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Diterin
Brand Name :
Diterin
Generic Name :
Sapropterin Dihydrochloride
Partner :
Dipharma
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Diterin Leaflet
What is this drug and what is it used for?
Diterin is used to treat hyperphenylalaninaemia (HPA) or phenylketonuria (PKU) in adults and children of all ages. HPA and PKU are due to abnormally high levels of phenylalanine in the blood, which can be harmful.
This medicine is also used to treat an inherited disease called BH4 deficiency in adults and children of all ages, in which the body cannot produce enough BH4.
How is this drug given?
PKU
The recommended starting dose of Diterin in adults and children with PKU is 10 mg for each kg of body weight. Your doctor may adjust your dose, usually between 5 and 20 mg for each kg of body weight per day, depending on your condition.
BH4 deficiency
The recommended starting dose of Diterin in adults and children with BH4 deficiency is 2 to 5 mg for each kg of body weight. Your doctor may adjust your dose up to 20 mg for each kg of body weight per day, depending on your condition.
Your doctor may decide to divide your total daily dose into 2 or 3 doses, distributed over the day, to achieve the best therapeutic effect.
Method of Administration
Use in all patients
Place the prescribed number of tablets in a glass or cup of water as accurately described below and stir until dissolved.
It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster you can crush them. Small particles may be visible in the solution, but they will not affect the effectiveness of the medicine. Drink the dissolved preparation of Diterin with a meal, at the same time each day within 15 to 20 minutes of its preparation.
Do not swallow the desiccant capsule contained in the bottle.
Use in adults
Place the prescribed number of tablets in a glass or cup (up to 120 ml) of water and stir until dissolved.
Use in children above 20 kg body weight Place the prescribed number of tablets in a glass or cup (up to 120 ml) of water and stir until dissolved.
Use in children up to 20 kg body weight
The dose of Diterin is based on body weight. This will change as your child grows. Your doctor will tell you:
- The number of Diterin tablets needed for one dose
- The amount of water needed to mix one dose of Diterin
- The amount of solution you will need to give your child for their prescribed dose
Possible side effects:
Few cases of allergic reactions (such as skin rash and serious reactions) have been reported.
Serious allergic reactions
Very common side effects (may affect more than 1 in 10 people)
Headache and runny nose.
Common side effects (may affect up to 1 in 10 people)
Sore throat, nasal congestion or stuffy nose, cough, diarrhea, vomiting, stomach ache and too low levels of phenylalanine in blood tests.