Gadopentetate dimeglumine

×

Overview

What is Gadopentetate dimeglumine?

Gadopentetate dimeglumineInjection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). Gadopentetate dimeglumine Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.

Gadopentetate dimeglumine Injection is a 0.5- mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]- glycinato (5-)]gadolinate(2-) (2:1) with a molecular weight of 938, an empirical formula of CHGdNO, and has the following structural formula:

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Gadopentetate dimeglumine Injection contains no antimicrobial preservative.

Gadopentetate dimeglumine Injection has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below:

Gadopentetate dimeglumine Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/kg water. Gadopentetate dimeglumine Injection is hypertonic under conditions of use.

What does Gadopentetate dimeglumine look like?

What are the available doses of Gadopentetate dimeglumine?

Sorry No records found.

What should I talk to my health care provider before I take Gadopentetate dimeglumine?

Sorry No records found

How should I use Gadopentetate dimeglumine?

Gadopentetate dimeglumine Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Gadopentetate dimeglumine Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

The recommended dosage of Gadopentetate dimeglumine Injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.

What interacts with Gadopentetate dimeglumine?

Gadopentetate dimeglumine Injection is contraindicated in patients with:

- •
- 2
- •
- •

What are the warnings of Gadopentetate dimeglumine?

Sorry No Records found

What are the precautions of Gadopentetate dimeglumine?

Sorry No Records found

What are the side effects of Gadopentetate dimeglumine?

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The mean age of the 1272 patients who received Gadopentetate dimeglumine Injection in pre-market clinical trials was 46.4 years (range 2 to 93 years). Of these patients, 55% (700) were male and 45% (572) were female. Of the 1271 patients who received Gadopentetate dimeglumine Injection and for whom race was reported, 82.1% (1043) were Caucasian, 9.7% (123) were Black, 5.3% (67) were Hispanic, 2.1% (27) were Oriental/Asian, and 0.9% (11) were other.

The most common adverse reaction was headache (4.8%). The majority of headaches were transient and of mild to moderate severity. Other adverse reactions that occurred in ≥ 1% of patients included: nausea (2.7%), injection site coldness/localized coldness (2.3%) and dizziness (1%).

The following additional adverse reactions occurred in less than 1% of the patients:

General Disorders:

WARNINGS AND PRECAUTIONS

Cardiovascular:

Gastrointestinal:

Nervous System:

Respiratory System:

Skin:

Special Senses:

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of gadopentetate dimeglumine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most serious reactions were nephrogenic systemic fibrosis (see) and acute reactions including cardiac or respiratory arrest, anaphylactic shock, shock, respiratory distress, and laryngeal edema. Life threatening and/or fatal adverse reactions have been reported. The most frequently reported adverse reactions in the postmarketing experience were nausea, vomiting, urticaria and rash.

General Disorders and Administration Site Conditions:

Warnings and Precautions

Hypersensitivity Reactions:

Warnings and Precautions

Renal and Urinary:

Warnings and Precautions

Vascular:

Cardiac:

Ear and Labyrinth Disorders:

Eye Disorders:

Musculoskeletal and Connective Tissue Disorder:

Nervous System Disorders:

Respiratory System Disorders:

Skin:

What should I look out for while using Gadopentetate dimeglumine?

Gadopentetate dimeglumine Injection is contraindicated in patients with:

What might happen if I take too much Gadopentetate dimeglumine?

Systemic consequences associated with overdosage of Gadopentetate dimeglumine Injection have not been reported.

How should I store and handle Gadopentetate dimeglumine?

Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Gadopentetate dimeglumine Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/mL of gadopentetate dimeglumine. Gadopentetate dimeglumine Injection is supplied in the following sizes:

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Gadopentetate dimeglumine is a paramagnetic agent and, as such, it develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent.

In magnetic resonance imaging (MRI), visualization of normal and pathological brain tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) changes in proton density; 2) alteration of the spin-lattice or longitudinal relaxation time (T1); and 3) variation of the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadopentetate dimeglumine decreases the T1 and T2 relaxation time in tissues where it accumulates. At usual doses the effect is primarily on the T1 relaxation time.

Gadopentetate dimeglumine does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that do not have an abnormal blood-brain barrier, e.g., cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of gadopentetate dimeglumine in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of gadopentetate dimeglumine in various lesions are not known.

Non-Clinical Toxicology

Gadopentetate dimeglumine Injection is contraindicated in patients with:

×

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.

×

Review

×

Professional

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. 315.72

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: