The reference site for Isotretinoin

Isotretinoin (INN), also known as 13-cis-retinoic acid, is an oral pharmaceutical drug primarily used to treat severe nodular acne.

WHAT IS ISOTRETINOIN?

Isotretinoin is a form of Vitamin A that is prescribed by dermatologists for severe acne that has not improved with other milder therapy.

It is especially recommended if cysts are present and when the body (e.g. chest and back) is affected rather than only the face.

This medicine makes the sebaceous glands less productive, reduces the size of the sebaceous glands and reduces the inflammation (redness and swelling) of the skin in acne. It affects the development of pimples and blackheads and reduces the amount of the bacteria “Propionibacterium acnes”.

 

Brand Name(s): Accutane; Amnesteem; Claravis; Sotret
CAS nº: 4759-48-2
(eye so treh tih noyn)

 

Product Info

The sections below will provide you with more specific information and guidelines related to isotretinoin and its correct use. Please read them carefully.

FDA Information

Prior to the development of isotretinoin, the mainstay treatment of severe acne was oral antibiotics such as the tetracyclines and erythromycin. While these drugs have proven efficacy, they worked against only one contributing factor of acne – the Propionibacterium acnes bacteria. The antibiotics gradually became less effective over time as more resistant strains of the bacterium became prominent.

An early, effective treatment of acne was high doses of the fat-soluble vitamin A. At these dose levels (sometimes 500,000 IU per day) effects such as reduced production of sebum and dry hair could be noticed. However the vitamin also had many other prominent side effects which inhibited its widespread use.

The development of the retinoic acid derivative isotretinoin (13-cis-retinoic acid), and its release in 1982 by Hoffmann-La Roche, was a great step forward in the treatment of acne. The synthetic compound provided better therapeutic benefit than vitamin A, while also producing fewer adverse effects. In February 2002, Roche’s patents for isotretinoin expired and there are now many other companies selling cheaper generic versions of the drug.

Today isotretinoin is usually prescribed after other acne treatments have failed to produce results. The treatment of acne usually begins with topical medications (e.g. benzoyl peroxide, adapalene, etc), followed by oral antibiotics (or a combination) and finally isotretinoin therapy. This is because other treatments, while less effective than isotretinoin, are associated with far fewer adverse effects and lower cost.

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Isotretinoin is a form of Vitamin A that is prescribed by dermatologists for severe acne that has not improved with other milder therapy. It is especially recommended if cysts are present and when the body (e.g. chest and back) is affected rather than only the face.

Acne is caused by inflammation of the skin. It primarily affects teenagers, but it also affects adults. Severe acne causes permanent scarring of the skin. The inflammation is caused in part by an increased secretion of sebum (oily substance) from glands in the skin (sebaceous glands). The sebum provokes inflammation, and the inflammation resolves (heals) with the formation of a scar (keratinization).

This medicine makes the sebaceous glands less productive, reduces the size of the sebaceous glands and reduces the inflammation (redness and swelling) of the skin in acne. It affects the development of pimples and blackheads and reduces the amount of the bacteria “Propionibacterium acnes”.

Other uses for this medicine

Isotretinoin has been used to treat other skin disorders, including keratosis follicularis, pityriasis rubra pilaris, lamellar ichthyosis, keratosis palmaris et plantaris, rosacea, and leukoplakia.

However, it is advised that you talk to your doctor about the possible risks of using this drug for your condition.

Dosage and using this medicine

Take isotretinoin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Isotretinoin is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, isotretinoin can cause serious side effects. Before starting treatment with isotretinoin, discuss with your doctor how bad the acne is, the possible benefits of isotretinoin and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with isotretinoin therapy.

Additionally, you will get no more than a 30-day supply of isotretinoin at a time. Your prescription should have a special yellow self-adhesive sticker attached to it. If your prescription does not have this yellow sticker, call your doctor. Your local pharmacy should not fill the prescription without this sticker.

Take each dose of isotretinoin with a full glass of water. This will help prevent the medication inside the capsule from irritating the lining of the esophagus. For the same reason, do not chew or suck on the capsule.

Furthermore, take isotretinoin twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.

Take all of the isotretinoin that has been prescribed to you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed.

Importantly, your doctor may suggest taking more than one course of therapy with isotretinoin, should it be required. So too, your doctor may perform blood tests during treatment with isotretinoin to monitor side effects from this medication.

Due to the serious side effects that may occur with the use of this medication, do not share it with anyone else.

What special precautions should I follow?

BEFORE TAKING ISOTRETINOIN:

It is important that you inform your doctor if you have a personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there), diabetes, asthma, heart disease, osteoporosis (bone loss) or weak bones, anorexia nervosa, high cholesterol or triglyceride levels (types of fat) in the blood, or liver disease. You may not be able to take isotretinoin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Do not take vitamin supplements containing vitamin A during treatment with isotretinoin. This could cause increased side effects.

Do not donate blood while taking isotretinoin and for at least 1 month following the end of treatment. Blood donated while taking isotretinoin may be given to a pregnant woman and be harmful to her baby.

Furthermore, it is advised not to use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking isotretinoin and for six months following treatment due to the possibility of scarring.

Avoid exposure to sunlight or UV rays while taking isotretinoin. Isotretinoin may increase the sensitivity of the skin to sunlight and a severe sunburn could result.

Use caution when driving a vehicle at night. Isotretinoin can cause decreased night vision. The onset of decreased night vision may be sudden.

Additionally, do not take isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking isotretinoin. Isotretinoin is in the FDA pregnancy category X. This means that isotretinoin is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that isotretinoin may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking isotretinoin. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with isotretinoin, during treatment with isotretinoin, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking isotretinoin. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking isotretinoin and notify your doctor.

It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose.

Do not take a double dose of this medication.

What side effects can this medication cause?

BEFORE TAKING ISOTRETINOIN:

It is important that you inform your doctor if you have a personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there), diabetes, asthma, heart disease, osteoporosis (bone loss) or weak bones, anorexia nervosa, high cholesterol or triglyceride levels (types of fat) in the blood, or liver disease. You may not be able to take isotretinoin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Do not take vitamin supplements containing vitamin A during treatment with isotretinoin. This could cause increased side effects.

Do not donate blood while taking isotretinoin and for at least 1 month following the end of treatment. Blood donated while taking isotretinoin may be given to a pregnant woman and be harmful to her baby.

Furthermore, it is advised not to use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking isotretinoin and for six months following treatment due to the possibility of scarring.

Avoid exposure to sunlight or UV rays while taking isotretinoin. Isotretinoin may increase the sensitivity of the skin to sunlight and a severe sunburn could result.

Use caution when driving a vehicle at night. Isotretinoin can cause decreased night vision. The onset of decreased night vision may be sudden.

Additionally, do not take isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking isotretinoin. Isotretinoin is in the FDA pregnancy category X. This means that isotretinoin is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that isotretinoin may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking isotretinoin. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with isotretinoin, during treatment with isotretinoin, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking isotretinoin. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking isotretinoin and notify your doctor.

It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.

What storage conditions are needed for this medicine?

Always keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Remeber to throw away any medication that is outdated or no longer needed. If you are unsure, please talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of an overdose, call your local poison control center at 1-800-222-1222. However, if the victim has collapsed or is not breathing, call the local emergency services on 911.

Symptoms of overdose may include:

– vomiting
– abdominal pain
– flushing of the face
– inflammation of the lips
– headache
– dizziness
– clumsiness

Product Images

PICTURES OF ISOTRETINOIN PILLS

Below you will find images and specific information on the principal types of isotretinoin that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

 

Name: AMNESTEEM®
Strength(s): 10 MG
Imprint: AMNESTEEM
Manufacturer: BERTEK PHARM.

Name: SOTRET®
Strength(s): 20 MG
Imprint: SOTRET
Manufacturer: RANBAXY

Name: AMNESTEEM®
Strength(s): 20 MG
Imprint: AMNESTEEM
Manufacturer: BERTEK PHARM.

Name: ACCUTANE®
Strength(s): 20 MG
Imprint: ACCUTANE 20 ROCHE
Manufacturer: ROCHE LABS.

Name: ACCUTANE®
Strength(s): 40 MG
Imprint: ACCUTANE 40 ROCHE
Distributor: PHYSICIANS TC.

Name: AMNESTEEM®
Strength(s): 40 MG
Imprint: AMNESTEEM
Manufacturer: BERTEK PHARM.

Name: SOTRET®
Strength(s): 40 MG
Imprint: SOTRET
Manufacturer: RANBAXY

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