Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Myorisan Capsule: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | isotretinoin |
|---|---|
| Drug class | Retinoid (miscellaneous antineoplastics / acne agent) |
| Forms | Capsules (10 mg, 20 mg, 30 mg, and 40 mg soft gelatin capsules) |
Quick overview
Myorisan Capsule (isotretinoin) is a prescription retinoid taken by mouth to treat severe nodular acne that has not responded to other treatments, including antibiotics. It works by reducing the amount of oil made by the skin's oil glands. Myorisan is only available through the restricted iPLEDGE program because of serious risks, including severe birth defects if taken during pregnancy.
What is Myorisan Capsule
Myorisan is a prescription medicine made from a form of vitamin A. It is taken by mouth to treat the most severe type of acne, called severe nodular acne, when other treatments like antibiotics have not worked.
Myorisan Capsule uses
- Treats severe nodular acne that has not responded to other treatments, including antibiotics
Benefits of Myorisan Capsule
- Can produce complete and prolonged clearing of severe nodular acne after one course of treatment
- Reduces the number and severity of acne nodules
How Myorisan Capsule works
Myorisan reduces the amount of oil (sebum) made by the skin's oil glands, which helps stop severe acne from forming. The exact way it works is not fully known.
Myorisan Capsule dosage
Take exactly as prescribed and follow all iPLEDGE program instructions. Take with a meal, as directed by your doctor, unless told otherwise. Swallow the capsule whole with a full glass of liquid; do not chew or suck on it. Do not lie down for at least 10 minutes after taking a dose. Your acne may seem to get worse at first before it improves. Never share this medicine with anyone else, even if they have similar symptoms. You may need frequent blood tests while taking this medicine.
| Age group | Dose |
|---|---|
| Under 12 years | Not recommended / safety and effectiveness not established |
| 12–17 years | 0.5–1 mg/kg/day, divided into 2 doses, for 15–20 weeks |
| 18–64 years | 0.5–1 mg/kg/day, divided into 2 doses, for 15–20 weeks |
| 65+ years | 0.5–1 mg/kg/day, divided into 2 doses; individualized by the prescriber |
Available forms and strengths
- Capsules (10 mg, 20 mg, 30 mg, and 40 mg soft gelatin capsules)
Side effects of Myorisan Capsule
Common
- Dry skin, lips, eyes, or nose (may cause nosebleeds)
- Vision problems
- Headache
- Back pain, joint pain, muscle problems
- Skin reactions or rash
- Cold-like symptoms such as stuffy nose, sneezing, sore throat
- Hair loss
- Skin peeling
- Nausea
Serious
- Signs of allergic reaction: hives, difficulty breathing, swelling of face, lips, tongue, or throat
- Severe skin reactions: fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling
- Vision or hearing problems, ringing in the ears
- Severe headache, blurred vision, dizziness, nausea or vomiting, seizures (signs of increased brain pressure)
- Signs of depression, mood changes, thoughts of self-harm or suicide, hallucinations
- Signs of liver or pancreas problems: loss of appetite, upper stomach pain, nausea or vomiting, dark urine, yellowing of skin or eyes
- Severe stomach or chest pain, painful swallowing, worsening heartburn, diarrhea, rectal bleeding, bloody or tarry stools
- Increased thirst or urination (possible blood sugar problems)
- Muscle weakness (possible sign of serious muscle damage)
- Bone fractures or slowed growth in children
- Signs of low blood cell counts: trouble breathing, fainting, feeling weak
Warnings and precautions
- Myorisan can cause severe, life-threatening birth defects, miscarriage, or death of a baby if taken during pregnancy, even with just one dose.
- Myorisan may cause serious mental health problems, including depression, psychosis, and suicidal thoughts or actions.
- Myorisan can increase pressure inside the skull, which can lead to permanent vision loss and, rarely, death.
- Myorisan is only available through a special restricted program called iPLEDGE, and patients must follow all program requirements including pregnancy testing and birth control rules.
- Do not have waxing, dermabrasion, or laser skin procedures during treatment and for at least 6 months after stopping, because of the risk of scarring.
- Do not donate blood while taking Myorisan and for at least one month after stopping, since donated blood given to a pregnant person could cause birth defects.
- Myorisan must never be used during pregnancy or by anyone who could become pregnant, because even one dose can cause severe birth defects, miscarriage, or death of the baby.
- Two negative pregnancy tests are required before starting, and effective birth control must be used starting one month before treatment, during treatment, and for one month after stopping.
- Breastfeeding is not recommended while taking Myorisan, because it is not known if the medicine passes into breast milk and could harm the baby.
- Tell your doctor if you have liver disease before taking Myorisan, since the medicine can affect liver function and cause hepatitis in some people.
- Avoid alcohol while taking this medicine because it may increase the risk of certain side effects such as pancreatitis.
- Avoid driving or hazardous activities, especially at night, until you know how this medicine affects your vision, since it can reduce your ability to see in the dark.
Storage
- Store at room temperature (68°-77°F / 20°-25°C)
- Protect from light
- Keep away from moisture and heat
- Keep out of the reach of children
- Do not store in the bathroom
- Do not flush medications down the toilet or pour them into a drain unless instructed to do so; properly discard when expired or no longer needed
When to see a doctor
- Get emergency help right away if you have signs of a severe allergic reaction, such as hives, difficulty breathing, or swelling of the face or throat.
- Stop the medicine and call your doctor right away if you notice signs of depression, mood changes, or thoughts of hurting yourself.
- Stop the medicine and get medical help right away if you have signs of increased pressure in the brain, such as severe headache, vision changes, dizziness, or nausea.
- Stop the medicine and call your doctor if you have signs of liver or pancreas problems, such as stomach pain, nausea, dark urine, or yellowing of the skin or eyes.
- Stop taking Myorisan and call your doctor immediately if you think you might be pregnant, have unprotected sex, stop using birth control, or miss your period.
- Stop the medicine and call your doctor right away if you have muscle weakness, which can be a sign of serious muscle damage.
Alternatives
- Absorica
- Doxycycline
- Minocycline
Watch the video
FAQs
What is Myorisan Capsule used for?
Myorisan is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
How does Myorisan Capsule work?
Myorisan reduces the amount of oil (sebum) made by the skin's oil glands, which helps stop severe acne from forming. The exact way it works is not fully known.
Why is Myorisan only available through iPLEDGE?
Myorisan is only available through the restricted iPLEDGE program because it can cause severe, life-threatening birth defects, miscarriage, or death of a baby if taken during pregnancy, even with just one dose. Patients must follow program requirements including pregnancy testing and birth control rules.
How should I take Myorisan Capsule?
Take exactly as prescribed with a meal, swallowing the capsule whole with a full glass of liquid without chewing or sucking it. Do not lie down for at least 10 minutes after taking a dose, and never share this medicine with anyone else.
What are the serious side effects of Myorisan Capsule?
Serious side effects include signs of depression or suicidal thoughts, increased pressure in the brain causing vision loss, liver or pancreas problems, severe skin reactions, muscle weakness, and low blood cell counts.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
Video
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