Generic name: Isotretinoin
Brand name: Accutane
What is Isotretinoin?
Isotretinoin is a type that contains vitamin A. It lowers the amount of oil produced by the glands that produce oil in your skin. It also aids in helping your skin to regenerate faster.
Isotretinoin is a treatment for chronic nodular acne which has not had a response to other treatments which include antibiotics.
- Isotretinoin, even in one dose may cause severe birth defects or even death of a child. Avoid using this medicine in case there is a possibility of pregnancy or are able to be pregnant.
- You must pass a positive pregnancy test before you can take Isotretinoin. It is also required to make use of two forms are contraception to avoid pregnancy while taking this medication.
- Women with a child-bearing capacity should sign a contract in writing that allows them to use two distinct methods of birth control and must undergo regular pregnancy tests prior to, after, and during the course of using Isotretinoin. Stop taking Isotretinoin and consult your doctor immediately if you believe you may be pregnant.
- Isotretinoin can only be purchased through the iPLEDGE program, which is a specific program. It’s risky to try and purchase this drug through the Internet or from retailers who are not located in the United States.
- Do not take any vitamin supplements that contain vitamin A while taking Isotretinoin. Don’t donate blood when you take Isotretinoin as well for at minimum 30 days following the last day of taking it.¶
Isotretinoin should not be used in women who are pregnant. To be eligible for isotretinoin, patients must meet the following requirements:
- It is required to be registered in the iPLEDGE Program by the prescriber
- It is important to recognize that serious birth defects are possible with Isotretinoin use patients who may become pregnant
- You must be able to trust your understanding and follow instructions
- Patients must sign a Patient Information/Informed Consent (for all patients) form that includes warnings on the risks of isotretinoin
- You must obtain the prescription within 7 days of the day of collection of the specimen to perform the pregnancy test on patients who are susceptible to becoming pregnant.
- The prescription must be obtained within 30 days from the date of the office consultation for those who have not been pregnant.
- Do not give blood to anyone during treatment with isotretinoin, and for one month following treatment has been completed
- Do not share isotretinoin with anyone else, not even someone who suffers from similar symptoms.
Patients Who Can Become Pregnant
Isotretinoin is not a suitable treatment for women who are expecting. Apart from the prerequisites for all patients mentioned above, those who be pregnant must satisfy the following requirements:
- Do not be nursing or pregnant.
- You must comply with the mandatory pregnancy tests at a CLIA certified laboratory
- You must obtain the prescription within 7 days from the date of collection of the specimen for the pregnancy test.
- Should be able to comply with the contraceptive measures that are required for isotretinoin therapy. Or pledge to abstinence throughout the year, from any sexual encounter with a partner which could lead to pregnancy, and be aware of the behaviors that are which increase the chance of becoming pregnant.
- It is the patient’s being pregnant and is responsible for avoiding pregnancy one month prior, during, and one month following isotretinoin therapy.
- It is required to sign an additional Patient Information/Informed Consent Regarding birth defects (for patients who are able to become pregnant) form prior to beginning isotretinoin. The form contains information regarding the possibility of birth defects in the fetus if it is exposed to isotretinoin.
- Must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654), before starting isotretinoin, on a monthly basis during therapy, and one month after the last dose to answer questions on the program requirements and to enter the patient’s two chosen forms of contraception
- It is essential to be aware of the reason and importance of providing the information for the iPLEDGE Program should the patient become pregnant while taking isotretinoin, or within one month after the dose taken last.
Before taking this medication, you must consult your physician.
Isotretinoin may result in miscarriage, premature birth, severe birth defects, or even death of a child when the mother is taking this medicine prior to the time of conception or the pregnancy. Even one dose of isotretinoin could cause serious birth defects to the baby’s eyes, ears or face, skull the heart, brain, and. Don’t take Isotretinoin in the event that you are pregnant, or have the potential to be pregnant.
For women: Unless you have been able to have your ovaries and uterus taken out (total Hysterectomy) or you have been in the menopausal phase for at minimum 12 months consecutively then you’re thought to be in a position to become pregnant. It is necessary to pass two positive pregnancy tests prior to when you begin taking Isotretinoin prior to each refill just after taking the last dose, and then another 30 days after.
You must have a written agreement to use two different methods of birth control starting 30 days prior to the date you begin taking Isotretinoin and ending thirty days after the last dose. Primary and the second type of birth control should be used in conjunction.
The most common birth control methods are:
- tubal ligation (tubes tied);
- Vasectomy for the sexual partner of a male
- an IUD (intrauterine device);
- Estrogen-rich birth-control pills (not miniature pills) and
- Birth control patch with hormonal hormones implant, injections, or vaginal rings.
Other forms of birth control are:
- A condom made of male latex with either the spermicide;
- A diaphragm and spermicide
- an upper cervical cap, as well as a spermicide
- A vaginal sponge that contains Spermicide.
Stop taking Isotretinoin and contact your doctor immediately if you experience unprotected sexual relations, if you have stopped using birth control, in the event that your period is delayed or you suspect that you are pregnant.
The absence of sexual contact (abstinence) can be the best method for keeping a woman from becoming pregnant.
You shouldn’t take Isotretinoin in the event that you have an allergy to isotretinoin.
To be sure Isotretinoin is appropriate for you, ask your doctor if ever experienced:
- Depression (or mental illness)
- Liver disease;
- Heart disease, chest pain, and the high level of cholesterol;
- osteoporosis or low bone mineral density
- an eating disorder like anorexia
- A food or drug allergy or
- an intestinal disorder, such as an inflammatory bowel disorder as well as ulcerative colitis.
Do not breastfeed.
Not permitted for use by anyone less than twelve years of age.
How to take Isotretinoin?
You should take Isotretinoin exactly as directed by your physician. Follow all instructions on the label of your prescription and also read the medication guide or instructions sheets.
Every prescription for Isotretinoin must be filed within seven days from the date it was prescribed by your physician. The amount you receive is not more than a 30 day supply of Isotretinoin at a time.
Always use Isotretinoin with an entire cup of liquid. Do not chew or chew into the capsule. Take it as a whole.
Follow the directions for the use of Isotretinoin either with food or not.
Make sure to take this medication for the entire prescribed amount of duration. Your acne may appear to worsen at first However, it should start to improve.
You might require regular blood tests.
Do not share this medication with a person else even if they suffer from similar symptoms as you do.
Keep at room temperature, free of heat, moisture, and light.
Isotretinoin dosing information
Usual Adult Dose for Acne:
Dosage for maintenance: 0.25 to 0.5 mg/kg orally, 2 times per day.
Maximum dose: Up to 2 mg/kg/day
Therapy duration: up to the 20-week mark.
Usual Pediatric Dose for Acne:
Age 12 or over:
Maintenance dose: 0.25 to 0.5 mg/kg orally, 2 times per day.
-Maximum dose: 2 mg/kg/day
The duration of treatment: Up to 20 weeks
Patients are advised to take certain forms of this medication together with food.
Prior to increasing the dose, the patient should be questioned about their compliance to the treatment (e.g. using the drug along alongside food).
Patients with extreme acne, scarring, or other primary manifestations on the trunk might require a dose of 2 mg/kg/day.
Refills for any patient require an updated prescription as well as a fresh authorization issued by the program iPLEDGE.
The safety and efficacy of a daily dosing schedule are not proven; so, daily dosing is not advised.
Use: Treatment for severe, recalcitrant nodular acne patients who do not respond to standard treatment, such as the use of systemic antibiotics
What if I miss a dose?
Take the missed dose off and take the next dose at your regular time. Avoid using two doses at the same time.
If I consume too much?
Get medical attention immediately or contact toll-free the Poison Help line at 1-800-222-1222. The symptoms of an overdose could be a headache, dizziness, vomiting, stomach pain, warmth or tingling on your face, swelling and cracked lips as well as an inability to equilibrium or coordination.
What to avoid while taking Isotretinoin?
Do not take any mineral or vitamin supplement that has vitamins Unless your physician advises you to.
Don’t donate blood while taking isotretinoin, and up to 30 days following you cease the medication. Donated blood that is later donated to a woman who is pregnant could cause birth defects in her child if the blood has any amount of isotretinoin.
When you’re on Isotretinoinas well for at minimum six months following your last dose: Avoid using wax hair removal products or laser treatments or dermabrasion. The result of scarring could be.
It can cause sunburn more quickly. Avoid sun exposure or tanning beds. Be sure to wear protective attire and sunblock (SPF 30 or greater) while you’re outdoors.
Avoid driving and other hazardous activities until you are aware of the effects this medication will have on you. It can affect your vision, particularly at night.
Isotretinoin side effects
See a doctor immediately If you are experiencing symptoms that indicate an allergy reaction Isotretinoin(hives or breathing problems and swelling of your throat or face) or an intense skin reaction (fever and sore throat eye burning, irritation or red or purple itching, blistering, and peeling).
Stop taking Isotretinoin and contact your doctor immediately if you experience:
- issues with your hearing or vision;
- joint or muscle pain or joint pain or lower back pain;
- Increased thirst, more frequent urine production;
- hallucinations (see or hear things that aren’t real);
- signs of depression abnormal mood changes emotional relapses, crying spells, feeling of low self-esteem and a loss of enthusiasm for things you previously were enjoying new sleeping problems, and thoughts of hurting yourself
- symptoms of pancreas or liver issues weight loss and stomach pain in the upper part of your stomach (that can be transferred into your lower rear), nausea or vomiting, fast heart rate dark urine, yellowing of the eyes or skin (yellowing in the eyes or skin);
- severe stomach issues stomach problems that are severe. heart pain or while eating, heartburn, diarrhea, rectal bleeding or bloody stool; or
- increased pressure in the skull Headaches that are severe and ear ringing nausea, dizziness eye problems, eye pain.
Common Isotretinoin side effects could be:
- dryness of your lips, skin, and eyes (you might have nasal bleeding);
- vision issues;
- headache, back pain, joint pain, muscle problems;
- skin reactions skin reactions
- signs of cold-like congestion, sneezing, and sore throat.
This is not a comprehensive list of possible side effects, and others could happen. Consult your physician for advice regarding medical adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.
What other medications can impact Isotretinoin?
Discuss with your doctor any other medications you take including:
- St. John’s wort (may cause birth control pills to be less efficient);
- Vitamin or mineral supplements;
- birth control pills that contain progestin (mini-pills are not guaranteed to work equally well when combined together with isotretinoin);
- steroid medicine; or
- a tetracycline antibiotic, including doxycycline or minocycline.
This list is not comprehensive. Other drugs can interact with isotretinoin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. There are many possible interactions between drugs. are listed here.
Your pharmacist doctor can give additional information on Isotretinoin.
Keep all medicines away from the reach of children. Do not give your medication to anyone else and make sure you use Isotretinoin only as given.
Always consult your doctor to make sure the information presented on this page is applicable to your specific situation.