Ascriptin

Name: Ascriptin

Proper Use of aspirin

This section provides information on the proper use of a number of products that contain aspirin. It may not be specific to Ascriptin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the capsule with a full glass of water at the same time each day.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Do not take Durlaza™ 2 hours before or 1 hour after drinking alcohol.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • To lower risk of heart attack and stroke:
      • Adults—162.5 milligrams (mg) (one capsule) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What happens if I miss a dose?

Since aspirin is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

For the Consumer

Applies to aspirin: oral capsule, oral capsule delayed release, oral capsule extended release 24 hr, oral gum, oral tablet, oral tablet chewable, oral tablet effervescent, oral tablet enteric coated, oral tablet extended release

Along with its needed effects, aspirin (the active ingredient contained in Ascriptin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aspirin:

Incidence not known
  • Abdominal or stomach pain, cramping, or burning
  • black, tarry stools
  • bloody or cloudy urine
  • change in consciousness
  • chest pain or discomfort
  • confusion
  • constipation
  • convulsions, severe or continuing
  • dark urine
  • decreased frequency or amount of urine
  • diarrhea
  • difficult breathing
  • drowsiness
  • fainting
  • fast breathing
  • feeling that something terrible will happen
  • fever
  • general tiredness and weakness
  • greatly decreased frequency of urination or amount of urine
  • headache
  • heartburn
  • increased thirst
  • indigestion
  • irregular heartbeat
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • muscle cramping and weakness
  • muscle tremors
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • panic
  • rapid, deep breathing
  • restlessness
  • seizures
  • skin rash
  • stomach cramps
  • swelling of the face, fingers, or lower legs
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach
  • vomiting of blood or material that looks like coffee grounds
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes and skin

Some side effects of aspirin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Acid or sour stomach
  • anxiety
  • belching
  • dizziness
  • dry mouth
  • hyperventilation
  • irritability
  • shaking
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Usual Adult Dose for Cardiovascular Risk Reduction

Primary Prophylaxis:
-50 years or older: 75 to 100 mg orally once a day
-Adults with type 1 or type 2 diabetes at increased CVD risk: 75 to 162 mg orally once a day

Comments:
-In adults 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk of bleeding, and have a life expectancy of at least 10 years, the United States Preventative Services Task Force (USPSTF) recommends initiating low dose aspirin for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) and colorectal cancer (CRC).
-The decision to initiate primary prophylaxis therapy in adults 60 to 69 years, should include the same parameters and additionally be individualized for risk; for adults 70 years or older, the current evidence is insufficient to assess the balance of benefits and harms.
-The American Diabetes Association Standards of Care recommends primary prophylaxis in adults with diabetes who are at increased risk of CVD; this includes most patients 50 years or older with at least 1 additional major risk factor; for patients less than 50 years, clinical judgement is required.

Secondary Prophylaxis:
Immediate-release (IR): 75 mg to 325 mg orally once a day
Extended-release (ER): 162.5 orally once a day

Comments:
-The optimal dose to prevent cardiovascular events is unknown; however, higher doses are associated with increased risk of bleeding.
-Current evidence supports use of low-dose IR aspirin 75 to 100 mg daily.
-ER capsules are designed to slowly release drug from encapsulated microparticles thereby prolonging the absorption across the gastrointestinal tract; the pharmacodynamic effect of ER 162.5 mg is similar to that attained with IR aspirin 81 mg.

Use: To reduce the combined risk of death and nonfatal myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a previous MI.

Usual Pediatric Dose for Pain

12 years or older: 300 to 650 mg orally every 4 to 6 hours as needed
Maximum dose: 4 g in 24 hours

Comments:
-This drug should be avoided in pediatric patients with viral illness due to risk of Reye's syndrome.

Uses: As a temporary fever reducer or for the temporary relief of minor pain due to headache, menstrual pain, arthritis, muscle pain, or toothache.

Renal Dose Adjustments

CrCl less than 10 mL/min: Contraindicated
CrCl 10 mL/min or greater: Use with caution

Aspirin Levels and Effects while Breastfeeding

Summary of Use during Lactation

After aspirin ingestion, salicylic acid is excreted into breastmilk, with higher doses resulting in disproportionately higher milk levels. Long-term, high-dose maternal aspirin ingestion probably caused metabolic acidosis in one breastfed infant. Reye's syndrome is associated with aspirin administration to infants with viral infections, but the risk of Reye's syndrome from salicylate in breastmilk is unknown. An alternate drug is preferred over continuous high-dose, aspirin therapy. After daily low-dose aspiring (75 to 325 mg daily), no aspirin is excreted into breastmilk and salicylate levels are low. Daily low-dose aspirin therapy may be considered as an antiplatelet drug for use in breastfeeding women.[1][2][3].

Drug Levels

Aspirin is rapidly metabolized to salicylate after ingestion, so most studies have measured salicylate levels in breastmilk after aspirin administration to the mother; however, some studies have not measured salicylate metabolites in breastmilk that may be hydrolyzed in the infant's gut and absorbed as salicylate.[4]

Maternal Levels. A woman taking aspirin 4 grams daily for rheumatoid arthritis was nursing her 5 kg infant (age not reported). Salicylate was not detectable (< 50 mg/L) in breastmilk with the relative insensitive assay used.[5]

Six nursing mothers who were 2 to 8 months postpartum (average 5 months) were given aspirin doses of 500, 1000 and 1500 mg of aspirin orally on 3 separate occasions. Peak breastmilk salicylate levels were 5.8 mg/L, 15.8 mg/L, and 38.8 mg/L, respectively. The time of the peak levels occurred between 2 and 6 hours after ingestion, with little variation in levels over time. The disproportionate increase in milk levels as the dose increased was attributed to nonlinear metabolism and protein binding.[6]

Milk and blood levels of the salicylate metabolites of aspirin were determined in 8 lactating women following oral administration of 1 g of aspirin. Peak salicylic acid milk levels averaging 2.4 mg/L occurred 3 hours after the dose. Milk contents of salicyluric acid were greater than those of salicylic acid; a mean peak level of 10.2 mg/L was reached after 9 hours, and averaged 4.4 mg/L 24 hours after the dose. Total salicylate and metabolite levels were 5.1 mg/L at 3 hours, 9.9 mg/L at 6 hours, 11.2 mg/L at 9 hours and 10.2 mg/L at 12 hours after the dose. Acid labile conjugates were less than 0.2 mg/L.[7] Using an average salicylate plus salicylurate level over the first 12 hours, a fully breastfed infant would receive an average of 9.4% of the maternal weight-adjusted dosage.

Two women given aspirin 454 mg orally had peak salicylate milk levels of about 1 mg/L 1 hour after the dose. The authors estimated that about 0.1% of the mothers' total dose would appear in breastmilk in 48 hours.[8] However, salicylate metabolites were not measured in milk.

A woman who was breastfeeding a 4-month-old was taking long-term aspirin therapy in dosages ranging from 2 to 5.9 g daily. During this therapy, milk was obtained 4 hours after a 650 mg dose and just before taking a dose of 975 mg. The trough milk salicylate level was 2 mg/L and a peak level of 10 mg/L occurred 3 hours after the dose. Salicylate levels ranged from 4 to 7 mg/L over the 5 hours after the peak.[9] Using the peak level from this study, a fully breastfed infant would receive about 10% of the maternal weight-adjusted dosage of salicylate. The assay method used should have measured both salicylate and metabolites in milk.

Seven nursing mothers between 1 and 8 months postpartum were taking enteric-coated aspirin daily; 6 took 81 mg and 1 took 325 mg. Aliquots of a complete collection of milk from both breasts were analyzed for aspirin and salicylic acid 6 times over the following 24-hour period. Aspirin was undetectable (<0.61 mcg/L) in all samples. In mothers taking 81 mg of aspirin daily, the peak salicylate concentration in milk was 115 mcg/L at 2 to 4 hours after the dose and the average milk concentration was 24 mcg/L. In the woman taking 325 mg of aspirin, the peak milk salicylate concentration was 745 mcg/L at 1 hour after the dose and the average salicylate concentration was 107.4 mcg/L. The authors calculated a weight-adjusted infant salicylate dosage of 0.4%.[3]

Infant Levels. A 9-week-old infant who was born at 36 weeks gestation was receiving about 50% breastmilk and 50% formula. The infant's mother was taking 2.4 g of aspirin daily and the infant's serum contained 65 mg/L of salicylate.[10]

Effects in Breastfed Infants

A 16-day-old breastfed infant developed metabolic acidosis with a salicylate serum level of 240 mg/L and salicylate metabolites in the urine. The mother was taking 3.9 g/day of aspirin for arthritis, and salicylate in breastmilk probably caused the infant's illness, but the possibility of direct administration to the infant could not be ruled out.[11]

Thrombocytopenia, fever, anorexia and petechiae occurred in a 5-month-old breastfed infant 5 days after her mother started taking aspirin for fever. One week after recovery, the infant was given a single dose of aspirin 125 mg and the platelet count dropped once again. The original symptoms were probably caused by aspirin or salicylate in breastmilk.[12]

Hemolysis after aspirin and phenacetin taken by the mother of a 23-day-old, G-6-PD-deficient infant was possibly due to aspirin in breastmilk.[13]

In a telephone follow-up study, mothers reported no side effects among 15 infants exposed to aspirin (dosages and infant ages were unspecified) in breastmilk.[14]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Acetaminophen, Ibuprofen

References

1. Bell AD, Roussin A, Cartier R et al. The use of antiplatelet therapy in the outpatient setting: Canadian Cardiovascular Society guidelines executive summary. Can J Cardiol. 2011;27:208-21. PMID: 21459270

2. Bates SM, Greer IA, Middeldorp S et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141 (2 Suppl):e691S-736S. PMID: 22315276

3. Datta P, Rewers-Felkins K, Kallem RR et al. Transfer of low dose aspirin into human milk. J Hum Lact. 2017;33:296-9. PMID: 28418802

4. Levy G. Salicylate pharmacokinetics in the human neonate. In: Morselli PL, Garattini S, Sereni F, eds. Basic and therapeutic aspects of perinatal pharmacology. New York: Raven Press, 1975:319-30.

5. Erickson SH, Oppenheim GL. Aspirin in breast milk. J Fam Pract. 1979;8:189-90. PMID: 759544

6. Jamali F, Keshavarz E. Salicylate excretion in breast milk. Int J Pharm. 1981;8:285-90.

7. Putter J, Satravaha P, Stockhausen H. Quantitative analysis of the main metabolites of acetylsalicylic acid. Comparative analysis in the blood and milk of lactating women. Z Geburtshilfe Perinatol. 1974;178:135-8. PMID: 4422623

8. Findlay JW, DeAngelis RL, Kearney MF et al. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981;29:625-33. PMID: 7214793

9. Bailey DN, Welbert RT, Naylor A. A study of salicylate and caffeine excretion in the breast milk of two nursing mothers. J Anal Toxicol. 1982;6:64-8. PMID: 7098450

10. Unsworth J, d'Assis-Fonseca A, Beswick DT. Serum salicylate levels in a breast fed infant. Ann Rheum Dis. 1987;46:638-9. PMID: 3662653

11. Clark JH, Wilson WG. A 16-day-old breast-fed infant with metabolic acidosis caused by salicylate. Clin Pediatr. 1981;20:53-4. PMID: 7214793

12. Terragna A, Spirito L. [Thrombocytopenic purpura in an infant after administration of acetylsalicylic acid to the wet-nurse]. Minerva Pediatr. 1967;19:613-6. PMID: 6069440

13. Harley JD, Robin H. "Late" neonatal jaundice in infants with glucose-6-phosphate dehydrogenase-deficient erythrocytes. Aust Ann Med. 1962;11:148-55. PMID: 13960788

14. Ito S, Blajchman A, Stephenson M, Eliopoulos C et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

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