(SAP roe TER in) Brand: Kuvan
• Till using sapropterin, speak your doctor if you are allergic to any drugs, or if you have liver malady, a history of stomach ulcer or bleeding, or a seizure disorder.
• Also speak your doctor about any medications you use, especially levodopa (Larodopa, Altamet, Parcopa, Sinemet), methotrexate (Rheumatrex, Trexall), or any medicine to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra).
• To be certain sapropterin is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
• Sapropterin is only part of a complete program of treatment that also includes a particular diet. It is very significant to follow the diet plan created for you by your doctor or nutrition counselor. You must become very familiar with the list of foods you should avoid to help control your condition.
• If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor if you have any of these symptoms.
• Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sapropterin.
• Sapropterin is a synthetic form of a natural salt that contributes to the function of a determined enzyme in the body. In people with a condition called phenylketonuria (PKU), this enzyme is lacking or missing in the body. Without the enzyme, phenylalanine levels can become elevated and reason a variety of neurologic symptoms.
• Sapropterin is used to help the body activate the enzyme needed to control blood levels of phenylalanine. This medicine is used in people with PKU.
• Sapropterin may also be used for another purposes not listed in this medicine guide.
• Till using sapropterin, speak your doctor if you are allergic to any drugs, or if you have:
· liver disease;
· a history of stomach ulcer or bleeding; or
· epilepsy or another seizure disorder.
• If you have any of these conditions, you may not be able to take sapropterin, or you may need a doze adjustment or particular trials during treatment.
• FDA pregnancy category C. This medicine may be deleterious to an unborn child. Speak your doctor if you are pregnant or plan to become pregnant during treatment.
• It is not known whether sapropterin passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.
• Take this medicine exactly as predesigned by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
• Sapropterin is generally given once daily. Follow your doctor's instructions.
• Sapropterin works excellent if you take it with food.
• Dissolve the tablet in 4 to 8 ounces of water or apple juice. It will take about 15 minutes for the tablet to dissolve. Stir this mixture and then drink all of it right away. To create certain you get the entire doze, add a few more water or juice to the same glass, swirl gently and drink right away.
• The tablet may not completely dissolve and you may see little pieces in the liquid. These pieces are safety for you to swallow.
• To be certain this medicine is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
• Sapropterin can reduce your phenylalanine blood levels within 24 hours of when you take it. However, it may take up to 30 days of using this medication till it reaches its fullest effect in your body. For excellent results, hold using the medicine as directed.
• Sapropterin is only part of a complete program of treatment that also includes a particular diet. It is very significant to follow the diet plan created for you by your doctor or nutrition counselor. You must become very familiar with the list of foods you should avoid to help control your condition.
• Store sapropterin at room temperature away from moisture and heat. Hold the bottle tightly closed when not in use.
• Take the missed doze as soon as you remember. If it is nearly time for your following doze, wait before then to take the medication and skip the missed doze. Do not take extra medication to create up the missed dose.
• Do not take 2 doses on the same day.
• Search abnormal medical attention if you think you have used too many of this medicine.
• Overdose symptoms may include headache and dizziness.
• Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sapropterin.
• If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.
• Call your doctor at once if you have any of the serious side effects below:
· seizure (convulsions);
· chest pain or hard feeling, pain spreading to the hand or shoulder, common ill feeling;
· light bruising or bleeding;
· fever, chills, body aches, flu symptoms;
· swelling in your hands or feet;
· pain or burning when you urinate;
· weakness or fainting;
· black, bloody, or tarry stools; or
· coughing up blood or vomit that looks like coffee grounds.
• Smaller serious side effects may include:
· nausea, vomiting, stomach pain, diarrhea;
· runny or stuffy nose, cough;
· headache, feeling agitated;
· dizziness; or
· joint pain.
• This is not a complete list of side effects and others may occur. Speak your doctor about any unusual or bothersome side effect. You may message side effects to FDA at 1-800-FDA-1088.
• The next drugs can interact with sapropterin. Speak your doctor if you are using any of these:
· levodopa (Larodopa, Altamet, Parcopa, Sinemet);
· methotrexate (Rheumatrex, Trexall);
· sildenafil (Viagra);
· tadalafil (Cialis); or
· vardenafil (Levitra).
• This list is not complete and there may be another drugs that can interact with sapropterin. Speak your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start a new medicine without telling your doctor.
• Your pharmacist can provide more information about sapropterin.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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