Accutane (Isotretinoin)

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Accutane is known by the generic name Isotretinoin and falls under a class of drugs called retinoids. Retinoids are derivatives of vitamin A, and Accutane specifically works by decreasing the production of sebum, the oily substance produced by the skin's sebaceous glands. Doctors prescribe isotretinoin for patients living with severe nodular acne that hasn't cleared up with other treatments. It helps reduce the size and output of sebaceous glands and helps the skin renew itself more efficiently.

    F act Table

    Formula

    C20H28O2

    License

    US FDA (1982)

    Bioavailability

    25% (fasting), 60-70% (with high-fat meal)

    Legal status

    Prescription only (?), iPLEDGE program

    Chemical Name

    (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

    Elimination half-life

    10-20 hours

    Dosage (Strength)

    10 mg, 20 mg, 40 mg soft gel capsules

    Pregnancy

    Contraindicated (Category X)

    Brands

    Accutane, Roaccutane, Amnesteem, Claravis

    Protein binding

    99.9%

    PubChem CID

    5282379

    MedlinePlus

    a681043

    ChEBI

    CHEBI:6067

    ATC code

    D10BA01

    DrugBank

    DB00982

    KEGG

    D00348

    Routes of administration

    Oral

    Directions

    Isotretinoin should be taken as prescribed by a healthcare professional. Typically, patients take the medication once or twice daily, alongside food to enhance absorption. The standard doses vary depending on individual factors, such as the severity of acne and patient response, but it often starts at 0.5 mg/kg and can be adjusted to as much as 1 mg/kg of body weight per day. Patients must swallow the capsules whole to avoid damaging the medication's integrity, and be aware that it may take several weeks to observe significant improvements in their acne condition.

    Ingredients

    Isotretinoin is the active ingredient in Accutane.

    Contraindications

    If any of the following contraindications apply, it's vital to avoid taking or using this medication:

    • Pregnancy or breastfeeding: Isotretinoin carries a high risk of birth defects, so it is crucial for individuals who are pregnant or breastfeeding to avoid this medication.
    • Hypersensitivity: Those with a known hypersensitivity or allergy to isotretinoin should avoid this medication.

    Cautions

    • Talk to a healthcare provider about any of the following before using Accutane:
      • Any known allergies
      • Whether you are pregnant or breastfeeding
      • Other medical conditions you may have
      • Medications you are presently taking
    • Accutane can affect your mood and mental health, potentially causing depression, aggressive behaviors, or even thoughts of suicide. Before starting Accutane, talk to your doctor about any past mental health issues, and keep an eye on how you're feeling during treatment. If you notice any changes, contact your doctor immediately.
    • In rare cases, Accutane pills can cause increased pressure in the brain, leading to symptoms like headache, nausea, vomiting, and vision problems. If you experience these, stop taking Accutane and see a doctor right away.
    • Accutane can cause severe skin reactions that might need hospital care. If your skin starts to peel, blister, or rash severely, get medical help immediately.
    • Accutane can lead to pancreatitis, which can be serious or even fatal. Watch out for severe stomach pain and contact your doctor if you have concerns.
    • Accutane can raise the levels of fats in your blood, so you'll need regular blood tests to monitor this. Following a healthy lifestyle can help manage these levels.
    • Some people on Accutane report hearing loss or ringing in the ears. If this happens to you, tell your doctor.
    • Since Accutane can affect liver function, your doctor will check your liver with blood tests. Report any symptoms like fatigue, yellowing of the skin or eyes, or nausea.
    • Accutane has been linked to conditions like inflammatory bowel disease. If you experience severe stomach pain, diarrhea, or bleeding, contact your healthcare provider.
    • There are reports of Accutane affecting bone growth and causing bone pain. If you experience any unusual discomfort, let your doctor know.
    • Accutane can impact your vision, including causing night vision problems. Be cautious when driving at night and inform your doctor of any vision changes.
    • Accutane's safety hasn't been established in very young children, pregnant women, or nursing mothers. It's crucial to use effective birth control during treatment and discuss any potential risks with your healthcare provider.

    Side Effects

    Accutane is known to cause dryness, especially of the skin and lips, which is similar to taking high doses of vitamin A. Common issues include red and dry lips, dryness in the nose leading to nosebleeds, and dry eyes. Some people might experience nausea, headaches, tiredness, and changes in mood. Cheilitis (cracked or dry lips) and high triglyceride levels in the blood are also related to the dose of the medication.

    Accutane has been linked to more serious health concerns, such as problems with the liver, increased risk of tendon injury, and changes in blood sugar levels. It can cause significant mood changes, including depression and thoughts of suicide. Other serious risks include difficulty seeing at night, which may last even after stopping the medication, hearing problems, and severe allergic reactions. There are also concerns about effects on the bones, muscle pain, and serious skin conditions. Due to these risks, it's crucial to monitor health closely while on Accutane and report any severe or unusual symptoms to a healthcare provider immediately.

    References:

    1. Accutane (Isotretinoin) Product Monograph. Nutley, NJ: Roche Pharmaceuticals; 2010.
    2. Accutane (Isotretinoin) Drug Label Information. Scottsdale, AZ: JG Pharma; 2022.



    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 1310

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