Finished product reference
Sapropterin Dihydrochloride
Powder · Oral · 100 mg
- List code
- 52050
Indications
Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet. Sapropterin dihydrochloride powder for oral solution is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet.
Dosage and administration (summary)
All patients with PKU who are being treated with sapropterin dihydrochloride powder for oral solution should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. Starting Dosage Pediatric patients 1 month to 6 years: The recommended starting dosage of sapropterin dihydrochloride powder for oral solution is 10 mg/kg administered orally once daily. Patients 7 years and older : The recommended starting dose of sapropterin dihydrochloride powder for oral solution is 10 to 20 mg/kg administered orally once daily. Dosage Adjustment Doses of sapropterin dihydrochloride powder for oral solution may be adjusted in the range of 5 to 20 mg/kg taken once daily.
Contraindications
None. None.
Warnings and precautions
Hypersensitivity reactions including anaphylaxis : Sapropterin dihydrochloride is not recommended in patients with a history of anaphylaxis to sapropterin dihydrochloride; discontinue treatment in patients who experience anaphylaxis and initate appropriate medical treatment. Continue dietary Phe restrictions. Upper Gastrointestinal Mucosal Inflammation : Monitor patients for signs and symptoms of these conditions including esophagitis and gastritis.
Storage and supply
Sapropterin Dihydrochloride Powder for Oral Solution Supplied as a off-white to pale yellow powder supplied in unit dose packets as follows: 100 mg sapropterin dihydrochloride per packet: NDC 52817-850-30 Carton of 30 unit dose packets NDC 52817-850-01 Single unit dose packet 500 mg sapropterin dihydrochloride per packet: NDC 52817-851-30 Carton of…
Source: Sapropterin Dihydrochloride (Sapropterin Dihydrochloride) — US FDA prescribing information, 2026-02-18, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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