1
tablet contains: Yellow, round 5/16” diameter, orange-flavored, flat, bevel-edged tablet, bisected on one side and plain on the other side For suspected adverse drug reaction, seek medical attention immediately and report to the FDA at www.fda.gov.ph AND Unilab at (+632) 858-1000 or [email protected]. By reporting undesirable effects, you can help provide more information on the safety of this medicine. Date of Revision: March 2018 Date of First Authorization: May 2007 DR-2350 P300000022411 P x About 80 to 100% of an oral dose of aspirin is absorbed from the gastrointestinal tract. However, the actual bioavailability of the drug as unhydrolyzed aspirin is lower since aspirin is partially hydrolyzed to salicylate in the gastrointestinal mucosa during absorption and on first pass through the liver. Food does not appear to decrease the bioavailability of unhydrolyzed aspirin; however, absorption is delayed and peak serum aspirin concentration may be decreased. Aspirin is rapidly and widely distributed into most body tissues and fluids. Aspirin’s volume of distribution is 0.15 to 0.2 L/kg. Aspirin is poorly bound to plasma proteins; the unhydrolyzed drug is 33% bound at a serum salicylate concentration of 120 mcg/mL. Aspirin’s elimination half-life is about 15 to 20 minutes. Unlike salicylate, unhydrolyzed aspirin does not undergo capacity-limited metabolism and does not accumulate in plasma after multiple doses. Aspirin is partially hydrolyzed to salicylate during absorption by esterases in the gastrointestinal mucosa after oral administration. After absorption, unhydrolyzed aspirin is rapidly and almost completely hydrolyzed by esterases principally in the liver but also in plasma, erythrocytes, and synovial fluid; hydrolysis occurs more slowly in synovial fluid since the amounts of esterases in synovial fluid are lower. Aspirin may be hydrolyzed more slowly in women since women apparently have lower amounts of plasma aspirin esterases. About 1% of an oral aspirin dose is excreted unhydrolyzed in urine. The remainder is excreted in urine as salicylate and its metabolites. - Acute myocardial infarction (MI) ASPIRIN MAINTENANCE SHOULD BE INITIATED ONCE HYPERTENSION IS CONTROLLED. INITIAL ADULT DOSE INDICATIONS MAINTENANCE ADULT DOSE Suspected Acute MI 160 mg as soon as MI is suspected 160 mg once daily for 30 days post MI After 30 days, consider further therapy based on dosage for prevention of recurrent MI. Prevention of Recurrent MI in blister pack x 20s (box of 500s) Tablet, STORE AT TEMPERATURES NOT EXCEEDING 30 o C KEEP THE PRODUCT OUT OF SIGHT AND REACH OF CHILDREN AMHERST LABORATORIES, INC. Bleeding

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Page 1: Px - Unilab

tablet contains:

Yellow, round 5/16” diameter, orange-flavored, flat, bevel-edged tablet, bisected on one side and plain on the other side

For suspected adverse drug reaction, seek medical attention immediately and report to the FDA at www.fda.gov.ph AND Unilab at (+632) 858-1000 or [email protected]. By reporting undesirable effects, you can

help provide more information on the safety of this medicine.

Date of Revision: March 2018Date of First Authorization: May 2007DR-2350P300000022411

Px

About 80 to 100% of an oral dose of aspirin is absorbed from the gastrointestinal tract. However, the actual bioavailabilityof the drug as unhydrolyzed aspirin is lower since aspirin is partially hydrolyzed to salicylate in the gastrointestinal mucosa during absorption and on first pass through the liver.

Food does not appear to decrease the bioavailability of unhydrolyzed aspirin; however, absorption is delayed and peakserum aspirin concentration may be decreased.

Aspirin is rapidly and widely distributed into most body tissues and fluids. Aspirin’s volume of distribution is 0.15 to 0.2 L/kg. Aspirin is poorly bound to plasma proteins; the unhydrolyzed drug is 33% bound at a serum salicylate concentration of 120 mcg/mL.

Aspirin’s elimination half-life is about 15 to 20 minutes. Unlike salicylate, unhydrolyzed aspirin does not undergo capacity-limited metabolism and does not accumulate in plasma after multiple doses. Aspirin is partially hydrolyzed to salicylate during absorption by esterases in the gastrointestinal mucosa after oral administration. After absorption, unhydrolyzed aspirin is rapidly and almost completely hydrolyzed by esterases principally in the liver but also in plasma, erythrocytes, and synovial fluid; hydrolysis occurs more slowly in synovial fluid since the amounts of esterases in synovial fluid are lower. Aspirin may be hydrolyzed more slowly in women since women apparently have lower amounts of plasma aspirin esterases. About 1% of an oral aspirin dose is excreted unhydrolyzed in urine. The remainder is excreted in urine as salicylate and its metabolites.

- Acute myocardial infarction (MI)

ASPIRIN MAINTENANCE SHOULD BE INITIATED ONCE HYPERTENSION IS CONTROLLED.INITIAL ADULT DOSEINDICATIONS MAINTENANCE ADULT DOSE

Suspected Acute MI 160 mg as soon as MI is suspected

160 mg once daily for 30 days post MIAfter 30 days, consider further therapybased on dosage for prevention ofrecurrent MI.

Prevention of Recurrent MI

in blister pack x 20s (box of 500s)Tablet,

STORE AT TEMPERATURES NOT EXCEEDING 30oCKEEP THE PRODUCT OUT OF SIGHT AND REACH OF CHILDREN

AMHERST LABORATORIES, INC.

Bleeding