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Dalbavancin

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Overview

What is DALVANCE?

DALVANCE (dalbavancin) for injection is a lipoglycopeptide synthesized from a fermentation product of species.

Dalbavancin is a mixture of five closely related active homologs (A, A, B, B, and B); the component B is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R) structure and/or the presence of an additional methyl group (R) on the terminal amino group (shown in the Figure 1 and Table 3 below).

The B INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride.

DALVANCE is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion see .



What does DALVANCE look like?



What are the available doses of DALVANCE?

For injection: 500 mg of lyophilized powder in a vial for reconstitution ()

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

Dosage adjustment is required in patients whose creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis. (, )

How should I use DALVANCE?

DALVANCE (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms: (including methicillin-susceptible and methicillin-resistant strains), , group (including )

The recommended dosage regimen of DALVANCE in patients with normal renal function is 1500 mg, administered either as a single dose, or 1000 mg followed one week later by 500 mg. DALVANCE should be administered over 30 minutes by intravenous infusion .


What interacts with DALVANCE?

Sorry No Records found


What are the warnings of DALVANCE?

Sorry No Records found


What are the precautions of DALVANCE?

Sorry No Records found


What are the side effects of DALVANCE?

Sorry No records found


What should I look out for while using DALVANCE?

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin.


What might happen if I take too much DALVANCE?

Specific information is not available on the treatment of overdose with DALVANCE, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered cumulative doses of up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.

Treatment of overdose with DALVANCE should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed .


How should I store and handle DALVANCE?

DALVANCE (dalbavancin) for injection is supplied in the following packaging configuration: Unreconstituted DALVANCE (dalbavancin) for injection should be stored at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature]. DALVANCE (dalbavancin) for injection is supplied in the following packaging configuration: Unreconstituted DALVANCE (dalbavancin) for injection should be stored at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Dalbavancin is an antibacterial drug .

Non-Clinical Toxicology
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin.

Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, treatment with DALVANCE should be discontinued. Before using DALVANCE, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy .

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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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