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

aphena pharma solutions - tennessee, llc - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - hypertension metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. angina pectoris metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. myocardial infarction metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (see dosage and administration,  contraindications, and warnings). hypertension and angina metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than fi

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

northwind pharmaceuticals, llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride tablets usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

quality care products, llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride tablets usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

aphena pharma solutions - tennessee, llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride tablets usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

advanced rx pharmacy of tennessee, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. 8.1 pregnancy risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic ef

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

advanced rx pharmacy of tennessee, llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - indications and usage cyclobenzaprine hydrochloride tablets, usp are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (ma

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

trupharma llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen delayed-release tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis naproxen delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see warnings and precautions (5.7, 5.9) ]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. use of nsaids, including naproxen delayed-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to

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

trupharma llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide tablets are contraindicated in patients with: - known hypersensitivity to the drug. - type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.

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

trupharma, llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. limitations of use baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. baclofen oral solution is contraindicated in patients with hypersensitivity to baclofen. risk summary there are no adequate data on the developmental risk associated with the use of baclofen oral solution in pregnant women. oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated backgroun

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

trupharma, llc - clonidine (unii: mn3l5rmn02) (clonidine - unii:mn3l5rmn02) - clonidine extended-release tablets are indicated in the treatment of hypertension. clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine extended-release tablets should not be used in patients with known hypersensitivity to clonidine [ see warnings and precautions (5.2) ]. pregnancy category c. reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (mrdhd) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. in rats, however, doses as low as 1/3 the oral mrdhd (1/15 the mrdhd on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral mrdhd) when the dams were treated on gestation days 6 to 15. increases in resorption were observed at much higher dose levels (40 times the oral mrdhd on a mg/kg basis; 4 to 8 times the mrdhd on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). no adequate, well-controlled studies have been conducted in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. clonidine is secreted in human milk. safety and effectiveness in pediatric patients have not been established. elderly patients may benefit from a lower initial dose [ see dosage and administration (2) ]. the initial dosage should be based on the degree of impairment. monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. only a minimal amount of clonidine is removed during routine hemodialysis.