Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Accupril (quinapril
hydrochloride) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head
and Neck Angioedema
- Intestinal Angioedema
ADVERSE REACTIONS
|
Angioedema subsection re-titled "Head and Neck Angioedema".
Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented with
abdominal pain (with or without nausea or vomiting); in some cases
there was no prior history of facial angioedema and C-1 esterase
levels were normal.
|
|
|
|
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets (click product name to read prescribing information)
|
WARNINGS
- Head
and Neck Angioedema
- Intestinal Angioedema
ADVERSE REACTIONS
- Postmarketing Experiences
|
Angioedema subsection re-titled "Head and Neck
Angioedema".
Intestinal angioedema has
been reported in patients treated with ACE inhibitors. These patients
presented with abdominal pain (with or without nausea or vomiting); in
some cases there was no prior history of facial angioedema and C-1
esterase levels were normal.
|
|
|
|
Aceon (perindopril erbumine) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head
and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck Angioedema".
Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented with
abdominal pain (with or without nausea or vomiting); in some cases
there was no prior history of facial angioedema and C-1 esterase
levels were normal.
|
|
|
|
Advil Cold and Sinus Caplets (200 mg ibuprofen and 30 mg pseudoephedrine HCl)
Tablets (click product name to read prescribing information) |
WARNINGS
ASK YOUR DOCTOR BEFORE USE IF YOU HAVE:
- Kidney Disease
- Ulcers
- Bleeding Problems
- Stomach Problems that last or come back, such as heartburn, upset stomach, or pain
- Had problems or serious side effects from taking pain
relievers or fever reducers
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:
- Under a doctor's care for any continuing medical condition
- Over 65 years of age
- Taking any other product that contains ibuprofen or any
other pain reliever/fever reducer
- Taking any other product that contains pseudoephedrine or
any other nasal decongestant
- Taking a prescription drug for anticoagulation (blood
thinner) or a diuretic
- Taking any other drug
STOP USE AND ASK A DOCTOR IF
|
Taking more than recommended may cause stomach bleeding.
|
|
|
|
Amerge (naratriptan) Tablets (click product name to read prescribing information) |
WARNINGS
- Other Vasospasm-Related Events
|
Both peripheral vascular ischemia and colonic ischemia with
abdominal pain and bloody diarrhea have been reported with naratriptan.
|
|
|
|
Avelox (moxifloxacin hydrochloride) Tablets and I.V.
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Hemic and Lymphatic
- Prothrombin Time Prolonged/International Normalized Ratio
(INR) increased
- Postmarketing Adverse Event Reports
|
Moxifloxacin should be used with caution in patients
with ongoing proarrhythmic conditions, such as clinically significant
bradycardia, acute myocardial ischemia. The magnitude of QT
prolongation may increase with increasing concentrations of the drug
or increasing rates of infusion of the intravenous formulation.
Therefore the recommended dose or infusion rate should not be
exceeded. QT prolongation may lead to an increased risk for
ventricular arrhythmias including torsade de pointes.
|
|
|
|
DepoCyt (cytarabine liposome injection)
Please contact SkyePharma Inc. at 1-858-625-2424 or 1-212-753-5780
for prescribing information. |
WARNINGS |
Infectious meningitis may be associated with intrathecal drug
administration. Hydrocephalus has also been reported, possibly
precipitated by arachnoiditis.
In the controlled lymphoma study, the patient incidence of seizures
was higher in the DepoCyt group (4/17, 23.5%) than in the cytarabine
group (1/16, 6.3%).
Following intrathecal administration of DepoCyt, central nervous
system toxicity, including persistent extreme somnolence, hemiplegia,
visual disturbances including blindness, deafness and cranial nerve
palsies have been reported. Symptoms and signs of peripheral
neuropathy, such as pain, numbness, paresthesia, weakness, and
impaired bowel and bladder control have also been observed.
|
|
|
|
Enbrel (etanercept)
(click product name to read prescribing information)
|
WARNINGS
ADVERSE REACTIONS
|
In the controlled portions of clinical trials of all the TNF-blocking
agents, more cases of lymphoma have been observed among patients
receiving the TNF blocker compared to control patients. (See
prescribing information for details of clinical trials.)
|
|
|
|
Herceptin (trastuzumab)
(click product name to read prescribing information)
|
WARNINGS
- Exacerbation of Chemotherapy-Induced Neutropenia
ADVERSE REACTIONS
- Neutropenia
- Elevated Blood Pressure
|
In randomized, controlled clinical trials designed to assess the
impact of the addition of Herceptin on chemotherapy, the per-patient
incidences of moderate to severe neutropenia and of febrile
neutropenia were higher in patients receiving Herceptin in combination
with myelosuppressive chemotherapy as compared to those who received
chemotherapy alone. In the postmarketing setting, deaths due to sepsis
in patients with severe neutropenia have been reported in patients
receiving Herceptin and myelosuppressive chemotherapy, although in
controlled clinical trials (pre- and post-marketing), the incidence of
septic deaths was not significantly increased.
|
|
|
|
Lotensin (benazepril HCl) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head
and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck
Angioedema".
Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented with
abdominal pain (with or without nausea or vomiting); in some cases
there was no prior history of facial angioedema and C-1 esterase
levels were normal.
|
|
|
|
Lotensin HCT (benazepril HCl and
hydrochlorothiazide) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head
and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck
Angioedema".
Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented with
abdominal pain (with or without nausea or vomiting); in some cases
there was no prior history of facial angioedema and C-1 esterase
levels were normal.
|
|
|
|
Micardis (telmisartan) Tablets (click product name to read prescribing information) |
WARNINGS
- Fetal/Neonatal Morbidity and Mortality
PRECAUTIONS
ADVERSE REACTIONS
|
In rabbits, embryolethality associated with maternal toxicity
(reduced body weight gain and food consumption) was observed at 45
mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of
80 mg on a mg/m2 basis].
|
|
|
|
Monopril (fosinopril
sodium) Tablets
(click product name to read prescribing information) |
WARNINGS
- Head and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck
Angioedema".
Intestinal angioedema has been
reported in patients treated with ACE inhibitors. These patients
presented with abdominal pain (with or without nausea or vomiting); in
some cases there was no prior history of facial angioedema and C-1
esterase levels were normal.
|
|
|
|
Monopril-HCT
(fosinopril sodium/hydrochlorothiazide) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck
Angioedema".
Intestinal angioedema has been
reported in patients treated with ACE inhibitors. These patients
presented with abdominal pain (with or without nausea or vomiting); in
some cases there was no prior history of facial angioedema and C-1
esterase levels were normal.
|
|
|
|
Permax (pergolide mesylate) Tablets
(click product name to read prescribing information)
See Dear Healthcare Provider letter, December 2003 |
WARNINGS
- Falling Asleep During Activities of Daily Living
- Serous Inflammation and
Fibrosis
PRECAUTIONS
- Information for Patients
- Geriatric Use
|
Patients treated with Permax have reported falling asleep while
engaged in activities of daily living, including the operation of
motor vehicles which sometimes resulted in accidents. Although many of
these patients reported somnolence while on Permax, some perceived
that they had no warning signs such as excessive drowsiness, and
believed that they were alert immediately prior to the event. Some of
these events had been reported as late as one year after the
initiation of treatment. There have been rare reports of pleuritis,
pleural effusion, cardiac valvulopathy involving one or more valves,
or retroperitoneal fibrosis in patients taking pergolide. In some
cases, symptoms or manifestations of cardiac valvulopathy improved
after discontinuation of pergolide.
|
|
|
|
Rapamune (sirolimus) Oral Solution and
Tablets
(click product name to read prescribing
information)
|
WARNINGS
ADVERSE REACTIONS
- Cardiovascular System
- Other Clinical Experience
|
Hypersensitivity reactions, including anaphylactic/anaphylactoid
reactions, have been associated with the administration of sirolimus.
|
|
|
|
Rebetol (ribavirin) Capsules and Oral Solution (click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Pediatric Patients
- Table 7
- Rebetol/Peg-Intron Combination Therapy
|
There are significant adverse events caused by Rebetol/Intron A
or Peg- Intron therapy, including severe depression and suicidal
ideation, hemolytic anemia, suppression of bone marrow function,
autoimmune and infectious disorders, pulmonary dysfunction,
pancreatitis, and diabetes. Suicidal ideation or attempts occurred
more frequently among pediatric patients, primarily adolescents,
compared to adult patients (2.4% versus 1%) during treatment and
off-therapy follow-up.
|
|
|
|
Sublimaze (fentanyl citrate)
Injection
Please contact Akorn, Inc at 1-800-535-7155 for prescribing
information. |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS |
If Sublimaze is administered with a tranquilizer, the user should
become familiar with the special properties of each drug,
particularly the widely different duration of action. In addition,
when such a combination is used, fluids and other countermeasures to
manage hypotension should be available. |
|
|
|
Tenoretic (atenolol and
chlorthalidone) Tablets (click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
-
Drug Interactions
-
Nursing Mothers
|
Neonates born to mothers who are receiving atenolol
at parturition or breast-feeding may be at risk for hypoglycemia. Caution should be exercised when
Tenoretic is administered during pregnancy or to a woman who is breast-feeding.
|
|
|
|
Uniretic (moexipril
hydrochloride/hydrochlorothiazide) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck Angioedema". Intestinal angioedema has been
reported in patients treated with ACE inhibitors. These patients
presented with abdominal pain (with or without nausea or vomiting);
in some cases there was no prior history of facial angioedema and
C-1 esterase levels were normal.
|
|
|
|
Univasc (moexipril hydrochloride)
Tablets (click product name to read prescribing information) |
WARNINGS
- Head and Neck Angioedema
- Intestinal Angioedema
|
Angioedema subsection re-titled "Head and Neck Angioedema".
Intestinal angioedema has been
reported in patients treated with ACE inhibitors. These patients
presented with abdominal pain (with or without nausea or vomiting);
in some cases there was no prior history of facial angioedema and
C-1 esterase levels were normal. |