Usage
- This combination medication is primarily prescribed for the treatment of hemorrhoids (piles), both internal and external, acute and chronic. It also addresses associated symptoms such as pain, inflammation, itching, swelling, and bleeding. It is also indicated for anal fissures, anorectal inflammation and swelling, and post-surgical treatment following a haemorrhoidectomy. Additionally, it is used for problems related to veins and venous circulation like varicose veins and for chronic venous insufficiency.
- Pharmacological Classification: Vasoprotective, Venotonic, Anorectal preparation.
- Mechanism of Action: Calcium dobesilate enhances venous tone, reduces capillary permeability and fragility, and improves lymphatic drainage. Euphorbia prostrata extract, containing flavonoids, phenolic acids, and tannins, contributes anti-inflammatory, antioxidant, astringent, and wound-healing properties. The combination synergistically reduces inflammation, controls bleeding, promotes healing, and strengthens vein walls.
Alternate Names
- No widely recognized alternate names exist for the combination itself. However, the individual components have other names:
- Calcium Dobesilate: Doxium
- Euphorbia Prostrata: No widely used alternate name
- Brand Names: Sitcom Forte, Thank OD Forte, Pilorute EP Forte
How It Works
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Pharmacodynamics: Calcium dobesilate improves microcirculation by reducing capillary permeability, increasing venous tone, and enhancing lymphatic drainage. Euphorbia prostrata extract’s flavonoids and tannins have anti-inflammatory, analgesic, and hemostatic effects. Together, they decrease swelling, pain, and bleeding in the anorectal area.
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Pharmacokinetics: Specific pharmacokinetic data for the combined formulation is limited. Calcium dobesilate is absorbed orally. Information regarding the absorption, metabolism, and elimination of Euphorbia prostrata extract is scarce. It can be administered orally and topically.
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Mode of Action: Flavonoids in Euphorbia prostrata inhibit inflammatory pathways and provide antioxidant effects. Tannins exert astringent and hemostatic effects, controlling bleeding. Calcium dobesilate works on the vascular system, improving venous tone and reducing capillary fragility. The combination addresses multiple aspects of hemorrhoid pathophysiology.
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Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Limited information is available on specific interactions at the receptor, enzyme, or neurotransmitter level. Further research is needed to elucidate the precise molecular mechanism.
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Elimination Pathways: Information regarding elimination pathways is limited in available resources.
Dosage
Standard Dosage
Adults:
- Hemorrhoids: 100 mg of Euphorbia prostrata extract + 500 mg of calcium dobesilate once daily for 14 days.
- Post-hemorrhoidectomy: 100 mg of Euphorbia prostrata extract + 500 mg of calcium dobesilate twice daily for 14 days.
- Varicose Veins: One tablet twice daily for 1 month and further once or twice daily (as per condition) for the next 2 months. Topical application of cream twice daily for 3 months.
- Maximum daily dose and dosing frequency should be determined by the prescribing physician based on individual patient needs and the severity of symptoms.
Children:
- Use in children below 12 years should be done with caution and in prescribed pediatric doses. Consult a pediatrician before use.
Special Cases:
- Elderly Patients: Exercise caution due to the potential for increased risk of adverse effects. Dosage adjustments may be necessary.
- Patients with Renal Impairment: Use with caution. Dose reduction may be required based on renal function.
- Patients with Hepatic Dysfunction: Use with caution as it has not been evaluated in patients with hepatic dysfunction. Dosage adjustments may be necessary based on liver function.
- Patients with Comorbid Conditions: Caution is advised in patients with bleeding disorders, inflammatory bowel disease, intestinal disorders, and other comorbidities. Consult a physician for appropriate dosage adjustments.
Clinical Use Cases
- Dosage in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined by the physician based on the patient’s individual needs.
Dosage Adjustments
- Modifications may be required based on patient-specific factors such as renal/hepatic dysfunction, metabolic disorders, and other relevant conditions.
Side Effects
Common Side Effects
- Nausea, diarrhea, headache, stomach ache, constipation, dry mouth, local rash, dizziness, skin irritation.
Rare but Serious Side Effects
- Severe allergic reactions (swelling, itching, difficulty breathing, hives).
- Agranulocytosis (rare).
Long-Term Effects
- Limited data is available on long-term effects. Monitor patients for any unusual or persistent side effects.
Adverse Drug Reactions (ADR)
- Severe allergic reactions require immediate medical attention. Monitor patients closely for any signs of hypersensitivity.
Contraindications
- Hypersensitivity to any components of the formulation (Calcium Dobesilate, Euphorbia Prostrata extract, or excipients).
- Bleeding disorders.
- Pregnancy and breastfeeding (unless explicitly advised by a doctor).
- Severe renal or hepatic impairment.
Drug Interactions
- Anticoagulants (e.g., warfarin, heparin): Use with caution due to potential for altered coagulation profiles.
- Antiplatelet medicines (e.g., aspirin, clopidogrel).
- Antihypertensive agents (e.g., lisinopril, amlodipine).
- Antidiabetic medications (e.g., metformin, gliclazide).
- Corticosteroids and immunosuppressants: Potential interactions.
- Alcohol: Avoid alcohol consumption while on this medication.
Pregnancy and Breastfeeding
- Contraindicated during pregnancy and breastfeeding due to limited safety data. Potential risks to the fetus and neonate are unknown.
Drug Profile Summary
- Mechanism of Action: Improves venous tone, decreases capillary permeability, provides anti-inflammatory and antioxidant effects.
- Side Effects: Nausea, diarrhea, headache, rash, stomach ache, constipation, dry mouth; rare but serious allergic reactions.
- Contraindications: Hypersensitivity, bleeding disorders, pregnancy, breastfeeding.
- Drug Interactions: Anticoagulants, antiplatelet medications, antihypertensives, antidiabetics, corticosteroids, immunosuppressants.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: See detailed dosage guidelines above. Children: Use with caution and in prescribed pediatric doses.
- Monitoring Parameters: Monitor for symptom relief, adverse effects, and allergic reactions.
Popular Combinations
- Topical lidocaine is often combined with Euphorbia prostrata extract for enhanced local anesthetic effect.
Precautions
- General Precautions: Evaluate patients for pre-existing medical conditions, especially renal/hepatic impairment and bleeding disorders. Screen for allergies.
- Specific Populations: See Dosage - Special Cases section above.
- Lifestyle Considerations: Avoid alcohol. Driving or operating machinery may be affected if dizziness occurs.
FAQs (Frequently Asked Questions)
A: Standard adult dosage for hemorrhoids is 100 mg Euphorbia prostrata extract + 500 mg calcium dobesilate once daily for 14 days. Post-hemorrhoidectomy dosage is twice daily for 14 days. Pediatric and special population dosing should be determined by a physician.
Q2: What are the common side effects?
A: Common side effects include nausea, diarrhea, headache, rash, stomach ache, constipation, and dry mouth.
Q3: Is it safe to use during pregnancy or breastfeeding?
A: No, it’s contraindicated due to limited safety data.
Q4: What are the major drug interactions?
A: Significant interactions may occur with anticoagulants, antiplatelet agents, antihypertensives, corticosteroids, and immunosuppressants.
Q5: What conditions is this medication used to treat?
A: Primarily hemorrhoids (piles) and associated symptoms, also varicose veins and venous insufficiency. It’s also used post-hemorrhoidectomy.
Q6: Are there any dietary restrictions while taking this medication?
A: While no specific dietary restrictions are listed in the provided information, avoiding spicy and oil-rich foods and increasing fiber intake is generally recommended for managing hemorrhoids.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s close to the next scheduled dose. Don’t double the dose.
Q8: What should patients with liver or kidney problems do?
A: They should exercise caution and consult their doctor, as dosage adjustments may be needed.
Q9: Can this medication be used for long-term treatment?
A: Long-term use should be evaluated by a physician, considering potential risks and benefits.
Q10: How quickly does this medication provide relief?
A: Some studies suggest significant improvement within the first few days, but individual responses may vary.
