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Claravis Isotretinoin

Claravis Isotretinoin

What is Claravis?

Claravis is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Claravis is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Claravis is available only from a certified pharmacy under a special program called iPLEDGE.

Claravis may also be used for purposes not listed in this medication guide.

Before taking this medicine

Claravis can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use this medicine if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking Claravis, before each prescription is refilled, right after you take your last dose of isotretinoin, 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 beginning 30 days before you start taking Claravis and ending 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 sexual partner;
  • an IUD (intrauterine device);
  • estrogen-containing birth control pills (not mini-pills); and
  • hormonal birth control patches, implants, injections, or vaginal ring.

How should I take Claravis?

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 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 at one time.

Always take Claravis with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking Claravis with or without food.

Use Claravis 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.

Warnings/Precautions:

Must register patient in iPLEDGE program (see literature for restrictions and stipulations on use). Be fully familiar with drug's toxicity before use. Counsel patient about need for contraception; obtain 2 negative pregnancy tests prior to initiation of drug and monthly thereafter; use 2 effective methods of contraception 1 month before, during, and 1 month after therapy; get written informed consent (see literature). Monitor blood lipids initially and for 1st 4 weeks. History of psychiatric disorders; monitor and discontinue if signs and symptoms develop. Osteoporosis risk (eg, osteomalacia, anorexia nervosa) or risk of metabolic bone disorders. Monitor bone growth, glucose, sed rate, CBC, liver enzymes. Discontinue if visual or auditory disturbances; colitis, pancreatitis or hepatitis symptoms; uncontrolled hypertriglyceridemia, or significant decrease in WBCs occurs. Refer to specialist if papilledema or hearing disturbances occur. Do not donate blood during and for 1 month after therapy. Avoid wax epilation or skin resurfacing during and for 6 months after therapy.

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