Amnesteem - Isotretinoin (Oral Route)

    Amnesteem – Isotretinoin (Oral Route)

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    Description and Brand Names of Amnesteem – Isotretinoin (Oral Route)

    US Brand Name

    1. Absorica
    2. Accutane
    3. Amnesteem
    4. Claravis
    5. Myorisan
    6. Sotret

    Descriptions

    Isotretinoin is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines 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 iPLEDGEâ„¢ program.

    Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, isotretinoin is used in certain patients with the following medical conditions:

    • Folliculitis, gram-negative (bacterial infection of the skin on the face beginning near the nose).
    • Hidradenitis suppurativa (sweat gland problem).
    • Rosacea (red skin disorder of the face, usually of the nose and cheeks).
    • Thickened or patchy skin disorders, such as keratosis follicularis, palmoplantar keratoderma, lamellar ichthyosis, or pityriasis rubra pilaris.

    This product is available in the following dosage forms:

    • Capsule
    • Capsule, Liquid Filled

    Before Using Amnesteem – Isotretinoin (Oral Route)

    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:

    Allergies

    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.

    Pediatric

    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.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients may have a greater risk of problems and side effects when taking isotretinoin.

    Pregnancy

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Desogestrel
    • Dienogest
    • Doxycycline
    • Drospirenone
    • Estradiol Cypionate
    • Estradiol Valerate
    • Ethinyl Estradiol
    • Ethynodiol Diacetate
    • Etonogestrel
    • Levonorgestrel
    • Medroxyprogesterone Acetate
    • Mestranol
    • Minocycline
    • Norelgestromin
    • Norethindrone
    • Norgestimate
    • Norgestrel
    • Tetracycline

    Other Interactions

    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.

    • Ethanol

    Other Medical Problems

    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
    • Diabetes 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.
    • Asthma or
    • Depression, history of or
    • Eye or vision problems or
    • Hearing problems or
    • Heart disease or
    • Hepatitis or
    • Hypertriglyceridemia (high triglycerides in the blood) or
    • Intestinal disorders, history of or
    • Pancreatitis (inflammation of the pancreas) or
    • Pseudotumor cerebri (swelling in the brain) or
    • Psychosis, 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.

    Proper Use of Amnesteem – Isotretinoin (Oral Route)

    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 iPLEDGEâ„¢ in order to receive their isotretinoin prescription each month. You can sign up on the internet (www.ipledge.com) or by telephone (1-866-495-0654). 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.

    Isotretinoin must not be taken by women of reproductive age unless two effective forms of contraception (birth control) have been used for at least 1 month before the beginning 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 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 prior to beginning treatment. In addition, you must have a pregnancy test each month while you are taking this medicine and one month after treatment is completed.

    Swallow the capsule whole with a full glass (8 ounces) of water or other liquid. Accutane(R) and its generic products should be taken with food. Absorica(TM) may be taken with or without food. Do not crush, break, or chew 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™ oral capsules should not be substituted with other forms of isotretinoin (e.g., Accutane®). Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

    Dosing

    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):

      • For acne:

        • Adults and teenagers 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, divided and given in 2 doses. Your doctor may adjust your dose as needed.
        • Children younger than 12 years of age – Use and dose must be determined by your doctor.

    Missed Dose

    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.

    Storage

    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.

    Precautions

    It is very important that your doctor check the progress of you or your child 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, stop taking this medicine and 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 one month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least one 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.

    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 (e.g., St. John’s wort) may cause your birth control pills to not work as well.

    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 taking 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 taking 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, use machines, or do anything else that could be dangerous if you are not able to see well. 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 taking isotretinoin and for up to 2 weeks after you stop taking 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 taking this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

    To help isotretinoin work properly, use sunscreen or sunblocking lotions with a skin 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. This may increase your risk of vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea or 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 heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

    Do not take vitamin A or any vitamin supplement containing vitamin A while taking this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

    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 (e.g., dermabrasion, laser) while you are taking 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 taking 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 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.

    Side Effects of Amnesteem – Isotretinoin (Oral Route)

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    1. Bone or joint pain
    2. burning, redness, itching, or other signs of eye inflammation
    3. difficulty moving
    4. nosebleeds
    5. scaling, redness, burning, pain, or other signs of inflammation of the lips
    6. skin infection or rash

    Rare

    1. Abdominal or stomach pain (severe)
    2. attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
    3. back pain
    4. bleeding or inflammation of the gums
    5. blurred vision or other changes in vision
    6. changes in behavior
    7. decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
    8. diarrhea (severe)
    9. headache (severe or continuing)
    10. mental depression
    11. nausea and vomiting
    12. pain or tenderness of the eyes
    13. pain, tenderness, or stiffness in the muscles (long-term treatment)
    14. rectal bleeding
    15. yellow eyes or skin

    Incidence not known

    1. Black, tarry stools
    2. bloating
    3. bloody cough
    4. bloody or cloudy urine
    5. bone pain, tenderness, or aching
    6. burning or stinging of the skin
    7. chest pain
    8. confusion
    9. constipation
    10. convulsions
    11. cough or hoarseness
    12. dark-colored urine
    13. decrease in height
    14. difficulty breathing
    15. difficulty speaking
    16. difficulty swallowing
    17. discharge from the eyes
    18. dizziness
    19. double vision
    20. ear pain
    21. excessive tearing
    22. fainting
    23. fast, irregular, pounding, or racing heartbeat or pulse
    24. fever with or without chills
    25. fractures and/or delayed healing
    26. heartburn
    27. high blood pressure
    28. hives
    29. inability to move the arms, legs, or facial muscles
    30. inability to speak
    31. indigestion
    32. inflamed tissue from infection
    33. irregular yellow patch or lump on the skin
    34. irritation
    35. joint pain, redness, stiffness, or swelling
    36. lack or slowing of normal growth in children
    37. loosening of the fingernails
    38. loss of appetite
    39. loss of bladder control
    40. loss or change in hearing
    41. muscle cramps, spasms, or weakness
    42. pain in the ribs, arms, or legs
    43. pain or burning in the throat
    44. pain or tenderness around the eyes and cheekbones
    45. painful cold sores or blisters on the lips, nose, eyes, or genitals
    46. painful or difficult urination
    47. pains in the chest, groin, or legs, especially calves of the legs
    48. pains in the stomach, side, or abdomen, possibly radiating to the back
    49. pale skin
    50. pinpoint red spots on the skin
    51. redness or soreness around the fingernails
    52. redness, soreness, or itching skin
    53. sensitivity of the eyes to sunlight
    54. shortness of breath
    55. skin rash
    56. sneezing
    57. sores, ulcers, or white spots on the lips or tongue or inside the mouth
    58. stuffy or runny nose
    59. sudden loss of consciousness
    60. sudden loss of coordination
    61. sudden onset of severe acne on chest and trunk
    62. sudden onset of slurred speech
    63. swelling of the eyelids, face, lips, hands, lower legs, or feet
    64. swollen, painful or tender lymph glands in the neck, armpit, or groin
    65. tightness in the chest
    66. unusual bleeding or bruising
    67. unusual weight gain or loss
    68. use of extreme physical or emotional force
    69. watery or bloody diarrhea
    70. wheezing

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    1. Crusting of the skin
    2. difficulty in wearing contact lenses (may continue after medicine is stopped)
    3. dryness of the eyes (may continue after treatment is stopped)
    4. dryness of the mouth or nose
    5. dryness or itching of the skin
    6. headache (mild)
    7. increased sensitivity of the skin to sunlight
    8. peeling of the skin on palms of the hands or soles of the feet
    9. stomach upset
    10. thinning of the hair (may continue after treatment is stopped)

    Incidence not known

    1. Abnormal menstruation
    2. burning, crawling, itching, numbness, prickling, “pins and needlesâ€, or tingling feeling
    3. changes in fingernails or toenails
    4. continuing ringing or buzzing, or other unexplained noise in the ears
    5. dandruff
    6. darkening of the skin
    7. flushing
    8. hair abnormalities
    9. hair loss
    10. increased hair growth, especially on the face
    11. lightening of normal skin color
    12. lightening of treated areas of dark skin
    13. nervousness
    14. oily skin
    15. redness of the face
    16. severe sunburn
    17. skin rash, encrusted, scaly and oozing
    18. stomach burning
    19. sweating
    20. trouble sleeping
    21. unable to sleep
    22. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
    23. unusually warm skin of the face
    24. voice changes

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.