Asasantin

Asasantin is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

Asasantin contains a combination of Aspirin (Asasantin) and Asasantin. Aspirin (Asasantin) belongs to a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Asasantin keeps platelets in your blood from sticking together to form clots.

Asasantin is used to reduce the risk of stroke in people who have had blood clots or a "mini-stroke" (also called a transient ischemic attack or TIA).

Asasantin is supplied as a capsule containing 200mg Asasantin in extended-release pellets and a round white tablet incorporating immediate-release Aspirin (Asasantin) 25mg.

Asasantin is not interchangeable with the individual components of Aspirin (Asasantin) and Asasantin tablets.

The recommended dose of Asasantin is one capsule given orally twice daily, one in the morning and one in the evening. Swallow capsules whole without chewing. Asasantin can be administered with or without food.

Alternative Regimen In Case Of Intolerable Headaches

In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose Aspirin (Asasantin) in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.

How supplied

Dosage Forms And Strengths

25 mg/200 mg capsules with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating Asasantin and a round white tablet incorporating immediate-release Aspirin (Asasantin). The capsule body is imprinted in red with the Boehringer Ingelheim logo and with “01A”.

Storage And Handling

Asasantin capsules are available as a hard gelatin capsule, with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating Asasantin and a round white tablet incorporating immediate-release Aspirin (Asasantin). The capsule body is imprinted in red with the Boehringer Ingelheim logo and with “01A”.

Asasantin capsules are supplied in unit-of-use bottles of 60 capsules (NDC 0597-0001-60).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from excessive moisture.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: November 2015

See also:
What is the most important information I should know about Asasantin?

  Hypersensitivity

Asasantin is contraindicated in patients with known hypersensitivity to any of the product components.

  Allergy

Aspirin (Asasantin) is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (NSAID) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin (Asasantin) may cause severe urticaria, angioedema or bronchospasm.

  Reye Syndrome

Do not use Aspirin (Asasantin) in children or teenagers with viral infections because of the risk of Reye syndrome.

Use Aspirin (Asasantin)/Asasantin extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Aspirin (Asasantin)/Asasantin extended-release capsules. Talk to your pharmacist if you have questions about this information.
• Take Aspirin (Asasantin)/Asasantin extended-release capsules by mouth with or without food.
• Swallow Aspirin (Asasantin)/Asasantin extended-release capsules whole. Do not break, crush, or chew before swallowing.
• Take Aspirin (Asasantin)/Asasantin extended-release capsules with a full glass of water (8 oz [240 mL]).
• Do not substitute this form of Aspirin (Asasantin) for any other Aspirin (Asasantin) or Asasantin products. Discuss any questions or concerns with your doctor.
• If you miss a dose of Aspirin (Asasantin)/Asasantin extended-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aspirin (Asasantin)/Asasantin extended-release capsules.

Use: Labeled Indications

Stroke prevention: Reduction in the risk of stroke in patients who have had transient ischemia of the brain or complete ischemic stroke due to thrombosis.

Off Label Uses

Carotid artery stenosis, symptomatic (including recent carotid endarterectomy)

Based on the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy and Prevention of Thrombosis, Aspirin (Asasantin)/Asasantin ER (eg, Asasantin) is an effective and recommended treatment option for the secondary prevention in patients with symptomatic carotid artery stenosis (including recent carotid endarterectomy).

See also:
What other drugs will affect Asasantin?

Drug Interaction Study Information Obtained From Literature

Adenosine

Asasantin has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary.

Angiotensin Converting Enzyme (ACE) Inhibitors

Due to the indirect effect of Aspirin (Asasantin) on the renin-angiotensin conversion pathway, the hyponatremic and hypotensive effects of ACE inhibitors may be diminished by concomitant administration of Aspirin (Asasantin).

Acetazolamide

Concurrent use of Aspirin (Asasantin) and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.

Anticoagulants and Antiplatelets

Patients taking Asasantin in combination with anticoagulants, antiplatelets, or any substance impacting coagulation are at increased risk for bleeding. Aspirin (Asasantin) can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Aspirin (Asasantin) can increase the anticoagulant activity of heparin, increasing bleeding risk.

Anagrelide

Patients taking Aspirin (Asasantin) in combination with anagrelide are at an increased risk of bleeding.

Anticonvulsants

Salicylic acid 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.

Beta Blockers

The hypotensive effects of beta blockers may be diminished by the concomitant administration of Aspirin (Asasantin) due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

Cholinesterase Inhibitors

Asasantin may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.

Diuretics

The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of Aspirin (Asasantin) due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

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 Aspirin (Asasantin) with other NSAIDs may increase bleeding or lead to decreased renal function.

Oral Hypoglycemics

Moderate doses of Aspirin (Asasantin) may increase the effectiveness of oral hypoglycemic drugs, leading to hypoglycemia.

Uricosuric Agents (probenecid and sulfinpyrazone)

Salicylates antagonize the uricosuric action of uricosuric agents.

See also:
What are the possible side effects of Asasantin?

The following adverse reactions are discussed elsewhere in the labeling:

• Hypersensitivity
• Allergy
• Risk of Bleeding

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 efficacy and safety of Asasantin was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo-controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry. Patients were randomized to either Asasantin, Aspirin (Asasantin), ER-DP, or placebo; primary endpoints included stroke (fatal or nonfatal) and death from all causes.

This 24-month, multicenter, double-blind, randomized study (ESPS2) was conducted to compare the efficacy and safety of Asasantin with placebo, extended-release Asasantin alone and Aspirin (Asasantin) alone. The study was conducted in a total of 6602 male and female patients who had experienced a previous ischemic stroke or transient ischemia of the brain within three months prior to randomization.

Table 1 presents the incidence of adverse events that occurred in 1% or more of patients treated with Asasantin where the incidence was also greater than in those patients treated with placebo. There is no clear benefit of the Asasantin/Aspirin (Asasantin) combination over Aspirin (Asasantin) with respect to safety.

Table 1 : Incidence of Adverse Events in ESPS2/mm³.

Post-Marketing Experience

The following is a list of additional adverse reactions that have been reported either in the literature or are from post-marketing spontaneous reports for either Asasantin or Aspirin (Asasantin). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Asasantin.

Body as a Whole: Hypothermia, chest pain

Cardiovascular: Angina pectoris

Central Nervous System: Cerebral edema

Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis, hypokalemia

Gastrointestinal: Pancreatitis, Reye syndrome, hematemesis

Hearing and Vestibular Disorders: Hearing loss

Immune System Disorders: Hypersensitivity, acute anaphylaxis, laryngeal edema

Liver and Biliary System Disorders: Hepatitis, hepatic failure

Musculoskeletal: Rhabdomyolysis

Metabolic and Nutritional Disorders: Hypoglycemia, dehydration

Platelet, Bleeding and Clotting Disorders: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia

Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding

Respiratory: Tachypnea, dyspnea

Skin and Appendages Disorders: Rash, alopecia, angioedema, Stevens-Johnson syndrome, skin hemorrhages such as bruising, ecchymosis, and hematoma

Urogenital: Interstitial nephritis, papillary necrosis, proteinuria

Vascular (Extracardiac) Disorders: Allergic vasculitis

Other Adverse Events: anorexia, aplastic anemia, migraine, pancytopenia, thrombocytosis.