Urinorm

Urinorm

febuxostat

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic management of hyperuricemia in patients w/ gout.
Dosage/Direction for Use
40-80 mg once daily. Initially 40 mg once daily.
Administration
May be taken with or without food: May be taken w/o regard to antacid use.
Contraindications
Hypersensitivity. Concomitant use w/ azathioprine, mercaptopurine or theophylline. Secondary hyperuricemia; patients w/ greatly increased rate of urate formation eg, malignant disease & treatment, Lesch-Nyhan syndrome.
Special Precautions
Discontinue use if gout flares occur. Not recommended in patients w/ ischemic heart disease or CHF. Monitor signs & symptoms of MI & stroke. Lab assessment of liver function prior to initiation of therapy & periodically thereafter. Discontinue use if serious allergic/hypersensitivity reactions including Stevens-Johnson syndrome occur. Patients w/ alteration of thyroid function. Organ transplant patients. Severe hepatic & renal impairment. May affect ability to drive & use machine. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Cellulitis, herpes zoster; malignant melanoma, myelodysplastic syndrome; anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia; anaphylaxis, hypersensitivity, rare serious reactions including anaphylactic reaction/shock; anorexia, decreased/increased appetite & wt, cow's milk intolerance, dehydration, DM, dyslipidemia, gout, gout flares, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia; agitation, anxiety, decreased libido, depression, insomnia, irritability, nervousness, panic attack, psychotic behavior including aggressive thoughts; altered taste, amnesia, balance disorder, burning sensation, CVA, dizziness, Guillain-Barre syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, peripheral neuropathy, somnolence, transient ischemic attack, tremor; blurred vision, cataract; deafness, tinnitus, vertigo; abnormal ECG, angina pectoris, atrial fibrillation/flutter, cardiac murmur, CV thromboembolic events [eg, CV death, MI (some fatal) & non-fatal stroke], palpitations, sinus bradycardia, tachycardia; flushing, hot flush, HTN, hypotension; bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, resp tract congestion, sinusitis, sneezing, throat irritation, upper resp tract infection, wheezing; abdominal distention & pain, colitis, constipation, dry mouth, dyspepsia, esophageal stenosis, flatulence, frequent stools, gastritis, gastroenteritis, GERD, GI discomfort, gingival pain, hematemesis, hematochezia, hyperchlorhydria, mouth ulceration, nausea, pancreatitis, peptic ulcer, rectal hemorrhage, vomiting; cholelithiasis/cholecystitis, hepatic failure (some fatal) & steatosis, hepatitis, hepatomegaly, jaundice, liver disorder/injury, serious cases of abnormal liver function test results; abnormal hair growth & skin odor, alopecia, angioedema, dermatitis, dermographism, drug reaction w/ eosinophilia & systemic symptoms, ecchymosis, eczema, erythema, exfoliative rash, hair color changes, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura; rash follicular, erythematous, macular, maculopapular, morbilliform, papular, pustular & vesicular; skin discoloration/altered pigmentation, skin hypersensitivity reactions & lesion, tinea pedis, toxic epidermal necrolysis, urticaria; arthralgia, arthritis, bunion, bursitis, costochondritis, gouty tophus, joint stiffness & swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, myalgia, rhabdomyolysis; hematuria, incontinence, kidney infection, micturition urgency, nephrolithiasis, pollakiuria, proteinuria, renal failure & insufficiency, tubulointerstitial nephritis, urgency, UTI; breast pain, erectile dysfunction, gynecomastia, mastitis; asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, flu-like symptoms, mass, pain, thirst; prolonged activated partial thromboplastin time & prothrombin time, abnormal EEG & coagulation test; increased alkaline phosphatase, amylase, BUN/creatinine ratio, blood urea, cholesterol, creatine phosphokinase, creatine, glucose, lactate dehydrogenase, LDL, mean corpuscular vol, K, prostate specific antigen, Na, TSH & triglycerides; decreased bicarbonate, hematocrit & Hb; decreased lymphocyte, neutrophil, platelet & RBC count; urinary casts, decreased/increased urine output & WBC count, urine +ve for WBC & protein; contusion.
Drug Interactions
Increased plasma conc of mercaptopurine & azathioprine resulting in toxicity. Alter the metabolism of xanthine oxidase substrate drugs (eg, theophylline).
MIMS Class
Hyperuricemia & Gout Preparations
ATC Classification
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Presentation/Packing
Form
Urinorm FC tab 20 mg
Packing/Price
30's (P510/box)
Form
Urinorm FC tab 40 mg
Packing/Price
30's (P910/box)
Form
Urinorm FC tab 80 mg
Packing/Price
30's (P1,213/box)
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