A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cleocin Indications, Dosage, Storage, Stability - Clindamycin
Cleocin Indications, Dosage, Storage, Stability - Clindamycin
INDICATIONS
AND USES
CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis
in non-pregnant women. There are no adequate and well-controlled studies of
CLEOCIN Vaginal Ovules in pregnant women.
NOTE: For purposes of this indication, a clinical diagnosis
of bacterial vaginosis is usually defined by the presence of a homogenous vaginal
discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor
when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic
examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis
include (a) markedly reduced or absent Lactobacillus morphology, (b)
predominance of Gardnerella morphotype, and (c) absent or few white blood
cells.
Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas
vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and
herpes simplex virus, should be ruled out.
DOSAGE AND ADMINISTRATION
The recommended dose is one CLEOCIN Vaginal Ovule (containing clindamycin phosphate
equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day,
preferably at bedtime, for 3 consecutive days.
HOW SUPPLIED
CLEOCIN Vaginal Ovules are supplied as follows:
Carton of three suppositories with one applicator NDC 0009-7667-01
Important Information: Store at 25 °C (77 °F); excursions
permitted to 15-30 °C (59-86 °F) [see USP Controlled Room Temperature]. Caution:
Avoid high humidity. See end of carton for the lot number and expiration
date.
Rx only
Pharmacia & Upjohn Company
Kalamazoo, Michigan 49001, USA
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