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Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Roxolyte. Please consult your doctor.
CONSULT YOUR DOCTOR
Roxolyte may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Roxolyte is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
UNSAFE
Roxolyte may cause side effects which could affect your ability to drive.
Roxolyte may cause dizziness or fainting. This may affect your driving ability.
CAUTION
Roxolyte should be used with caution in patients with kidney disease. Dose adjustment of Roxolyte may be needed. Please consult your doctor.
Use of Roxolyte is not recommended in patients with severe kidney disease.
UNSAFE
Roxolyte is probably unsafe to use in patients with liver disease and should be avoided. Please consult your doctor.
Medicine Overview of Roxolyte 10mg Tablet
Introduction
Roxolyte is a medicine known as an anticoagulant or blood thinner. It helps prevent and treat blood clots. It is used to reduce the risk of stroke and heart attack. It prevents and treats clot formation in the veins of your legs, lungs, brain and heart. Roxolyte is commonly used in patients with irregular heart rhythm (atrial fibrillation) to prevent clot formation. It also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries. It should be taken with food and it is best to take them at the same time each day. You...
... Show moreUses of Roxolyte
- Deep vein thrombosis
- Pulmonary embolism
- Stroke prevention
Side effects of Roxolyte
Common
- Anemia (low number of red blood cells)
- Nausea
How to use Roxolyte
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Roxolyte is to be taken with food.
How Roxolyte works
Roxolyte is a novel oral anticoagulant (NOAC). It works by preventing the formation of blood clots in the body.
What if you forget to take Roxolyte?
If you miss a dose of Roxolyte, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- For best results, take Roxolyte at the same time every day. It is better to take at night with meals.
- It interacts less with food or other medicines. Hence, frequent dose changes are not required.
- It increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, using sharp objects or engaging in contact sports (e.g. football, wrestling).
- It may cause dizziness. Avoid driving or activity requiring mental focus until you know how it affects you.
- If you are going to have a surgery or dental treatment, you may be asked to stop taking Roxolyte temporarily.
- Notify your doctor if you have any kidney problem.
- Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
- Do not stop taking medication without talking to your doctor.
Brief Description
Indication
Atrial fibrillation, Strokes, Deep venous thrombosis
Administration
10-Mg Tab: May be taken with or without food.
15- & 20-Mg Tab: Should be taken with food.
Adult Dose
DVT Prophylaxis (Orthopedic Surgery) Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery Knee replacement: 10 mg PO qDay for 12 days; may take with or without food Hip replacement: 10 mg PO qDay for 35 days; may take with or without food Administer initial dose at least 6-10 hr after surgery once hemostasis has been established Nonvalvular Atrial Fibrillation Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 20 mg/day PO with the evening meal DVT or PE...
... Show moreChild Dose
Safety and efficacy not established
Renal Dose
Renal impairment (nonvalvular AF)
CrCl 30-50 mL/min: 20 mg/day
CrCl 15-50 mL/min: 15 mg/day
ESRD on intermittent renal dialysis: 15 mg/day
Renal impairment (postoperative thromboprophylaxis)
CrCl >50 mL/min: Dose adjustment not necessary
CrCl 30-50 mL/min: Use with caution; dose adjustment not necessary
CrCl <30 mL/min: Avoid use
Contraindication
Patient w/ active pathologic bleeding, significant risk of major bleeding (e.g. recent GI ulcer, oesophageal varices, recent brain, spine, or ophth surgery, recent intracranial haemorrhage, malignant neoplasms, vascular aneurysm).
Mode of Action
Factor Xa inhibitor that inhibits platelet activation by selectively blocking the active site of factor Xa without requiring a cofactor (eg, antithrombin III) for activity.
Blood coagulation cascade is dependent on the activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the blood coagulation cascade.
Dose-dependent inhibition of factor Xa activity observed; antifactor Xa activity is also influenced by rivaroxaban; prolongs PT and aPTT and HepTest .
Precaution
Patient w/ hepatic disease associated w/ coagulopathy, severe HTN, prosthetic heart valve, vascular retinopathy, bronchiectasis. Anaesth w/ post-op indwelling epidural catheter. Hepatic and renal impairment. Pregnancy and lactation.
Lactation: Unknown whether distributed in human breast milk; not recommended; a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Side Effect
1-10%
Abdominal pain (<2%),Back pain (<4%),Blister (1%),Bruising (3%),Constipation (<3%),Diarrhea (<5%),Dizziness (<6%),Dyspepsia (<2%),Epistaxis (4-10%),Fatigue (<3%),Headache (3-5%),Nausea (1-3%),Hematuria (<4%),Muscle spasm (1%),Oropharyngeal pain (<1%),Osteoarthritis (<2%),Peripheral edema (<6%),Pruritus (<2%),Pyrexia (1-3%),Rash (2%),Syncope (<2%),Toothache (<1%),Urinary tract infection (<1%),Vomiting (<2%),Wound secretion (<3%)
Bleeding
Atrial fibrillation (21%; major bleeding 6%)
DVT prophylaxis (5-6%; major bleeding <1%)
DVT treatment (6-10%; major bleeding 1%)
Hematoma (<3%)
<1%
Agranulocytosis,Hepatitis,Dysuria,Fatal bleeding,Hematoma,Hemiparesis,Hemorrhage,Hypotension,Increased amylase,Increased BUN,Jaundice,Menorrhagia,Retroperitoneal bleeding,Stevens-Johnson syndrome,Thrombocytopenia,Urticaria,Xerostomia
Interaction
Reduced hepatic & renal clearance w/ strong CYP3A4 inhibitors (clarithromycin, erythromycin, fluconazole). Increased bleeding risk w/ azole antimycotics (eg ketoconazole, itraconazole, voriconazole, posaconazole) or HIV-PIs (eg ritonavir); other anticoagulants; NSAIDs (including acetylsalicylic acid) & platelet aggregation inhibitors. Reduced plasma conc w/ CYP3A4 inducers (eg rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). 20-mg FC tab: Increased prothrombin time/INR of warfarin.
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