Brand (Generic) Name | Sections Modified | Summary of Changes to Contraindications and Warnings | Fludara (fludarabine phosphate), 50 milligrams, for intravenous injection Prescribing Information | BOXED WARNING WARNINGS PRECAUTIONS | BOXED WARNING - ....including coma, seizures, agitation and confusion,.....
WARNINGS - ....Similar severe central nervous system toxicity, including coma,......
- Pregnancy Category D
- on its mechanism of action, fludarabine phosphate can cause fetal harm ...
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| Novantrone (mitoxantrone HCl) Injection Prescribing Information | BOXED WARNING WARNINGS PATIENT PACKAGE INSERT - What is the most important information I should know about NOVANTRONE?
- What are the possible side effects of NOVANTRONE?
| BOXED WARNING - Cardiotoxicity: Congestive heart failure (CHF), potentially fatal, may occur either during therapy with NOVANTRONE or months to years after termination of therapy. Cardiotoxicity risk increases with cumulative NOVANTRONE dose and may occur whether or not cardiac risk factors are present.......
WARNINGS - Cardiac Effects
- Multiple Sclerosis
- Changes in cardiac function may occur in patients with multiple sclerosis treated with NOVANTRONE. In one controlled study.......MS patients should be assessed for cardiac signs and symptoms by history, physical examination, ECG, and quantitative LVEF evaluation using appropriate methodology....
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Back to Summary Page | Back to Top Brand (Generic) Name | Sections Modified | Summary of Changes to Contraindications and Warnings | Furadantin (nitrofurantoin) Oral Suspension Prescribing Information | CONTRAINDICATIONS | CONTRAINDICATIONS - Furadantin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.
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Back to Summary Page | Back to Top Brand (Generic) Name | Sections Modified | Summary of Changes to Contraindications and Warnings | Heparin Sodium in 5% Dextrose Injection Heparin Sodium in 0.9% Sodium Chloride Injection The latest label is not available on this site | WARNINGS - Fatal Medication Errors
- Thrombocytopenia
- Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis
- Delayed Onset of HIT and HITT
- Use in Neonates
PRECAUTIONS ADVERSE REACTIONS - Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT), Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT
| WARNINGS - Fatal Medication Errors
- Heparin is supplied in a wide range of strengths. Fatal hemorrhages have occurred in infants and pediatric patients ....
- Thrombocytopenia
- ...of up to 30%. Platelet counts
should be obtained at baseline....
- Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis
- Delayed Onset of HIT and HITT
- Use in Neonates
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| | Implanon (etonogestrel implant) 68 mg Prescribing Information | WARNINGS - Complications of Insertion and Removal
| WARNINGS - Complications of Insertion and Removal
- IMPLANON should be inserted subdermally so that it is palpable after insertion....
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| Luvox (fluvoxamine maleate) Tablets Luvox CR (fluvoxamine maleate) Extended-release Capsules Prescribing Information | WARNINGS - Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
| WARNINGS - The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Luvox treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists.....
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| Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mg Prograf (tacrolimus) Injection, 5 mg/ml Prescribing Information | WARNINGS - Nephrotoxicity
- Neurotoxicity
- Latent Viral Infections
- Prograf in Combination with MMF or Sirolimus
| WARNINGS - Nephrotoxicity
- can cause nephrotoxicity, particularly when used in high doses...
- Neurotoxicity
- can cause neurotoxicity, particularly when used in high doses
- Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES)...
- Latent Viral Infections
- Immunosuppressed patients are at increased risk for opportunistic infections...
- Prograf in Combination with MMF or Sirolimus
- In one randomized, open-label, multi-center trial... A safe and effective dosing regimen of MMF in combination with Prograf has not been established in kidney transplantation.
- The use of full-dose Prograf with sirolimus (2 mg per day) in heart transplant recipients...
PRECAUTIONS - Other Drug Interactions
- a second paragraph added...At a given MMF dose, mycophenolic acid (MPA) exposure is higher with Prograf co-administration than with cyclosporine co-administration...
ADVERSE REACTIONS - Urogenital
- Post Marketing/Nervous System
- posterior reversible encephalopathy syndrome (PRES), progressive multifocal
leukoencephalopathy (PML)
- Post Marketing/Respiratory
- interstitial lung disease
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| Toprol XL (metoprolol succinate) 25 mg, 50 mg, 100 mg, and 200 mg Extended Release Tablets Prescribing Information | WARNINGS | WARNINGS - Pheochromocytoma
- If Toprol-XL is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated....
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| | Tracleer (bosentan) 62.5 and 125 mg Tablets Prescribing Information Medication Guide | WARNINGS ADVERSE REACTIONS - Post-Marketing Experience
| WARNINGS - Decreased Sperm Counts
- An open-label, single arm, multicenter, safety study evaluated the effect on testicular function of TRACLEER.....Based on these findings and preclinical data from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as TRACLEER have an adverse effect on spermatogenesis
MEDICATION GUIDE - What are the possible side effects of Tracleer
- Sperm Count Reduction
- Reduced sperm counts have been observed ....
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| Zerit (stavudine) Capsules, 15 mg, 20 mg, 30 mg and 40 mg Zerit (stavudine) Powder for Oral Solution, 1mg/mL Prescribing Information | WARNINGS - Hepatic Impairment and Toxicity
- deletion... use with Didanosine and Hydroxyurea Based Regimen
| WARNINGS - Hepatic Impairment and Toxicity
- ...this combination should be avoided
ADVERSE REACTIONS - Use with Didanosine- and Hydroxyurea-Based Regimens
- ...explaining the potential hepatoxicity, pancreatitis, and peripheral neuropathy with didanosine and hydroxyurea was revised and moved from the Adults subsection to Observed During Clinical Practice
PATIENT PACKAGE INSERT - What are the possible side effects of ZERIT?
- Deletion Zerit, didanosine, and hydroxyurea combination
- Deletion of "with or without hydroxyurea" in the subsection Pancreatitis
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Back to Summary Page | Back to Top | Brand (Generic) Name | Sections Modified | Altace (ramipril) 1.25, 2.5, 5, and 10 Capsules Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets Prescribing Information | PRECAUTIONS - Drug Interactions
- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including ALTACE.
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| | Amaryl (glimepiride) Tablets Prescribing Information | PRECAUTIONS - General
- Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction...
- Drug Interactions
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| | Capozide (captopril/hydrochlorothiazide) 25/15, 50/15, 25/25, 50/25 mg Tablets The latest label (approved 02/26/2009) is not available on this site | PRECAUTIONS - Drug Interactions
- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including CAPOZIDE.
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| | Casodex (bicalutamide) Tablets Prescribing Information | PRECAUTIONS ADVERSE REACTIONS - (6.2) Postmarketing Experience
- reduction in glucose tolerance....
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| | Comtan (entacapone) Tablets Prescribing Information | PRECAUTIONS - Melanoma
- Information for Patients
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| | Monopril (fosinopril sodium) 10, 20, and 40 mg Tablets Monopril HCT (fosinopril/hydrochlorothiazide) 20/12.5mg and 10/12.5mg Tablets The latest label (approved 02/09/2009) is not available on this site | PRECAUTIONS - Drug Interaction
- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and
hypotension) have been reported rarely in patients on therapy with injectable gold (sodium
aurothiomalate) and concomitant ACE inhibitor therapy including MONOPRIL/ MONOPRIL HCT.
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| | Noxafil (posaconazole) Oral Suspension, 40mg/mL Prescribing Information | PRECAUTIONS - Information for Patients
- ...advised to take each dose of NOXAFIL Oral Suspension during or immediately (i.e. within 20 minutes) following a full meal.....
- Drug Interactions
- Table 8
- Esomeprazole and Metoclopramide....monitor closely for breakthrough fungal infections
PATIENT PACKAGE INSERT - How do I take Noxafil?
- Take each dose of NOXAFIL with during or immediately (i.e. within 20 minutes) following a full meal, or with a liquid nutritional supplement if you are unable to eat a full meal. Alternatively, NOXAFIL may be taken with an acidic carbonated beverage (e.g. gingerale)
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| | | Revlimid (lenalidomide) Capsules Prescribing Information | PRECAUTIONS - Renal Impairment
- Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. See DOSAGE AND AMINISTRATION.
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| | | Roxicodone (Oxycodone Hydrochloride Tablets USP) Prescribing Information | PRECAUTIONS - Carcinogenicity, Mutagenesis, and Impairment of Fertility
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| | Stalevo (levodopa/carbidopa/entacapone) Tablets 200/50/200 mg The latest approved label is not available on this site | PRECAUTIONS - Melanoma
- Information for Patients
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| | Symmetrel (amantadine hydrochloride) Syrup and Tablets The latest approved label is not available on this site | PRECAUTIONS - Melanoma
- Information for Patients
ADVERSE REACTIONS - Miscellaneous section
- addition of impulse control disorder
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| | | Tasmar (tolcapone) Tablets Prescribing Information | PRECAUTIONS - Melanoma
- Information for Patients
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| | | Xenical (orlistat) Capsules, 120 mg Prescribing Information | PRECAUTIONS - Drug Interactions
- Levothyroxine
- Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine.....
ADVERSE REACTIONS - Other Clinical Studies or Postmarketing
Surveillance - Hypothyroidism has been reported in patients treated concomitantly with orlistat and
levothyroxine.
PATIENT PACKAGE INSERT - What should I tell my doctor before taking XENICAL?
- make sure your doctor knows if you are taking thyroid medicine....
- Can I take XENICAL while taking other medications?
- ..... XENICAL and levothyroxine should be taken at least 4 hours apart
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| | Zantac 150/300 (ranitidine hydrochloride) Tablets, Zantac (ranitidine hydrochloride) Syrup, USP; Zantac 25/150 (ranitidine hydrochloride) EFFERdose Tablets and 150 (ranitidine hydrochloride effervescent) Granules Zantac (ranitidine hydrochloride) Injection and Injection Bulk Pharmacy Pack Zantac (ranitidine hydrochloride) Injection Premixed The latest label (approved 02/17/2009) is not available on this site | PRECAUTIONS - Drug Interactions
- Inhibition....
- Competition....
- Alteration....
- Midazolam
- ...in another interaction study in 8 volunteers receiving IV midazolam, a 300 mg oral dose of ranitidine increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when ranitidine is coadministered with oral midazolam
ADVERSE REACTIONS - Other
- the addition of "acute interstitial nephritis".
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| | Zithromax (azithromycin) 200 mg Tablets Zithromax (azithromycin) 500 mg Tablets Zithromax (azithromycin) IV The latest label (approved 02/27/2009) is not available on this site | PRECAUTIONS - General
- Exacerbations of symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy.
- Drug Interactions
- ...study of 22 healthy men, a 5-day course of azithromycin did not affect the prothrombin time from a subsequently administered dose of warfarin, spontaneous post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
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Back to Summary Page | Back to Top | Brand (Generic) Name | Sections Modified | Arthrotec (diclofenac sodium and misoprostol) Tablets Prescribing Information | ADVERSE REACTIONS - (addition of risk of elevations in liver enzymes associated with the use of diclofenac)
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| | Baraclude (entecavir) tablets and oral solution Prescribing Information | ADVERSE REACTIONS - Postmarketing Experience section
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| | Cataflam (diclofenac potassium immediate-release tablets) Prescribing Information | ADVERSE REACTIONS - (addition of risk of elevations in liver enzymes associated with the use of diclofenac)
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| | Cedax (ceftibuten capsules) 400 mg Cedax (ceftibuten for oral suspension) 18 mg/mL Prescribing Information | ADVERSE REACTIONS - Post-marketing
- ..... Stevens-Johnson Syndrome
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| | Emend (aprepitant) capsules 40 mg, 80 mg, and 125 mg Emend (fosaprepitant dimeglumine) for Injection, 115 mg/mL Prescribing Information | ADVERSE REACTIONS - Post-Marketing Experience
- pruritus, rash, urticaria; hypersensitivity reactions including anaphylactic reactions
PATIENT PACKAGE INSERT - What are the possible side effects of EMEND?
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| | Voltaren-XR (diclofenac sodium extended-release tablets) Voltaren (diclofenac sodium enteric-coated tablets) Prescribing Information | ADVERSE REACTIONS - (addition of risk of elevations in liver enzymes associated with the use of diclofenac)
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