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OptiMARK

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OptiMARK

Indications
Dosage
How Supplied

INDICATIONS

MRI Of Central Nervous System (CNS)

OptiMARK is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues.

MRI Of Liver

OptiMARK is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.

DOSAGE AND ADMINISTRATION

Dosing Guidelines

  • Administer OptiMARK as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (Table 1)
  • Use sterile technique to withdraw and administer OptiMARK
  • Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast
  • Discard unused portions of the drug

Table 1 : Dosage Chart for OptiMARK Injection

Body Weight Kilograms (kg) 0.1 mmol/kg Volume (mL)
40 8
50 10
60 12
70 14
80 16
90 18
100 20
110 22
120 24
130 26
140 28
150 30

Drug Handling

  • Visually inspect OptiMARK for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present
  • Do not mix OptiMARK with other medications or parenteral nutrition and do not administer OptiMARK in the same intravenous line as other medications because of the potential for chemical incompatibility

Imaging

  • Complete the imaging procedure within 1 hour of the injection of OptiMARK
  • Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret OptiMARK MR images with companion non-contrast MR images [see CLINICAL PHARMACOLOGY]

HOW SUPPLIED

Dosage Forms And Strengths

OptiMARK is supplied as a clear, colorless to slightly yellow solution for injection containing 330.9 mg gadoversetamide per mL (equivalent to 0.5 mmol/mL)

Storage And Handling

OptiMARK is a clear, colorless to slightly yellow solution containing 330.9 mg/mL (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. OptiMARK is supplied in 10 mL vials containing 5 mL or 10 mL of solution and is also provided in 20 mL vials containing 15 mL or 20 mL of solution. Each single dose vial is rubber stoppered with an aluminum seal and the contents are sterile. OptiMARK is supplied in 10 mL, 15 mL, 20 mL or 30 mL syringes containing 10 mL, 15 mL, 20 mL or 30 mL of solution respectively. Each syringe is sealed with rubber closures and the contents are sterile. Vials and syringes are contained in shipping cartons with the following configurations:

5 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-02)

10 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-04)

15 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-06)

20 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-08)

10 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-11)

15 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-16)

20 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-21)

30 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-31)

Storage

OptiMARK should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. OptiMARK may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).

Manufactured and Distributed by: Mallinckrodt Inc., St. Louis, MO 63042 U.S.A. Revised: Aug 2014

Last reviewed on RxList: 9/5/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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