It is unsafe to consume alcohol with Fonidel.
SAFE IF PRESCRIBED
Fonidel is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Fonidel is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
CONSULT YOUR DOCTOR
It is not known whether Fonidel alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
Fonidel should be used with caution in patients with kidney disease. Dose adjustment of Fonidel may be needed. Please consult your doctor. Use of Fonidel is not recommended in patients with severe kidney disease.
Fonidel should be used with caution in patients with severe liver disease. Dose adjustment of Fonidel may be needed. Please consult your doctor.
Fonidel is an anticoagulant medicine used in the treatment of deep vein thrombosis (clot in veins of leg) and pulmonary embolism (clot in artery of lungs). It helps to prevent formation of harmful blood clots in blood vessels. Fonidel also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries, or who have been bedridden for long. It is administered under the supervision of a doctor. Your doctor will decide the dose and duration of the medicine for you. You should continue all your other medicines that are advised by the doctor for your long-term treatment even after this injection. Use of this medicine may increase your risk of bleeding. Let your doctor know immediately if you see pinpoint rash or blood in your vomits, urine, or stool. Before taking it, you must inform the doctor if you are suffering from any bleeding disorder, kidney or liver disease. Also, let your doctor know if you are pregnant or breastfeeding and about all the other medications that you are taking regularly.
Uses of Fonidel
- Deep vein thrombosis
- Pulmonary embolism
Side effects of Fonidel
- Anemia (low number of red blood cells)
How to use Fonidel
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Fonidel works
Fonidel is an anticoagulant. It stops the action of a substance (clotting factor Xa) from working in the blood. This prevents the formation of unwanted blood clots (thrombosis) in the blood vessels.
What if you forget to take Fonidel?
If you miss a dose of Fonidel, 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.
- Fonidel prevents the formation of blood clots in the blood vessels of legs or lungs.
- It may make you feel dizzy, tired or weak. Do not drive or do anything that requires mental focus until you know how it affects you.
- It increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or using sharp objects.
- Notify your doctor if you see blood in your vomit, urine or stool (black, tarry stools or bright red blood).
- Do not discontinue use without consulting your doctor as this may increase your chances of having another heart attack or stroke.
Venous thromboembolic events, acute DVT, pulmonary embolism (PE), unstable angina, non-ST segment elevation MI
Administration Administer initial dose 6-8 hours after surgery, once hemostasis has been established SC administration is deep, alternating right and left anterior and posterior abdominal walls
Deep Vein Thrombosis/Acute Pulmonary Embolism Treatment <50 kg: 5 mg SC once daily 50-100 kg: 7.5 mg SC once daily >100 kg: 10 mg SC once daily Administer for 5-9 days; up to 26 days administered in clinical trials Prophylaxis >50 kg: 2.5 mg SC once daily for 5-9 days or up to 10 days following abdomonal surgery; for hip replacement, 11 days recommended and a minimum 10-14 days recommended for patients undergoing total hip or knee arthroplasty, or hip fracture surgery; administered for up to 35 days in some instances
Safety and efficacy not established
Renal impairment: CrCl (ml/min) Dosage Recommendation <20 Contraindicated. 20-50 1.5 mg once daily.
Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis.
Mode of Action
Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to ATIII, and potentiates the neutralisation of Factor Xa. This will interrupt the blood coagulation cascade and inhibit both thrombin formation and thrombus development. At the recommended dosage, fondaparinux does not affect fibrinolytic activity or platelet function. It cannot lyse established thrombi and does not affect clotting function tests (e.g. aPPT, INR).
Patient w/ increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders, history or active GI ulceration, intracranial haemorrhage, recent brain, spinal or ophth surgery); body wt <50 kg. Increased risk of spinal or epidural haematomas in patient undergoing neuraxial (spinal/epidural) anaesth or spinal puncture esp w/ post-op use of indwelling epidural catheters and concurrent use of medications affecting haemostasis. Moderate renal and severe hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor CBC, platelet count, serum creatinine and stool occult blood regularly. Lactation: Unknown whether drug is excreted in milk; use with caution
>10% Anemia (1-20%),Fever (4-14%),Nausea (3-11%) 1-10% Rash (7.5%),Dizziness (4%),Confusion (3%),Constipation (5-9%),Diarrhea (2-3%),Edema (9%),Headache (2-5%),Hypokalemia (1-4%),Hypotension (4%),Insomnia (4-5%),Purpura (4%),Thrombocytopenia (3%),Urinary retention (3%),Urinary tract infection (2-4%),Vomiting (1-6%)
Pregnancy Category Note
Pregnancy Available data from published literature and postmarketing reports have not reported clear association with adverse developmental outcomes; fondaparinux sodium plasma concentrations obtained from four women treated during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy Fetal/neonatal adverse reactions Drug has been demonstrated to cross placenta in humans; use of anticoagulants, may increase risk of bleeding in the fetus and neonate; monitor neonates for bleeding Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; pregnant women receiving therapy should be carefully monitored for evidence of bleeding or unexpected changes in coagulation parameters; consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches Lactation There are no data on presence in human milk, or effects on milk production; limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Increased risk of bleeding w/ (e.g. desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).
The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.