Panretin

DRUG DESCRIPTION

Panretin® gel 0.1% contains alitretinoin and is intended for topical application only. The chemical name is 9-cis-retinoic acid and the structural formula is as follows:

Panretin® (alitretinoin) Structural Formula Illustration

Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C20H28O2. It is slightly soluble in ethanol (7.01 mg/g at 25oC) and insoluble in water. Panretin (alitretinoin) ® gel is a clear, yellow gel containing 0.1% (w/w) alitretinoin in a base of dehydrated alcohol USP, polyethylene glycol 400 NF, hydroxypropyl cellulose NF, and butylated hydroxytoluene NF.

What are the possible side effects of alitretinoin topical (Panretin)?

Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor

  • redness;
  • itching;
  • irritation;
  • warmth;
  • burning, stinging, or...

Read All Potential Side Effects and See Pictures of Panretin »

What are the precautions when taking alitretinoin (Panretin)?

Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids (e.g., tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of cancer (skin T-cell lymphoma).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this...

Read All Potential Precautions of Panretin »


Panretin Consumer (continued)

SIDE EFFECTS: Redness, rash, pain, burning, itching, stinging, or tingling at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/crusting/oozing/peeling of the skin, severe burning/stinging of the skin, swelling of the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids (e.g., tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of cancer (skin T-cell lymphoma).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Panretin Patient Information Including Side Effects

Brand Names: Panretin

Generic Name: alitretinoin topical (Pronunciation: ah lih TREH tin oyn)

  • What is alitretinoin topical (Panretin)?
  • What are the possible side effects of alitretinoin topical (Panretin)?
  • What is the most important information I should know about alitretinoin topical (Panretin)?
  • Who should not use alitretinoin topical (Panretin)?
  • How should I use alitretinoin topical (Panretin)?
  • What happens if I miss a dose (Panretin)?
  • What happens if I overdose (Panretin)?
  • What should I avoid while using alitretinoin topical (Panretin)?
  • What other drugs will affect alitretinoin topical (Panretin)?
  • Where can I get more information?

What is alitretinoin topical (Panretin)?

Alitretinoin is a topical retinoid. Alitretinoin affects the growth and development of skin cells.

Alitretinoin topical is used to treat skin lesions caused by AIDS-related Kaposi's sarcoma.

Alitretinoin topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of alitretinoin topical (Panretin)?

Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor

  • redness;
  • itching;
  • irritation;
  • warmth;
  • burning, stinging, or pain;
  • rash;
  • peeling;
  • swelling or inflammation;
  • numbness or tingling;
  • cracking, crusting, or scabbing; or
  • drainage.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alitretinoin topical (Panretin)?

Avoid prolonged exposure to sunlight. Alitretinoin topical may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Do not use products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products, while using alitretinoin topical. There is an increased risk of harmful effects from DEET when it is used with alitretinoin topical.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

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