CLINDAMYCIN HYDROCHLORIDE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Clindamycin Hydrochloride (UNII: T20OQ1YN1W) (Clindamycin - UNII:3U02EL437C)

זמין מ:

Cardinal Health 107, LLC

INN (שם בינלאומי):

Clindamycin Hydrochloride

הרכב:

Clindamycin 150 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Clindamycin 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 WARNING box, 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 tract such as endometritis

leaflet_short:

Clindamycin Hydrochloride Capsules USP (equivalent to 150 mg of Clindamycin) are opaque gray and opaque pink capsules imprinted DAN 5708 supplied in: Overbagged with 10 capsules per bag, NDC 55154-6827-0 Dispense in a tight container. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
CARDINAL HEALTH 107, LLC
----------
CLINDAMYCIN
HYDROCHLORIDE
CAPSULES USP
RX only
Revised: March 2009
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin HCl and other antibacterial drugs, clindamycin
hydrochloride should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
WARNING
PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH NEARLY ALL
ANTIBACTERIAL AGENTS, INCLUDING CLINDAMYCIN, AND MAY RANGE IN SEVERITY
FROM MILD TO LIFE-THREATENING. THEREFORE, IT IS IMPORTANT TO CONSIDER
THIS
DIAGNOSIS IN PATIENTS WHO PRESENT WITH DIARRHEA SUBSEQUENT TO THE
ADMINISTRATION OF ANTIBACTERIAL AGENTS.
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
USAGE section. It should not be used in patients with nonbacterial
infections such
as most upper respiratory tract infections. Treatment with
antibacterial agents
alters the normal flora of the colon and may permit overgrowth of
clostridia.
Studies indicate that a toxin produced by _Clostridium difficile_ is
one primary cause
of “antibiotic-associated colitis”.
After the diagnosis of pseudomembranous colitis has been established,
therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis
usually
respond to drug discontinuation alone. In moderate to severe cases,
consideration
should be given to management with fluids and electrolytes, protein
supplementation, and treatment with an antibacterial drug clinically
effective against
_C. difficile_ colitis.
Diarrhea, colitis, and pseudomembranous colitis have been observed to
begin up to
several weeks following cessation of therapy with clindamycin.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Clindamycin
is a semisynthetic antibiot