Claravis Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Claravis Capsule (isotretinoin) is a prescription retinoid medicine taken by mouth to treat severe nodular acne that has not responded to other treatments, including antibiotics. It works by shrinking the skin's oil glands, which reduces oil production and helps clear severe acne. Claravis carries serious risks, including birth defects if used during pregnancy, and requires close medical supervision with regular blood tests and doctor visits.

What is Claravis Capsule

Claravis is a prescription medicine related to vitamin A. It is taken by mouth to treat the most severe form of acne, called nodular acne, when other treatments like antibiotics have not worked.

Claravis Capsule uses

• Treatment of severe nodular acne in patients 12 years and older who have not responded to other treatments, including antibiotics

Benefits of Claravis Capsule

• Can produce complete and long-lasting clearing of severe nodular acne after one course of treatment
• Reduces the number and severity of acne nodules by shrinking oil (sebaceous) glands

How Claravis Capsule works

Claravis is a form of vitamin A that reduces the size and activity of the skin's oil glands, which lowers oil production and helps clear severe acne.

Claravis Capsule dosage

Take with a meal, usually twice a day, unless your doctor tells you otherwise. Swallow the capsule whole with a full glass of liquid; do not split, crush, chew, or suck on it, because it can irritate the tube connecting your mouth to your stomach. Taking it with food is important because it helps your body absorb the medicine properly; skipping food with your dose can significantly reduce how much medicine your body absorbs.

If you miss a dose, skip it and take your next dose at the regular time; do not take two doses together. Your acne may seem to get worse for a short time when you first start treatment before it begins to improve. You will need regular blood tests and doctor visits during treatment. Never share this medicine with anyone else, even if they have similar symptoms.

Available forms and strengths

• Capsules: 10 mg, 20 mg, 30 mg, and 40 mg

Side effects of Claravis Capsule

Common

• Dry skin, lips, eyes, or nose (may cause nosebleeds)
• Headache
• Back pain, joint pain, muscle problems
• Vision problems
• Cold-like symptoms such as stuffy nose, sneezing, sore throat

Serious

• Signs of an allergic reaction such as hives, trouble breathing, or swelling of the face or throat
• Severe skin reactions with fever, sore throat, burning eyes, skin pain, or a red or purple rash with blistering and peeling
• Problems with vision or hearing
• Increased pressure inside the skull, with severe headaches, ringing in the ears, dizziness, nausea, vision problems, or pain behind the eyes
• Signs of depression or other mental health changes, including thoughts of hurting yourself
• Signs of liver or pancreas problems, such as loss of appetite, upper stomach pain, nausea or vomiting, dark urine, or yellowing of skin or eyes
• Severe stomach problems including chest pain, pain when swallowing, heartburn, diarrhea, or bloody or tarry stools
• Increased thirst or urination, which may signal blood sugar problems
• Bone fractures or unusual bone pain

Warnings and precautions

• Claravis must never be used during pregnancy, even for a short time or in a small amount, because it can cause severe birth defects, miscarriage, or death of the baby. 
• Patients who can become pregnant must have negative pregnancy tests and use two forms of birth control before, during, and after treatment.
• Breastfeeding is not recommended while taking Claravis and for a period after stopping it, since it is not known if the drug passes into breast milk and it could harm the baby.
• Tell your doctor if you have liver disease before starting Claravis, since the medicine can cause liver problems including hepatitis, and liver function will be tested before and during treatment.
• Increased alcohol intake can raise the risk of high triglyceride levels while taking Claravis, and alcohol should be limited before certain blood tests.
• Claravis can affect your ability to see at night, so avoid driving or risky activities until you know how the medicine affects you.
• Claravis is only available through a special restricted program because of the serious risk of birth defects.
• Claravis can cause serious mental health problems, including depression, psychosis, and suicidal thoughts or actions.
• Do not take tetracycline antibiotics with Claravis because together they can raise the risk of dangerous pressure build-up in the brain.
• Serious, potentially life-threatening skin reactions have occurred with this medicine.
• Do not donate blood while taking Claravis and for one month after stopping, since donated blood could expose a pregnant person to the drug and harm her baby.
• Avoid waxing, dermabrasion, or laser skin treatments during treatment and for at least 6 months afterward because of the risk of scarring.
• Avoid taking vitamin A supplements while on Claravis, since this can add to the drug's toxic effects.

Storage

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
• Protect from light
• Keep this and all medicines out of the reach of children

When to see a doctor

• Get emergency help right away for signs of a serious allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, or throat.
• Stop the medicine and call your doctor immediately if you notice signs of depression, mood changes, or thoughts of hurting yourself.
• Seek care right away for signs of increased pressure in the brain, such as a bad headache, blurred vision, dizziness, nausea, vomiting, or seizures.
• Get medical help for serious skin reactions, such as a rash with fever, blistering, peeling skin, or sores in the mouth, throat, nose, or eyes.
• Seek care right away for signs of pancreas problems, such as severe upper stomach pain, swelling, nausea, vomiting, or fever.
• Contact your doctor immediately if you have severe stomach or chest pain, painful or difficult swallowing, new or worsening heartburn, diarrhea, or rectal bleeding, since these can signal organ damage.
• Stop the medicine and tell your doctor if your hearing worsens or you notice ringing in your ears, as hearing loss may be permanent.
• Contact your doctor about muscle weakness with or without pain, which can be a sign of serious muscle damage.

Alternatives

• Absorica
• Amnesteem
• Adapalene