um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
1. Primary hypogonadism (congenital or acquired)- testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
2. Hypogonadotropic hypogonadism (congenital or acquired)- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y
12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets
has been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets
has been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Fluconazole tablets, USP are indicated for the treatment of:
1.Vaginal candidiasis (vaginal yeast infections due to Candida).
2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets, USP were also effective for the treatment of Candida urinary tract infections, peritonitis and systemic Candida infections including candidemia, disseminated candidiasis and pneumonia.
3.Cryptococcal meningitis. Before prescribing fluconazole tablets, USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. Fluconazole tablets, USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1INDICATIONS AND USAGE
ILEVRO 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.
ILEVRO 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery (1).
INDICATIONS & USAGE
Citalopram tablets, USPare indicated for the treatment of depression.The efficacy of citalopram tablets, USPin the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
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. The antidepressant action of citalopram tablets, USPin hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram tablets, USPin maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram tablets, USPfor extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
In patients without structural heart disease, Flecainide Acetate Tablets USP are indicated for the prevention of:
paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
Flecainide Acetate Tablets USP are also indicated for the prevention of:
documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
Use of Flecainide Acetate Tablets USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of Flecainide Acetate Tablets USP is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of Flecainide Acetate Tablets USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide Acetate Tablets USP should not be used in patients with recent myocardial infarction. (See Boxed
WARNINGS
).
Use of Flecainide Acetate Tablets USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed
WARNINGS
).
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Flecainide Acetate Tablets USP favorably affects survival or the incidence of sudden death.
USES
For the treatment and/or prevention of diaper rash.
Temporarily protects and helps relieve chapped or cracked skin.
INDICATIONS AND USAGE
Postmenopausal Osteoporosis
FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. Use of FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (400 International Units per day) intake to retard the progressive loss of bone mass. The evidence of efficacy for calcitonin-salmon is based on increases in spinal bone mineral density (BMD) observed in clinical trials.
Two randomized, placebo-controlled trials were conducted in 325 postmenopausal women (227 treated with calcitonin-salmon nasal spray and 98 treated with placebo) with spinal, forearm or femoral BMD at least one standard deviation below the normal value for healthy premenopausal women. These studies conducted over two years demonstrated that 200 International Units daily of calcitonin-salmon nasal spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic women who were greater than 5 years postmenopause. Calcitonin-salmon nasal spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as 6 months after initiation of therapy with persistence of this level for up to 2 years of observation.
No effects of calcitonin-salmon nasal spray on cortical bone of the forearm or hip were demonstrated. However, in one study, BMD of the hip showed a statistically significant increase compared with placebo in a region composed of predominantly trabecular bone after 1 year of treatment changing to a trend at 2 years that was no longer statistically significant.
1
INDICATIONS AND USAGE
SABRIL is indicated for the
treatment of:
Refractory Complex
Partial Seizures as adjunctive therapy in patients 2 years of age and older who have
responded inadequately to several alternative treatments; SABRIL is not
indicated as a first line agent (1.1)
Infantile Spasms -
monotherapy in infants 1 month to 2 years of age for whom the potential
benefits outweigh the potential risk of vision loss (1.2)
1.1
Refractory Complex Partial Seizures (CPS)
SABRIL is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1)]. SABRIL is not indicated as a first line agent for complex partial seizures.
1.2
Infantile Spasms (IS)
SABRIL is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of agefor whom the potential benefits outweigh the potential risk of vision loss [see
Warnings and Precautions (5.1)
].
1 INDICATIONS AND USAGE
Desloratadine is a histamine-1 (H1) receptor antagonist indicated for:
Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.1)
Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.2)
Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older. (1.3)
1.1 Seasonal Allergic Rhinitis
Desloratadine
tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
1.2 Perennial Allergic Rhinitis
Desloratadine
tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.
1.3 Chronic Idiopathic Urticaria
Desloratadine
tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.
INDICATIONS
Haloperidol injection is indicated for use in the treatment of schizophrenia.
Haloperidol is indicated for the control of tics and vocal utterances of Tourette's Disorder.
INDICATIONS AND USAGE
Ergocalciferol Capsules, USP are indicated for use in the treatment of
hypoparathyroidism, refractory rickets, also known as vitamin D
resistant rickets, and familial hypophosphatemia.
INDICATIONS AND USAGE
Cimetidine Hydrochloride Oral Solution is indicated in:
(1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.
(2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years.
(3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.
(4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD).
(5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis,multiple endocrine adenomas).
1 INDICATIONS AND USAGE
XURIDEN is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.
XURIDEN is a pyrimidine analog for uridine replacement indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. (1)
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are 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
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine delayed-release capsule 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
(1)
Chronic musculoskeletal pain in adults
(1)
1 INDICATIONS AND USAGE
Alfentanil HCl Injection is indicated:
as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen.
as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia.
as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.
as the analgesic component for monitored anesthesia care (MAC).
Alfentanil HCl Injection is an opioid indicated:
as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen.
as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia
as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.
as the analgesic component for monitored anesthesia care (MAC) (1)
1 INDICATIONS AND USAGE
1.1 Infections of the Ear, Nose, and Throat:
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus species. (- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract:
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Escherichia coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure:
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5
Helicobacter pylori Infection
Triple therapy for
Helicobacter pylori with clarithromycin and lansoprazole:
Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for
H. pylori with lansoprazole
: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Haloperidol is indicated for use in the management of manifestations of psychotic disorders.
Haloperidol is indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
INDICATIONS & USAGE
Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
INDICATIONS AND USAGE
Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to short ragweed pollen. Confirmation is determined by skin testing.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-Release Tablets, USP and other treatment options before deciding to use Diclofenac Sodium Extended-Release Tablets, USP.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac Sodium Extended-Release Tablets, USP are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Latanoprost is a prostaglandin F2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
INDICATIONS & uSAGE
Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.
Antihistaminic: For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
Motion sickness: For active treatment of motion sickness.
Antiparkinsonism: For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
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.
INDICATIONS AND USAGE
HMS (medrysone ophthalmic suspension) is indicated for the treatment of allergic conjunctivitis, vernal conjunctivitis, episcleritis, and epinephrine sensitivity.
INDICATIONS AND USAGE:
Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.
1. Indications and Usage Section
1 INDICATIONS & USAGE
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy