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puracap laboratories llc dba blu pharmaceuticals - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - sulindac 150 mg - carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. osteoarthritis 2. rheumatoid arthritis** 3. ankylosing spondylitis 4. acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) 5. acute gouty arthritis **the safety and effectiveness of sulindac tablets usp have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care). sulindac is contraindicated in patients with known hypersensitivity to sulindac or the excipients (see description ). sulindac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic/anaphylactoid reactions to nsaids have been reported in such patients (see warnings – anaphylactic/anaphylactoid reactions , and precautions – preexisting asthma ). sulindac is contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

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puracap laboratories llc dba blu pharmaceuticals - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride capsule is recommended for the treatment of: the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in children under 12 years of age. doxepin hydrochloride is contraindicated in individuals who have shown hypersensitivity to the drug. possibility of cross sensitivity with other dibenzoxepines should be kept in mind. doxepin hydrochloride is contraindicated in patients with glaucoma or a tendency to urinary retention. these disorders should be ruled out, particularly in older patients.

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puracap laboratories llc dba blu pharmaceuticals - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., rifater® (sanofi-aventis u.s. llc)) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimina

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puracap laboratories llc dba blu pharmaceuticals - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , serratia marcescens , proteus mirabilis , providencia rettgeri , morganella morganii , citrobacter koseri , citrobacter freundii , pseudomonas aeruginosa , methicillin-susceptible staphylococcus epidermidis , staphylococcus saprophyticus , or enterococcus faecalis . ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by esche

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puracap laboratories llc dba blu pharmaceuticals - flavoxate hydrochloride (unii: 9c05j6089w) (flavoxate - unii:3e74y80mey) - flavoxate hydrochloride 100 mg - flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections. flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

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puracap laboratories llc dba blu pharmaceuticals - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 1 mg - guanfacine hydrochloride tablets are indicated in the management of hypertension. guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine hydrochloride tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine.

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puracap laboratories llc dba blu pharmaceuticals - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 20 mg - nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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puracap laboratories llc dba blu pharmaceuticals - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - diltiazem hydrochloride extended-release capsules usp (once-a-day dosage) are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive medications. diltiazem hydrochloride extended-release capsules usp (once-a-day dosage) are indicated for the treatment of chronic stable angina. diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

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puracap laboratories llc dba blu pharmaceuticals - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1. treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. drug therapy is not indicated for patients with type i hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (vldl). inspection of plasma refrigerated for 14 hours is helpful in distinguishing types i, iv, and v hyperlipoproteinemia. 2. reducing the risk of developing coronary heart disease only in type iib patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce ldl- and raise hdl-cholesterol) and who have the following triad of lipid abnormalities: low hdl-cholesterol levels in addition to elevated ldl-cholesterol and elevated triglycerides (see warnings, precautions, and clinical pharmacology). the national cholesterol education program has defined a serum hdl-cholesterol value that is consistently below 35 mg/dl as constituting an independent risk factor for coronary heart disease. patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. in some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in ldl-cholesterol. because of potential toxicity such as malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality, and the 44% relative increase during the trial period in age-adjusted all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefit of gemfibrozil in treating type iia patients with elevations of ldl-cholesterol only is not likely to outweigh the risks. gemfibrozil is also not indicated for the treatment of patients with low hdl-cholesterol as their only lipid abnormality. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (greater than 46.4 mg/dl), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see table i). the initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. physical exercise can be an important ancillary measure, and has been associated with rises in hdl-cholesterol. diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. in such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. the use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. if the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. 1. hepatic or severe renal dysfunction, including primary biliary cirrhosis. 2. preexisting gallbladder disease (see warnings). 3. hypersensitivity to gemfibrozil. 4. combination therapy of gemfibrozil with simvastatin (see warnings and precautions). 5. combination therapy of gemfibrozil with repaglinide (see precautions). 6. combination therapy of gemfibrozil with dasabuvir (see precautions). 7. combination therapy of gemfibrozil with selexipag (see precautions).

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puracap laboratories, llc - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. ursodiol, usp (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. it is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. the chemical name for ursodiol is 3α, 7β-dihydroxy-5β-cholan-24-oic acid (c24 h40 o4 ). ursodiol, usp has a molecular weight of 392.57. its structure is shown below: inactive ingredients : corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, d&c red # 28, fd&c blue # 1 and fd&c red # 40. the imprinting ink contains the following: black iron oxide, d&c yellow # 10 aluminum lake, fd&c blue # 1 aluminum lake, fd&c blue # 2 aluminum lake, fd&c red # 40 aluminum lake, propylene glycol and shellac glaze.