NO- URIC®
100 or 300 Tablets
Composition :
Each tablet contains:
Allopurinol 100 or 300 mg
Properties:
NO- URIC- (allopurinol) is an inhibitor 0 xanuune oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthin(. and of xanthine to uric acre, the end product of purine metabolism. Therefore. it reduces uric acid production by inhibiting biochemical reactions preceding its formation. This results In the reduction of urate and uric acid concentrations in plasma and urine. Most of the activity is due to the metabolite oxypurinol, which also is an inhibitor of xanthine oxidase.
Phannacokinetics:
Up to 90% of a dose of allopurinol is absorbed from the gastrointestinal tract after oral administration. 11 is distributed widely throughout body; its plasma half-life is about 1 – 2 hours. Allopurinol is metabolized by xanthine oxidase to oxypurinol which has a plasma half-life of about 15 hours. This is prolonged by renal impairment. Allopurinol and oxypurinol are not bound to plasma proteins. Excretion occurs primarily in urine, with minute amounl excreted in faeces. AbO’Ut 70% of a daily dose may be excreted as oxypurinol and up 10 10 % as allopurinol.
Indications:
Gout, primary or secondary to hyperuricamia: acute attacks, tophi, joint destruction. uric acid lithiasis, or nephropathy. Hyperuricemia secondary to malignancies leukemia. lymphoma Prevention of acute gouty attacks. Prevention of uric acid nephropathy durior cancer chemotherapy. Recurrent calcium oxalate calculi in preset-ea of hyperuricosuria.
Dosage and Administration:
– Gout, primary or secondary to hyperuricemia: Dosage varies with severity of diseasecan be given as single dose or In divided doses, but doses larger than 300 mg should be divided. Adults: Mild gout, 200 to 300 mg daily; severe gout with large tophi, 400 to 600 mg daily. Same dosage lor maintenance in gout secondary to hyperuricemia.
– Hyperuricemia secondary to malignancies: Children ages 6 to 10 : 300 mg daily in single or divided doses. Children younger than age 6 : 50 mg three times daily.
– Prevention of acute gouty attacks: Adults: 100 mg daily; increase at weekly intervals by 100 mg without exceeding maximum dose (800 mg), until uric acid level falls to 6 mgll00 ml or less.
– Prevention of uric acid nephropathy during cancer chemotherapy: Adults: 600 to 800 mg daily for 2 to 3 days, with high fluid intake.
– Recurrent calcium oxalate calculi: Adults: 200 to 300 mg daily in single or divided doses.
– Patients with renal impairment: 100 mg every 3 days if creatinine clearance is up to 9 ml/minute; 100 mg every 2 days, 10 to 19 ml/minute; 100 mg daily, 20 to 39 ml/mlnute; 150 mg daily, 40 to 59 mllmiunte; 200 mg daily, 60 to 79 mllminute; 250 mg daily, 80 ml/minule.
– Give drug with or immediately after meals to minimize adverse GI reactions.
Drug Interactions:
– ACE inhibitors: Higher risk of hypersensitvrty reaction. Monitor patient closely.
– Amoxicillin, ampicillin, bacampicilhn: Increases poSSibility of rash. Avoid using together.
– Anticoagulants, dicumarol: Potentiales anticoagulant effect. Dosage adjustment may be needed .
– Antineoplastics: May increase potential lor bone marrow suppression. Monitor patient carefuUy.
– Azathioprine, mercaptopurine (purinelhoQ: May increase levels of these drugs. Dosage adjustments may be needed.
– Chlorpropamide: May increase hypoglycemic effect. Avoid using together.
– Diazoxide, diuretics, mecamylamine, pyrazinamide: May increase uric acid level.
Allopurinol dosage adjustment may be needed.
– Ethacrynic acid, thiazide diuretics: May increase risk of allopurinol toxicity. Reduce
dosage 01 allopurinol and closely monitor renal function.
– Ur!cosuric drugs: Additive e~ect. May be us~d to therapeutic advantage.
– Urine-acidifying drugs: May Increase possibility of kidney stone forrnanon.Monitor patient carefully.
– Xanthines: May increase theophylline level. Adjust dosage of theophylline.
– Alcohol use: May increase uric acid level. Discourage using together.
Precautions:
-No.. URIC* should be discontinued at first appearance of skin rash or other signs of
allergic reactions.
– Patients with impaired renal function require careful observation during the early stages Of treatment; reduce dosage or discontinue therapy if increased abnormalities in renal function appear and persist.
– The drug should be used with caution in:
– pregnancy.
– Lactation.
– Hepatic or renal impairment.
– NO· URIC~ is rarely indicated for use in children, with the exceptions of those with
bvperurtcemla secondary to malignancy.
– CBC, liver, and kidney function should be periodically determined especially during the first few months of therapy.
– Acute attacks of gout may occur during the earty stages of NO- URIC administration. A prophylactic dose of colchicine (0.5 mg three times daily) may be given for at least one month.
– Monitor fluid intake and output. Daily urine output of at least 2 liters and maintenance of neutral or slightly alkaline urine are desirable.
– Patients should observe caution while driving or performing other tasks requiring
etertness. coordination or physical dexterity.
– Advise patient taking allopurinol for treatment of recurrent calcium oxalate stones to reduce intake of animal protein, sodium, refined sugars, oxalate-rich foods, and calcium.
Contraindications:
– Hypersensitivity to the product.
– Patients with idiopathic hemochromatosis.
Side Effects:
– Skin rash, usually maculopapular, sometimes scaly or exfoliative, is the most common. It may be increased in renal disorders. It is recommended that NO- URIC411 be withdrawn immediately if a rash occurs. Other side effects may include drowsiness, headache, nausea, vomiting, diarrhea, and abdominal pain,
Packaging:
No -URIC411100 Tablets: Box of 5 strips of 10 tablets each.
NO-URIC411300 Tablets: Box of 2 strips of 10 tablets each.
– Keep out of reach of children.
– To be used under medical supervision.
produced by :
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO. E_I.P_I. CO.
EGYPT
