$47.00

ACITRETIN

(Also Known As: SORIATANE)

Patient information is usually provided with acitretin. Read it carefully before using this medicine.

Take acitretin with a main meal or with a glass of milk.

For women This medicine may cause birth defects . To make sure you are not pregnant before beginning treatment, your doctor will ask you to:

• Use two effective forms of birth control (contraception) for at least 1 month before beginning treatment.
• Report when your menstrual periods are normal .
• Take a pregnancy test within 1 week before beginning the treatment to make sure you are not pregnant.
• Begin your acitretin treatment on Day 2 or Day 3 of your next menstrual period.
• Sign a paper to show that you understand the importance of not becoming pregnant for at least 2 to 3 years after you stop taking this medicine, according to the advice of your doctor.

Dosing

Take acitretin with food. Taking with food is important for getting the right amount of medicine out of your stomach.

The dose of acitretin 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 acitretin. If your dose is different, do not change it unless your doctor tells you to do so.

It is important that you do not share this medicine with anyone else because of the risk of birth defects and other serious side effects.

The number of tablets 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 taking acitretin.

• For oral dosage form (tablets):
  • For severe psoriasis:
    • Adults 25 to 50 milligrams (mg) a day as a single dose. After four weeks, your doctor may increase your dose depending on how well this medicine is working for you
    • Children Use and dose must be determined by your doctor.
  • For other severe skin disorders (such as bullous or nonbullous erythroderma, lamellar ichthyoses, and keratosis follicularis):
    • Adults 25 milligrams (mg) a day. After four weeks, a dose of 10 to 75 mg a day is used.
    • Children Use and dose must be determined by your doctor.

Missed dose

Take the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you have any questions about this, check with your doctor.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 acitretin, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual reaction to acitretin, etretinate, isotretinoin, tretinoin, or vitamin Alike preparations, including vitamin A supplements. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet Make certain your health care provider knows if you are on any special diet, such as a low-sodium, low-cholesterol, or low-sugar diet. Discuss with your doctor how often you drink alcohol, even if it is only an occasional drink.

Pregnancy Acitretin must not be taken during pregnancy. It has been shown to cause serious birth defects and other problems in humans.

Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Beginning at least 1 month before you start to take acitretin, you should plan on using two effective forms of birth control to prevent pregnancy. In addition, since it is not known how long pregnancy should be avoided after treatment stops, you should plan not to become pregnant for at least 2 or 3 years after you stop taking acitretin or as directed by your doctor. If you become pregnant, stop taking the medicine and tell your doctor.

Breast-feeding It is not known whether acitretin passes into the breast milk. However, use of acitretin should not be used during breast-feeding because it may cause unwanted effects in nursing babies. You also should plan not to breast-feed for at least 2 or 3 years after you stop taking acitretin.

Children This medicine has been tested in some children and has been shown not to cause different side effects or problems in children than it does in adults. However, children may be more sensitive to some of the medicine's effect on bones, which may prevent normal bone growth during puberty. This can cause them to grow up to be shorter adults than expected. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Older adults This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, some older patients may have higher levels of the medicine in the blood stream as compared to younger adults, and they may be more sensitive to its effects. This may increase their chance of developing side effects during treatment.

Other medicines 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 acitretin, it is especially important that your health care professional know if you are taking any of the following:

• Alcoholic beverages Drinking alcohol may convert acitretin to a much longer-acting product that can stay in the body 60 times longer than acitretin does. This may result in a greater chance of developing side effects for months or years, depending on how much and how often one drinks. This unusual effect can occur even after you stop taking acitretin, especially for the first 2 months after you stop taking this medicine

• Cyclosporine (e.g., Sandimmune or Neoral) or
• Phenytoin (e.g., Dilantin) Acitretin may increase the effects of this medicine

• Etretinate (e.g., Tegison) or
• Isotretinoin (e.g., Accutane) or
• Tretinoin (oral) (e.g., Vesanoid) or
• Tretinoin (topical) (e.g., Avita, Renova, or Retin A) or
• Vitamin A, including vitamin supplements Etretinate, isotretinoin, and tretinoin are not used together with acitretin; problems in skin, vision, and bone may be more likely to occur when they are used at the same time. If vitamin A is taken with acitretin, the dose of vitamin A should not exceed the minimum recommended daily allowance (RDA)

• Methotrexate (e.g., Rheumatrex, Trexall) Should not be used with acitretin

• Oral contraceptives, progestin-only or mini pills (birth control pills) (e.g., Micronor, Nor-QD, Ovrette) Acitretin may prevent progestin-only oral contraceptives from working properly and may result in an unplanned pregnancy. This does not occur with oral contraceptives containing both estrogens and progestins

• Tetracyclines (demeclocycline [e.g., Declomycin], doxycycline [e.g., Doxycin] minocycline [e.g., Minocin] oxytetracycline [e.g., Terramycin] tetracycline [e.g., Symycin]) Should not be used with acitretin

• Diabetes mellitus (sugar diabetes) or
• High cholesterol or triglycerides, uncontrollable (or history of) or
• Inflammation of pancreas (or history of) Acitretin may make these conditions worse or increase cholesterol or triglyceride problems

• Hypervitaminosis A (or history of) If you have past or current problems with toxic symptoms from vitamin A, acitretin may increase the chance that they will occur again

• Kidney disease, severe or
• Liver disease, severe May cause acitretin to stay in the body for a longer period of time and increase the chance of side effects