CLINDAMYCIN HYDROCHLORIDE- clindamycin hydrochloride capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)

Доступно од:

Bryant Ranch Prepack

INN (Међународно име):

CLINDAMYCIN HYDROCHLORIDE

Састав:

CLINDAMYCIN 150 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Clindamycin HCl is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital trac

Резиме производа:

NDC: 71335-0429-1: 12 Capsules in a BOTTLE NDC: 71335-0429-2: 28 Capsules in a BOTTLE NDC: 71335-0429-3: 42 Capsules in a BOTTLE NDC: 71335-0429-4: 60 Capsules in a BOTTLE NDC: 71335-0429-5: 30 Capsules in a BOTTLE NDC: 71335-0429-6: 21 Capsules in a BOTTLE NDC: 71335-0429-7: 4 Capsules in a BOTTLE NDC: 71335-0429-8: 56 Capsules in a BOTTLE NDC: 71335-0429-9: 20 Capsules in a BOTTLE NDC: 71335-0429-0: 40 Capsules in a BOTTLE

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CLINDAMYCIN HYDROCHLORIDE - CLINDAMYCIN HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
CLINDAMYCIN HYDROCHLORIDE CAPSULES USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin hydrochloride capsules, USP and other antibacterial drugs,
clindamycin
hydrochloride capsules, USP should be used only to treat or prevent
infections that are
proven or strongly suspected to be caused by bacteria.
WARNING
_Clostridium difficile_ associated diarrhea (CDAD) has been reported
with use of
nearly all antibacterial agents, including clindamycin and may range
in severity from
mild diarrhea to fatal colitis. Treatment with antibacterial agents
alters the normal
flora of the colon, leading to overgrowth of _C. difficile_.
Because clindamycin therapy has been associated with severe colitis
which may
end fatally, it should be reserved for serious infections where less
toxic
antimicrobial agents are inappropriate, as described in the
INDICATIONS AND
USAGEsection. It should not be used in patients with nonbacterial
infections such
as most upper respiratory tract infections.
_C. difficile _produces toxins A and B, which contribute to the
development of CDAD.
Hypertoxin producing strains of _C. difficile _cause increased
morbidity and mortality,
as these infections can be refractory to antimicrobial therapy and may
require
colectomy. CDAD must be considered in all patients who present with
diarrhea
following antibiotic use. Careful medical history is necessary since
CDAD has been
reported to occur over two months after the administration of
antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against _C._
_difficile _may need to be discontinued. Appropriate fluid and
electrolyte
management, protein supplementation, antibiotic treatment of _C.
difficile_, and
surgical evaluation should be instituted as clinically indicated.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Clindamycin
is a semisynth