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sigmapharm laboratories, llc - amiloride hydrochloride anhydrous (unii: 7m458q65s3) (amiloride - unii:7dzo8eb0z3) - amiloride hcl tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:                a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic                b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. the use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. amiloride hcl tablets have little additive diuretic or antihypertensive effect when added to a thiazide diuretic. amiloride hcl tablets should rarely be used alone. it has weak (compared with thiazides) diuretic and antihypertensive effects. used as single agents, potassium sparing diuretics, including amiloride hcl tablets, result in

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

sigmapharm laboratories, llc - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 0.94 g in 1 g - sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (see nutritional supplementation subsection of t

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

sigmapharm laboratories, llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride extended-release tablets, usp are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene and amiloride. risk summary there are no human data related to use of potassium chloride extended-release tablets, usp during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary the normal potassium ion content o

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

sigmapharm laboratories, llc - liothyronine sodium (unii: gca9vv7d2n) (liothyronine - unii:06lu7c9h1v) - liothyronine 5 ug - liothyronine sodium tablets, usp are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. liothyronine sodium tablets, usp are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. liothyronine sodium tablets, usp are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. limitations of use - liothyronine sodium tablets, usp are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium tablets, usp may induce hyperthyroidism [see warnings and precautions (5.4)]. - liothyronine sodium tablets, usp are not indicated for treatment of hypothyroidism during the recovery phase of s

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sigmapharm laboratories, llc - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. do not use nitroglycerin in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)] . do not use nitroglycerin in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. concomitant use can cause hypotension. nitroglycerin is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). nitroglycerin may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury). nitroglycerin is contraindicated

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

sigmapharm laboratories, llc - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir dipivoxil 10 mg - adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis b in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. pregnancy exposure registry there is a pregnancy exposure registry that moni

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sigmapharm laboratories, llc - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine sublingual tablet(s) is indicated for: - bipolar i disorder  [see clinical studies ( 14.2)] adjunctive treatment to lithium or valproate in adults - adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and ra

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

rising pharmaceuticals, inc - protriptyline hydrochloride (unii: 44665v00o8) (protriptyline - unii:4ndu154t12) - protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. its activating properties make it particularly suitable for withdrawn and anergic patients. protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. it should not be given concomitantly with a monoamine oxidase inhibiting compound. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. when it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. protriptyline is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interaction

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

rising pharmaceuticals, inc. - disulfiram (unii: tr3mlj1uai) (disulfiram - unii:tr3mlj1uai) - disulfiram 250 mg - disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. disulfiram is not a cure for alcoholism. when used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic. patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcohol-containing preparations, e.g., cough syrups, tonics and the like, should not be given disulfiram. disulfiram is contraindicated in the presence of severe myocardial disease or coronary occlusion, psychoses, and hypersensitivity to disulfiram or to other thiuram derivatives used in pesticides and rubber vulcanization.