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MultiHance
Overview
What is MultiHance?
MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow, aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives.
Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of CHGdNO • 2CHNO. The structural formula is as follows:
MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below:
MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.
What does MultiHance look like?
What are the available doses of MultiHance?
Each mL of MultiHance Injection contains 529 mg gadobenate dimeglumine and is available in single use vials.
What should I talk to my health care provider before I take MultiHance?
How should I use MultiHance?
p808122
MultiHance is indicated
for intravenous use in magnetic resonance imaging (MRI) of the central
nervous system (CNS) in adults and pediatric patients (including term
neonates), to visualize lesions with abnormal blood-brain barrier
or abnormal vascularity of the brain, spine, and associated tissues.
The recommended dose of MultiHance is 0.2 mL/kg (0.1 mmol/kg)
administered as a rapid bolus intravenous injection.
For MRI of the CNS in pediatric patients below 2 years of
age the recommended dosage range is 0.1 to 0.2 mL/kg.
To ensure complete injection of the contrast medium, follow
the injection with a saline flush of at least 5 mL in MRI of the CNS
and at least 20 mL in MRA. ()
What interacts with MultiHance?
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What are the warnings of MultiHance?
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What are the precautions of MultiHance?
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What are the side effects of MultiHance?
Sorry No records found
What should I look out for while using MultiHance?
MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [].
p40122
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.
What might happen if I take too much MultiHance?
Clinical consequences of overdosage with MultiHance have not been reported. Treatment of an overdosage should be directed toward support of vital functions and prompt institution of symptomatic therapy. In a Phase 1 clinical study, doses up to 0.4 mmol/kg were administered to patients. MultiHance has been shown to be dialyzable [].
How should I store and handle MultiHance?
Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N Rev. 01/18 Vienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows:Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side.NDC 70700-118-84, one box containing 1 individual blister cartons NDC 70700-118-85, one box containing 3 individual blister cartonsStore at 20° to 25°C (68° to 77°F). [See USP controlled room temperatureVienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows:Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side.NDC 70700-118-84, one box containing 1 individual blister cartons NDC 70700-118-85, one box containing 3 individual blister cartonsStore at 20° to 25°C (68° to 77°F). [See USP controlled room temperatureVienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows:Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side.NDC 70700-118-84, one box containing 1 individual blister cartons NDC 70700-118-85, one box containing 3 individual blister cartonsStore at 20° to 25°C (68° to 77°F). [See USP controlled room temperatureVienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows:Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side.NDC 70700-118-84, one box containing 1 individual blister cartons NDC 70700-118-85, one box containing 3 individual blister cartonsStore at 20° to 25°C (68° to 77°F). [See USP controlled room temperature
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue.
In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadobenate dimeglumine decreases the T1 and T2 relaxation time in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.
Non-Clinical Toxicology
MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [].p40122
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.
Psychotropic Agents:
The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see , and )
After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C, AUC, and C) of amitriptyline or its metabolite nortriptyline were observed.
After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C, AUC, and C) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.
In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.
[see ].
There is one report suggesting that the concomitant use of Desyrel (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.
Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine.
Other Psychotropics:
Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.
Buspirone has been shown to be metabolized by CYP3A4. This finding is consistent with the interactions observed between buspirone and the following:
In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and Cof buspirone 3.4-fold while diltiazem increased AUC and C 5.5-fold and 4-fold, respectively.) Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil. Subsequent dose adjustment may be necessary and should be based on clinical assessment.
In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations (5-fold increase in C and 6-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3-fold increase in C; 9.2-fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.
In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13-fold increase in C and 19-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20-fold in C and up to 50-fold in AUC) and statistically significant decreases (about 50%) in plasma concentrations of the buspirone metabolite 1-PP. With 5 mg b.i.d. doses of buspirone, slight increases in AUC were observed for nefazodone (23%) and its metabolites hydroxynefazodone (HO-NEF) (17%) and meta-chlorophenylpiperazine (9%). Slight increases in C were observed for nefazodone (8%) and its metabolite HO-NEF (11%).
Subjects receiving buspirone 5 mg b.i.d. and nefazodone 250 mg b.i.d experienced lightheadedness, asthenia, dizziness, and somnolence, adverse events also observed with either drug alone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
In a study in healthy volunteers, coadministration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in C; 89.6% decrease in AUC) and pharmacodynamic effects of buspirone. If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Other Inhibitors and Inducers of CYP3A4:
Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone, or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Other Drugs:
Coadministration of buspirone with cimetidine was found to increase C (40%) and T (2–fold), but had minimal effects on the AUC of buspirone.
Protein Binding:
Therapeutic levels of aspirin, desipramine, diazepam, flurazepam, ibuprofen, propranolol, thioridazine, and tolbutamide had only a limited effect on the extent of binding of buspirone to plasma proteins (see ).
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30-59 mL/min/1.73m) and little, if any, for patients with chronic, mild kidney disease (GFR 60-89 mL/min/1.73m). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following MultiHance administration to Bracco Diagnostics (1-800-257-5181) or FDA (1-800-FDA-1088 or ).
Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown [].
The following adverse reactions are discussed in greater detail in other sections of the label:
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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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. 315.72Tips
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Interactions
Interactions
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