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Toctino

Toctino

Alitretinoin

Toctino (Alitretinoin) is a vitamin A derivative that belongs to the class of medications called retinoids. Retinoids are usually used to treat skin problems.

Available form

Capsule

Dosage

10mg, 30mg

Manufacturers

Glaxosmithkline

Generic brand of

Alitretinoin

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Toctino information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The usual starting dose of Toctino (Alitretinoin) is 30 mg taken once daily at the same time every day with a meal. People who experience severe side effects may find it necessary to reduce the dose to 10 mg daily. The 30 mg dose will cause the skin to clear faster, but both strengths work to clear the skin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Toctino (Alitretinoin) should be taken with food, preferably with a main meal.

Toctino (Alitretinoin) is usually taken for 12 to 24 weeks depending on your response. If your eczema is still severe after 12 weeks, discuss with your doctor whether continuing the medication will improve your skin.

It is important to take Toctino (Alitretinoin) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Toctino (Alitretinoin) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Toctino (Alitretinoin). If you are concerned about side effects, discuss the risks and benefits of Toctino (Alitretinoin) with your doctor.

The following side effects have been reported by at least 1% of people taking Toctino (Alitretinoin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

change to hair texture
difficulty in wearing contact lenses (may continue after treatment is stopped)
dizziness
dry eyes (may continue after treatment is stopped)
dry or itchy skin (especially of lips and face)
Dry Mouth or nose
flushing
headache (mild)
increased sensitivity of skin to sunlight
nosebleeds
pain or tenderness of eyes
persistent noise in ears
stomach upset
thinning of hair (may continue after treatment is stopped)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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

back pain
bone or joint pain
burning, redness, itching, or other signs of eye inflammation
decreased night vision
headache (severe or continuing)
increased blood pressure
increased cholesterol and triglycerides in the blood
increased frequency of infections
increased liver enzymes in the blood
mood changes
muscle pain or stiffness
peeling of skin on palms of hands or soles of feet
scaling, redness, burning, pain, or other signs of inflammation of lips
signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of decreased thyroid function (e.g., Constipation, cold intolerance, weight gain, fatigue)
signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of inflammatory bowel disease (e.g., severe abdominal or stomach pain, severe Diarrhea, nausea, vomiting, rectal bleeding)
swelling of feet and lower legs
symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

signs of increased blood pressure in the brain (e.g., lasting headache, nausea, vomiting, changes in vision)
signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen)
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
signs of vision changes (e.g. blurred vision, distorted vision, cloudy surface on the eye)
thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Toctino (Alitretinoin).

Do not take Toctino (Alitretinoin) if you:

are allergic to Toctino (Alitretinoin), other retinoids (e.g., Isotretinoin), or any ingredients of the medication
are allergic to peanuts or soya
are breast-feeding
are under 18 years of age
are pregnant
are taking Tetracycline antibiotics (e.g., tetracycline, doxycycline, Minocycline)
have fructose intolerance
have High Cholesterol and/or triglyceride blood levels
have reduced liver function
have reduced Thyroid function that is not being treated
have severe Kidney Disease
have very high levels of vitamin A

Toctino (Alitretinoin) should not be taken by women who may become pregnant unless ALL of the following conditions apply:

You have severe chronic hand eczema that has not responded to high potency topical corticosteroids.
You are reliable in understanding and carrying out instructions.
You are able and willing to comply with the mandatory birth control measures for at least one month before, during, and at least one month after treatment.
You have received, and acknowledged understanding of, a careful oral and printed explanation of the hazards of fetal exposure to Toctino (Alitretinoin), and the risk of possible birth control failure.
You have been informed and understand the need to quickly consult your doctor if there is a risk that you may be pregnant.
You understand the need for strict monthly follow-up with regular monthly pregnancy tests.
You use effective birth control without any interruption for one month before, during, and for one month after stopping Toctino (Alitretinoin). You are aware that 2 reliable forms of birth control should be used at the same time without interruption including a barrier method.
You have had two blood or urine pregnancy tests with negative results, performed in a licensed laboratory, at least 3 weeks apart, before beginning treatment on Toctino (Alitretinoin). You have had 2 or 3 days of your next normal menstrual period before Toctino (Alitretinoin) therapy is initiated.
Take a pregnancy test at your doctor’s office one month after stopping treatment with Toctino (Alitretinoin).
If you require additional treatment with Toctino (Alitretinoin) in the future, you must also follow the same requirement for birth control before, during and after taking Toctino (Alitretinoin).
Your doctor has counselled you using the TOCTINO Pregnancy Prevention Program which includes detailed information about Toctino (Alitretinoin), a checklist of the above conditions, detailed information on birth control options, and a consent form for your review and signature.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Toctino (Alitretinoin).

Blood donation: You should not give blood during treatment with Toctino (Alitretinoin) and for one month after stopping treatment in case the blood is given to a pregnant woman.

Bones and joints: Toctino (Alitretinoin) may cause some minor bone changes. Talk to your doctor if you notice aches or pains in the bones or joints, or have difficulty moving. Your doctor may monitor you for bone changes while you are taking Toctino (Alitretinoin).

Cholesterol: Toctino (Alitretinoin) can cause increases in cholesterol and other lipids in the blood. If you are already at an increased risk of developing high cholesterol, for example if you have a family history of high cholesterol, Diabetes, are overweight, or have an increased alcohol intake, you are more likely to experience this.

If you are at any increased risk of developing increased blood lipids, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed.

Depression and suicidal thoughts: Retinoid medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Toctino (Alitretinoin), contact your doctor as soon as possible.

Diabetes: Toctino (Alitretinoin) may cause a loss of control of blood sugar levels for people with diabetes. If you have diabetes, or anyone in your family has diabetes, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Stomach and bowels: Toctino (Alitretinoin) may cause inflammatory bowel disease (IBD). If you have inflammatory bowel disease, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed.

If you experience severe abdominal pain, rectal bleeding, or severe diarrhea, you should stop using Toctino (Alitretinoin) and contact your doctor.

Liver function: Retinoids like Toctino (Alitretinoin) have been linked to inflammation of the liver in some cases. If you have liver problems, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Toctino (Alitretinoin).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Neurologic effects: Toctino (Alitretinoin) has been linked to causing intracranial hypertension (increased pressure around the brain), also known as pseudotumor cerebri. Early symptoms of this condition include headache, nausea, vomiting, and visual disturbances. If you have these symptoms call your doctor immediately.

Skin care: Toctino (Alitretinoin) causes irritated, dry skin and lips. Ask your doctor or pharmacist for appropriate moisturizers and lip balms to use to prevent severe dryness. While you are taking Toctino (Alitretinoin), avoid exfoliators, waxing, and dermabrasion.

Sun sensitivity: Toctino (Alitretinoin) may make you more likely to burn in the sun. Use appropriate measures to prevent excessive exposure to the sun. Wear a hat and sunglasses when out in the sun, use a sunscreen that provides an SPF of 30 or higher, and avoid going out in the sun between 10 am and 2 pm when the sun is at its strongest. Avoid using sun lamps and tanning beds.

Thyroid disease: Toctino (Alitretinoin) may cause changes in thyroid function. The thyroid gland produces hormones that help the body make energy and organs work properly. If you experience unexpected fatigue, intolerance to cold or weight gain, contact your doctor as soon as possible. If you have thyroid problems, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. Your doctor may want to test your thyroid function regularly with blood tests while you are taking Toctino (Alitretinoin).

Vision: Toctino (Alitretinoin) may cause dry eyes. This usually disappears after stopping the medication. Using a lubricating eye drop may help with this side effect. Also, decreased night vision has been reported by people taking Toctino (Alitretinoin) . This may happen suddenly and without warning. Use caution when driving or operating any vehicle at night. Report any night vision changes to your doctor. Stop taking the medication and seek immediate medical attention if you notice other signs of vision changes, such as blurred vision, distorted vision, or a cloudy surface on the eye.

Vitamin supplements: You should not take vitamin supplements containing vitamin A if you also take Toctino (Alitretinoin) as this may increase the side effects of vitamin A. Talk to your doctor or pharmacist if you are not sure which of your supplements might contain vitamin A.

Pregnancy: Toctino (Alitretinoin) causes severe birth defects in an extremely high percentage of infants born to women who take Toctino (Alitretinoin) even for a short period of time during pregnancy.

Toctino (Alitretinoin) must not be used during pregnancy. Women must not become pregnant while taking Toctino (Alitretinoin) or for at least one month after stopping the medication. Your doctor may perform monthly pregnancy tests while you are taking Toctino (Alitretinoin) to confirm the safety of continuing to take Toctino (Alitretinoin).

Women who may become pregnant must not be given Toctino (Alitretinoin) until pregnancy is excluded. A pregnancy test must be performed at the initial assessment appointment with your doctor. A second pregnancy test must be performed within 11 days of starting treatment. Toctino (Alitretinoin) treatment should start on the second or third day of the next normal menstrual period following this negative pregnancy test. Effective birth control must be used for at least one month before starting Toctino (Alitretinoin) treatment, during the treatment, and for at least one month following the discontinuation of treatment.

Two reliable forms of birth control should be used at the same time during treatment unless abstinence is the chosen method.

Breast-feeding: It is likely that Toctino (Alitretinoin) passes into breast milk. If you are a breast-feeding mother and are taking Toctino (Alitretinoin), it may harm your baby. Women who are taking Toctino (Alitretinoin) must not breast-feed.

Children: The safety and effectiveness of using Toctino (Alitretinoin) have not been established for children. Toctino (Alitretinoin) is not recommended for use if you are under the age of 18.

Seniors: The use of Toctino (Alitretinoin) by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from Toctino (Alitretinoin).

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