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Gliadel

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Overview

What is Gliadel?

GLIADEL Wafer is an implant for intracranial use, containing carmustine, a nitrosourea alkylating agent, and polifeprosan, a biodegradable copolymer used to control the release of carmustine. It is a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 7.7 mg of carmustine [1, 3-bis (2-chloroethyl)-1-nitrosourea, or BCNU] and 192.3 mg of a biodegradable polyanhydride copolymer. The copolymer, polifeprosan 20, consists of poly [bis (p-carboxyphenoxy)] propane and sebacic acid in a 20:80 molar ratio. Carmustine is homogeneously distributed in the copolymer matrix.

The structural formula for polifeprosan 20 is:

The structural formula for carmustine is:



What does Gliadel look like?



What are the available doses of Gliadel?

GLIADEL Wafer is an off-white to pale yellow round wafer. Each GLIADEL Wafer contains 7.7 mg of carmustine.

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

How should I use Gliadel?

GLIADEL Wafer is indicated for the treatment of patients with:

The recommended dose of GLIADEL Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of repeat administration have not been studied.


What interacts with Gliadel?

Sorry No Records found


What are the warnings of Gliadel?

Sorry No Records found


What are the precautions of Gliadel?

Sorry No Records found


What are the side effects of Gliadel?

Sorry No records found


What should I look out for while using Gliadel?

None.


What might happen if I take too much Gliadel?

Sorry No Records found


How should I store and handle Gliadel?

Protect vials and glass or polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY:DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.Protect vials and glass or polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY:DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.Protect vials and glass or polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY:DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.GLIADEL Wafer is supplied in a single dose treatment box containing eight individually pouched wafers. Each wafer contains 7.7 mg of carmustine and is packaged in two aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product from moisture. The outer pouch is a peelable overwrap. The outside surface of the outer pouch is not sterile.NDC for single dose treatment box: 24338-050-08GLIADEL Wafer is supplied in a single dose treatment box containing eight individually pouched wafers. Each wafer contains 7.7 mg of carmustine and is packaged in two aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product from moisture. The outer pouch is a peelable overwrap. The outside surface of the outer pouch is not sterile.NDC for single dose treatment box: 24338-050-08


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The activity of GLIADEL Wafer is due to release of cytotoxic concentrations of carmustine, a DNA and RNA alkylating agent, into the tumor resection cavity. On exposure to the aqueous environment of the resection cavity, the anhydride bonds in the copolymer are hydrolyzed, releasing carmustine, carboxyphenoxypropane, and sebacic acid into the surrounding brain tissue.

Non-Clinical Toxicology
None.





Furosemide

Nifedipine

Cationic drugs

Other

In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.

Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.

Seizures occurred in 37% of patients treated with GLIADEL Wafers for recurrent glioma in Study 2. New or worsening (treatment emergent) seizures occurred in 20% of patients; 54% of treatment emergent seizures occurred within the first 5 post-operative days The median time to onset of the first new or worsened post-operative seizure was four days. Institute optimal anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively.

The following serious adverse reactions are discussed elsewhere in the label:

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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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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
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Interactions

Interactions

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