Sotret caps 20mg #30

Instruction for Sotret

You can buy Sotret capsules on this page

Release form, composition and packaging

Soft gelatin capsules, burgundy, oval, opaque, printed with black food ink "RR", the contents of the capsules - oily suspension of orange-yellow color; there are seams on the sides of the capsules.
1 caps
isotretinoin 20 mg
Auxiliary substances: soybean oil, hydrogenated - 15.3 mg, vegetable oil, hydrogenated - 64.26 mg, white beeswax - 18.36 mg, disodium edetate - 0.16 mg, butylhydroxyanisole - 0.032 mg, soybean oil, refined - 201.888 mg.
The composition of the gelatin capsule: gelatin - 123.651 mg, glycerol - 64.645 mg, allurer red dye - 0.198 mg, diamond blue dye FCF - 0.011 mg, titanium dioxide - 0.495 mg, purified water - qs, light paraffin liquid * - qs, isopropanol * - qs
Food ink black S-1-17823 - 1.5 mg.
The composition of food ink black S-1-17823: shellac 45% (20% esterified) in ethanol - 0.666 mg, ferrous oxide black oxide - 0.35 mg, isopropanol * - 0.404 mg, n-butanol * - 0.034 mg, propylene glycol - 0.03 mg , ammonium hydroxide * - 0.016 mg.
10 pieces. - blisters (1) - packs cardboard.
10 pieces. - blisters (3) - packs cardboard.
10 pieces. - blisters (6) - packs cardboard.
* The solvent is not present in the final product, evaporates during the production process.

pharmachologic effect

Isotretinoin is a stereoisomer of polytransretinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been elucidated, 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. In addition, isotretinoin has an anti-inflammatory effect on the skin.
Hyperkeratosis of the epithelium cells of the hair follicle and the sebaceous gland leads to desquamation of corneocytes in the duct of the gland and to the occlusion of the latter with keratin and an excess of sebaceous secretion. This is followed by the formation of comedo and, in some cases, the addition of the inflammatory process. Isotretinoin inhibits sebocyte proliferation and acts on acne, restoring the normal process of cell differentiation. Sebum is the main substrate for the growth of Propionibacterium acnes, therefore reducing the formation of sebum suppresses bacterial colonization of the duct.

Pharmacokinetics

Since the kinetics of isotretinoin and its metabolites is linear, its plasma concentration during therapy can be predicted on the basis of data obtained after a single dose. This property of Sotret also suggests that it does not affect the activity of liver enzymes involved in the metabolism of drugs.

Suction

Isotretinoin absorption from the gastrointestinal tract is directly proportional to dose dependence in the therapeutic range. The absolute bioavailability of isotretinoin was not determined, since the person does not have a drug in the dosage form for iv administration of isotretinoin. However, extrapolating the data obtained in the preclinical study suggests a rather low and variable systemic bioavailability. In patients with acne, the maximum plasma concentrations (C max) in the equilibrium state after taking 80 mg of isotretinoin on an empty stomach were 310 ng / ml (range 188–473 ng / ml) and were reached after 2–4 hours. The concentration of isotretinoin in plasma was approximately 1.7 times higher concentrations in the blood due to poor penetration of isotretinoin into red blood cells.
Taking isotretinoin with food increases its bioavailability by 2 times compared to fasting.

Distribution

Isotretinoin is largely bound to plasma proteins, mainly albumin (99.9%). Vd isotretinoin in humans was not determined, since the dosage form for IV injection does not exist. The equilibrium blood concentrations of isotretinoin (Cmin ss) in patients with severe acne, taking 40 mg of isotretinoin 2 times / day, ranged from 120 to 200 ng / ml. Data on the penetration of isotretinoin into human tissue is extremely small. The concentration of isotretinoin in the epidermis is two times lower than in serum.
The concentration of isotretinoin in plasma is approximately 1.7 times higher than the concentration in the blood as a whole, due to the low level of penetration of isotretinoin into red blood cells.

Metabolism

After ingestion, three major metabolites are found in plasma: 4-oxo-isotretinoin, tretinoin (polytretretinoic acid) and 4-oxo-tretinoin. The main metabolite is 4-oxo-isotretinoin, the plasma concentrations of which in equilibrium are 2.5 times higher than the concentrations of the original preparation. Less significant metabolites have also been found, which also include glucuronides, however, the structure of not all metabolites has been established.
The isotretinoin metabolites have biological activity confirmed in several in vitro studies. Thus, the clinical effects of Sotret in patients may be the result of the pharmacological activity of isotretinoin and its metabolites.
Since in vivo isotretinoin and tretinoin (polytransretinoic acid) are reversibly transformed into each other, the metabolism of tretinoin is associated with the metabolism of isotretinoin. 20-30% of the dose of isotretinoin is metabolized by isomerization. In the pharmacokinetics of isotretinoin in humans, an important role may be played by hepato-intestinal recycling. In vitro metabolism studies have shown that several cytochrome P450 enzymes are involved in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin. Apparently, none of the isoforms plays a dominant role. Isotretinoin and its metabolites have no significant effect on the activity of cytochrome P450 enzymes.

Removal

After ingestion of isotretinoin, labeled with radioactive isotopes, an approximately equal amount of it is found in the urine and feces. The T1 / 2 of the terminal phase for the unchanged active component in patients with acne averages 19 hours. The T1 / 2 of the terminal phase for 4-oxo-isotretinoin seems to be longer, and its average duration is 29 hours. Isotretinoin is a natural ( physiological) retinoids. Endogenous concentrations of retinoids are reached approximately 2 weeks after the end of the intake of isotretinoin.

Pharmacokinetics in special cases

Since isotretinoin is contraindicated in violation of the liver, data on the pharmacokinetics of Sotret in this group of patients is limited. Renal failure does not significantly reduce the clearance of isotretinoin or 4-oxo-isotretinoin in the blood plasma.

Indications

- severe forms of acne (nodular-cystic, conglobate acne or acne with the risk of scarring);
- acne, not amenable to other types of therapy.

Contraindications

- pregnancy;
- breastfeeding period;
- ability to bear children in women who do not comply with contraception while taking Sotret Sotret;
- liver failure;
- hypervitaminosis A;
- severe hyperlipidemia;
- concomitant tetracycline therapy;
- Hypersensitivity to isotretinoin or excipients of the drug Sotret;
- Allergy to peanuts and soybeans (the product contains soybean oil, hydrogenated oil, vegetable oil, hydrogenated, soybean oil, refined oil);
- children's age up to 12 years.
With caution: a history of depression, diabetes, obesity, lipid metabolism, alcoholism.

Dosage

Standard dosing regimen
Inside, during meals 2 times / day.
The therapeutic efficacy of the drug Sotret and its side effects depend on the dose and vary in different categories of patients. This dictates the need for individual selection of doses during treatment.
Adults, including adolescents, and elderly patients
Drug treatment Sotret should start with a dose of 0.5 mg / kg / day. In most patients, the dose ranges from 0.5 to 1.0 mg / kg body weight / day. Patients with very severe forms of the disease or with acne torso may require higher daily doses - up to 2.0 mg / kg. Expect significant additional benefits when the total dose of more than 120-150 mg / kg should not be. The duration of treatment depends on the individual daily dose. To achieve remission, a course of treatment lasting 16-24 weeks is usually sufficient. In patients who very poorly tolerate the recommended dose, treatment can be continued at a lower dose, but it can be carried out longer.
In most patients, acne disappears completely after a single course of treatment. With a pronounced relapse, a repeated course of drug treatment is shown. It Sotret in the same daily and course dose as the first. Since the improvement can continue up to 8 weeks after discontinuation of Sotret, a second course should be prescribed not earlier than the end of this period.

Dosing in special cases

In patients with severe renal insufficiency, treatment should begin with a lower dose (for example, 10 mg / day) and further increase to 1 mg / kg / day or the maximum tolerated dose.
Patients with intolerance to the recommended dose
Patients who have shown intolerance to the recommended dose, you can continue to take the drug at a lower dose, given the effects of longer therapy and a higher risk of relapse. In order to achieve the highest possible efficacy, such patients should continue their treatment, taking the maximum tolerated dose of Sotret.

Side effects

Most of the side effects of isotretinoin are dose dependent. As a rule, when prescribing the recommended doses, the ratio of benefits and risks, taking into account the severity of the disease, is acceptable to the patient. Side effects are usually reversible after dose adjustment or drug withdrawal, but some may persist after stopping treatment. The following symptoms of adverse events associated with isotretinoin are most frequently reported: dry skin, dry mucous membranes, such as lips (cheilitis), nose (epistaxis), and eyes (conjunctivitis).
Categorization of the frequency of side effects: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10 000 and < 1/1000), very rarely (<1/10 000), the frequency is unknown (it is impossible to estimate the frequency of occurrence according to the available data).
Metabolism: very rarely - diabetes, hyperuricemia.
Allergic reactions: rarely - allergies, anaphylactic reaction, hypersensitivity, systemic hypersensitivity reactions.
From the side of the central nervous system: rarely - depression, exacerbation of depression, aggressive behavior, irritability, frequent mood swings; very rarely - inappropriate behavior, psychotic disorder, suicidal thoughts, suicidal attempts, suicide.
From the nervous system: often - headache; very rarely, benign intracranial hypertension (“brain pseudotumor”: headache, nausea, vomiting, blurred vision, swelling of the optic nerve), convulsions, drowsiness, dizziness; frequency unknown (including individual messages) - excessive fatigue.
On the part of the skin: very often - dermatitis, dry skin and mucous membranes, they are dystrophies, increased proliferation of granulation tissue, rash, itching, erythema of the face, cheilitis, easy trauma to the skin; rarely - alopecia; very rarely - increased sweating, pyogenic granuloma, paronychia, persistent thinning of hair, reversible hair loss, nail dystrophy, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitization, photodermatosis, vasculitis (Wegener granulomatosis, allergic vasculitis). At the beginning of treatment, acne may worsen, lasting for several weeks. The frequency is unknown (including individual reports) - Stevens-Johnson syndrome, toxic epidermal necrolysis, peeling of the skin of the palms and soles.
From the urinary system: often - hematuria, proteinuria; very rarely - glomerulonephritis.
On the part of the musculoskeletal system: very often - myalgia (with increased activity of creatinine phosphokinase (CPK) in serum or without it) *, arthralgia; very rarely - hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendonitis; frequency is unknown (including individual reports) - rhabdomyolysis, in some cases with a fatal outcome.
On the part of the digestive system: very often - a transient and reversible increase in the activity of hepatic transaminases **; very rarely - nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), gastrointestinal bleeding; pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL), dry throat, hepatitis; frequency is unknown (including individual messages) - dryness of the oral mucosa, bleeding from the gums, inflammation of the gums. Rare cases of pancreatitis with a fatal outcome have been described.
From the side of blood-forming organs: very often - anemia, increased ESR, thrombocytopenia, thrombocytosis; often - neutropenia; very rarely - lymphadenopathy; frequency is unknown (including individual reports) - decrease in hematocrit, leukopenia, thrombocytopenic purpura.
On the part of the respiratory system: often - nasal cavity bleeding, dryness of the nasal mucosa and larynx, nasopharyngitis; very rarely - bronchospasm (more often in patients with a history of bronchial), hoarseness.
From the senses: very often - blepharitis, conjunctivitis, dry eye syndrome, eye irritation; very rarely - isolated cases of visual acuity, reduced night vision acuity, contact lens intolerance, corneal clouding, color blindness and other color perception anomalies, cataracts, keratitis, optic nerve edema (as a manifestation of benign intracranial hypertension), visual disturbances, hearing loss .
Laboratory indicators: very often - hypertriglyceridemia, a decrease in high-density lipoprotein parameters; often - hypercholesterolemia, hyperglycemia; very rarely - increased activity of CK in the serum.
Other: very rarely - local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus).
* In some patients, especially those engaged in intense physical activity, isolated cases of increased CK activity in serum have been described.
** 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 may be necessary to reduce the dose or discontinue the drug.

Overdose

Isotretinoin is a derivative of vitamin A. Although the acute toxicity of vitamin A is low, an accidental overdose may show signs of hypervitaminosis (dry skin and mucous membranes, cheilitis, nasal bleeding, hoarseness, conjunctivitis, reversible corneal opacity, intolerance to contact lenses . The manifestation of acute toxicity of vitamin A is expressed in severe headache, nausea or vomiting, drowsiness, irritability and skin itching.
The signs and symptoms of an accidental or intentional overdose of isotretinoin should be similar. These symptoms should probably be reversible and go away without any treatment.

Drug interaction

Because of the possible increase in symptoms of hypervitaminosis A, co-administration of isotretinoin with vitamin A and other retinoids (including acitretin, tretinoin, retinol, tazaroten, adapalen) should be avoided.
Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with isotretinoin is contraindicated.
Isotretinoin can weaken the effectiveness of progesterone drugs, so do not use contraceptives containing small doses of progesterone.
The combined use of isotretinoin with local keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of the possible increase in local irritation.

special instructions

Sotret should be prescribed only by doctors, preferably dermatologists who have experience with the use of systemic retinoids and who are aware of the risk of drug teratogenicity.

Precautionary measures

In order to avoid accidental effects of the drug on the body of other people, patients who take or shortly before that (1 month) took the drug Sotret, donor blood cannot be taken.

Disorders of the liver and biliary tract

It is recommended to monitor liver function and liver enzymes before treatment, 1 month after it starts, and then every 3 months, if more frequent analysis is not shown. An unstable and reversible increase in hepatic transaminases is noted, in most cases within normal limits. If the activity of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of Sotret or cancel it.

Lipid exchange

The level of serum lipids should be checked before starting treatment (on an empty stomach), one month after starting treatment, and then successively after three months, unless more frequent analysis is shown. Elevated levels of serum lipids usually return to normal values ​​when the dose is lowered, the drug is withdrawn, and also when the diet is applied. Isotretinoin causes plasma triglycerides to increase. If hypertriglyceridemia can not be controlled at an acceptable level or if symptoms of pancreatitis are observed, isotretinoin should be stopped. Triglyceride levels in excess of 800 mg / dL (9.01 mmol / L) can sometimes be caused by acute pancreatitis, which can be fatal.

Mental disorders

Depression, depression, irritability, aggressiveness, change of mood, psychotic symptoms, and, very rarely, suicidal thoughts, suicidal attempts and suicide were recorded in patients taking isotretinoin. Special attention should be given to patients with a history of depression, and all patients should be monitored for signs of depression and, if necessary, receive appropriate treatment. However, withdrawal of isotretinoin may not be enough to alleviate the symptoms, and therefore a psychiatric or psychological assessment of the patient’s condition may be required in the future.

Violations of the skin and subcutaneous tissues

An acute attack of acne is sometimes observed at the initial stage of treatment, but with continued treatment, it goes out within 7-10 days, and dose adjustment is usually not required.
Exposure to intense sunlight and ultraviolet radiation should be avoided. If necessary, use sunscreen with a high protection factor, at least SPF 15.
Intensive chemical dermabrasion and laser skin treatment are contraindicated for patients taking isotretinoin for 5-6 months after the end of the intake because of the risk of hypertrophic scars on atypical sites and, less often, post-inflammatory hyper or hypopigmentation on the treated sites. Patients taking isotretinoin, is also contraindicated procedure of waxing with the use of wax due to the risk of exfoliation of the epidermis.
The simultaneous administration of isotretinoin and external keratolytic or exfoliating agents should be avoided, since local irritation may increase. Patients are advised to use moisturizing ointments or creams and lip balm from the start of taking isotretinoin, since dry skin and lips may occur at the beginning of taking isotrethionine.
Serious skin reactions associated with isotretinoin have been reported several times (erythema polymorphic, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Since these adverse events may be difficult to distinguish from other possible skin reactions, patients should be instructed about the possibility of occurrence and signs of similar symptoms and kept under close observation to detect serious adverse reactions. If a serious adverse reaction is suspected, isotretinoin should be discontinued.

Allergic reactions

There are rare reports of anaphylactic reactions, in some cases occurring after the local application of retinoids. In rare cases, allergic skin reactions are reported. Serious cases of allergic vasculitis of the limbs are also reported, often with purpura and affected additional skin areas. If serious allergic reactions occur, discontinuation of Sotret and careful observation of the patient are necessary.

Violations of the musculoskeletal system

A few years after the use of isotretinoin for the treatment of dyskeratosis with changes in the total dose and duration of therapy, higher than those recommended for the treatment of acne, changes in the bones developed, including premature closure of epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. In patients receiving isotretinoin, myalgia and arthralgia are possible, an increase in serum CPK, which, in particular, can appear during intensive exercise.

Violations of view

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. 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. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients complaining of vision should be referred to an ophthalmologist and consider the appropriateness of discontinuing isotretinoin. If contact lenses are intolerant, glasses should be used at the time of therapy. Exposure to sunlight and UV rays should be limited.

Benign intracranial hypertension

Rare cases of the development of benign intracranial hypertension ("brain pseudotumor"), including when combined with tetracyclines. The signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, visual disturbances and swelling of the optic nerve head. In these patients, you should immediately stop taking the drug Sotret.

Renal dysfunction

Impaired renal function and renal failure do not affect the pharmacokinetics of isotretinoin. Therefore, isotrethionine can be administered to patients with impaired renal function. However, it is recommended for such patients to start receiving isotretinoin from small doses and gradually bring them to the maximum tolerated dose.

Disorders of the digestive system

Isotretinoin is the cause of inflammatory bowel disease in patients with no history of intestinal disorders. Patients with severe hemorrhagic diarrhea should immediately discontinue Sotret.

High-risk patients

High-risk patients (with diabetes mellitus, obesity, alcoholism, or lipid metabolism) may need more frequent laboratory monitoring of glucose and blood lipids in the treatment with isotretinoin. An increased level of blood glucose and new cases of diabetes have been reported with isotretinoin.

Influence on ability to drive motor transport and control mechanisms

Since the decline in the severity of twilight vision while taking isotretinoin may be sudden, the patient should be informed about the possibility of such a situation.
Drowsiness, dizziness and visual disturbances were very rarely observed. Patients should be warned that in the event of a similar occurrence they should not drive vehicles, use different mechanisms, and also take part in any activity where similar symptoms may put them or other people at risk.

Pregnancy and lactation

Pregnancy - an absolute contraindication for drug therapy Sotret, the active substance of which is isotretinoin. Isotretinoin has a strong teratogenic effect. If pregnancy occurs, despite the warnings, during treatment with isotretinoin (by mouth, at any dose or even a short time) or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe developmental defects.

Pregnancy Prevention Program

The drug Sotret contraindicated in women of childbearing age, unless the condition of a woman does not meet all the following criteria:
- it must have a severe form of acne that is resistant to the usual methods of treatment;
- she must understand precisely the need for careful monthly medical observation and follow the instructions of the doctor;
- she is informed by the doctor about the danger of pregnancy in the course of treatment with the drug Sotret and within one month after treatment, and about the need for urgent consultation at risk of pregnancy;
- she should be warned about the possible ineffectiveness of contraception;
- it must confirm that it understands and understands the risk factors and the essence of the precautionary measures;
- she understands the need for use and must continuously use effective methods of contraception for one month before treatment with the drug Sotret, during treatment and for a month after the end of treatment; It is desirable to use simultaneously 2 different methods of contraception, including barrier;
- the patient is aware and accepts that the pregnancy test should be carried out monthly during treatment and 5 weeks after the end of therapy;
- she should start treatment with Sotret. It will only wipe for 2-3 days of the next normal menstrual cycle;
- when treating for the recurrence of the disease, she should constantly use the same effective methods of contraception for one month prior to the start of treatment with the drug Sotret, during treatment and for one month after its completion, as well as undergo the same reliable pregnancy test;
- she fully understands the need for precautions and confirms her understanding and desire to use reliable methods of contraception, which the doctor explained to her;
- Even in the presence of amenorrhea, the patient should follow all recommendations for effective contraception.
The use of contraceptives according to the above instructions during treatment with isotretinoin should be recommended even to women who usually do not use contraceptive methods due to infertility (except for patients who have undergone hysterectomy), amenorrhea, or who report that they are not sexually active.
The physician must be sure that:
- the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with the risk of scarring), acne that is not amenable to other types of therapy;
- a negative result of a reliable pregnancy test was obtained before the start of Sotret intake, during therapy and 5 weeks after the end of therapy; the dates and results of the pregnancy test must be documented;
- the patient uses at least 1, preferably 2 effective methods of contraception, including a barrier method, for at least one month before the start of treatment with Eraser, during treatment and within a month after its termination;
- the patient is able to understand and fulfill all the above requirements for the prevention of pregnancy;
- the patient meets all the above conditions;
- The patient confirmed the understanding of the above conditions and agreement with them.

Contraception

Female patients should be provided with comprehensive information on the prevention of pregnancy and receive recommendations on contraception if they are not using effective methods of contraception.
The minimum requirement for patients with a potential risk of pregnancy is the use of at least one method of contraception. It is better that the patient uses two complementary methods of contraception, including a barrier method. The use of contraception, even in patients with amenorrhea, should continue for at least 1 month after discontinuing isotretinoin.

Pregnancy test

In accordance with existing practice, a pregnancy test with a minimum sensitivity of 25 mIU / ml should be carried out in the first 3 days of the menstrual cycle:

Before the start of therapy

To exclude a possible pregnancy before the start of contraception, the result and the date of the initial pregnancy test must be recorded by a doctor. In patients with irregular menstruation, the time of the pregnancy test depends on sexual activity, it should be carried out 3 weeks after unprotected intercourse. The physician should inform the patient about contraceptive methods.
A pregnancy test is carried out on the day the drug is prescribed. It will be erased or 3 days before the patient's visit to the doctor. The specialist should register the test results. Sotret can be prescribed only to patients who receive effective contraception for at least 1 month before the start of therapy with the drug Sotret.

During therapy

The patient should visit the doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity, previous violations of the menstrual cycle. If there is evidence, a pregnancy test is carried out on the day of the visit or 3 days before the visit to the doctor, the test results must be recorded.

End of therapy

5 weeks after the end of therapy, a test is performed to rule out pregnancy. The prescription for Sotret will be eaten by a woman capable of childbirth, can be discharged only for 30 days of treatment, the continuation of therapy requires a new prescription of the drug by a doctor. We recommend a pregnancy test, prescription and receiving the drug in one day.
The issuance of Sotret at the pharmacy should be carried out only within 7 days from the date of prescription.
Full information on teratogenic risk and strict adherence to measures to prevent pregnancy should be provided to both men and women.

Male patients

Existing evidence suggests that in women, isotretinoin exposure from men and women taking isotretinoin is insufficient for the appearance of isotretinoin teratogenic effects.
Male patients should be reminded that they should not share their medication with anyone, especially with women.

In the event of pregnancy

If during the treatment with the drug it is erased or within a month after its termination, despite the precautions described in the pregnancy prevention program, the patient still has a pregnancy, there is a high risk of very severe fetal malformations (in particular, from the CNS, heart and large blood vessels). In addition, the risk of miscarriage increases.
If pregnancy occurs, drug therapy Sotret. It is necessary to discuss the feasibility of its preservation with a physician specializing in teratology. Severe congenital fetal malformations in humans associated with the administration of isotretinoin, including hydrocephalus, microcephaly, cerebellar malformations, anomalies of the external ear (microtia, narrowing or absence of the external auditory canal, absence of the external ear), microphthalmia, cardiovascular anomalies, have been documented. (Fallot's tetrad, transposition of the great vessels, defects of the septum), facial deformities (cleft palate), thymus, parathyroid pathology.
Since isotretinoin has a high lipophilicity, it is very likely that it passes into breast milk. Because of the possible side effects, isotretinoin should not be given to nursing mothers.

Use in childhood

The use of Sotret is contraindicated in children under 12 years of age.

In case of impaired renal function

In patients with severe renal failure, treatment should begin with a lower dose.

With abnormal liver function

Contraindicated use of the drug for liver failure.

Pharmacy sales terms

You can buy Sotret without a prescription.

Terms and conditions of storage

Sotret should be stored in a dark place, out of reach of children at a temperature not higher than 25 ° C. Shelf life - 2 years. The drug should not be used after the expiration date printed on the package.