Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - ​ quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see clinical studies (14.1) ]. quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i di

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide 2.5 mg - glyburide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan.

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (pgtc) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (aed). safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - cyproheptadine hydrochloride (unii: nj82j0f8qc) (cyproheptadine - unii:2yhb6175do) - cyproheptadine hydrochloride 4 mg - perennial and seasonal allergic rhinitis vasomotor rhinitis allergic conjunctivitis due to inhalant allergens and foods mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma cold urticaria dermatographism as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. newborn or premature infants this drug should not be used in newborn or premature infants. nursing mothers because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. other conditions hypersensitivity to cyproheptadine and other drugs of similar chemical structure. monoamine oxidase inhibitor therapy (see drug interactions. ) angle-closure glaucoma stenosing peptic ulcer symptomatic prostatic hypertrophy bladder neck obstruction pyloroduodenal obstruction elderly, debilitated

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride 5 mg - 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 (mao) inhibitors or withi

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - 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 ).

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen tablets, usp 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, usp may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen tablets, usp 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.

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam extended-release tablets is indicated as adjunctive therapy in the treatment of partial onset seizures in patients >16 years of age with epilepsy. none pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [mrhd] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - 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 (mao) inhibitors or withi

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma 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