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

lannett company, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hcl extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients aged 6 years and older. the effectiveness of dexmethylphenidate hcl extended-release capsules in the treatment of adhd in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting dsm-iv criteria for adhd [see clinical studies (14) ]. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/care

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

lannett company, inc. - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 30 mg - isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

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

lannett company, inc. - terbutaline sulfate (unii: 576pu70y8e) (terbutaline - unii:n8onu3l3pg) - terbutaline sulfate 2.5 mg - terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema. 1. tocolysis oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis [see boxed warning: tocolysis ]. 2. hypersensitivity terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

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

lannett company, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg - 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.

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

lannett company, inc. - diethylpropion hydrochloride (unii: 19v2pl39ng) (diethylpropion - unii:q94yyu22b8) - diethylpropion hydrochloride tablets usp, 25 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of bmi based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds divided by 2.2 = kg; inches × 0.0254 = meters. the usefulness of agents of this class (see clinical pharmacology ) should be measured against possible risk factors inherent in their use such as those described below. diethylpropion hydrochloride tablets usp, 25 mg are indicated for use as monotherapy only. pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sy

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

lannett company, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the treatment of adhd was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met dsm-iv® criteria for adhd [ see clinical studies (14) ] . a diagnosis of adhd (dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic,  or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better

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

lannett company inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [seeclinical studies(14.1) ]. bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

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

lannett company, inc. - loxapine succinate (unii: x59sg0mryu) (loxapine - unii:ler583670j) - loxapine 5 mg - loxapine capsules, usp are indicated for the treatment of schizophrenia. the efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.

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

lannett company, inc. - fluphenazine hydrochloride (unii: zou145w1xl) (fluphenazine - unii:s79426a41z) - fluphenazine hydrochloride 1 mg - fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation. phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. the presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

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

lannett company, inc. - danazol (unii: n29qww3buo) (danazol - unii:n29qww3buo) - danazol 50 mg - endometriosis. danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. hereditary angioedema. danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females. danazol capsules should not be administered to patients with: - undiagnosed abnormal genital bleeding. - markedly impaired hepatic, renal, or cardiac function. - pregnancy (see warnings ). - breast feeding. - porphyria-danazol capsules can induce ala synthetase activity and hence porphyrin metabolism. - androgen-dependent tumor. - active thrombosis or thromboembolic disease and history of such events. - hypersensitivity to danazol.