um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole
is indicated for the prophylaxis of invasive Aspergillus
and Candida
infections in patients who are at high risk of developing these
infections due to being severely immunocompromised, such as hematopoietic
stem cell transplant (HSCT) recipients with graft-versus-host disease
(GVHD)or those with hematologic malignancies with prolonged neutropenia
from chemotherapy as follows: (1.1)
Posaconazole
delayed-release tablets: adults and pediatric patients 13 years of age
and older
1.1 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.1)]
as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older.
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.'s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Atrial Fibrillation
Propranolol hydrochloride tablets USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
1 INDICATIONS & USAGE
Pregabalin is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
INDICATIONS AND USAGE: Ciprofloxacin ophthalmic solution 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescens*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)*
Conjunctivitis:
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
1 INDICATIONSAND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH (ED/BPH) (
1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1	Erectile Dysfunction
Tadalafil tablets areindicated for the treatment of erectile dysfunction (ED).
1.2	Benign Prostatic Hyperplasia
Tadalafil tablets areindicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3	Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets areindicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4	Limitation of Use
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown
[see Clinical Studies (
14.3)]
.
INDICATIONS AND USAGE
Azurette (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use
% of Women
Continuing Use at
One Year
*
(4)
Method
(1)
Typical Use
(2)
Perfect Use
(3)
Chance
85
85
Spermicides
26
6
40
Periodic Abstinence
25
63
Calendar
9
Ovulation Method
3
Sympto-Thermal
#
2
Post-Ovulation
1
Withdrawal
19
4
Cap
Parous Women
40
26
42
Nulliparous Women
20
9
56
Sponge
Parous Women
40
20
42
Nulliparous Women
20
9
56
Diaphragm
20
6
56
Condom
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
Progestin Only
0.5
Combined
0.1
IUD
Progesterone T
2
1.5
81
Copper T 380A
0.8
0.6
78
LNg 20
0.1
0.1
81
Depo-Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female Sterilization
0.5
0.5
100
Male Sterilization
0.15
0.10
100
Adapted from Hatcher et al., 1998, ref #1.
1 INDICATIONS AND USAGE
OSMITROL is indicated for:
The reduction of intracranial pressure and treatment of cerebral edema;
The reduction of elevated intraocular pressure.
OSMITROL is an osmotic diuretic, indicated for the reduction of:
intracranial pressure and treatment of cerebral edema. (1)
elevated intraocular pressure. (1)
Indications and Usage
PARCOPA is indicated in the treatment of the symptoms of idiopathic Parkinsons disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. PARCOPA is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).In some patients, a somewhat smoother antiparkinsonian effect results from therapy with carbidopa-levodopa than with levodopa. However, patients with markedly irregular (on-off) responses to levodopa have not been shown to benefit from carbidopa-levodopa therapy.Although the administration of carbidopa permits control of parkinsonism and Parkinsons disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.Certain patients who responded poorly to levodopa have improved when carbidopa-levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes.In considering whether to give PARCOPA to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa-levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
INDICATIONS AND USAGE
1. Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
2.Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
1 INDICATIONS AND USAGE
SAXENDA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
Adult patients with an initial body mass index (BMI) of [see Dosage and Administration (2.1)]:
30 kg/m2 or greater (obese), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Pediatric patients aged 12 years and older with:
body weight above 60 kg and
an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria, Table 2) [see Dosage and Administration (2.1)]
Limitations of Use
SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist.
The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.
The safety and effectiveness of SAXENDA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
Adult patients with an initial body mass index (BMI) of
30 kg/m2 or greater (obese), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) (1).
Pediatric patients aged 12 years and older with:
body weight above 60 kg and
an initial BMI corresponding to 30 kg/m2 for adults (obese) by international cut-offs (1).
Limitations of Use:
SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist (1).
The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established (1).
The safety and efficacy of SAXENDA in combination with other products intended for weight loss have not been established (1).
1 INDICATIONS AND USAGE
E-Z-PAQUE is indicated for use
in single contrast radiographic examinations of the esophagus, stomach,
duodenum and small bowel to visualize the gastrointestinal tract (GI)
in adult and pediatric patients.
E-Z-PAQUE is a radiographic contrast agent indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients (1)
INDICATIONS AND USAGE
Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (See
WARNINGS
).
1 INDICATIONS AND USAGE
Leflunomide Tablets, USPare indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1)
INDICATIONS AND USAGE
Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
The mode of action of this drug has not been clearly identified, but may be related to its sedative properties.
Chlorzoxazone does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
1.1 Major Depressive Disorder
Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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.
1.2 Generalized Anxiety Disorder
Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
KEPPRA is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1
Partial-Onset Seizures
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
KEPPRA is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3
Primary Generalized Tonic-Clonic Seizures
KEPPRA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.
1 INDICATIONS & USAGE
Phentermine hydrochloride tablets USPare indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (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
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
Height (feet, inches)
Weight
(pounds)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The limited usefulness of agents of this class, including phentermine, [see
Clinical Pharmacology (
12.1,
12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (
1)
The limited usefulness of agents of this class, including phentermine hydrochloride tablets USP, should be measured against possible risk factors inherent in their use. (
1)
1 INDICATIONS AND USAGE
Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).
INDICATIONS AND USAGE
Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
1 INDICATIONSAND USAGE
Metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.
INDICATIONS AND USAGE
Norgesic Forte 50 mg/770mg/60 mg Tablets are indicated in:
Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic Forte Tablets do not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets, USP are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets, USP are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin chloride extended release tablets, USP are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
Oxybutynin chloride extended-release tablets, USP are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (1)
INDICATIONS AND USAGE
Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil capsules and other antibacterial drugs, cefadroxil capsules 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.
Indications and Usage
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
1 INDICATIONS & USAGE
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.
ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
INDICATIONS
Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.
1
INDICATIONS AND USAGE
COMBIGAN
(brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN
dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.
COMBIGAN
is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN
dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day. (1)
1 INDICATIONS AND USAGE
Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium chloride extended-release tablets is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)