Aspirin (delayed release tablet)

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Aspirin (delayed release tablet) is an analgesic that is FDA approved for the treatment of minor aches and pains. Common adverse reactions include dyspepsia, hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, and tinnitus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Temporarily relieves minor aches and pains.
• For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Dosage

• Drink a full glass of water with each dose.
• Adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor.
• Children under 12 years: consult a doctor.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Aspirin (delayed release tablet) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aspirin (delayed release tablet) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Aspirin (delayed release tablet) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Aspirin (delayed release tablet) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aspirin (delayed release tablet) in pediatric patients.

Contraindications

There is limited information regarding Aspirin (delayed release tablet) Contraindications in the drug label.

Warnings

• Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
• Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
• Hives
• Facial swelling
• Shock
• Asthma (wheezing)
• Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• Are age 60 or older
• Have had stomach ulcers or bleeding problems
• Take a blood thinning (anticoagulant) drug
• Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• Have 3 or more alcoholic drinks every day while using this product
• Take more or for a longer time than directed.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Aspirin (delayed release tablet) in the drug label.

Postmarketing Experience

Dyspepsia, hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, tinnitus.

Drug Interactions

There is limited information regarding Aspirin (delayed release tablet) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aspirin (delayed release tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Aspirin (delayed release tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Aspirin (delayed release tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Aspirin (delayed release tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Aspirin (delayed release tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Aspirin (delayed release tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral.

• Intravenous.

Monitoring

There is limited information regarding Monitoring of Aspirin (delayed release tablet) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Aspirin (delayed release tablet) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Aspirin (delayed release tablet) in the drug label.

Pharmacology

Template:Px
Aspirin (delayed release tablet)
Systematic (IUPAC) name
2-(acetoxy)benzoic acid
Identifiers
CAS number	50-78-2
ATC code	A01AD05 B01AC06 (WHO), N02BA01 (WHO)
PubChem	2244
DrugBank	DB00945
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	180.157 g/mol
SMILES	eMolecules & PubChem
Synonyms	2-acetoxybenzoic acid acetylsalicylate acetylsalicylic acid O-acetylsalicylic acid
Physical data
Density	1.40 g/cm³
Melt. point	136 °C (277 °F)
Boiling point	140 °C (284 °F) (decomposes)
Solubility in water	3 mg/mL (20 °C)
Pharmacokinetic data
Bioavailability	80–100%[1]
Protein binding	80–90%[2]
Metabolism	Hepatic, (CYP2C19 and possibly CYP3A), some is also hydrolysed to salicylate in the gut wall.[2]
Half life	Dose-dependent; 2–3 hours for low doses, 15–30 hours for large doses.[2]
Excretion	Urine (80–100%), sweat, saliva, feces[1]
Therapeutic considerations
Pregnancy cat.	C(AU) C(US)
Legal status	Pharmacy Only (S2)(AU) GSL(UK) OTC(US)
Routes	Most commonly oral, also rectal, lysine acetylsalicylate may be given intravenously or intramuscularly

Mechanism of Action

There is limited information regarding Aspirin (delayed release tablet) Mechanism of Action in the drug label.

Structure

There is limited information regarding Aspirin (delayed release tablet) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aspirin (delayed release tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aspirin (delayed release tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Aspirin (delayed release tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Aspirin (delayed release tablet) in the drug label.

How Supplied

There is limited information regarding Aspirin (delayed release tablet) How Supplied in the drug label.

Storage

There is limited information regarding Aspirin (delayed release tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aspirin (delayed release tablet) in the drug label.

Precautions with Alcohol

• Alcohol-Aspirin (delayed release tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ASPIRIN DELAYED RELEASE®^[3]

Look-Alike Drug Names

There is limited information regarding Aspirin (delayed release tablet) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

1. ↑ ^{1.0 1.1} "Zorprin, Bayer Buffered Aspirin (aspirin) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 3 April 2014.
2. ↑ ^{2.0 2.1 2.2} Brayfield, A, ed. (14 January 2014). "Aspirin". Martindale: The Complete Drug Reference. Pharmaceutical Press. Retrieved 3 April 2014.
3. ↑ "ASPIRIN DELAYED RELEASE- aspirin tablet, delayed release".

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CME Category::Cardiology