um-ids/dailymed-annotations huggingface dataset:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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.
Azithromycin is 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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)]
1.1 Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae .
Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis. or Streptococcus pneumoniae .
Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae .
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae .
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2 Pediatric Patients
[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]
Acute otitis media (>6 months of age) caused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae
Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumonia , or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis (> 2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3 Limitations of Use
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomial infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
1 INDICATIONS AND USAGE
CYMBALTA is indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults and pediatric patients 13 years of age and older
Chronic musculoskeletal pain in adults
CYMBALTA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)
Chronic musculoskeletal pain in adults (1)
INDICATIONS AND USAGE
Amphetamine sulfate tablets, USP are indicated for:
1.
Narcolepsy
2.
Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
3.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below.
1 INDICATIONS AND USAGE
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use:
Metoclopramide tablets are 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)].
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy (1)
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis (1)
Limitations of Use:
Metoclopramide tablets are 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)
Celecoxib capsules are indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis(JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
INDICATIONS AND USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy
in edema associated with congestive heart failure, hepatic cirrhosis, and
corticosteroid and estrogen therapy.
Hydrochlorothiazide tablets have also been found useful in edema due to
various forms of renal dysfunction such as nephrotic syndrome, acute
glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide tablets are indicated in the management of hypertension
either as the sole therapeutic agent or to enhance the effectiveness of other
antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate
and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent
development of toxemia of pregnancy and there is no satisfactory evidence that
they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the
physiologic and mechanical consequences of pregnancy. Thiazides are indicated in
pregnancy when edema is due to pathologic causes, just as they are in the
absence of pregnancy (see PRECAUTIONS,
Pregnancy).
Dependent edema in pregnancy, resulting from restriction
of venous return by the gravid uterus, is properly treated through elevation of
the lower extremities and use of support stockings. Use of diuretics to lower
intravascular volume in this instance is illogical and unnecessary. During
normal pregnancy there is hypervolemia which is not harmful to the fetus or the
mother in the absence of cardiovascular disease. However, it may be associated
with edema, rarely generalized edema. If such edema causes discomfort, increased
recumbency will often provide relief. Rarely this edema may cause extreme
discomfort which is not relieved by rest. In these instances, a short course of
diuretic therapy may provide relief and be appropriate.
INDICATIONS AND USAGE
Hyoscyamine sulfate Injection, USPis effective as adjunctive therapy in the treatment of peptic ulcer. In acute episodes,Hyoscyamine sulfate Injection, USP can be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Parenterally administeredHyoscyamine sulfate Injection, USP is also effective in reducing gastrointestinal motility to facilitate diagnostic procedures such as endoscopy or hypotonic duodenography.Hyoscyamine sulfate Injection, USP may be used to reduce pain and hypersecretion in pancreatitis, in certain cases of partial heart block associated with vagal activity, and as an antidote for poisoning by anticholinesterase agents.
In Anesthesia:
Hyoscyamine sulfate Injection, USP is indicated as a pre-operative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.Hyoscyamine sulfate Injection, USP protects against the peripheral muscarinic effects such as bradycardia and excessive secretions produced by halogenated hydrocarbons and cholinergic agents such as physostigmine, neostigmine, and pyridostigmine given to reverse the actions of curariform agents.
In Urology:
Hyoscyamine sulfate Injection, USPmay also be used intravenously to improve radiologic visibility of the kidneys. It is also indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic.
INDICATIONS AND USAGE
Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration.
Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation,
except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes).
In controlled studies in the U.S., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous Verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in heart rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after Verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. The effect of a single injection lasts for 3060 minutes when conversion to sinus rhythm does not occur.
Because a small fraction (<1.0%) of patients treated with Verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation with an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole
see
Contraindications
and
Warnings
),
the initial use of intravenous Verapamil hydrochloride should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see
Suggested Treatment of Acute Cardiovascular Adverse Reactions
)
. As familiarity with the patients response is gained, an office setting may be acceptable.
Cardioversion has been used safely and effectively after intravenous Verapamil.
INDICATIONS AND USAGE
Depression-For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis-May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
INDICATIONS AND USAGE
Status Epilepticus
ATIVAN Injection is indicated for the treatment of status epilepticus.
Preanesthetic
ATIVAN Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see
PRECAUTIONS, Information for Patients
).
1 INDICATIONS AND USAGE
Potassium Phosphates Injection is indicated as a source of phosphorus:
in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated.
for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus:
in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. (1)
for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. (1)
1 INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].
Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (1)
INDICATIONS AND USAGE
Estradiol Tablets USP are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See
CLINICAL PHARMACOLOGY,
Clinical Studies.)
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
INDICATIONS AND USAGE
Tobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].
Limitations of Use
Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss [see Use in Specific Populations (8.4)].
Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. (1)
Limitations of Use:
Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss. (8.4)
1 INDICATIONS AND USAGE
Palonosetron hydrochloride injection is indicated in adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC).
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat coursesof moderately emetogenic cancer chemotherapy (MEC). (1)
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1)
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1)
Pediatric patients aged 1 month to less than 17 years for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC). (1)
INDICATIONS AND USAGE
NARDIL has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features.
NARDIL should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
1 INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
Ketorolac tromethamine
ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:
The treatment of inflammation following cataract surgery.
The temporary relief of ocular itching due to seasonal allergic conjunctivitis (1).
1.1 Class 3 Beta-Thalassemia
TEPADINA is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia [see Clinical Studies (14)].
1
INDICATIONS AND USAGE
ALPHAGAN
P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alphaadrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
ALPHAGAN
P
is an alphaadrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
Trazodone Hydrochloride Tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Trazodone Hydrochloride Tablets USP has been established in trials with the immediate release formulation of trazodone
[see Clinical Studies (
14)].