Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }
- association label "spironolactone tablets usp are indicated in the management of for primary hyperaldosteronism establishing the diagnosis of primary hyperaldosteronism by therapeutic trial short term preoperative treatment of patients with primary hyperaldosteronism long term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks or who decline surgery long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia idiopathic hyperaldosteronism for patients with edematous conditions for the management of edema and sodium retention when the patient is only partially responsive to or is intolerant of other therapeutic measures spironolactone tablets usp are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate congestive heart failure spironolactone levels may be exceptionally high in this condition spironolactone tablets usp are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium cirrhosis of the liver accompanied by edema and or ascites for nephrotic patients when treatment of the underlying disease restriction of fluid and sodium intake and the use of other diuretics do not provide an adequate response nephrotic syndrome spironolactone tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal 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 one 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 and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy usually in combination with other drugs spironolactone tablets usp are indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate for the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate spironolactone tablets usp are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate severe heart failure nyha class iii to iv to increase survival and to reduce the need for hospitalization for heart failure when used in addition to standard therapy 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 developing toxemia edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy spironolactone tablets usp are indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy however see 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 unsupported and unnecessary precautions pregnancy there is hypervolemia during normal pregnancy which is not harmful to either the fetus or 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 that is not relieved by rest in these cases a short course of diuretics may provide relief and may be appropriate" assertion.
- association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
- association label "for the management of schizophrenia trifluoperazine hydrochloride tablets usp are effective for the short term treatment of generalized non psychotic anxiety however trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments i e benzodiazepines when used in the treatment of non psychotic anxiety trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible see warnings the effectiveness of trifluoperazine hydrochloride tablets as a treatment for non psychotic anxiety was established in a 4 week clinical multicenter study of outpatients with generalized anxiety disorder dsm iii this evidence does not predict that trifluoperazine hydrochloride tablets will be useful in patients with other non psychotic conditions in which anxiety or signs that mimic anxiety are found i e physical illness organic mental conditions agitated depression character pathologies etc trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation" assertion.
- association label "rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old information related to usage of rizatriptan benzoate in pediatric patients 6 to 17 years old is approved for merck co inc s rizatriptan benzoate tablets however due to merck co inc s marketing exclusivity rights this drug product is not labeled with that pediatric patient 6 to 17 years old usage information limitations of use rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets is administered to treat any subsequent attacks rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine see contraindications 4 rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache rizatriptan benzoate tablets are a serotonin 5 ht 1b 1d receptor agonist triptan indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age 1 limitations of use use only after clear diagnosis of migraine has been established 1 not indicated for the prophylactic therapy of migraine 1 not indicated for the treatment of cluster headache 1" assertion.
- association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
- association label "fluvoxamine maleate extended release capsules are a selective serotonin reuptake inhibitor ssri indicated for the treatment of obsessive compulsive disorder ocd 1 one 12 week study with fluvoxamine maleate extended release capsules in adults 14 1 two 1 week studies with immediate release ir fluvoxamine tablets in adults and one 1 week study with ir fluvoxamine tablets in children and adolescents 14 1 14 3 one maintenance study with ir fluvoxamine tablets 14 2 fluvoxamine maleate extended release capsules are indicated for the treatment of obsessive compulsive disorder ocd as defined in the dsm iv obsessive compulsive disorder is characterized by recurrent and persistent ideas thoughts impulses or images obsessions that are ego dystonic and or repetitive purposeful and intentional behaviors compulsions that are recognized by the person as excessive or unreasonable the obsessions or compulsions cause marked distress are time consuming or significantly interfere with social or occupational functioning the efficacy of fluvoxamine maleate extended release capsules was demonstrated in one 12 week trial in adults with fluvoxamine maleate extended release capsules as well as in two 1 week trials in adults and in one 1 week trial in children and adolescents ages 8 to 17 years with immediate release fluvoxamine tablets in outpatients with the diagnosis of ocd as defined in dsm iv or dsm iii r see clinical studies 14 1 14 3 the efficacy of fluvoxamine for long term use was established in one maintenance study in adults with immediate release fluvoxamine tablets see clinical studies 14 2 see dosage and administration 2 4" assertion.
- association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension usp is indicated as follows control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis to tide the patient over a critical period of the disease in regional enteritis systemic therapy ulcerative colitis acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis symptomatic sarcoidosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension usp is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension usp is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension usp also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
- association label "venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of major depressive disorder the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm iii r or dsm iv category of major depressive disorder see clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed mood or the loss of interest or pleasure in nearly all activities representing a change from previous functioning and includes the presence of at least five of the following nine symptoms during the same two week period depressed mood markedly diminished interest or pleasure in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial see the safety and efficacy of venlafaxine hydrochloride extended release capsules usp in hospitalized depressed patients have not been adequately studied clinical trials the efficacy of venlafaxine hydrochloride extended release capsules usp in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial the efficacy of venlafaxine hydrochloride tablets in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo controlled trial see nevertheless the physician who elects to use venlafaxine hydrochloride tablets venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see clinical trials dosage and administration social anxiety disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of social anxiety disorder also known as social phobia as defined in dsm iv 3 23 social anxiety disorder dsm iv is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others exposure to the feared situation almost invariably provokes anxiety which may approach the intensity of a panic attack the feared situations are avoided or endured with intense anxiety or distress the avoidance anxious anticipation or distress in the feared situation s interferes significantly with the person s normal routine occupational or academic functioning or social activities or relationships or there is a marked distress about having the phobias lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of social anxiety disorder was established in four 12 week and one 6 month placebocontrolled trials in adult outpatients with social anxiety disorder dsm iv see clinical trials although the effectiveness of venlafaxine hydrochloride extended release capsules usp has been demonstrated in a 6 month clinical trial in patients with social anxiety disorder the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration panic disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of panic disorder with or without agoraphobia as defined in dsm iv panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks worry about the implications or consequences of the attacks and or a significant change in behavior related to the attacks panic disorder dsm iv is characterized by recurrent unexpected panic attacks ie a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of panic disorder was established in two 12 week placebo controlled trials in adult outpatients with panic disorder dsm iv the efficacy of venlafaxine hydrochloride extended release capsules usp in prolonging time to relapse in panic disorder among responders following 12 weeks of open label acute treatment was demonstrated in a placebo controlled study see clinical pharmacology clinical trials nevertheless the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
- association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g procaine and other antibacterial drugs penicillin g procaine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin g procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin g susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below therapy should be guided by bacteriological studies including susceptibility tests and by clinical response note when high sustained serum levels are required aqueous penicillin g either im or iv should be used the following infections will usually respond to adequate dosages of intramuscular penicillin g procaine moderately severe to severe infections of the upper respiratory tract skin and soft tissue infections scarlet fever and erysipelas due to susceptible streptococci group a without bacteremia note streptococci in groups a c g h l and m are very sensitive to penicillin g other groups including group d enterococcus are resistant aqueous penicillin is recommended for streptococcal infections with bacteremia moderately severe infections of the respiratory tract due to susceptible pneumococci note severe pneumonia empyema bacteremia pericarditis meningitis peritonitis and arthritis of pneumococcal etiology are better treated with aqueous penicillin g during the acute stage moderately severe infections of the skin and soft tissues due to susceptible staphylococci penicillin g susceptible note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections indicated surgical procedures should be performed fusospirochetosis vincent s gingivitis and pharyngitis moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes note necessary dental care should be accomplished in infections involving the gum tissue syphilis all stages due to susceptible treponema pallidum note this drug should not be used in the treatment of beta lactamase producing organisms which include most strains of neisseria gonorrhea yaws bejel pinta due to susceptible organisms penicillin g procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible c diphtheriae anthrax due to bacillus anthracis bacillus anthracis rat bite fever due to susceptible streptobacillus moniliformis spirillum minus erysipeloid due to susceptible erysipelothrix rhusiopathia subacute bacterial endocarditis only in extremely sensitive infections due to susceptible group a streptococci" assertion.
- association label "saphris is indicated for schizophrenia in adults see clinical studies 14 1 bipolar i disorder see clinical studies 14 2 acute monotherapy of manic or mixed episodes in adults and pediatric patients 1 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults saphris is an atypical antipsychotic indicated for 1 schizophrenia in adults bipolar i disorder acute monotherapy treatment of manic or mixed episodes in adults and pediatric patients 1 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults" assertion.
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