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About Sotret®

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Description

Sotret® is manufactured by Sun Pharma. This is an oral treatment for recalcitrant nodular acne (also called nodulocystic or cystic acne), acne conglobata, and acne fulminans. Sotret® capsules should be used in patients who failed to respond to safer acne treatments, including oral antibiotics. The active substance comprised in Sotret® is Isotretinoin, a first-generation anti-acne retinoid, derivative of vitamin A.

Indications:

- severe acne vulgaris (cystic, nodulocystic or recalcitrant nodular acne), characterized by red painful bumps, cysts, nodules with a diameter of 5 mm or greater, and painful lesions beneath the skin. It occurs if skin produces too much sebum and pores get clogged, as the acne-causing bacteria P. acnes (Propionibacterium acnes) proliferate inside of a clogged pore.

- acne conglobata, characterized by abscesses and draining sinus tracts in addition to nodulocystic acne symptoms.

- acne fulminans, that develops after an unsuccessful treatment of acne conglobata and is much harder to treat due to its unresponsiveness to the variety of medications.

MOA (mechanism of action):

Isotretinoin has strong comedolytic, keratolityc, sebostatic, and anti-inflammatory properties. It cures acne by suppressing skin oil secretion and follicular hyperkeratinization (overabundance of the dead epithelial cells in the pores). Isotretinoin reduces the size of sebaceous glands (microscopic organs producing skin oil) and exfoliates the dead skin cells from the pores. By these actions Isotretinoin indirectly reduces the amount of P. acnes in the skin.

Dosage

Sotret® capsules are swallowed whole and taken with food.

The treatment duration is between 16-24 weeks depending on the severity of condition and tolerance.

The daily intake should be divided in two doses.

For adults and children over 12 years:

The recommended starting dose: 0,5-1,0 mg per kg of body weight a day. After a few weeks the dose should be adjusted by the doctor.

For patients with severe kidney problems: 10 mg a day. After a few weeks the dose should be adjusted by the doctor.

For severe skin condition: 2,0 mg per kg of body weight a day as tolerated.

Precautions

Never exceed the doctor’s recommended dose.

Do not adjust the dose without your doctor’s approval.

Do not take your daily dose of Sotret® at once.

If you notice any of the more serious side effects, stop taking Sotret® immediately and seek medical advice.

Women of child-bearing potential must not get pregnant 1 month before starting the Sotret® treatment course, during it, and 1 month after stopping the course.

Your acne may get worse during the first week of the Sotret® treatment course. This does not mean you should stop taking Sotret®. Your skin condition will most likely improve with continuous treatment.

If your acne has not improved after 4-6 weeks of the Sotret® treatment, seek medical advice.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not apply a double dose.

Overdose

Do not exceed the doctor's recommended dose. The symptoms of Sotret® overdose may include vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. If any of these occurs and you are feeling unwell, you should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at a room temperature from 20 and 25 degrees C (68 and 77 degrees F) away from moisture and heat. Throw away the tube after the expiration date. Keep away from children.

Side effects

The most common side effects associated with the use of Sotret® are:

  • dry skin
  • chapped lips
  • dry eyes
  • dry nose and nosebleeds

Less common but much more serious side effects of Sotret® are:

  • serious allergic reactions (hives, difficulty breathing, swelling of the face or mouth, fever, rash)
  • mental health problems (depression, psychosis, etc.)
  • brain problems (bad headache, blurred vision, dizziness, nausea or vomiting, seizures, stroke)
  • abdomen problems (severe stomach, chest or bowel pain, trouble swallowing, heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, dark urine)
  • bone and muscle problems (back pain, joint pain, muscle weakness, broken bone)
  • hearing and vision problems
  • blood sugar problems
  • raise of fats and cholesterol in blood

Side effects occurrence does not only depend on the medication you are using, but also on your overall health and other factors.

Contraindications

Do not take Sotret® if you are allergic to Isotretinoin.

Do not take Sotret® if you have a history of severe allergic reactions associated with the use of retinoids or Vitamin A.

Do not take Sotret® if you are allergic to any of the other ingredients comprised in Sotret®.

Do not take Sotret® if you are allergic to peanut or soya.

Do not take Sotret® if you have mental problems, asthma, liver disease, diabetes, heart disease, osteoporosis or eating disorder (anorexia nervosa).

Do not take Sotret® if you are taking any acne medications (benzoyl peroxide, adapalene, sulfur, salicylic acid), antihistamines (azelastine), Vitamin A, corticosteroids (fluticasone, beclomethasone), antibiotics (clindamycin, erythromycin, tetracyclines), antipruritics (cholestyramine), diarrhea drugs (colestipol), obesity drugs (orlistat), photosensitizing agents (porfimer, verteporfin), antidepressants (hypericum perforatum) or anticoagulant (warfarin).

Do not take Sotret® for mild or moderate acne.

Sotret® is strictly prohibited in women who are pregnant, plan to have a baby or are breastfeeding.

Do not use Sotret® in patients under 12 years of age.

Do not drive or operate machinery at night while using Sotret®, as it decreases night vision.

Do not take Sotret® if you have very high levels of cholesterol or triglycerides in your blood.

Do not take Sotret® if you are overweight or addicted to alcohol.

Do not take Sotret® if you have hypervitaminosis A.

Q: What Sotret® is used for?

A: Sotret® is used to treat severe acne vulgaris, acne conglobata, and acne fulminans.

Q: Is Sotret® safe for teenagers?

A: Sotret® is considerably safe for the use in patients over 12 years of age, as long as used for prescribed condition and at prescribed doses.

Q: Can Sotret® be used in pregnant women?

A: Sotret® is strictly prohibited in women who are pregnant, plan to have a baby or are breastfeeding.

Target Point Shipping Method Tracking Delivery Time Price
Worldwide shipping

Worldwide shipping

Registered Mail  Not trackable 14-21 business days USD 20.00 per order
EMS  Trackable, where available 5-9 business days USD 30.00 per order

Delivery time is:

Registered Mail - 14-21 business days, price - USD 20.00, no signature is required on delivery.
EMS - 5-9 business days, price - USD 30.00, signature is required on delivery.
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