General

Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. Most of these reports involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have been contributory.
Fluconazole in Sodium Chloride Injection, USP should be administered with caution to patients with these potentially proarrhythmic conditions.
Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsade de pointes) and consequently sudden heart death. This combination should be avoided. 
Fluconazole should be administered with caution to patients with renal dysfunction. 
Fluconazole is a potent…

14.1 Hypertension
The antihypertensive effects of irbesartan were examined in 7 placebo-controlled 8- to 12-week trials in patients with baseline diastolic blood pressures of 95 to 110 mmHg. Doses of 1 to 900 mg were included in these trials in order to fully explore the dose-range of irbesartan. These studies allowed comparison of once or twice-daily regimens at 150 mg/day, comparisons of peak and trough effects, and comparisons of response by sex, age, and race. Two of the seven placebo-controlled trials identified above examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination.
The 7 studies of irbesartan monotherapy included a total of 1915 patients randomized to irbesartan (1–900 mg) and 611 patients randomized to placebo. Once-daily doses of 150 mg and…

For external use only. Flammable, Keep away from heat or flame.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

In case of eye contact flush thoroughly with water for at least 15 seconds.

Keep out of reach of children. If swallowed, give copious amounts of water to dilute and seek medical attention immediately. Children age 6 and under should be supervised
…

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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=04561ae0-b511-485f-abad-cfc68adc5828 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…

Water(Aqua), Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E), Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Parfum.

May Contain:

Yellow 5 Lake (CI 19140), Red 34 (CI 15880), Red 6 Lake (CI 15850), Ferric Ferrocyanide (CI 77510). …

Each 375 mg Chlorzoxazone Tablet USP contains: chlorzoxazone USP, 375 mg.
Each 750 mg Chlorzoxazone Tablet USP contains: chlorzoxazone USP, 750 mg.
Chemical Name: 5-Chloro-2-benzoxazolinone.
Structural Formula:

Molecular Formula: C7H4ClNO2

Molecular Weight: 169.56 g/mol
Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder.
Chlorzoxazone USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia.
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium benzoate. …

The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.

Adults:

The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

Pediatric Patients:

For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours. Children weighing 45 kg or more should receive the adult…

The following serious adverse reactions are described below and elsewhere in the labeling:

Hepatic failure [see Warnings and Precautions (5.1)]

Birth defects [see Warnings and Precautions (5.2)]

Decreased IQ following in utero exposure [see Warnings and Precautions (5.3)]

Pancreatitis [see Warnings and Precautions (5.5)]

Hyperammonemic encephalopathy [see Warnings and Precautions (5.6, 5.9, 5.10)]

Suicidal behavior and ideation [see Warnings and Precautions (5.7)]

Bleeding and other hematopoietic disorders [see Warnings and Precautions (5.8)]

Hypothermia [see Warnings and Precautions (5.11)]

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions [see Warnings and Precautions (5.12)]

Somnolence in the elderly [see Warnings and Precautions (5.14)]

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical…

Metformin Hydrochloride Extended-Release Tablets, USP (met for′ min hye″ droe klor′ ide)

Read the Patient Information that comes with metformin hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about metformin hydrochloride extended-release tablets?

Serious side effects can happen in people taking metformin hydrochloride extended-release tablets, including:

Lactic Acidosis. Metformin hydrochloride, the medicine in metformin hydrochloride extended-release tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is…