Aspirin (rectal)

Aspirin (rectal)
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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 (rectal) is an analgesic that is FDA approved for the treatment of minor aches, pains and headache and for reduction of fever. Common adverse reactions include hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, and tinnitus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

For the relief of minor aches, pains and headache and for reduction of fever.

Dosage

Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Aspirin (rectal) Contraindications in the drug label.

Warnings

There is limited information regarding Aspirin (rectal) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

Hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, tinnitus

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Rectal

Monitoring

There is limited information regarding Monitoring of Aspirin (rectal) in the drug label.

IV Compatibility

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

Overdosage

There is limited information regarding Aspirin (rectal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology


Template:Px
Aspirin (rectal)
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 atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template: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 (rectal) Mechanism of Action in the drug label.

Structure

There is limited information regarding Aspirin (rectal) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aspirin (rectal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aspirin (rectal) in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Suppositories sealed in imprinted plastic packet.

Storage

Do not use if imprinted packet is opened or damaged. Store in a cool place 8˚- 15˚C (46˚- 59˚F) or refrigerate.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

ASPIRIN®^[3]

Look-Alike Drug Names

There is limited information regarding Aspirin (rectal) 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.

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

CME Category::Cardiology

[MSR-1] 1.0 ^1.1 "Zorprin, Bayer Buffered Aspirin (aspirin) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 3 April 2014.

[MD-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- aspirin suppository".

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