Active ingredients: Minoxidil
ALOXIDIL 2% cutaneous solution
Why is Aloxidil used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY.
Topical dermatologicals.
THERAPEUTIC INDICATIONS.
ALOXIDIL 2% cutaneous solution is indicated in the symptomatic treatment of androgenic alopecia.
The efficacy of ALOXIDIL 2% cutaneous solution in the following forms has not been ascertained: localized or generalized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychic or infectious origin); acute alopecia diffused by toxic substances, by medicaments in where hair regrowth is conditioned by the suppression of the specific cause; area celsi.
Furthermore, the tolerability and efficacy of ALOXIDIL ALOXIDIL 2% cutaneous solution in patients under the age of 18 and in patients over the age of 55 have not been established.
Contraindications When Aloxidil should not be used
ALOXIDIL 2% cutaneous solution is contraindicated in patients with a history of hypersensitivity to the components of the product. ALOXIDIL should not be used in the presence of coronary artery disease, arrhythmias, congestive heart failure or valvulopathies. Faced with other cardiovascular disorders, the use of ALOXIDIL is subject to the judgment of the physician. Patients suffering from hypertension, including those being treated for this pathology, must be kept under close medical supervision.
Precautions for use What you need to know before taking Aloxidil
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, stop the treatment and consult the doctor to institute suitable therapy. In case of accidental contact with sensitive surfaces (eyes, abrasions skin, mucous membranes) ALOXIDIL 2% cutaneous solution causes burns and irritation, therefore the area should be washed with plenty of fresh water.
Interactions Which drugs or foods can modify the effect of Aloxidil
No interactions associated with the use of ALOXIDIL are currently known. Although it has not been clinically demonstrated, there is a potential for increased orthostatic hypotension in patients receiving concomitant therapy with guanethidine, peripheral vasodilators.
The effects of ALOXIDIL 2% cutaneous solution in patients suffering from concomitant dermatological diseases, or patients receiving topical corticosteroid therapy or other dermatological preparations are currently unknown.
Warnings It is important to know that:
Although the following effects have not been associated with the topical use of ALOXIDIL 2% cutaneous solution with the use of the drug there is some absorption of minoxidil through the scalp (mean value: 1.4%) and there is a potential risk of systemic effects such as: tachycardia, angina, edema, pericarditis, pericardial effusion, cardiac tamponade or increased orthostatic hypotension induced by antihypertensive drugs such as guanethidine and derivatives.
Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. Patients with a history of underlying cardiac disorders should be advised that ALOXIDIL 2% cutaneous solution may worsen these disorders. In carcinogenicity experiments performed on rats and mice, there have been reports of mammary tumors in female mice and tumors of the adrenal glands and foreskin in male rats. However, there is no evidence that these results are predictive of a similar risk for humans.
In the event of systemic side effects or dermatological reactions, discontinue administration of the drug and consult your doctor.
KEEP DRUG - AS "AS ALL DRUGS - OUT OF REACH OF CHILDREN.
PREGNANCY AND BREASTFEEDING
The effects of ALOXIDIL 2% cutaneous solution used in pregnancy are not known. Systemically administered minoxidil is excreted in human milk. ALOXIDIL should not be used in pregnant or lactating women.
Dosage and method of use How to use Aloxidil: Dosage
FOR EXTERNAL USE ONLY. ALOXIDIL 2% cutaneous solution should only be used on the scalp and nowhere else on the body. The dosage is 1 ml, twice a day, applied to the areas affected by baldness, starting from the center. The dose is independent of the surface of the area to be treated. The daily dosage must not exceed 2 ml. The application relates to the device for the application itself in the following ways:
Using the dropper: Fill the dropper to the 1ml mark.Then apply a few drops of ALOXIDIL 2% cutaneous solution on the scalp distributing the liquid by rubbing with the fingertips on the entire area affected by baldness. Repeat until all the dose contained in the dropper has been applied. Close the bottle carefully.
After applying ALOXIDIL 2% cutaneous solution, wash your hands by rinsing thoroughly with water.
Apply ALOXIDIL 2% cutaneous solution only on completely dry hair and scalp.
Do not apply ALOXIDIL 2% cutaneous solution to other areas of the body. Do not use hair dryers to facilitate the drying of ALOXIDIL 2% cutaneous solution, since this system could diminish the effect of the product.
Clinical experience with ALOXIDIL 2% cutaneous solution indicates that bi-daily applications lasting 3-4 months may be necessary before there are evident signs of hair growth.
The onset of these signs and their intensity vary from patient to patient. In all cases the doctor will have to evaluate the advisability of discontinuing treatment if no therapeutic result is observed within this period. Relapse to the pretreatment state following discontinuation of therapy occurs within 3-4 months.
Overdose What to do if you have taken too much Aloxidil
Accidental ingestion can cause systemic effects related to the vasodilating action of the drug (5 ml of ALOXIDIL 2% solution for topical use contain 100 mg of minoxidil). The signs and symptoms of drug overdose are likely to be cardiovascular effects associated with fluid retention, lowering blood pressure, and tachycardia. Fluid retention can be treated with appropriate diuretic therapy.
Tachycardia can be controlled by administering a beta-blocking agent. Hypotension could be treated with intravenous administration of normal saline.
Sympathomimetic drugs, such as noradrenaline and adrenaline, should be avoided due to their excessive cardiac stimulating activity.
Side Effects What are the side effects of Aloxidil
The most frequent undesirable effects that occurred during clinical studies with ALOXIDIL 2% cutaneous solution were minor dermatological reactions. The most frequent side effect was local irritation, consisting of peeling, erythema, dermatitis, dry skin, hypertrichosis (in areas other than those treated with ALOXIDIL 2% skin solution), burning sensation and rash. Other side effects that occur infrequently include: allergic reactions (sensitization, hives, generalized erythema and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eye irritation, taste disturbance, ear infections (particularly otitis externa ) and visual disturbances.
Rarely occurring side effects include hair abnormalities, hair loss exacerbations, alopecia, chest pains, blood pressure changes, heart rate changes, hepatitis, kidney stones and sexual dysfunction.
Expiry and Retention
The bottle of ALOXIDIL 2% cutaneous solution must not be used beyond the expiry date shown on the outside of the box.
This leaflet was updated on May 2012.
Do not dispose of the bottle in the environment after use.
Medicinal product not subject to medical prescription.
Composition and pharmaceutical form
COMPOSITION WHICH - QUANTITATIVE.
ALOXIDIL is a solution containing minoxidil, at a concentration of 2% (equal to 20 mg / ml) and excipients consisting of propylene glycol 20.72 g, ethyl alcohol 51.40 g and purified water q. B. At 100 ml.
PHARMACEUTICAL FORM.
Bottle of 60 ml of 2% cutaneous solution.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ALOXIDIL 2% SKIN SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of cutaneous solution contain:
Active principle:
Minoxidil 2.00 g
03.0 PHARMACEUTICAL FORM
Skin solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
ALOXIDIL 2% cutaneous solution is indicated in the symptomatic treatment of androgenic alopecia.
The efficacy of ALOXIDIL 2% cutaneous solution in the following forms has not been ascertained: localized or generalized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychic or infectious origin); acute alopecia diffused by toxic substances, by medicaments in where hair regrowth is conditioned by the suppression of the specific cause; area celsi.
Furthermore, the tolerability and efficacy of ALOXIDIL 2% cutaneous solution in patients under the age of 18 and in patients over the age of 55 have not been established.
04.2 Posology and method of administration
FOR EXTERNAL USE ONLY.
ALOXIDIL 2% cutaneous solution should only be used on the scalp and nowhere else on the body.
The dosage is 1 ml, twice a day, applied to the areas affected by baldness, starting from the center. The dose is independent of the surface of the area to be treated. The daily dosage should not exceed 2 ml.
The application relates to the device for the application itself in the following ways:
Using the dropper: Fill the dropper to the 1ml mark. Then apply a few drops of ALOXIDIL 2% cutaneous solution on the scalp distributing the liquid by rubbing with the fingertips on the entire area affected by baldness. Repeat until all the dose contained in the dropper has been applied. Close the bottle carefully.
After applying ALOXIDIL 2% cutaneous solution, wash your hands by rinsing thoroughly with water.
Apply ALOXIDIL 2% cutaneous solution only on completely dry hair and scalp.
Do not apply ALOXIDIL 2% cutaneous solution to other areas of the body. Do not use hair dryers to facilitate the drying of ALOXIDIL 2% cutaneous solution since this system could diminish the effect of the product.
Clinical experience with ALOXIDIL 2% cutaneous solution indicates that bi-daily applications lasting 3-4 months may be necessary before there are evident signs of hair growth.
The onset of these signs and their intensity vary from patient to patient.
In all cases the doctor will have to evaluate the opportunity to suspend the treatment if no therapeutic result is observed within this period. The relapse to the pretreatment state following the suspension of the therapy occurs within 3-4 months.
04.3 Contraindications
ALOXIDIL 2% cutaneous solution is contraindicated in patients with a history of hypersensitivity to minoxidil, propylene glycol or ethanol.
ALOXIDIL 2% cutaneous solution should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valvulopathies. In the face of other cardiovascular disorders, the use of ALOXIDIL 2% cutaneous solution is subject to the judgment of the physician. Patients suffering from hypertension, including those being treated for this pathology, must be kept under strict medical supervision.
04.4 Special warnings and appropriate precautions for use
Although the following effects have not been associated with the topical use of ALOXIDIL 2% cutaneous solution, with the use of the drug there is some absorption of minoxidil through the scalp (mean value: 1.4%) and there is a risk potential for systemic effects such as: tachycardia, angina, edema or guanethidine-induced increase in orthostatic hypotension. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil.
In carcinogenicity experiments performed on rats and mice, there have been reports of mammary tumors in female mice and tumors of the adrenal glands and foreskin in male rats. However, there is no evidence that these results are predictive of a similar risk for humans.
In the event of systemic side effects or dermatological reactions, discontinue administration of the drug and consult your doctor.
In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) ALOXIDIL 2% cutaneous solution causes burning and irritation. Therefore the area should be washed with plenty of fresh water.
Accidental ingestion of the solution could lead to serious side effects.
KEEP DRUG - AS "AS ALL DRUGS - OUT OF REACH OF CHILDREN.
The effects of ALOXIDIL 2% cutaneous solution in patients suffering from concomitant dermatological diseases, or patients receiving topical corticosteroid therapy or other dermatological preparations are currently unknown. It is still not entirely clear whether an occlusive dressing can increase drug absorption.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions associated with the use of ALOXIDIL 2% cutaneous solution are currently known. Although it has not been clinically demonstrated, there is a possibility of orthostatic hypotension in patients receiving concomitant therapy with guanethidine.
04.6 Pregnancy and lactation
The effects of ALOXIDIL 2% cutaneous solution used in pregnancy are not known. Systemically administered minoxidil is excreted in human milk.
ALOXIDIL 2% cutaneous solution should not be used in pregnant or lactating women.
04.7 Effects on ability to drive and use machines
No effects on driving ability and use of machines have been reported.
04.8 Undesirable effects
The most frequent side effects that occurred during clinical trials with ALOXIDIL 2% cutaneous solution were minor dermatological reactions. The most frequent side effect was local irritation, consisting of peeling, erythema, dermatitis, dry skin, hypertrichosis (in areas other than those treated with ALOXIDIL 2% skin solution), burning sensation and rash. Other side effects that occurred infrequently included: allergic reactions (sensitization, hives, generalized erythema and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eye irritation, taste disturbance, ear infections (particularly otitis externa ) and visual disturbances.
Rarely occurring side effects included hair abnormalities, chest pains, blood pressure changes, heart rate changes, hepatitis and kidney stones.
04.9 Overdose
Accidental ingestion can cause systemic effects related to the vasodilating action of the drug (5 ml of ALOXIDIL 2% cutaneous solution contain 100 mg of minoxidil). The signs and symptoms of drug overdose are likely to be cardiovascular effects associated with fluid retention, lowering blood pressure, and tachycardia.
Sympathomimetic drugs, such as norepinephrine and epinephrine, should be avoided due to their excessive cardiac stimulating activity.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ALOXIDIL 2% cutaneous solution, by topical application, has been shown to stimulate hair growth in individuals suffering from androgenic alopecia. The stimulation of hair growth generally begins after about 3-4 months of application of the product and varies from patient to patient. With discontinuation of the use of ALOXIDIL 2% cutaneous solution, the growth of new hair ceases and the reappearance of pre-treatment symptoms occurs within 3-4 months. The exact mechanism of action of the "ALOXIDIL 2% cutaneous solution in the treatment of androgenic baldness.
05.2 Pharmacokinetic properties
ALOXIDIL 2% cutaneous solution, applied topically, is little absorbed by the healthy scalp, with an average of 1.4% (range 0.3-4.5%) of the total applied dose reaching the systemic circulation. application of 1 ml of ALOXIDIL 2% cutaneous solution containing 20 mg of minoxidil leads to an absorption of about 0.280 mg of minoxidil itself. The effect of concomitant dermatological diseases or occlusive dressing on absorption is unknown.
The serum levels of minoxidil after topical application of ALOXIDIL 2% cutaneous solution are regulated by the percutaneous absorption rate of the drug. After the suspension of the topical application of ALOXIDIL 2% cutaneous solution, approximately 95% of the systemically absorbed minoxidil is eliminated within 4 days. The biotransformation processes that minoxidil undergoes after topical application of ALOXIDIL 2% cutaneous solution have not yet been fully determined.
Minoxidil and its metabolites are haemodialysable and are mainly excreted in the urine.
05.3 Preclinical safety data
Toxicity:
The LD50 after dermal administration in rats and rabbits was> 1000 mg / animal.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ethyl alcohol 51.40 g
Propylene Glycol 20.72 g
Purified water q.s. to 100 ml
06.2 Incompatibility
There is no data in this regard.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Glass bottle; screw cap in plastic material with dropper.
60 ml bottle;
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
IDI FARMACEUTICI SRL - Pomezia (RM), Via dei Castelli Romani, 83/85.
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 027261015
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first marketing: 1/4/1991.
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