ALOXIDIL 20 MG/ML SOLUZIONE CUTANEA

  • IDI FARMACEUTICI Srl
  • 027261027
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ALOXIDIL 20 MG/ML SOLUZIONE CUTANEA

Therapeutic indications

ALOXIDIL is indicated for the symptomatic treatment of androgenic alopecia. The efficacy of ALOXIDIL in the following forms has not been established: 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 which hair regrowth is conditioned by the suppression of the specific cause; area celsi. Furthermore, the tolerability and efficacy of ALOXIDIL in patients under the age of 18 and in patients over the age of 55 have not been established.

Dosage and method of use

FOR EXTERNAL USE ONLY. ALOXIDIL 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 up to the 1 ml mark. Then apply a few drops of ALOXIDIL 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, wash your hands by rinsing thoroughly with water. Apply ALOXIDIL only on completely dry hair and scalp. Do not apply ALOXIDIL to other areas of the body. Do not use hair dryers to facilitate the drying of ALOXIDIL as this system may decrease the effect of the product. Clinical experience with ALOXIDIL indicates that bi-daily applications lasting 3-4 months may be required before there are obvious 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. Relapse to the pretreatment state following discontinuation of therapy occurs within 3-4 months.

Contraindications

ALOXIDIL is contraindicated in patients with a history of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ALOXIDIL 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 is subject to the judgment of the doctor. Patients with hypertension, including those being treated for this condition, should be closely monitored.

Side effects

The most frequent side effects that occurred during clinical trials with ALOXIDIL 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), 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. Immune system disorders Not known (frequency cannot be estimated from the available data) Allergic reactions, including angioedema Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorization of the medicinal product is important, in how much it allows for continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system www.agenziafarmaco.gov.it/it/responsabili

Special warnings

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) 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 suffering from concomitant dermatological diseases, or patients receiving topical corticosteroid therapy or other dermatological preparations are currently unknown. It is not yet fully understood whether an occlusive dressing can increase drug absorption. Although the following effects have not been associated with the topical use of ALOXIDIL, some absorption of minoxidil through the scalp occurs with the use of the drug (mean value: 1.4%) and there is a potential risk of systemic effects such as: tachycardia, angina, edema or increased orthostatic hypotension induced by guanethidine. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil. In the event of systemic side effects or dermatological reactions, discontinue administration of the drug and consult your doctor.

Pregnancy and breastfeeding

The effects of ALOXIDIL used in pregnancy are not known. Systemically administered minoxidil is excreted in human milk. ALOXIDIL should not be used in pregnant or lactating women.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interactions associated with the use of ALOXIDIL are currently known. Although not clinically demonstrated, there is a possibility of orthostatic hypotension in patients receiving concomitant therapy with guanethidine.

Overdose

Accidental ingestion can cause systemic effects related to the vasodilating action of the drug (5 ml of ALOXIDIL 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.

Active principles

1 ml of cutaneous solution contains: Active principle: Minoxidil 20 mg Excipient with known effects: propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Excipients

Ethyl alcohol g 51.40
Propylene glycol g 20.72
Purified water to taste a 100 ml
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