VIBATIV Powder for solution for injection Ref.[27433] Active ingredients: Telavancin

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

VIBATIV contains telavancin hydrochloride (Figure 1), a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin. The chemical name of telavancin hydrochloride is vancomycin, N3''[2(decylamino)ethyl]-29[[(phosphonomethyl)-amino]-methyl]-hydrochloride. Telavancin hydrochloride has the following chemical structure:

Figure 1. Telavancin Hydrochloride:

Telavancin hydrochloride is an off-white to slightly colored amorphous powder with the empirical formula C80H106Cl2N11O27P•xHCl (where x = 1 to 3) and a free-base molecular weight of 1755.6. It is highly lipophilic and slightly soluble in water.

VIBATIV is a sterile, preservative-free, white to slightly colored lyophilized powder containing telavancin hydrochloride (equivalent to 750 mg of telavancin as the free base) for intravenous use. The inactive ingredients are Hydroxypropylbetadex, (hydroxypropyl-beta-cyclodextrin) (7500 mg per 750 mg telavancin), mannitol (937.5 mg per 750 mg telavancin), and sodium hydroxide and hydrochloric acid used in minimal quantities for pH adjustment. When reconstituted, it forms a clear to slightly colored solution with a pH of 4.5 (4.0 to 5.0).

Dosage Forms and Strengths

VIBATIV is supplied in single-dose vials containing 750 mg telavancin as a sterile, lyophilized powder.

How Supplied
  • Individual cartons of 750 mg single-dose vials (NDC 66220-315-11)
  • Cartons of 12 individually packaged 750 mg single-dose vials (NDC 66220-315-22)

Manufactured for: Cumberland Pharmaceuticals Inc., Nashville, TN 37203

Drugs

Drug Countries
VIBATIV Canada, Estonia, Lithuania, United States

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