Acnecutane capsules 8mg №30

Capsules

Composition

1 capsule contains isotretinoin 8 mg;
Excipients:Gelutsir 50/13 (a mixture of esters of stearic acid polyethylene oxide and glycerin), purified soybean oil, Span 80 (sorbitan oleate - mixed esters of oleic acid and sorbitol).

Packing

30 pieces

Mechanism of action

Acnecutane - a drug for the treatment of acne. Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been identified, but it has been established that the improvement in the clinical picture of severe acne is associated with the suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. Sebum is the main substrate for the growth of Propionibacterium acnes, therefore reducing the formation of sebum suppresses bacterial colonization of the duct. Acnecutane suppresses sebocyte proliferation and acts on acne, restoring the normal process of cell differentiation, stimulates regeneration processes. In addition, isotretinoin has an anti-inflammatory effect on the skin.

Indications and usage

Severe forms of acne (nodular-cystic, conglobate, acne with the risk of scarring); Acne, not amenable to other therapies.

Contraindications

- pregnancy established and planned (possibly teratogenic and embryotoxic action);
- lactation period (breastfeeding);
- liver failure;
- hypervitaminosis A;
- severe hyperlipidemia;
- concomitant Tetracycline therapy;
- hypersensitivity to the drug or its components.
- not indicated in the treatment of acne during puberty and is not recommended for use in children under 12 years.
- pregnancy and lactation.
Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs at a time when a woman orally takes isotretinoin (at any dose or even a short time), there is a very high risk of having a baby with developmental disabilities.

CarefullyIt should appoint a drug for diabetes, depression in history, obesity, lipid metabolism disorders, alcoholism.

Dosage and administration

Inside, preferably with meals, 1-2 times a day.

The initial dose of Acnecutane is 400 mcg / kg / day, in some cases up to 800 mcg / kg / day. Atsevere forms of the disease or with acne torso dosage up to 2 mg / kg / day may be required.

Complete remission is usually achieved in 16-24 weeks. If the recommended dose is poorly tolerated, treatment can be continued at a lower dose, but longer. In most patients, acne completely disappears after a single course of treatment.

In case of relapse, it is possible to repeat the course of treatment in the same daily and cumulative dose. Repeated course prescribed not earlier than 8 weeks after the first, because improvement may be delayed.

With chronic severe renal failure, the initial dose should be reduced to 8 mg per day.

Adverse reactions

Symptoms associated with hypervitaminosis A: dry skin, mucous membranes, incl. lips (cheilitis), nasal cavity (bleeding), larynx and pharynx (hoarseness), eyes (conjunctivitis, reversible corneal clouding and contact lens intolerance).

Dermatologic: peeling of the skin of the palms and soles, rash, pruritus, facial erythema / dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased proliferation of granulation tissue, persistent thinning of hair, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation,,,,,,,,,.. At the beginning of treatment, acne may worsen, lasting for several weeks.

Musculoskeletal system: muscle pain with increased serum CPK levels or without it, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, tendinitis.

From the side of the central nervous system: excessive fatigue, headache, increased intracranial pressure (pseudotumor of the brain: headache, nausea, vomiting, blurred vision, swelling of the optic nerve), seizures; rarely - depression, psychosis, suicidal thoughts.

Special senses: xerophthalmia, isolated cases of visual acuity, photophobia, impaired dark adaptation (reduced acuity of twilight vision); rarely - color disturbance (passing after drug withdrawal), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, optic neuritis, optic nerve edema (as a manifestation of intracranial hypertension); impaired hearing at certain sound frequencies, difficulty in wearing contact lenses.

Gastrointestinal: dryness of the oral mucosa, bleeding from the gums, gum inflammation, nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL). Rare cases of pancreatitis with a fatal outcome have been described. A transient and reversible increase in the activity of hepatic transaminases, isolated cases of hepatitis was noted. In many of these cases, the changes did not go beyond the limits of the norm and returned to the original indicators in the course of treatment, but in some situations it was necessary to reduce the dose or cancel Acnecutane.

Respiratory: rarely - bronchospasm (more often in patients with bronchial asthma in history).

Hemic and lymphatic: anemia, decrease in hematocrit, leukopenia, neutropenia, increase or decrease in the number of platelets, accelerated ESR.

Laboratory values: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, reduction of HDL levels; rarely - hyperglycemia. During the reception of Acnecutane, cases of newly diagnosed diabetes were reported. In some patients, especially those engaged in intense physical activity, isolated cases of an increase in the activity of CK in serum have been described.

Infections: local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus).

Other: lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener's granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis.

Teratogenic and embryotoxic effects: congenital malformations - hydro- and microcephaly, hypoplasia of the cranial nerves, microphthalmia, malformations of the cardiovascular system, parathyroid glands, impaired skeletal formation (underdevelopment of the phalanges, skull, cervical vertebrae, femur, ankles, forearm bones, skull, cervical vertebrae, femur, ankle, forearm bones, skull, cervical vertebrae, femur, ankle, forearm, bones, skull, cervical vertebrae, femur, ankle, forearm cleft palate), low location of the auricles, underdevelopment of the auricles, underdevelopment or complete absence of the external auditory canal, hernia of the brain and spinal cord, bone adhesions, fusion of the fingers and toes, eniya development of the thymus; fetal death during the perinatal period, premature birth, miscarriages, premature closure of the epiphyseal growth zones; in the experiment on animals - pheochromocytoma.

Special notes

It is recommended to monitor liver function and liver enzymes before treatment, 1 month after its onset, and then every 3 months or according to indications. A transient and reversible increase in hepatic transaminases is noted, in most cases within normal limits. If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it.

You should also determine the level of lipids in the serum on an empty stomach before treatment, 1 month after the start, and then every 3 months or according to indications. Usually, lipid concentrations are normalized after dose reduction or withdrawal of the drug, as well as diet.

It is necessary to control the clinically significant increase in triglycerides, since their elevation above 800 mg / dL or 9 mmol / L may be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. If persistent hypertriglyceridemia or pancreatitis symptoms Acnecutane should be canceled.

In rare cases, patients treated with Acnecutane described depression, psychotic symptoms, and very rarely - suicide attempts. Although their causal relationship with the use of the drug has not been established, special care must be taken in patients with depression in history and all patients should be monitored for depression during treatment with the drug, if necessary, referring them to the appropriate specialist. However, the removal of Acnecutane may not lead to the disappearance of symptoms and may require further observation and treatment by a specialist.

In rare cases, at the beginning of therapy, acne exacerbation is noted, which disappears within 7–10 days without a dose adjustment.

In appointing the drug to any patient should first carefully evaluate the ratio of the possible benefits and risks.

Patients receiving Acnecutane, it is recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy.

With the use of Acnecutane, there may be pain in muscles and joints, an increase in serum CK, which may be accompanied by a decrease in the tolerance of intense exercise.

Deep chemical dermoabrasion and laser treatment in patients receiving Acnecutane should be avoided, as well as for 5-6 months after the end of treatment due to the possibility of enhanced scarring in atypical sites and the occurrence of hyperpigmentation and hypopigmentation.During treatment with Acnecutane and for 6 months after it, epilation cannot be performed using wax applications because of the risk of epidermis detachment, development of scars and dermatitis.

Since some patients may experience a decrease in visual acuity at night, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, recommending that they be careful when driving a car at night. The state of visual acuity must be carefully monitored. Dry conjunctival eyes, corneal opacities, blurred night vision and keratitis usually disappear after discontinuation of the drug. For dryness of the mucous membrane of the eyes, you can use applications of moisturizing eye ointment or preparation of artificial tears. It is necessary to observe patients with dry conjunctiva for possible development of keratitis. Patients complaining of vision should be referred to an ophthalmologist and consider the advisability of canceling Acnecutane. If contact lenses are intolerant, glasses should be used at the time of therapy.

The effects of solar insolation and UV therapy should be limited. If necessary, use a sunscreen with a high protective factor of at least 15 SPF.

Rare cases of the development of benign intracranial hypertension (brain pseudotumor) are described, incl. when combined with tetracyclines. In such patients, Acnecutane should be abolished immediately.

With Acnecutane therapy, an inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Acnecutane should be discontinued immediately.

Rare cases of Anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and closely monitor the patient.

High-risk patients (with diabetes, obesity, chronic alcoholism or impaired fat metabolism) may need more frequent laboratory monitoring of glucose and lipids in the treatment of Acnecutane. If diabetes is present or suspected, a more frequent determination of glycemia is recommended.Patients with diabetes are recommended to conduct more frequent monitoring of glucose in the blood.

During the period of treatment and within 30 days after its termination, it is necessary to completely eliminate blood from potential donors in order to completely exclude the possibility of this blood getting to pregnant patients (high risk of developing teratogenic and embryotoxic effects).

Influence on ability to drive motor transport and control mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed (when taking the first dose)

Tetracycline antibiotics, GCS reduce efficacy.

Simultaneous use with drugs that increase photosensitivity (including sulfonamides, tetracyclines, thiazide diuretics) increases the risk of sunburn.

Simultaneous use with other retinoids (including acitretin, tretionin, Retinol , tazaroten, adapalen) increases the risk of hypervitaminosis A.

Isotretinoin can weaken the effectiveness of Progesterone drugs, so do not use contraceptives containing small doses of progesterone.

Combined use with keratolytic topical preparations for the treatment of acne is not recommended because of the possible increase in local irritation.

Since tetracyclines increase the risk of increasing ICP, concurrent use with isotretinoin is contraindicated.

Symptoms: possible development of signs of hypervitaminosis A.

Treatment: gastric lavage may be necessary in the first few hours after an overdose.

Store in a dry, protected from light, out of reach of children at a temperature not exceeding 25 ° C.