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ENTROPHEN is a brand name for Aspirin (also known as Acetylsalicylic Acid), supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ENTROPHEN is indicated for the following uses, based on its platelet aggregation inhibitory properties: • for reducing the risk of vascular mortality in patients with a suspected acute myocardial infarction; • for reducing the risk of a first non-fatal myocardial infarction in individuals deemed to be at sufficient…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Please see below for specific dosing instructions for each indication. 2 Recommended Dose and Dosage Adjustment • Platelet aggregation inhibitor: o Suspected Acute Myocardial Infarction: An initial dose of at least 162 mg chewed to ensure rapid absorption as soon as a myocardial infarction is suspected.
The same dose should be given as maintenance over the next 30 days. After 30 days, consider further therapy based on dosage and administration for prevention of recurrent MI (see Prior Myocardial Infarction).
Risk in Pregnancy:
Caution should be exercised in prescribing ENTROPHEN during the first and second trimesters of pregnancy. Use of NSAIDS at approximately 20 weeks of gestation or later may cause oligohydramnios, and renal dysfunction including renal failure (see 7 WARNINGS AND PRECAUTIONS).
ENTROPHEN is CONTRAINDICATED for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see 2 CONTRAINDICATIONS). ENTROPHEN Page 6 of 32 o Prevention of a first non-fatal myocardial infarction: 81 – 325 mg once daily, according to the individual needs of the patient, as determined by the physician.
o Prior Myocardial Infarction or Unstable Angina Pectoris: 81 – 325 mg daily according to the individual needs of the patient, as determined by the physician. o Transient Ischemic Attack and Secondary Prevention of Atherothrombotic Cerebral Infarction: 81 – 325 mg daily according to the individual needs of the patient, as determined by the physician.
o Prophylaxis of Venous Thromboembolism after total hip replacement: 162 – 325 mg daily according to the individual needs of the patient, as determined by the physician. 4 Administration ENTROPHEN tablets should preferably be taken after meals, with plenty of liquid.
5 Missed dose Take the missed dose as soon as you remember. But do not take an extra dose to compensate for a missed dosage unless instructed by your doctor.
1 Adverse Reaction Overview Many adverse reactions due to ASA ingestion are dose-related. The following is a list of adverse reactions that have been reported in the literature and from both clinical and post- marketing experience. Gastrointestinal: (the frequency and severity of these adverse effects are dose-related): nausea, vomiting, diarrhea, gastrointestinal bleeding and/or ulceration, dyspepsia, heartburn, hematemesis, melena, abdominal pain, rarely gastrointestinal inflammation, and intestinal diaphragm disease with frequency not known (especially in long-term treatment).
, perioperative haemorrhage, hematomas, epistaxis, urogenital bleedings, and gingival bleedings may occur. Serious bleedings, such as gastrointestinal tract hemorrhages, and cerebral hemorrhages are rare. Isolated cases of potentially life-threatening bleedings have been reported, especially in patients with uncontrolled hypertension and/or concomitant antihemostatic agents.
Ear: dizziness, tinnitus, vertigo, hearing loss. Dizziness and tinnitus have been reported, which may be indicative of an overdose. Hematologic: leukopenia, thrombocytopenia, purpura, anemia. , occult microbleeding, acute or chronic bleeding).
Hemolysis and hemolytic anemia in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency has been reported. Dermatologic and hypersensitivity: urticaria, pruritus, skin eruptions, asthma, anaphylaxis, edema nasal congestion and rhinitus.
Severe allergic reactions, including anaphylactic shock are very rarely reported. Miscellaneous: mental confusion, drowsiness, sweating, thirst. Transient hepatic impairment with increase in liver transaminases has very rarely been reported.
Renal impairment and acute renal failure have been reported.
). 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. (See 7 WARNINGS AND PRECAUTIONS) In general, ASA should be used with caution in elderly patients (≥ 60 years of age), as these patients may be more susceptible to adverse reactions.
ENTROPHEN Page 5 of 32 2 CONTRAINDICATIONS ENTROPHEN is contraindicated in patients who are/have: • Hypersensitive to ASA, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container.
For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING of the product monograph. • Acute gastrointestinal ulcer • History of gastrointestinal ulcers • Hemorrhagic diathesis • Active or Severe hepatic failure, renal failure, or congestive heart failure • History of asthma induced by the administration of salicylates or substances with a similar action, notably NSAIDs • Concomitant treatment with methotrexate at doses of 15mg/week or more (see 9 DRUG INTERACTIONS).
• The third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. 1 Dosing Considerations • Please see below for specific dosing instructions for each indication. 2 Recommended Dose and Dosage Adjustment • Platelet aggregation inhibitor: o Suspected Acute Myocardial Infarction: An initial dose of at least 162 mg chewed to ensure rapid absorption as soon as a myocardial infarction is suspected.
The same dose should be given as maintenance over the next 30 days. After 30 days, consider further therapy based on dosage and administration for prevention of recurrent MI (see Prior Myocardial Infarction).
Risk in Pregnancy:
Caution should be exercised in prescribing ENTROPHEN during the first and second trimesters of pregnancy. Use of NSAIDS at approximately 20 weeks of gestation or later may cause oligohydramnios, and renal dysfunction including renal failure (see 7 WARNINGS AND PRECAUTIONS).
ENTROPHEN is contraindicated in patients who are/have: • Hypersensitive to ASA, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container.
For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING of the product monograph. • Acute gastrointestinal ulcer • History of gastrointestinal ulcers • Hemorrhagic diathesis • Active or Severe hepatic failure, renal failure, or congestive heart failure • History of asthma induced by the administration of salicylates or substances with a similar action, notably NSAIDs • Concomitant treatment with methotrexate at doses of 15mg/week or more (see 9 DRUG INTERACTIONS).
• The third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. 1 SPECIAL POPULATIONS)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ENTROPHEN is CONTRAINDICATED for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see 2 CONTRAINDICATIONS). ENTROPHEN Page 6 of 32 o Prevention of a first non-fatal myocardial infarction: 81 – 325 mg once daily, according to the individual needs of the patient, as determined by the physician.
o Prior Myocardial Infarction or Unstable Angina Pectoris: 81 – 325 mg daily according to the individual needs of the patient, as determined by the physician. o Transient Ischemic Attack and Secondary Prevention of Atherothrombotic Cerebral Infarction: 81 – 325 mg daily according to the individual needs of the patient, as determined by the physician.
o Prophylaxis of Venous Thromboembolism after total hip replacement: 162 – 325 mg daily according to the individual needs of the patient, as determined by the physician. 4 Administration ENTROPHEN tablets should preferably be taken after meals, with plenty of liquid.
5 Missed dose Take the missed dose as soon as you remember. But do not take an extra dose to compensate for a missed dosage unless instructed by your doctor. 5 OVERDOSAGE Mild Overdose or Early Poisoning - burning in the mouth, lethargy, nausea, vomiting, tinnitus, sweating, thirst, tachycardia or dizziness.
Moderate Overdose - all of the symptoms from mild overdose plus tachypnea, hyperpyrexia, sweating, dehydration, loss of coordination, restlessness, mental confusion. Severe Overdose - all of the symptoms from moderate overdose plus hypotension, hallucinations, stupor, hypoglycemia, convulsions, cerebral edema, oliguria, renal failure, cardiovascular failure, coma, hemorrhage, metabolic acidosis, respiratory alkalosis and/or failure.
Emergency Management: 1. Immediate transfer to hospital and maintain cardiovascular and respiratory support. 2. Gastric lavage, administration of activated charcoal, 3. Check of acid-base balance and correct if necessary. 4. 2 mmol/L) in children ENTROPHEN Page 7 of 32 5.
0 mmol/L) in children, as renal elimination of salicylates may be slow due to the presence of acidic urine and renal failure. 2), acute renal failure, pulmonary edema or CNS symptoms such as: drowsiness, agitation, coma or convulsions.
6. g. half saline) and supplemented with glucose 50 to 100g/L. 7. Symptomatic treatment. Fatal Dose: varies from 10 to 30g of ASA. However, (in one case) 130g of ASA was ingested without fatal outcome. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral ENTROPHEN: Round, white to off-white, film-coated tablet, 81mg acetylsalicylic acid Colloidal Silicon Dioxide, Glyceryl Stearate, Lactose Anhydrous, Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose, Polydimethylsiloxane, Polysorbate 65, Pregelatinized Starch, Sodium Bicarbonate, Sodium Lauryl Sulphate, Sorbic Acid, Stearic Acid, Sulfuric Acid, Talc, Titanium Dioxide and Triethyl Citrate.
ENTROPHEN: are packaged in bottles of 30, 120, 150, 180, 225, 255, 300, 360, 365, 500 and 1000 (for dispensing use only) tablets. For management of a suspected drug overdose, contact your regional poison control centre. ENTROPHEN Page 8 of 32 7 WARNINGS AND PRECAUTIONS […]