ALOXIDIL SOLUZ 3FL 60ML20MG/ML

ALOXIDIL 20 MG/ML EDUCATION

active ingredients

1 ml of skin solution contains: Active ingredient: Minoxidil 20 mg Excipients with known effects: propylene glycol, ethanol. For the full list of excipients, see paragraph 6.1.

Excellent

Excipient Ethyl alcohol 51.40 g Propilenic glycol 20.72 g Clean water q.b. 100 ml

Therapeutic indications

ALOXIDIL is indicated in the symptomatic treatment of androgenic alopecia. The effectiveness of the ALOXIDIL in the following forms: localized or generalized congenital alopecia; alopecia cicatriziale of various nature (post-traumatic, of psychic or infectious origin); alopecia acute diffused by toxic substances, from medicines in which the regrowth of hair is conditioned by the suppression of the specific cause; celtic area. Moreover, the tolerance and effectiveness of ALOXIDIL in patients under the age of 18 and in patients over 55.

Contraindications

ALOXIDIL is contraindicated in patients with anamnesi of hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. ALOXIDIL should not be used in the presence of coronaropathy, arrhythmia, congestive heart failure or valvulopathy. In the face of other cardiovascular disorders the use of ALOXIDIL is subordinate to the judgement of the doctor. Patients with hypertension, including those in treatment for such pathology, must be kept under strict medical control.

Population

ONLY FOR EXTERNAL USE. ALOXIDIL must be used only for scalp and nowhere else in the body. Posology is of 1 ml, twice a day, applied on areas with baldness, starting from the center. The dose is independent from the surface of the area to be treated. The daily dosage should not exceed 2 ml. The application is related to the application device itself with the following modes: Use of the dropper: fill the dropper to the sign of 1 ml. Then apply some drops of ALOXIDIL on the scalp distributing the liquid by frying with the tip of the fingers on the entire area affected by baldness. Repeat until all the dose contained in the dropper has been applied. Carefully close the bottle. After applying ALOXIDIL wash your hands thoroughly with water. Apply ALOXIDIL only on hair and scalp completely dry. Do not apply ALOXIDIL in other areas of the body. Do not use hair dryers to facilitate drying ALOXIDIL since this system could decrease the effect of the product. The clinical experience gained with ALOXIDIL indicates that it may be necessary trimming applications lasting 3-4 months before there are obvious signs of hair growth. The beginning of such signs and their intensity vary from patient to patient. In all cases the doctor will have to assess the opportunity to suspend the treatment if no therapeutic results are observed within that period. Relapse in pretreatment after suspension of therapy occurs within 3-4 months.

Conservation

This medicine does not require any special condition of conservation.

Warnings

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucosa) ALOXIDIL 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. The effects of ALOXIDIL in patients with concomitant dermatological diseases, or patients in treatment with topical corticosteroid therapy or other dermatological preparations are currently unknown. It is not entirely clear if an occlusive bandage can increase the absorption of the drug. Although the following effects were not associated with topical use of ALOXIDIL, with the use of the drug a certain absorption of minoxidil occurs through the scalp (average value: 1.4%) and there is the potential risk of systemic effects such as: tachycardia, angina, edema or increase of orthostatic hypotension induced by guanetidine. Patients should be periodically monitored to detect any suspicion of systemic effects caused by minoxidil. In the event of systemic side effects or dermatological reactions, suspend the administration of the drug and consult your doctor. ALOXIDIL contains 207 mg of propylene glycol per ml. This medicine contains 514 mg of alcohol in every ml. It can cause burning sensation on damaged skin.

Interactions

You do not know for the moment interactions associated with the use of ALOXIDIL. Although it has not been clinically demonstrated, there is the possibility of orthostatic hypotension in patients subjected to concurrent therapies with guanetidine.

Effects

The most frequently occurring side effects during clinical studies with ALOXIDIL were minor dermatological reactions. The most common side effect was the local irritation, consisting of desquamations, erythematis, dermatitis, dry skin, hypertricosis (in areas other than those treated with ALOXIDIL), burning sensation and rash. Other undesirable effects that occurred not frequently included: allergic reactions (sensitivity, hives, generalized erythema and facial edema), dizziness, formicolii, headache, weakness, neuritis, edema, irritation to the eyes, alteration of taste, ear infections (particularly external otitis) and visual disorders. Undesirable effects rarely verified included abnormal hair, chest pain, blood pressure variations, heart rate variations, hepatitis and kidney stones. Immune disorders Not known (frequency cannot be defined on the basis of available data) allergic reactions, including angioedema Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Accidental ingestion can cause systemic effects related to vasodilating action of the drug (5 ml of ALOXIDIL contain 100 mg of minoxidil). Signs and symptoms of overdose of the drug would be with all probability 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 heart stimulation activity.

The effects of ALOXIDIL used in pregnancy are not known. Minoxidil administered by systemic means is excreted in human milk. ALOXIDIL should not be used in pregnant or nursing women.

Source: Farmadati