Vesanoid

DRUG DESCRIPTION

VESANOID (tretinoin) is a retinoid that induces maturation of acute promyelocytic leukemia (APL) cells in culture. It is available in a 10 mg soft gelatin capsule for oral administration. Each capsule also contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oils and soybean oil. The gelatin capsule shell contains glycerin, yellow iron oxide, red iron oxide, titanium dioxide, methylparaben and propylparaben.

Chemically, tretinoin is all-trans retinoic acid and is related to retinol (Vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44.

The structural formula is as follows:

VESANOID® (tretinoin) Structural Formula Illustration

What are the possible side effects of tretinoin (Vesanoid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, breathing problems, weight gain, swelling of your hands or feet;
  • sudden and severe pain behind your eyes, with nausea, vomiting, and vision problems;
  • black, bloody, or tarry stools; or
  • vomit that looks like blood or coffee grounds.

Less...

Read All Potential Side Effects and See Pictures of Vesanoid »

What are the precautions when taking tretinoin (Vesanoid)?

Before taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A or related drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, paraben preservatives), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high cholesterol/triglycerides (blood fats).

This drug may cause dizziness, severe headaches, or vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely....

Read All Potential Precautions of Vesanoid »


Vesanoid Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, dizziness, fever, weakness, tiredness, dry mouth, dry skin, other skin changes, thinning hair, nausea, vomiting, itching, bone pain, mouth sores, increased sweating, and earache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Headache may occur several hours after taking a dose. Mild pain medications (e.g., acetaminophen) usually help relieve these headaches, which tend to go away as your body gets used to tretinoin. Talk with your doctor about which pain relievers are right for you.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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: stomach/abdominal pain, yellowing eyes/skin, dark urine, hearing problems (e.g., hearing loss), change in the amount of urine, mental/mood changes, severe headache, persistent nausea/vomiting, vision changes, fast/slow/irregular heartbeat.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, trouble breathing, weakness on one side of the body, slurred speech, confusion, pain/redness/swelling of arms/legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A or related drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, paraben preservatives), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high cholesterol/triglycerides (blood fats).

This drug may cause dizziness, severe headaches, or vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Children may be more sensitive to the effects of this drug, especially if they are also taking tetracycline medication. Tell your doctor immediately if your child experiences severe headache, nausea/vomiting, or vision problems.

Do not donate blood while you are taking this medication and for at least 1 month after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.

This medication is not recommended for use during pregnancy due to the risk of birth defects and harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Use two effective forms of birth control together to prevent pregnancy. Talk to your doctor about reliable birth control options. (See also Warning section.)

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


Vesanoid Patient Information Including Side Effects

Brand Names: Vesanoid

Generic Name: tretinoin (Pronunciation: TRET i noin)

  • What is tretinoin (Vesanoid)?
  • What are the possible side effects of tretinoin (Vesanoid)?
  • What is the most important information I should know about tretinoin (Vesanoid)?
  • What should I discuss with my healthcare provider before taking tretinoin (Vesanoid)?
  • How should I use tretinoin (Vesanoid)?
  • What happens if I miss a dose (Vesanoid)?
  • What happens if I overdose (Vesanoid)?
  • What should I avoid while using tretinoin (Vesanoid)?
  • What other drugs will affect tretinoin (Vesanoid)?
  • Where can I get more information?

What is tretinoin (Vesanoid)?

Tretinoin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Tretinoin is used to treat acute promyelocytic leukemia (a type of blood cancer).

Tretinoin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of tretinoin (Vesanoid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, breathing problems, weight gain, swelling of your hands or feet;
  • sudden and severe pain behind your eyes, with nausea, vomiting, and vision problems;
  • black, bloody, or tarry stools; or
  • vomit that looks like blood or coffee grounds.

Less serious side effects may include:

  • feeling tired or weak;
  • headache;
  • fever;
  • dry skin, mouth, or nose;
  • bone pain;
  • nausea and vomiting;
  • rash or itching;
  • white patches or sores inside your mouth or on your lips;
  • increased sweating;
  • vision problems; or
  • hair loss or skin changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tretinoin (Vesanoid)?

Do not use vitamin A supplements or multivitamins that contain vitamin A while you are taking tretinoin.

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Tretinoin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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