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Isotretinoin

Generic Name: Isotretinoin (oral) [EYE-so-TRET-i-noyn]
Names of brands: Absorica, Absorica LD, Accutane, Amnesteem, Claravis, etc. List the 11 brands.
Dosage Form: Micronized 16 mg; micronized 24 mg; micronized 32 mg; micronized 8 mg)oral capsule (10 mg; 20 mg; 25 mg; 30 mg; 35 mg; 40 mg;
Classification of Drugs: Miscellaneous antineoplastics, miscellaneous uncategorized agents

What is Isotretinoin?

Isotretinoin is one form of vitamin A that can be used for treating acne nodules that haven't responded to other treatments, which include antibiotics.

Isotretinoin is only available from a pharmacy that is certified as part of a specific program known as iPLEDGE.Isotretinoin can also be used for reasons not mentioned in this guideline.

Side effects of Isotretinoin?

Contact emergency medical assistance. If you notice symptoms warning signs of an allergic response (hives, breathing problems, and swelling in your throat or face) or an extreme skin reaction (fever and sore throat, burnt eyes, irritation, and an ailment that is purple or red with peeling and blisters),

Isotretinoin may cause serious side effects. Stop taking isotretinoin and contact your doctor immediately if you experience:

  • Issues with your hearing or vision;
  • Muscle as well as joint discomfort; bone pain; lower back pain;
  • increased thirst and more frequent urine production;
  • Hallucinations (seeing or hearing sounds that don't exist);
  • Signs of symptoms of depression—unusual mood swings emotional relapses, crying spells, low self-esteem, a loss of interest in things that you previously enjoyed, sleep issues, and thoughts about harming yourself
  • Indications of pancreas or liver problems: decreased appetite, stomach pain in the upper part of your stomach (that can be aggravated by back pain), nausea or vomiting, fast heart rate, and dark urine the appearance of jaundice (yellowing in the eyes or skin);
  • Serious stomach problems, such as severe chest or stomach pains and pain when swallowing stomach pain, heartburn, diarrhea, bleeding in the rectal area, bloody or tarry stool,
  • Increased pressure in the skull: severe headaches, ringing of your ears, nausea, dizziness, eye problems, headaches behind your eyes

Common side effects of isotretinoin include:

  • Dryness of your lips, skin, eyelids, nose, or lips (you may experience nosebleeds);
  • Vision issues;
  • Headache, back pain, joint pain, muscle problems;
  • Skin reactions skin reactions
  • Symptoms like nasal stuffiness, sneezing, and a sore throat.

This is not a comprehensive list of all the side effects. Others could happen. Consult your physician to seek medical advice on adverse effects. You can report any symptoms to the FDA at 1-800-FDA-1088.

Warnings

Isotretinoin taken in one dose may cause serious birth defects or even the death of a child. Do not take isotretinoin if you are pregnant or planning to become pregnant.

It is necessary to have a positive pregnancy test before you can take isotretinoin. Additionally, you will be required to utilize two types of contraceptives to avoid the possibility of becoming pregnant while taking this medication. Stop taking isotretinoin and contact your doctor immediately. If you suspect you may be pregnant,

Before you Take this Drug

Isotretinoin could cause miscarriage and premature births, as well as severe birth defects or even the death of a child, when the mother is taking this medication at the moment of conception or during pregnancy. Even one dose of isotretinoin could cause serious birth defects in the baby's eyes, ears, face, skull, heart, brain, and Do not take isotretinoin if pregnancy is imminent or you have the potential to become pregnant.

For women: Unless you have had your ovaries and uterus eliminated (total hysterectomy with an oophorectomy) or you have been in the menopausal stage for a minimum of 12 consecutive months, you're thought to be in a position to become pregnant. It is necessary to pass two negative pregnancy tests prior to when you begin taking isotretinoin, prior to each refill just after taking the last dosage of isotretinoin, and then again after 30 days. Every pregnancy test is obligatory through the iPLEDGE program.

You must have a written agreement to use two different types of birth control, beginning 30 days before the day you begin taking isotretinoin and lasting for 30 days after the expiration of your last dose. Primary and secondary types of birth control need to be used in conjunction.

Birth control options that are primary comprise:

  • Tubal ligation (tubes tied);
  • The vasectomy procedure of the sexual partner, who is male
  • An IUD (intrauterine device);
  • Estrogen-based birth-control pills (not miniature pills) and
  • Hormone-based birth control pills, implants, patches, injections, or vaginal rings.

Other forms of birth control are:

  • A condom made of male latex with or without spermicide
  • A diaphragm plus spermicide;
  • A cervical cap and a spermicide
  • Vaginal sponges that contain spermicide

Stop taking isotretinoin and contact your doctor right away in the event of unprotected sexual activity after quitting birth control, if you notice that your period is not on time, or if you suspect that you are pregnant. If you become pregnant while using isotretinoin, contact the iPLEDGE pregnancy registry at 1-86-495-0654.

Avoiding sexual interaction (abstinence) can be the best way to stop pregnancy.It is recommended not to take isotretinoin if you have an allergy to it.

Speak to your doctor if you have ever suffered from:

  • Depression or mental illnesses
  • Asthma;
  • Liver disease;
  • Diabetes;
  • The heart condition, also known as high cholesterol;
  • Osteoporosis or low bone mineral density
  • An eating disorder like anorexia;
  • A food or drug intolerance
  • An intestinal disorder such as inflammatory bowel disease and ulcerative colitis.

Do not breastfeed.

Not authorized to be used by anyone less than 12 years old.

How to Take Isotretinoin?

Follow the directions on the prescription label and also read all medication guides or instruction sheets. Follow the medication exactly as prescribed.

Every prescription for isotretinoin has to be filled within seven days from the day it was issued by your physician. You can receive no more than 30 days of isotretinoin.

Always take isotretinoin with a complete glass of drinking water. Don't chew or chew into the capsule. Take it in whole.Follow all instructions for taking isotretinoin, either with or without food.

Utilize isotretinoin for the entire prescribed duration. The acne might appear to be getting worse initially, but it should start to improve.You might require regular blood tests.

Do not share this medication with anyone else, even if they share the same symptoms as you do.Maintain at room temperature and free of heat, moisture, and light.

Details on Dosage

Usual Adult Dose for Acne:

Dosage for maintenance: 0.25 to 0.5 mg/kg taken orally twice a day.
Maximum dose: up to 2 mg/kg/day
Time of treatment: up to 20 weeks
Comments:
Patients should take a few forms of this medication in conjunction with food.
Prior to increasing the dosage, the patient should be questioned about their compliance with the medication (e.g., taking this medication alongside food).
Patients suffering from extreme acne, scarring, or primary signs 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 effectiveness of daily dosing have not been proven, so daily dosing is not advised.
Use: Treatment for severe, recalcitrant nodular acne patients who do not respond to standard treatment, such as antimicrobials that are systemic.

Usual Pediatric Dose for Acne:

Age 12 or over:
Maintenance dose: 0.25 to 0.5 mg/kg orally twice a day.
Maximum dose: 2 mg/kg/day
The duration of treatment: up to 20 weeks
Comments:
Patients should take a few doses of this medication along with food.
Prior to increasing the dosage, patients should be questioned about their compliance with treatment (e.g., taking the drug alongside food).
Patients with extreme acne, scarring, or primary signs on the trunk could require 2 mg/kg/day of dosing.
Any patient who wants to refill their prescription requires an updated prescription as well as authorization from the iPLEDGE Program.
The safety and effectiveness of a daily dosing schedule aren't proven, so daily dosing is not advised.

Treatment for severe recalcitrant nodular acne in patients who do not respond to conventional treatment, which includes the use of systemic antibiotics

What Happens If I Miss a Dose?

Don't miss the dose you missed; take the next dose at the normal time. Don't take two doses at once.

What Happens If I Overdose?

Get medical attention immediately, contact emergency medical attention, or call the Poison Help line at 1-800-222-1222. The symptoms of an overdose could include nausea, headache, dizziness, stomach pain, warm or tingling sensations in your face, swelling, and cracked lips, as well as a loss of stability or coordination.

What Should be Avoided?

Don't consume a vitamin or mineral supplement that has vitamin A or other vitamin A unless your physician has told you to.

Don't donate blood during the time you take isotretinoin or up to 30 days following your cessation of the medication. Donated blood that is later donated to a pregnant woman may cause birth defects in the child if the blood has a high concentration of isotretinoin.If you are taking isotretinoin, for at least six months following your last dose, don't use wax hair removers or undergo laser or dermabrasion treatments. The result of scarring could be

Isotretinoin can cause skin to burn more quickly. Avoid tanning beds or sunlight. Be sure to wear protective attire and apply sunblock (SPF 30 or greater) while you're outdoors.Avoid driving and other hazardous activities until you understand how isotretinoin affects your vision. Isotretinoin can impair your vision, particularly at night.

Interaction with Other Drugs

Discuss with your doctor any other medications you take, particularly:

  • Phenytoin;
  • St. John's wort (which may cause birth control pills to be less efficient);
  • Vitamin or mineral supplements;
  • Birth control pills that are progestin only (mini-pills are not guaranteed to work effectively when used in conjunction with isotretinoin);
  • Steroid medicine,
  • A tetracycline antibiotic that includes doxycycline and minocycline.

This list isn't complete. Other medications can affect isotretinoin, such as medications that are prescribed and available over the counter, vitamins, and herbal supplements. There are many possible interactions between drugs. are included here.

DRUG STATUS

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Prescription only

Pregnancy & Lactation

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