Tinzaparin Sodium
Pronunciation: (tin-ZA-pa-rin SO-dee-uhm)Class: Low molecular weight heparin
Trade Names:
Innohep
- Injection 20,000 units/mL
Pharmacology
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Inhibits reactions that lead to the clotting of blood, including the formation of fibrin clots.
Pharmacokinetics
Absorption
Tinzaparin T max is about 4 to 5 h and C max is approximately 0.25 to 0.87 units/mL. Bioavailability is 86.7%.
Distribution
Tinzaparin Vd is 3.1 to 5 L.
Elimination
Tinzaparin t ½ is approximately 3 to 4 h. Clearance is approximately 1.7 L/h and the primary route of elimination is renal.
Special Populations
Renal Function ImpairmentPatients with severe renal function impairment should be dosed with caution.
Indications and Usage
Treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered with warfarin.
Contraindications
Active major bleeding, heparin-induced thrombocytopenia, hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products.
Dosage and Administration
AdultsSubcutaneous 175 anti-Xa units/kg once daily for more than 6 days and until patient is adequately anticoagulated with warfarin.
General Advice
- Place the patient in the supine or sitting position before administration.
- Alternate injection sites between the left and right anterolateral and left and right posterolateral abdominal wall.
- Hold skinfold between the thumb and forefinger until the injection is completed.
- Introduce the full length of the needle into the skinfold and inject without aspiration.
- Administer with extreme caution and under close medical supervision to patients with increased risk of hemorrhage, uncontrolled arterial hypertension, history of GI ulceration, and diabetic retinopathy.
Storage/Stability
Store at room temperature (77°F; 25°C) range allowed (59° to 86°F; 15° to 30°C).
Drug Interactions
Anticoagulants, platelet inhibitors (eg, dipyridamole, NSAIDs, salicylates)Use with caution because of increased risk of bleeding.
Laboratory Test Interactions
Asymptomatic reversible increases in AST and ALT concentrations.
Adverse Reactions
Cardiovascular
Cardiac arrhythmia, hypertension; hypotension; pulmonary embolism; tachycardia; thrombophlebitis.
CNS
Confusion; dizziness; headache; insomnia.
Dermatologic
Bullous eruption; epidermal necrolysis; rash; skin disorder; skin necrosis.
EENT
Epistaxis; hearing impairment; ocular hemorrhage.
GI
Abdominal pain; constipation; dyspepsia; flatulence; nausea; vomiting.
Genitourinary
Dysuria; hematuria; priapism; urinary retention; urinary tract infection.
Hematologic
Anemia; bleeding; ecchymosis; hematoma; hemorrhage; thrombocytopenia.
Hepatic
Elevated ALT and AST.
Respiratory
Dyspnea; pneumonia; respiratory disorder.
Miscellaneous
Anaphylactoid reactions; back pain; chest pain; fever; hypersensitivity; local irritation; pain; pruritus; rectal bleeding.
Precautions
WarningsSpinal/Epidural hematomasRisk of spinal/epidural hematomas increased in patients receiving neuraxial anesthesia or spinal puncture and are anticoagulated with low molecular weight heparins or heparinoids. Other risk factors include indwelling epidural catheters, repeated/traumatic epidural/spinal puncture, or other drugs affecting hemostasis (eg, NSAIDs, platelet inhibitors, anticoagulants). Risk of long-term or permanent paralysis. Frequent monitoring for signs/symptoms of neurological impairment. |
Pregnancy
Category B .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Hypersensitivity
Allergic-type reactions may occur caused by sodium metabisulfite present in tinzaparin.
Renal Function
Effect of tinzaparin may be prolonged.
Special Risk Patients
Use drug with caution in patients with diabetic retinopathy, bleeding diathesis, uncontrolled arterial hypertension, or history of recent GI ulceration and hemorrhage.
Fatal gasping syndrome
Fatal gasping syndrome in premature infants has been associated with benzyl alcohol preservative present in tinzaparin.
Hemorrhage
Use with caution in conditions with increased risk of hemorrhage (eg, bacterial endocarditis, severe uncontrolled hypertension, active ulcerative GI disease).
Interchangeability with heparin
Cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins.
Priapism
Has been reported as a rare occurrence.
Overdosage
Symptoms
Bleeding complications, nosebleeds, blood in urine, tarry stools, bruising, petechial hemorrhage, frank bleeding.
Patient Information
- Instruct patient to take safety precautions to avoid cuts and bruises (eg, soft toothbrush, electric razor, handrails).
- Caution patient to avoid aspirin or other OTC anticoagulants.
- Instruct patients to report any current or future prescription, OTC, or herbal medication use to primary care provider.
- Advise patient to report bruises, bleeding, nosebleeds, bleeding gums, coffee-ground emesis, red-flecked sputum, or tarry, black, or red stools.
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