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

lannett company, inc. - cetirizine hydrochloride (unii: 64o047ktoa) (cetirizine - unii:yo7261me24) - cetirizine hydrochloride 5 mg in 5 ml - perennial allergic rhinitis: cetirizine hydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. chronic urticaria: cetirizine hydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. it significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. there is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

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

major pharmaceuticals - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril tablets are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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. 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

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

kaiser foundation hospitals - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 160 mg - fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated ldl-c, total-c, triglycerides and apo b, and to increase hdl-c in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dl) may increase the risk of developing pancreatitis.

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

major pharmaceuticals - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg - donepezil hydrochloride is indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochlorideis contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.  pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day and 10 mg/kg/day (approximately 7 times the mrhd on a mg/m2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the hig

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

teva pharmaceuticals usa, inc. - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - hydrochlorothiazide 25 mg - hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. routine use of diuretics during normal pregnancy 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 toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. thiazides are indicated in pregnancy when edema is du

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

teva pharmaceuticals usa, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg - baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen.

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: citric acid monohydrate; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; microcrystalline cellulose; propyl gallate; butylated hydroxyanisole; hypromellose; croscarmellose sodium - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; citric acid monohydrate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; butylated hydroxyanisole; propyl gallate; hypromellose - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

aphena pharma solutions - tennessee, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). diclofenac sodium delayed-release tablets are indicated: • for relief of the signs and symptoms of osteoarthritis • for relief of the signs and symptoms of rheumatoid arthritis • for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium delayed-release should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions, and precautions, pre

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

aphena pharma solutions - tennessee, llc - carvedilol (unii: 0k47ul67f2) (carvedilol - unii:0k47ul67f2) - carvedilol tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ace inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see clinical studies (14.1)]. carvedilol tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see clinical studies (14.2) ]. carvedilol tablet is indicated for the management of essential hypertension [see clinical studies (14.3, 14.4) ]. it can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see drug interactions (7.2) ]. carvedilol tablet is contraindicated in the following conditions: studies performed in pregnant rats and rabbits given carvedilol tablet revealed increased post-impl