Safety labeling changes approved by CDER--April 2007. - Free Online Library
Enjuvia (synthetic conjugated estrogens, B) Tablets BOXED WARNING
Cardiovascular and Other Risks: See highlighted labeling for revised text.
WARNINGS
Cardiovascular Disorders
* Stroke
* Coronary Heart Disease
* Venous Thromboembolism
Malignant Neoplasms
* Breast Cancer
Dementia
PRECAUTIONS
General
* Addition of a progestin when a woman has not had a hysterectomy
* Ovarian Cancer Geriatric Use
ADVERSE REACTIONS
* Table 8
* In a second 12-week clinical trial, 310 women with symptoms of vulvar and vagular atrophy were treated ...
PATIENT PACKAGE INSERT
* What is the most important information I should know about Enjuva (an estrogen hormone mixture)?
* What is Enjuvia?
* What is Enjuvia used for?
* How should I take Enjuva?
* What can I do to lower my chances of a serious side effect with Enjuva?
Fentora (fentanyl buccal tablet)
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 opioid therapy for their underlying persistent cancer pain.
The concomitant use of Fentora with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
PRECAUTIONS
Information for Patients and Caregivers:
* Patients and caregivers should be advised that if they have been receiving treatment with Fentora and the medicine is no longer needed they should flush any remaining product down the toilet ...
DRUG INTERACTIONS
* ... strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug effects including fatal respiratory depression ...
* Grapefruit and grapefruit juice decrease CYP3A4 activity, increasing blood concentrations of fentanyl ...
* Drugs that induce cytochrome P450 3A4 activity may have the opposite effects.
* Concomitant use of Fentora with an MAO inhibitor, or within 14 days of discontinuation, is not recommended.
MEDICATION GUIDE
* What is Fentora?
* How should I use Fentora?
* How should I store Fentora?
Ativan (lorazepam) Tablets
CONTRAINDICATIONS
Ativan (lorazepam) is contraindicated in patients with hypersensitivity to benzodiazepines or to any components of the formulation ...
WARNINGS: Initial Section
* Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam ...
* Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression.
* Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. WARNINGS: Physical and Psychological Dependence See highlighted labeling for revised text.
PRECAUTIONS
* Initial Section
* Clinically Significant Drug Interactions
* Pregnancy
* Nursing Mothers
* Geriatric Use
ADVERSE REACTIONS
Femara (letrozole tablets)
CONTRAINDICATIONS
Femara is contraindicated in women of premenopausal endocrine status.
WARNINGS
Pregnancy
* The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who recently became postmenopausal, until their postmenopausal status is fully established.
ADVERSE REACTIONS
First-Line and Second-Line Breast Cancer
Invirase (saquinavir mesylate) Capsules and Table
CONTRAINDICATIONS
Initial Paragraph
Invirase must be used in combination with ritonavir, which significantly inhibits saquinavir's metabolism and provides increased plasma saquinavir levels.
WARNINGS: Interaction with Fluticasone A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone propionate exposures, resulting in significantly decreased serum cortisol concentrations. Concomitant use of Invirase with ritonavir and fluticasone propionate is expected to produce the same effects. Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported during postmarketing use in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate. Therefore, coadministration of fluticasone propionate and Invirase/ ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
PRECAUTIONS
General
Invirase must be used in combination with ritonavir. Immune Reconstitution Syndrome Drug Interactions:
* Table 5--Garlic Capsules
* Table 6--HIV Protease Inhibitor
** Tipranavir/ritonavir;
* Antifungal
** Ketoconazole
** Intraconazole
* Inhaled/Nasal Steroid
** Fluticasone
* Antidepressant
** Trazodone
* Proton Pump Inhibitors Omeprazole
ADVERSE REACTIONS
Initial Statement: Invirase must be used in combination with ritonavir, which significantly inhibits saquinavir's metabolism to provide increased plasma saquinavir levels.
Additional Adverse Reactions Reported with Saquinavir
PATIENT PACKAGE INSERT
Are there other medications that I should not take with Invirase/Norvir (ritonavir)?
Advicor (niacin extended-release/lovastatin tablets)
WARNINGS
Skeletal Muscle
* Lovastatin
** Potent Inhibitors of CYP3A4
*** Ketolide antibiotic telithromycin added
Use of Advicor with other Drugs
* Gemfibrozil, particularly with higher doses of lovastatin
* Cyclosporine or danazol, with higher doses of lovastatin
WARNINGS: Skeletal Muscle/Lovastatin
Potent inhibitors of CYP3A4: The risk of myopathy appears to be increased by high levels of HMG-CoA reductase inhibitory activity in plasma. Lovastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which share this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. These include cyclosporine, itraconazole, ketoconazole and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, the antidepressant nefazodone, or large quantities of grapefruit juice (>1 quart daily).
WARNINGS: Use of Advicor with other Drugs: Gemfibrozil, particularly with higher doses of lovastatin
... The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with gemfibrozil ...
Cyclosporine or danzaol, with higher doses of lovastatin: In patients taking concomitant cyclosporine, danazol or fibrates, the dose of Advicor should generally not exceed 1000 mg/20 mg, as the risk of myopathy may increase at higher doses. Interruption of Advicor therapy during a course of treatment with a systemic antifungal azole a macrolide antibiotic, or a ketolide antibiotic should be considered.
PRECAUTIONS
Lovastatin
* Endocrine Function
* ... The effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of male patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown ...
* Information for Patients
** ... flushing is a common side effect of niacin therapy that usually subsides ...
Drug Interactions
* Lovastatin
** Serious skeletal muscle disorders, e.g., rhabdomyolysis, have been reported during concomitant therapy of lovastatin or other HMG-CoA reductase inhibitors with cyclosporine, danazol, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, telithromycin, nefazodone or HIV protease inhibitors ...
Baraclude (entecavir) Tablets and Oral Solution
WARNINGS: Exacerbations of Hepatitis After Discontinuation of Treatment
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy.
PATIENT PACKAGE INSERT
General Information
* How Should I Store Baraclude?
* Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Baraclude for a condition for which it was not prescribed. Do not give Baraclude to other people, even if they have the same symptoms you have. It may harm them. The leaflet summarizes the most important information about Baraclude. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Baraclude that is written for healthcare professionals. You can also call 1-800-321-1335 or visit the Baraclude website at www.Baraclude.com.
* Contact Bristol-Myers Squibb Company at 1800-321-1335 for prescribing information and patient package insert.
Exjade (deferasirox) Tablets for Oral Suspension
See MedWatch Safety Alert posted 5/22/2007 for additional information on Exjade labeling revisions.
WARNINGS: Renal
Cases of acute renal failure, some with a fatal outcome, have been reported following the postmarketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders. Particular attention should be given to monitoring serum creatinine in patients who: are at increased risk of complications, have preexisting renal conditions, are elderly, have co-morbid conditions, or are receiving medicinal products that depress renal function ...
WARNINGS: Cytopenias
There have been postmarketing reports (both spontaneous and from clinical trials) of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia, in patients treated with Exjade. Some of these patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure. In line with the standard clinical management of such hematological disorders, blood counts should be monitored regularly. Interruption of treatment with Exjade should be considered in patients who develop unexplained cytopenia. Reintroduction of therapy with Exjade may be considered, once the cause of the cytopenia has been elucidated.
ADVERSE REACTIONS
Post-marketing Experience
Levitra (vardenafil HCl) Tablets
WARNINGS: Effect of Co-administration of Potent CYP3A4 Inhibitors
... Patients taking indinavir, saquinavir, atazanavir or other potent CYP3A4 inhibitors such as clarithromycin, ketoconazole 400 mg daily, or itraconazole 400 mg daily, should not exceed a dose of Levitra 2.5 mg once daily. For patients taking ketoconazole 200 mg daily or itraconazole 200 mg daily, a single dose of 5 mg Levitra should not be exceeded in a 24-hour period ...
PRECAUTIONS
* Congenital or Acquired QT Prolongation
* Drug Interactions
** Other CYP3A4 Inhibitors
PATIENT PACKAGE INSERT
Can Other Medications Affect Levitra?
Minocin (minocycline hydrochloride) Pellet-Filled Capsules
WARNINGS: Clostridium difficile associated diarrhea (CDAD)
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Minocin, 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 ...
... 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.
PRECAUTIONS
Information for Patients
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Sarafem (fluoxetine hydrochloride tablets) ee MedWatch Safety Alert posted on 7/19/2006 which discusses SSRIs and Treatment Challenges of Depression in Pregnancy.
WARNINGS: Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including Sarafem treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms 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). The concomitant use of Sarafem with MAOIs intended to treat depression is contraindicated ...
If concomitant treatment of Sarafem with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases ...
The concomitant use of Sarafem with serotonin precursors (such as tryptophan) is not recommended ...
PRECAUTIONS
Information for Patients
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Sarafem and triptans, tramadol or other serotonergic agents. Drug Interactions
** Drugs metabolized by CYP2D6
** Serotonergic Drugs
** Triptans
Pregnancy
** Nonteratogenic Effects
** Pulmonary hypertension of the newborn (PPHN)
... Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Zerit (stavudine) Capsules
Zerit (stavudine) for Oral Solution
WARNINGS: Hepatic Impairment and Toxicity/ Use with Didanosine and Hydroxyurea Based Regimens An increased risk of hepatotoxicity may occur in patients treated with Zerit in combination with didanosine and hydroxyurea compared to when Zerit is used alone. Deaths attributed to hepatotoxicity have occurred in patients receiving this combination. This combination should be avoided.
PRECAUTIONS
Patient Information
An increased risk of hepatotoxicity, which may be fatal, may occur in patients treated with Zerit in combination with didanosine and hydroxyurea. This combination should be avoided.
PATIENT PACKAGE INSERT
What are the possible side effects of Zerit?
The combination of Zerit, didanosine, and hydroxyurea may increase your risk for liver damage, which may cause death. This combination should be avoided.
Zyvox (linezolid) Injection and Tablets
Zyvox (Iinezolid) for Oral Suspension
WARNINGS: Clostridium difficile associated diarhea (CDAD)
Clostridium difficile associated diarhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zyvox, 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 diarhea 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. difcile[] 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.
PRECAUTIONS
Convulsions
In some of these cases, a history of seizures or risk factors for seizures was reported.
Information for Patients
Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued ...
Pregnancy
Teratogenic Effects, Pregnancy Category C
Non-teratogenic Effects
Animal Pharmacology
Actonel (risedronate sodium tablets)
PRECAUTIONS
Information for Patients
ADVERSE REACTIONS
Daily Dosing
Osteoporosis
Laboratory Test Findings
Once-a-week Dosing
Laboratory Test Findings
Monthly Dosing (new)
Table 7
Acute Phase Reactions
Gastrointestinal Adverse Events
Ocular Adverse Events
Laboratory Test Findings
Paget's Disease
Ocular Adverse Events
PATIENT PACKAGE INSERT
How should I take Actonel?
What is my Actonel schedule?
If your doctor has prescribed Actonel 75 mg
Two Consecutive Days each Month ...
What are the ingredients of Actonel?
Apidra (insulin glulisine [rDNA origin] injection)
PRECAUTIONS
* General
* Laboratory Tests
* Mixing of Insulins
PATIENT PACKAGE INSERT(S) See highlighted labeling for revised text.
Aranesp (darbepoetin alfa) for Injection
PRECAUTIONS
General
* The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
PATIENT PACKAGE INSERT
What are the possible or reasonably likely side effects of Aranesp?
The needle cover on the prefilled syringe contains a derivative of latex. If you know you are allergic to latex, talk to your healthcare provider before using Aranesp.
Asacol (mesalamine) Delayed Release Tablets
Contact Procter & Gamble Pharmaceuticals, Inc. at 1-800-836-0658 for prescribing information.
PRECAUTIONS
Renal
Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy
ADVERSE REACTIONS
Body as a Whole
Drug Fever (rare)
Urogenital
Renal Failure (rare)
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
PRECAUTIONS
Pregnancy
Pregnancy Category C
Human Data
Rosiglitazone maleate
Animal Stuides
ADVERSE REACTIONS
Post-marketing Experience
Rash
Pruritus
Anaphylactic Reaction
Avandia (rosiglitazone maleate) Tablets
PRECAUTIONS
Pregnancy
Pregnancy Category C
Human Data
Animal Studies
ADVERSE REACTIONS
Adult
Post-marketing Experience
Rash
Pruritus
Anaphylactic Reaction
Azmacort (triamcinolone acetonide) Inhalation Aerosol
PRECAUTIONS
Initial Paragraph
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients ...
Pediatric Use
ADVERSE REACTIONS
... Cases of growth suppression have been reported for orally inhaled corticosteroids ...
BAL in Oil Ampules (dimercaprol injection, USP)
PRECAUTIONS
BAL in Oil Ampules is formulated with peanut oil. Peanut oil may cause allergic reactions in some individuals ...
IV Busulfex (busulfan) Injection
PRECAUTIONS
Special Populations
Pediatrics
... One patient who died on day +20 had not recovered to an ANC > 0.5 x 109/L ...
ADVERSE REACTIONS
Edema
Patients receiving allogenic transplant exhibited some form of edema (79%), hypervolemia, or documented weight increase (8%); all events were reported as mild or moderate.
Cardiovascular
Third-Degree Heart Block
Carafate (sucralfate) Suspension
PRECAUTIONS
Geriatric Use
Carafate (sucralfate) Tables
PRECAUTIONS
Geriatric Use
Cardizem LA (diltiazem hydrochloride) Extended Release Tablets
PRECAUTIONS
Drug Interactions
Bispirone
Quinidine
Focalin (dexmethylphenidate hydrochloride) Tablets
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Focalin XR (dexmethylphenidate hydrochloride) Extended- Release Capsules
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Fortamet (metformin hydrochloride) Extended-Release Tablets
PRECAUTIONS
Information for Patients
... Fortamet must be swallowed whole and not chewed, cut, or crushed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet ...
PATIENT PACKAGE INSERT
How do I take Fortamet
Fortamet tablets should not be cut, crushed, or chewed and should be taken whole with a full glass of water once daily with the evening meal ...
Isoniazid Tablets, USP
PRECAUTIONS
Drug Interactions
Food
... Tyramine-and histamine-containing foods should be avoided in patients receiving isoniazid. Because isoniazid has some monoamine oxidase inhibiting activity, an interaction with tyramine-containing foods (cheese, red wine) may occur. Diamine oxidase may also be inhibited, causing exaggerated response (e.g., headache, sweating, palpitations, flushing, hypotension) to foods containing histamine (e.g., skipjack, tuna, other tropical fish).
Lantus (insulin glargine [rDNA origin] injection)
PRECAUTIONS
Drug Interactions
PATIENT PACKAGE INSERT (new)
Mevacor (lovastatin) Tablets
PRECAUTIONS
Pregnancy
Pregnancy Category X
Nexium (esomeprazole magnesium) Delayed-Release Capsules
Nexium (esomeprazole magnesium) for Delayed-Release Oral Suspension
PRECAUTIONS
Drug Interactions
Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure ...
Nexium I.V. (esomeprazole sodium) for Injection
PRECAUTIONS
Drug Interactions
Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure ...
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container
PRECAUTIONS
General
Initial Paragraph
Prilosec (omeprazole) Delayed-Release Capsules
PRECAUTIONS
Drug Interactions
Other
Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure. Dose adjustment of omeprazole is not normally required. However, in patients with Zollinger-Ellison's syndrome, who may require higher doses up to 240 mg/day, dose adjustment may be considered..
Remicade (infliximab) for IV Injection
PRECAUTIONS
Pediatric Use
Juvenile Rheumatoid Arthritis
Ritalin hydrochloride (methylphenidate hydrochloride tablets, USP)
Ritalin-SR (methylphenidate hydrochloride, USP sustained-release tablets)
Medication Guides:
Ritalin (methylphenidate hydrochloride tablets, USP)
Ritalin-SR (methylphenidate hydrochloride, USP) Sustained-Release Tablets
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDES (new)
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules
PRECAUTIONS
Information for Patients
Daily administration of Singulair for the chronic treatment of asthma has not been established to prevent acute episodes of exercise-induced bronchoconstriction.
PATIENT PACKAGE INSERT
What is Singulair?
Prevention of exercise-induced asthma
How should I take Singulair?
For patients 15 years of age and older for the prevention of exercise-induced asthma ... What is the dose of Singulair?
For exercise-induced asthma ...
What is exercise-induced asthma?
Strattera (atomoxetine HCl) Capsules
PRECAUTIONS
General
Effects on Blood Pressure and Heart Rate
Orthostatic hypotension and syncope ...
Peripheral Vascular Effects
Aggressive Behavior or Hostility (new)
Priapism
Information for Patients
Occular Irritant
Rare post-marketing cases of priapism ...
ADVERSE REACTIONS
Child and Adolescent Clinicial Trials
Seizures (new)
Adult Clinical Trials
Seizures (new)
Post-marketing Spontaneous Reports (new)
Cardiovascular System
QT Prolongation
Syncope
Seizures
MEDICATION GUIDE
What is the most important information I should know about Strattera?
Suicidal thoughts and actions in children and teenagers
Severe liver damage
Heart-related problems
New mental (psychiatric) problems in children and teenagers
What Is Strattera?
Who should not take Strattera?
Can Strattera be taken with other medications?
How should Strattera be taken?
What are possible side effects of Strattera?
How should I store Strattera?
General Information about Strattera
What are the ingredients in Strattera?
Symbyax (olanzapine and fluoxetine HCl capsules)
PRECAUTIONS
Nursing Mothers
Olanzapine
In a study in lactating healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1.8% of the maternal olanzapine dose.
Tarceva (erlotinib) Tablets
PRECAUTIONS
Drug Interactions
... grapefruit or grapefruit juice
Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3 to 4/5, which is equivalent to a dose of about 30 to 50 mg in NSCLC patients. Use of alternative treatments lacking CYP3A4 inducing activity is strongly recommended. If an alternative treatment is unavailable, adjusting the starting dose should be considered ...
Renal Failure (new)
Information for Patients
Smokers should be advised to stop smoking ...
ADVERSE REACTIONS
Table 5 (title revised)
NSCLC and Pancreatic Indications
... Cases of acute renal failure or renal insufficiency, including fatalities, with or without hypokalemia have been reported ...
Viramune (nevirapine) Tablets and Oral Suspension
PRECAUTIONS
Drug Interactions
Table 3
Lopinavir/Ritonavir
Methadone
Immune Reconstitution Syndrome
Information for Patients
Pregnancy: Pregnancy Category B [change in Pregnancy Category C to B]
ADVERSE REACTIONS
Pediatric Patients
In post-marketing surveillance anemia has been more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out ...
Combivir (lamivudine/zidovudine) Tablets
ADVERSE REACTIONS
Pancreatitis was observed in 9 of the 2,613 adult patients (0.3%) who received Epivir in controlled clinical trials. DepoCyt (cytarabine liposome injection) for Intrathecal Use Only
ADVERSE REACTIONS
Initial Section
Table 2
Table 3
Fosamax Plus D (alendronate sodium/ cholecalciferol) Tablets (in new labeling format)
ADVERSE REACTIONS
Clinical Trials Experience
Laboratory Test Findings
Fosamax Plus D
... In the 24-week double-blind extension study in women (n=619) and men (n=33), the safety profile of Fosamax Plus D (70 mg/2800 IU) administered with an additional 2800 IU vitamin D3 was similar to that of Fosamax Plus D (70 mg/2800 IU).
PATIENT COUNSELING INFORMATION
Osteoporosis Recommendations, including Calcium and Vitamin D Supplementation
Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) ...
PATIENT PACKAGE INSERT
What is Fosamax Plus D?
Fosamax Plus D should not be used to treat vitamin D deficiency.
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution
ADVERSE REACTIONS
Adults
Treatment-Emergent Adverse Events
Table 11
Study 720 [results updated]
Body as a Whole
Neoplasm
Cardiovascular System
Myocardial Infarct
Digestive System
Hepatomegaly
Liver Fatty Deposit
Liver Tenderness
Musculoskeletal System
Joint Disorder
Myasthenia
Nervous System
Extrapyramidal Syndrome
Respiratory System
Cough Increased
Skin Appendages
Skin Striae
Urogenital System
Impotence
Laboratory Abnormalities--Table 13
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
ADVERSE REACTIONS
Adults
Treatment-Emergent Adverse Events
Table 11--Study 720 [results updated]
Body as a Whole
Neoplasm
Cardiovascular System
Myocardial Infarct
Digestive System
Hepatomegaly
Liver Fatty Deposit
Liver Tenderness
Musculoskeletal System
Joint Disorder
Myasthenia
Nervous System
Extrapyramidal Syndrome
Respiratory System
Cough Increased
Skin Appendages
Skin Striae
Urogenital System
Impotence
Laboratory Abnormalities--Table 13
Methergine (methylergonovine maleate) Tablets and Injection, USP
ADVERSE REACTIONS
Arterial Spasm (Coronary and Peripheral)
Bradycardia
Tachycardia
Rash
Prialt (ziconotide intrathecal infusion)
ADVERSE REACTIONS
See highlighted labeling for revised text.
Rebetol (ribavirin, USP) Capsules and Oral Solution
ADVERSE REACTIONS
Post-marketing Experiences (new)
Solage (mequinol 2%, tretinoin 0.01%) Topical Solution
ADVERSE REACTIONS
Initial Section
Table: Adverse Events Occurring in >1% of the Population --All Studies
PATIENT PACKAGE INSERT (new)
EC-Naprosyn (naproxen delayed-release tablets)
Naprosyn (naproxen tablets)
Anaprox/Anaprox DS (naproxen sodium tablets)
Naprosyn (naproxen suspension)
MEDICATION GUIDE
NSAID Medicines that need a prescription: Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack
NicoDerm CQ (nicotine transdermal system)
Over-the-Counter Drug Product
PATIENT PACKAGE INSERT
Some Important Warnings
When using this product: To avoid possible burns, remove the patch before undergoing any MRI (magnetic resonance imaging) procedures (for opaque NicoDerm CQ patch only).
How to Use Nicoderm CQ Patches: When to apply and remove NicoDerm CQ patches ... To avoid possible burns, remove the patch before undergoing any MRI (magnetic resonance imaging) procedures (for opaque NicoDerm CQ patch only).