Cutaneous solution for the treatment of alopecia 60ml

Product Description

Aloxidil cutaneous solution is indicated for the symptomatic treatment of androgenic alopecia.

Indications

The efficacy of Aloxidil cutaneous solution has not been established in the following forms: localized or generalized congenital alopecia; cicatricial alopecia of various types (post-traumatic, psychological, or infectious); acute diffuse alopecia caused by toxic substances or medications in which hair regrowth depends on the suppression of the specific cause; and celsi area. Furthermore, the tolerability and efficacy of Aloxidil cutaneous solution in patients under 18 years of age and in patients over 55 years of age have not been established.

Composition

Active ingredients

100 ml of cutaneous solution contains: Active ingredient: Minoxidil 2.00 g.

Excipients

Ethyl Alcohol 51.40 g Propylene Glycol 20.72 g Purified Water to taste to 100 ml.

Directions for use and Dosage

For external use only.
Aloxidil skin solution should be used only on the scalp and no other parts of 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 area to be treated.
The daily dosage should not exceed 2 ml.
The application depends on the application device itself, as follows: Using the dropper: Fill the dropper to the 1 ml mark.
Then apply a few drops of Aloxidil skin solution to the scalp, distributing the liquid by rubbing it with your fingertips over the entire area affected by baldness.
Repeat until the entire dose in the dropper has been applied. Close the bottle tightly.
After applying Aloxidil cutaneous solution, wash your hands and rinse thoroughly with water.
Apply Aloxidil cutaneous solution only to completely dry hair and scalp.
Do not apply Aloxidil cutaneous solution to other areas of the body.
Do not use a hair dryer to facilitate drying of Aloxidil cutaneous solution as this may reduce the product's effect.
Clinical experience with Aloxidil cutaneous solution indicates that twice-daily applications for 3–4 months may be necessary before there are visible signs of hair growth. The onset of these signs and their intensity vary from patient to patient.
In all cases, the physician should evaluate the possibility of discontinuing treatment if no therapeutic results are observed within this period.
Relapse to the pretreatment state following discontinuation of therapy occurs within 3–4 months.

Warnings

Although the following effects have not been associated with topical use of Aloxidil cutaneous solution, some absorption of minoxidil through the scalp occurs with the use of the drug (average value: 1.4%), and there is a potential risk of systemic effects such as tachycardia, angina, edema, or increased guanethidine-induced orthostatic hypotension.
Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil.
In carcinogenicity experiments performed on rats and mice, cases of mammary tumors in female mice and tumors of the adrenal glands and prepuce in male rats have been reported.
However, there is no evidence that these findings predict a similar risk for humans. In the event of systemic side effects or dermatological reactions, discontinue administration of the drug and consult a doctor.
In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), Aloxidil 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 the medicine out of the reach of children.
The effects of Aloxidil cutaneous solution in patients with concomitant dermatological diseases, or patients being treated with topical corticosteroids or other dermatological preparations are currently unknown.
It is not yet entirely clear whether an occlusive dressing can increase the absorption of the drug.

Contraindications

Aloxidil cutaneous solution is contraindicated in patients with a history of hypersensitivity to minoxidil, propylene glycol, or ethanol.
Aloxidil cutaneous solution should not be used in the presence of coronary artery disease, arrhythmias, congestive heart failure, or valvular heart disease.
In the presence of other cardiovascular disorders, the use of Aloxidil cutaneous solution is subject to the physician's judgment.
Patients with hypertension, including those being treated for this condition, should be kept under close medical supervision.

Interactions

There are currently no known interactions associated with the use of Aloxidil cutaneous solution.
Although not clinically demonstrated, the possibility of orthostatic hypotension exists in patients receiving concomitant therapy with guanethidine.

Undesirable Effects

The most frequent side effects observed during clinical studies with Aloxidil cutaneous solution were minor dermatological reactions.
The most frequent side effect was local irritation, consisting of scaling, erythema, dermatitis, dry skin, hypertrichosis (in areas other than those treated with Aloxidil cutaneous solution), burning sensation, and rash.
Other side effects that occurred infrequently included: allergic reactions (sensitization, urticaria, generalized erythema, and facial edema), dizziness, tingling, headache, weakness, neuritis, edema, eye irritation, taste disturbance, ear infections (particularly otitis externa), and visual disturbances.
Rarely reported side effects included hair abnormalities, chest pain, changes in blood pressure, changes in heart rate, hepatitis, and kidney stones.

Overdose

Accidental ingestion may cause systemic effects related to the vasodilatory action of the drug (5 ml of Aloxidil 2% topical solution contains 100 mg of minoxidil).
The signs and symptoms of drug overdose would most likely be cardiovascular effects associated with fluid retention, decreased blood pressure, and tachycardia.
Fluid retention can be treated with appropriate diuretic therapy.
Tachycardia can be controlled by administering a beta-blocking agent.
Hypotension may be treated with intravenous administration of normal saline solution.
Drugs with sympathomimetic action, such as norepinephrine and epinephrine, should be avoided due to their excessive cardiac stimulatory effect.

Pregnancy and breastfeeding

The effects of Aloxidil cutaneous solution used during pregnancy are unknown.
Systemically administered minoxidil is excreted in human milk.
Aloxidil cutaneous solution should not be used by pregnant or breastfeeding women.

Format

60 ml bottle