WARNING

Claravis is a brand name for the medication isotretinoin, which is primarily used to treat severe acne. Like any medication, Claravis comes with potential risks and side effects that should be carefully considered:

• Birth Defects: Claravis is known to cause severe birth defects if taken during pregnancy. It’s essential for women of childbearing potential to use highly effective contraception or abstain from sexual intercourse during treatment and for one month after stopping the medication.
• Mental Health Effects: Some individuals may experience mood changes, depression, or suicidal thoughts while taking Claravis. Close monitoring by healthcare providers is recommended, especially for those with a history of depression or mental health issues.
• Dryness and Skin Sensitivity: Claravis commonly causes dryness of the skin, lips, eyes, and nose. This can lead to discomfort and, in rare cases, more severe skin reactions.
• Liver and Lipid Abnormalities: Claravis can affect liver function and lipid levels in the blood. Regular monitoring of these parameters is necessary during treatment.
• Musculoskeletal Effects: Isotretinoin may rarely cause musculoskeletal symptoms such as joint pain or stiffness.
• Vision Changes: Some people may experience changes in vision or difficulty wearing contact lenses while on Claravis.
• Gastrointestinal Effects: Isotretinoin can cause gastrointestinal disturbances like nausea, diarrhea, or abdominal pain.

It’s crucial for individuals prescribed Claravis to discuss these risks with their healthcare provider, adhere strictly to recommended dosages and monitoring schedules, and promptly report any unusual symptoms or side effects.

Why is this medication prescribed?

Claravis, which is a brand name for isotretinoin, is primarily prescribed to treat severe acne that has not responded adequately to other treatments. It is especially effective for cystic acne, nodular acne, and acne that has not responded well to antibiotics or topical treatments.

Isotretinoin works by reducing the size and activity of the sebaceous glands in the skin, which helps to reduce the production of sebum (oil) and prevents clogged pores that lead to acne. It also has anti-inflammatory properties that help to reduce the inflammation associated with acne lesions.

How should this medicine be used?

Claravis should be taken exactly as prescribed by a healthcare provider. Here are some general guidelines for its use:

• Dosage: The typical starting dose is usually based on body weight and severity of acne. It is usually taken once or twice daily with food.
• Duration: Treatment with Claravis is usually a course of several months (usually 4 to 6 months), but this can vary depending on the individual’s response to the medication and severity of acne.
• Monitoring: Regular visits to the healthcare provider are essential during treatment with Claravis. This includes monitoring for side effects, checking blood tests (such as liver function tests and lipid levels), and discussing contraception for women of childbearing potential.
• Birth Control: Women of childbearing age must use two reliable forms of contraception simultaneously for at least one month before starting Claravis, throughout the entire course of treatment, and for one month after stopping the medication. This is due to the severe risk of birth defects if taken during pregnancy.
• Side Effects: Patients should be aware of potential side effects such as dryness of the skin, lips, eyes, and nose, mood changes, and changes in lipid and liver function tests. Any concerning symptoms should be reported promptly to the healthcare provider.
• Sun Exposure: Isotretinoin can make the skin more sensitive to sunlight. Patients should use sunscreen and protective clothing when outdoors to avoid sunburn.
• Avoid Vitamin A Supplements: During treatment with Claravis, it is advisable to avoid taking vitamin A supplements, as isotretinoin is a derivative of vitamin A and excessive intake could lead to toxicity.

It’s important for patients to follow their healthcare provider’s instructions closely and to inform them of any other medications or supplements they are taking to avoid potential interactions.

Other uses for this medicine

• Severe Rosacea: Isotretinoin may be used in cases of severe rosacea that have not responded to other treatments. Rosacea is a chronic skin condition that causes redness and visible blood vessels in the face, often accompanied by pimples and bumps.
• Seborrheic Dermatitis: Isotretinoin has been used in some cases to treat severe seborrheic dermatitis, a common skin condition that causes red, scaly patches on the scalp and face.
• Hidradenitis Suppurativa: Isotretinoin may be considered as a treatment option for severe cases of hidradenitis suppurativa, a chronic skin condition characterized by painful lumps under the skin.

What special precautions should I follow?

When taking Claravis (isotretinoin), there are several special precautions that should be followed to ensure safe and effective treatment:

• Pregnancy Prevention Program: Due to the risk of severe birth defects, Claravis should not be used during pregnancy. Women of childbearing potential must use two forms of contraception simultaneously for at least one month before starting treatment, throughout the entire course of treatment, and for one month after stopping the medication.
• Regular Monitoring: Regular visits to the healthcare provider are essential during treatment with Claravis. This includes monitoring for side effects such as dry skin, mood changes, and liver function abnormalities. Blood tests may also be required to monitor lipid levels and other parameters.
• Sun Protection: Isotretinoin can increase the skin’s sensitivity to sunlight, making it more prone to sunburn. Patients should use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
• Avoid Vitamin A Supplements: During treatment with isotretinoin, it is advisable to avoid taking vitamin A supplements, as this could increase the risk of toxicity.
• Liver Function: Isotretinoin can affect liver function, so individuals with a history of liver disease or abnormal liver function tests should be closely monitored by their healthcare provider.
• Mental Health Monitoring: Patients should be monitored for any signs of depression, mood changes, or suicidal thoughts. It is essential to report any changes in mood or behavior to a healthcare provider immediately.
• Interactions: Claravis can interact with other medications, including oral contraceptives and certain antibiotics. It is important to inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting treatment with Claravis.

By following these precautions and guidelines, patients can minimize the risks associated with Claravis while maximizing its potential benefits for treating severe acne or other prescribed conditions.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Claravis. However, it is important to maintain a healthy diet and stay well-hydrated during treatment. Some individuals may experience gastrointestinal side effects such as nausea or diarrhea, so eating smaller, more frequent meals and avoiding spicy foods or alcohol may be helpful.

What should I do if I forget a dose?

If you forget to take a dose of Claravis, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Claravis, or isotretinoin, can cause a range of side effects, some of which can be severe. It’s essential for individuals taking Claravis to be aware of these potential side effects and to discuss any concerns with their healthcare provider. Here are some common and serious side effects associated with Claravis:

Common Side Effects:

• Dryness: Dry skin, lips, eyes, and nose are very common side effects of Claravis. This dryness can sometimes be severe.
• Skin Sensitivity: Increased sensitivity to sunlight, leading to sunburn more easily.
• Muscle and Joint Pain: Some individuals may experience muscle aches, joint pain, or stiffness.
• Itching: Mild to moderate itching of the skin.
• Nosebleeds: Due to drying of the nasal passages.
• Dry Mouth: Less common than dry skin but can occur.
• Temporary Hair Thinning: Hair may become thinner or more brittle during treatment.
• Increased Blood Lipid Levels: Isotretinoin can elevate triglyceride levels in the blood, which may require monitoring.

Serious Side Effects:

• Birth Defects: Isotretinoin is highly teratogenic and can cause severe birth defects if taken during pregnancy. It is essential for women of childbearing potential to use effective contraception throughout treatment and for one month after stopping Claravis.
• Depression and Mood Changes: Some individuals may experience mood swings, depression, or, in rare cases, suicidal thoughts or behaviors.
• Liver Damage: Isotretinoin can affect liver function, leading to elevated liver enzymes or, rarely, hepatitis.
• Inflammatory Bowel Disease: There have been reports of isotretinoin contributing to the onset or exacerbation of inflammatory bowel disease (IBD) symptoms.
• Vision Changes: While rare, isotretinoin may cause visual disturbances or difficulty wearing contact lenses.
• Pancreatitis: In rare cases, Claravis can cause inflammation of the pancreas.
• Allergic Reactions: Rarely, isotretinoin can cause severe allergic reactions, including anaphylaxis.

It’s important for individuals taking Claravis to report any side effects to their healthcare provider promptly. Regular monitoring by a healthcare professional can help detect and manage any potential side effects early. Following all recommended precautions and guidelines, including contraception for women of childbearing potential, is crucial to minimize risks associated with Claravis treatment.

What should I know about storage and disposal of this medication?

Storage and Disposal of Claravis:

• Storage: Store Claravis capsules at room temperature away from light and moisture. Keep them in a tightly closed container, out of reach of children and pets.
• Disposal: Properly dispose of any unused Claravis capsules that are outdated or no longer needed. Do not flush them down the toilet or pour them into a drain unless instructed to do so. Contact your pharmacist or local waste disposal company for proper disposal instructions.

In case of emergency/overdose

In case of an overdose or emergency related to Claravis, seek immediate medical attention or contact a poison control center (1-800-222-1222 in the United States). Symptoms of an overdose may include severe headache, dizziness, vomiting, stomach pain, and vision changes. Do not attempt to treat an overdose on your own without medical guidance.

What other information should I know?

• Follow Directions: Take Claravis exactly as prescribed by your healthcare provider. Do not adjust your dose or take it for longer than recommended.
• Regular Monitoring: Attend all scheduled appointments with your healthcare provider for monitoring of your progress and any potential side effects.
• Avoid Pregnancy: Avoid becoming pregnant while taking Claravis and for at least one month after stopping treatment. Isotretinoin can cause severe birth defects.
• Inform Healthcare Providers: Inform all healthcare providers (including dentists and surgeons) that you are taking Claravis. This medication may affect certain medical tests and procedures.
• Avoid Vitamin A Supplements: Do not take vitamin A supplements while taking Claravis, as this can increase the risk of vitamin A toxicity.
• Patient Education: Educate yourself about the potential side effects and risks associated with Claravis. Be vigilant for any signs of mood changes, depression, or other serious side effects and report them to your healthcare provider promptly.
• Sun Protection: Isotretinoin can increase sensitivity to sunlight. Use sunscreen and wear protective clothing when outdoors to prevent sunburn.
• Interactions: Inform your healthcare provider about all other medications, supplements, and herbal products you are taking. Some medications may interact with Claravis.

By following these guidelines and staying informed, you can ensure safe and effective use of Claravis for the treatment of severe acne or other prescribed conditions.