Verocutan (Capsules) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

D10BA01 (Isotretinoin)

Active Substance

Isotretinoin (Rec.INN registered by WHO)

Dosage Forms

	Verocutan	Capsules 10 mg: 30 or 100 pcs.
		Capsules 20 mg: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, brownish-red, oblong in shape with a longitudinal seam; the capsule contents are a homogeneous oily suspension from yellow to dark yellow.

Excipients: refined soybean oil – 133.44 mg, beeswax – 0.82 mg, hydrogenated soybean oil – 19.68 mg, butylated hydroxyanisole – 0.04 mg, edetate disodium (Trilon B) – 0.02 mg.

Capsule shell composition: medical gelatin – 84.368 mg, glycerol (glycerin) – 30.52 mg, methylparaben – 0.59 mg, propylparaben – 0.084 mg, titanium dioxide – 0.38 mg, iron oxide red dye – 0.058 mg.

Capsule mass – 280 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Capsules soft gelatin, two-tone: one half brownish-red, the other half white with a yellowish tint; oblong in shape with a longitudinal seam; the capsule contents are a homogeneous oily suspension from yellow to dark yellow.

Excipients: refined soybean oil – 266.88 mg, beeswax – 1.64 mg, hydrogenated soybean oil – 39.36 mg, butylated hydroxyanisole – 0.08 mg, edetate disodium (Trilon B) – 0.04 mg.

Capsule shell composition: medical gelatin – 139.748 mg, glycerol (glycerin) – 50.45 mg, methylparaben – 0.98 mg, propylparaben – 0.14 mg, titanium dioxide – 0.634 mg, iron oxide red dye – 0.048 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Acne treatment drug. Retinoid

Pharmacotherapeutic Group

Remedy for acne

Pharmacological Action

An agent for the treatment of acne. It promotes the normalization of terminal cell differentiation, inhibits the hyperproliferation of the epithelium of the excretory ducts of the sebaceous glands, the formation of detritus, and facilitates its evacuation.

This reduces the production of sebum, facilitates its secretion, normalizes its composition, and reduces the inflammatory reaction around the glands.

With topical and systemic use, it has antiseborrheic, sebostatic, anti-inflammatory, kerato- and immunomodulatory effects; enhances regeneration processes in the skin.

Pharmacokinetics

After oral administration, Isotretinoin is absorbed from the gastrointestinal tract; absorption may increase when taken with food.

C_max in blood plasma is reached 1-4 hours after oral administration.

Oral bioavailability is low, which may be due to parietal metabolism in the intestinal wall and the first-pass effect through the liver.

Isotretinoin is highly bound to plasma proteins. It is metabolized in the liver to form the main metabolite 4-oxo-isotretinoin; some isomerization of isotretinoin to tretinoin also occurs.

Isotretinoin, tretinoin, and its metabolites undergo enterohepatic recirculation.

The final T_1/2 of tretinoin is 10-20 hours. An equivalent amount is determined in feces, mainly unchanged, and in urine in the form of metabolites.

Indications

For oral administration: severe forms of nodular-cystic acne, especially with localization on the trunk.

For rectal administration: severe recurrent forms of acne, rashes with an accompanying seborrheic process.

For topical application: papulo-pustular acne, seborrhea, rosacea, perioral dermatitis.

ICD codes

Dosage Regimen

For oral administration, the initial dose is 500 mcg/kg/day; the maximum daily dose is used for a limited time and is 1 mg/kg; the maintenance dose is 0.1-1 mg/kg/day; the duration of treatment is 16 weeks, a repeat course is carried out with an interval of 8 weeks.

It is taken with meals in one or several doses.

Rectally – 0.5-1 mg/kg once/day at night (in a lying position); the course of treatment is 8-12 weeks, intervals between courses are 1-2 months.

The ointment is applied in a thin layer to the affected areas of the skin 2 times/day. The duration of treatment is 4-6 weeks.

Adverse Reactions

Dermatological reactions: dryness of mucous membranes, skin rash, dermatitis, itching, cheilitis, erythema (especially on the face), sweating, palmar-plantar desquamation, paronychia, nail dystrophy, increased growth of granulation tissue in the affected area; rarely – thinning of hair, vasculitis, photosensitivity.

From the sensory organs: conjunctivitis, photophobia, decreased night vision, corneal opacity, hearing loss.

From the central and peripheral nervous system: headache; rarely – depression, seizures, suicidal tendency; in isolated cases – intracranial hypertension.

From the digestive system: nausea; rarely – colitis, gastrointestinal bleeding, transient increase in liver transaminase activity; in isolated cases – hepatitis.

From the hematopoietic system: anemia, neutropenia, changes in platelet count, increased ESR.

From metabolism: increased concentration of triglycerides, glucose.

From the musculoskeletal system: muscle and joint pain; rarely – hyperostoses.

Other: nosebleed.

With rectal and topical application: during the 1st-2nd week of treatment, the appearance of new rashes, itching, swelling, and redness of the skin is possible.

Contraindications

Pregnancy, established and planned, lactation, hypersensitivity to isotretinoin, simultaneous use of antibiotics of the tetracycline group.

For oral administration: severe impairment of liver and/or kidney function, hypervitaminosis A, significantly increased plasma lipid levels, neoplasms.

For rectal administration – diseases of the rectum.

Use in Pregnancy and Lactation

Isotretinoin has a pronounced teratogenic and embryotoxic effect.

Contraindicated in established and planned pregnancy.

Contraindicated during lactation.

Use in Hepatic Impairment

Use rectally and topically with caution in liver diseases.

Use in Renal Impairment

Use rectally and topically with caution in kidney diseases.

Pediatric Use

The safety of use in children and prepubertal patients has not been established.

Special Precautions

Use rectally and topically with caution in liver diseases, kidney diseases, chronic pancreatitis, decompensated cardiac activity, chronic intoxications (including alcoholic).

With rectal and topical application, in case of a sharply pronounced exacerbation reaction (during the 1st-2nd week of treatment), it is recommended to cancel treatment for several days until it subsides, then therapy can be resumed.

With oral administration, regular monitoring of liver function and plasma lipid levels is necessary before treatment, 1 month after the start of therapy, and then every 3 months.

In diabetes mellitus, obesity, alcoholism, or lipid metabolism disorders, more frequent monitoring of laboratory parameters is recommended. In diabetes mellitus or suspected diabetes, plasma glucose levels should be strictly controlled.

With long-term use, the development of symptoms of chronic hypervitaminosis A is possible.

During treatment or for some time after its completion, one cannot be donors for women of childbearing age.

During therapy, patients should not be prescribed UV therapy; patients should avoid direct exposure to solar radiation.

During treatment, intolerance to contact lenses may occur.

The safety of use in children and prepubertal patients has not been established.

Simultaneous use of isotretinoin and 19-nortestosterone derivatives should be avoided, especially in patients with gynecological/endocrinological diseases.

Simultaneous use of other drugs with keratolytic or exfoliative properties (including other retinoids), as well as progesterone in microdoses (including mini-pill drugs) is not recommended.

Drug Interactions

The effect of isotretinoin is weakened with the simultaneous use of progesterone in microdoses.

With simultaneous use of isotretinoin and vitamin A, an increase in toxic effects is possible.

With simultaneous use of isotretinoin and antibiotics of the aminoglycoside group, there is a risk of developing intracranial hypertension.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.