|
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
|
Actos (pioglitazone HCl) Tablets
(click product name to read prescribing information) |
WARNINGS
- Cardiac Failure and Other Cardiac Effects
PRECAUTIONS
- Edema
- Table 6
- Hematologic
- Hepatic Effects
ADVERSE REACTIONS
- Laboratory Abnormalities
- Serum Transaminase Levels
- CPK Levels
|
In a 24-week dose-controlled study in which Actos was
co-administered with insulin, 0.3% of patients (1/345) on 30 mg
and 0.9% (3/345) of patients on 45 mg reported CHF as a serious
adverse event. |
|
|
|
|
|
Cuprimine (penicillamine capsules)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Central Nervous System
- mental disorders
- agitation
- anxiety
- Neuromuscular
|
Because of the potential for serious hematological and renal
adverse reactions to occur at any time, routine urinalysis, white
and differential blood cell count, hemoglobin determination, and
direct platelet count must be done twice weekly, together with
monitoring of patients skin, lymph nodes and body temperature,
during the first month of therapy, every two weeks for the next
five months, and monthly thereafter.
In Wilson's disease, liver function tests are
recommended every three months, at least during the first year of
treatment.
Onset of new neurologic symptoms has been reported with
Cuprimine. Occasionally, neurologic symptoms become worse during
initiation of therapy with Cuprimine.
Wilson's Disease - Reported experience shows that continued
treatment with penicillamine throughout pregnancy protects the
mother against relapse of the Wilson's disease, and that
discontinuation of penicillamine has deleterious effects on the
mother, which may be fatal.
If penicillamine is administered during pregnancy to patients
with Wilson's disease, it is recommended that the daily dosage be
limited to 750 mg. If cesarean section is planned the daily dose
should be reduced to 250 mg, but no lower, for the last six weeks
of pregnancy and postoperatively until wound healing is complete.
|
|
|
|
|
|
DDAVP Injection (desmopressin acetate) (click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
When DDAVP Injection is administered to patients who do not have
need of antidiuretic hormone for its antidiuretic effect, in
particular in pediatric and geriatric patients, fluid intake
should be adjusted downward to decrease the potential occurrence
of water intoxication and hyponatremia with accompanying signs and
symptoms (headache, nausea/vomiting, decreased serum sodium and
weight gain.) |
|
|
|
|
|
DDAVP Nasal Spray (desmopressin acetate)
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
When DDAVP Nasal Spray is administered, in particular in pediatric and
geriatric patients, fluid intake should be adjusted downward in
order to decrease the potential occurrence of water intoxication
and hyponatremia with accompanying signs and symptoms (headache,
nausea/vomiting, decreased serum sodium and weight gain).
|
|
|
|
|
|
DDAVP Rhinal Tube (desmopressin acetate)
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
When DDAVP is administered, in particular, in pediatric and
geriatric patients, fluid intake should be adjusted downward in
order to decrease the potential occurrence of water intoxication
and hyponatremia with accompanying signs and symptoms (headache,
nausea/vomiting, decreased serum sodium and weight gain). |
|
|
|
|
|
DDAVP Tablets (desmopressin acetate)
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
When DDAVP Tablets are administered, in particular in pediatric
and geriatric patients, fluid intake should be adjusted downward
to decrease the potential occurrence of water intoxication and
hyponatremia with accompanying signs and symptoms (headache,
nausea/vomiting, decreased serum sodium and weight gain). |
|
|
|
|
|
ReoPro (abciximab)
(click product name to read prescribing information)
|
WARNINGS PRECAUTIONS
ADVERSE REACTIONS
|
Abciximab has the potential to increase the risk
of bleeding, particularly in the presence of anticoagulation,
e.g., from heparin, other anticoagulants, or thrombolytics.
The risk of major bleeds due to abciximab
therapy is increased in patients receiving
thrombolytics and should be weighed against the anticipated
benefits.
|
|
|
|
|
|
Risperdal (risperidone) Tablets and Oral Solution
Risperdal M-TAB (risperidone) Orally Disintegrating Tablets
(click product name to read prescribing information) |
WARNINGS
-
Hyperglycemia and Diabetes Mellitus
ADVERSE REACTIONS
|
Hyperglycemia, in some cases extreme and
associated with ketoacidosis or hyperosmolar coma or death,
has been reported in patients treated with atypical
antipsychotics including Risperdal. Assessment of the
relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an
increased background risk of diabetes mellitus in patients
with schizophrenia and the increasing incidence of diabetes
mellitus in the general population.
|
|
|
|
|
| Symmetrel (amantadine
HCl) Syrup and Tablets
(click product name to
read prescribing information) |
WARNINGS
PRECAUTIONS
- Abrupt Discontinuation
- Other
ADVERSE REACTIONS
- Nervous System/Psychiatric
|
Deaths have been reported from overdose with
Symmetrel. The lowest reported acute lethal dose was 1 gram.
Acute toxicity may be attributable to the anticholinergic
effects of amantadine.
|
|
|
|
|
| Tenormin
(atenolol) I.V. Injection
(click product name to read prescribing information) |
WARNINGS
- Pregnancy and Fetal Injury
PRECAUTIONS
|
Neonates born to
mothers who are receiving Tenormin at parturition or
breast-feeding may be at risk for hypoglycemia. Caution should
be exercised when Tenormin is administered during pregnancy or
to a woman who is breast-feeding. |
|
|
|
|
| Tenormin (atenolol)
Tablets
(click product name to read prescribing information) |
WARNINGS
- Pregnancy and Fetal Injury
PRECAUTIONS
|
Neonates born to
mothers who are receiving Tenormin at parturition or
breast-feeding may be at risk for hypoglycemia. Caution should
be exercised when Tenormin is administered during pregnancy or
to a woman who is breast-feeding. |
