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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
| Sporanox (itraconazole) Capsules
(click product name to read prescribing information)
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CONTRAINDICATIONS
- Drug Interactions
- Levacetylmethadol
- Ergot Alkaloids
BOXED WARNING
- Drug Interactions
- Levacetylmethadol (levomethadyl)
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
PATIENT PACKAGE INSERT |
CONTRAINDICATIONS
Cisapride, oral midazolam, pimozide, quinidine, dofetilide, triazolam and levacetylmethadol (levomethadyl) are contraindicated with Sporanox. HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with Sporanox. Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with Sporanox.
BOXED WARNING
Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with Sporanox and/or other CYP3A4 inhibitors.
WARNINGS
Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with Sporanox and/or other CYP3A4 inhibitors.
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Sporanox (itraconazole) Injection
(click product name to read prescribing information)
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CONTRAINDICATIONS
- Drug Interactions
- Levacetylmethadol
- Ergot Alkaloids
BOXED WARNING
- Drug Interactions
- Levacetylmethadol (levomethadyl)
WARNINGS
PRECAUTIONS
- Table 1
- Antiarrhythmics
- Other
- Pregnancy: Teratogenic Effects
ADVERSE REACTIONS
|
CONTRAINDICATIONS Cisapride, oral
midazolam, pimozide, quinidine, dofetilide, triazolam and
levacetylmethadol (levomethadyl) are contraindicated with Sporanox.
HMG CoA-reductase inhibitors metabolized by CYP3A4, such as
lovastatin and simvastatin, are also contraindicated with Sporanox.
Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine,
ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine)
are contraindicated with Sporanox.
BOXED WARNING
Serious cardiovascular events, including QT
prolongation, torsades de pointes, ventricular tachycardia,
cardiac arrest, and/or sudden death have occurred in patients
using cisapride, pimozide, levacetylmethadol (levomethadyl), or
quinidine concomitantly with Sporanox and/or other CYP3A4
inhibitors.
WARNINGS
Life-threatening cardiac dysrhythmias and/or
sudden death have occurred in patients using cisapride, pimozide,
levacetylmethadol (levomethadyl), or quinidine concomitantly with
Sporanox and/or other CYP3A4 inhibitors. |
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| Ziagen (abacavir sulfate)
Tablets and Oral Solution
(click product name to read prescribing information)
|
CONTRAINDICATIONS
BOXED WARNING
- Hypersensitivity Reactions
WARNINGS
- Hypersensitivity Reaction
- Signs and Symptoms of Hypersensitivity
- Clinical Management of Hypersensitivity
PRECAUTIONS
-
Information for Patients
- Hypersensitivity Reaction
- General
ADVERSE REACTIONS
- Hypersensitivity Reaction
- Observed During Clinical Practice
- Hepatic
- Lactic Acidosis
- Hepatic Steatosis
MEDICATION GUIDE
WARNING CARD
|
CONTRAINDICATIONS
Ziagen Tablets and Oral Solution are
contraindicated in patients with previously demonstrated
hypersensitivity to abacavir or any other component of the
products.. Following a hypersensitivity reaction to abacavir,
NEVER restart Ziagen or any other abacavir-containing product.
Fatal rechallenge reactions have been associated with
readministration of abacavir to patients with a prior history of a
hypersensitivity reaction to abacavir.
BOXED WARNING
Hypersensitivity Reactions: Serious and
sometimes fatal hypersensitivity reactions have been associated
with Ziagen (abacavir sulfate). Hypersensitivity to abacavir is a
multi-organ clinical syndrome usually characterized by a sign or
symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or
abdominal pain), (4) constitutional (including generalized
malaise, fatigue, or achiness), and (5) respiratory (including
dyspnea, cough, or pharyngitis). Discontinue Ziagen as soon as a
hypersensitivity reaction is suspected. Permanently discontinue
Ziagen if hypersensitivity cannot be ruled out, even when other
diagnoses are possible. Following a hypersensitivity reaction to
abacavir, NEVER restart Ziagen or any other abacavir-containing
product because more severe symptoms can occur within hours and
may include life-threatening hypotension and death. Reintroduction
of Ziagen or any other abacavir-containing product, even in
patients who have no identified history or unrecognized symptoms
of hypersensitivity to abacavir therapy, can result in serious or
fatal hypersensitivity reactions. Such reactions can occur within
hours.
WARNINGS
Extensive revisions to WARNINGS section of
labeling. Please see prescribing information. |
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|
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
|
Delestrogen (estradiol valerate injection, USP)
(click product name to read prescribing information)
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
PRECAUTIONS
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BOXED WARNING
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 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.
WARNINGS
In the Women's Health Initiative Memory Study
(WHIMS), 4,532 generally healthy postmenopausal women 65 years
of age and older were studied, of whom 35% were 70 to 74 years
of age and 18% were 75 or older. 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. The absolute risk of
probable dementia for CE/MPA versus placebo was 45 versus 22
cases per 10,000 women-years, and the absolute excess risk for
CE/MPA was 23 cases per 10,000 women-years. It is unknown
whether these findings apply to younger postmenopausal women.
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Prefest (estradiol/norgestimate) Tablets
(click product name to read prescribing information)
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BOXED WARNING
-
Women's Health Initiative Memory Study (WHIMS)
WARNINGS
PRECAUTIONS
- Ovarian Cancer
- Geriatric Use
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BOXED WARNING
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
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.
WARNINGS
In the Women's Health Initiative Memory Study
(WHIMS), 4,532 generally healthy postmenopausal women 65 years
of age and older were studied, of whom 35% were 70 to 74 years
of age and 18% were 75 or older. 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. The absolute risk of probable dementia for CE/MPA
versus placebo was 45 versus 22 cases per 10,000 women-years,
and the absolute excess risk for CE/MPA was 23 cases per 10,000
women-years. It is unknown whether these findings apply to
younger postmenopausal women. |
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Viread (tenofovir disoproxil fumerate) Tablets
(click product name to read prescribing information)
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BOXED WARNING
WARNINGS
- Patients Co-infected with HIV and Hepatits B Virus
PRECAUTIONS
-
Carcinogenesis, Mutagenesis, Impairment of
Fertility
|
BOXED WARNING
Viread is not indicated for the treatment of chronic
hepatitis B virus (HBV) infection and the safety and efficacy of
Viread have not been established in patients co-infected with
HBV and HIV. Severe acute exacerbations of hepatitis B have been
reported in patients who are co-infected with HBV and HIV and
have discontinued Viread. Hepatic function should be monitored
closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue Viread and are
co-infected with HBV and HIV. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
WARNINGS
It is recommended that all patients with HIV be
tested for the presence of chronic hepatitis B virus (HBV)
before initiating antiretroviral therapy. Viread is not
indicated for the treatment of chronic HBV infection and the
safety and efficacy of Viread have not been established in
patients co-infected with HBV and HIV. Severe acute
exacerbations of hepatitis B have been reported in patients who
are co-infected with HBV and HIV and have discontinued Viread.
Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients
who discontinue Viread and are co-infected with HIV and HBV. If
appropriate, initiation of anti-hepatitis B therapy may be
warranted. |
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Back to Summary Page
|
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Advil (ibuprofen) Tablets, Caplets and Gel
Caplets
(click product name to read prescribing information)
|
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
- Stomach problems that last or come back,
such as heartburn, upset stomach or pain
- Ulcers
- Bleeding problems
- High blood pressure, heart or kidney
disease, are taking a diuretic, or are over 65 years of age
ASK A DOCTOR OR PHARMACIST BEFORE USE IF
YOU ARE
- Under a doctor's care for any serious
medical condition
- taking a prescription drug for
anticoagulation (blood thinning)
- taking any other drug
When using this product take with food
or milk if stomach upset occurs.
STOP USE AND ASK A DOCTOR IF
- Stomach pain or upset gets worse or lasts
- Redness or swelling is present in the
painful area
- any new symptoms appear
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WARNINGS
Taking more than recommended may cause
stomach bleeding.
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Avelox (moxifloxacin hydrochloride) Tablets
Avelox I.V. (moxifloxacin hydrochloride in
sodium chloride injection)
(click product name to read prescribing information)
|
WARNINGS
- Peripheral Neuropathy
- Tendon Effects
|
WARNINGS
Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large
axons resulting in paresthesias, hypoesthesias, dysesthesias and
weakness have been reported in patients receiving quinolones.
Tendon Effects: Ruptures of the shoulder, hand,
Achilles tendon or other tendons that required surgical
repair or resulted in prolonged disability have been reported in
patients receiving quinolones, including moxifloxacin. |
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ChloraPrep One Step (chlorhexidine gluconate 2%
topical solution)
(click product name to read prescribing information)
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WARNINGS
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WARNINGS Do not use with
electrocautery procedures.
Allow the prep to completely dry.
Drying time for surgical sites is approximately 30 seconds and
drying time for moist surgical sites is approximately one minute.
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Cipro (ciprofloxacin) IV for Intravenous
Infusion
(click product name to read prescribing information)
|
SYSTEMIC ANTIBACTERIAL
DRUG PRODUCTS STATEMENT to reduce the development of
drug-resistant bacteria WARNINGS
-
Pseudomembranous Colitis
- Peripheral Neuropathy
- Tendon Effects
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Methotrexate
- Non-steroidal Anti-inflammatory Drugs
(but not acetyl salicylic acid)
ADVERSE REACTIONS
-
Adverse Reactions in Adult Patients
- Cardiovascular
- Atrial Flutter
- Ventricular Ectopy
- (Thrombo)-phlebitis
- Vasodilation
- Migraine
- Central Nervous System
- Abnormal Gait
- Grand Mal Convulsion
- Anorexia
- Hemic/Lymphatic
- Renal/Urogenital
- Respiratory
- Laryngeal or Pulmonary Edema
- Skin/Hypersensitivity
- Allergic Reactions
- Thrombophlebitis
- Burning
- Paresthesia
- Erythema
- Swelling
- Special Senses
- Post-marketing Adverse Events
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WARNINGS
Pseudomembranous Colitis:
After the diagnosis of pseudomembranous colitis has been
established, therapeutic measures should be initiated. Mild cases
of pseudomembranous colitis usually respond to drug
discontinuation alone. In moderate to severe cases, consideration
should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug
clinically effective against C. difficile colitis.
Drugs that inhibit peristalsis should be avoided.
Peripheral Neuropathy:
Rare cases of sensory or sensorimotor axonal
polyneuropathy affecting small and/or large axons resulting in
paresthesias, hypoesthesias, dysesthesias and weakness have been
reported in patients receiving quinolones, including
ciprofloxacin. Ciprofloxacin should be discontinued if the patient
experiences symptoms of neuropathy including pain, burning,
tingling, numbness, and/or weakness, or is found to have deficits
in light touch, pain, temperature, position sense, vibratory
sensation, and/or motor strength in order to prevent the
development of an irreversible condition.
Tendon Effects: Ciprofloxacin should be discontinued if the patient experiences
pain, inflammation, or rupture of a tendon. Patients should rest
and refrain from exercise until the diagnosis of tendonitis or
tendon rupture has been excluded. Tendon rupture can occur during
or after therapy with quinolones, including ciprofloxacin.
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Cipro (ciprofloxacin hydrochloride)
Tablets and Oral Suspension
(click product name to read prescribing information)
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WARNINGS
-
Peripheral Neuropathy
-
Tendon Effects
PRECAUTIONS
- Information for Patients
- Drug Interactions
-
Non-steroidal Anti-Inflammatory Drugs (but not
acetyl salicylic acid)
ADVERSE REACTIONS
- Post-marketing Adverse Events
- Moniliasis
- Peripheral Neuropathy
- Torsades de Pointes
|
WARNINGS Peripheral
Neuropathy: Rare cases of sensory or
sensorimotor axonal polyneuropathy affecting small and/or large
axons resulting in paresthesias, hypoesthesias, dysesthesias and
weakness have been reported in patients receiving quinolones,
including ciprofloxacin. Ciprofloxacin should be discontinued if
the patient experiences symptoms of neuropathy including pain,
burning, tingling, numbness, and/or weakness, or is found to have
deficits in light touch, pain, temperature, position sense,
vibratory sensation, and/or motor strength in order to prevent the
development of an irreversible condition.
Tendon Effects: Ciprofloxacin should
be discontinued if the patient experiences pain, inflammation, or
rupture of a tendon. Patients should rest and refrain from
exercise until the diagnosis of tendonitis or tendon rupture has
been excluded. Tendon rupture can occur during or after therapy
with quinolones, including ciprofloxacin.
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| Cipro XR (ciprofloxacin extended-release tablets)
(click product name to read prescribing information)
|
SYSTEMIC ANTIBACTERIAL
DRUG PRODUCTS STATEMENT to reduce the development of
drug-resistant bacteria WARNINGS
-
Pseudomembranous Colitis
-
Peripheral Neuropathy
-
Tendon Effects
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
ADVERSE REACTIONS
|
WARNINGS
Pseudomembranous Colitis: After the diagnosis of
pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous
colitis usually respond to drug discontinuation alone. In moderate
to severe cases, consideration should be given to management with
fluids and electrolytes, protein supplementation, and treatment
with an antibacterial drug clinically effective against C.
difficile colitis. Drugs that inhibit peristalsis should be
avoided.
Peripheral Neuropathy:
Rare cases of sensory or sensorimotor axonal
polyneuropathy hypoesthesias, dysesthesias and weakness have been
reported in patients receiving quinolones, including
ciprofloxacin. Ciprofloxacin should be discontinued if the patient
experiences symptoms of neuropathy including pain, burning,
tingling, numbness, and/or weakness, or is found to have deficits
in light touch, pain, temperature, position sense, vibratory
sensation, and/or motor strength in order to prevent the
development of an irreversible condition.
Tendon Effects:
Ruptures of the shoulder, hand, Achilles tendon or
other tendons that required surgical repair or resulted in
prolonged disability have been reported in patients receiving
quinolones, including ciprofloxacin. Post-marketing surveillance
reports indicate that this risk may be increased in patients
receiving concomitant corticosteroids, especially the elderly.
Ciprofloxacin should be discontinued if the patient experiences
pain, inflammation, or rupture of a tendon. Patients should rest
and refrain from exercise until the diagnosis of tendonitis or
tendon rupture has been excluded. Tendon rupture can occur during
or after therapy with quinolones, including ciprofloxacin.
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Noroxin (norfloxacin) Tablets
(click product name to read prescribing information)
|
SYSTEMIC ANTIBACTERIAL
DRUG PRODUCTS STATEMENT to reduce the development of
drug-resistant bacteria WARNINGS
-
Peripheral Neuropathy
-
Tendon Effects
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Oral Anticoagulants
- Glyburide
- Geriatric Use
ADVERSE REACTIONS
- Post-Marketing
- Cardiovascular
- Prolonged QTc interval
- Ventricular arrhythmia including Torsades de
Pointes
- Musculoskeletal
- Elevated Creatine Kinase (CK)
- Hematologic
- Special Senses
|
WARNINGS Peripheral
Neuropathy: Rare cases of sensory or
sensorimotor axonal polyneuropathy affecting small and/or
largeaxons resulting in paresthesias, hypoesthesias, dysesthesias
and weakness have been reported in patients receiving quinolones,
including norfloxacin. Norfloxacin should be discontinued if the
patient experiences symptoms of neuropathy including pain,
burning, tingling, numbness, and/or weakness, or is found to have
deficits in light touch, pain, temperature, position sense,
vibratory sensation, and/or motor strength in order to prevent the
development of an irreversible condition.
Tendon Effects:
Ruptures of the shoulder, hand, Achilles tendon
or other tendons that required surgical repair or resulted in
prolonged disability have been reported in patients receiving
quinolones, including norfloxacin. Post-marketing surveillance
reports indicate that this risk may be increased in patients
receiving concomitant corticosteroids, especially in the elderly. |
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Purinethol (mercaptopurine) Tablets
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
WARNINGS
If a patient has clinical or laboratory evidence
of severe toxicity, particularly myelosuppression, TPMT testing
should be considered.
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Rapamune (sirolimus) Tablets and Oral Solution
(click product name to read prescribing information)
|
WARNINGS PRECAUTIONS
- Drug Interactions
- Cyclosporine capsules MODIFIED
- Rapamune Oral Solution
- Diltiazem
- Erythromycin
- Ketoconazole
- Rifampin
- Verapamil
- Other Drug Interactions
ADVERSE REACTIONS
|
WARNINGS Co-administration of sirolimus with strong
inhibitors of CYP3A4 and/or P-gp (such as ketoconazole,
voriconazole, itraconazole, erythromycin, telithromycin, or
clarithromycin) or strong inducers of CYP3A4 and/or P-gp (such as
rifampin or rifabutin) is not recommended. |
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Reyataz (atazanavir sulfate) Capsules
(click product name to read prescribing information)
|
WARNINGS
ADVERSE REACTIONS
- Table 13
- Table 16
-
Patients Co-infected With Hepatitis B and/or
Hepatitis C Virus
|
WARNINGS Atazanavir has been shown to prolong the PR
interval of the electrocardiogram in some patients. In healthy
volunteers and in patients, abnormalities in atrioventricular (AV)
conduction were asymptomatic and generally limited to first-degree
AV block. Because of limited clinical experience, atazanavir
should be used with caution in patients with preexisting
conduction system disease (eg, marked first-degree AV block or
second- or third-degree AV block). |
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Thallous Chloride T1-201
(click product name to read prescribing information)
|
WARNINGS
ADVERSE REACTIONS
|
WARNINGS
Pharmacologic induction of cardiovascular
stress may be associated with serious adverse events such as
myocardial infarction, arrhythmia, hypotension,
bronchoconstriction, and cerebrovascular events. Caution
should be used when pharmacologic stress is selected as an
alternative to exercise; it should be used when indicated and
in accordance with the pharmacologic stress agent's labeling.
|
MedWatch
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Back to Summary Page
MedWatch
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Back to Summary Page
|
|
