SOTRET (Isotretinoine, Accutane) - is used to treat acne including severe type. You should discuss the benefits and risks with your dermatologist. Severe acne can be difficult to treat. When other treatments fail to clear the skin, isotretinoin may be an option. Treatment with isotretinoin often results in prolonged clearance of acne, which can be permanent for some patients. Isotretinoin (13-cis retinoic acid) is a vitamin-A derivative (retinoid). The liver naturally makes small quantities of isotretinoin from vitamin-A. Isotretinoin was developed in the 1950s, but only started being used in the mid 1970s. The original brand names were Accutane® and Roaccutane®.
USES
GUARANTEE & EXPIRY DAY
100% original from the Indian Sun Pharmaceutical Industries Ltd or Runbaxy Laboratories Ltd.
All packs are air tight sealed and expire up to 03.2026.
DESCRIPTION
Treatment with isotretinoin often results in prolonged clearance of acne, which can be permanent for some patients. A course of treatment generally lasts about 4 to 5 months. It can run shorter or longer.
Some patients do not clear after one course of treatment, and a second course of treatment may be an option. Studies show this helps some patients see clear skin. You should wait at least 8 weeks between treatments. The skin often continues to clear for a while after patients stop taking the medicine.
SIDE EFFECTS
Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety, thoughts of suicide), tingling feeling in the skin, back/joint/muscle pain, signs of infection (e.g., fever, persistent sore throat), painful swallowing, peeling skin on palms/soles.
Isotretinoin may rarely cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor right away if you develop: severe stomach pain, severe or persistent nausea vomiting.
Stop taking this medication and tell your doctor right away if you develop these unlikely but very serious side effects: severe headache, vision changes, ringing in the ears, hearing loss, chest pain, yellowing eyes skin, dark urine, severe diarrhea, rectal bleeding.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS
Women who are pregnant must not use isotretinoin.
Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), mental/mood problems (such as depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density).
Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.
PACKAGE & DOSAGE
Sotret comes in 10 or 20 mg tablets. The pack contains 30 tablets.
Active ingredient: Iinoine 10 or 20 mg.
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, refined soybean oil - 100.944 mg.
Gelatin capsule: gelatin -56.00 mg, glycerol - 29.277 mg, iron dye red oxide - 0.0325 mg, titanium dioxide - 0.190 mg, purified water - q.s., light liquid paraffin * - q.s., isopropanol * - q.s. * The solvent is not present in the final product, it evaporates during the production process.
Standard dosage regimen: orally, with meals, once or twice a day.
The therapeutic efficacy of Sotret and its side effects depend on the dose and vary from patient to patient.
Sotret treatment should be started with a dose of 0.5 mg per kg of body weight per day. In most patients, the dose ranges from 0.5 to 1.0 mg per kg of body weight per day. Patients with very severe forms of acne may require higher daily doses - up to 2.0 mg / kg.
It has been proven that the frequency of remission and prevention of relapses are optimal when using a course dose of 120-150 mg / kg (for a course of treatment), therefore, the duration of therapy in specific patients varies depending on the daily dose. Complete remission of acne is often achieved within 16-24 weeks of treatment. In patients who poorly tolerate the recommended dose, treatment can be continued at a lower dose, but it should be continued for longer.
In most patients, acne disappears completely after a single course of treatment. In case of a clear relapse, a repeated course of treatment with Sotret is shown in the same daily and course dose as the first one. Since the improvement can last up to 8 weeks after discontinuation of the drug, a second course should be prescribed no earlier than the end of this period.
STORAGE
Store the medication at normal room temperature in a dry place. It is necessary to preserve the drug in its original packing, away from heat. If the capsules stick to each other due to heat or were destroyed, the product should not be taken. Throw away cracked or leaking medication.
QUESTIONS
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