Allopurinol 100 mg/1
Allopurinol · TABLET · Redpharm Drug
Allopurinol is a tablet containing allopurinol at 100 mg/1, taken oral. Manufactured by Redpharm Drug.
Key Facts
- Brand Name
- Allopurinol
- Generic Name
- Allopurinol
- NDC Code (Product)
67296-1897- Manufacturer
- Redpharm Drug
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204467
- Drug Class
- Xanthine Oxidase Inhibitor [EPC]
- Marketing Start
- 09/22/2020
Recall History
Accord Healthcare, Inc.
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Preferred Pharmaceuticals, Inc.
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Dr. Reddy's Laboratories, Inc.
Presence of foreign substance.
Aidapak Services, LLC
Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25, EXP: 5/20/2014.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Mylan Institutional LLC
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult 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, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablets are a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malig…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Gout : Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. ( 2.1 , 2.2 ) Patients with normal kidney function: Initial dosage is 100 mg orally daily. Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maximum 800 mg daily). ( 2.3 ) Patients with impaired kidney function: The initial dosage is 50 mg orally daily. Follow recommendations for titration in patients with renal impairment until target serum uric acid level is reached. ( 2.6 ) See complete information in the Full Prescribing Information (FPI). Hyperuricemia Associated with Cancer Therapy : The recommended dosage is: Adults: 300 mg to 800 mg orally daily. Pediatric patients: 100 mg/m 2 orally every 8 hours to 12 hours (10 mg/kg/day, maximum 800 mg/day) See complete information in the FPI. ( 2.4 , 2.6 ) Recurrent Calcium Oxalate Calculi : The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily. ( 2.5 ) Dosage in Patients with Renal Impairment: See FPI for dosage modifications in …
Contraindications
4 CONTRAINDICATIONS Allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets. Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets.
Drug Interactions
7 DRUG INTERACTIONS The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. ( 7.1 ) Capecitabine: Avoid concomitant use. ( 7.2 ) Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. ( 7.2 ) Pegloticase: Discontinue and refrain from initiating treatment with allopurinol tablets. ( 7.2 ) See FPI for complete list of significant drug interactions. ( 7.2 ) 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 kidney function and reduce the dose of allopurinol tablets in patients with concomitant thiazide diuretic use and impaired renal function [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.1 )]. Discontinue allopurinol tablets at the first appearance of skin rash…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions ( 5.1 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Hepatoxicity [see Warnings and Precautions ( 5.4 )] Myelosuppression [see Warnings and Precautions ( 5.5 )] Potential Effect on Driving and Use of Machinery [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of allopurinol tablets were identified in literature, unpublished clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent adverse reaction to allopurinol tablets is skin rash. Most Common Adverse Reactions (≥ 1%) Gastrointestinal : Diarrhea, nausea, alkaline phosphatase increase, AST/ALT increase. Metabolic and Nutritional : Acute attacks of gout. Skin and Appendages : Rash, maculopapular rash. Less Common Adverse Reactions (< 1%) Body As a Whole : Ecchymosis, fever, headache, malaise. Ca…
Frequently Asked Questions
What is Allopurinol used for?
Allopurinol contains Allopurinol. It is a tablet taken oral. Consult your doctor for specific uses.
Is Allopurinol a controlled substance?
Allopurinol is not classified as a controlled substance by the DEA.
What is the generic name for Allopurinol?
The generic name for Allopurinol is Allopurinol. There are no other listed brand versions of Allopurinol.
What is the NDC code for Allopurinol 100 mg/1?
The NDC (National Drug Code) for Allopurinol 100 mg/1 is 67296-1897, listed by Redpharm Drug.
Other Allopurinol Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)