VERAPAMIL HYDROCHLORIDE capsule, delayed release pellets [Actavis Pharma, Inc.]

Serious adverse reactions are uncommon when verapamil HCl therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil.
In clinical trials involving 285 hypertensive patients on verapamil hydrochloride sustained-release capsules for greater than 1 week the following adverse reactions were reported in greater than 1.0% of the patients: In clinical trials of other formulations of verapamil HCl (N=4,954) the following reactions have occurred at rates greater than 1.0%: In clinical trials related to the control of ventricular response in digitalized…

DIFLORASONE DIACETATE ointment [Innovida Pharmaceutique Corporation]

General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis…

CVS ADULT ENEMA (docusate sodium w/benzocaine) liquid [Summit Pharmaceuticals]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages? Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. …

CLOPIDOGREL BISULFATE tablet [PD-Rx Pharmaceuticals, Inc.]

Medication Guide     

Clopidogrel (kloe PID oh grel) Tablets, USP

Read this Medication Guide before you start taking clopidogrel tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about clopidogrel tablets?

1. Clopidogrel tablets  may not work as well in people who:

have certain genetic factors that affect how the body breaks down clopidogrel tablets. Your doctor may do genetic tests to make sure clopidogrel tablets are right for you.

take certain medicines, especially omeprazole (Prilosec®) or esomeprazole (Nexium®). Your doctor may change the medicine you take…

FEXOFENADINE HYDROCHLORIDE tablet, film coated [PD-Rx Pharmaceuticals, Inc.]

To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=03b74881-408d-496a-a717-92e8191eebba To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such…

MUCINEX DM (guaifenesin and dextromethorphan hydrobromide) tablet, extended release [ATLANTIC BIOLOGICALS CORP]

NDC 17856-0056-1
Mucinex DM600 mg guaifenesin & 30 mg dextromethorphan HBrextended-release bi-layer tablets
EXPECTORANT & COUGH SUPPRESSANT
12HOUR
✓Controls Cough✓Thins and Loosens Mucus✓Immediate and Extended Release
20EXTENDED-RELEASEBI-LAYER TABLETS
Distributed by:Atlantic BiologicalsMiami, Fl 33179

ZIPRASIDONE HYDROCHLORIDE capsule [REMEDYREPACK INC.]

6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical trials for oral ziprasidone included approximately 5,700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5,700, over 4,800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1,831 patient-years. These patients include: (1) 4,331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1,698 patient-years of exposure as of February 5, 2000, and (2) 472 patients who participated in bipolar mania trials…

METHYLDOPA tablet, film coated [Accord Healthcare Inc.]

Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia, or weakness may be noted as early and transient symptoms. However, significant adverse effects due to methyldopa have been infrequent and this agent usually is well tolerated.
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

Cardiovascular: Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus hypersensitivity, orthostatic hypotension (decrease daily dosage), edema or weight gain, bradycardia.

Digestive: Pancreatitis, colitis, vomiting, diarrhea, sialadenitis, sore or “black” tongue, nausea, constipation, distension, flatus, dryness of mouth.

Endocrine: Hyperprolactinemia.

Hematologic: Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia; positive tests for antinuclear antibody, LE cells, and…

HYDROCHLOROTHIAZIDE tablet [Bryant Ranch Prepack]

General
All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present or after prolonged therapy.
Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the…

ATORVASTATIN CALCIUM tablet, film coated [Bryant Ranch Prepack]

14.1Prevention of Cardiovascular Disease
In the Anglo-Scandinavian Cardiac Outcomes Trial(ASCOT), the effect of atorvastatin calcium on fatal and non-fatal coronary heart disease was assessed in 10,305 hypertensive patients 40 to 80 years of age (mean of 63 years), without a previous myocardial infarction and with TC levels ≤251 mg/dL (6.5 mmol/L). Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81.1%), age >55 years (84.5%), smoking (33.2%), diabetes (24.3%), history of CHD in a first-degree relative (26%), TC: HDL >6 (14.3%), peripheral vascular disease (5.1%), left ventricular hypertrophy (14.4%), prior cerebrovascular event (9.8%), specific ECG abnormality (14.3%), proteinuria/albuminuria (62.4%). In this double-blind, placebo-controlled study, patients were treated with anti-hypertensive therapy (Goal BP <140/90 mm…