um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Promethazine HCl Oral Solution is useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
Amiodarone hydrochloride is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. (
1)
Recurrent hemodynamically unstable ventricular tachycardia. (
1)
1 INDICATIONS AND USAGE
GATTEX is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
GATTEX is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. (1)
INDICATIONS AND USAGE
For use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis,
cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
INDICATIONS AND USAGE
Levothyroxine sodium is used for the following indications:
Hypothyroidism
As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression
In the treatment or prevention of various types of euthyroid goiters (see WARNINGS andPRECAUTIONS), including thyroid nodules (see WARNINGS andPRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimotos thyroiditis), multinodular goiter (see WARNINGSandPRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
1 INDICATIONS AND USAGE
ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults.
ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults (1).
1 INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets
is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral Contraceptive
Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone and ethinyl estradiol tablets for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Drospirenone and ethinyl estradiol tablets
have not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3 Acne
Drospirenone and ethinyl estradiol tablets are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1 INDICATIONS AND USAGE
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
GIMOTI is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (1)
Limitations of Use:
GIMOTI is not recommended for use in:
pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. (1, 8.4)
moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. (1, 5.9, 7.1)
Limitations of Use:
GIMOTI is not recommended for use in:
pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4)].
moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions [see Warnings and Precautions (5.9)].
INDICATIONS AND USAGE
Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I 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 I: 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.
Adapted from Hatcher et al, 1998, Ref #1.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use
% of Women Continuing Use at One Year
Method
(1)
Typical Use
(2)
Perfect Use
(3)
(4)
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
CapWith spermicidal cream or jelly.
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
2.0
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
In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.
1 INDICATIONS AND USAGE
These highlights do not include all the information needed to use levetiracetam oral solution, USP safely and effectively. See full prescribing information for levetiracetam oral solution, USP.
Levetiracetam oral solution, USP
Initial U.S. Approval: 1999
Levetiracetam oral solution, USPis an antiepileptic drug indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients one month of age and older with epilepsy
(1.1)
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
Levetiracetam oral solution, USPis indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam oral solution, USPis indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution, USPis indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE:
Pilocarpine hydrochloride can be used in the medical management of glaucoma, especially open-angle glaucoma, in those cases in which the intraocular pressure can be controlled adequately by the topical administration of pilocarpine. In acute (closed-angle) glaucoma, pilocarpine hydrochloride may be used alone, or in combination with other cholinergic agents or carbonic anhydrase inhibitors, to relieve tension prior to emergency surgery.
Patients may be maintained on pilocarpine hydrochloride as long as intraocular pressure is controlled and there is no deterioration in the visual fields. The choice of concentration should be determined by the severity of the condition and the response of the patient. Pilocarpine hydrochloride is also indicated to counter the effects of cycloplegics and mydriatics following surgery or ophthalmoscopic examination.
1 INDICATIONS AND USAGE
FABIOR (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.
FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. (1)
1 INDICATIONS AND USAGE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
INDICATIONS
Prednisone tablets and solutions are indicated in the following conditions:
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
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Allergic conjunctivitis
Keratitis
Chorioretinitis
Optic neuritis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Loefflers syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
1. INDICATIONS AND USAGE
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:
Control and prevention of bleeding episodes
Perioperative management
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:
Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX. (1)
1 INDICATIONS AND USAGE
Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3)
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4)
1.1 Prophylaxis of Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1)]
in patients undergoing hip replacement surgery, during and following hospitalization
in patients undergoing knee replacement surgery
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
1.2 Treatment of Acute Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for:
the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin Sodium Injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
1 INDICATIONS AND USAGE
Digoxin Tablets, USP are a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3)
1.1 Heart Failure in Adults
Digoxin Tablets, USP are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets, USP increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, Digoxin Tablets, USP should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2 Heart Failure in Pediatric Patients
Digoxin Tablets, USP increase myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults
Digoxin Tablets, USP are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
1 INDICATIONS AND USAGE
Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.
Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, is indicated for reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery (1).
1 INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria.
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see DOSAGE AND ADMINISTRATION (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablets, taken in combination with ethambutol, are indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (
14.1
)].
Generalized Anxiety Disorder [see Clinical Studies (
14.2
)].
Diabetic Peripheral Neuropathy [see Clinical Studies (
14.3
)].
Chronic Musculoskeletal Pain [see Clinical Studies (
14.5
)].
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)