Isotretinoin (Eqv-Absorica)

Isotretinoin (Eqv-Absorica) is a type of vitamin A used to treat severe nodular acne that has not improved with other treatments, including antibiotics.

Isotretinoin (Eqv-Absorica) can only be obtained from a certified pharmacy through a special program called iPLEDGE.

Isotretinoin (Eqv-Absorica) may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of Isotretinoin (Eqv-Absorica) must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of Isotretinoin (Eqv-Absorica) at one time.

Always take Isotretinoin (Eqv-Absorica) with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking Isotretinoin (Eqv-Absorica) with or without food.

Use Isotretinoin (Eqv-Absorica) for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Isotretinoin (Eqv-Absorica) in just a single dose can cause severe birth defects or death of a baby. Never use Isotretinoin (Eqv-Absorica) if you are pregnant or able to become pregnant.

You must have a negative pregnancy test before taking Isotretinoin (Eqv-Absorica). You will also need to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using Isotretinoin (Eqv-Absorica) and call your doctor right away if you think you might be pregnant.

Isotretinoin (Eqv-Absorica) can cause miscarriage, premature birth, serious birth defects, or death of a baby if a mother takes this medicine during conception or pregnancy. Even a single dose of Isotretinoin (Eqv-Absorica) can lead to significant birth defects in the baby's ears, eyes, face, skull, heart, and brain. Never use Isotretinoin (Eqv-Absorica) if you are pregnant or can become pregnant.

For Women: Unless you have had a total hysterectomy (removal of the uterus and ovaries) or have been in menopause for at least 12 consecutive months, you are considered able to get pregnant. You must have 2 negative pregnancy tests before starting Isotretinoin (Eqv-Absorica), before each prescription refill, right after your last dose of Isotretinoin (Eqv-Absorica), and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control starting 30 days before you begin taking Isotretinoin (Eqv-Absorica) and continuing for 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

• tubal ligation (tubes tied);
• vasectomy of the male partner;
• an IUD (intrauterine device);
• estrogen-containing birth control pills (not mini-pills); and
• hormonal birth control patches, implants, injections, or vaginal rings.

Secondary forms of birth control include:

• a male latex condom with or without spermicide;
• a diaphragm plus spermicide;
• a cervical cap plus spermicide; and
• a vaginal sponge containing spermicide.

Stop using Isotretinoin (Eqv-Absorica) and call your doctor immediately if you have unprotected sex, stop using birth control, have a late period, or think you might be pregnant. If you become pregnant while taking Isotretinoin (Eqv-Absorica), call the iPLEDGE pregnancy registry at 1-866-495-0654.

Not having sexual intercourse (abstinence) is the most effective way to prevent pregnancy.

You should not use Isotretinoin (Eqv-Absorica) if you are allergic to it.

Tell your doctor if you have ever had:

• depression or mental illness;
• asthma;
• liver disease;
• diabetes;
• heart disease or high cholesterol;
• osteoporosis or low bone mineral density;
• an eating disorder like anorexia;
• a food or drug allergy; or
• an intestinal disorder like inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for anyone younger than 12 years old.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Isotretinoin (Eqv-Absorica) and call your doctor immediately if you experience:

• problems with your vision or hearing;
• muscle or joint pain, bone pain, back pain;
• increased thirst, increased urination;
• hallucinations (seeing or hearing things that are not real);
• symptoms of depression--unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• severe stomach problems--severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or
• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects of Isotretinoin (Eqv-Absorica) may include:

• dryness of your skin, lips, eyes, or nose (you may have nosebleeds);
• vision problems;
• headache, back pain, joint pain, muscle problems;
• skin reactions; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.

Do not donate blood while taking Isotretinoin (Eqv-Absorica) and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of Isotretinoin (Eqv-Absorica).

While you are taking Isotretinoin (Eqv-Absorica) and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Isotretinoin (Eqv-Absorica) could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid driving or hazardous activity until you know how Isotretinoin (Eqv-Absorica) will affect you. Isotretinoin (Eqv-Absorica) may impair your vision, especially at night.

Tell your doctor about all your other medicines, especially:

• phenytoin;
• St. John's wort (may make birth control pills less effective);
• vitamin or mineral supplements;
• progestin-only birth control pills (mini-pills, may not work as well when taken with Isotretinoin (Eqv-Absorica));
• steroid medicine; or
• a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may affect Isotretinoin (Eqv-Absorica), including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.