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Orbactiv

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Overview

What is Orbactiv?

ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug.

The chemical name for oritavancin is [4"R]-22--(3-amino-2,3,6-trideoxy-3--methyl-α-L--hexopyranosyl)-3''-[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is CHNOCl∙2HPO and the molecular weight is 1989.09. The chemical structure is represented below:

ORBACTIV is supplied as a sterile white to off-white lyophilized powder for intravenous infusion that contains oritavancin diphosphate, mannitol (an inactive ingredient) and phosphoric acid (to adjust pH 3.1 to 4.3). Each 50 ml capacity glass vial contains 449 mg oritavancin diphosphate (equivalent to 405 mg of oritavancin, 5 mg excess is to ensure withdrawal of 400 mg oritavancin), 400 mg oritavancin (free base equivalent).

Each vial is reconstituted with sterile water for injection and further diluted with 5% Dextrose in sterile Water for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be clear, colorless to pale yellow solution .



What does Orbactiv look like?



What are the available doses of Orbactiv?

For injection: 400 mg of lyophilized powder in a single-use vial for reconstitution. ()

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

How should I use Orbactiv?

ORBACTIV (oritavancin) 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:

Staphylococcus aureus

Streptococcus pyogenes

Streptococcus agalactiae

Streptococcus dysgalactiae

Streptococcus anginosus

S. anginosus

S. intermedius

S. constellatus

Enterococcus faecalis

The recommended dosing for ORBACTIV is a single 1200 mg dose administered by intravenous infusion over 3 hours in patients 18 years and older.


What interacts with Orbactiv?

Sorry No Records found


What are the warnings of Orbactiv?

Sorry No Records found


What are the precautions of Orbactiv?

Sorry No Records found


What are the side effects of Orbactiv?

Sorry No records found


What should I look out for while using Orbactiv?

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. (, )

Known hypersensitivity to ORBACTIV (, )


What might happen if I take too much Orbactiv?

In the ORBACTIV clinical program there was no incidence of accidental overdose of ORBACTIV.

Based on an in vitro hemodialysis study, ORBACTIV is unlikely to be removed from blood by hemodialysis. In the event of overdose, supportive measures should be taken.


How should I store and handle Orbactiv?

VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [].VFEND Tablets should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].VFEND Powder for Oral Suspension should be stored at 2° – 8°C (36°– 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [].VFEND Tablets should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].VFEND Powder for Oral Suspension should be stored at 2° – 8°C (36°– 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [].VFEND Tablets should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].VFEND Powder for Oral Suspension should be stored at 2° – 8°C (36°– 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [].VFEND Tablets should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].VFEND Powder for Oral Suspension should be stored at 2° – 8°C (36°– 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000Isosorbide dinitrate tablets, USP are supplied as:5 mg:NDC 68001-223-00 bottles of 100NDC 68001-223-08 bottles of 100010 mg:NDC 68001-225-00 bottles of 100NDC 68001-225-08 bottles of 100020 mg:NDC 68001-222-00 bottles of 100NDC 68001-222-08 bottles of 1000


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Oritavancin is an antibacterial drug .

Non-Clinical Toxicology
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. (, )

Known hypersensitivity to ORBACTIV (, )

The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).

Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see )

ORBACTIV has been shown to artificially prolong aPTT for up to 120 hours, PT and INR for up to 12 hours, and activated clotting time (ACT) for up to 24 hours following administration of a single 1200 mg dose by binding to and preventing action of the phospholipid reagents commonly used in laboratory coagulation tests. ORBACTIV has also been shown to elevate D-dimer concentrations up to 72 hours after ORBACTIV administration.

For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered .

ORBACTIV has no effect on the coagulation system in vivo.

The following adverse reactions are also discussed in the Warnings and Precautions section of labeling:

Hypersensitivity Reactions

Infusion Related Reactions

Clostridium difficile

[see ]

Osteomyelitis

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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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Interactions

Interactions

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