Usage
This combination medication is primarily prescribed for the management of heavy menstrual bleeding (menorrhagia) and associated pain (dysmenorrhea). Ethamsylate is a haemostatic agent, and mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID).
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Pharmacological Classification: Ethamsylate is a haemostatic, antihemorrhagic agent. Mefenamic acid is an NSAID (analgesic, anti-inflammatory, antipyretic).
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Mechanism of Action: Ethamsylate works by enhancing platelet adhesion and improving capillary resistance, thereby promoting clot formation and reducing bleeding. Mefenamic acid inhibits prostaglandin synthesis, which reduces pain and inflammation.
Alternate Names
There is no internationally recognized non-proprietary name for this combination. It’s often referred to by the names of its components. Several brand names exist, including Osemic-MF and Tenxima MF. Regional variations may also exist.
How It Works
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Pharmacodynamics: Ethamsylate promotes hemostasis by enhancing platelet aggregation and adhesion, leading to reduced bleeding time. Mefenamic acid reduces pain and inflammation by inhibiting cyclooxygenase (COX) enzymes, decreasing prostaglandin production.
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Pharmacokinetics: Ethamsylate is rapidly absorbed after oral administration, reaching peak plasma concentrations within 4 hours. It is primarily excreted unchanged in the urine. Mefenamic acid is also well-absorbed orally, with peak plasma levels achieved in 2-4 hours. It undergoes hepatic metabolism and is excreted primarily in the urine and bile.
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Mode of Action: Ethamsylate works by increasing interaction between endothelial cells and platelets. Mefenamic acid inhibits COX-1 and COX-2 enzymes, leading to reduced prostaglandin synthesis.
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Elimination Pathways: Ethamsylate primarily through renal excretion. Mefenamic acid through hepatic metabolism and renal and biliary excretion.
Dosage
Standard Dosage
Adults:
The typical dose is one tablet (containing 250mg mefenamic acid and 500 mg of tranexamic acid or 500 mg of etamsylate) two to three times a day, starting on the first day of menstruation or as prescribed by the physician. It’s often recommended to take the medication with food to reduce gastrointestinal side effects.
Children:
Use in children under 14 is generally not recommended, as safety and efficacy haven’t been established in this age group.
Special Cases:
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Elderly Patients: Dose adjustment may be necessary, starting with the lower end of the dosing range.
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Patients with Renal Impairment: Caution is advised, and dose reduction may be necessary depending on the degree of impairment.
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Patients with Hepatic Dysfunction: Use with caution, as dose adjustments might be required.
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Patients with Comorbid Conditions: Use with caution in patients with a history of thromboembolic disorders, cardiovascular diseases, or gastrointestinal problems.
Clinical Use Cases
The combination of ethamsylate and mefenamic acid isn’t typically used in the following clinical settings: intubation, surgical procedures, mechanical ventilation, ICU, and emergency situations. In such cases, intravenous tranexamic acid might be utilized alone or in combination with other agents, depending on the clinical context. Ethamsylate may be used in surgery to minimize capillary bleeding.
Dosage Adjustments
Adjustments are based on patient response, renal or hepatic dysfunction, and other medical conditions. Individualized dosing is crucial, emphasizing close patient monitoring.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain, headache, indigestion, heartburn, dizziness.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), thromboembolic events (chest pain, shortness of breath), gastrointestinal bleeding or ulceration, visual disturbances, severe skin reactions (toxic epidermal necrolysis).
Long-Term Effects:
Long-term continuous use isn’t typically recommended. Prolonged use of mefenamic acid carries the risk of gastrointestinal issues, renal dysfunction, and cardiovascular complications.
Adverse Drug Reactions (ADR):
Severe allergic reactions, thromboembolic complications, gastrointestinal bleeding, and severe skin reactions.
Contraindications
Hypersensitivity to either component, active intravascular clotting, subarachnoid hemorrhage, history of thromboembolic events, severe renal impairment, severe hepatic impairment, porphyria.
Drug Interactions
Anticoagulants (warfarin, heparin), other NSAIDs (aspirin, ibuprofen), antihypertensives, hormonal contraceptives, estrogens, retinoids, some antibiotics, alcohol.
Pregnancy and Breastfeeding
This combination should be avoided during pregnancy, especially in the third trimester, due to the risk of premature closure of the ductus arteriosus in the fetus. Mefenamic acid can be excreted in breast milk, and its use during breastfeeding isn’t generally recommended.
Drug Profile Summary
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Mechanism of Action: Ethamsylate enhances platelet function and capillary resistance; mefenamic acid inhibits prostaglandin synthesis.
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Side Effects: Nausea, vomiting, diarrhea, gastrointestinal issues, thromboembolic events.
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Contraindications: Hypersensitivity, active clotting disorders, thromboembolic history, pregnancy.
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Drug Interactions: Anticoagulants, NSAIDs, hormonal contraceptives.
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Pregnancy & Breastfeeding: Avoid during pregnancy, especially the third trimester; use with caution during breastfeeding.
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Dosage: 1 tablet (250 mg mefenamic acid, 500 mg tranexamic acid or 500 mg etamsylate) 2-3 times/day during menstruation.
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Monitoring Parameters: Menstrual blood loss, pain scores, liver and kidney function, signs of thromboembolic complications.
Popular Combinations
This specific combination is commonly prescribed, and adding other drugs isn’t usually required.
Precautions
Assess renal and hepatic function, history of thromboembolic events, gastrointestinal issues, and allergies before prescribing. Monitor for signs of clotting disorders and adverse reactions. Caution during breastfeeding and avoid in pregnancy, especially the third trimester. Avoid alcohol to minimize potential adverse effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ethamsylate + Mefenamic Acid?
A: The standard dosage is one tablet (250 mg mefenamic acid, 500 mg tranexamic acid or 500 mg etamsylate) two to three times a day, starting on the first day of menses, for a duration determined by the physician.
Q2: What are the primary uses of this combination therapy?
A: To manage heavy menstrual bleeding (menorrhagia) and associated pain (dysmenorrhea).
Q3: What are the potential side effects?
A: Common side effects include nausea, vomiting, diarrhea, and gastrointestinal upset. More serious side effects include thromboembolic events and allergic reactions.
Q4: Is this combination safe during pregnancy or breastfeeding?
A: It should be avoided during pregnancy, particularly in the third trimester. Caution is advised during breastfeeding.
Q5: Are there any drug interactions I should be aware of?
A: Yes, it can interact with anticoagulants, other NSAIDs, and hormonal contraceptives.
Q6: How does this combination work to reduce heavy menstrual bleeding?
A: Ethamsylate improves platelet function and capillary resistance, while mefenamic acid reduces prostaglandin production, which contributes to heavy bleeding.
Q7: What precautions should I take when prescribing this medication?
A: Assess renal and hepatic function, history of thromboembolic events, and allergies before starting treatment. Monitor patients for adverse events.
Q8: Can this drug be used for other types of bleeding?
A: While both components have individual uses in other bleeding conditions, this combination is primarily indicated for menorrhagia.
Q9: How long should a patient typically take this medication?
A: Generally, it’s prescribed for a few days during each menstrual cycle where heavy bleeding and pain are a concern. Long-term continuous use is not generally advised.
Q10: What should patients do if they miss a dose?
A: Take the missed dose as soon as remembered, unless it’s close to the next scheduled dose. Do not double the dose.
