Isotretinoin (Generic Accutane) 10mg
Istroin-10 (Isotretinoin 10mg)
Strips of 10 x 10mg Capsules
Manufactured by Cipla
What is Isotretinoin?
Isotretinoin is prescribed for the treatment of severe cystic acne that has not cleared up in response to milder medications such as antibiotics. It works on the oil glands within the skin, shrinking them and diminishing their output.
Most important fact about Isotretinoin
Because Isotretinoin can cause severe birth defects, including mental retardation and physical malformations, a woman must not become pregnant while taking it. Before starting Isotretinoin therapy, women of childbearing age will be asked to read a pamphlet, watch a video, and sign a detailed consent form regarding the danger of birth defects. You must have two negative pregnancy tests before beginning Isotretinoin therapy, and must take monthly pregnancy tests while using this drug.
In addition, you must use 2 forms of birth control during Isotretinoin therapy, and for 1 month before and after. Each prescription for Isotretinoin must bear a yellow qualification sticker signifying that you meet these requirements. Scientists have not ruled out the possibility that hormone-based contraceptives (birth control pills and implants) may be less reliable when taken with Isotretinoin, so a second form of birth control should always be used while taking this drug. If you accidentally become pregnant while taking Isotretinoin, you should immediately consult your doctor.
How should you take Isotretinoin?
Take Isotretinoin two times a day with a meal, unless your doctor tells you otherwise. Swallow the capsule. Don't suck or chew it. Take it with a full glass of water, milk, or other nonalcoholic liquid. Follow your doctor's instructions carefully.
Depending on your reaction to Isotretinoin, your doctor may need to adjust the dosage upward or downward. If you respond quickly and very well, your doctor may take you off Isotretinoin even before the 15 or 20 weeks are up.
After you finish taking Isotretinoin, there should be at least a 2-month "rest period" during which you are off the drug. This is because your acne may continue to get better even though you are no longer taking the medication. Once the 2 months are up, if your acne is still severe, your doctor may want to give you a second course of Isotretinoin. If you are still growing, your doctor may recommend a longer "rest period".
Avoid consumption of alcoholic beverages.
Read the patient information leaflet available with the product.
Do not crush the capsules.
Do not share Isotretinoin with anyone because of the risk of birth defects and other serious side effects.
If you miss a dose, Take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Isotretinoin.
More common side effects may include: Abnormal hair growth or loss, allergic reaction, bleeding gums, blood in urine, bowel inflammation and pain, bruising, changes in blood sugar or cholesterol levels, changes in skin pigmentation, chest pain, decreased night vision, decreased tolerance to contact lenses, delay in wound healing, depression, difficulty sleeping, dizziness, drowsiness, dry or fragile skin, dry or cracked lips, dry mouth, dry nose, fatigue, flushing, headache, hearing problems, heartbeat irregularities, herpes, inflammation or sores in the esophagus, itching, joint pain, liver disorders, menstrual changes, muscle wasting, nail disorders, nausea, nervousness, nosebleeds, peeling palms or soles, pinkeye, rash, skin infections, stomach and intestinal discomfort, stroke, sudden drop in blood pressure (causing unconsciousness), sunburn-sensitive skin, suppression of growth, sweating, swelling due to fluid retention, tendon and ligament problems, urinary discomfort, vision problems, vomiting, weakness, weight loss.
Why should Isotretinoin not be prescribed?
If Isotretinoin gives you an allergic reaction, you will not be able to use it.
If you are a woman of childbearing age, you should not take Isotretinoin if you are pregnant, if you think there is a possibility you might get pregnant during the treatment, or if you are unable to keep coming back to the doctor for monthly checkups, including pregnancy testing.
Special warnings about Isotretinoin
Stop taking Isotretinoin and notify your doctor immediately at the first sign of a skin rash or any other allergic reaction. Although they are rare, serious and even fatal allergic reactions have been known to occur.
When you first start taking Isotretinoin, it is possible that your acne will get worse before it starts to get better.
Isotretinoin may cause depression or other mental problems. In rare cases, it has prompted thoughts of suicide. If you begin to feel depressed or become troubled by suicidal thoughts, contact your doctor immediately.
Before starting Isotretinoin therapy, all patients must sign a consent form noting that they are aware of the possibility of mental side effects, the danger of birth defects, and the need for certain other precautions.
If you are a woman of childbearing age and you are considering taking Isotretinoin, you will be given both spoken and written warnings about the importance of avoiding pregnancy during the treatment. You will also be asked to sign a second consent form noting that:
- You must not take Isotretinoin if you are pregnant or may become pregnant during treatment;
- If you get pregnant while taking Isotretinoin, your baby will be at high risk for birth defects;
- If you take Isotretinoin, you must use 2 effective forms of birth control from 1 month before the start of treatment through 1 month after the end of treatment;
- You must have 2 negative pregnancy tests (one just before starting Isotretinoin therapy), and must be tested every month during therapy;
- You may participate in a program that includes an initial free pregnancy test and birth control counseling session;
- If you become pregnant, you must immediately stop taking Isotretinoin and see your doctor;
- You have read and understood the Isotretinoin patient brochure and asked your doctor any questions you had;
- You have been invited to participate in a survey of women being treated with Isotretinoin.
Some people taking Isotretinoin, including some who simultaneously took tetracycline, have experienced headache, nausea, and visual disturbances caused by increased pressure within the skull. Avoid taking tetracycline while using Isotretinoin. See a doctor immediately if you have these symptoms; if the doctor finds swelling of the optic nerve at the back of your eye, you must stop taking Isotretinoin at once and see a neurologist for further care.
Be careful driving at night. Some people have experienced a sudden decrease in night vision.
Isotretinoin affects the body's processing of fats and sugars. It should be used cautiously by people with diabetes, excess weight, high triglyceride or cholesterol levels, or a tendency to drink too much alcohol. If you have any of these conditions, your doctor will monitor you closely during Isotretinoin therapy.
You may not be able to tolerate your contact lenses during and after your therapy with Isotretinoin.
You should stop taking Isotretinoin immediately if you have abdominal pain, bleeding from the rectum, or severe diarrhea. You may have an inflammatory disease of the bowel.
You should not donate blood during your therapy with Isotretinoin and for a month after you stop taking it.
You may become more sensitive to light while taking this drug. Try to stay out of the sun as much as possible.
You should not use wax hair removal treatments or skin resurfacing procedures (dermabrasion, laser treatments) while taking Isotretinoin or for 6 months after completing therapy.
Some people taking Isotretinoin develop vision or hearing problems. If you notice changes in your vision or hearing, stop taking this drug and contact your doctor.
Possible food and drug interactions when taking Isotretinoin
While taking Isotretinoin, do not take vitamin supplements containing vitamin A. Isotretinoin and vitamin A are chemically related; taking them together is like taking an overdose of vitamin A.
Remember, too, that Isotretinoin should not be combined with tetracycline antibiotics such as Doryx, Minocin, and Vibramycin.
Special information if you are pregnant or breastfeeding
Isotretinoin causes birth defects; do not use it while pregnant. Nursing mothers should not take Isotretinoin because of the possibility of passing the drug on to the baby via breast milk.
Recommended dosage
The recommended dosage range for Isotretinoin is 0.5 to 1 milligram per 2.2 pounds of body weight, divided into 2 doses daily, for 15 to 20 weeks. For very severe cases, the doctor may increase the daily dose to as much as 2 milligrams per 2.2 pounds.
If after a period of 2 months or more off therapy, severe cystic acne persists, your doctor may prescribe a second course of therapy.
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