Aspilets/Aspilets-EC Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Aspirin

Indications/Uses

Primary prevention of thromboembolic disorders & CV events eg, ischemic stroke, transient ischemic attack, prevention of recurrent MI; unstable & chronic stable angina pectoris. Secondary prevention of CV disease in patients w/ DM especially w/ history of MI, vascular bypass procedure, stroke or transient ischemic attack, & angina; patients w/ additional risk factors: HTN, smoking, dyslipidemia, & family history of CV disease. Revascularization procedures. Pregnancy-induced HTN. Aspilets Acute MI.

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Dosage/Direction for Use

Ischemic stroke & transient ischemic attack 50-325 mg once daily. Prevention of recurrent MI, unstable angina pectoris & chronic stable angina pectoris, primary & secondary prevention of CV events in patients w/ type 1 or 2 DM 75-325 mg once daily. CABG 325 mg daily starting 6 hr post-op. Continue therapy for 1 yr post-op. Percutaneous transluminal coronary angioplasty Initially 325 mg given 2 hr pre-op. Maintenance dose: 160-325 mg daily. Carotid endarterectomy 80 mg once daily to 650 mg bid, started pre-op. Prevention of complications of pregnancy 80 mg daily from 13th-26th wk of gestation. Aspilets Suspected acute MI Initially 160 mg as soon as MI is suspected. Maintenance dose: 160 mg/day for 30 days post MI.

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Overdosage

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Administration

Should be taken with food: Take immediately after meals w/ a full glass of water unless patient is fluid-restricted. Aspilets-EC tab: Swallow whole, do not chew/crush/bite.

Contraindications

Hypersensitivity. Asthma, rhinitis & nasal polyps. Viral infections (w/ or w/o fever) in childn & adolescents due to risk of Reye's syndrome.

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Special Precautions

Severe GI bleeding. Heavy alcohol consumption. Avoid use in patients w/ inherited (hemophilia) or acquired (liver disease or vit K deficiency) bleeding disorders. Avoid use 1 wk prior to & during labor, delivery & any surgery. Do not use in severe renal failure (GFR >10 mL/min) & severe hepatic insufficiency. Pregnancy (3rd trimester) & lactation. Childn & infants.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fever, hypothermia, thirst; dysrhythmias, hypotension, tachycardia; dehydration, hyperkalemia, metabolic acidosis, resp alkalosis; dyspepsia, GI bleeding, ulceration & perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, pancreatitis; prolongation of prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia; acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria; hypoglycemia (in childn), hyperglycemia; rhabdomyolysis; agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures; prolonged pregnancy & labor, stillbirths, lower birth wt infants, antepartum & postpartum bleeding; hyperpnea, pulmonary edema, tachypnea; hearing loss, tinnitus; interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency & failure.

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Drug Interactions

Diminished hyponatremic & hypotensive effects of ACE inhibitors; hypotensive effects of β-blockers; effectiveness of diuretics in patients w/ underlying renal or CV disease. Increased serum acetazolamide conc & toxicity. Increased risk of bleeding w/ heparin & warfarin. Decreased total conc of phenytoin & increased serum valproic acid levels. May inhibit renal clearance of methotrexate. Increased bleeding or may lead to decreased renal function w/ NSAIDs. May increase the effectiveness of oral hypoglycemic drugs leading to hypoglycemia. Antagonize the uricosuric action of probenecid & sulfinpyrazone.

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Storage

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Description

View Aspilets/Aspilets-EC description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

B01AC06 - acetylsalicylic acid ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

Regulatory Classification

Presentation/Packing

Form

Aspilets-EC enteric-coated tab 80 mg

Packing/Price

150's (P437/pack)

Form

Aspilets tab 80 mg

Packing/Price

500's (P1,453/pack)

Aspilets/Aspilets-EC

aspirin

Manufacturer:

LRI

Distributor:

UNILAB, Inc