um-ids/dailymed-annotations huggingface dataset:
INDICATIONSAND USAGE
Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day
[see
Clinical Studies (14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (
1)
INDICATIONS AND USAGE
Luxq is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
INDICATIONS & USAGE SECTION
1.1 Monotherapy EpilepsyTopiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2 Adjunctive Therapy EpilepsyTopiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for: Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1,14.2) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
1	INDICATIONS AND USAGE
Alendronate sodium tabletsare a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2)
Treatment to increase bone mass in men with osteoporosis (1.3)
Treatment of glucocorticoid-induced osteoporosis (1.4)
Treatment of Paget's disease of bone (1.5)
Limitations of use:Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6)
1.1	Treatment of Osteoporosis in Postmenopausal Women
Alendronate sodium tabletsare indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women,alendronate sodium tablets increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see Clinical Studies (14.1)
].
1.2	Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tabletsare indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)
].
1.3	Treatment to Increase Bone Mass in Men with Osteoporosis
Alendronate sodium tabletsare indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)
].
1.4	Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tabletsare indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)
].
1.5	Treatment of Paget's Disease of Bone
Alendronate sodium tabletsare indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease [see Clinical Studies (14.5)
].
1.6	Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness ofalendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Budesonide inhalation suspension is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1.1)
Important Limitations of Use:
Not indicated for the relief of acute bronchospasm (1.1)
1.1 Maintenance Treatment of Asthma
Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Important Limitations of Use:
Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Panic Disorder
Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).
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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Escitalopram oral solution is indicated for the treatment of:
major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.
Escitalopram oral solution is a selective serotonin reuptake inhibitor (SSRI) indicated for the:
treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1).
treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older (1).
1 INDICATIONS AND USAGE
Lacosamide tablet is indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (
1.1)
1.1 Partial-Onset Seizures
Lacosamidetablet is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.'s VIMPAT
(lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Cardiovascular Risk Reduction
Telmisartan tablets, USP are indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.
High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage
[see Clinical Studies (
14.2
)]. Telmisartan can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy)
[see Clinical Studies (
14.2
)].
Studies of telmisartan in this setting do not exclude the possibility that telmisartan may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.
Use of telmisartan with an ACE inhibitor is not recommended
[see Warnings and Precautions (
5.6
)].
2.1 Recommended
Dosage
Administer alprazolam extended-release tablets orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or chew.
The recommended starting oral dosage for alprazolam extended-release tablets is 0.5 mg to 1 mg once daily. Depending on the response, the dosage may be adjusted at intervals of every 3 to 4 days in increments of no more than 1 mg daily. The recommended dosage range is 3 mg to 6 mg once daily.
Controlled trials of alprazolam extended-release tablets for the treatment of panic disorder included dosages in the range of 1 mg to 10 mg per day. Most patients showed a response in the dosage range of 3 mg to 6 mg per day. Occasional patients required as much as 10 mg per day.
The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated. If alprazolam extended-release tablets is used for periods longer than 8 weeks, the healthcare provider should periodically reassess the usefulness of the drug for the individual patient.
After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat 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.
Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.
1 INDICATIONS AND USAGE
Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use
only if a clear diagnosis of migraine has been established. If a patient
has no response to the first migraine attack treated with naratriptan
tablets reconsider the diagnosis of migraine before naratriptan tablets are
administered to treat any subsequent attacks.
Naratriptan
tablets are not indicated for the prevention of migraine attacks.
Safety
and effectiveness of naratriptan tablets have not been established for
cluster headache.
Naratriptan Tablets are serotonin (5-HT 1B/1D) receptor agonists (triptan) indicated for the acute treatment of migraine with or without aura in adults.
(1)
Limitations of Use:
Use
only if a clear diagnosis of migraine has been established.
(1)
Not
indicated for the prophylactic therapy of migraine attacks.
(1)
Not
indicated for the treatment of cluster headache.
(1)
1 INDICATIONS AND USAGE
Aripiprazole oral tablets are indicated for the treatment of:
Schizophrenia [see CLINICAL STUDIES (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator receptor alpha (PPAR) activator indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. (1.1)
For treatment of adult patients with severe hypertriglyceridemia. (1.2)
Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. (5.1)
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG) and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. >2000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
INDICATIONS AND USAGE
Ocupress Ophthalmic Solution, 1%, has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.
INDICATIONS AND USAGE
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is indicated for steroid-responsive inflammatory ocular conditions
for which a corticosteroid is indicated and where bacterial infection or a risk
of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where
the inherent risk of corticosteroid use in certain infective conjunctivitides is
accepted to obtain a diminution in edema and inflammation. They are also
indicated in chronic anterior uveitis and corneal injury from chemical,
radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated
where the risk of infection is high or where there is an expectation that
potentially dangerous numbers of bacteria will be present in the eye (See
CLINICAL
PHARMACOLOGY: Microbiology
).
The particular anti-infective drugs in this product are active against the
following common bacterial eye pathogens: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa.
The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Triamcinolone Acetonide Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.
Labeling describing use of triamcinolone acetonide nasal spray in pediatric patients 2 to 5 years of age is approved for Sanofi-Aventis U.S. Inc.s Nasacort AQ Nasal Spray. However, due to Sanofi-Aventis U.S. Inc.s marketing exclusivity rights, a description of that use is not approved for this triamcinolone acetonide nasal spray labeling.
Triamcinolone Acetonide Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older. (1)
1 INDICATIONS AND USAGE
Sodium Fluoride F18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
INDICATIONS AND USAGE
Hydrochlorothiazide capsules USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazidecapsules USPmay be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
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 developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. 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 illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor 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 which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
1 INDICATIONS AND USAGE
Clonidine hydrochloride extended-release tablets is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. (1)
Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (
14
)].
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATIONsection.)
INDICATIONS AND USAGE
Fluorouracil cream, 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
1 INDICATIONS AND USAGE
Calcium Acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium Acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.(1)
INDICATIONS AND USAGE
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
CONJUNCTIVITIS
:
Gram
-
positive
bacteria
:
Gram
-
negative
bacteria
:
Staphylococcus
aureus
Enterobacter
cloacae
Staphylococcus
epidermidis
Haemophilus
influenzae
Streptococcus
pneumoniae
Proteus
mirabilis
Pseudomonas
aeruginosa
CORNEAL
ULCERS
:
Gram
-
positive
bacteria
:
Gram
-
negative
bacteria
:
Staphylococcus
aureus
Pseudomonas
aeruginosa
Staphylococcus
epidermidis
Serratia
marcescens
*
Streptococcus
pneumoniae
Anaerobic
species
:
Propionibacterium
acnes
* Efficacy for this organism was studied in fewer than 10 infections