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Sotret

Isotretinoin

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Description | Uses & Side Effects | Warnings

There is currently no information to display in this section. RateADrug provides information about drugs and supplements though a wiki format provided by researchers, health care providers and others. We encourage you to add to this description by clicking on the button below.

Common Uses:

This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

Off Label Uses:

Currently there are no known off label uses for Sotret

Side Effects:
The side effects of Sotret are
• Sotret can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What
is the most important information I should know about Sotret?”
• Sotret may cause serious mental health problems. See “What is the most important information I should know about Sotret?”
• serious brain problems. Sotret can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking
Sotret and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea or vomiting
• seizures (convulsions)
• stroke
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas,
bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking
Sotret. Stop taking Sotret and call your doctor if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine
• bone and muscle problems. Sotret may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard
physical activity during treatment with Sotret. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Sotret if you break a bone.
Stop Sotret and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Sotret may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Sotret and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• vision problems. Sotret may affect your ability to see in the dark. This condition usually clears up after you stop taking Sotret, but it may be permanent.
Other serious eye effects can occur. Stop taking Sotret and call your doctor right away if you have any problems with your vision or dryness of the eyes that
is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Sotret and after treatment.
• lipid (fats and cholesterol in blood) problems. Sotret can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to
your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Sotret treatment is finished.
• serious allergic reactions. Stop taking Sotret and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing.
Stop taking Sotret and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Sotret may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
• The common, less serious side effects of Sotret are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get
any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Sotret. Your doctor or pharmacist can give you more detailed information. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cautions / Warnings:

Sotret is not recommended for female patients who are already or considering becoming pregnant. Risks invovled include severe birth defects if pregnancy occurs while taking Sotret or isotretinoin capsules in any amount, even for short periods of time. Chances are any fetus exposed to Sotret or isotretinoin during pregnancy can be affected.

Birth defects which have been documented following Sotret or isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Risks also include spontaneous abortion, and premature births.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking iSotretinoin capsules, iSotretinoin capsules must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Drug Interactions:
It is advisable to inform your physician regarding all prescription and nonprescription drugs you may use, especially of: vitamin A-type drugs (including etretinate and vitamin A itself), tetracyclines (e.g., minocycline), drugs which cause bone loss (e.g., phenytoin, corticosteroids such as prednisone). Avoid use of St John's wort or any other product/drug which may decrease the effectiveness of birth control pills.

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About Sotret

The generic name of Sotret is isotretinoin Active Ingredients: Isotretinoin. Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. Due to isotretinoin’s teratogenicity and in an attempt to reduce fetal exposure, Sotret is approved for marketing only under certain terms and conditions approved by the FDA and this feature is referred to as iPLEDGE. Therefore, Sotret can be prescribed by only those who are registered and activated with the iPLEDGE program. Similarly Sotret can be dispensed by pharmacies that are registered and activated with iPLEDGE. Again, Sotret can be dispensed only to patients who are registered and meet all the requirements of iPLEDGE.

About Isotretinoin

Isotretinoin (INN) (IPA) is a medication used for the treatment of severe acne. It is sometimes used in prevention of certain skin cancers. It is a retinoid i.e. it is derived from vitamin A and is found in small quantities naturally in the body. Oral isotretinoin is marketed under various trade names, most commonly Accutane (Roche), Amnesteem (Mylan), Claravis (Barr), Sotret (Ranbaxy), or Roaccutane (Roche) or NetLook (Delta Pharma) while topical isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel).

Source: Wikipedia

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