Registered Malawi · PMRA

ACETYLSALICYLIC 300MG TABLET

ACETYLSALICYLIC ACID

PMPB/PL173/1 TABLET

What it does

Acetylsalicylic acid is a medication commonly known as aspirin, used to relieve pain, reduce inflammation, and lower fever.

Commonly used for: pain relief (analgesic), inflammation reduction (anti-inflammatory), fever reduction (antipyretic), prevention of heart attacks and strokes

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL173/1
Registration date
22/08/2001
Expiry date
30/06/2014
Status
Registered
Active ingredient
ACETYLSALICYLIC ACID
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
91101
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:38 · updated 2026-09-22 04:33:02

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Acetylsalicylic acid is a medication commonly known as aspirin, used to relieve pain, reduce inflammation, and lower fever.

What it treats

  • pain relief (analgesic)
  • inflammation reduction (anti-inflammatory)
  • fever reduction (antipyretic)
  • prevention of heart attacks and strokes

How it works

Aspirin works by blocking certain chemicals in the body that cause pain and inflammation, and it also helps to prevent blood clots.

Who it's for

Aspirin is suitable for adults and children over a certain age, but it's important to consult a healthcare provider before use.

Cautions

  • • May cause stomach upset or ulcers.
  • • Not recommended for people with certain bleeding disorders.
  • • Should be used with caution in those with asthma or allergies to NSAIDs.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: acetylsalicylic

Acetylsalicylic acid, commonly known as aspirin, is a nonsteroidal anti-inflammatory drug (NSAID) that is widely used for its analgesic, antipyretic, and anti-inflammatory properties. It is also utilized in low doses for its antiplatelet effects, making it an important medication in the prevention of cardiovascular events such as myocardial infarctions and strokes.

Indications

  • Mild to moderate pain relief
  • Fever reduction
  • Management of inflammatory conditions such as rheumatoid arthritis and osteoarthritis
  • Prevention of cardiovascular events in patients with a history of myocardial infarction or stroke
  • Management of acute coronary syndrome

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients, as this may differ significantly from adult dosing.

Adults: Refer to the BNF for specific dosing guidelines, as doses may vary based on the indication and patient factors.

Mechanism of action

Aspirin works primarily by irreversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, leading to a decrease in the synthesis of prostaglandins and thromboxanes. This results in reduced inflammation, pain, and fever. The inhibition of COX-1 also reduces platelet aggregation by decreasing thromboxane A2 production, which is crucial for platelet activation and aggregation.

Pharmacodynamics

The analgesic effects of aspirin are attributed to its ability to inhibit the generation of prostaglandins, which mediate pain and inflammation. In addition to its pain-relieving and anti-inflammatory effects, aspirin's antiplatelet action is significant in the context of cardiovascular health, as it reduces the risk of thrombus formation in blood vessels.

Pharmacokinetics

Aspirin is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours after oral administration. It is extensively metabolized in the liver, primarily via hydrolysis to salicylic acid, which has its own therapeutic effects. The elimination half-life varies depending on the dose, ranging from 15 to 20 minutes for aspirin and several hours for salicylic acid. Aspirin and its metabolites are excreted primarily in the urine.

Contra-indications

  • Active gastrointestinal bleeding
  • History of peptic ulcer disease
  • Severe renal impairment
  • Severe hepatic impairment
  • Hypersensitivity to acetylsalicylic acid or other NSAIDs
  • Children and teenagers with viral infections (risk of Reye's syndrome)

Adverse effects

  • Gastrointestinal irritation and bleeding
  • Nausea and vomiting
  • Dyspepsia
  • Allergic reactions such as rash or asthma exacerbation
  • Tinnitus (ringing in the ears)
  • Renal impairment
  • Hepatic dysfunction

Interactions

  • Increased risk of gastrointestinal bleeding with other NSAIDs or anticoagulants
  • Enhanced effects of anticoagulants (e.g., warfarin, heparin)
  • Reduced effectiveness of antihypertensive drugs (e.g., ACE inhibitors)
  • Increased risk of renal impairment with diuretics
  • Potential interaction with methotrexate, leading to increased toxicity

Precautions

  • Use with caution in patients with a history of gastrointestinal disorders
  • Monitor renal function in long-term use or in patients with renal impairment
  • Assess the risk of bleeding before surgery or dental procedures
  • Caution in patients with asthma or nasal polyps due to potential hypersensitivity reactions
  • Consider the potential for Reye's syndrome in children and adolescents

Pregnancy

Use during pregnancy is generally not recommended, particularly in the third trimester, due to the risk of adverse effects on the fetus and complications during delivery.

Breast-feeding

Acetylsalicylic acid is excreted in breast milk; caution is advised if used while breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Enteric-coated tablets
  • Effervescent tablets
  • Suppositories
  • Oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.