|
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications and Warnings |
|
Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
Prescribing Information
Patient Package Insert
|
BOXED WARNING
WARNINGS
- Patients Coinfected with HIV and HBV
- Renal Impairment
PRECAUTIONS
- Bone Effects
- Cases of osteomalacia (associated with proximal renal tubulopathy)...
- Drug Interactions
- ...Suppression of CD4 cell counts has been observed in patients receiving tenofovir DF with didanosine at a dose of 400 mg daily.
ADVERSE REACTIONS
- Postmarketing Experience
- Tenofovir Disoproxil Fumarate
- Skin and Subcutaneous Tissue Disorders
- Musculoskeletal and Connective Tissue Disorders
- Myopathy, Osteomalacia...
- Renal and Urinary Disorders
- Interstitial Nephritis...
- General Disorders and Administration Site Conditions
PATIENT PACKAGE INSERT
- Medicines You Should Not Take With Atripla
- Atripla also should not be used with Combivir (lamivudine/zidovudine),
Emtriva, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine),
Sustiva, Truvada, or Viread.
|
BOXED WARNING
...Atripla is not approved for the treatment of chronic Hepatitis B Virus (HBV) infection and the safety and efficacy of Atripla have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of Hepatitis B have been reported in patients who have discontinued Emtriva or Viread which are components of Atripla...
WARNINGS
Patients Coinfected with HIV and HBV
...Severe acute exacerbations of
hepatitis B have been reported in patients who are coinfected with HBV and HIV and have discontinued Emtriva or Viread. In some of these patients treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation
and liver failure...
Renal Impairment
Emtricitabine and tenofovir are principally eliminated by the kidney, however efavirenz is
not. Since Atripla is a combination product and the dose of the individual components cannot be altered, patients with creatinine clearance <50 mL/min should
not receive Atripla.
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal
tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir DF...
It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Atripla... |
|
|
|
|
|
Cleocin Sterile Solution (clindamycin injection)
Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution
Prescribing Information
|
BOXED WARNING
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics...
|
BOXED WARNING
Clostridium difficile associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including Cleocin Phosphate and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters
the normal flora of the colon leading to overgrowth of C. difficile.
...C. difficile produces toxins A and B which contribute to the development of
CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and
mortality, as these infections can be refractory to antimicrobial therapy and may
require colectomy. CDAD must be considered in all patients who present with
diarrhea following antibiotic use. Careful medical history is necessary since
CDAD has been reported to occur over two months after the administration of
antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued. Appropriate fluid and electrolyte
management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including Cleocin Phosphate, and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters
the normal flora of the colon leading to overgrowth of C. difficile...
|
|
|
|
|
|
Duragesic (fentanyl) Transdermal System
Prescribing Information
Medication Guide
|
BOXED WARNING
WARNINGS
PRECAUTIONS
- Information for Patients (see highlighted label)
MEDICATION GUIDE
- Read the Medication Guide that comes with Duragesic before you start using it
and each time you get a new prescription. There may be new information...
|
BOXED WARNING
...Because serious or life-threatening hypoventilation could occur,
Duragesic (fentanyl transdermal system) is contraindicated:
- in the management of intermittent pain (e.g., use on an as needed basis
[prn])...
The concomitant use of Duragesic with all cytochrome P450 3A4
inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin,
clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant,
diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and
verapamil)...
Duragesic patches are intended for transdermal use (on intact skin) only. Do not
use a Duragesic patch if the seal is broken or the patch is cut, damaged or changed
in any way...
Avoid exposing the Duragesic application site and surrounding area to direct
external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot
tubs, and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for
temperature-dependent increases in fentanyl released from the system resulting in
possible overdose and death...
WARNINGS
Duragesic patches are intended for transdermal use (on intact skin) only. Do
not use Duragesic patch if the seal is broken or the patch is cut, damaged or
changed in any way...
Based on a pharmacokinetic model, serum fentanyl concentrations could theoretically
increase by approximately one-third for patients with a body temperature of 40ºC (104ºF)
due to temperature-dependent increases in fentanyl released from the system and
increased skin permeability... |
|
|
|
|
|
Emsam (selegiline transdermal system) Patches
(Prescribing Information not currently available)
|
BOXED WARNING
- Suicidality and Antidepressant Drugs
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Pediatric Use
- Due to limited data, Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.
- Commercially available doses of Emsam have not been studied in children under the age of 12 years. Limited pharmacokinetic data with lower doses than in the commercially available formulations suggest that children under the age of 12 years treated with Emsam may be exposed to increased levels of selegiline compared to adolescents or adults. Therefore, the possibility exists for an increased risk of hypertensive crisis, even at the lowest dose of
commercially available Emsam, when administered without dietary modifications.
MEDICATION GUIDE
- Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.
|
BOXED WARNING
Suicidality and Antidepressant Drugs
...Furthermore, Emsam at any dose should not be used in children under the age of 12, even when administered with dietary modifications...
WARNINGS
Clinical Worsening and Suicide Risk
Due to the limited data, Emsam at any dose should not be used in children uder the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients... |
|
|
|
Fentora (fentanyl buccal tablet)
Prescribing Information
Medication Guide |
BOXED WARNING
MEDICATION GUIDE
- What are the possible or reasonably likely side effects of Fentora?
|
BOXED WARNING
Fentora is indicated only for the management of breakthrough pain in patients
with cancer who are already receiving and who are tolerant to around-the-clock
opioid therapy for their underlying persistent cancer pain. |
|
|
|
Lincocin (lincomycin) Injection
Prescribing Information |
BOXED WARNING
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics...
|
BOXED WARNING
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including Lincomycin and may range in severity
from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the
normal flora of the colon leading to overgrowth of C. difficile.
Because lincomycin therapy has been associated with severe colitis which may
end fatally, it should be reserved for serious infections where less toxic
antimicrobial agents are inappropriate, as described in the INDICATIONS AND
USAGE section. It should not be used in patients with nonbacterial infections
such as most upper respiratory tract infections.
C.difficile produces toxins A and B which contribute to the development of
CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and
mortality, as these infections can be refractory to antimicrobial therapy and may
require colectomy. CDAD must be considered in all patients who present with
diarrhea following antibiotic use. Careful medical history is necessary since
CDAD has been reported to occur over two months after the administration of
antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued. Appropriate fluid and electrolyte
management, protein supplementation, antibiotic treatment of C. difficile, and
surgical evaluation should be instituted as clinically indicated.
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly
all antibacterial agents, including Lincomycin, and may range in severity from mild
diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of
the colon leading to overgrowth of C. difficile... |
Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Asmanex Twisthaler (mometasone furoate inhalation powder)
Prescribing Information (in new labeling format)
|
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Local Effects
- Acute Asthma Episodes
- Immunosuppression
- Transferring Patients from Systemic Corticosteroid Therapy
- Hypercorticism and Adrenal Suppression
- Reduction in Bone Mineral Density
- Effect on Growth
- Glaucoma and Cataracts
ADVERSE REACTIONS
- The most common adverse reactions (incidence >5%) are headache, allergic
rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral
candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia.
|
CONTRAINDICATIONS
Hypersensitivity
...In the clinical trials and post-marketing experience with
Asmanex Twisthaler, cases of allergic reaction, facial edema,
urticaria, hypersensitivity, and throat tightness have been reported.
WARNINGS AND PRECAUTIONS
Local Effects
Candida albicans infection of the mouth and pharynx. Monitor patients
periodically for signs of adverse effects in the mouth and pharynx.
Advise patients to rinse mouth after inhalation.
Acute Asthma Episodes
...Instruct patients to contact their physician immediately if episodes of
asthma that are not responsive to bronchodilators occur during the course
of treatment with Asmanex Twisthaler. During such episodes, patients may require therapy with oral corticosteroids.
Immunosuppression
Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex. More serious or even fatal
course of chickenpox or measles in susceptible patients...
Transferring Patients from Systemic Corticosteroid Therapy
Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids...
Hypercorticism and Adrenal Suppression
Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals...
Reduction in Bone Mineral Density
Reduction in bone mineral density with long-term administration.
Monitor patients with major risk factors for decreased bone mineral
content.
Effect on Growth
Suppression of growth in children. Monitor growth routinely in pediatric
patients...
Glaucoma and Cataracts
Development of glaucoma, increased intraocular pressure and posterior subcapsular cataracts. Monitor patients with a change in vision or with a
history of increased intraocular pressure, glaucoma, and/or cataracts
closely. |
Back to Summary Page | Back to Top
|
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
|
Abilify (aripiprazole) Tablets and Oral Solution
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets
Abilify (aripiprazole) Injection for Intramuscular Use Only
Prescribing Information (in new labeling format)
|
WARNINGS
AND PRECAUTIONS
- Orthostatic Hypotension
- Seizures/Convulsions
- Potential for Cognitive and Motor Impairment
ADVERSE REACTIONS
- Clinical Studies Experience
- Pediatric Patients (10 to 17 years) with Bipolar Mania
- Commonly Observed Adverse Reactions
- Table 7
- Somnolence
- Extrapyramidal Disorder
- Fatigue
- Nausea
- Akathisia
- Blurred Vision
- Salivary Hypersecretion
- Dizziness
USE IN SPECIFIC POPULATIONS
|
WARNINGS AND PRECAUTIONS
Orthostatic Hypotension
Aripiprazole may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. The incidence of orthostatic hypotension-associated events from short-term, placebo-controlled trials...of pediatric patients 10 to 17 years of age (n=399) on oral Abilify included orthostatic hypotension (1.0%, 0%)...
The incidence of a significant orthostatic change in blood pressure...In pediatric oral aripiprazole-treated patients aged 10 to 17
years (0%, 0.5%), or in aripiprazole injection-treated patients (3%, 2%).
Seizures/Convulsions
In short-term, placebo-controlled trials, seizures/convulsions occurred in 0.2% (3/1894)
of adult patients treated with oral aripiprazole, in 0.3% (1/399) of pediatric patients (10 to
17 years), and in 0.2% (1/501) of adult aripiprazole injection-treated patients...
Potential for Cognitive and Motor Impairment
Abilify, like other antipsychotics, may have the potential to impair judgment, thinking,
or motor skills... |
|
|
|
|
|
Avastin (bevacizumab) for Intravenous Use
Prescribing Information
|
WARNINGS
ADVERSE REACTIONS
|
WARNINGS
Congestive Heart Failure
...In Study 7, the rate of congestive heart failure (defined as NCI-CTC Grade 3 and 4) in the Avastin plus paclitaxel arm was 2.2% versus 0.3% in the control arm. Among patients receiving anthracyclines, the rate of CHF was 3.8% for Avastin treated patients and 0.6% for patients receiving paclitaxel alone... |
|
|
|
|
Claforan Sterile (cefotaxime for injection, USP)
and
Injection (cefotaxime injection, USP)
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including Claforan, and may range in severity from mild diarrhea to fatal colitis. Treatment
with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing
strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to
antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present
with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been
reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be
discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment
of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
|
|
|
|
|
Cortenema (hydrocortisone retention enema)
Contact ANI Pharmaceuticals at 1-800-434-1121 for Prescribing Information.
|
WARNINGS
PRECAUTIONS
- General
- Cortenema hydrocortisone retention enema should be used with caution...
- Information for Patients
- Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles...
|
WARNINGS
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If expsosed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated...
...If chicken pox develops, treatment with antiviral agents may be considered. |
|
|
|
|
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including Doryx Capsules, 75 mg and 100 mg, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over
two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
|
|
|
|
Eryc (erythromycin delayed-release capsules, USP)
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including Eryc Capsules, and may range in severity from mild diarrhea to
fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
|
|
|
|
Erythrocin Lactobionate (erythromycin lactobionate), Injection, Powder, Lyophilized, For Solution
For I.V. Use Only
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly
all antibacterial agents, including erythromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein
supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be
instituted as clinically indicated. |
|
|
|
Geocillin
(carbenicillin indanyl sodium) Tablets
Prescribing Information |
WARNINGS
PRECAUTIONS
- General
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Geocillin (carbenicillin indanyl sodium), and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein
supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be
instituted as clinically indicated. |
|
|
|
Halcion (triazolam tablets)
Prescribing Information
Medication Guide |
WARNINGS
- Sleep Disturbances
- Severe Anaphylactic and Anaphylactoid Reactions
PRECAUTIONS
- Information for Patients
- "Sleep-driving" and other Complex Behaviors
- Drug Interactions
- Drugs that inhibit triazolam metabolism via cytochrome P450 3A:
- Ketoconzaole
- Itraconazole
- Nefazodone
- Tolerance/Withdrawal Phenomena
MEDICATION GUIDE (new)
|
WARNINGS
Sleep Disturbances
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated...
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedativehypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons...
Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Halcion. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis... |
|
|
|
Janumet (sitagliptin/metformin HCl) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert |
WARNINGS AND PRECAUTIONS
PATIENT PACKAGE INSERT
- What is Janumet?
- Tell your doctor about all the medications you take...
- What are the possible side effects of Janumet?
|
WARNINGS AND PRECAUTIONS
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction
with Janumet or any other oral anti-diabetic drug. |
|
|
|
Letairis (ambrisentan) Tablets
Prescribing Information (in new labeling format)
Medication Guide |
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
MEDICATION GUIDE
- The most common side effects of Letairis
- Swelling of hands, legs, ankles and feet (peripheral edema)...
|
WARNINGS AND PRECAUTIONS
Fluid Retention
Peripheral edema is a known class effect of endothelin receptor antagonists, and is
also a clinical consequence of PAH and worsening PAH. In the placebo-controlled
studies, there was an increased incidence of peripheral edema in patients treated with doses of 5 or 10 mg Letairis compared to placebo [see Adverse Reactions (6)]. Most
edema was mild to moderate in severity, and it occurred with greater frequency and severity in elderly patients... |
|
|
|
Premarin Intravenous
(conjugated estrogens, USP) for injection
Prescribing Information
Patient Package Insert |
WARNINGS
- Malignant Neoplasms
- Endometrial Cancer
- Breast Cancer
PRECAUTIONS
- General
- Ovarian Cancer
- The estrogen plus progestin substudy of WHI reported a non-statistically significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95 percent nCI 0.77-3.24)...
ADVERSE REACTIONS
- Gastrointestinal
- Central Nervous System
- Possible growth potentiation of benign meningioma
PATIENT PACKAGE INSERT
- What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?
- If you have a uterus, talk with your healthcare provider about whether the addition of a progestin...
|
WARNINGS
Malignant Neoplasms
Endometrial Cancer
An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in women with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in non-users, and appears dependent on duration of treatment and on estrogen dose...
Breast Cancer
...The results from observational studies are generally consistent with those of the WHI clinical
trial. Observational studies have also reported an increased risk of breast cancer for estrogen plus
progestin therapy, and a smaller increased risk for estrogen alone therapy, after several years of use. The risk increased with duration of use, and appeared to return to baseline over about
5 years after stopping treatment (only the observational studies have substantial data on risk after
stopping). Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen alone therapy... |
|
|
|
Remodulin (treprostinil sodium) Injection
Prescribing Information |
WARNINGS
- Adverse Events Attributable to the Intravenous Drug Delivery System
ADVERSE REACTIONS
- Adverse Events Attributable to the Drug Delievery System
- ...In addition to these adverse events due to the drug delivery system during subcutaneous administration...
- Adverse Events Observed During Clinical Practice
- ...These events are thrombophlebitis associated with peripheral intravenous infusion, thrombocytopenia and bone pain...
|
WARNINGS
Adverse Events Attributable to the Intravenous Drug Delivery System
Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal.
In an open-label study of IV treprostinil (n=47), there were seven catheter-related line infections during approximately 35 patient years, or about 1 BSI event per 5 years of use. A CDC survey of seven sites that used IV treprostinil for the
treatment of PAH found approximately 1 BSI (defined as any positive blood culture) event per 3 years of use. |
|
|
|
Restoril (temazepam) Capsules
Prescribing Information
Medication Guide |
WARNINGS
- Complex Behaviors
- Severe Anaphylactic and Anaphylactoid Reactions
PRECAUTIONS
- Special Concerns
- "Sleep-Driving" and Other Complex Behaviors
MEDICATION GUIDE
- What is the most important information I should know about Restoril?
- Who should not take Restoril?
- What is Restoril?
- How should I take Restoril?
- What are the possible side effects of Restoril?
|
WARNINGS
Complex Behaviors
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced
persons...
...Due to the risk to the patient and the community, discontinuation of Restoril should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic...
Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Restoril. Some patients
have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Restoril should not be rechallenged with the drug. |
|
|
|
Reyataz (atazanavir sulfate) Capsules
Prescribing Information
Patient Package Insert |
WARNINGS
- Drug Interactions
- Cardiac Conduction Abnormalities
ADVERSE REACTIONS
- Postmarketing Experience
- Cardiovascular System
- Second-degree AV block
- Third-degree AV block
- Left Bundle Branch Block
- QTc Prolongation...
- Hepatobiliary Disorders
- Cholelithiasis
- Cholecystitis
- Cholestasis
PATIENT PACKAGE INSERT
- What are the possible side effects of Reyataz?
- What important information should I know about taking Reyataz with other medicines?
- How should I store Reyataz?
|
WARNINGS
Drug Interactions: Rosuvastatin
...Use the lowest possible dose of atorvastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin when in concomitant use with Reyataz. The risk of myopathy, including rhabdomyolysis, may be increased when HIV protease inhibitors, including
Reyataz, are used in combination with these drugs.
Cardiac Conduction Abnormalities
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. There have been rare reports of second-degree AV block and other conduction abnormalities... |
|
|
|
Sensipar (cinacalcet) Tablets
Prescribing Information |
WARNINGS
- Hypotension and/or Worsening Heart Failure
PRECAUTIONS
- General
- Hypocalcemia
- Sensipar is not indicated for CKD patients not on dialysis...
- ...In a phase 3 study of 32 weeks duration and including 404 subjects...
ADVERSE REACTIONS
- Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
on Dialysis
- In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug...
- Table 2. Adverse Event Incidence (> 5%) in Patients on DialysisTable 2 Adverse Event Incidence
- Postmarketing Experience with Sensipar
|
WARNINGS
Hypotension and/or Worsening Heart Failure
In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or
worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to Sensipar could not be completely excluded and may be
mediated by reductions in serum calcium levels. Clinical trial data showed hypotension occurred in 7% of Sensipar-treated patients, 12% of placebo-treated patients, and heart
failure occurred in 2% of patients receiving Sensipar or placebo. |
|
|
|
Ultram ER
(tramadol HCI) Extended-Release Tablets
Prescribing Information |
WARNINGS
PRECAUTIONS
- Use in Renal and Hepatic Disease
- Information for Patients
- ...Patients should be informed that ULTRAM ER may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SRIs, NRIs, and
triptans) or drugs that significantly reduce the metabolic clearance of tramadol...
- Drug Interactions
- CYP2D6 and CYP3A4 Inhibitors
- Serotonergic Drugs
- Triptans
ADVERSE REACTIONS
- The frequency of adverse events generally increased with doses...
- Table 2
|
WARNINGS
Serotonin Syndrome Risk
The development of a potentially life-threatening serotonin syndrome may occur with use of tramadol products, including ULTRAM ER, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, with drugs which impair metabolism of serotonin (including MAOIs) and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4
inhibitors). This may occur within the recommended dose...
Serotonin syndrome may include mental-status changes (e.g., agitation,
hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood
pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia,
incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting,
diarrhea)... |
|
|
|
Vibramycin Calcium
(doxycycline calcium oral suspension, USP) Oral Suspension Syrup
Vibramycin Hyclate
(doxycycline hyclate capsules, USP)
Capsules
Vibramycin
Monohydrate
(doxycycline monohydrate)
for Oral Suspension
Vibra-Tabs
(doxycycline hyclate tablets, USP) Film Coated Tablets
Prescribing Information
|
WARNINGS
PRECAUTIONS
- General
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
|
WARNINGS
Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vibramycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
Back to Summary Page | Back to Top
|
Brand
(Generic) Name
|
Sections Modified |
Arestin (minocycline hydrochloride) Microspheres
Prescribing Information
|
PRECAUTIONS
- Hypersensitivity Reactions
- Autoimmune Syndromes
- Information for Patients
|
|
|
|
Avelox
(moxifloxacin hydrochloride) Tablets
Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)
Prescribing Information
Patient Package Insert
|
PRECAUTIONS
- Moderate to severe photosensitivity/phototoxicity reactions...
- Information for Patients
- Photosensitivity/Phototoxicity has been reported...
ADVERSE REACTIONS
- Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of moxifloxacin treated patients were...
- photosensitivity/phototoxicity reactions...
- Postmarketing Adverse Event Reports
- Photosensitivity/Phototoxicity Reaction...
PATIENT PACKAGE INSERT
- What are possible side effects of Avelox?
- Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can
occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial
ultraviolet light (UV) (e.g. tanning beds). Avelox has been infrequently associated with
photosensitivity...
|
|
|
|
Corgard (nadolol tablets, USP)
Prescribing Information
|
PRECAUTIONS
- Drug Interactions
- Digitalis Glycosides
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
|
|
|
|
|
Daytrana (methylphenidate transdermal system)
Prescribing Information
Medication Guide
|
PRECAUTIONS
- Information for Patients
- Skin redness or itching is common with Daytrana, and small bumps on the skin may also
occur in some patients. If any swelling or blistering occurs the patch should not be worn and
the patient should be seen by the prescriber...
ADVERSE REACTIONS
- Postmarketing Reports
- Cardiac Disorders
- Eye Disorders
- Visual Disturbances
- Blurred Vision
- Mydriasis
- Accommodation Disorder
- Gastrointestinal Disorders
- General Disorders & Administration Site Disorders
- Application Site Reactions
- Bruising
- Burn...
- Immune System Disorders
- Hypersensitivity Reactions including Generalized Erythematous and Urticarial Rashes, Allergic Contact Dermatitis...
- Investigations
- Heart Rate Increased
- Blood Pressure Increased
- Nervous System Disorders
- Psychiatric Disorders
- Transient Depressed Mood
- Hallucination
- Nervousness
- Skin and Subcutaneous Tissue Disorders
MEDICATION GUDE
- Before You Apply Daytrana
- How To Remove And Discard Daytrana
|
|
|
|
| Diskets Dispersible Tablets (methadone hydrochloride tablets for oral suspension, USP)
Prescribing Information
|
PRECAUTIONS
- Information for Patients
- Breastfeeding Women
- Methadone use is usually compatible with breastfeeding. Pregnant mothers using methadone should be counseled about the benefits and risks of breastfeeding while using methadone...
|
|
|
|
| Ditropan (oxybutynin chloride) Tablets and Syrup
Prescribing Information |
PRECAUTIONS
- Central Nervous System Effects
- Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholingeric effects have been reported...
- Ditropan should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
ADVERSE REACTIONS (see highlighted section)
- The following adverse events were reported by 1 to <5% of patients using Ditropan (5 - 20 mg/day):
- Infections and Infestations
- Metabolism and Nutrition Disorders
- Psychiatric Disorders
- Nervous System Disorders
- Eye Disorders
- Cardiac Disorders
- Vascular Disorders
- Respiratory, Thoracic and Mediastinal Disorders
- Gastrointestinal Disorders
- Skin and Subcutaneous Tissue Disorders
- Musculoskeletal and Connective Tissue Disorders
- Renal and Urinary Disorders
- General Disorders and Administration Site Conditions
- Investigations
- Injury, Poisoning, and Procedural Complications
- Postmarketing Surveillance
- Psychiatric Disorders
- Nervous System Disorders
- Eye Disorders
- Cardiac Disorders
- Gastrointestinal Disorders
- Skin and Subcutaneous Tissue Disorders
- Renal and Urinary Disorders
- Reproductive System and Breast Disorders
|
|
|
|
Ditropan XL (oxybutynin chloride) Extended Release Tablets
Prescribing Information
|
PRECAUTIONS
- Central Nervous System Effects
- Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence.
- Ditropan XL should be used with caution in patients with preexisting dementia
treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
ADVERSE REACTIONS (see highlighted section)
- ...The following adverse events were reported by >1 to < 5% of all patients
who received Ditropan XL in the 6 adjustable and fixed dose efficacy and safety studies...
- Infections and Infestations
- Psychiatric Disorders
- Nervous System Disorders
- Eye Disorders
- Cardiac Disorders
- Vascular Disorders
- Respiratory, Thoracic and Mediastinal Disorders
- Gastrointestinal Disorders
- Skin and Subcutaneous Tissue Disorders
- Musculoskeletal and Connective Tissue Disorders
- Renal and Urinary Disorders
- General Disorders and Administration Site Conditions
- Investigations
- Postmarketing Surveillance
- Psychiatric Disorders
- Nervous System Disorders
- Cardiac Disorders
- Vascular Disorders
- Skin and Subcutaneous Tissue Disorders
- Renal and Urinary Disorders
- Injury, Poisoning, and Procedural Complications
|
|
|
|
Effexor (venlafaxine hydrochloride) Tablets
Prescribing Information
|
PRECAUTIONS
- Abnormal Bleeding
- Information for Patients
- Patients should be cautioned about the concomitant use of Effexor and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation...
- Drug Interactions
- Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
|
|
|
|
Effexor XR (venlafaxine hydrochloride)
Extended-Release Capsules
Prescribing Information
|
PRECAUTIONS
- Abnormal Bleeding
- Information for Patients
- Patients should be cautioned about the concomitant use of Effexor XR and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation...
- Drug Interactions
- Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
|
|
|
|
| Lexiva (fosamprenavir calcium) Tablets and Oral Suspension
Prescribing Information (in new labeling format)
|
DRUG INTERACTIONS
- Table 6: Established and Other Potentially Significant Drug Interactions
- Narcotic analgesic
- Methadone
- Data suggest that the interaction is not clinically relevant; however, patients should be monitored for opiate withdrawal symptoms.
|
|
|
|
Methadose Oral Concentrate (methadone hydrochloride oral concentrate USP)
Methadose Sugar-Free Oral Concentrate
(methadone hydrochloride oral concentrate USP)
Prescribing Information
|
PRECAUTIONS
- Information for Patients
- Breastfeeding
- Methadone use is usually compatible with breastfeeding. Pregnant
mothers using methadone should be counseled about the benefits and risks of breastfeeding while using methadone...
|
|
|
|
Nexium (esomeprazole magnesium) Delayed-Release Capsules
Nexium (esomeprazole magnesium) For Delayed-Rlease Oral Suspension
Prescribing Information (in new labeling format) |
DRUG INTERACTIONS
- Concomitant use of atazanavir and proton pump inhibitors is not recommended...
ADVERSE REACTIONS
- Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.
|
|
|
| Tekturna (aliskren) Tablets
Prescribing Information
|
PRECAUTIONS
- Hyperkalemia
- Renal Artery Stenosis
|
|
|
|
Trandate (labetalol hydrochloride) Tablets
Prescribing Information
|
PRECAUTIONS
- Drug Interactions
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
|
|
|
|
|
Viracept (nelfinavir mesylate) Tablets and Oral Powder
Prescribing Information
|
PRECAUTIONS
- Table 11: Established and Other Potentially Significant Drug Interactions
|
Back to Summary Page | Back to Top
|
Brand
(Generic) Name
|
Sections Modified |
|
Forteo teriparatide (rDNA origin) Injection
Prescribing Information
|
ADVERSE REACTIONS
- Postmarketing Reports
- Muscle spasms, such as of the leg or back, are reported commonly (between 1 and 10
patients per 100 patients treated)...
|
|
|
|
MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral Solution
Prescribing Information
|
ADVERSE REACTIONS
- Postmarketing Experience
- General
- Hypersensitivity reactions including anaphylaxis, rash, urticaria, lip and facial swelling, dyspnea, chest tightness and throat tightness.
|
|
|
|
|
VESIcare (solifenacin succinate) Tablets
Prescribing Information |
ADVERSE REACTIONS
- Postmarketing Surveillance
- Cardiovascular
- QT Prolongation
- Torsade de Pointes
|
|
|
Viagra (sildenafil citrate) Tablets
Prescribing Information
|
ADVERSE REACTIONS
|
|
|
|
|
Vytorin (ezetimibe/simvastatin tablets)
Prescribing Information
Patient Package Insert
|
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
- What are the possible side effects of Vytorin?
|
|
|
|
Zetia (ezetimibe) Tablets
Prescribing Information
Patient Package Insert
|
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
- What are the possible side effects of Zetia?
|
Back to Summary Page | Back to Top
|
Brand (Generic) Name
|
Sections Modified |
Avandia (rosiglitazone maleate tablets)
Medication Guide |
MEDICATION GUIDE
- Other Heart Problems
- What is Avanda?
- What are the possible side effects of Avandia?
|
Back to Summary Page | Back to Top
|
|
