Source: FDA, National Drug Code (US) | Revision Year: 2021 | Publisher:
Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a yellowish crystalline powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-de monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
It has the following structural formula:
(C22H24N2O8 • HCl)2 • C2H6O • H2O
Doxycycline hyclate is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum.
Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.
Doxycycline for Injection, USP, sterile powder, supplied as follows:
|Product Code||Unit of Sale||Strength||Each|
Unit of 10
|Doxycycline hyclate equivalent to|
100 mg doxycycline per vial
10 mL Single Dose Vial
The brand names mentioned in this document are the trademarks of their respective owners.
Novaplus is a registered trademark of Vizient. Inc.
Manufactured by: Fresenius Kabi, Lake Zurich, IL 60047
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