Dotarem
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
History
There is currently no drug history available for this drug.
Other Information
DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis).
The structural formula of gadoterate meglumine in solution is as follows:
CAS Registry No. 92943-93-6
DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0.
The main physiochemical properties of DOTAREM are provided below:
| Parameter |
Value |
| Density @ 20°C |
1.1753 g/cm3 |
| Viscosity @ 20°C |
3.4 mPa.s |
| Viscosity @ 37°C |
2.4 mPa.s |
| Osmolality |
1350 mOsm/kg water |
The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.
Sources
Dotarem Manufacturers
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Guerbet Llc
![Dotarem (Gadoterate Meglumine) Injection [Guerbet Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dotarem | Guerbet Llc
2.1 Dosing GuidelinesFor adult and pediatric patients (2 years and older), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.
Table 1: Volumes of DOTAREM Injection by Body WeightBody Weight
Volume
Pounds (lb)
Kilograms (kg)
Milliliters (mL)
22
10
2
44
20
4
66
30
6
88
40
8
110
50
10
132
60
12
154
70
14
176
80
16
198
90
18
220
100
20
242
110
22
264
120
24
268
130
26
308
140
28
330
150
30
To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.
2.2 Drug HandlingVisually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.
When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.
Pharmacy Bulk Package Preparation:
The Pharmacy Bulk Package is not for use in direct intravenous infusion. The transfer of DOTAREM from the Pharmacy Bulk Package should be performed in an aseptic work area, such as laminar flow hood and using aseptic technique and suitable transfer device. The closure shall be penetrated only one time. Once the container closure is punctured, the Pharmacy Bulk Package should not be removed from the aseptic work area. The Pharmacy bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes. Each individual dose of DOTAREM should be promptly used following withdrawal from the Pharmacy Bulk Package. The contents of the Pharmacy Bulk Package should be used within 24 hours after initial puncture. -
Guerbet Llc
Dotarem | Guerbet Llc
2.1 Dosing GuidelinesFor adult and pediatric patients (2 years and older), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.
Table 1: Volumes of DOTAREM Injection by Body WeightBody Weight
Volume
Pounds (lb)
Kilograms (kg)
Milliliters (mL)
22
10
2
44
20
4
66
30
6
88
40
8
110
50
10
132
60
12
154
70
14
176
80
16
198
90
18
220
100
20
242
110
22
264
120
24
268
130
26
308
140
28
330
150
30
To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.
2.2 Drug HandlingVisually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.
When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.
![Dotarem (Gadoterate Meglumine) Injection [Guerbet Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc&name=box-syringe.jpg)
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