Used to treat:

• Severe Cystic Acne (nodular acne)

General Directions for Taking Medication:

• Read the medication guide provided with this medication, ask your doctor questions, and complete a patient consent form prior to starting medication.
• Take only as directed. Changing the dose may worsen side effects and condition.
• Take the dose with food. DO NOT chew or crush capsules.
• If you miss a dose, take the medicine as soon as you remember. If it is time for your next dose, take only 1 dose. DO NOT double up the doses.
• DO NOT stop taking this medicine without talking to your doctor first. Your symptoms may worsen initially, but then start to improve with additional doses.
• Use sunscreen and wear protective clothing when outdoors in direct sunlight and avoid ultraviolet light sources such as tanning beds. This medicine may increase your skin’s sensitivity to ultraviolet light.
• See your eye doctor regularly if you wear contact lenses. Your eyes may become more sensitive to contact lenses during treatment.
• See your doctor regularly to monitor the effectiveness of this medication with routine blood lab tests and a physical exam.
• Females:
• DO NOT take this medicine if you are pregnant or if you are planning on becoming pregnant while taking this medicine.
• Continue to practice acceptable forms of birth control (2 types) for 1 month after you stop taking this medicine.
• Your physician will usually order 2 pregnancy tests prior to starting treatment. One of the tests must be done either on the 2nd day after your next period or 11 days after your last sexual intercourse without using birth control.
• You will be required to get a pregnancy test EVERY time prior to getting a refill.
• You must use 2 forms of acceptable birth control at least 1 month prior to taking this medicine, during treatment, and for 1 month after stopping this medicine. Talk to your doctor about which birth control option is best for you.
• If you take mini pills (low dose of progesterone) for birth control, talk to your doctor BEFORE taking this medicine. This medicine may decrease the effectiveness of this birth control pill.

Contraindications:

• Allergies - Hypersensitivity to this medication, or its other components
• Pregnancy - May cause birth defects, miscarriage, premature birth, or death of the baby. Talk to your doctor about risks and benefits
• Breast Feeding - Enters breast milk. May cause harm to baby. DO NOT breast feed while taking this medicine or for 1 month after stopping the dose.
• Children
• Patients with depression, psychosis, or suicidal thoughts
• Female patients who are of childbearing age, who are sexually active, and who will not use 2 forms of acceptable birth control
• Use with caution in:
• Female patients of childbearing age
• Patients who have diabetes, liver disease, intestinal disease, vision problems, bleeding or clotting disorders, or high cholesterol levels.
• Patients who drink alcoholic beverages and who are blood donors.
• Patients who are obese.

Common Side Effects:

• May occur during the first few days after beginning therapy, but usually resolve:
• Cheilitis (lip inflammation); dry mouth, lips; dry, irritated eyes; bone, joint or muscle pain, dry nose, nosebleeds, an intolerance to contact lenses, nausea, vomiting, stomach ache, changes in appetite, headache, skin sensitivity to sunlight

Serious Side Effects:

• Notify your doctor immediately if you experience any of the following:
• Severe abdominal pain; bowel pain; diarrhea; rectal bleeding; jaundice (yellowing of the skin and eyeballs); dark urine; ringing in your ears or hearing loss (may become permanent); vision problems (sudden loss of night vision); fainting; frequent urination and thirst (varying blood sugar levels); muscle weakness, convulsions, or slurred speech
• Pseudotumor cerebri - Severe headache, blurred vision, dizziness, nausea and vomiting. This may indicate increased pressure in the brain.
• Mental problems - Depression; suicidal thoughts; loss of appetite; feelings of sadness, irritability, fatigue; problems with concentration; withdrawal from family and friends; and difficulty with sleeping
• Female Patients - Birth defects, premature births, and death in babies
• Allergic reaction symptoms such as a red skin rash; itching; swelling of the face, lips, tongue, and throat; wheezing; chest pain; and difficulty breathing

Interactions:

• Drug - There are many medications, both over-the-counter and prescription, which will alter the action of this medication. Some include antibiotics such as Tetracycline, anti-seizure medications such as carbamazepine (Tegretol), and vitamin A supplements.
• It is extremely important that you consult with your doctor about dosing schedules if you take a variety of medications along with this medication.
• DO NOT take any new medication without talking with your doctor first.

Warnings:

• Overdose - Can lead to worsening of side effects, including abdominal pain, dizziness, lip inflammation, facial flushing, headache and vomiting
• Female patients should not get pregnant. If you suspect that you might be pregnant, STOP taking this medicine and see your doctor as soon as possible!
• DO NOT donate blood while taking this medicine or for 1 month after stopping. If a pregnant woman receives this blood, there is a risk that the baby may suffer birth defects.
• DO NOT take vitamin A supplements. This may increase side effects.
• DO NOT take this medicine with antibiotics unless directed by your doctor. Concurrent use may increase side effects such as increased pressure in your brain.
• DO NOT share this medication with anyone.
• DO NOT have any cosmetic procedures such as waxing, dermabrasion, or laser procedures while you are taking this medicine or for 6 months after stopping. This medicine may increase the risk of scarring from these procedures.
• Avoid alcoholic beverages while taking this medication. May worsen side effects.
• STOP taking this medicine and notify your doctor if you develop symptoms of depression, severe diarrhea, or if you are diabetic and notice varying blood sugar levels.
• Keep this medication and all others out of reach of children and pets.

General Dosage Information:

Storage:

• Keep at room temperature.
• Protect from sunlight and moisture.
• DO NOT store in the bathroom.