Description
Sintrom contains acenocoumarol, an oral anticoagulant belonging to the coumarin class. It functions as a vitamin K antagonist, inhibiting the synthesis of vitamin K–dependent clotting factors (II, VII, IX, and X), thereby reducing the blood’s ability to clot. Sintrom is indicated for the prevention and treatment of thromboembolic disorders such as deep vein thrombosis (DVT), pulmonary embolism (PE), and for stroke prevention in patients with atrial fibrillation or prosthetic heart valves. It is commonly used as a long-term anticoagulant in outpatient settings.
F act Table |
Formula | C19H15NO6 |
License | EMA (European Medicines Agency) |
Bioavailability | 60–100% |
Legal status | Prescription only (Rx) |
Chemical Name | Acenocoumarol |
Elimination half-life | 8–11 hours |
Dosage (Strength) | 1 mg, 4 mg tablets (individualized dosing based on INR) |
Pregnancy | Contraindicated (Category X) |
Brands | Sintrom, Sinthrome |
Protein binding | 98.7% |
PubChem CID | 1981 |
MedlinePlus | a682749 |
ChEBI | 135506 |
ATC code | B01AA07 |
DrugBank | DB01418 |
KEGG | D07436 |
Routes of administration | Oral |
Directions
Dosage must be individualized based on the patient's International Normalized Ratio (INR), with a typical therapeutic range of 2.0 to 3.0 for most indications, and 2.5 to 3.5 for mechanical heart valves. Treatment should begin under medical supervision with frequent INR monitoring. The initial dose for adults is typically 2 to 4 mg daily, adjusted according to INR response. Once stable, INR monitoring may be spaced to every 2–4 weeks. Patients should take Sintrom at the same time each day, preferably in the evening, and avoid any abrupt changes in diet or concomitant medications without consulting a healthcare provider.
Ingredients
Each tablet of Sintrom contains acenocoumarol as the active ingredient. The tablets are available in various strengths (commonly 1 mg, 2 mg, or 4 mg), and may include excipients such as lactose monohydrate, maize starch, magnesium stearate, and talc.
Contraindications
Sintrom is contraindicated in patients with known hypersensitivity to acenocoumarol or any component of the formulation, active bleeding disorders, severe hepatic impairment, recent major surgery with high bleeding risk, pregnancy (particularly during the first trimester and near term), and in patients with a history of warfarin- or acenocoumarol-induced skin necrosis.
Cautions
Close INR monitoring is essential to prevent over-anticoagulation and bleeding complications. Use with caution in patients with renal or hepatic dysfunction, uncontrolled hypertension, recent gastrointestinal bleeding, or those with a history of falls. Patients should maintain a consistent intake of vitamin K–rich foods, avoid alcohol abuse, and inform all healthcare providers of their anticoagulant therapy. Numerous drug interactions exist, including with NSAIDs, antibiotics, antifungals, and other antithrombotic agents.
Side Effects
Possible side effects include:
- Bleeding (e.g., epistaxis, hematuria, gastrointestinal bleeding)
- Skin rash or allergic reactions
- Gastrointestinal discomfort or nausea
- Rare: skin necrosis, hepatic enzyme elevation, alopecia
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 10240