Fondaparinux Sodium

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Overview

What is Fondaparinux Sodium?

Fondaparinux sodium injection, USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt.

The molecular formula of fondaparinux sodium is CHNNaOS and its molecular weight is 1728. The structural formula is provided below:

Fondaparinux sodium injection is supplied as a sterile, preservative-free injectable solution for subcutaneous use.

Each single-dose, prefilled syringe of fondaparinux sodium injection, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium in 0.5 mL, 5.0 mg of fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL, or 10.0 mg of fondaparinux sodium in 0.8 mL of an isotonic solution of sodium chloride and water for injection. The final drug product is a clear and colorless to slightly yellow liquid with a pH between 5.0 and 8.0.

What does Fondaparinux Sodium look like?

What are the available doses of Fondaparinux Sodium?

Single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10 mg of fondaparinux sodium. ()

What should I talk to my health care provider before I take Fondaparinux Sodium?

How should I use Fondaparinux Sodium?

Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

Do not mix other medications or solutions with fondaparinux sodium injection. Administer fondaparinux sodium injection only subcutaneously.

What interacts with Fondaparinux Sodium?

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What are the warnings of Fondaparinux Sodium?

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What are the precautions of Fondaparinux Sodium?

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What are the side effects of Fondaparinux Sodium?

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What should I look out for while using Fondaparinux Sodium?

Fondaparinux sodium injection is contraindicated in the following conditions:

What might happen if I take too much Fondaparinux Sodium?

There is no known antidote for fondaparinux sodium. Overdose of fondaparinux sodium may lead to hemorrhagic complications. Discontinue treatment and initiate appropriate therapy if bleeding complications associated with overdosage occur.

Data obtained in patients undergoing chronic intermittent hemodialysis suggest that clearance of fondaparinux sodium can increase by 20% during hemodialysis.

How should I store and handle Fondaparinux Sodium?

Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F).Protect from light.Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F).Protect from light.Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Fondaparinux Sodium Injection, USP is available in the following strengths:2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The antithrombotic activity of fondaparinux sodium is the result of antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development.

Fondaparinux sodium does not inactivate thrombin (activated Factor II) and has no known effect on platelet function. At the recommended dose, fondaparinux sodium does not affect fibrinolytic activity or bleeding time.

Non-Clinical Toxicology

Fondaparinux sodium injection is contraindicated in the following conditions:

Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine.

Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease, however, it is not known if other phenothiazines produce a similar response. Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson’s disease. It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response.

Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.

The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine.

Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur with the use of anticoagulants and neuraxial (spinal/epidural) anesthesia or spinal puncture. The risk of these events may be higher with post-operative use of indwelling epidural catheters or concomitant use of other drugs affecting hemostasis such as NSAIDs . In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of fondaparinux sodium by subcutaneous (SC) injection. Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known. Monitor patients undergoing these procedures for signs and symptoms of neurologic impairment such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), and bowel or bladder dysfunction. Consider the potential risks and benefits before neuraxial intervention in patients anticoagulated or who may be anticoagulated for thromboprophylaxis.

The following serious adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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