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Accutane Roche

Accutane Roche - General Information

Accutane Roche is a medication used for the treatment of severe acne. It is sometimes used in prevention of certain skin cancers. It is a retinoid, meaning it derives from vitamin A and is found in small quantities naturally in the body. Accutane Roche binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization.

 

Pharmacology of Accutane Roche

Accutane Roche, a retinoid, is indicated in the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with Accutane, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

 

Accutane Roche for patients

MEDICATION GUIDE

Read this Medication Guide every time you get a prescription or a refill for Accutane (ACK-u-tane). There may be new information. This information does not take the place of talking with your prescriber (doctor or other health care provider).

What is the most important information I should know about Accutane?

Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. However, Accutane can cause serious side effects. Before starting Accutane, discuss with your prescriber how bad your acne is, the possible benefits of Accutane, and its possible side effects, to decide if Accutane is right for you. Your prescriber will ask you to read and sign a form or forms indicating you understand some of the serious risks of Accutane.

Possible serious side effects of taking Accutane include birth defects and mental disorders.

1. Birth defects. Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Accutane if you are pregnant or plan to become pregnant while you are taking Accutane. Do not get pregnant for 1 month after you stop taking Accutane. Also, if you get pregnant while taking Accutane, stop taking it right away and call your prescriber.

All females should read the section in this Medication Guide "What are the important warnings for females taking Accutane?"

2. Mental problems and suicide. Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on Accutane becoming aggressive or violent. No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane.

All patients should read the section in this Medication Guide "What are the signs of mental problems?"

For other possible serious side effects of Accutane, see "What are the possible side effects of Accutane?" in this Medication Guide.

What are the important warnings for females taking Accutane?

You must not become pregnant while taking Accutane, or for 1 month after you stop taking Accutane. Accutane can cause severe birth defects in babies of women who take it while they are pregnant, even if they take Accutane for only a short time. There is an extremely high risk that your baby will be deformed or will die if you are pregnant while taking Accutane. Taking Accutane also increases the chance of miscarriage and premature births.

Female patients will not get their first prescription for Accutane unless there is proof they have had 2 negative pregnancy tests. The first test must be done when your prescriber decides to prescribe Accutane. The second pregnancy test must be done during the first 5 days of the menstrual period right before starting Accutane therapy, or as instructed by your prescriber. Each month of treatment, you must have a negative result from a urine or serum pregnancy test. Female patients cannot get another prescription for Accutane unless there is proof that they have had a negative pregnancy test.

A yellow self-adhesive Accutane Qualification Sticker on your prescription indicates to the pharmacist that you are qualified by your prescriber to get Accutane.

While you are taking Accutane, you must use effective birth control. You must use 2 separate effective forms of birth control at the same time for at least 1 month before starting Accutane, while you take it, and for 1 month after you stop taking it. You can either discuss effective birth control methods with your prescriber or go for a free visit to discuss birth control with another physician or family planning expert. Your prescriber can arrange this free visit, which will be paid for by the manufacturer.

You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. There are only 2 reasons you would not need to use 2 separate methods of effective birth control:

  1. You have had your womb removed by surgery (a hysterectomy).
  2. You are absolutely certain you will not have genital-to-genital sexual contact with a male before, during, and for 1 month after Accutane treatment.

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your period, stop using Accutane and call your prescriber right away.

All patients should read the rest of this Medication Guide.

What are the signs of mental problems?

Tell your prescriber if, to the best of your knowledge, you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there. Also, tell your prescriber if you take medicines for any of these problems.

Stop using Accutane and tell your provider right away if you:

  • Start to feel sad or have crying spells
  • Lose interest in activities you once enjoyed
  • Sleep too much or have trouble sleeping
  • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • Have a change in your appetite or body weight
  • Have trouble concentrating
  • Withdraw from your friends or family
  • Feel like you have no energy
  • Have feelings of worthlessness or inappropriate guilt
  • Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)

What is Accutane?

Accutane is used to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. However, because Accutane can have serious side effects, you should talk with your prescriber about all of the possible treatments for your acne, and whether Accutaneís possible benefits outweigh its possible risks.

Who should not take Accutane?

  • Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. All females should read the section "What are the important warnings for females taking Accutane?" for more information and warnings about Accutane and pregnancy.
  • Do not take Accutane unless you completely understand its possible risks and are willing to follow all of the instructions in this Medication Guide. Tell your prescriber if you or someone in your family has had any kind of mental problems, asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), weak bones, anorexia nervosa (an eating disorder where people eat too little), or any other important health problems. Tell your prescriber about any food or drug allergies you have had in the past. These problems do not necessarily mean you cannot take Accutane, but your prescriber needs this information to discuss if Accutane is right for you.

How should I take Accutane?

  • You will get no more than a 30-day supply of Accutane at a time, to be sure you check in with your prescriber each month to discuss side effects.
  • Your prescription should have a special yellow self-adhesive sticker attached to it. The sticker is YELLOW. If your prescription does not have this yellow self-adhesive sticker, call your prescriber. The pharmacy should not fill your prescription unless it has the yellow self-adhesive sticker.
  • The amount of Accutane you take has been specially chosen for you and may change during treatment.
  • You will take Accutane 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow your Accutane capsules with a full glass of liquid. This will help prevent the medication inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.
  • If you miss a dose, just skip that dose. Do not take 2 doses the next time.
  • You should return to your prescriber as directed to make sure you donít have signs of serious side effects. Because some of Accutaneís serious side effects show up in blood tests, some of these visits may involve blood tests (monthly visits for female patients should always include a urine or serum pregnancy test).

What should I avoid while taking Accutane?

  • Do not get pregnant while taking Accutane. See "What is the most important information I should know about Accutane?" and "What are the important warnings for females taking 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 vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
  • 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 prescriber 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.
  • Do not use birth control pills that do not contain estrogen ("minipills"). They may not work while you take Accutane. Ask your prescriber or pharmacist if you are not sure what type you are using.
  • Talk with your doctor if you plan to take other drugs or herbal products. This is especially important for patients using birth control pills and other hormonal types of birth control because the birth control may not work as effectively if you are taking certain drugs or herbal products. You should not take the herbal supplement St. Johnís Wort because this herbal supplement may make birth control pills not work as effectively.
  • Talk with your doctor if you are currently taking an oral or injected corticosteroid or anticonvulsant (seizure) medication prior to using Accutane. These drugs may weaken your bones.
  • Do not share Accutane with other people. It can cause birth defects and other serious health problems.
  • Do not take Accutane with antibiotics unless you talk to your prescriber. For some antibiotics, you may have to stop taking Accutane until the antibiotic treatment is finished. Use of both drugs together can increase the chances of getting increased pressure in the brain.

What are the possible side effects of Accutane? Accutane has possible serious side effects

  • Accutane can cause birth defects, premature births, and death in babies whose mothers took Accutane while they were pregnant. See "What is the most important information I should know about Accutane?" and "What are the important warnings for females taking Accutane?"
  • Serious mental health problems. See "What is the most important information I should know about Accutane?"
  • Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of sight, or in rare cases, death. Stop taking Accutane and call your prescriber right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking Accutane have had seizures (convulsions) or stroke.
  • Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.
  • Bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan vigorous physical activity during treatment with Accutane. Tell your prescriber if you develop pain, particularly back pain or joint pain. There are reports that some patients have had stunted growth after taking Accutane for acne as directed. There are also some reports of broken bones or reduced healing of broken bones after taking Accutane for acne as directed. No one knows if taking Accutane for acne will affect your bones. If you have a broken bone, tell your provider that you are taking Accutane. Muscle weakness with or without pain can be a sign of serious muscle damage. If this happens, stop taking Accutane and call your prescriber right away.
  • Hearing problems. Some people taking Accutane have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Accutane and call your prescriber if your hearing gets worse or if you have ringing in your ears.
  • Vision problems. While taking Accutane you may develop a sudden inability to see in the dark, so driving at night can be dangerous. This condition usually clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant.
  • Lipid (fats and cholesterol in blood) problems. Many people taking Accutane develop high levels of cholesterol and other fats in their blood. This can be a serious problem. Return to your prescriber for blood tests to check your lipids and to get any needed treatment. These problems generally go away when Accutane treatment is finished.
  • Allergic reactions. In some people, Accutane can cause serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your prescriber if you develop a fever, rash, or red patches or bruises on your legs.
  • Signs of other possibly serious problems. Accutane may cause other problems. Tell your prescriber if you have trouble breathing (shortness of breath), are fainting, are very thirsty or urinate a lot, feel weak, have leg swelling, convulsions, slurred speech, problems moving, or any other serious or unusual problems. Frequent urination and thirst can be signs of blood sugar problems.

Serious permanent problems do not happen often. However, because the symptoms listed above may be signs of serious problems, if you get these symptoms, stop taking Accutane and call your prescriber. If not treated, they could lead to serious health problems. Even if these problems are treated, they may not clear up after you stop taking Accutane.

Accutane has less serious possible side effects

The common less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who wear contact lenses may have trouble wearing them while taking Accutane and after therapy. Sometimes, peopleís acne may get worse for a while. They should continue taking Accutane unless told to stop by their prescriber.

These are not all of Accutaneís possible side effects. Your prescriber or pharmacist can give you more detailed information that is written for health care professionals.

This Medication Guide is only a summary of some important information about Accutane. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about Accutane, ask your prescriber. Do not use Accutane for a condition for which it was not prescribed.

 

Accutane Roche 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 women who have used combined oral contraceptives, as well as topical/injectable/implantable/insertable hormonal birth control products. These reports are more frequent for women 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 women 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, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy.

· 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 assess 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 assess if there is an interactive effect on bone loss between systemic corticosteroids and Accutane. Therefore, caution should be exercised when using these drugs together.

Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Accutane use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. Johnís 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.

Laboratory Tests

Pregnancy Test

Female patients of childbearing potential must have negative results from 2 urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Accutane prescription. The first test is obtained by the prescriber when the decision is made to pursue qualification of the patient for Accutane (a screening test). The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of Accutane therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception).

Each month of therapy, the patient must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month prior to the female patient receiving each prescription.

· Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Accutane is established. The incidence of hypertriglyceridemia is 1 patient in 4 on Accutane therapy.

· Liver Function Tests: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Accutane has been established.

· Glucose: Some patients receiving Accutane have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during Accutane therapy, although no causal relationship has been established.

· CPK: Some patients undergoing vigorous physical activity while on Accutane therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.

 

Accutane Roche Contraindications

Pregnancy: Category X. Allergic Reactions Accutane is contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

 

Additional information about Accutane Roche

Accutane Roche Indication: For the treatment of severe recalcitrant nodular acne
Mechanism Of Action: Accutane Roche noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilises keratinization and prevents comedones from forming. The exact mechanism of action is unknown, however it is known that it alters DNA transcription.
Drug Interactions: Anisindione Retinoids decreases the anticoagulant effect
Dicumarol Retinoids decreases the anticoagulant effect
Acenocoumarol Retinoids decreases the anticoagulant effect
Warfarin Retinoids decreases the anticoagulant effect
Carbamazepine Accutane Rochee decreases the effect of carbamazepine
Demeclocycline Increased risk of intracranial hypertension
Doxycycline Increased risk of intracranial hypertension
Minocycline Increased risk of intracranial hypertension
Methacycline Increased risk of intracranial hypertension
Oxytetracycline Increased risk of intracranial hypertension
Tetracycline Increased risk of intracranial hypertension
Rolitetracycline Increased risk of intracranial hypertension
Food Interactions: Avoid alcohol.
Take with food to increase absorption.
Take with a full glass of water Do not take supplements containing Vitamin A.
Generic Name: Isotretinoin
Synonyms: Not Available
Drug Category: Anti-acne Agents; Skin and Mucous Membrane Agents
Drug Type: Small Molecule; Approved
Other Brand Names containing Isotretinoin: Accutane Roche;
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: 99.9%
Biotransformation: Not Available
Half Life: 17-50 hours
Dosage Forms of Accutane Roche: Capsule Oral
Chemical IUPAC Name: 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic acid
Chemical Formula: C20H28O2
Isotretinoin on Wikipedia: http://en.wikipedia.org/wiki/Isotretinoin
Organisms Affected: Humans and other mammals