Afogatran 110 Capsule (10 Cap)

AFOGATRAN 110 CAPSULE

AFOGATRAN 110 CAPSULE is a prescription medication manufactured by Torrent Pharmaceuticals Ltd. used to prevent and treat blood clots.

Name

• Brand Name: Afogatran 110 Capsule
• Common Name: Dabigatran Etexilate (110mg)

Composition

• Each capsule contains Dabigatran Etexilate 110mg as the active ingredient. Dabigatran Etexilate works by inhibiting thrombin, a key enzyme involved in blood clot formation, thereby preventing the conversion of fibrinogen to fibrin and allowing blood to flow more easily through the veins.

Uses AFOGATRAN 110 CAPSULE is primarily used for the prevention and treatment of blood clots. It helps reduce the risk of stroke and heart attack. Specific uses include:

• Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (irregular heart rhythm).
• Treatment and prevention of deep vein thrombosis (DVT) (blood clots in the leg veins).
• Treatment and prevention of pulmonary embolism (PE) (blood clots in the lung).
• Reduction of blood clot formation in patients who have undergone knee or hip replacement surgeries.

Dosage and Administration AFOGATRAN 110 CAPSULE should be taken orally with water, with or without food, as prescribed by your doctor. It is recommended to take the capsule at the same time each day to maintain consistent blood levels. Do not chew, crush, or open the capsule; swallow it whole. Do not discontinue or alter the dose without consulting a healthcare professional, as this could increase the risk of serious cardiovascular events. The duration of treatment can vary, potentially requiring long-term use.

Side Effects Common side effects may include:

• Bleeding (e.g., nosebleeds, bruising)
• Anaemia (low number of red blood cells)
• Nausea
• Stomach pain
• Indigestion/Stomach upset
• Headaches
• Fatigue

More serious side effects can include uncontrolled bleeding, allergic reactions, seizures, or changes in eyesight. Report any persistent or severe side effects to your doctor immediately.

Precautions

• Allergies: Inform your doctor if you are allergic to Dabigatran Etexilate or any of its components.
• Medical Conditions: Contraindicated in individuals with severe kidney or liver problems, active major bleeding, or a disease that increases the risk of bleeding.
• Other Medications: Avoid taking with other blood-thinning medications (e.g., warfarin, rivaroxaban, apixaban, heparin) as this may increase the risk of bleeding. Certain medications like ketoconazole, cyclosporin, dronedarone, glecaprevir, pibrentasvir, rifampicin, carbamazepine, phenytoin, verapamil, amiodarone, quinidine, clarithromycin, and posaconazole can interact with Afogatran 110 Capsule.
• Pregnancy and Breastfeeding: Considered unsafe during pregnancy due to potential harm to the fetus and not recommended during breastfeeding as it may excrete via breast milk. Consult your doctor if pregnant or breastfeeding.
• Surgery/Dental Procedures: You may be advised to temporarily stop taking this medicine before any surgery or dental treatment.
• Alcohol: It is considered unsafe to consume alcohol while taking this medication.
• Liver Function: While generally having a mild effect, long-term use may increase the chances of mild liver injury in patients with elevated liver enzymes. Inform your doctor about any history of liver disease.
• Unlike some other anticoagulants, routine blood tests may not be necessary during treatment with Afogatran 110 Capsule.

Storage Store AFOGATRAN 110 CAPSULE in a cool and dry place, protected from moisture, at room temperature (between 15°C to 30°C). Keep it out of sight and reach of children. Once the bottle is opened, it should be used within 4 months; discard safely if unused within this period.

Here are frequently asked questions about Afogatran 110 Capsule, along with concise answers:

What is Afogatran 110 Capsule used for?

Afogatran 110 Capsule is an anticoagulant, also known as a blood thinner, primarily used to prevent and treat blood clots. It helps reduce the risk of stroke and heart attack, especially in patients with an irregular heart rhythm called atrial fibrillation. It also prevents and treats clot formation in the veins of the legs (Deep Vein Thrombosis), lungs (Pulmonary Embolism), brain, and heart, and is used after knee or hip replacement surgeries to prevent clot formation.

How does Afogatran 110 Capsule work?

Afogatran 110 Capsule contains Dabigatran Etexilate, which is a novel oral anticoagulant (NOAC). It works by directly inhibiting thrombin, a key enzyme involved in the blood clotting process. By blocking thrombin, it prevents the conversion of fibrinogen to fibrin, thereby stopping the formation of new blood clots and preventing existing ones from getting larger, allowing the body to dissolve them over time.

What is the usual dosage for Afogatran 110 Capsule?

Afogatran 110 Capsule is typically taken twice daily at the same time each day, usually with a gap of about 12 hours between doses. It can be taken with or without food. It is crucial to follow your doctor's specific instructions regarding the dose and duration, and to swallow the capsule whole without chewing, crushing, or breaking it. Do not stop taking the medication or change your dose without consulting your doctor.

What are the possible side effects of Afogatran 110 Capsule?

Common side effects include stomach upset, nausea, indigestion (dyspepsia), abdominal pain, and diarrhea. Due to its blood-thinning action, an increased risk of bleeding is also common, which may manifest as nosebleeds or easy bruising. More serious but less common side effects can include gastrointestinal bleeding, anemia, headaches, allergic reactions, changes in eyesight, and fatigue. If any side effects persist or are concerning, or if you notice any unusual bleeding, contact your doctor immediately.

Is Afogatran 110 Capsule safe during pregnancy or breastfeeding?

Afogatran 110 Capsule is generally considered unsafe during pregnancy as animal studies have shown harmful effects on the developing baby, and human studies are limited. Women of childbearing age should avoid becoming pregnant while on this medication. It is also likely unsafe during breastfeeding as the drug may pass into breast milk and could harm the baby. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can Afogatran 110 Capsule be taken with other medications?

Afogatran 110 Capsule generally interacts less with food or other medicines compared to some other anticoagulants, and regular lab tests like PT-INR are often not required. However, it's essential to inform your doctor about all prescription and over-the-counter medications, supplements, and herbal products you are taking. Certain medications, such as some oral antifungals (e.g., ketoconazole), immunosuppressants (e.g., cyclosporin), and antivirals, should not be taken with Afogatran 110 Capsule. Concomitant use with other blood thinners can significantly increase the risk of bleeding.

What precautions should be taken while using Afogatran 110 Capsule?

Since Afogatran 110 Capsule increases your risk of bleeding, exercise caution with activities that may cause injury, such as shaving, cutting nails, or engaging in contact sports. Inform your doctor if you notice blood in your vomit, urine, or stool. This medication should be used with caution in patients with severe kidney or liver disease, a history of bleeding disorders, or certain stomach conditions. Always inform your doctor or dentist you are taking this medication before any surgery or dental procedure, as it may need to be temporarily stopped. Avoid alcohol consumption, as it can increase the risk of stomach bleeding.

What should I do if I miss a dose of Afogatran 110 Capsule?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten one, as this can increase your risk of bleeding. It is very important not to miss doses, as this could increase your risk of blood clot formation.

How should Afogatran 110 Capsule be stored?

Afogatran 110 Capsule should be stored at room temperature, typically between 15°C and 30°C (59°F and 86°F). Keep the medicine in a dry place, protected from moisture and direct sunlight. Ensure the bottle is tightly closed after each use, and always keep it out of the reach and sight of children and pets. Once the bottle is opened, the capsules should generally be used within 4 months, and any unused medication after this period should be discarded safely.