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Agrylin
(anagrelide hydrochloride) Capsules
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
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CONTRAINDICATIONS
Anagrelide
is contraindicated in patients with severe hepatic impairment.
Exposure to anagrelide is increased eight-fold in patients with
moderate hepatic impairment. Use of anagrelide in patients with
severe hepatic impairment has not been studied.
WARNINGS
Exposure to anagrelide
is increased eight-fold in patients with moderate hepatic
impairment. Use of anagrelide in patients with severe hepatic
impairment has not been studied. The potential risks and benefits
of anagrelide therapy in a patient with mild and moderate
impairment of hepatic function should be assessed before treatment
is commenced. In patients with moderate hepatic impairment, dose
reduction is required and patients should be carefully monitored
for cardiovascular effects.
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Estraderm (estradiol transdermal
system)
(click product name to read prescribing information)
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CONTRAINDICATIONS
BOXED WARNING
WARNINGS
- Cardiovascular Disorder
- Breast Cancer
- Dementia
- Visual Abnormalities
PRECAUTIONS
- General
- Hypertriglyceridemia
- Impaired Liver Function and Past
History of Cholestatic Jaundice
- Ovarian Cancer
- Exacerbation of Endometriosis
- Exacerbation of Other Conditions
- Drug/Laboratory Test
Interactions
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Geriatric Use
ADVERSE REACTIONS
- Genitourinary System
- Gastrointestinal
- Enlargement of Hepatic
HemangiomasCentral Nervous System
PATIENT PACKAGE INSERT
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CONTRAINDICATIONS
Estrogens should not
be used in individuals with any of the following conditions:
BOXED WARNING
The Women's Health
Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli,
and deep vein thrombosis in postmenopausal women (50-79 years of
age) during 5 years of treatment with oral conjugated equine
estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo.
The Women's Health
Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with
oral conjugated equine estrogens plus medroxyprogesterone acetate
relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women or to women taking estrogen alone
therapy.
Other doses of oral
conjugated estrogens with medroxyprogesterone acetate, and other
combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of
comparable data, these risks should be assumed to be similar.
WARNINGS
Cardiovascular Disorders
Risk factors for
arterial vascular disease (e.g. hypertension, diabetes mellitus,
tobacco use, hypercholesterolemia, and obesity) and/or venous
thromboembolism (e.g., personal history or family history of VTE,
obesity, and systemic lupus erythematosus) should be managed
appropriately.
Breast Cancer
The use of estrogens
and progestins by postmenopausal women has been reported to
increase the risk of breast cancer. The most important randomized
clinical trial providing information about this issue is the Women's
Health Initiative (WHI) substudy of CE/MPA. The results from
observational studies are generally consistent with those of the
WHI clinical trial and report no significant variation in the risk
of breast cancer among different estrogens or progestins, doses,
or routes of administration......(See prescribing information.)
Dementia
In the Women's
Health Initiative Memory Study (WHIMS) ...... After an average follow-up of 4 years, 40 women being treated with
CE/MPA (1.8%, n = 2,229) and 21 women in the placebo group (0.9%,
n = 2,303) received diagnoses of probable dementia. The relative
risk for CE/MPA versus placebo was 2.05 (95% confidence interval
1.21 - 3.48), and was similar for women with and without
histories of menopausal hormone use before WHIMS......(See
prescribing information.)
Visual
Abnormalities
If examination
reveals papilledema or retinal vascular lesions, estrogens should
be permanently discontinued.
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| Lac-Hydrin
(ammonium lactate) 12% Cream
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
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CONTRAINDICATIONS
Lac-Hydrin Cream is
contraindicated in those patients with a history of
hypersensitivity to any of the label ingredients.
WARNINGS
Sun exposure to areas
of the skin treated with Lac-Hydrin Cream should be minimized or
avoided. The use of Lac-Hydrin Cream should be discontinued if any
hypersensitivity is observed.
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