Accutane (isotretinoin) Capsules

What is Accutane (Isotretinoin, Isotroin)?

• Oral Isotretinoin is marketed under various trade names, most commonly Accutane (Roche), Amnesteem (Mylan), Claravis (Barr), Tretiva (Intas Pharmaceuticals), Isotane (Pacific Pharmaceuticals), Sotret (Ranbaxy), Claravis (Barr), or Roaccutane (Roche); while topical isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel).
• Accutane is a form of vitamin A. It decreases the amount of sebum (oil) that is released by the sebaceous (oil) glands, and it increases that rate at which the skin renews itself. Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

What should I tell my doctor before taking Accutane?

• Tell your doctor if you or a family member has any of the following health conditions:
  • mental problems;
  • asthma;
  • liver disease;
  • diabetes;
  • heart disease;
  • bone loss (osteoporosis) or weak bones;
  • an eating problem called anorexia nervosa (where people eat too little)
  • food or medicine allergies.
• You may not be able to take Accutane, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Do not take Accutane if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking Accutane. Accutane is in the FDA pregnancy category X. This means that Accutane is known to cause severe birth defects in an unborn baby. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking Accutane and notify your doctor.
• It is not known whether Accutane passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.

How should I take Accutane?

• Take Accutane exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Accutane is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, Accutane can cause serious side effects. Before starting treatment with Accutane, discuss with your doctor how bad the acne is, the possible benefits of Accutane and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with Accutane therapy.
• You will get no more than a 30-day supply of Accutane at a time. Your prescription should have a special yellow self-adhesive sticker attached to it. If your prescription does not have this yellow sticker, call your doctor. The pharmacy should not fill the prescription without this sticker.
• Take each dose of Accutane with a full glass of water. This will help prevent the medication inside the capsule from irritating the lining of the esophagus. For the same reason, do not chew or suck on the capsule.
• Take Accutane twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.
• Take all of the Accutane that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with Accutane.
• Your doctor may perform blood tests during treatment with Accutane to monitor side effects from this medication.
• Due to the serious side effects that may occur with the use of this medication, do not share it with anyone else.
• Store Accutane at room temperature away from moisture and heat.

Dosage and Administration.

• Accutane should be administered with a meal.
• The recommended dosage range for Accutane is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of desease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects - some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Accutane with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
• The safety of once daily dosing with Accutane has not be established. Once daily dosing is not recommended.
• If the total nodule count has been reduced by more than 70% prior completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Accutane, even in low doses, has not been studied, and is not recommended. It is important that Accutane be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Accutane on bone loss is unknown.
• Contraceptive measures must be followed for any subsequent course of therapy.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of an Accutane overdose include vomiting, abdominal pain, flushing of the face, inflammation of the lips, headache, dizziness, and clumsiness.

What should I avoid while taking Accutane?

• Do not get pregnant while taking Accutane and for 1 month after stopping Accutane.
• Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby
• Do not give blood while you take Accutane and for 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you talk your doctor.
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.

What are the possible side effects of Accutane?

• Stop taking Accutane and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • changes in vision, blurred vision, or decreased vision (especially at night);
  • painful or constant dryness of the eyes;
  • depression including feelings of sadness, crying spells, irritability, changes in sleep patterns, unusual tiredness, trouble concentrating, loss of appetite, and/ or suicidal thoughts or other mental problems;
  • stomach, chest, or bowel pain;
  • rectal bleeding, or severe or bloody diarrhea;
  • difficulty or pain when swallowing;
  • new or worsening heartburn;
  • yellowing of the skin or eyes or persistently dark urine;
  • severe headache or dizziness;
  • seizures;
  • nausea and vomiting;
  • joint or muscle pain or bone problems;
  • hearing problems or hearing loss;
  • trouble breathing;
  • fainting;
  • increased thirst or urination;
  • slurred speech or problems moving;
  • leg swelling;
  • increased levels of cholesterol or triglyceride (types of fat) in your blood (detected by blood tests).
• Other, less serious side effects are more likely to occur. Continue to take Accutane and talk to your doctor if you experience
  • inflammation, dryness, or cracking of the lips;
  • dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ or difficulty wearing contact lenses;
  • itching; or
  • increased sensitivity of the skin to the sun.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Drug Interactions.

• Vitamin A: Because of the relationship of Accutane to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
• Tetracyclines: Concomitant treatment with Accutane and tetracyclines should be avoided because Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
• Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations ("minipills" that do not contain an estrogen) may be an inadequate method of contraception during Accutane therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from female patients who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for female patients who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Accutane. Therefore, it is critically important for female patients of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form.
• Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Accutane at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert od medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
• St. John's Wort: Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort.
• Phenytoin: Accutane has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to access if there is an interactive effect on bone loss between phenytoin and Accutane. Therefore, caution should be exercised when using these drugs together.
• Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to access if there is an interactive effect on bone loss between systemic corticosteroids and Accutane. Therefore, caution should be exercised when using these drugs together.
• alcohol
• benzoyl peroxide, salicylic acid, or other drying medicines used for acne
• medicines for seizures
• orlistat
• other drugs that make you more sensitive to the sun such as sulfa drugs
• warfarin

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.