Isotretinoin is a vitamin A derivative that belongs to the class of medications called retinoids. Retinoids are typically used to treat certain skin conditions. Isotretinoin is used to treat major forms of acne, such as nodular acne or inflammatory acne when other drugs with less potential for side effects have proven ineffective. It can also be used to treat acne conglobata and recalcitrant acne.
Isotretinoin helps reduce sebum production, which is often associated with the presence of bacteria that contributes to acne. In many cases, it can produce acne remission.
Your doctor may have suggested this medication for a condition that is not listed in this medication information article. Also, some forms of this medication may not be used for all of the conditions mentioned in this article. If you haven't discussed this with your doctor yet, or if you're not sure why you're taking this medicine, check with your doctor. Do not stop taking this medication without consulting your doctor first.
Do not give this medicine to anyone, even someone who has the same symptoms as yours. This medicine could harm people for whom it was not prescribed.
What forms does this medicine come in?
Each soft, oval, red-brown opaque gelatin capsule, imprinted "ROA 10", contains isotretinoin 10 mg. Non-medicinal ingredients: beeswax, black iron oxide, hydrolyzed hydrogenated starch, gelatin, glycerol, hydrogenated soybean oil, propylene glycol, red iron oxide, mannitol, partially hydrogenated soybean oil, shellac, sorbitol, oil soy, and titanium dioxide.
Each soft, oval, opaque yellow gelatin capsule imprinted "ROA 40" contains isotretinoin 40 mg. Non-medicinal ingredients: beeswax, iron oxide black, gelatin, glycerol, hydrogenated soybean oil, methylparaben, partially hydrogenated soybean oil, propylene glycol, propylparaben, quinoline yellow WS, shellac, soybean oil, yellow FCF sun, and titanium dioxide.
How should this drug be used?
The usual dose for starting treatment is 0.5 mg per kilogram of body weight taken daily for a period of 2 to 4 weeks. Your doctor will then adjust your dose based on your weight, the severity of the acne, and your response to the medicine. Isotretinoin should be taken as a single dose or in 2 divided doses during the day.
Several factors can be taken into account to determine the dose a person needs: their weight, their state of health, and the taking of other medicines. If your doctor has recommended a dose other than those given here, do not change the way you take the medicine without consulting your doctor first.
Your acne symptoms may get worse before they get better. After the initial treatment, your doctor will adjust your daily dose according to your response to the medicine.
Food increases the amount of medicine available to the body. It also helps reduce stomach discomfort. For these reasons, isotretinoin should be taken with food.
The first signs of healing usually occur after 2-3 weeks of treatment, but it may take one (1) to 2 months to see the first beneficial effects. The complete series of treatments usually lasts 12 to 16 weeks. Most people with severe acne notice significant improvement after 1-2 sets of treatments. You may continue to see more improvement in your acne for several months after stopping the medication.
If any of the side effects of the medicine do not go away within a few weeks after stopping treatment, consult your doctor. Be sure to read the patient instructions included in the medicine package.
It is very important that this medicine is taken as directed by your doctor. If you miss a dose, take the medicine as soon as you remember and resume treatment as soon as possible. If it is almost time for your next dose, don't worry about the missed dose and go back to the usual dosing schedule. Do not use a double dose to make up for a missed dose. If you are unsure of what to do after missing a dose, ask your doctor or pharmacist for advice.
Store this medication at room temperature, in its original container, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medicines in the wastewater (eg not in the sink or in the toilet bowl) or with household waste. Ask your pharmacist how to dispose of unused or expired medicines.
In which cases is this drug not recommended?
Do not use isotretinoin in the following circumstances:
- an allergy to isotretinoin or any ingredient in the medication;
- if you are taking tetracycline antibiotics (eg tetracycline, doxycycline, minocycline);
- the presence of very high blood cholesterol levels;
- the presence of very high levels of vitamin A;
- reduced kidney or liver function.
Isotretinoin should not be taken by women who could become pregnant unless all of the following conditions are met:
- You have a significant form of nodular or inflammatory acne, conglobate or recalcitrant acne which may disfigure you and which has not responded to standard treatments, in particular taking systemic antibiotics.
- You can understand and follow the instructions.
- You received a negative pregnancy test before each 30-day prescription and another negative one month after you stopped taking isotretinoin.
- You can comply with mandatory contraceptive measures for at least one month before, during, and at least one month after treatment.
- You have received and acknowledged an understanding of a thorough oral and printed explanation of the dangers to the fetus of exposure to isotretinoin and the risk of possible contraceptive failure.
- You have been informed and you understand the need to consult a doctor quickly if there is a possibility that you are pregnant.
- You understand the need for monthly follow-up visits.
- You use an effective method of birth control continuously for one month before, while taking isotretinoin, and for one month after stopping this medicine. You understand that 2 effective methods of contraception must be used at the same time.
- You have undergone a negative urine or blood pregnancy test, analyzed by a recognized laboratory, during the 2 weeks preceding the treatment. Your normal period has been on for 2 or 3 days when you start using isotretinoin.
- If you need another treatment with isotretinoin in the future, you must also meet the same conditions for contraception before, during, and after taking isotretinoin.
What are the possible side effects of this medication?
Many medications can cause side effects. A side effect is an adverse response to a drug when taken in normal doses. It can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
At least 1% of people taking this medication have reported the following side effects. Many of these side effects are manageable and a few may go away on their own over time.
Consult your doctor if you experience these side effects and if they are severe or bothersome. Your pharmacist may be able to advise you on what to do if these side effects appear:
- thinning hair (may continue after stopping treatment);
- peeling skin on the palms or soles of the feet;
- difficulty wearing contact lenses (may continue after stopping treatment);
- an upset stomach;
- unusual fatigue;
- flaky skin;
- dry skin or itchy skin;
- a dry mouth or nose;
- dry eyes (may continue after stopping treatment);
- increased sensitivity of the skin to sunlight.
Most of the side effects listed below do not happen very often, but they could cause serious problems if you do not see your doctor or get medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- the appearance of redness, pain, peeling, burning sensation, or other signs of inflammation of the lips;
- decreased hearing acuity;
- decreased visual acuity after sunset or before sunrise (sudden or may continue after stopping the drug);
- bone or joint pain or fractures;
- a rash on the face or body;
- skin infection or rash;
- behavioral changes;
- redness, itching, burning, or other signs of eye inflammation;
- bleeding or inflammation of the gums;
- muscle tenderness, pain, or stiffness (long-term treatment);
- signs of muscle damage (eg, unexplained muscle pain or tenderness, weakness, or brownish or discolored urine);
- signs attributable to increased intracranial pressure (eg, severe headache, blurred vision, dizziness, nausea, vomiting, seizures);
- signs of depression (eg, lack of concentration, weight fluctuations, trouble sleeping, indifference to many activities, suicidal thoughts);
- signs of inflammatory bowel disease (eg, severe stomach or abdominal pain, severe diarrhea, rectal bleeding);
- signs of heart problems (eg, rapid, irregular heartbeat, chest pain, sudden weight gain, difficulty breathing);
- signs of liver problems (e.g. nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools );
- symptoms of high blood sugar (eg, frequent urination, increased thirst, excessive appetite, unexplained weight loss, poorly healing wounds, infections, fruity breath);
- ringing in the ears;
- blurred vision or other visual impairment.
Stop taking the drug and seek medical attention immediately if a response such as:
- the appearance of suicidal thoughts or suicide attempts;
- signs of pancreatitis (eg pain on the upper left side of the abdomen, back pain, nausea, fever, rapid heartbeat, swollen abdomen);
- signs of a serious allergic reaction (eg, abdominal cramps, difficulty breathing, nausea and vomiting, or facial swelling and throat swelling);
- signs of a serious skin reaction (such as blistering, peeling, rash covering a large area of the body, rash that spreads rapidly, or rash with fever or discomfort).
Some people may experience side effects other than those listed. Consult your doctor if you notice any symptom that worries you while using this medication.
Are there any other precautions or warnings?
Before using any medication, be sure to tell your doctor about any medical conditions or allergies you may have, the medications you use, and any other important facts about your health. Women should mention if they are pregnant or breastfeeding. These factors may affect how you should use this medicine.
Liver disease: Several cases of hepatitis (inflammation of the liver) possibly or probably associated with treatment with isotretinoin have been reported.
If you observe the occurrence of symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or the whites of the eyes, dark urine, pale stools, abdominal pain, or swelling and itchy skin, contact your doctor immediately.
Cholesterol: Use of isotretinoin may cause an increase in cholesterol and other blood lipids. If you already have an increased risk of high cholesterol, for example, if you have a family history of this condition or diabetes, if you are overweight, or if you drink a significant amount of alcohol, you are at an increased risk of experiencing this increase in cholesterol levels while you are taking isotretinoin.
If you have any of the risk factors for high blood lipids, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing, and efficacy of this medicinal product, and the relevance of specific medical supervision.
Birth control: Isotretinoin causes birth defects in a high percentage of babies born to women who take this drug during pregnancy. Isotretinoin interacts with hormonal types of contraception (eg oral contraception), which makes it very important for women of childbearing potential to use an additional type of contraception.
Two effective methods of contraception should be used at the same time during treatment unless abstinence is required. You should use birth control for at least one month before you start taking isotretinoin, during treatment with this medicine, and for at least one month after you stop taking it.
Diabetes: Isotretinoin may cause loss of blood sugar control for people with diabetes. If you have diabetes or a member of your family has diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect dosing, the efficacy of this medicinal product, and the relevance of specific medical supervision. You may need to test your blood sugar more often.
Blood donation: You should not donate blood during your treatment with isotretinoin or for one month after stopping treatment, as pregnant women cannot receive your blood if it contains isotretinoin.
Neurological effects: Isotretinoin has been associated with a type of raised intracranial pressure known as benign raised intracranial syndrome. Early symptoms of this condition include headache, nausea, vomiting, and visual disturbances. If you observe these symptoms, contact your doctor immediately.
Muscle Effects: There have been reports of muscle damage associated with isotretinoin use, particularly after strenuous physical activity. Any unexplained muscle pain, pressure pain, weakness, cramping, or passing dark or abnormally colored urine should be reported to your doctor immediately, especially if you also experience malaise (a general painful feeling) or fever.
Rash: Isotretinoin may cause a rash or itching to appear. Rarely, do people who use isotretinoin experience a serious skin reaction that could be life-threatening. If you experience a rash that worsens or progresses to blistering, sore lips or eyes, or covering a large area of your body, contact your doctor immediately.
Sun hypersensitivity: Isotretinoin may increase your susceptibility to sunburn. Use appropriate measures to avoid excessive sun exposure. For example, wear a hat and sunglasses when you go outdoors on a sunny day, use sunscreen that provides an SPF of 15 or higher, and avoid going out in the sun between 10 a.m. and 2 p.m. The sun is at its strongest.
Contact lenses: This medication may cause dry eyes. If you wear contact lenses, you may feel uncomfortable. You can treat dry eyes by using lubricating eye ointment or artificial tears.
Inflammatory bowel disease: Use of this medication may cause irritation of the digestive system. If you experience abdominal pain, rectal bleeding, or diarrhea, contact your doctor immediately.
Behavioral changes and suicidal thoughts: Some people who have taken this medication have experienced depression, including thoughts of suicide. If you notice behavioral changes or symptoms such as sadness, hopelessness, guilt, lack of pleasure or disinterest in your usual activities, change in your sleep, irritability, or restlessness while you are taking this medication, contact your doctor immediately.
If you have a history of depression or are predisposed to depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and the relevance of specific medical monitoring.
Family members or caregivers of people taking this medication should contact their doctor immediately if they notice any unusual behavior changes.
Bones and joints: Isotretinoin can cause some minor bone changes. Consult your doctor if you notice tenderness or pain in your bones or joints or if you have difficulty moving. Your doctor may monitor you for bone changes while you are taking this medication.
Pancreatitis: Isotretinoin can cause inflammation of the pancreas. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any further specific medical supervision.
Tell your doctor right away if you notice any signs of pancreatitis such as pain on the upper left side of the abdomen, back pain, nausea, fever, chills, rapid heartbeat, or swelling of the stomach. abdomen.
If you have a history of pancreatitis, gallstones, alcoholism, or hypertriglyceridemia, you may be more likely to experience this complication.
Skin Care: Isotretinoin use causes irritation and dryness of the skin and lips. Ask your doctor or pharmacist to recommend moisturizers and lip balms that will help prevent dryness. While using isotretinoin, avoid exfoliating agents, waxing, dermabrasion, and laser treatments.
Vitamin supplements: If you are taking isotretinoin, you should not also take vitamin supplements containing vitamin A, as this may increase the side effects of vitamin A. If you do not know if any of your supplements contain vitamin A, consult your doctor or pharmacist.
Night vision: During treatment with isotretinoin, cases of reduced visual acuity at night have been reported. As some patients experience a sudden onset of visual problems, use caution when operating a motor vehicle or other vehicle at night. Report changes in your vision to your doctor.
Pregnancy: Isotretinoin causes significant birth defects in an extremely high percentage of newborns whose mothers took this drug, even for a short time during pregnancy.
Isotretinoin should not be used during pregnancy. Women should not become pregnant while taking isotretinoin or for at least one month after stopping the drug. Your doctor will perform monthly pregnancy tests while you are taking isotretinoin to confirm that continued use of this medication is safe for you.
Women who could become pregnant should not be given isotretinoin until the possibility of pregnancy has been ruled out. A pregnancy test should be taken during your first visit to the doctor. A second pregnancy test should be taken within 11 days of starting treatment. Treatment with isotretinoin should be started on the second or third day of normal menstruation following a negative pregnancy test. It is necessary to use two effective methods of contraception for at least one month before starting treatment with isotretinoin, during treatment, and for at least one month after stopping treatment.
Breast-feeding: It is not known if isotretinoin passes into breast milk. If you take this medicine while you are breastfeeding, your baby may feel the effects. Consult your doctor to find out if you should continue breastfeeding. Because of the potential for side effects, women should consider not breastfeeding if taking isotretinoin.
Children: The long-term safety of using this medication has not been established for children under 12 years of age.
Seniors: The use of isotretinoin by seniors has not been well studied. Seniors are likely to be at an increased risk of experiencing side effects from this medication.
Can other agents interact with this medicine?
There may be an interaction between isotretinoin and any of the following medicines:
- the alcohol;
- tetracycline antibiotics (e.g. doxycycline, minocycline, tetracycline);
- progestin-only contraceptives;
- St. John's wort;
- multivitamins with vitamin A;
- vitamin A.
If you are taking any of these medicines, consult your doctor or pharmacist. In your case, your doctor may ask you to:
- stop taking any of the drugs;
- replacing one of the drugs with another;
- change the way you take one or both of the medicines;
- change nothing at all.
The interference of one drug with another does not always lead to the discontinuation of taking one of them. Ask your doctor what to do in case of drug interactions.
Medications other than those listed above may interact with this medication. Tell your doctor about everything you take, including prescription and over-the-counter medications and herbal remedies. Do not forget to mention any supplements you take. If you consume caffeine, alcohol, nicotine, or illicit drugs, you should tell your prescribing doctor since these substances can affect the action of many drugs.