Pradaxa (Dabigatran Etexilate Capsules) - Product Information
Pradaxa capsules are used to reduce the risk of stroke and blood clots in patients that have a medical condition called atrial fibrillation. Pradaxa is an anticoagulant medication that slows and inhibits the formation of blood clots. In patients that have a medical condition called atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase the risk of a stroke.
Name of Drug
Manufacturer Of Pradaxa Capsules
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Active Pharmaceutical Ingredients in Pradaxa Capsules
The active pharmaceutical ingredients present in Pradaxa capsules is Dabigatran Etexilate Mesylate.
Inactive Pharmaceutical Ingredient in Pradaxa Capsules
The inactive pharmaceutical ingredient present in Pradaxa capsules are acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2 (150 mg strength only), FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.
Drug Class and Mechanism
The process of clotting is facililitated by the enzyme thrombin which aids the conversion of the protein fibrinogen to fibrin. Thrombin causes fibrinogen to convert to fibrin and assemble
into large fibrous networks which then trap blood cells, leading to the formation of blood clots or thrombi.
Dabigatran etexilate works by specifically and selectively binding to thrombin, blocking both free and clot-bound thrombin,providing more effective thrombin inhibition, binding with existing thrombin and interfering with thrombin and its effects on the coagulation cascade viz. conversion of fi brinogen to fibrin by thrombin, platelet activation by thrombin and activation of clotting Factors by thrombin.
Pradaxa Capsules - Dosage
The recommended dosage of Pradaxa capsules is as given below:
For patients with creatinine clearance greater than 30 mL/min: 150 mg orally, twice daily
For patients with creatinine clearance between 15 and 30 mL/min: 75 mg orally, twice daily
Do not to chew, break, or open capsules. Pradaxa Capsules can be taken with or without food.
If you miss a dose Pradaxa capsules take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of Pradaxa at the same time.
Storage Instructions for Pradaxa Capsules
Pradaxa capsules should be kept at room temperature, 15-30°C (59-86°F) in a light-resistant, tight container. After opening the bottle, use Pradaxa Capsules within 4 months. Safely dispose any unused medication after 4 months. Keep Pradaxa in the original bottle or blister package to protect the capsules from moisture and keep it dry. Please close the bottle of Pradaxa tightly soon after you take your dose. Keep Pradaxa capsules away from children and pets.
Warnings and Precautions when using Pradaxa Capsules
Before using Pradaxa capsules please tell your doctor if you have kidney problems, have ever had bleeding problems, have ever had stomach ulcers any medical conditions are pregnant or plan to become pregnant. You also have to inform your doctor about all the medicines that you take including prescription and non-prescription medicines, vitamins, and herbal remedies. Do not forget to tell your doctor if you take Rifampin (Rifater, Rifamate, Rimactane, Rifadin). Inform all of your doctors and dentists that you are taking Pradaxa. Dabigatran etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.
Side Effects of Pradaxa Capsules
In some patients Pradaxa can cause symptoms of an allergic reaction, including hives, rash, and itching.
Get medical help immediately in case of the following symptoms of a serious allergic reaction:
- chest pain or chest tightness
- feeling dizzy or faint
- swelling of your face or tongue
- trouble breathing or wheezing
Common side effects of Pradaxa Capsules include indigestion, upset stomach, or burning, stomach pain, dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and gastrointestinal ulcer).
Pradaxa Capsules – Contraindications
Pradaxa capsules is contraindicated in patients with hypersensitivity to Dabigatran Etexilate or any inactive ingredient of Pradaxa capsules. Pradaxa is also contraindicated in patients with active pathological bleeding.
Pradaxa Capsules and Pregnancy
It is not known whether Pradaxa will harm your unborn baby. It is not known if Pradaxa passes into your breast milk. Hence it is recommended to either breastfeed and discontinue Pradaxa or discontinue breastfeeding.
Accidental overdose of Pradaxa capsules may lead to hemorrhagic complications. There is no reversal agent for dabigatran etexilate. In the case of hemorrhagic complications, appropriate clinical support has to be initiated and treatment with Pradaxa has to be discontinued. Dabigatran etexilate is primarily excreted in the urine and shows low plasma protein binding. Therefore, dabigatran etexilate can be dialyzed with the removal of about 60% of drug over 2 to 3 hours.
Buy Pradaxa Capsules 150 mg and 110 mg Online at Cheap Price
You can buy Pradaxa capsules at a cheap price online from the Swiss Pharmacy. It is available in pills of 150 mg and 110 mg. The pills are priced at only $5.42 per unit, if you place an order for 60 capsules.
This Product was added to our catalogue on Tuesday, 12. June 2012.
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