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Rx Item-Orfadin- Nitisinone Capsule 2Mg 60 Caps

ORFADIN- nitisinone capsule 2MG 60 CAPS 
 NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60
 Packager: SWEDISH ORPHAN BIOVITRUM AB (PUBL)

 Category: HUMAN PRESCRIPTION DRUG LABEL
 DBRAND: ORFADIN NDC: RX66658-0102-60 ,RX66658010260  UPC: 366658-102603,366658102603 ORFADIN- nitisinone capsule 2MG 60 CAPS 
 NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60
 PackaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Orfadin- Nitisinone Capsule 2Mg 60 Caps

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item No.:RX66658-0102-60 NDC No.RX66658010260 UPC No.:366658102603 Item No.:RX66658-0102-60 ORFADIN- nitisinone capsule 2MG 60 CAPS
NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60
Packager: SWEDISH ORPHAN BIOVITRUM AB (PUBL)
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

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hese highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN � (nitisinone) capsules, for oral use ORFADIN � (nitisinone) oral suspension Initial U.S. Approval: 2002 RECENT MAJOR CHANGES Dosage and Administration, Dosage (2.1) 09/2017 INDICATIONS AND USAGE ORFADIN is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. (1) DOSAGE AND ADMINISTRATION Recommended Dosage (2.1): The recommended starting dosage is 0.5 mg/kg orally twice daily. In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose may be given once daily. Titrate the dosage based on biochemical and/or clinical response, as described in the full prescribing information. The maximum total daily dosage is 2 mg/kg orally . Preparation and Administration Instructions (2.2): For instructions on preparing, measuring and administering the oral suspension, see the full prescribing information. Maintain dietary restriction of tyrosine and phenylalanine Take ORFADIN capsules at least one hour before, or two hours after a meal For patients who have difficulties swallowing capsules and who are intolerant to the oral suspension, the capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use. Take ORFADIN oral suspension without regard to meals. DOSAGE FORMS AND STRENGTHS Capsules: 2 mg, 5 mg, 10 mg, 20 mg. (3) Oral suspension: 4 mg/mL (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques: Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust ORFADIN dosage in order to lower the plasma tyrosine concentration. Obtain slit-lamp examination prior to treatment and re-examination if symptoms develop. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status. (5.1) Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts. (5.2) Risk of Adverse Reactions Due to Glycerol Content of ORFADIN Oral Suspension: Doses of 20 mL of ORFADIN oral suspension may cause headache, upset stomach and diarrhea due to the glycerol content. Consider switching patients to ORFADIN capsules. (5.3) ADVERSE REACTIONS Most common adverse reactions (>1%) are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS CYP2C9 Substrates: Potential for increased systemic exposure of these co-administered drugs, additional monitoring may be warranted. (7.1) See 17 for PATIENT COUNSELING INFORMATION. Revised: 9/2017

ORFADIN- nitisinone capsule 2MG 60 CAPS 
 NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60
 Packager: SWEDISH ORPHAN BIOVITRUM AB (PUBL)

 Category: HUMAN PRESCRIPTION DRUG LABEL
 D
RX ITEM-Orfadin- Nitisinone Capsule 2Mg
ORFADIN- nitisinone capsule 2MG 60 CAPS NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60 Packager: SWEDISH ORPHAN BIOVITRUM AB (PUBL) Category: HUMAN PRESCRIPTION DRUG LABEL D

BRAND: ORFADIN NDC: RX66658-0102-60 ,RX66658010260  UPC: 366658-102603,366658102603 ORFADIN- nitisinone capsule 2MG 60 CAPS 
 NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60
 Packa
Orfadin- Nitisinone Capsule 2Mg 60 Caps
BRAND: ORFADIN NDC: RX66658-0102-60 ,RX66658010260 UPC: 366658-102603,366658102603 ORFADIN- nitisinone capsule 2MG 60 CAPS NDC Code(s): 66658-102-60, 66658-105-60, 66658-110-60, 66658-120-60 Packa

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.