United States - English - NLM (National Library of Medicine)

camber, pharmaceuticals inc - nadolol (unii: fen504330v) (nadolol - unii:fen504330v) - nadolol 20 mg - nadolol tablets, usp are indicated for the long-term management of patients with angina pectoris. nadolol is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with nadolol. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals inc. - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - finasteride tablets usp are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to: -improve symptoms -reduce the risk of the need for surgery including transurethral resection of the prostate (turp) and prostatectomy. finasteride tablets usp are contraindicated in the following: hypersensitivity to any component of this medication. pregnancy. finasteride use is contraindicated in women when they are or may potentially be pregnant. because of the ability of type ii 5α-reductase inhibitors to inhibit the conversion of testosterone to dht, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. if this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (see also warnings, exposure of women — risk to male fetus and precautions, information for patients and pregnancy .) in female

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.  neostigmine methylsulfate injection is contraindicated in patients with:    - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).    - peritonitis or mechanical obstruction of the intestinal or urinary tract.  risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardle

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. acute pain in adult patients ketorolac tromethamine tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and adm

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - captopril (unii: 9g64rsx1xd) (captopril - unii:9g64rsx1xd) - hypertension:  captopril tablets, usp are indicated for the treatment of hypertension. in using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see warnings ). captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. in patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive. heart failure: captopril tablets, usp are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. the beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. left ventricular dysfunction after myocardial infarction: captopril tablets, usp are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients. diabetic nephropathy: captopril tablets, usp are indicated for the treatment of diabetic nephropathy (proteinuria ˃500 mg/day) in patients with type i insulin-dependent diabetes mellitus and retinopathy. captopril decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). in considering use of captopril, it should be noted that in controlled trials ace inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. in addition, ace inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see warnings: head and neck angioedema and intestinal angioedema ). captopril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ace inhibitor). do not co-administer aliskiren with captopril in patients with diabetes (see precautions: drug interactions ). captopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer captopril within 36 hours of switching to or from sacubitril/valsartan, a nepriltsin inhibitor (see precautions: drug interactions ).

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see clinical pharmacology: special populations, warnings, and adverse reactions: post-marketing experience for more information.) congestive heart failure: itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf except for the treatment of life-threatening or other serious infections. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) drug interactions: coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), met

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - zafirlukast (unii: xz629s5l50) (zafirlukast - unii:xz629s5l50) - zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older. zafirlukast is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients. zafirlukast is contraindicated in patients with hepatic impairment including hepatic cirrhosis.

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see warnings and precautions (5.1)], reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immedia

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increa