Allopurinol is a xanthine oxidase inhibitor sold in the U.S. under 3 brand and generic names, for gout. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Aloprim (application NDA020298). Other allopurinol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Dosage ( 2.2 ) Adult Patients 200 mg/m 2 /day to 400 mg/m 2 /day Maximum 600 mg/day Pediatric Patients Starting Dose 200 mg/m 2 /day Maximum 400 mg/day • Recommended Dosage in Adult Patients with Renal Impairment ( 2.2 , 5.2 , 8.6 ) Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day Less than 10 mL/min 100 mg/day On dialysis 50 mg every 12 hours, or 100 mg every 24 hours 2.1 Recommended Dosage Initiate therapy with ALOPRIM 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis. Additionally, administer fluids sufficient to yield a daily urinary output of at least two liters in adults with a neutral or, preferably, slightly alkaline urine. The recommended daily dose of ALOPRIM is shown in Table 1. Administer the daily dose as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at a rate appropriate for the volume of infusate. Table 1: Recommended Daily Dose of ALOPRIM Adult Patients 200 mg/m 2 /day to 400 mg/m 2 /day intravenously Maximum 600 mg/day Pediatric Patients Starting Dose 200 mg/m 2 /day intravenously Maximum 400 mg/day The dosage of ALOPRIM to lower serum uric acid to normal or near-normal varies with the severity of the disease. Monitor serum uric acid levels at least daily and administer ALOPRIM at a dose and frequency to maintain the serum uric acid…
The following clinically significant adverse reactions are described elsewhere in the labeling: • Skin Rash and Hypersensitivity [see Warnings and Precautions (5.1) ] • Renal Function Impairment [see Warnings and Precautions (5.2) ] • Hepatoxicity [see Warnings and Precautions (5.3) ] • Myelosuppression [see Warnings and Precautions (5.4) ] • Drowsiness [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence > 1%) are skin rash, nausea, vomiting, and renal failure/insufficiency. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ALOPRIM was evaluated in an uncontrolled compassionate use study of 1,378 patients with advanced malignancies requiring treatment with cytotoxic chemotherapy and in patients with other serious conditions. Adverse reactions were reported in 9% (125/1378) of the patients treated with ALOPRIM. The most common adverse reaction was skin rash. Two patients experience serious adverse reactions (decreased renal function and generalized…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 60/100 | Prescription | Injectable | Generic | $2 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 349;U | 100 mg | white | round | — |
| I;136 | 300 mg | pink | capsule | — |
| MP;71 | 100 mg | white | round | — |
| 2083;V | 100 mg | white | round | — |
| 2084;V | 300 mg | orange | round | — |
| I;135 | 100 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ALOPRIM is contraindicated in patients with a history of severe reaction to any formulation of allopurinol. Known hypersensitivity to allopurinol. ( 4 )
Clinically important interactions with the drugs listed below were observed in patients undergoing treatment with an oral allopurinol formulation. • Capecitabine: Avoid the concomitant use of allopurinol ( 7.2 ). • Pegloticase: Discontinue and do not institute allopurinol therapy during treatment with pegloticase ( 7.2 ). • Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information ( 7.2 ). • See full prescribing information for complete list of significant drug interactions ( 7 ). 7.1 Drugs Known to Affect the Occurrence of Skin Rash and Hypersensitivity Concomitant use of the following drugs may increase the risk of skin rash, which may be severe: bendamustine, thiazide diuretics, ampicillin and amoxicillin. Renal impairment may further increase risk with concomitant use of thiazide diuretics [see Warnings and Precautions (5.1) (5.2) and Clinical Pharmacology (12.2) ] . Monitor renal function and reduce the dose of ALOPRIM in patients with concomitant thiazide diuretic use and impaired renal function [see Dosage and Administration (2.2) ]. Discontinue ALOPRIM at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction when use concomitantly with these drugs. 7.2 Other Drugs Known to Have Clinically Important Drug Interactions with ALOPRIM Table 4: Interventions for…
| 3 | Not yet rated | Prescription | Tablet | Generic | $2 | View → |
| white |
| capsule |
| — |