Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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, oxalate 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.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Allopurionol tablets, USP are supplied as follows: Allopurinol tablets, 100 mg round, white, scored, debossed MP 71 Allopurinol tablets, 300 mg round, orange, scored, debossed MP 80
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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(5.6) ] The following adverse reactions associated with the use of allopurinol tablets were identified in literature, unpublished clinical trials or postmarketing reports.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. Cardiovascular: Necrotizing angiitis, vasculitis, pericarditis, peripheral vascular disease, thrombophlebitis, bradycardia, vasodilation. Gastrointestinal: Hepatic necrosis, granulomatous hepatitis, hepatomegaly, hyperbilirubinemia, cholestatic jaundice, vomiting, intermittent abdominal pain, gastritis, dyspepsia, hemorrhagic pancreatitis, gastrointestinal bleeding, stomatitis, salivary gland swelling, hyperlipidemia, tongue edema, anorexia. Hemic and Lymphatic: Thrombocytopenia, eosinophilia, leukocytosis, leukopenia, aplastic anemia, agranulocytosis, eosinophilic fibrohistiocytic lesion of bone marrow, pancytopenia, prothrombin decrease, anemia, hemolytic anemia, reticulocytosis, lymphadenopathy, lymphocytosis. Musculoskeletal: Myopathy, arthralgias, myalgia. Nervous: Peripheral neuropathy, neuritis, paresthesia, somnolence, optic neuritis, confusion, dizziness, vertigo, foot drop, decrease in libido, depression, amnesia, tinnitus, asthenia, insomnia. Respiratory: Epistaxis, bronchospasm, asthma, pharyngitis, rhinitis. Skin and Appendages: Erythema multiforme exudativum (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), hypersensitivity vasculitis, purpura, vesicular bullous dermatitis, exfoliative dermatitis, eczematoid dermatitis, pruritus, urticaria, alopecia, onycholysis, lichen planus, furunculosis, facial edema, sweating, skin edema. Special Senses: Taste loss/perversion, cataracts, macular retinitis, iritis, conjunctivitis, amblyopia. Urogenital: Renal failure, uremia, nephritis, impotence, primary hematuria, albuminuria. Endocrine: Infertility (male), hypercalcemia, gynecomastia (male).
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
In the management of overdosage there is no specific antidote for allopurinol tablets. Both allopurinol and oxipurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of allopurinol tablets is unknown.
11 DESCRIPTION
DESCRIPTION SECTION
Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula: Allopurinol is known chemically as 1, 5-Dihydro-4 H -pyrazolo [3, 4- d ]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white round tablet contains 100 mg allopurinol USP and the inactive ingredients corn starch, croscarmellose sodium, lactose, magnesium stearate, and povidone. Each scored orange round tablet contains 300 mg allopurinol USP and the inactive ingredients corn starch, croscarmellose sodium, lactose, magnesium stearate, povidone, and FD&C yellow #6 lake.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Allopurinol tablets, USP are supplied as follows: Allopurinol tablets, 300 mg round, orange, scored, debossed MP 80 Bottles of 30 NDC 43063-976-30 Bottles of 90 NDC 43063-976-90 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) (see USP Controlled Room Temperature). Dispense in tight, light-resistant container.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Administration Advise patients to take allopurinol tablets after meals to minimize gastric irritation. If a single dose of allopurinol tablets is occasionally forgotten, there is no need to double the dose at the next scheduled time. Skin Rash and Hypersensitivity Inform patients that allopurinol tablets may increase the risk of serious and sometimes fatal dermatologic reactions. Instruct patients to discontinue allopurinol tablets and to seek medical attention immediately, at the first sign of a skin rash, blisters, fever, painful urination, blood in the urine, irritation of the eyes, swelling of the lips or mouth, or other signs and symptoms of hypersensitivity reactions [see Warnings and Precautions (5.1) ] . Gout Flares During Treatment With Allopurinol Tablets Inform patients that gout flares may occur during initiation of treatment with allopurinol tablets, even when their serum uric acid is normal. Concurrent use of additional medications such as colchicine or other anti-inflammatory agents can prevent gout flares. Advise patients to continue treatment with both, allopurinol tablets and the prophylactic therapy as prescribed, even if gout flares occur. Reassure them that it may take months to achieve control of the flares but the flares typically become shorter and less severe after several months of therapy [see Warnings and Precautions (5.2) ] . Nephrotoxicity Inform patients that allopurinol tablets may affect kidney function. Advise them to increase fluid intake during therapy (i.e., for adults, at least 2 liters of liquids per day) and to stay well hydrated to prevent kidney stones [see Warnings and Precautions (5.3) ] . Hepatotoxicity Inform patients of the risk of hepatotoxicity and to report to their healthcare provider any signs and symptoms of liver failure, including jaundice, pruritus, bleeding, bruising, or anorexia [see Warnings and Precautions (5.4) ] . Myelosuppression Advise patients of the risk of myelosuppression and to report any signs and symptoms of infection, fever, bleeding, shortness of breath, or significant fatigue to their healthcare provider [see Warnings and Precautions (5.5) ] . Potential Effect on Driving and Use of Machinery Inform patients that drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. Inform also that the central nervous system depressant effects of allopurinol tablets may be additive to those of alcohol and other CNS depressants. Advise patients to avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting allopurinol tablets or increasing the dose, until they know how the drug affects them [see Warnings and Precautions (5.6) ] . Risks Associated with Use of Concomitant Medications Inform patients that there are risks of adverse effects when allopurinol tablets are used with the following drugs: dicumarol, warfarin, sulfinpyrazone, mercaptopurine, azathioprine, ampicillin, amoxicillin, pegloticase, theophylline, and thiazide diuretics. Advise patients to disclose all medications in use and they should follow the instructions of their physician [see Drug Interactions (7.2) ] . Pregnancy Advise pregnant women of the potential risk to a fetus. Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with allopurinol tablets [see Use in Specific Populations (8.1) ] . Lactation Advise women not to breastfeed during treatment with allopurinol tablets and for one week after the last dose [see Use in Specific Populations (8.2) ] . Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári, Kabay János u. 29. Hungary Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: 10/2023
Allopurinol tablets 300 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL