um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
LOTEMAX is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication.
LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.
1 INDICATIONS AND USAGE
WELCHOL is a bile acid sequestrant indicated as an adjunct to diet and exercise to:
reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (
1.1).
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (
1.1).
improve glycemic control in adults with type 2 diabetes mellitus (
1.2).
Limitations of Use (
1.3):
Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V dyslipidemias
1.1
Primary Hyperlipidemia
WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
WELCHOL is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.
1.2
Type 2 Diabetes Mellitus
WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
.
1.3
Limitations of Use
WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
WELCHOL has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
Bethanechol Chloride Tablets USP are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)
Congenital adrenal hyperplasia
Non suppurative thyroiditis
Hypercalcemia associated with cancer
1 INDICATIONS AND USAGE
SOLOSEC is a nitroimidazole antimicrobial indicated for
Treatment of bacterial vaginosis in female patients 12 years of age and older. (1.1)
Treatment of trichomoniasis in patients 12 years of age and older. (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.3)
1.1 Bacterial Vaginosis
SOLOSEC is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older [see Use in Specific Populations (8.1) and Clinical Studies (14)].
1.2 Trichomoniasis
SOLOSEC is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis in patients 12 years of age and older. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, treat partners of infected patients simultaneously in order to prevent reinfection [see Dosage and Administration (2.2)andClinical Studies (14.2)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC 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
Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment
of acute, uncomplicated influenza A and B in patients 2 weeks of age and
older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis
of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not
a substitute for annual influenza vaccination. (1.3)
Consider
available information on influenza drug susceptibility patterns and
treatment effects when deciding whether to use. (1.3)
Not
recommended for patients with end-stage renal disease not undergoing
dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir Phosphate for Oral Suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir Phosphate for Oral Suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir
Phosphate for Oral Suspension is not a substitute for early influenza vaccination
on an annual basis as recommended by the Centers for Disease Control and
Prevention Advisory Committee on Immunization Practices.
Influenza
viruses change over time. Emergence of resistance substitutions could decrease
drug effectiveness. Other factors (for example, changes in viral
virulence) might also diminish clinical benefit of antiviral drugs. Prescribers
should consider available information on influenza drug susceptibility
patterns and treatment effects when deciding whether to use Oseltamivir
Phosphate for Oral Suspension [see Microbiology
(12.4)] .
Oseltamivir
Phosphate for Oral Suspension is not recommended for patients with
end-stage renal disease not undergoing dialysis [see Dosage
and Administration (2.4) and Use in Specific
Populations (8.6)].
INDICATION AND USAGE
Doxepin is recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety.
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in pediatric patients under 12 years of age
INDICATIONS AND USAGE
In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.
In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.
To relieve hypertonicity of the uterine muscle.
To relax the spasm of biliary and uretered colic and bronchial spasm.
To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.
To control the crying and laughing episodes in patients with brain lesions.
In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs.
In the management of peptic ulcer.
In anesthesia to control excessive salivation and bronchial secretions.
To control rhinorrhea of acute rhinitis or hay fever.
As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.
In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. Adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. If an atropine effect is not apparent within thirty minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements, and excessive sweating, salivation, and bronchial secretion), atropine sulfate, 2 mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to 6 mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.
INDICATIONS AND USAGE
Ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older.Ipratropium bromide nasal solution, 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.
The safety and effectiveness of the use of ipratropium bromide nasal solution,0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
INDICATIONS AND USAGE
Lithium carbonate is indicated in the treatment of manic episodes
of manic-depressive illness. Maintenance therapy prevents or diminishes the
intensity of subsequent episodes in those manic-depressive patients with a
history of mania.
Typical symptoms of mania include pressure of speech, motor hyperactivity,
reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment,
aggressiveness and possibly hostility. When given to a patient experiencing a
manic episode, lithium carbonate may produce a
normalization of symptomatology within 1 to 3 weeks.
INDICATIONS & USAGE SECTION
Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitisVasomotor
rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild,
uncomplicated allergic skin manifestations of urticaria and
angioedema.Amelioration of allergic reactions to blood or plasmaCold
urticariaDermatographismAs therapy for anaphylactic reactions adjunctive
to epinephrine and other standard measures after the acute manifestations have
been controlled.
1	INDICATIONS AND USAGE
Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
Zydelig is a kinase inhibitor indicated for the treatment of patients with:
Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. (1)
Limitations of use:
Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. (1, 6.1)
Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas. (6.1)
Limitations of Use
Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas.
Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.
1 INDICATIONS AND USAGE
ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. (1.1)
ZYCLARA Cream, 3.75% is also indicated for the topical treatment of external genital and perianal warts/condyloma acuminata (EGW) in patients 12 years or older. (1.2)
Limitations of Use: Efficacy of imiquimod cream was not demonstrated for molluscum contagiosum in children 2 to 12 years of age. (1.3, 8.4)
1.1 Actinic Keratosis
ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
1.2 External Genital Warts
ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
1.3 Limitations of Use
Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].
Treatment with ZYCLARA Cream has not been studied for prevention or transmission of human papillomavirus (HPV).
1.4 Unevaluated Populations
The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:
urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease.
actinic keratosis when treated with more than one 2-cycle treatment course in the same area.
patients with xeroderma pigmentosum.
superficial basal cell carcinoma.
immunosuppressed patients.
INDICATIONS AND USAGE
Hypertension
Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Chronic Stable Angina
Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of chronic stable angina.
FULL PRESCRIPING INFORMATION
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].
Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.
Zolmitriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
INDICATIONS AND USAGE
Dipyridamole is a coronary vasodilator and is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately
1 INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia. (14.1)
Irritability Associated with Autistic Disorder. (14.4)
Treatment of Tourettes disorder. (14.5)
INDICATIONS & USAGE
Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.
Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.
The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N.gonorrhoeae is not established.
For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
caused by Haemophilusinfluenzae (including -lactamase producing strains), Haemophilusparainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis
caused by Haemophilusinfluenzae (including -lactamase producing strains), Haemophilusparainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
caused by Haemophilusinfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis
caused by
Streptococcus pyogenes
(see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media
caused by Haemophilusinfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Ziprasidone capsules are 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 ziprasidones 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)].
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)].
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 (5.3)
Ziprasidone is indicated as an oral formulation for the:
Treatment of schizophrenia. (1)
Acute treatment 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. (1)
1 INDICATIONS AND USAGE
Mesalamine delayed-release tablets are indicated for the:
induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis.
Pediatric use information is approved for Takeda Pharmaceuticals U.S.A., Inc.s LIALDA (mesalamine) delayed-release tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Mesalamine delayed-release tablets are an aminosalicylate indicated for the:
induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. (1)