About Isotroin®

Description

Isotroin® is manufactured by Cipla. This is a medication for severe forms of acne, such as recalcitrant nodular acne, acne conglobata, and acne fulminans. Isotroin® should be used in patients who failed to cure acne with milder treatments, including systemic antibiotics. The active ingredient of Isotroin® is Isotretinoin. This is a first-generation retinoid and 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 is a strong comedolytic, sebostatic, keratolytic, and anti-inflammatory agent. It destructs acne pathogenesis by normalizing keratinization and reducing sebaceous glands in size, thereby decreasing sebum (skin oil) secretion. When skin gets less oily and the dead skin cells residue peels off the pores, P. acnes bacteria loose the positive environment to proliferate in.

Dosage

Isotroin® capsules are swallowed whole and taken with food.

The treatment duration is between 15-20 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 Isotroin® at once.

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

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

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

If your acne has not improved after 4-6 weeks of the Isotroin® treatment course, 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 Isotroin® 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 Isotroin® are:

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

Less common but much more serious side effects of Isotroin® 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 Isotroin® if you are allergic to Isotretinoin.

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

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

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

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

Do not take Isotroin® 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), epilepsy drugs (phenytoin) or anticoagulants (warfarin).

Do not take Isotroin® for mild or moderate acne.

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

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

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

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

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

Do not take Isotroin® if you have hypervitaminosis A.

Q: What is Isotroin®?

A: Isotroin® is a retinoid treatment for severe forms of acne.

Q: Is Isotroin® safe?

A: Isotroin® is considerably safe as far as used for prescribed condition and at prescribed doses.

Q: Is it safe to use Isotroin® in pregnant women?

A: Isotroin® is strcictly prohibited for women who are pregnant, planning to have a baby or breastfeeding.

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