our experience, these side effects have occurred in less than 0.1% of patients.
Finasteride can cause a decrease in libido in 2% of patients and a smaller number report an "ache in the groin area". These negative side effects are reversible usually within two weeks of discontinuance of taking the finasteride. Even when patients continue to take the finasteride, the majority of the men will gradually regain their former libido and the side effects abate.
When you are getting a physical examination or are having laboratory tests on your blood, inform your doctor that you are using finasteride. Finasteride will decrease the PSA (Prostate Specific Antigen) level by approximately 50%. Assessing the PSA level is a screening test for possible prostate cancer.
There is no association between birth defects and impregnation by the father on finasteride treatment. Millions of doses of finasteride have been taken since it became available in the U.S. in 1996 and there has not been a single case of a reported birth defect.
Storage Instructions:
Keep at room temperatures and protect from direct sunlight. Because of the volatility of the ethyl alcohol, the bottle should be tightly capped when the solution is not being used. Xandrox15-PLUS is best kept at room temperatures.
Since the Xandrox15-PLUS is a highly saturated solution of minoxidil, there may be rare occasions when a precipitate will form in the bottle. If and when this happens, the capped bottle of Xandrox15-PLUS should be placed in water that has been heated to gently simmering temperatures and shaken vigorously. As long as the bottle of Xandrox15-PLUS is kept tightly capped, it can be kept in the heated water for prolonged periods, until all the minoxidil goes back into solution.
PACKAGE INSERT
XANDROX15-PLUS
XANDROX15-PLUS is a custom formulated solution containing 15% minoxidil, 5% azelaic acid and 0.1% finasteride. Xandrox15-PLUS is prescribed and dispensed exclusively for the patients of Regrowth to treat areas of alopecia androgenetica that are or have been resistant to other forms of therapy
Minoxidil 15%
Description: Minoxidil topical solution is a non-specific hair growth stimulant. Minoxidil appears as a white or off-white, odorless crystalline solid that is soluble in water to the extent of approximately 2 mg/mL, but more readily soluble in glycerin or ethanol. The chemical name for minoxidil is 2, 4-pyrimidinediamine, 6-(1-piperinedinyl)-, 3-oxide (MW= 209.25). Xandrox15-PLUS contains 150 mg minoxidil per milliliter.
Clinical Pharmacology: Minoxidil topical solutions stimulate hair growth in individuals with androgenetic alopecia, typically expressed in males as thinning of the hair at the vertex, crown, temporal and/or frontal areas and in females usually as diffuse hair loss or thinning in the frontoparietal areas. The exact mechanism by which minoxidil stimulates hair growth is not known but is thought to have a direct effect on the hair follicle to sustain the anagen phase of the hair cycle. It has also been shown to have a vasodilatory effect on the scalp. Although minoxidil is a direct acting peripheral arterial dilator that reduces blood pressure by decreasing peripheral vascular resistance, the vasodilating effect of minoxidil has not been proven to directly result in hair growth. The failure to detect evidence of systemic effects during treatment with topical minoxidil reflects the poor absorption of topical minoxidil, which averages about 1.4% (range 0.3 to 4.5%) from normal intact scalp. Since it requires 20 ng / mL of serum to have any systemic effects in the human body and allowing for an average absorption rate of 1.4%, there remains a greater than 5-fold safety margin in the use of Xandrox15-PLUS. Following cessation of topical dosing of minoxidil, approximately 95% of systemically absorbed minoxidil is eliminated within four days. Minoxidil and its metabolites are excreted principally in the urine.
Indications and Usage: Xandrox15-PLUS topical solution is indicated for the treatment of alopecia androgenetica. At least four months of once daily applications are usually required before evidence of hair growth can be expected. Even in patients for whom topical minoxidil or finasteride does not seem effective for restoring hair loss, for most patients it will prevent further thinning and loss due to alopecia androgenetica.
Contraindications: Xandrox15-PLUS is contraindicated for any patient with a hypersensitivity to any of the components of the preparation. Xandrox15-PLUS should also not be used by any patient with a known cardiac abnormality.
Warnings: Although extensive use of topical minoxidil has not revealed evidence that enough minoxidil is absorbed to have systemic effects, greater absorption or individual variability or sensitivity could theoretically cause a systemic effect. If systemic effects were to occur, patients with underlying heart disease would be at particular risk. Minoxidil could also have additive effects with other therapies in patients being treated for hypertension. Topical finasteride may cause a low PSA (Prostate Specific Antigen) determination. Your doctor should be informed that you are using topical finasteride, if a serum PSA test is ordered.
Drug Interactions: There are no known drug interactions associated with the use of a topical minoxidil or finasteride.
Adverse Reactions: In placebo controlled trials, the rate of adverse reactions were no more common, other than dermatologic events such as irritation and allergic dermatitis.
Overdosage: There have been no reported cases of overdosage resulting from topical minoxidil or finasteride administration. Minoxidil and its metabolites are hemodialyzable.
Azelaic Acid 5%
Description: Azelaic acid is a naturally occurring saturated dicarboxylic acid with the chemical name of 1,7-heptanedicarboxylic acid and a molecular weight of 188.22. Azelaic acid is a dietary component of whole grain cereals and animal products.
Clinical Pharmacology: The exact mechanism of action of azelaic acid is not known. Azelaic acid at high concentrations is bactericidal. In vitro, azelaic acid acted as a scavenger of oxy radicals and inhibits a variety of oxidoreductive enzymes including 5-alpha reductase. Azelaic acid (0.1 to 3.0 mmol/l) has been shown to produce a competitive concentration dependent inhibition of 5-alpha reductase activity in homogenates of human foreskin. The multiple actions of azelaic acid cause a normalization of keratinization and a decrease in the free fatty acid content of skin surface lipids.
Pharmacodynamics: Following a single application to human skin, 3% to 5% of the azelaic acid penetrates into the strateum corneum (up to 10% is present in the dermis and epidermis). There is negligible cutaneous metabolism after topical application. Approximately 4% of topically applied azelaic acid is systemically absorbed and mainly excreted unchanged in the urine. The half-life is approximately 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics. After topical treatment with azelaic acid, plasma concentration and urinary excretion are not significantly
different from baseline levels.
Contraindications: XANDROX15-PLUS is contraindicated in individuals who have known hypersensitivity to any of its components.
Warnings: There have been isolated reports of hypopigmentation after use of azelaic acid, although there is no depigmenting effect on normal melanocytes.
Precautions: If sensitivity or severe irritation develops with the use of XANDROX15-PLUS, treatment should be discontinued. The most common adverse reactions occurring in approximately 1%-5% of patients were pruritis, burning, stinging and tingling, usually at the start of treatment. These reactions may last 5 to 20 minutes, especially if the skin is inflamed or broken. The adverse effects commonly subside if treatment is continued. Other adverse reactions such as erythema, dryness, rash, peeling, irritation and dermatitis were reported in less than 1% of patients. The following additional adverse experiences have been rarely reported: worsening of asthma, vitilago hypopigmentation, ypertrichosis and reddening (signs of keratosis pilaris). Note: azelaic acid will consistently lighten hyperpigmented skin (skin that is darker than normal for a given individual) but will not typically lighten skin beyond its normal color. Rarely, patients with dark complexions may notice hypopigmentation of skin. There are no systemic adverse effects.
Considerations: Azelaic acid is normally found in the human diet and is not considered to be a carcinogenic substance. Mutagenicity studies are negative and animal studies have shown no adverse effects on fertility or reproduction. Human problems have not been reported during pregnancy.
Dosage and Administration: Hair and scalp can be dry or hydrated prior to topical application of XANDROX15-PLUS. A total daily dose of 1 mL should be applied to the affected areas of the scalp where regrowth of hair has been resistant to treatment. Each bottle of Xandrox15-PLUS is accompanied with a medicine dropper calibrated at 1mL If you choose to use the dropper, place the tip of the dropper onto the scalp and squeeze the rubber bulb to release a small amount of Xandrox15-PLUS. Divide the total 1mL quantity into as many smaller aliquots as are required to moisten/wet the scalp in all the areas affected by male pattern baldness. The fingertips can be used to spread the liquid within the desired areas and/or to restrict the flow to other areas. Wash your hands thereafter.
Daily applications for four months or longer may be required before evidence of hair growth is observed. Onset and degree of hair growth is variable among patients. XANDROX15-PLUS is best used in conjunction with lower concentration Xandrox solutions and/or lower concentration minoxidil solutions. Topical minoxidil should be applied to the scalp twice/day at least 8 hours apart.
How Supplied: XANDROX15-PLUS is available in 125mL bottles and is dispensed exclusively by Regrowth.
Storage: XANDROX15-PLUS solution is best kept at normal room temperatures. XANDROX15-PLUS can be kept for up to 24 months without deterioration or loss of efficacy.
