um-ids/dailymed-annotations huggingface dataset:
Rx only
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Salicylic
Acid, 27.5%
is a topical preparation containing 27.5%
Salicylic Acid in a film-forming vehicle composed of: acrylates
copolymer, isopropyl alcohol, isobutyrate, n-butyl acetate, and
polyvinyl butyrate. The pharmacologic activity of this medication is
generally attributed to the keratolytic activity of salicylic acid
which is incorporated into a film-forming vehicle designed to cover the
wart without the need for a bandage. The chemical structural formula of
salicylic acid is:
chemical structure
CLINICAL PHARMACOLOGY
Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.
INDICATIONS AND USES
Salicylic Acid, 27.5%
is indicated for the topical treatment and removal of common warts and plantar warts.
CONTRAINDICATIONS
Salicylic Acid, 27.5% should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 27.5% should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.
PRECAUTIONS
Salicylic Acid, 27.5%
is for external use only. Do not permit Salicylic Acid, 27.5%
to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Salicylic Acid, 27.5%
should not be allowed to contact normal skin surrounding the wart. Treatment should be discontinued if excessive irritation occurs. Salicylic Acid, 27.5% is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use.
ADVERSE REACTIONS
A localized irritant reaction may occur if Salicylic Acid, 27.5%
is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.
DOSAGE AND ADMINISTRATION
Prior to application of Salicylic Acid, 27.5%
soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, emery board or pumice stone. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin. Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of drug use.
HOW SUPPLIED
Salicylic Acid, 27.5% is supplied in 10 mL amber glass bottles with brush applicator - NDC 54295-304-11.
Store at 20C to 25C (68F to 77F)., excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized. Protect from freezing.
INDICATIONS:
Anesthetic for relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.
INDICATIONSAND USAGE
Midazolam Injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
INDICATIONS AND USAGE
Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.
Dopamine HCl in Dextrose Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. (1)
INDICATIONS AND USAGE
Thyroid hormone drugs are indicated:
As replacement or supplemental therapy in patients with hypothyroidism of
any etiology, except transient hypothyroidism during the recovery phase of
subacute thyroiditis. This category includes cretinism, myxedema and ordinary
hypothyroidism in patients of any age (pediatric patients, adults, the elderly),
or state (including pregnancy); primary hypothyroidism resulting from functional
deficiency, primary atrophy, partial or total absence of thyroid gland, or the
effects of surgery, radiation, or drugs, with or without the presence of goiter;
and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see
WARNINGS
).
As pituitary thyroid-stimulating hormone (TSH) suppressants, in the
treatment or prevention of various types of euthyroid goiters, including thyroid
nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's) and
multinodular goiter.
As diagnostic agents in suppression tests to differentiate suspected mild
hyperthyroidism or thyroid gland autonomy.
Liothyronine Sodium Tablets, USP can be used in patients allergic to
desiccated thyroid or thyroid extract derived from pork or beef.
1 INDICATIONS AND USAGE
Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (
8.4)].
Contraindicated in pediatric patients under 12 years of age [see Contraindications (
4) and Use in Specific Populations (
8.4)].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy and/or adenoidectomy [see Contraindications (
4) and Use in Specific Populations (
8.4)].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (
5.1)], reserve Promethazine with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Promethazine with Codeine Oral Solution is a combination of codeine, an opioid agonist; and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. (
1)
Important Limitations of Use (
1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
INDICATIONS & USAGE
Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.
1. INDICATIONS AND USAGE
Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see
CLINICAL STUDIES (14)
].
Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
1 INDICATIONS AND USAGE
Zolmitriptan orally disintegrating tablets are a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a 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)
Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks.
Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan have not been established for cluster headache.
INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction.
If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL.
If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSAHS and SWSD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSAHS, or SWSD should periodically reevaluate long-term usefulness for the individual patient.
1 INDICATIONS AND USAGE
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important
[see Dosage and Administration (
2.1)]
.
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. (
1)
1 INDICATIONS AND USAGE
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are [see Clinical Studies (14)]:
Hospitalized, or
Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are:
Hospitalized, or
Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. (1)
1 INDICATIONS AND USAGE
Adults
Sildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)
Pediatric Patients (1 to17 years old)
Sildenafil tablet is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise (1, 14)
Adults
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Pediatric Patients (1 to 17 Years old)
Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram Tablets, USP 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 is 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 six months and which the person finds difficult to control. It must be associated with at least three 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
Ziprasidone is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)].
Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first. (1)
Ziprasidone capsules are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
Schizophrenia
Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].
Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Therapy
Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G.
Therapy with Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued.
CLINICAL INDICATION
INFECTING ORGANISM
Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis
Streptococcus pyogenes (group A -hemolytic streptococcus), other -hemolytic streptococci including groups C, H, G, L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains)
Anthrax
Bacillus anthracis
Actinomycosis (cervico-facial disease and thoracic and abdominal disease)
Actinomyces israelii
Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin)
Clostridium species
Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state)
Corynebacterium diphtheriae
Erysipelothrix endocarditis
Erysipelothrix rhusiopathiae
Fusospirochetosis (severe infections of the oropharynx [Vincent's], lower respiratory tract and genital area)
Fusobacterium species and spirochetes
Listeria infections including meningitis and endocarditis
Listeria monocytogenes
Pasteurella infections including bacteremia and meningitis
Pasteurella multocida
Haverhill fever
Streptobacillus moniliformis
Rat bite fever
Spirillum minus or Streptobacillus moniliformis
Disseminated gonococcal infections
Neisseria gonorrhoeae (Penicillin-susceptible)
Syphilis (congenital and neurosyphilis)
Treponema pallidum
Meningococcal meningitis and/or septicemia
Neisseria meningitidis
Gram-negative bacillary infections (bacteremias)
Penicillin G is not the drug of choice in the treatment of Gram-negative bacillary infections.
Gram-negative bacillary organisms (i.e. Enterobacteriaceae)
To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium and other antibacterial drugs, Penicillin G Potassium 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.
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin is an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8): Rosuvastatin has not been studied in Fredrickson Type I and V dyslipidemias.
1.3Hypertriglyceridemia
Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8Limitations of Use
Rosuvastatin has not been studied in Fredrickson Type I and Vdyslipidemias.
1
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USPare indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USPare indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets, USP 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, USP 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
).
INDICATIONS AND USAGE
Megace
ES (megestrol acetate) oral suspension is indicated for the
treatment of anorexia, cachexia, or an unexplained, significant weight loss in
patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
1
INDICATIONS AND USAGE
Asacol HD is indicated for the treatment of moderately active ulcerative colitisin adults.
Limitations of Use:Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.
AsacolHDisanaminosalicylateindicatedforthetreatmentofmoderately activeulcerativecolitisinadults.(1)
Li
m
itation
of
Use:
SafetyandeffectivenessofAsacolHDbeyond6weeks havenotbeenestablished(1)
Indications and Usage
Thermazene (Silver Sulfadiazine) Cream, 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
1 INDICATIONS AND USAGE
Bromday (bromfenac ophthalmic solution) 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bromday is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction .
(1)