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

concordia pharmaceuticals inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg - plaquenil is indicated in adult and pediatric patients for the: • treatment of uncomplicated malaria due to plasmodium falciparum, plasmodium malariae, plasmodium vivax,  and plasmodium ovale. • prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use: plaquenil is not  recommended for: • treatment of complicated malaria. • treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of plasmodium  species [see microbiology (12.4)].   • treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium  species has not been identified. • prophylaxis of malaria in geographic areas where chloroquine resistance occurs. • prevention of relapses of p. vivax  or p. ovale  because it is not active against the hypnozoite liver stage forms of these parasites. for radical cure of p. vivax  and p. ovale  infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see microbiology (12.4)] . for the most current information about drug resistance, refer to the latest recommendations from the center for disease control and prevention1  .   plaquenil is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. plaquenil is indicated for the treatment of systemic lupus erythematosus in adults. plaquenil is indicated for the treatment of chronic discoid lupus erythematosus in adults. plaquenil is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to plaquenil during pregnancy. encourage patients to register by contacting 1-877-311-8972. risk summary  prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with plaquenil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see data ).  there are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see clinical considerations ). animal reproduction studies were not conducted with hydroxychloroquine.   the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations  disease-associated maternal and/or embryo-fetal risk         malaria:  malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.       rheumatoid arthritis:  published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.        systemic lupus erythematosus:  pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. data human data data from published epidemiologic and clinical studies have not established an association with plaquenil use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.  hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels.  no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero .  available epidemiologic and clinical studies have methodological limitations including small sample size and study design. risk summary  published lactation data report that hydroxychloroquine is present in human milk at low levels. no adverse reactions have been reported in breastfed infants.  no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk.  there is no information on the effect of hydroxychloroquine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for plaquenil and any potential adverse effects on the breastfed child from plaquenil or from the underlying maternal condition. the safety and effectiveness of plaquenil have been established in pediatric patients for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. vivax , and p. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.  however, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see dosage and administration (2.1, 2.2)] .   the safety and effectiveness of plaquenil have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. clinical trials of plaquenil did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.  nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. in general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. a reduction in the dosage of plaquenil may be necessary in patients with hepatic or renal disease.

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

concordia pharmaceuticals inc. - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - metoprolol tartrate 25 mg - dutoprol is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide. 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 1 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 joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes

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

concordia pharmaceuticals inc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - uroxatral is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. uroxatral is not indicated for the treatment of hypertension. uroxatral is not indicated for use in the pediatric population. uroxatral is contraindicated for use: - in patients with moderate or severe hepatic impairment (childs-pugh categories b and c), since alfuzosin blood levels are increased in these patients [see use in specific populations (8.7) and clinical pharmacology (12.3)]. - with potent cyp3a4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see drug interactions (7.1) and clinical pharmacology (12.3)] . - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of uroxatral tablets [see adverse reactions (6.2)] risk summary uroxatral is not indicated for use in women. there are no adequate data on the developmental risk associated with use of uroxatral in pregnant women. b

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

concordia pharmaceuticals inc. - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium cation 4.1 meq in 1 g

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

concordia pharmaceuticals inc. - phenoxybenzamine hydrochloride (unii: x1ieg24ohl) (phenoxybenzamine - unii:0ttz664r7z) - phenoxybenzamine hydrochloride 10 mg - conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

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

concordia pharmaceuticals inc. - prednisolone sodium phosphate (unii: iv021nxa9j) (prednisolone - unii:9phq9y1olm) - prednisolone 10 mg - orapred odt (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: - atopic dermatitis - drug hypersensitivity reactions - seasonal or perennial allergic rhinitis - serum sickness - bullous dermatitis herpetiformis - contact dermatitis - exfoliative erythroderma - mycosis fungoides - pemphigus - severe erythema multiforme (stevens-johnson syndrome) - congenital adrenal hyperplasia - hypercalcemia of malignancy - nonsuppurative thyroiditis - primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. during acute episodes in: - crohn's disease - ulcerative colitis - acquired (autoimmune) hemolytic anemia - diamond-blackfan anemia - idiopathic thrombocytopenic

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

pd-rx pharmaceuticals, inc. - phenobarbital (unii: yqe403bp4d) (phenobarbital - unii:yqe403bp4d) - phenobarbital 16.2 mg

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

redpharm drug, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - plaquenil is indicated for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. ovale, and p. vivax . plaquenil is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria • plaquenil is not recommended for the treatment of complicated malaria. • plaquenil is not effective against chloroquine or hydroxychloroquine-resistant strains of plasmodium species (see clinical pharmacology – microbiology ). plaquenil is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. • plaquenil is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. • plaquenil does not prevent relapses of p. vivax or p. ovale becau

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

trupharma llc - triamterene (unii: ws821z52lq) (triamterene - unii:ws821z52lq) - triamterene capsules usp is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. triamterene capsules usp may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. it also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. usage in pregnancy. the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. diuretics are indicated in pregnancy (however, see precautions below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. there is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. if this edema produces discomfort, increased recumbency will often provide relief. in rare instances, this edema may cause extreme discomfort which is not relieved by rest. in these cases, a short course of diuretics may provide relief and may be appropriate. anuria. severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. severe hepatic disease. hypersensitivity to the drug or any of its components. triamterene capsules usp should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with triamterene. triamterene should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. two deaths have been reported in patients receiving concomitant spironolactone and triamterene or dyazide®. although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

rph pharmaceuticals ab - labetalol hydrochloride - solution for injection - 5mg/1ml