DURLAZA

DURLAZA — aspirin capsule, extended release
New Haven Pharmaceuticals, Inc.

Structural FormulaFigure 190 count label30 count label

1 INDICATIONS AND USAGE

DURLAZA is indicated to:

  1. 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
  2. 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Avoid use during the third trimester of pregnancy because NSAIDs such as DURLAZA may cause premature closure of the fetal ductus arteriosus. Salicylate products have also been associated with alterations in maternal and neonatal hemostasis mechanisms, decreased birth weight, and with perinatal mortality.

8.2 Labor and Delivery

Avoid DURLAZA 1 week prior to and during labor and delivery because it can result in excessive blood loss at delivery. Prolonged gestation and prolonged labor due to prostaglandin inhibition have been reported.

8.3 Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from DURLAZA, choose either to discontinue DURLAZA or discontinue nursing.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

In a large collaborative overview of aspirin for vascular event prevention, including over 14000 patients over 65 years of age, no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Hepatic Impairment

Avoid DURLAZA in patients with severe hepatic insufficiency.

8.7 Renal Impairment

Avoid DURLAZA in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute).

10 OVERDOSAGE

Salicylate toxicity may result from acute ingestion (overdose) or chronic intoxication. The early signs of salicylic overdose (salicylism), including tinnitus (ringing in the ears), occur at plasma concentrations approaching 200 mcg/mL. Plasma concentrations of aspirin above 300 mcg/mL are clearly toxic. Severe toxic effects are associated with levels above 400 mcg/mL [see Clinical Pharmacology (12.3)]. A single lethal dose of aspirin in adults is not known with certainty but death may be expected at 30 g. For real or suspected overdose, contact a Poison Control Center immediately.

Signs and Symptoms: In acute overdose, severe acid-base and electrolyte disturbances may occur and are complicated by hyperthermia and dehydration. Respiratory alkalosis occurs early while hyperventilation is present, but is quickly followed by metabolic acidosis.

Treatment: Treatment consists primarily of supporting vital functions, increasing salicylate elimination, and correcting the acid-base disturbance. Gastric emptying or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage or emesis, administer activated charcoal, as a slurry, if less than 3 hours have passed since ingestion.

Severity of aspirin intoxication is determined by measuring the blood salicylate level. Monitor acid-base status with serial blood gas and serum pH measurements. Maintain fluid and electrolyte balance.

In severe cases, hyperthermia and hypovolemia are the major immediate threats to life. Replace fluid intravenously and correct acidosis. Monitor plasma electrolytes and pH to promote alkaline diuresis of salicylate if renal function is normal. Glucose may be required to control hypoglycemia.

Hemodialysis and peritoneal dialysis can reduce the body aspirin content. In patients with renal insufficiency or in cases of life-threatening intoxication, dialysis is usually required. Exchange transfusion may be indicated in infants and young children.

Page 1 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.