isotretinoin - oral, Absorica, Accutane, Amnesteem, (cont.)
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.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using isotretinoin and each time you get a refill. Read and sign a Patient Information/Informed Consent form before you start taking this medication. If you have any questions about isotretinoin, consult your doctor or pharmacist before taking the medication.Swallow capsules whole. Do not crush or chew them. Isotretinoin is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of isotretinoin state that it should be taken with meals. However, the FDA has indicated that the Absorica brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it.Dosage is based on your medical condition and response to therapy.Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of isotretinoin. Do not take more than the recommended dose.
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 immediately if you have any of these unlikely but serious side effects: mental/mood changes (e.g., depression, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling feeling in the skin, quick/severe sunburn (sun sensitivity), back/joint/muscle pain, signs of infection (e.g., fever, persistent sore throat), painful swallowing, peeling skin on palms/soles.Isotretinoin may infrequently cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting.Stop taking this medication and tell your doctor immediately 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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