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Tretinoin (Oral route)

Pronunciation:

TRET-i-noin

Brand Names:

  • Vesanoid

Dosage Forms:

  • Capsule, Liquid Filled

Warnings:

Oral route(Capsule, Liquid Filled)

Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to tretinoin including retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. High-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. Patients can also develop rapidly evolving leukocytosis during therapy which can lead to an increased risk of life-threatening complications. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. Pregnancy testing is necessary prior to initiation of treatment in women of childbearing potential and the patient must be instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

Retinoid

Uses of This Medicine:

Tretinoin belongs to the group of medicines known as retinoids (RET-i-noyds). It is used to treat a form of leukemia (acute promyelocytic leukemia [APL]).

Tretinoin has side effects that can be very serious. Be sure that you discuss with your doctor the good that this medicine can do as well as the risks of taking it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies in a limited number of children between 1 and 16 years of age have shown that children may be especially sensitive to the effects of this medicine, and may be more likely than adults to experience severe headaches and some other side effects during treatment.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tretinoin in the elderly with use in other age groups.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aminocaproic Acid
  • Aprotinin
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Tetracycline
  • Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Fluconazole
  • Ketoconazole
  • Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

It is very important that you take tretinoin only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For acute promyelocytic leukemia (APL):
      • Adults—Dose is based on body size and must be determined by your doctor. The usual dose is 45 milligrams (mg) for each square meter of body surface area a day, given in two equally divided doses.
      • Children—The dose will be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it is almost time for your next dose, check with your health care professional to find out how much medicine to take for the next dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects.

Tretinoin causes fever, headache, tiredness, and weakness in most people who take it. It is very important that you continue taking the medicine even if it makes you feel ill. Your health care professional may be able to suggest ways to relieve some of these effects. However, if you develop a very severe headache or a headache that occurs together with nausea, vomiting, or vision problems, check with your doctor right away.

Tretinoin sometimes causes a severe reaction that affects the lungs at first, but can later spread to other parts of the body. Signs of this reaction include breathing problems, bone pain, chest pain, and fever. Check with your doctor right away if any of these effects occur during treatment .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Black, tarry stools
bleeding
blistering
bloody stools
bone pain
burning
coldness
difficulty in moving
discomfort or pain in chest
enlarged heart
feeling of pressure
fever
hives
infection
inflammation
joint pain
lumps
numbness
paleness of skin
rash
redness
scaring
seizures
shortness of breath, troubled breathing, tightness in chest, or wheezing
soreness
stinging
sweating increased
swelling
swollen joints
tenderness
tingling
ulceration
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
warmness at site
weight gain (occurring together with any of the other symptoms listed before)
Less common
Blue lips and fingernails
convulsions (seizures)
difficulty in speaking, slow speech, or inability to speak
faintness
feeling of heaviness in chest
headache (severe)
inability to move arms, legs, or muscles of the face
nausea and vomiting (occurring together with a headache)
no blood pressure or pulse
pain in back or left arm
painful, red lumps under the skin, mostly on the legs
prominent superficial veins over affected area
stopping of heart
unconsciousness
vision problems (occurring together with a headache)
warmth

Check with your doctor as soon as possible if any of the following side effects occur:

More common
Any change in vision (not occurring with a headache)
coughing, sneezing, sore throat, and stuffy or runny nose
cracked lips
crusting, redness, pain, or sores in mouth or nose
decreased urination
earache or feeling of fullness in the ear
increase or decrease in blood pressure
irregular heartbeat
mental depression
pain in stomach, side, abdomen or back
pain and swelling in leg or foot
skin rash
swelling of abdomen (stomach area)
swelling of face, fingers, hands, feet, or lower legs
Less common
Bone swelling
cramping or pain in stomach (severe)
difficult or painful urination
drowsiness (very severe and continuing)
hallucinations (seeing, hearing, or feeling things that are not there)
hearing loss
heartburn, indigestion, or nausea (severe and continuing)
mood, mental, or personality changes
pain in lower back or side
swollen area that feels sore and tender
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Acid or sour stomach
agitation
anxiety
belching
blurred vision
bloating
burning, crawling, or tingling feeling in the skin
chills
confusion
constipation
darkened urine
diarrhea
dizziness
dryness of skin, mouth, or nose
fast heartbeat
flushing
general feeling of discomfort or illness
hair loss
headache (mild and not occurring together with other side effects)
indigestion
irritability
itching of skin
loss of appetite
mood or mental changes
muscle pain
nausea and vomiting (not occurring together with a headache)
shivering
trouble sleeping
weakness
weight loss
Less common
Anxiety and restlessness (occurring together)
clumsiness or unsteadiness when walking
difficulty sleeping
disorientation
forgetfulness
frequent urination
lethargy
lightheadedness
low body temperature
redness, soreness or itching skin
sores, welting or blisters
sores on genitals
swelling of feet or lower legs
thirst
trembling, sometimes with a flapping movement
weak or feeble pulse
weakness in legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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