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Tretiva®

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Tretiva®

Tretiva® is a medication developed to treat severe forms acne. This is a retinoid treatment with very potent keratolytic and comedolytic properties. Tretiva® capsules are formulated for the use in adults and children over 12 years of age. Read more

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Description

Tretiva® is manufactured by Intas Pharmaceuticals. This is an oral retinoid in the capsule form. Tretiva® is formulated specifically for severe forms of acne, such as recalcitrant nodular acne, acne conglobata, and acne fulminans. The active ingredient of Tretiva® is Isotretinoin, 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 potent comedolytic, keratolityc, sebostatic, and anti-inflammatory agent. It fights acne by making skin less oily and normalizing follicular keratinization (dead epithelial cells built up in the pores). It reduces the size of sebaceous glands (microscopic organs producing skin oil) so it produces less sebum, while removing the residue of old skin cells from the pores. By these actions Isotretinoin indirectly reduces the amount of P. acnes in the skin.

Dosage

Tretiva® 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 Tretiva® at once.

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

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

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

If your acne has not improved after 4-6 weeks of the Tretiva® 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 Tretiva® 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 Tretiva® are:

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

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

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

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

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

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

Do not take Tretiva® 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 Tretiva® for mild or moderate acne.

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

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

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

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

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

Do not take Tretiva® if you have hypervitaminosis A.

Q: What Tretiva® is used for?

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

Q: Is Tretiva® safe for teenagers?

A: Tretiva® 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 Tretiva® be used in pregnant women?

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

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