DURLAZA - aspirin capsule, extended release
New Haven Pharmaceuticals, Inc.
Structural FormulaFigure 190 count label30 count label
1 INDICATIONS AND USAGE
DURLAZA is indicated to:
Reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina
Reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack
Limitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).
2 DOSAGE AND ADMINISTRATION
The recommended dose of DURLAZA is one capsule (162.5 mg) once daily. Take the capsules with a full glass of water at the same time each day.
Swallow DURLAZA capsules whole. Do not cut, crush or chew capsules.
Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol [see Warnings and Precautions (5)].
3 DOSAGE FORMS AND STRENGTHS
DURLAZA (aspirin) Extended Release Capsules are supplied as white to off-white opaque capsules each containing 162.5 mg of aspirin.
4 CONTRAINDICATIONS
DURLAZA is contraindicated:
In patients with a hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
In patients with the syndrome of asthma, rhinitis, and nasal polyps. DURLAZA may cause severe urticaria, angioedema, or bronchospasm.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Bleeding
DURLAZA increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, and chronic use of NSAIDs) [see Drug Interactions (7)].
5.2 Peptic Ulcer Disease
DURLAZA may cause gastric ulceration and bleeding. Avoid DURLAZA in patients with active peptic ulcer disease.
5.3 Fetal Toxicity
DURLAZA can cause fetal harm when administered to a pregnant woman. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal death. Because NSAIDs may cause premature closure of the fetal ductus arteriosus, avoid DURLAZA in the third trimester of pregnancy [see Use in Specific Populations (8.1)].
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
The following is a list of adverse reactions that have been reported in the literature for products containing low dose aspirin [see Warnings and Precautions (5)].
Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, lethargy, seizures.
Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis.
Gastrointestinal: Dyspepsia, hepatic enzyme elevation, hepatitis, Reye's Syndrome.
Renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.
7 DRUG INTERACTIONS
Alcohol: Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol. Alcohol can interfere with the controlled release properties of DURLAZA.
Renin-angiotensin system (RAS) inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy), or who have compromised renal function, coadministration of NSAIDs, including DURLAZA, with RAS inhibitors may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving RAS inhibitors and DURLAZA.
NSAIDs, including DURLAZA may attenuate the antihypertensive effects of RAS inhibitors.
Anticoagulant and antiplatelets: Increased risk of bleeding
Anticonvulsants: Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Methotrexate: Salicylate can inhibit renal clearance of methotrexate, leading to bone marrow toxicity, especially in the elderly or renal impaired.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs): The concurrent use of DURLAZA with other NSAIDs increases the risk of bleeding and may result in renal impairment.
Ibuprofen can interfere with the anti-platelet effect of low dose aspirin. Patients who use DURLAZA and take a single dose of ibuprofen 400 mg should dose the ibuprofen at least 2-4 hours or longer after ingestion of DURLAZA. Wait 8 hours after ibuprofen dosing, before giving aspirin, to avoid significant interference.
Nonselective NSAIDs may interfere with the antiplatelet effect of low-dose aspirin.
