BAXDELA- delafloxacin meglumine tablet BAXDELA- delafloxacin meglumine injection, powder, lyophilized, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DELAFLOXACIN MEGLUMINE (UNII: N7V53U4U4T) (DELAFLOXACIN - UNII:6315412YVF)

Beszerezhető a:

Melinta Therapeutics, LLC

INN (nemzetközi neve):

delafloxacin meglumine

Összetétel:

delafloxacin 450 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae , Streptococcus anginosus Group (including Streptococcus anginosus , Streptococcus intermedius , and Streptococcus constellatus ), Streptococcus pyogenes , Enterococcus faecalis , Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa. BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae , Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae , Chlamydia pneumoniae , Legione

Termék összefoglaló:

BAXDELA is supplied as a sterile, lyophilized powder in single-dose clear glass vials of 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine). The lyophilized powder is a light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and color. They are supplied as follows: 300 mg single-dose vials (NDC 70842-102-01), packaged in cartons of 10 vials (NDC 70842-102-03). BAXDELA Tablets contain 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine); each modified capsule-shaped tablet in beige to mottled beige color is debossed with RX3341 on one side. They are supplied as follows: Bottles of 20 tablets with child-resistant closure (NDC 70842-101-01) Unit dose blister packs which contain 20 tablets (2 blister cards of 10 tablets each) (20 tablet blister pack: NDC 70842-101-02, 10 tablet blister card: NDC 70842-101-03) BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion. The reconstituted solution in the infusion bag may be stored under refrigerated or controlled room temperature conditions for up to 24 hours [see Dosage and Administration (2.4)] . Do not freeze.

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

BAXDELA- delafloxacin meglumine injection, powder, lyophilized, for
solution
Melinta Therapeutics, LLC
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration
MEL011-R007
Revised: 6/2021
MEDICATION GUIDE
BAXDELA® (Bax-de'-lah)
(delafloxacin) for injection
BAXDELA® (Bax-de'-lah)
(delafloxacin) tablets for oral use
What is the most important information I should know about BAXDELA?
BAXDELA, a fluoroquinolone antibacterial medicine, can cause serious
side effects. Some of these serious
side effects can happen at the same time and could result in death. If
you get any of the following serious
side effects while you take BAXDELA, you should stop taking BAXDELA
immediately and get medical
help right away.
1.
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take BAXDELA.
Tendons are tough
cords of tissue that connect muscles to bones. Symptoms of tendon
problems may include:
•
Pain, swelling, tears and inflammation of tendons including the back
of the ankle
(Achilles), shoulder, hand, or other tendon sites.
•
The risk of getting tendon problems while you take BAXDELA is higher
if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant
•
Tendon problems can happen in people who do not have the above risk
factors when they take
BAXDELA. Other reasons that can increase your risk of tendon problems
can include:
•
physical activity or exercise
•
kidney failure
•
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
•
Stop taking BAXDELA immediately and call your healthcare provider
right away at the first
sign of tendon pain, swelling or inflammation. Stop taking BAXDELA
until tendinitis or
tendon rupture has been ruled out by your healthcare provider. Avoid
exercise and using the
affected area. The most common area of pain and swelling is in the
Achilles tendon at the back
of your ankle. This can also happen with other t

Termékjellemzők

BAXDELA- DELAFLOXACIN MEGLUMINE TABLET
BAXDELA- DELAFLOXACIN MEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MELINTA THERAPEUTICS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BAXDELA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BAXDELA.
BAXDELA (DELAFLOXACIN) TABLETS, FOR ORAL USE
BAXDELA (DELAFLOXACIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2017
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND
EXACERBATION
OF MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY
IRREVERSIBLE
SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1),
INCLUDING:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE BAXDELA IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING
BAXDELA, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS. (5.1)
FLUOROQUINOLONES MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH
MYASTHENIA
GRAVIS. AVOID BAXDELA IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS. (5.5)
INDICATIONS AND USAGE
BAXDELA is a fluoroquinolone antibacterial indicated for the treatment
of adults with the following
infections caused by designated susceptible bacteria:
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (1.1)
Community-Acquired Bacterial Pneumonia (CABP) (1.2)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of BAXDELA and
other antibacterial drugs, BAXDELA should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. (1.3)
DOSAGE AND ADMINISTRATION
For ABSSSI and CABP: Administer BAXDELA for injection 300 mg by
intravenous infusion over 60
minutes, every 12 hours, or a 450 mg BAXDELA tablet orally every 12
hours. (2.1, 2.2)
Recommended duration of