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
Cenestin Indications, Dosage, Storage, Stability - Synthetic conjugated estrogens
Cenestin Indications, Dosage, Storage, Stability - Synthetic conjugated estrogens
INDICATIONS AND USAGE
Cenestin therapy is indicated for the:
1. Treatment of moderate to severe vasomotor symptoms associated
with the menopause.
· 0.45 mg Cenestin
· 0.625 mg Cenestin
· 0.9 mg Cenestin
· 1.25 mg Cenestin
2. Treatment of moderate to severe symptoms of vulvar and
vaginal atrophy associated with the menopause. When prescribing solely for the
treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products
should be considered.
· 0.3 mg Cenestin
DOSAGE AND ADMINISTRATION
When estrogen is prescribed for a postmenopausal woman with
a uterus, progestin should also be initiated to reduce the risk of endometrial
cancer. A woman without a uterus does not need progestin. Use of estrogen, alone
or in combination with a progestin, should be with the lowest effective dose
and for the shortest duration consistent with treatment goals and risks for
the individual woman. Patients should be reevaluated periodically as clinically
appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is
still necessary (see BOXED WARNINGS and WARNINGS).
For women who have a uterus, adequate diagnostic measures, such as endometrial
sampling, when indicated, should be undertaken to rule out malignancy in cases
of undiagnosed persistent or recurring abnormal vaginal bleeding.
1. For treatment of moderate to severe vasomotor symptoms
associated with the menopause.
• Cenestin 0.45 mg
• Cenestin 0.625 mg
• Cenestin 0.9 mg
• Cenestin 1.25 mg
Patients should be started at Cenestin 0.45 mg daily. Subsequent
dosage adjustment may be made based upon the individual patient response. This
dose should be periodically reassessed by the healthcare provider. The lowest
effective dose of Cenestin for the treatment of moderate to severe vasomotor
symptoms has not been determined.
2. For treatment of moderate to severe symptoms of vulvar
and vaginal atrophy associated with the menopause. When prescribing solely for
the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products
should be considered.
• Cenestin 0.3 mg daily
HOW SUPPLIED
Cenestin (synthetic conjugated estrogens, A) Tablets are available
as:
0.3 mg: Round, green, film-coated, and are debossed with letters,
dp, and number, 41. Available in bottles of:
30 NDC 51285-441-30
100 NDC 51285-441-02
1000 NDC 51285-441-05
0.45 mg: Round, orange, film-coated, and are debossed with
letters, dp , and number, 46. Available in bottles of:
30 NDC 51285-446-30
100 NDC 51285-446-02
1000 NDC 51285-446-05
0.625 mg: Round, red, film-coated, and are debossed with letters,
dp , and number, 42. AVAILABLE IN BOTTLES OF:
30 NDC 51285-442-30
100 NDC 51285-442-02
1000 NDC 51285-442-05
0.9 mg: Round, white, film-coated, and are debossed with letters,
dp , and number, 43. Available in bottles of:
30 NDC 51285-443-30
100 NDC 51285-443-02
1000 NDC 51285-443-05
1.25 mg: Round, blue, film-coated, and are debossed with letters,
dp , and number, 44. Available in bottles of:
30 NDC 51285-444-30
100 NDC 51285-444-02
1000 NDC 51285-444-05
Store at 20-25ºC (68-77ºF); excursions are permitted to15-30°C
(59-86°F) [See USP Controlled Room Temperature]., Dispense in tight container.,
Dispense in child-resistant packaging.
Pharmacist: Include one "Information
for the patient" leaflet with each package dispensed.
Manufactured By: Duramed Pharmaceuticals,
Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970,
Revised FEBRUARY 2004, BR - 41, 46, 42,
43, 44
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