Oral route (Capsule, Liquid Filled)
Pregnancy Category XIsotretinoin must not be used by patients who are or may become pregnant.There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time.Potentially any fetus exposed during pregnancy can be affected.There are no accurate means of determining whether an exposed fetus has been affected.Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.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 patient who is taking isotretinoin, isotretinoin must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.Special Prescribing Requirements:Because of the risk of teratogenicity and to minimize fetal exposure, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE (R). Under the isotretinoin REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program .
This medicine is available only with your doctor’s prescription. Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.
Isotretinoin is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines or antibiotics have been tried and have failed to help the acne. Isotretinoin may also be used to treat other skin diseases as determined by your doctor.
Isotretinoin must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Isotretinoin must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for isotretinoin.
This medicine is available only under a registered distribution program called the iPLEDGE™ program.
Isotretinoin comes with a patient information form and Medication Guide. It is very important that you read and understand this information. Be sure to carefully follow these instructions and ask your doctor if you have any questions.
Women of reproductive age must sign up for a pregnancy risk program called iPLEDGE™ in order to receive their isotretinoin prescription each month.
Patients who cannot become pregnant: You should understand the risks and benefits of this medicine, follow the iPLEDGE™ program, and sign a patient consent form before using it.
Patients who can become pregnant: You should not use this if you are or may be pregnant.
Patients who are not pregnant but can become pregnant: You should understand the risks and benefits of this medicine, follow the iPLEDGE™ program, and sign a patient consent form before using it. You should also use effective birth control and check for pregnancy every month.
Be sure to ask your doctor if you have any questions about this program. It is very important that you understand and follow all of the requirements. You will not get another prescription unless you follow the instructions for the program.
Swallow the capsule whole with a full glass (8 ounces) of water or other liquid. Accutane® and its generic products should be taken with food. Absorica® may be taken with or without food. Do not crush, break, chew, or suck the capsule.
It is very important that you take isotretinoin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
It is very important that you not share this medicine with anyone else because of the risk of birth defects and other serious side effects.
Absorica® capsules should not be substituted with other forms of isotretinoin (eg, Accutane®). Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (capsules):
Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 to 1 milligram (mg) per kilogram (kg) of body weight per day, taken as 2 divided doses for 15 to 20 weeks. Your doctor may adjust your dose as needed.
Children younger than 12 years of age—Use and dose must be determined by your doctor.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of Absorica®, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established.
This medicine should be used with caution in teenagers, especially those with bone problems or diseases.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving isotretinoin.
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Alcoholism, severe or
Allergy to aspirin, history of or
Metabolism disorder, family history of or
Severe weight problems—Use with caution. May increase risks for more serious problems.
Anorexia (eating disorder) or
Epiphyseal closure, premature or
Osteomalacia (softening of the bones) or
Osteoporosis (brittle bones), childhood or family history of or
Other bone disorders or diseases—Use with caution. It is not known whether this medicine affects bone loss.
Depression, history of or
Eye or vision problems or
Hearing problems or
Heart disease or
Hypertriglyceridemia (high triglycerides in the blood) or
Liver disease (eg, hepatitis) or
Pancreatitis (swelling of the pancreas) or
Pseudotumor cerebri (swelling in the brain) or
Psychosis (mental illness), history of or
Vitamin A overdose (too much vitamin A in the body)—Use with caution. May make these conditions worse.
Kidney disease or
Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
It is very important that your doctor check your or your child’s progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, check with your doctor right away.
Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant 1 month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.
Isotretinoin must not be taken by women of reproductive age who may become pregnant unless 2 effective forms of birth control have been used for at least 1 month before the start of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure that you have discussed this information with your doctor.
If you are a woman who is able to have children, you must have 2 pregnancy tests before beginning treatment with isotretinoin to make sure you are not pregnant. The second pregnancy test must be taken at least 19 days after the first test and during the first 5 days of the menstrual period immediately before beginning treatment. In addition, you must have a pregnancy test each month while you are using this medicine and 1 month after treatment is completed.
Do not take vitamin A or any vitamin supplement containing vitamin A while using this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop using isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.
You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop using it. This is to prevent a pregnant patient from receiving blood that contains the medicine.
In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive or do anything else that could be dangerous until you know how this medicine affects you. Also, check with your doctor.
Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are using isotretinoin and for up to 2 weeks after stopping it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.
Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.
To help isotretinoin to work properly, use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.
Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.
This medicine may increase pressure in your head, which may lead to vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea, vomiting, or seizures.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may also heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.
It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.
It is very important that you or your child not have any cosmetic procedures to smooth your skin (eg, dermabrasion, laser) while you are using isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.
This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Isotretinoin may cause some people to have hearing problems within a few weeks after they start using it. Check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, redness, soreness, or itching skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine contains FD&C Yellow No.5 (tartrazine) which may cause an allergic reaction, including asthma, in some people. This reaction is more often seen in people who also have an allergy to aspirin.
This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (eg, St. John’s wort) may cause your birth control pills to not work as well.