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Innohep
Overview
What is Innohep?
INNOHEP® is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It is available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of tinzaparin sodium per mL, for a total of 40,000 IU, and 3.1 mg/mL sodium metabisulfite as a stabilizer. The vial contains 10 mg/mL benzyl alcohol as a preservative. Sodium hydroxide may be added to achieve a pH range of 5.0 to 7.5.
Tinzaparin sodium is the sodium salt of a low molecular weight heparin obtained by controlled enzymatic depolymerization of heparin from porcine intestinal mucosa using heparinase from . The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulpho-D-glucosamine structure at the reducing end of the chain.
Potency is determined by means of a biological assay and interpreted by the first International Low Molecular Weight Heparin Standard as units of anti-factor Xa (anti-Xa) activity per milligram. The mean tinzaparin sodium anti-factor Xa activity is approximately 100 IU per milligram. The average molecular weight ranges between 5,500 and 7,500 daltons. The molecular weight distribution is:
What does Innohep look like?
What are the available doses of Innohep?
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What should I talk to my health care provider before I take Innohep?
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How should I use Innohep?
INNOHEP® is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP® were established in hospitalized patients.
All patients should be evaluated for bleeding disorders before administration of INNOHEP®. Since coagulation parameters are unsuitable for monitoring INNOHEP® activity, routine monitoring of coagulation parameters is not required (see ).
What interacts with Innohep?
INNOHEP® is contraindicated in patients with active major bleeding, in patients with (or history of) heparin-induced thrombocytopenia, or in patients with hypersensitivity to tinzaparin sodium.
INNOHEP® is contraindicated in patients aged 90 years or older with creatinine clearance ≤ 60 mL/min.
Patients with known hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products should not be treated with INNOHEP®.
What are the warnings of Innohep?
After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.
INNOHEP® is not intended for intramuscular or intravenous administration.
INNOHEP® cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medications has its own instructions for use.
INNOHEP® should not be used in patients with a history of heparin-induced thrombocytopenia (see ).
Hemorrhage:
Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or heparinoids and spinal/epidural anesthesia or spinal puncture which can result in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters or with the concomitant use of additional drugs affecting hemostasis such as NSAIDs (see and ).
Thrombocytopenia:
In clinical studies, thrombocytopenia (platelet count <100,000/mm if baseline value ≥150,000/mm, ≥50% decline if baseline <150,000/mm) was identified in 1% of patients given INNOHEP®; severe thrombocytopenia (platelet count less than 50,000/mm) occurred in 0.13%.
Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm, INNOHEP® should be discontinued. Cases of thrombocytopenia with disseminated thrombosis also have been observed in clinical practice with heparins, and low molecular weight heparins, including tinzaparin sodium. Some of these cases were complicated by organ infarction with secondary organ dysfunction or limb ischemia, and have resulted in death.
Hypersensitivity:
Priapism:
Miscellaneous:
What are the precautions of Innohep?
General:
INNOHEP® should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension, or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.
Consistent with expected age-related changes in renal function, elderly patients and patients with renal insufficiency may show reduced elimination of tinzaparin sodium. INNOHEP® should be used with care in these patients (see ). Patients aged 90 years or older with creatinine clearance ≤ 60 mL/min should not be treated with INNOHEP® (see ).
Laboratory Tests:
Drug Interactions:
Laboratory Test Interactions
Elevation of Serum Transaminases:
Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like INNOHEP® should be interpreted with caution.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Tinzaparin sodium displayed no genotoxic potential in an bacterial cell mutation assay (AMES test), Chinese hamster ovary cell forward gene mutation test, human lymphocyte chromosomal aberration assay, and mouse micronucleus assay. Tinzaparin sodium at SC doses up to 1800 IU/kg/day in rats (about 2 times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance.
Pregnancy
All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. The fetal risk summary below describes the potential of INNOHEP® to increase the risk of developmental abnormalities above background risk.
INNOHEP® is not predicted to increase the risk of developmental abnormalities. INNOHEP® does not cross the placenta, based on human and animal studies, and shows no evidence of teratogenic effects or fetotoxicity.
Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with preexisting thromboembolic disease, certain high risk pregnancy conditions, and a history of complications during a previous pregnancy.
All patients receiving anticoagulants such as tinzaparin, including pregnant women, are at risk for bleeding. Pregnant women receiving tinzaparin should be carefully monitored for evidence of bleeding or excessive anticoagulation. Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women should be apprised of the potential hazard to the fetus and the mother if tinzaparin is administered during pregnancy. Consideration for use of a shorter acting agent should be specifically addressed as delivery approaches.
Nursing Mothers:
Pediatric Use:
Geriatric Use:
What are the side effects of Innohep?
Bleeding
Fatal or nonfatal hemorrhage from any tissue or organ can occur. The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding. Hemorrhagic complications may present as, but are not limited to, paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; swelling; weakness; hypotension, shock, or coma. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis (see ).
| 1 | ||
| 2 | ||
| 3 | ||
| Major Bleeding Events | 0.8 | 2.7 |
Thrombocytopenia
Elevations of Serum Aminotransferases
Local Reactions
Hypersensitivity
Adverse Events
| NOS = not otherwise specified | ||
| 1 | ||
| Urinary Tract Infection | 19 (3.7%) | 18 (3.4%) |
| Pulmonary Embolism | 12 (2.3%) | 12 (2.3%) |
| Chest Pain | 12 (2.3%) | 8 (1.5%) |
| Epistaxis | 10 (1.9%) | 7 (1.3%) |
| Headache | 9 (1.7%) | 9 (1.7%) |
| Nausea | 9 (1.7%) | 10 (1.9%) |
| Hemorrhage NOS | 8 (1.5%) | 23 (4.4%) |
| Back Pain | 8 (1.5%) | 2 (0.4%) |
| Fever | 8 (1.5%) | 11 (2.1%) |
| Pain | 8 (1.5%) | 7 (1.3%) |
| Constipation | 7 (1.3%) | 9 (1.7%) |
| Rash | 6 (1.2%) | 8 (1.5%) |
| Dyspnea | 6 (1.2%) | 9 (1.7%) |
| Vomiting | 5 (1.0%) | 8 (1.5%) |
| Hematuria | 5 (1.0%) | 6 (1.1%) |
| Abdominal Pain | 4 (0.8%) | 6 (1.1%) |
| Diarrhea | 3 (0.6%) | 7 (1.3%) |
| Anemia | 0 | 7 (1.3%) |
Other Adverse Events in Completed or Ongoing Trials
Body as a Whole:
Cardiovascular Disorders, General:
Central and Peripheral Nervous System Disorders:
Gastrointestinal System Disorders:
Heart Rate and Rhythm Disorders:
Myo-, Endo-, Pericardial and Valve Disorders:
Platelet, Bleeding and Clotting Disorders:
Psychiatric Disorders:
Red Blood Cell Disorders:
Resistance Mechanism Disorders:
Respiratory System Disorders:
Skin and Appendages Disorders:
Urinary System Disorders:
Vascular (Extracardiac) Disorders:
Serious adverse events reported in clinical trials or from post-marketing experience are included in and , respectively:
| Bleeding-related | Anorectal bleedingCerebral/intracranial bleedingEpistaxisGastrointestinal hemorrhageHemarthrosisHematemesisHematuriaHemopericardiumHemorrhage NOSInjection site bleedingMelenaPurpuraRetroperitoneal/intra-abdominal bleedingVaginal hemorrhageWound hematoma |
| Organ dysfunction | Angina pectorisCardiac arrhythmiaDependent edemaMyocardial infarction/coronary thrombosisThromboembolism |
| Fetal/neonatal | Congenital anomalyFetal deathFetal distress |
| Cutaneous | Bullous eruptionErythematous rashMaculopapular rashSkin necrosis |
| Hematologic | GranulocytopeniaThrombocytopenia |
| Allergic reactions | Allergic reaction |
| Injection site reaction | Cellulitis |
| Neoplastic | Neoplasm |
| Organ dysfunction | Cholestatic hepatitisIncrease in hepatic enzymesPeripheral ischemiaPriapism |
| Bleeding-related | HematomaHemoptysisOcular hemorrhageRectal bleeding |
| Cutaneous reactions | Epidermal necrolysisIschemic necrosisStevens-Johnson syndromeUrticaria |
| Hematologic | AgranulocytosisPancytopeniaThrombocythemia |
| Injection site reactions | AbscessNecrosis |
| Allergic reactions | Allergic purpuraAngioedema |
| Fetal/neonatal | Cutis aplasia of the scalpNeonatal hypotonia |
| General | Acute febrile reaction |
Ongoing Safety Surveillance
Spinal epidural hematoma with INNOHEP® administered at a therapeutic dose has been reported in at least one patient who had not received neuraxial anesthesia or spinal puncture.
What should I look out for while using Innohep?
INNOHEP® is contraindicated in patients with active major bleeding, in patients with (or history of) heparin-induced thrombocytopenia, or in patients with hypersensitivity to tinzaparin sodium.
INNOHEP® is contraindicated in patients aged 90 years or older with creatinine clearance ≤ 60 mL/min.
Patients with known hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products should not be treated with INNOHEP®.
INNOHEP® is not intended for intramuscular or intravenous administration.
INNOHEP® cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medications has its own instructions for use.
INNOHEP® should not be used in patients with a history of heparin-induced thrombocytopenia (see ).
Drug Interactions:
Array
PRECAUTIONS, Laboratory Tests
What might happen if I take too much Innohep?
How should I store and handle Innohep?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayINNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.INNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.INNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.INNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.INNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.INNOHEP® is available in a multiple dose 2 mL vial in the following packages:Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].Keep out of the reach of children. MANUFACTURED FOR:Boulder, CO 80301MANUFACTURED BY:DK-2750 Ballerup, DenmarkInnohep® is a registered trademark of LEO Pharmaceutical Products.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tinzaparin sodium is a low molecular weight heparin with antithrombotic properties. Tinzaparin sodium inhibits reactions that lead to the clotting of blood including the formation of fibrin clots, both and . It acts as a potent co-inhibitor of several activated coagulation factors, especially Factors Xa and IIa (thrombin). The primary inhibitory activity is mediated through the plasma protease inhibitor, antithrombin.
Bleeding time is usually unaffected by tinzaparin sodium. Activated partial thromboplastin time (aPTT) is prolonged by therapeutic doses of tinzaparin sodium used in the treatment of deep vein thrombosis (DVT). Prothrombin time (PT) may be slightly prolonged with tinzaparin sodium treatment but usually remains within the normal range. Neither aPTT nor PT can be used for therapeutic monitoring of tinzaparin sodium.
Neither unfractionated heparin nor tinzaparin sodium have intrinsic fibrinolytic activity; therefore, they do not lyse existing clots. Tinzaparin sodium induces release of tissue factor pathway inhibitor, which may contribute to the antithrombotic effect. Heparin is also known to have a variety of actions that are independent of its anticoagulant effects. These include interactions with endothelial cell growth factors, inhibition of smooth muscle cell proliferation, activation of lipoprotein lipase, suppression of aldosterone secretion, and induction of platelet aggregation.
Non-Clinical Toxicology
INNOHEP® is contraindicated in patients with active major bleeding, in patients with (or history of) heparin-induced thrombocytopenia, or in patients with hypersensitivity to tinzaparin sodium.INNOHEP® is contraindicated in patients aged 90 years or older with creatinine clearance ≤ 60 mL/min.
Patients with known hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products should not be treated with INNOHEP®.
INNOHEP® is not intended for intramuscular or intravenous administration.
INNOHEP® cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medications has its own instructions for use.
INNOHEP® should not be used in patients with a history of heparin-induced thrombocytopenia (see ).
Array
General:
INNOHEP® should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension, or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.
Consistent with expected age-related changes in renal function, elderly patients and patients with renal insufficiency may show reduced elimination of tinzaparin sodium. INNOHEP® should be used with care in these patients (see ). Patients aged 90 years or older with creatinine clearance ≤ 60 mL/min should not be treated with INNOHEP® (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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