الأدوية والمكملات الغذائية

Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine exactly 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. Also, do not stop using this medicine without checking first with your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

For patients taking the powder form of this medicine:

• Sodium phenylbutyrate should be mixed with water or any food (solid or liquid). If the medicine is mixed with food, it should be taken right away. However, if it is mixed with water, the solution can be stored for up to one week at room temperature or in the refrigerator.
• Shake the mixed solution lightly before each use. Measure the dose with the level teaspoon or tablespoon that comes together with the package of this medicine.

Take this medicine with food.

To use the Olpruva™ oral liquid:

• Pour the entire contents of the Mix-Aid packet into 4 ounces of water in a cup and stir with spoon for 30 seconds to make the water thicker.
• Add the Olpruva™ in the mixture and stir for 15 seconds. Take the mixture within 5 minutes to prevent the coating from dissolving.
• Pour another 4 ounces of water in the cup to make sure you get full dose.
• Throw away the mixture if you have not taken it within 30 minutes of mixing.
• Do not give this medicine through a feeding tube.

To use the Pheburane® oral pellets:

• Measure the medicine with a marked measuring spoon.
• You may swallow the oral pellets with a drink (eg, water, fruit juices, protein-free infant formulas) or you may sprinkle the pellets with apple sauce or carrot puree. Take the mixture right away.
• Do not chew the pellets directly or mix with liquids.

It is important that you follow any special instructions from your doctor, such as following a low-protein diet. Also, your doctor may recommend that you take amino acid supplements. If you have any questions about this, check with your doctor.

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 the treatment of urea cycle disorders:
  • For oral dosage form (pellets):
    • Adults and children weighing 20 kilograms (kg) or more—Dose is based on body size and must be determined by your doctor. The dose is usually 9.9 to 13 grams (g) per square meter (m[2]) per day divided into 3 to 6 doses. However, the dose is usually not more than 20 g per day.
    • Children weighing less than 20 kg—Dose is based on weight and must be determined by your doctor. The dose is usually 450 to 600 milligrams per kilogram (mg/kg) of body weight per day divided into 3 to 6 doses. However, the dose is usually not more than 20 g per day.
  • For oral dosage form (powder for solution):
    • Adults, teenagers, and children weighing 20 kilograms (kg) (44 pounds) or more—The dose is based on body size and must be determined by your doctor. It is usually given 4 to 6 times a day. However, the dose is usually not more than 20 grams a day.
    • Children weighing up to 20 kg (44 pounds)—The dose is based on body weight and must be determined by your doctor. The usual dose is 450 to 600 milligrams (mg) per kilogram (kg) (205 to 273 mg per pound) of body weight per day. The dose is divided in equal amounts and given 3 to 6 times a day. However, the dose is usually not more than 20 grams a day.
  • For oral dosage form (suspension):
    • Adults and children weighing 20 kilograms (kg) or more—The dose is based on body size and must be determined by your doctor. The usual dose is 9.9 to 13 grams (g) per square meter (m[2]) per day divided into 3 to 6 doses. However, the dose is usually not more than 20 g per day.
    • Children weighing less than 20 kg—Use of the suspension is not recommended.
  • For oral dosage form (tablets):
    • Adults, teenagers, and children weighing 20 kg (44 pounds) or more—The dose is based on body size and must be determined by your doctor. It is usually given 3 times a day. However, the dose is usually not more than 20 grams (40 tablets) a day.
    • Children weighing up to 20 kg (44 pounds)—Use of the tablets is not recommended.

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.

Pheburane® oral pellets: If you have less than 3 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away unused Pheburane® oral pellets 45 days after opening the bottle.