Fondaparinux Sodium Dr. Reddy's

Subcutaneous

Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery

Adult: 2.5 mg once daily, starting 6-8 hr after surgery, continue for at least 5-9 days. In high-risk patients, 6-14 days or up to 32 days in hip fracture.

Renal impairment:

Subcutaneous

Venous thromboembolism

Adult: <50 kg: 5 mg once daily; 50-100 kg: 7.5 mg once daily; >100 kg: 10 mg once daily. Treatment duration: 5-9 days, or until oral anticoagulation is established.

Renal impairment:

Subcutaneous

Superficial vein thrombosis

Adult: 2.5 mg once daily for 30-45 days.

Renal impairment:

Fondaparinux Sodium Dr. Reddy's is used to prevent deep vein thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. Fondaparinux Sodium Dr. Reddy's is used for several days after hip fracture surgery, hip or knee replacement surgery, and in some cases following abdominal or stomach surgery, while you are unable to walk. It is during this time that blood clots are most likely to form.

Fondaparinux Sodium Dr. Reddy's is also used together with warfarin to treat acute deep vein thrombosis (blood clot in the leg) and pulmonary embolism (blood clot in the lung).

Fondaparinux Sodium Dr. Reddy's is available only with your doctor's prescription.

Subcutaneous

Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery

Adult: 2.5 mg once daily, starting 6-8 hr after surgery, continue for at least 5-9 days. In high-risk patients, 6-14 days or up to 32 days in hip fracture.

Renal impairment:

Subcutaneous

Venous thromboembolism

Adult: <50 kg: 5 mg once daily; 50-100 kg: 7.5 mg once daily; >100 kg: 10 mg once daily. Treatment duration: 5-9 days, or until oral anticoagulation is established.

Renal impairment:

Subcutaneous

Superficial vein thrombosis

Adult: 2.5 mg once daily for 30-45 days.

Renal impairment:

See also:
What is the most important information I should know about Fondaparinux Sodium Dr. Reddy's?

Fondaparinux Sodium Dr. Reddy's injection is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min). Fondaparinux Sodium Dr. Reddy's is eliminated primarily by the kidneys, and such patients are at increased risk for major bleeding episodes

Fondaparinux Sodium Dr. Reddy's prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery, and abdominal surgery. During the randomized clinical trials of prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery, occurrence of major bleeding was doubled in patients with a body weight <50 kg compared with those with a body weight 50 kg (5.4% versus 2.1%). In the clinical trial in patients undergoing abdominal surgery, the major bleeding rate was also higher in patients with a body weight <50 kg as compared to those with a body weight 50 kg (5.3% versus 3.3%), respectively.

The use of Fondaparinux Sodium Dr. Reddy's is contraindicated in patients with active major bleeding, bacterial endocarditis, in patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Fondaparinux Sodium Dr. Reddy's, or in patients with known hypersensitivity to Fondaparinux Sodium Dr. Reddy's

Fondaparinux Sodium Dr. Reddy's is also contraindicated in patients with hypersensitivity to Fondaparinux Sodium Dr. Reddy's.

Use Fondaparinux Sodium Dr. Reddy's as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fondaparinux Sodium Dr. Reddy's. Talk to your pharmacist if you have questions about this information.
• Fondaparinux Sodium Dr. Reddy's is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fondaparinux Sodium Dr. Reddy's at home, a health care provider will teach you how to use it. Be sure you understand how to use Fondaparinux Sodium Dr. Reddy's. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Fondaparinux Sodium Dr. Reddy's if it contains particles, is cloudy or discolored, or if the syringe is cracked or damaged.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• Use a different injection site each day to prevent problems at the injection site (eg, hematomas).
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Fondaparinux Sodium Dr. Reddy's, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fondaparinux Sodium Dr. Reddy's.

Use: Labeled Indications

Deep vein thrombosis: Treatment of acute deep vein thrombosis in conjunction with warfarin.

Pulmonary embolism: Treatment of acute pulmonary embolism in conjunction with warfarin.

Venous thromboembolism prophylaxis in surgical patients: Prophylaxis of venous thromboembolism in patients undergoing surgery for hip replacement, knee replacement, hip fracture (including extended prophylaxis following hip fracture surgery), or abdominal surgery (in patients at risk for thromboembolic complications).

Off Label Uses

Acute coronary syndrome

Non-ST-elevation acute coronary syndrome (NSTE-ACS): Data from a randomized, double-blind, double-dummy trial comparing Fondaparinux Sodium Dr. Reddy's and enoxaparin demonstrated that Fondaparinux Sodium Dr. Reddy's is similar to enoxaparin in reducing the risk of ischemic events, major bleeding, and improves long-term mortality and morbidity also report the use of Fondaparinux Sodium Dr. Reddy's for treatment of patients with HIT.

Based on the American Society of Hematology 2018 guidelines for management of VTE: HIT, Fondaparinux Sodium Dr. Reddy's is an effective and recommended agent for HIT complicated by thrombosis or HIT without thrombosis (isolated HIT).

Venous thromboembolism prophylaxis in medical patients with acute illness

Based on the, Fondaparinux Sodium Dr. Reddy's is an effective and recommended agent for VTE prophylaxis in acutely ill medical patients.

Venous thromboembolism prophylaxis in patients undergoing major surgery for cancer

Based on the 2019 American Society of Clinical Oncology clinical practice guideline update for VTE prophylaxis and treatment in patients with cancer, Fondaparinux Sodium Dr. Reddy's may be considered as an option for pharmacologic thromboprophylaxis in patients undergoing major surgery for cancer, unless contraindicated due to high risk of bleeding or active bleeding.

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What other drugs will affect Fondaparinux Sodium Dr. Reddy's?

In clinical studies performed with Fondaparinux Sodium Dr. Reddy's, the concomitant use of oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of Fondaparinux Sodium Dr. Reddy's. In addition, Fondaparinux Sodium Dr. Reddy's neither influenced the pharmacodynamics of warfarin, acetylsalicylic acid, piroxicam, and digoxin, nor the pharmacokinetics of digoxin at steady state.

Agents that may enhance the risk of hemorrhage should be discontinued prior to initiation of Fondaparinux Sodium Dr. Reddy's therapy. If co-administration is essential, close monitoring may be appropriate.

In an in vitro study in human liver microsomes, inhibition of CYP2A6 hydroxylation of coumarin by Fondaparinux Sodium Dr. Reddy's (200 m m M i.e., 350 mg/L) was 17-28%. Inhibition of the other isozymes evaluated (CYPs 2A1, 2C9, 2C19, 2D6, 3A4, and 3E1) was 0-16%. Since Fondaparinux Sodium Dr. Reddy's does not markedly inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4) in vitro, Fondaparinux Sodium Dr. Reddy's is not expected to significantly interact with other drugs in vivo by inhibition of metabolism mediated by these isozymes.

Since Fondaparinux Sodium Dr. Reddy's does not bind significantly to plasma proteins other than ATIII, no drug interactions by protein-binding displacement are expected.

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What are the possible side effects of Fondaparinux Sodium Dr. Reddy's?

Hip-fracture, hip-replacement, or knee-replacement surgery: Anaemia, fever, nausea, oedema, constipation, rash, vomiting, insomnia, increased wound drainage, hypokalaemia, UTI, dizziness, purpura, hypotension, confusion, bullous eruption, urinary retention, haematoma, major bleeding, diarrhoea, dyspepsia, post-op haemorrhage, and headache. Treatment of venous thromboembolism: Constipation, headache, insomnia, fever, nausea, UTI, and coughing. Abdominal surgery: Post-op wound infection and haemorrhage, fever, surgical site reaction, anaemia, HTN, pneumonia, vomiting.

Potentially Fatal: Epidural or spinal haematomas that may result in permanent paralysis.

Fondaparinux Sodium Dr. Reddy's (Fondaparinux Sodium Dr. Reddy's) is a synthetic pentasaccharide anticoagulant. Apart from the O-methyl group at the reducing end of the molecule, the identity and sequence of the five monomeric sugar units contained in Fondaparinux Sodium Dr. Reddy's is identical to a sequence of five monomeric sugar units that can be isolated after either chemical or enzymatic cleavage of the polymeric glycosaminoglycan heparin and heparan sulfate (HS). This monomeric sequence in heparin and HS is thought to form the high affinity binding site for the natural anti-coagulant factor, antithrombin III (ATIII). Binding of heparin/HS to ATIII has been shown to increase the anti-coagulant activity of antithrombin III 1000-fold. Fondaparinux Sodium Dr. Reddy's potentiates the neutralizing action of ATIII on activated Factor X 300-fold. Fondaparinux Sodium Dr. Reddy's may be used: to prevent venous thromboembolism in patients who have undergone orthopedic surgery of the lower limbs (e.g. hip fracture, hip replacement and knee surgery); to prevent VTE in patients undergoing abdominal surgery who are are at high risk of thromboembolic complications; in the treatment of deep vein thrombosis (DVT) and pumonary embolism (PE); in the management of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI); and in the management of ST segment elevation myocardial infarction (STEMI).