Isotretinoin (Oral)

Overview

Isotretinoin is a prescription medication that is an effective treatment for patients that suffer from disfiguring nodular acne that is severe in nature. This medication should not be used until all other options have been exhausted. Doctors have also had success in prescribing this medication for certain other skin disorders and diseases.

Women who are of childbearing age are advised to seek other medications as this drug has been reported to cause serious birth defects in women who become pregnant while taking this medication. It is important that any patients that are of childbearing age exercise a significant amount of caution and practice effective birth control methods. Patients must also advise their doctors right away if they become pregnant while taking isotretinoin. Women of childbearing age will be required to undergo a pregnancy test prior to starting this medication and will need to take another one within the first 19 days of taking the drug. Regular pregnancy tests will be required for the duration of their use of this drug, and for a six-month period following its conclusion.

Due to the potential harm that can be caused in female patients of childbearing age who are taking this medication, it is only available via the registered distribution program known as iPLEDGEâ„¢.

This medication has been reported to cause a serious allergic reaction known as anaphylaxis in some cases. Patients and their family members or caretakers are strongly advised to know the signs and symptoms of this reaction and understand what to do should they occur. This reaction can cause severe harm and even death in some cases.

Instances of some serious conditions such as pancreatitis and liver disease have been associated with the use of this medication. Patients are encouraged to review all possible side effects and ailments that can arise while taking this medication with their healthcare team prior to beginning their course of treatment.

Isotretinoin is currently available in the following delivery methods:

  • Liquid capsule
  • Capsule

Conditions Treated

  • Acne

Type Of Medicine

  • Retinoid
  • Anti-acne

Side Effects

Similar to many other prescription and non-prescription medications, isotretinoin can cause unwanted side effects in addition to the successful treatment that it provides. Certain side effects require further medical attention, while others will typically dissipate on their own without further intervention. Patients are encouraged to understand the difference between the types of side effects and how each group should be handled. Inform your doctor or another medical advisor of all of the medications that you are currently taking as they may have an effect on how your body reacts to isotretinoin.

Patients who experience any of the side effects listed below should contact their prescribing physician as they may be a sign of a more serious problem:

More likely:

  • Scaling, redness, burning, pain in the lips
  • Bone or joint pain
  • Nosebleeds
  • Trouble moving
  • Skin infection or rash
  • Burning, redness, itching or other eye inflammation

Rare likelihood:

  • Pain, tenderness, or stiffness in the muscles
  • Rectal bleeding
  • Nausea and vomiting
  • Bleeding or inflammation of the gums
  • Headaches
  • Changes in behavior
  • Abdominal or stomach pain
  • Severe diarrhea
  • Back pain
  • Mental depression
  • Pain or tenderness of the eyes
  • Decreased vision ability between dusk and dawn
  • Blurred vision or other changes in vision
  • Attempts at suicide or suicide ideation

An unknown incidence of occurrence:

  • Black, tarry stools
  • Unusual weight gain or loss
  • A bloody cough
  • Tightness in the chest
  • Bone pain, tenderness, or aching
  • Swelling of the eyelids, face, lips, hands, lower legs or feet
  • Chest pain
  • Sudden onset of severe acne on the chest and trunk
  • Constipation
  • Sudden loss of consciousness
  • Coughing or hoarseness
  • Any type of sore or spots inside the mouth, on the tongue or lips
  • A decrease in height
  • Sensitivity bright lights or sunshine
  • Difficulty speaking
  • Redness or soreness around the fingernails
  • Discharge from the eyes
  • Pale skin
  • Double vision
  • Pains in the chest, groin, or legs, especially calves of the legs
  • Excessive tearing
  • Painful cold sores or blisters on the lips, nose, eyes, or genitals
  • Fast, irregular, pounding or accelerated heartbeat
  • Pain or burning in the throat
  • Fractures and/or delayed healing
  • Muscle cramps, spasms, or weakness
  • High blood pressure
  • Loss of bladder control
  • Inability to move the arms, legs or facial muscles
  • Loosening of the fingernails
  • Indigestion
  • Joint pain, redness, stiffness, or swelling
  • Irregular yellow patch or lump on the skin
  • Irritation
  • Watery or bloody diarrhea
  • Lack or slowing of normal growth in children
  • Inflamed tissue from infection
  • Loss of appetite
  • Inability to speak
  • Loss or change in hearing
  • Hives or skin rash
  • Pain in the ribs, arms, or legs
  • Heartburn
  • Pain or tenderness around the eyes and cheekbones
  • Fever with or without chills
  • Painful or difficult urination
  • Fainting
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Ear pain
  • Pinpoint red spots on the skin
  • Dizziness
  • Redness, soreness, or itching skin
  • Difficulty swallowing
  • Sneezing
  • Difficulty breathing
  • A stuffy or a runny nose
  • Dark-colored urine
  • Sudden loss of coordination
  • Convulsions
  • Significant slurred speech
  • Confusion
  • Painful, tender or swollen feeling in the area of the lymph glands
  • Burning or stinging skin
  • Unexplained bleeding or bruising
  • Bloody or cloudy urine
  • Use of extreme physical or emotional force
  • Bloating

As the body acclimates to the introduction of isotretinoin the patient may experience certain symptoms as their system adjusts. This group of symptoms will typically go away on their own after a few days. Any side effects that cause concern can and should be discussed with the prescribing physician. If any of the following side effects linger after a few days or become worse, additional medical advice should be sought.

More likely:

  • Thinning hair
  • Peeling of the skin on palms of the hands or soles of the feet
  • Dryness of the eyes
  • Headaches
  • Dryness or itching of the skin
  • Crusting of the skin
  • Increased sensitivity of the skin to sunlight
  • Dryness of the mouth or nose
  • Stomach upset
  • Difficulty in wearing contact lenses

An unknown incidence of occurrence:

  • Lightening of treated areas of dark skin
  • Unusual drowsiness, dullness, tiredness or weakness
  • Changes in fingernails or toenails
  • Sweating
  • Dandruff
  • Skin rash, encrusted, scaly and oozing
  • Flushing
  • Redness of the face
  • Hair loss
  • Nervousness
  • Abnormal menstruation
  • Lightening of normal skin color
  • Voice changes
  • Oily skin
  • Increased hair growth, especially on the face
  • Severe sunburn
  • Hair abnormalities
  • Stomach burning
  • Darkening of the skin
  • Trouble sleeping
  • Continuing ringing or buzzing, or other unexplained noise in the ears
  • Unusually warm skin of the face
  • Burning, crawling, itching, or numbness in the hands and feet

Patients may also experience side effects that are not listed here; if the symptoms last longer than a few days, or if they worsen over time, or are of concern to the patient, it is always best practice to contact the prescribing physician for further guidance.

Dosage

Due to the harm that isotretinoin can cause to unborn, developing fetuses, it is required that women of childbearing age register with the iPLEDGEâ„¢ distribution program. This can be achieved either online or via telephone. Review the program guidelines with your doctor prior to registering; your prescription can be halted if all of the iPledge program requirements are not met.

Patients are advised to drink eight ounces of water when taking this medication; take isotretinoin with food, or as directed by your doctor. Make sure to take the capsule whole without crushing or otherwise breaking it open.

The dosage guidelines that are outlined below represent the typical way in which isotretinoin is taken. Doctors may subscribe the drug differently in certain situations, and isotretinoin should always be taken as directed by the prescribing physician.

Patients that do not find the medication effective or working as expected must first speak with their doctors prior to making any changes to the way that they take this medication.

This drug should not be taken by anyone without a prescription, and patients who are taking it under medical supervision should not share their isotretinoin with anyone, especially due to the risk of birth defects and other serious side effects.

Do not change the brand of medication that is taken as this may have an effect on the efficacy of the drug. Speak with the pharmacist immediately if it looks like a different drug has been given for your prescription.

This medication is not recommended for use in children under the age of 12.

Guidelines for the capsule delivery method of isotretinoin for the treatment of acne:

Because isotretinoin dosage is determined by the severity of the acne condition and the weight and size of the patient, there is no typical dosage amount. However, the following guidelines do exist:

  • 0.5 to 1 milligram per kilogram of body weight each day, spread over two doses. This is a typical guideline and dosage amounts and frequency of taking the drug may be changed by the prescribing physician as deemed necessary.

Never take a double dose of isotretinoin. If a scheduled dose is missed, take it immediately. If a dose is missed and the patient is unsure of how to proceed, contact the prescribing physician or pharmacist for further instruction.

Major drug interactions:

Like many other drugs, isotretinoin is contraindicated for use with other prescription and non-prescription drugs. Patients are advised to inform their doctors of all medications that they are currently taking or have recently stopped taking. Prior to prescribing isotretinoin, your doctor will determine if it is appropriate for use with your current medications and may make some alterations to how you are taking one or both of the medications.

Prior to starting the isotretinoin course of treatment, ensure that your medical team is aware of all prescription and non-prescription medications that you are taking, as well as any herbal remedies and all vitamin and mineral supplements. Also let your doctor know of any allergies that you may have, including reactions to any medications, foods, animals, cleaning solutions, or other substances prior to starting to take this medication. Asthma sufferers may experience unwanted reactions due to the inclusion Yellow dye in this medication.

Patients who are taking any of the drugs that are listed below may have the dosage amount and frequency of one or both of the medications altered:

  • Chlortetracycline
  • Lymecycline
  • Oxytetracycline
  • Desogestrel
  • Norgestimate
  • Doxycycline
  • Norelgestromin
  • Estradiol Cypionate
  • Methacycline
  • Ethinyl Estradiol
  • Medroxyprogesterone Acetate
  • Etonogestrel
  • Tetracycline
  • Meclocycline
  • Levonorgestrel
  • Mestranol
  • Ethynodiol Diacetate
  • Minocycline
  • Estradiol Valerate
  • Norethindrone
  • Drospirenone
  • Norgestrel
  • Dienogest
  • Rolitetracycline
  • Demeclocycline

Patients are advised to inform their doctor and medical team of all allergies that they have, including other medications, food, animal, cleaning solutions, and other substances. Avoid the following while you are taking isotretinoin:

  • Ethanol

The regular use of alcohol and tobacco products may interfere with how the body reacts to isotretinoin and such lifestyle habits should be relayed to the prescribing prescription for consideration.

Patients who suffer from any of the following conditions may experience complications due to the use of isotretinoin and need to inform their physician of any adverse reactions that they experience:

  • Alcoholism
  • Vitamin A overdose
  • Diabetes
  • Swelling of the brain
  • Severe weight problems
  • Intestinal disorders
  • Epiphyseal closure
  • Hepatitis
  • Osteoporosis
  • Hearing problems
  • Asthma
  • Liver disease
  • Eye or vision problems
  • Depression
  • Heart disease
  • Other bone disorders or disease
  • Hypertriglyceridemia
  • Osteomalacia
  • Pancreatitis
  • Anorexia
  • Psychosis
  • Metabolism disorder
  • Kidney disease
  • Allergy to aspirin

Warnings

The use of this medication will likely require regular diagnostic testing, such as blood or urine tests, in order to monitor the effectiveness of the drug as well as to detect and monitor any unwanted side effects. Be sure to keep all follow-up appointments and undergo all testing as scheduled while you are taking this medication.

This medication can cause serious harm to developing fetuses and every precaution should be taken by women of childbearing age who are taking isotretinoin. Doctors advise that two methods of contraception are used while on this medication in order to avoid pregnancy and the subsequent harm to the developing fetus. Alert your doctor immediately if you do become pregnant while taking isotretinoin. Make sure that you understand effective contraception and how to implement it prior to beginning your isotretinoin course of treatment.

At the conclusion of your course of treatment with isotretinoin, you must still continue to take a contraceptive for a period no less than one month. Doctors will also advise you to begin your contraceptive methods one month prior to the start of your use of isotretinoin.

Patients who are of childbearing age must have two negative pregnancy test results before they begin using this medication. They will also need to take a follow-up test 19 days following the first test and on one of the first five days of their cycle. Once it has been established that you are not pregnant, your regular course of treatment will begin. You will be required to take a monthly pregnancy test during your use of this medication as well as for a period of one month following the conclusion of your course of treatment.

Vitamin A or any vitamin or supplement that includes vitamin A must be avoided during the isotretinoin course of treatment as this vitamin can increase the likelihood of unwanted side effects. Consult with the prescribing physician for further guidance on this topic.

At the start of the isotretinoin course of treatment, the acne that is being treated may actually worsen and the affected skin may become more irritated. The first three weeks may prove difficult as the skin adjusts to the isotretinoin. If after two months, the skin condition has not improved or has become worse, the prescribing physician should be notified immediately. They may be able to alter the dosage to a more effective level or suggest a different medication.

Patients are advised against donating any blood or plasma while taking this medication and for at least 30 days following the course of treatment is completed as it could be harmful if the donation is received by a pregnant woman.

There have been some cases reported where patients who are taking isotretinoin have reported decreased night vision. This affliction can happen suddenly and patients are advised to cease driving and operating any machinery until they see their physician for further medical advice should this side effect occur.

Many patients report eye irritation while taking this medication due to the dryness that it can cause. Products such as eye drops or artificial tears can be effective temporary solutions. Patients who wear contact lenses may need to revert to eyeglasses while they are taking this medication. Any eye inflammation should be reported to your doctor as soon as possible.

This medication can cause mouth and nasal dryness that can lead to severe discomfort. Patients are advised to eat ice chips, chew gum, or utilize mints in order to receive relief from these symptoms. A saline nasal spray can be used to alleviate the discomfort that you may feel in your nose. These symptoms should dissipate as your body becomes acclimated to the presence of isotretinoin in your system. In the event that they persist for two weeks or more, notify your doctor as prolonged instances of dry mouth can lead to complications such as fungus infections, gum disease, and tooth decay.

Do not allow your skin to be exposed to harsh sunlight, cold weather, or high levels of wind. Due to the use of isotretinoin, you will be more susceptible to conditions such as skin irritation, windburn, excessive skin dryness, and sunburn. This likelihood may dissipate somewhat after two to three weeks of treatment, but preventative measures must still be taken, even after this period of time.

Patients should not utilize tanning beds or any type of tanning lamp while they are taking this medication.

Prior to spending time outside, patients are advised to generously apply an SPF of 15 or higher while taking this medication. The use of sun and other wide-brimmed hats and long-sleeved clothing is also helpful in the protecting the skin.

The use of this drug has been reported to cause some emotional and behavioral issues. If you experience any abnormal behavior such as becoming agitated or highly irritated or have suicidal thoughts or ideation or become depressed, notify your doctor right away. Any caregivers or friends and family that will be spending a lot of time with the patient using isotretinoin should also be aware of these signs and symptoms and know what to do should they occur.

The use of isotretinoin has been reported to increase the level of pressure in the patient's head while they are taking this medication. This increased pressure can lead to a higher risk of loss of vision, and may even lead to more significant brain issues and damage. Notify our doctor immediately if you experience any seizures, vomiting, blurry vision, or bad headaches. Any teenagers or adolescents who are taking this medication should also be made aware of these signs and symptoms and know what to do should they occur.

You may experience some skin reactions while taking this drug in addition to the desired changes to your acne. The following skin symptoms may warrant further medical attention and should be discussed with your doctor right away:

  • Blistering
  • Red skin lesions, often with a purple center
  • Loosening of the skin
  • Joint or muscle pain
  • Diarrhea
  • Rash
  • Chills
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Itching
  • Peeling
  • Unusual tiredness or weakness.

The use of this drug can impede progress when healing from an illness or injury, and if at any time you feel that you are experiencing any negative reaction due to the use of this medication it is important to discuss your concerns with the prescribing physician right away.

Scarring can be possible during routine hair removal procedures such as waxing; this activity should be avoided by anyone taking this medication for their entire course of treatment and for a period of six months following the conclusion of their treatment.

Do not undergo any cosmetic treatments that are designed to smooth your skin due to the possibility of scarring; these treatments should be avoided during the entire course of treatment and for a six month period following its conclusion. If you are unsure of the safety of any procedure, be sure to discuss them with your doctor beforehand.

Your blood sugar levels may be affected while you are taking this medication and you may need to undergo regular blood and urine testing, especially if you suffer from diabetes. It is important to discuss this condition with your doctor prior to starting your course of treatment.

A serious condition known as pancreatitis can happen while you are taking this drug. Be aware of any symptoms such as constipation, nausea and vomiting, severe and sudden stomach pain, lightheadedness, and chills with or without fever. Contact your doctor immediately if you experience these symptoms as you will likely need immediate medical attention.

Hearing problems have been reported in some cases. Patients who are using isotretinoin can experience symptoms such as buzzing in their ear, continuous ringing, or other hearing issues. Confer with your physician right away if you experience any issues with your ears as you may develop hearing loss if they go untreated.

Serious liver issues have been known to occur with the use of this drug and patients should notify their doctor immediately if they experience:

  • Pain or tenderness in the upper stomach
  • Loss of appetite
  • Nausea
  • Dark urine
  • Yellow eyes or skin
  • Unusual tiredness or weakness
  • Pale stools

Irritable bowel disease can also develop in patients who are taking this medication; patients are advised to contact their doctor immediately if they suffer from any of the following:

  • Severe diarrhea
  • Rectal bleeding
  • Abdominal or stomach pain

The most common symptoms of this reaction include:

  • Rash
  • Difficulty breathing
  • Redness
  • Swelling of the hands, face, or mouth
  • Itching skin
  • Soreness
  • Trouble swallowing
  • Itching

Isotretinoin has been reported to cause a serious allergic reaction known as anaphylaxis in some cases. This condition can be very dangerous to the patient and can even cause death in some cases. Patients are advised to thoroughly understand the signs and symptoms of this reaction and know what to do should they occur. If you experience this condition is important to seek emergency medical attention right away.

Patients who are allergic to aspirin may have an adverse reaction to the FD&C Yellow Number 5 that is contained in this medication. Asthma sufferers may also be more likely to have a negative reaction to this substance. Discuss any concerns that you may have about this dye with your doctor prior to beginning your isotretinoin course of treatment.

The use of this medication may lower your platelet level or white blood count; should this occur, you may be more susceptible to infection and also have complications caused by your body's decreased ability to handle bleeding and your blood may clot more slowly which can cause complications. Patients who are taking isotretinoin are advised to avoid contact with people who are currently suffering from an infection.

Alert your doctor right away if you experience any of the signs that are typically associated with infections. Do not engage in full-contact sports, and avoid situations that can cause injury or bruising. Exercise caution when using common household items such as knives and other sharp objects like nail clippers and razors.

Your doctor may want you to adjust your daily dental care habits in order to minimize the likelihood of bleeding., especially in the gum area. You may need to visit with your dentist to discuss alternative methods from brushing and flossing; however, do not undergo any dental treatment without first discussing with your doctor.

Storage

It is always best practice to store all medications in its original packaging. Isotretinoin should be kept away from direct light in a low-moisture or moisture-free environment. It should not be exposed to extreme heat or cold or be allowed to freeze.

Patients are advised to confer with their pharmacist about the safest and most appropriate way to dispose of this product as any unused isotretinoin should not be kept. Do not store expired, unused, or excess isotretinoin.

Like all other medications, isotretinoin should be kept out of the reach of both small children and pets.

Summary

Isotretinoin is a prescription medication that is an effective treatment for patients that suffer from disfiguring nodular acne that is severe in nature. This medication should not be used until all other options have been exhausted. Doctors have also had success in prescribing this medication for certain other skin disorders and diseases.

Women who are of childbearing age are advised to seek other medications as this drug has been reported to cause serious birth defects in women who become pregnant. It is important that any patients that are of childbearing age exercise a significant amount of caution and practice effective birth control methods. Patients in this group will be required to undergo regular pregnancy testing before, during, and for a six-month period after taking this medication. Discuss any concerns that you may have with your current birth control methods with your doctor prior to starting this medication.

Due to the potential harm that can be caused in female patients of childbearing age who are taking this medication, it is only available via the registered distribution program known as iPLEDGEâ„¢.

There are a number of potentially harmful side effects that can occur while taking this drug, such as pancreatitis and severe liver issues. Patients are encouraged to discuss any of their concerns with their doctors, no matter how slight they may appear to be.