Components:
Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 28.05.2022
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Top 20 medicines with the same components:
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Zyloric 100 (Zyloric 100) reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharma-cokinetics. Zyloric 100 (Zyloric 100) is indicated in:
- the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
- the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with Zyloric 100 (Zyloric 100) should be discontinued when the potential for overproduction of uric acid is no longer present.
- the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
Zyloric 100 is used to prevent or treat high uric acid levels in the blood. Gout or gouty arthritis (inflammation and pain in a joint) is caused by high uric acid levels. Zyloric 100 is a xanthine oxidase inhibitor that works by causing less uric acid to be produced by the body.
Zyloric 100 is also used to prevent or treat high uric acid levels that may be caused by cancer medicines or for patients with kidney stones that contain calcium.
Zyloric 100 is available only with your doctor's prescription.
The dosage of Zyloric 100 (Zyloric 100) to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg/day for patients with mild gout and 400 to 600 mg/day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg-tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The minimal effective dosage is 100 to 200 mg daily and the maximal recommended dosage is 800 mg daily. To reduce the possibility of flare-up of acute gouty attacks, it is recommended that the patient start with a low dose of Zyloric 100 (Zyloric 100) (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximal recommended dosage.
Normal serum urate levels are usually achieved in 1 to 3 weeks. The upper limit of normal is about 7 mg/dL for men and postmenopausal women and 6 mg/dL for premenopausal women. Too much reliance should not be placed on a single serum uric acid determination since, for technical reasons, estimation of uric acid may be difficult. By selecting the appropriate dosage and, in certain patients, using uricosuric agents concurrently, it is possible to reduce serum uric acid to normal or, if desired, to as low as 2 to 3 mg/dL and keep it there indefinitely.
While adjusting the dosage of Zyloric 100 (Zyloric 100) in patients who are being treated with colchicine and/or anti-inflammatory agents, it is wise to continue the latter therapy until serum uric acid has been normalized and there has been freedom from acute gouty attacks for several months.
In transferring a patient from a uricosuric agent to Zyloric 100 (Zyloric 100), the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of Zyloric 100 (Zyloric 100) gradually increased to the required dose needed to maintain a normal serum uric acid level.
It should also be noted that Zyloric 100 (Zyloric 100) is generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least 2 liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.
Since Zyloric 100 (Zyloric 100) and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of Zyloric 100 (Zyloric 100) should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of Zyloric 100 (Zyloric 100) is suitable. When the creatinine clearance is less than 10 mL/min, the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clearance less than 3 mL/min) the interval between doses may also need to be lengthened.
The correct size and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.
For the prevention of uric acid nephropathy during the vigorous therapy of neoplastic disease, treatment with 600 to 800 mg daily for 2 or 3 days is advisable together with a high fluid intake. Otherwise similar considerations to the above recommendations for treating patients with gout govern the regulation of dosage for maintenance purposes in secondary hyper-uricemia.
The dose of Zyloric 100 (Zyloric 100) recommended for management of recurrent calcium oxalate stones in hyperuricosuric patients is 200 to 300 mg/day in divided doses or as the single equivalent. This dose may be adjusted up or down depending upon the resultant control of the hyperuricosuria based upon subsequent 24 hour urinary urate determinations. Clinical experience suggests that patients with recurrent calcium oxalate stones may also benefit from dietary changes such as the reduction of animal protein, sodium, refined sugars, oxalate-rich foods, and excessive calcium intake, as well as an increase in oral fluids and dietary fiber.
Children, 6 to 10 years of age, with secondary hyperuricemia associated with malignancies may be given 300 mg Zyloric 100 (Zyloric 100) daily while those under 6 years are generally given 150 mg daily. The response is evaluated after approximately 48 hours of therapy and a dosage adjustment is made if necessary.
How supplied
100-mg (white) scored, flat cylindrical tablets imprinted with "Zyloric 100 (Zyloric 100) 100" on a raised hexagon, bottles of 100 (NDC 65483-991-10).
Store at 15° to 25°C (59° to 77°F) in a dry place.
300-mg (peach) scored, flat, cylindrical tablets imprinted with "Zyloric 100 (Zyloric 100) 300" on a raised hexagon, bottles of 100 (NDC 65483-993-10) and 500 (NDC 65483-993-50).
Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.
Manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834 for Prometheus Laboratories Inc. San Diego, CA 92121. October 2003. FDA Rev date: 7/17/2002
See also:
What is the most important information I should know about Zyloric 100?
Known hypersensitivity to Zyloric 100 or to any of the ingredients of Zyloric 100.
Patients who have developed a severe reaction to Zyloric 100 should not be restarted on the drug.
Patients with mild uratemia without symptom (uric acid <90 mg/L).
Use in lactation: There are reports which indicates that Zyloric 100 and oxipurinol are excreted in human breastmilk. Therefore, Zyloric 100 should not be used during lactation.
Use in children: Zyloric 100 is contraindicated in children (except in malignant conditions especially leukemia and certain enzyme disorders eg, Lesch-Nyhan syndrome).
Use Zyloric 100 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Zyloric 100 by mouth after meals to decrease stomach upset.
- Drinking extra fluids while you are taking Zyloric 100 is recommended. Check with your doctor for instructions.
- Continue to take Zyloric 100 even if you feel well. Do not miss any doses.
- If you miss a dose of Zyloric 100, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zyloric 100.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Oral:
Gout, treatment: Management of primary or secondary gout (acute attack, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)
Guideline recommendations: EULAR guidelines: Urate-lowering therapy (ULT) (eg, Zyloric 100) is indicated in all patients with recurrent flares, tophi, urate arthropathy, and/or renal stones. ULT initiation is recommended close in time to first diagnosis in patients presenting at a young age (<40 years of age) or with very high serum uric acid levels (>8 mg/dL) and/or comorbidities (eg, renal impairment, hypertension, ischemic heart disease, heart failure) (EULAR [Richette 2017]).
Nephrolithiasis, prevention of recurrent calcium stones: Management in patients with hyperuricosuria (uric acid excretion >800 mg/day in men and >750 mg/day in women)
Tumor lysis syndrome, prevention: Management of hyperuricemia associated with cancer treatment for leukemia, lymphoma, and other malignancies
Limitations of use: Zyloric 100 is not recommended for the treatment of asymptomatic hyperuricemia. Zyloric 100 reduces serum and urinary uric acid concentrations; its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics.
IV:
Tumor lysis syndrome, prevention: Management of hyperuricemia associated with cancer treatment for leukemia, lymphoma, or solid tumor malignancies in patients who cannot tolerate oral therapy.
Off Label Uses
Nephrolithiasis, prevention of recurrent uric acid stones
Clinical experience suggests the utility of Zyloric 100 in the management of patients with recurrent nephrolithiasis due to uric acid stones.
See also:
What other drugs will affect Zyloric 100?
In patients receiving mercaptopurine or IMU-RAN (azathioprine), the concomitant administration of 300 to 600 mg of Zyloric 100 (Zyloric 100) per day will require a reduction in dose to approximately one third to one fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects.
It has been reported that Zyloric 100 (Zyloric 100) prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when Zyloric 100 (Zyloric 100) is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and Zyloric 100 (Zyloric 100) has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with Zyloric 100 (Zyloric 100) alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on ZYLO-PRIM alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of Zyloric 100 (Zyloric 100) and thi-azide diuretics may contribute to the enhancement of allopuri-nol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of Zyloric 100 (Zyloric 100) was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thi-azide diuretics and Zyloric 100 (Zyloric 100) even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with Zyloric 100 (Zyloric 100) compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of Zyloric 100 (Zyloric 100). However, in a well-controlled study of patients with lymphoma on combination therapy, Zyloric 100 (Zyloric 100) did not increase the marrow toxicity of patients treated with cyclophos-phamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.
Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.
Chlorpropamide's plasma half-life may be prolonged by Zyloric 100 (Zyloric 100), since Zyloric 100 (Zyloric 100) and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if Zyloric 100 (Zyloric 100) and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with Zyloric 100 (Zyloric 100). Monitoring of cyclosporine levels and possible adjustment of cyclo-sporine dosage should be considered when these drugs are co-administered.
Drug/Laboratory Test Interactions: Zyloric 100 (Zyloric 100) is not known to alter the accuracy of laboratory tests.
See also:
What are the possible side effects of Zyloric 100?
In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving Zyloric 100 (Zyloric 100 sodium) for Injection. Most of the patients had advanced malignancies or serious underlying diseases and were taking multiple concomitant medications. Side effects directly attributable to Zyloric 100 (Zyloric 100 sodium) for Injection were reported in 19 patients. Fifteen of these adverse experiences were allergic in nature (rash, eosinophilia, local injection site reaction). One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to Zyloric 100 (Zyloric 100 sodium) for Injection. Two patients had serious adverse experiences (decreased renal function and generalized seizure) reported as being possibly attributable to Zyloric 100 (Zyloric 100 sodium) for Injection.
A listing of the adverse reactions regardless of causality reported from clinical trials follows:
Incidence Greater Than 1%
Cutaneous/Dermatologic: rash (1.5%)
Genitourinary: renal failure/insufficiency (1.2%)
Gastrointestinal: nausea (1.3%), vomiting (1.2%)
Incidence Less Than 1%
The most frequent adverse reaction to oral Zyloric 100 is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with Zyloric 100 (Zyloric 100 sodium for injection) (Zyloric 100 sodium) for Injection should be discontinued immediately if a rash develops. For further details on hypersensitivity reactions to treatment with oral Zyloric 100, refer to the package insert for Zyloric 100 tablets.
Each tablet contains allopurinol 300 mg.
However, we will provide data for each active ingredient