- May 11, 2022
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Brand Name :
Orfadin, nityr
Synonyms :
Nitisinone, nitisinona
Class :
Enzyme inhibitors, therapeutic agents
Dosage Forms & Strengths
Capsule
2mg
5mg
10mg
20mg
Oral suspension
4mg/ml
Tablet
2mg
5mg
10mg
Initial dose
:
0.5
mg/kg
Orally
every 12 hours twice a day
Tablet
If succinylcholine is present in urine, increase the dose to 0.75mg/kg orally twice a day
Alternate maintenance regimen-Undetectable concentration of succinyl acetone:
Maintenance dose: 1-2mg/day
Maximum dose: 2mg/day
Dosage Forms & Strengths
Capsule
2mg
5mg
10mg
20mg
Oral suspension
4mg/ml
Tablet
2mg
5mg
10mg
Initial dose
:
0.5
mg/kg
Orally
every 12 hours twice a day
Tablet
If succinylcholine is present in urine, increase the dose to 0.75mg/kg orally twice a day
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may increase serum concentration of OAT1/3 substrates
may increase serum concentration of OAT1/3 substrates
may increase the serum concentration of oat1/3 substrates
it enhances by affecting the hepatic enzyme CYP2C9 metabolism
may increase the level by affecting hepatic enzyme CYP2C9 metabolism
may enhance the serum concentration of OAT1/3 Substrates
Frequency defined:
>10%
Increased tyrosine levels
Liver transplantation
1-10%
Malignant hepatic neoplasm
Thrombocytopenia
Corneal opacity
Photophobia
Blepharitis
Dry skin
Exfoliative dermatitis
Granulocytopenia
Porphyria
Liver failure
Leukopenia
Conjunctivitis
Keratitis
Alopecia
Cataracts
Epistaxis
Eye pain
Maculopapular rash
Pruritis
<1%
Brain tumor
Hyperkinesia
Abdominal pain
Enanthema
Melena
Hypoglycemia
Bronchitis
Seizure
Encephalopathy
Cyanosis
Diarrhea
Hemorrhage
Elevated hepatic enzymes
Septicemia
Pregnancy consideration:
US FDA Pregnancy category: C
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient information leaflet
Generic Name: nitisinone
Pronounced: [ nye-TIS-i-none]
Why do we use nitisinone?
It is used to treat type 1 hereditary tyrosinemia (excessive tyrosine in the blood)
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