Maxicortan 10 mg/ g, cream, 15 g

Maxicortan 10 mg/g is a medicinal product in the form of a cream designed for topical use on the skin. The product contains the active substance hydrocortisone acetate, which has anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive (blood vessel narrowing) effects. This medication belongs to a group of drugs known as corticosteroids.

Maxicortan 10 mg/g – Indications

Maxicortan 10 mg/g is intended for use by people with the following conditions:

• Atopic dermatitis,
• Allergic contact eczema,
• Hives (urticaria),
• Reactions occurring after insect bites or stings.

This product helps to alleviate symptoms such as redness, swelling, pain, and itching by providing multi-directional action on affected areas.

Mechanism of Action

Hydrocortisone is used topically to reduce the symptoms of inflammation. It also has an anti-itch effect and constricts blood vessels. Hydrocortisone penetrates the cell membrane and binds to a specific receptor inside the cell. This results in the inhibition of substances that cause inflammation and enzymes that damage tissues.

Maxicortan contains the maximum allowed dose* of hydrocortisone (10 mg/g), now available over the counter.

*Refers to Hydrocortisoni acetas in cream form available on the Polish market.

Indications for Use

It is applied topically in cases of skin inflammation of various origins, including:

• Atopic dermatitis,
• Allergic contact eczema,
• Hives (urticaria),
• Reactions such as itching and irritation following insect bites or stings.

Composition

Each gram of cream contains:

• Active substance: 10 mg hydrocortisone acetate.
• Other ingredients: cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben, propylparaben, cetostearyl alcohol ethoxylate, liquid paraffin, sorbitan stearate, white petrolatum, purified water.

Effects

Maxicortan acts to reduce inflammation, itching, and the dilation of blood vessels.

Dosage

• The cream is for topical use only.
• Adults: Apply a thin layer to the affected skin 1 or 2 times daily.
• Children: Maxicortan is not intended for children under 12 years of age.
• Do not use for more than 7 days without consulting a doctor.
• Use the FTU (Fingertip Unit) method to measure the dose: 1 FTU corresponds to the amount of cream squeezed from the tip to the first joint of an adult’s index finger (approximately 2.5 cm), equivalent to 0.5 g of cream. Smaller areas will require proportionally smaller amounts.
• Avoid applying to large skin areas without a doctor’s recommendation.
• Do not use double doses to make up for missed applications.
• If symptoms worsen or do not improve after 7 days, consult a doctor.

Contraindications

Do not use Maxicortan if:

• You are allergic to hydrocortisone acetate or any of the other ingredients,
• You have a bacterial, viral, or fungal infection,
• You have acne or rosacea,
• You have skin atrophy (thinning),
• You have skin cancer or a precancerous skin condition,
• You have inflammation of the skin around the mouth,
• You have tuberculosis of the skin,
• You have open wounds or damaged skin,
• It is on the face,
• It is for children under 12 years of age.

Storage

• Store the cream in a place out of the reach of children.
• Keep it at a temperature below 25°C in a dry place, tightly sealed.
• Do not freeze.
• The product is good for 28 days after opening.

Side Effects

Like any medication, Maxicortan may cause side effects, though not everyone will experience them. Long-term use (more than 14 days) or application over large areas, under dressings, or in children may lead to side effects such as:

• Skin atrophy (thinning) and stretch marks,
• Recurrence of infection,
• Post-steroid purpura (skin discoloration),
• Dilation of superficial blood vessels,
• Acne,
• Inflammation around the mouth or eyes,
• Folliculitis, excessive hair growth,
• Delayed wound healing,
• Secondary bacterial, fungal, or viral infections,
• Petechiae (small red or purple spots on the skin),
• Skin irritation such as burning, redness, or dryness,
• Glaucoma or cataracts when used around the eyes,
• Suppression of the hypothalamic-pituitary-adrenal axis,
• Cushing’s syndrome,
• Growth and developmental delay in children,
• Elevated blood sugar or sugar in urine.

Drug Interactions

There are no known interactions between Maxicortan and other medications. However, it is important to inform your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.

The cream contains:

• Cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis),
• Methylparaben and propylparaben, which may cause allergic reactions, sometimes delayed,
• Propylene glycol (30 mg per gram), which may cause skin irritation.

Warnings and Precautions

If symptoms worsen or do not improve after 7 days, consult a doctor. Large doses or application over large areas may cause growth and developmental disorders in children and suppression of the hypothalamic-pituitary-adrenal axis.

Symptoms of overdose include:

• Elevated blood sugar,
• Sugar in the urine (glycosuria),
• Cushing’s syndrome (characteristic appearance: moon face, rounded torso, and thin limbs).

Consult your doctor if:

• You have diabetes,
• You have glaucoma or cataracts (application near the eyes may worsen symptoms),
• You have psoriasis, as topical use may trigger a flare-up.

Do not apply the cream to healthy skin, in large doses, or over large areas for long periods of time, as corticosteroids can be absorbed into the bloodstream and cause adverse effects.

Avoid covering the treated area with any dressing (especially plastic or waterproof covers), as this increases the absorption of the medication.

Maxicortan should only be used in children under 12 under medical supervision.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, consult your doctor before using this medication. Maxicortan should not be used during pregnancy and breastfeeding unless advised by a doctor.

Driving and Operating Machinery

No known effect on the ability to drive or operate machinery.