Instructions for use Minoxidil Inteli cutaneous solution 2% bottle 60 ml
Composition
active ingredient: minoxidil;
1 ml of solution contains 20 mg of minoxidil;
excipients: ethanol 96%, propylene glycol, purified water.
Dosage form
The solution is topical.
Main physicochemical properties: aqueous-alcoholic transparent, colorless solution with the smell of alcohol.
Pharmacotherapeutic group
Medicinal products used in dermatology. Other dermatological products. Minoxidil. ATX code D11A X01.
Pharmacological properties
Pharmacodynamics
Minoxidil is a potent peripheral vasodilator that acts on vascular smooth muscle. When applied to the scalp, minoxidil stimulates hair regrowth in patients with male pattern alopecia. The mechanism of hair growth enhancement is that when applied topically, minoxidil increases blood circulation in the scalp and, therefore, improves nutrient supply, which leads to the regeneration of atrophied hair follicles.
Hair growth is usually observed after 2–4 months of therapy and is individual for each patient.
Pharmacokinetics
When topically applied to the skin, a small amount of minoxidil (up to 4.5%) is absorbed through intact scalp. Absorption of minoxidil through the skin increases with increasing dose, frequency, or area of application of the lotion. Metabolism of absorbed minoxidil occurs in the liver, excretion of minoxidil and its metabolites is mainly by the kidneys. After the end of topical treatment, 95% of minoxidil is excreted within 4 days.
Indication
Male pattern alopecia in women and men.
Contraindication
Hypersensitivity to the components of the drug; scalp diseases (including psoriasis and sunburn); simultaneous application of other topical medications to the scalp; pheochromocytoma; treated and untreated arterial hypertension; pregnancy or breastfeeding; patient age less than 18 or over 65 years. Do not use after shaving the head.
Interaction with other medicinal products and other types of interactions
Minoxidil should not be used simultaneously with other topical scalp medications.
Concomitant use of MINOXIDIL INTELI and other topical preparations containing corticosteroids, tretinoin, dithranol or petrolatum may increase the absorption of minoxidil. It is possible that orthostatic hypotension may be increased during the absorption of minoxidil in patients taking peripheral vasodilators, although this has not been clinically confirmed.
Guanethidine has been reported to interact with topical minoxidil preparations, resulting in a rapid and pronounced decrease in blood pressure. There is a theoretical possibility that topical minoxidil may interact with guanethidine.
Application features
Before you start using MINOXIDIL INTELI, you must make sure that the scalp is healthy and undamaged.
Minoxidil should not be used if there is inflammation, infection, irritation, or soreness of the scalp.
MINOXIDIL INTELI 2%, cutaneous solution, is indicated for the treatment of male pattern alopecia in women and men. It should not be used for other causes of hair loss, such as no family history of hair loss, sudden and/or patchy hair loss, hair loss associated with childbirth, or if the cause of hair loss is unknown.
MINOXIDIL INTELI 5%, cutaneous solution, is indicated for the treatment of male pattern alopecia in men. It should not be used for other causes of hair loss, such as no family history of hair loss, sudden and/or patchy hair loss, or if the cause of hair loss is unknown.
You should stop using the drug and consult a doctor if you experience low blood pressure, chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of the hands and feet, persistent redness, scalp irritation, or other unexpected new symptoms.
If you have cardiovascular disease or arrhythmia, you should consult a doctor before starting to use MINOXIDIL INTELI.
MINOXIDIL INTELI, cutaneous solution, is for external use only. It should not be applied to any area of the body other than the scalp.
Increasing the dose of the drug or using the drug more often than recommended will not improve results.
Unwanted hair growth may be caused by applying the drug to areas other than the scalp.
Some patients have reported increased hair loss after starting treatment with minoxidil cutaneous solution. This is most likely due to the transition from the resting phase (telogen phase) to the growing phase (anagen phase). This is when old hair falls out and new hair grows in its place. This temporary increase in hair loss usually occurs 2–6 weeks after starting treatment and resolves within a few weeks. If hair loss persists for >2 weeks, minoxidil cutaneous solution should be discontinued and a doctor should be consulted.
The drug should be used with caution in patients with ischemic heart disease, angina pectoris, arrhythmia, and patients with arterial hypotension due to the possible systemic effects of minoxidil.
It is also necessary to use the drug with caution in patients with individual variability, unusual sensitivity, impaired skin integrity caused by inflammation or skin disease processes (for example, scalp damage or scalp psoriasis).
Accidental ingestion of the solution may cause serious cardiac side effects, so it is necessary to store the drug out of the reach of children.
MINOXIDIL INTELI, cutaneous solution, contains ethanol, which may cause eye irritation. If the drug gets on mucous membranes, damaged skin or in the eyes, these areas should be thoroughly rinsed with running water.
The medicine contains propylene glycol, which may cause skin irritation.
If there is no satisfactory result after 4 months, a dermatologist's consultation is necessary. Continuation of the course or repeated treatment is recommended after consultation with a dermatologist.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to the possible development of dizziness or a decrease in blood pressure, caution should be exercised when driving or operating machinery. If the described undesirable effects occur, one should refrain from performing these types of activities.
Use during pregnancy or breastfeeding
The drug is contraindicated for women during pregnancy or breastfeeding.
Method of administration and doses
A doctor's consultation is required before use.
The drug is intended for external use only by adults aged 18 to 65 years.
The recommended daily dose is 1 ml every 12 hours, which corresponds to 10 pumps of the measuring pump supplied with the bottle. Apply to dry scalp in the balding area, starting from the center to the periphery of the area. The recommended daily dose must be followed regardless of the degree of alopecia.
The maximum recommended daily dose is 2 ml.
Do not exceed the recommended dosage.
The duration of therapy depends on its results, usually the course is 4 months.
There are reports of hair loss returning 3-4 months after stopping minoxidil treatment.
Treatment should be discontinued if there is no effect within 1 year of use.
Elderly patients.
The drug is not recommended for use in the elderly. The safety and effectiveness of minoxidil in patients over 65 years of age have not been established.
Special populations.
There are no special recommendations for the use of minoxidil in patients with impaired renal and hepatic function.
Children
The drug is not prescribed to children under 18 years of age.
Overdose
Accidental or intentional overdose after topical application of minoxidil will lead to an increase in the intensity of adverse dermatological reactions, especially itching, dry skin, irritation and eczema. Increased systemic absorption of minoxidil is possible when applied to large body surfaces or to areas other than the scalp in doses exceeding the recommended ones.
Accidental ingestion of minoxidil solution into the digestive tract may cause systemic effects due to the vasodilatory effect of minoxidil (5 ml of MINOXIDIL INTELI 2% contains 100 mg of minoxidil, which is the maximum recommended dose in the treatment of hypertension. 2 ml of MINOXIDIL INTELI 5% contains 100 mg of minoxidil, which is the maximum recommended dose in the treatment of hypertension).
Symptoms of minoxidil overdose are primarily cardiovascular disorders associated with sodium and fluid retention. Tachycardia, hypotension, dizziness, and drowsiness may also occur.
Treatment
Treatment of minoxidil overdose should be symptomatic and supportive.
Beta-blockers are prescribed for tachycardia. Diuretics are used to correct fluid retention. Possible hypotension is treated with intravenous saline.
Adverse reactions
There is evidence that the overall incidence of adverse reactions by system organ class in women is approximately five times higher than in men.
Adverse reactions have been reported in men and women using minoxidil topical solution (20 mg/ml and 50 mg/ml combined). In addition, adverse reactions have been reported in post-marketing experience with this medicinal product.
The adverse reactions listed below are listed according to the following frequency classification: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000); frequency unknown (cannot be estimated from the available data).
On the part of the immune system
Common: hypersensitivity reactions (including facial swelling, generalised erythema, generalised pruritus, facial swelling and throat tightness).
Frequency unknown - angioedema (including lip swelling, lip swelling, oral swelling, oropharyngeal swelling, pharyngeal swelling, tongue swelling and tongue swelling).
From the psyche
Frequency unknown – depressed mood.
From the nervous system
Very common is headache.
Uncommon: dizziness.
From the organs of vision
Frequency unknown – eye irritation.
From the heart
Common – chest pain.
Uncommon – rapid heartbeat.
Frequency unknown - increased heart rate.
From the vascular side
Frequency unknown - decreased blood pressure.
Respiratory, thoracic and mediastinal disorders
Uncommon: shortness of breath.
Gastrointestinal tract
Uncommon – nausea.
Frequency unknown – vomiting.
Skin and subcutaneous tissue disorders
Common: hypertrichosis (unwanted hair growth in areas other than the scalp, including facial hair growth in women), pruritus (including generalized itchy rash and eye itching), rash (including pustular, papular, generalized, vestibular, and macular rashes), dermatitis (including application site contact, allergic, atopic, seborrheic).
Rarely common – change in hair texture.
Frequency unknown - dry skin, peeling skin (including exfoliative rash and exfoliative dermatitis), acne (acne-like rash), temporary hair loss, hair color change.
General disorders and administration site conditions
Peripheral edema is common.
Frequency unknown - application site reactions (sometimes spreading to adjacent areas of the body, including the ears and face), including itching, irritation, pain, rash, swelling, dry skin, erythema and erythematous rash, which can sometimes be more serious and include peeling, dermatitis, blistering, bleeding and ulceration.
Research results
Common – weight gain.
You should stop using the drug and consult a doctor if you experience chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of the hands and feet, persistent redness or irritation of the scalp.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
60 ml in a bottle complete with a measuring pump in a cardboard box.
Vacation category
Without a prescription.
Producer
Industrial Farmaceutica Cantabria, S.A.
Location of the manufacturer and its business address
Barrio Solia No. 30 – La Concha – Villaescusa, Santander, Cantabria, 39690, Spain.
