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Sotret

Generic name: isotretinoin oral [EYE-sotret-i-noyn]

Brand names include: Absorica (oral), Absorica LD (oral), Accutane (oral), Amnesteem (oral), Claravis… Show all nine brands

Drug Classes: Other antineoplastics Uncategorized Agents

What is Sotret?

Sotret, a vitamin A form, is used for severe nodular acne that hasn't responded to any other treatment. This includes antibiotics. Sotret can only be purchased from a pharmacy that is certified under the ipledge program. Sotret can be used in other ways not mentioned in this guide.

Side effects of Sotret

If you experience symptoms of an allergic response (hives or difficulty breathing, swelling on your face or in your throat) or a severe reaction to the skin (fever or sore throat with burning eyes or skin, blistering or peeling skin, or red or purple skin rash), seek emergency medical attention.

Sotret may cause serious side effects. Call your doctor immediately if:

  • You may have problems with your hearing or vision.
  • Back pain, joint or muscle pain, muscle or bone pain
  • Increased thirst leads to increased urination.
  • Hallucinations (the experience of seeing or hearing something that is not real)
  • Symptoms of depression include mood swings, tears, low self-esteem, loss of interest in activities you used to enjoy, sleep disturbances, and thoughts of harming yourself.
  • If you have liver or pancreas issues, look out for the following symptoms: nausea, vomiting, rapid heart rate (yellowing skin or eyes), and dark urine.
  • Severe stomach problems: severe abdominal pain or chest pain; pain when swallowing; heartburn; diarrhea; rectal bleeding or bloody or tarry stool.
  • Increased pressure in the skull can cause severe headaches, ringing ears, dizziness, and nausea, as well as vision problems and pain behind the eyes.

Sotret can cause the following side effects:

  • Dryness of the skin, lips, eyeballs, or nose;
  • Vision problems
  • Headache, back pain, joint pain, muscle problems;
  • Skin reactions
  • Cold symptoms like stuffy noses, sneezing, and sore throats.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Warnings

Sotret can be fatal to a newborn if taken in a single dose. Use Sotret only if you're not pregnant or are able to get pregnant.

Before taking Sotret, you must perform a pregnancy test and get a negative result. While taking Sotret, you will be required to use birth control. If you suspect that you are pregnant, stop using this medication and contact your doctor immediately.

Before you take this drug

Sotret may cause miscarriage or premature birth. It can also cause severe birth defects in the ears, eyes, and face of a child. Do not use this medication if you're pregnant or planning to get pregnant.

For women: If you have not had your uterus or ovaries removed (total surgery including oophorectomy) or if you have been in menopause for at least 12 consecutive months, you can be considered able to become pregnant. Before you begin taking Sotret and before every prescription refill, you must perform two negative pregnancy tests. You should also repeat the test 30 days after your last dose. The ipledge Program requires all pregnancy tests.

You must agree to two forms of birth control in writing, starting 30 days before taking Sotret. This agreement will end 30 days after the last dose. Primary and secondary birth control methods must be used in conjunction.

The primary forms of contraception include:

  • Tubal ligation (tubes tied);
  • Vasectomy is the removal of the male partner from a sexual relationship.
  • An IUD (intrauterine device);
  • Birth control pills that contain estrogen but not mini-pills
  • Vaginal rings, patches, injections, or hormonal birth control implants.

Other forms of contraception include:

  • A male latex condom that contains or does not contain spermicide
  • A diaphragm and a spermicide
  • A cervical cap and a spermicide
  • A vaginal sponge that contains a spermicide.

If you are having unprotected sexual activity, have stopped using birth control, or your period is delayed, you should stop using Sotret immediately and contact your doctor. Call the ipledge registry at 1-866-495-0654 if you become pregnant while taking Sotret.

Abstinence (no sexual activity) is the best way to prevent pregnancy. If you have an allergy to Sotret, then it is best not to use the product.

Inform your physician of any of the following issues:

  • Depression or mental illness
  • Asthma;
  • Liver disease
  • Diabetes;
  • Heart disease, or high blood cholesterol.
  • Osteoporosis, or low bone mineral densities;
  • An eating disorder, such as anorexia.
  • A food or drug allergy;
  • An intestinal disorder such as ulcerative colitis.

Breastfeeding is not recommended. No one under the age of 12 is allowed to use this product.

How to take Sotret?

Read and follow all instructions or guides included with your medication. Follow the directions on the label. You must fill out each prescription within seven days from the date your doctor wrote it. At any one time, you will not receive more than 30 days of isotretinoin. Take Sotret along with a glass of full water. The capsule should not be chewed or sucked. It is best to swallow it whole.

Take Sotret as directed, with or without food. Sotret should be used for the entire prescribed time. At first, your acne may appear to worsen. However, it should improve. Blood tests may be required frequently. Do not share this medication with anyone else, even if you both have the same symptoms. Store away from moisture, heat, and light at room temperature for best results.

What happens if I miss the dose?

Do not take the missed dose. Use your next dose as usual. Do not take two doses in one go.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Overdose symptoms include nausea, vomiting, tingling or warmth in the face, swelling or cracking of your lips, and loss of coordination.

What should be avoided?

Take vitamin A-containing supplements only if your doctor has prescribed them. Don't donate blood for 30 days or more after stopping Sotret. Blood that has been donated to a woman who is pregnant could cause birth defects if it contains isotretinoin. While taking Sotret and for 6 months following your last dose, do not wax your hair or undergo dermabrasion treatments or laser skin treatments. It is possible that scarring will result.

Sunburns can be more severe if you use Sotret. Avoid tanning beds or sunlight. When you're outdoors, wear protective clothing and apply sunscreen (SPF 30) or higher. Do not drive or engage in hazardous activities until you have determined how Sotret affects you. Sotret can impair your ability to see, particularly at night.

Interaction with other drug

Tell your doctor what other medications you are taking, including:

  • Phenytoin;
  • John's Wort (which may reduce the effectiveness of birth control pills);
  • Vitamin or mineral supplements
  • Progestin is the only birth control pill. (Mini-pills may not be as effective when combined with Sotret.)
  • Steroids are a type of medicine.
  • A tetracycline antibacterial, such as minocycline

This list is incomplete. Sotret may be affected by other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.

DRUG STATUS

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Prescription only

Pregnancy & Lactation

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