Absorica (Isotretinoin)

Sun Pharmaceutical Industries Inc

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Miscellaneous Antineoplastics

Acne

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. This medication may also be used to treat a certain type of cancer (neuroblastoma).

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. The dosage is based on your medical condition, weight, and response to treatment. 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.

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. Tell your doctor right away 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 rarely cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor right away if you develop: severe stomach pain, severe or persistent nausea/vomiting. Stop taking this medication and tell your doctor right away 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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: tetracyclines (e.g., minocycline, tetracycline), vitamin A-type drugs (e.g., acitretin, bexarotene), vitamin A, drugs that cause bone loss (e.g., anti-seizure drugs such as phenytoin, corticosteroids such as prednisone). Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. (See also Warning section.)

Symptoms of overdose may include: vomiting, stomach pain, facial flushing, headache, loss of balance. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 59-86 degrees F (between 15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines out of reach of children and pets.