Tretinoin

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for other skin conditions, including acne.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Read the Patient Information Leaflet if available from your pharmacist before you start taking tretinoin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily. Swallow the capsules whole with water. Do not chew, dissolve, or open the capsule. If you vomit, do not take another dose to catch up. Take your next dose at the regular time.

The dosage is based on your medical condition, body size, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

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 last or get worse, notify your doctor or pharmacist promptly.

Headache may occur several hours after taking a dose. Mild pain medications (such as 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 this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: stomach/abdominal pain, yellowing eyes/skin, dark urine, hearing problems (such as hearing loss), signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as depression, anxiety, thoughts of suicide), fast/slow/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: nausea/vomiting that doesn't stop, severe headache, vision changes, chest pain, jaw/left arm pain, trouble breathing, weakness on one side of the body, trouble speaking, confusion, pain/redness/swelling of arms/legs.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Before taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); 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, heart problems, mental/mood problems (such as depression).

This drug may make you dizzy or cause severe headaches or vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Children may be at greater risk for increased pressure in the brain (intracranial hypertension) while using this drug. Get medical help right away if your child has symptoms such as severe headache, nausea/vomiting that doesn't stop, or vision changes.

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 must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Warning section.)

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts, liver function, blood cholesterol and triglyceride levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is less than 10 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Tretinoin may cause serious (sometimes fatal) side effects, usually within the first month of treatment with this medication. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you have symptoms such as fever, trouble breathing, unusual tiredness, weight gain, swelling of the arms/legs/ankles/feet, dizziness, or fainting. Your doctor may temporarily stop your treatment if you get serious side effects.

This drug may cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. You must have a negative pregnancy test before starting treatment and monthly pregnancy tests may also be done while you are taking this medication. Women using this medication should discuss the use of at least 2 reliable forms of birth control (such as condoms, birth control pills) during treatment and for 1 month after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 1 week after the last dose. Consult your doctor for more details. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away. (See also Precautions section).