Erase caps. 10 mg 30 pcs

Description

Composition
Active substance:
1 capsule contains: 10 mg of isotretinoin.
Excipients:
Hydrogenated soybean oil – 7.65 mg Hydrogenated vegetable oil – 32.13 mg, white beeswax – 9.18 mg Disodium edetate – 0.08 mg, butylhydroxyanisole – 0,016 mg, soybean oil, refined -100.944 mg. Gelatine Capsule: -56.00 mg gelatine, glycerol – 29.277 mg iron oxide red dye – 0.0325 mg of titanium dioxide – 0.190 mg Purified Water – q.s., light liquid paraffin * – q.s., isopropanol * – q.s. Food Black Black S-1-17823 – 0,75 mg.
Food black ink composition S-1-17823: Shellac 45% (20% esterified) in ethanol – 0.333 mg iron oxide black dye – 0,175 mg, isopropanol * – 0.202 mg, n-butanol * – 0.017 mg propylene glycol – 0.015 mg ammonium hydroxide * – 0,008 mg.
Description:
Oval opaque soft gelatin capsules light pink color, with printed «RR» edible black ink containing an orange-yellow oily suspension. On the sides of the capsules are seams.
Product form:
Capsules of 10 mg. 10 capsules in blisters ( “rip” blister) of transparent PVC film laminated with polyethylene, the coated film of PVDC having a substrate of aluminum foil and paper. 10 capsules in the contour cellular packaging ( “pressed” blister) of transparent PVC film laminated with polyethylene, the coated film of PVDC having a substrate made of aluminum foil, paper and polyester film. 1, 3 or 6 blisters with instructions for use in a cardboard package.
Contraindications
Pregnancy, lactation (see. Section “Pregnancy and lactation”), hepatic failure, hypervitaminosis A, marked hyperlipidemia, concomitant tetracycline therapy.
Increased sensitivity to the drug or its components. Children up to age 12 years.
Precautions: a history of depression, diabetes, obesity, lipid metabolism, alcoholism.
Dosage
10 mg
Indications
Severe acne (nodulocystic, acne conglobata or acne with risk of scarring). Acne is not amenable to other treatments.
Interaction with other drugs
Because of the possible gain hypervitaminosis A symptoms avoid simultaneous erase destination and vitamin A. Because tetracyclines can also cause increased intracranial pressure, their use in combination with erase contraindicated. Isotretinoin can weaken the effectiveness of progesterone drugs, so do not use contraceptives containing low doses of progesterone. Combined use with local keratolytic or exfoliative preparations for acne treatment is contraindicated due to the possible increase of local irritation.
Overdose
In the case of overdose can be signs of hypervitaminosis A. In the first few hours after the overdose may need gastric lavage.
pharmachologic effect
Pharmacological group:
A treatment for acne.
Pharmacological properties:
Retinoid for the systemic treatment of acne. Isotretinoin – stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action has not been elucidated erase, however, it found that the improvement in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically confirmed decrease in their size. In addition, the proven anti-inflammatory effect of isotretinoin on the skin. Hyperkeratosis of epithelial cells of hair follicles and sebaceous glands leads to shedding of corneocytes into the prostate gland and duct clogging last keratin and excess sebaceous secretion. This is followed by the formation of comedones and, in some cases, the inflammatory process connection. Erase inhibit proliferation of sebocytes, and acts on acne, restoring the normal process of cell differentiation. Sebum – the main substrate for the growth Rropionibacterium acnes, so the reduction in the formation of sebum inhibits bacterial colonization of the duct.
Pregnancy and breast-feeding
Pregnancy – absolute contraindication to therapy will erase. If pregnancy occurs despite the warnings, during treatment or within one month after completion of therapy, there is a great risk of having a child with severe developmental disabilities. Isotretinoin – a drug with strong teratogenic. If pregnancy occurs during this period, when a woman takes oral isotretinoin (at any dose, even for a short time), there is a great risk of having a child with developmental disabilities. As isotretinoin is highly lipophilic, it is very likely that it passes into breast milk. Because of possible side effects can not be erased prescribe nursing mothers.
Conditions of supply of pharmacies
On prescription.
side effects
Most side effects are dose dependent erase. As a rule, the appointment of the recommended dose and the risk-benefit ratio, taking into account the severity of the disease, it is acceptable to the patient. Usually, side effects are reversible after dose adjustment or discontinuation of the drug, but some may persist after treatment has stopped. Symptoms associated with hypervitaminosis A: dry skin, mucous membranes, including lips (cheilitis), nasal cavity (bleeding), laryngopharynx (hoarseness), eye (conjunctivitis, corneal clouding and reversible intolerance of contact lenses). Skin and appendages: rash, pruritus, facial erythema / dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased proliferation of granulation tissue, persistent hair thinning, reversible hair loss, fulminant form of acne, hirsutism, hyperpigmentation, photosensitivity, photoallergy, easy traumatized skin. Early treatment can occur exacerbation of acne that persists for several weeks. Musculoskeletal system: muscle pain with an increase in serum CK levels, or without it, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, bones other changes tendinitis. Central nervous system and mental health problems: conduct disorder, depression, headache, increased intracranial pressure ( “brain pseudotumor”: headache, nausea, vomiting, blurred vision, swelling of the optic nerve), seizures. Senses: individual cases of violations of visual acuity, photophobia, impaired dark adaptation (decrease in visual twilight vision), rarely – a violation of color (going after drug discontinuation), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, swelling of the optic nerve (as a manifestation intracranial hypertension); hearing loss at certain frequencies. Gastrointestinal tract: nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia higher than 800 mg / dl). Described rare cases of pancreatitis with fatal outcome. Transient and reversible increases in liver transaminases, some cases of hepatitis. In many cases, these changes do not go beyond the limit of normal and returned to baseline performance during the treatment, but in some cases there was a need to reduce the dose or cancel the erase. respiratory system: rarely – bronchospasm (more frequently in patients with bronchial asthma in history). blood system: anemia, reduced hematocrit, leukopenia, neutropenia, an increase or decrease in platelet count, erythrocyte sedimentation rate acceleration. Laboratory findings: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, decrease in high-density lipoprotein, rarely – hyperglycemia. During the reception will be erased have been reported cases of new-onset diabetes. In some patients, particularly those engaged in strenuous described isolated cases increase in serum CK activity. Immune system: local and systemic infections caused by Gram-positive pathogens (Staphylococcus aureus). Others: Lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener’s granulomatosis, hypersensitivity vasculitis), systemic hypersensitivity reactions, glomerulonephritis.
special instructions
Erase must appoint a doctor, preferably dermatologists who have experience in the application of systemic retinoids and knowledgeable about the risk of teratogenicity of the drug. To avoid accidental exposure to the drug in the body of other people, in patients who are or shortly before (1 month) received erase, can not take blood transfusions. It is recommended to control the function of the liver and liver enzymes prior to treatment, within 1 month after the start and then every 3 months or indicated. Observed a transient and reversible increase in liver transaminases, in most cases within the normal range. If the level of liver transaminases above the norm, it is necessary to reduce the dose or cancel it. It is necessary to determine the level of lipids in the serum of fasting before treatment, 1 month after the start and then every 3 months or as indicated. Typically, a lipid concentration normalized after decreasing the dose or discontinuation of the drug, but also with diet. It is necessary to control a clinically significant increase in triglycerides, as they rise above 800 mg / dl or 9 mmol / l can be accompanied by development of acute pancreatitis, possibly with fatal consequences. When resistant hypertriglyceridemia or symptoms of pancreatitis erase should be abolished. In rare cases, patients receiving erase described depression, psychotic symptoms, and very rarely – suicide attempts. Although their causal relationship to the use of the drug has not been established, you must take special care in patients with a history of depression and observe all patients for the occurrence of depression in the course of drug treatment, referring them to a specialist if necessary. However, cancellation of erase can not lead to the disappearance of symptoms and may need further observation and treatment by a specialist. In rare cases, therapy is celebrated at the beginning of the exacerbation of acne, which takes place within 7-10 days without a correction dose. Within a few years after applying the erase for the treatment of dyskeratosis a total course dose and duration of therapy recommended above for the treatment of acne, developed bone changes, including premature closure of the epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. Therefore, when administering the drug to any patient should first thoroughly evaluate the ratio of the potential benefits and risks. Patients receiving erase, it is recommended to use a moisturizing cream or body cream, lip balm to reduce the dryness of the skin and mucous membranes at the beginning of therapy. While taking erase may be pain in muscles and joints, increased creatinine phosphokinase serum, which may be accompanied by a reduction in tolerability intense exercise. Avoid carrying out a deep chemical dermoabrazii and laser treatment in patients receiving erase, as well as within 5-6 months after treatment because of the potential power of scarring in atypical areas and the occurrence of hyper- and hypopigmentation. In the course of treatment will be erased, and for 6 months after hair removal can not be performed with the help of applications of wax due to the risk of detachment of the epidermis, the development of scarring and dermatitis. Because some patients may experience a decrease in the severity of night vision, which sometimes persists after the end of therapy, patients should be informed about the possibility of this state, encouraging them to use caution when driving at night. Status of visual acuity should be carefully monitored. Dryness of the conjunctiva of the eye, corneal opacity, Decreased night vision and keratitis usually disappear after discontinuation of the drug. When the mucous membrane of dry eye can be used application moisturizing eye ointment or preparation of artificial tears. Should be monitored in patients with dryness of the conjunctiva for the possible development of keratitis. Patients complained of vision, should be sent to the ophthalmologist and to consider whether to cancel the erase. Intolerance to contact lenses at the time of therapy should be used glasses. Should limit exposure to the sun and UV rays. If necessary, use a sunscreen with a high shielding factor of not less than 15 SPF. Described rare cases of benign intracranial hypertension ( “brain pseudotumor”) including When combined with use of tetracyclines. These patients should be lifted immediately be erased. In therapy will erase may cause inflammatory bowel disease. In patients with severe hemorrhagic diarrhea should immediately cancel the erase. Described rare cases of anaphylactic reactions that occurred only after prior external application of retinoids. Severe allergic reactions necessitate discontinuation of therapy and careful monitoring of the patient. Patients at high risk (diabetes, obesity, alcoholism or disorders of lipid metabolism) in the treatment of erase may require more frequent laboratory control of glucose and lipid. In the presence of diabetes or suspected, it is recommended more frequent blood glucose determination.
Storage conditions
Store in a dark place at a temperature not higher than 25 ° C.
Dosing and Administration
The standard dosing regimen: inside, during a meal once or twice a day. Erase the therapeutic efficacy and side effects are dose dependent and vary between patients. This necessitates individual adjustment of the dosage during the treatment. Erase treatment should begin with a dose of 0.5 mg / kg per day. In most patients, the dose ranges from 0.5 to 1.0 mg / kg of body weight per day. Patients with very severe disease or torso with acne may require higher daily doses – up to 2.0 mg / kg. It is proved that the frequency of remission and relapse prevention by using optimal course dose of 120-150 mg / kg (per treatment), so the duration of therapy in individual patients varies depending on the daily dose. Complete remission of acne is often possible to achieve at 16-24 weeks of treatment. Patients undergoing very bad the recommended dose, treatment may be continued at a lower dose, but to hold it longer. Most patients with acne disappear completely after a single course of treatment. By explicitly shown relapse re-treatment will be erased at the same daily dose and the exchange rate as the first. As improvement may continue for up to 8 weeks after discontinuation of therapy, a second course should be administered no earlier than the end of this period. Dosing in special cases: patients with severe renal failure treatment should be initiated at a lower dose (e.g. 10 mg / day), and then increased to 1 mg / kg / day or maximum tolerated.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist