um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of:
Parkinson's disease (PD) (1.1)
Moderate-to-severe
primary Restless Legs Syndrome (RLS) (1.2)
1.1 Parkinson's Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
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 ). 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 ). 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.
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.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
Seizure Disorders:
Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.
In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.
Panic Disorder:
Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see
CLINICAL PHARMACOLOGY: Clinical Trials).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. (1)
Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are indicated for use by females of reproductive potential to prevent pregnancy.
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Adapalene and benzoyl peroxide topical gel, is a combination of adapalene, a retinoid and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. (1)
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, USPare 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 Pneumoniacaused by
Haemophilus influenzae(including -lactamase producing strains),
Haemophilus parainfluenzae(including -lactamase producing strains),
Streptococcus pneumoniae(penicillin-susceptible strains only), and
Moraxella catarrhalis(including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitiscaused by
Haemophilus influenzae(including -lactamase producing strains),
Haemophilus parainfluenzae(including-lactamase producing strains),
Streptococcus pneumoniae(penicillin-susceptible strains only), and
Moraxella catarrhalis(including -lactamase producing strains).
Acute Maxillary Sinusitiscaused by
Haemophilus influenzae(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. pyogenesfrom the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenespharyngitis/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 Mediacaused by
Haemophilus influenzae(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. pyogenesfrom the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenespharyngitis/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
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.
Neostigmine Methylsulfate, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery (1).
INDICATIONS AND USAGE
Edema
Furosemide tablets, USP is indicated in adults and
pediatric patients for the treatment of edema associated with congestive heart
failure, cirrhosis of the liver, and renal disease, including the nephrotic
syndrome. Furosemide is particularly useful when an agent with greater diuretic
potential is desired.
Hypertension
Furosemide tablets, USP may be used in adults for the
treatment of hypertension alone or in combination with other antihypertensive
agents. Hypertensive patients who cannot be adequately controlled with thiazides
will probably also not be adequately controlled with furosemide alone.
CONTRAINDICATIONS
Furosemide tablets are contraindicated in patients with
anuria and in patients with a history of hypersensitivity to furosemide.
1.1	Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
INDICATIONS AND USAGE
Methazolamide Tablets USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.
INDICATIONS AND USAGE:
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the
BOXED WARNING
, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes,
Streptococcus pneumoniae
, other streptococci (except
E. faecalis
), and
Staphylococcus aureus
.
Skin and skin structure infections caused by
Streptococcus pyogenes, Staphylococcus aureus
, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by
Staphylococcus aureus
, streptococci (except
Enterococcus faecalis
), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by
Staphylococcus aureus
and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP 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
Gabapentin capsules are indicated for:
Management of postherpetic neuralgia in adults
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
INDICATIONS & USAGE SECTION
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS AND USAGE
For relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions.
INDICATIONS AND USAGE
Baclofen Injection is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of Baclofen Injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen Injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of Baclofen Injection into the intrathecal space.
Spasticity
of
Spinal
Cord
Origin: Evidence supporting the efficacy of Baclofen Injection was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of Baclofen Injection to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen Injection was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.
Spasticity
of
Cerebral
Origin: The efficacy of Baclofen Injection was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; Baclofen Injection was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.
Baclofen Injection therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of Baclofen Injection, patients must show a response to Baclofen Injection in a screening trial (see Dosage and Administration).
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia
1.1 Hypertension
Amlodipine besylate tablet, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablet, USP.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Amlodipine besylate tablet, USP may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
VIGAMOX solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic Gram-positive microorganisms
:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Aerobic Gram-negative microorganisms
:
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*
Other microorganisms
:
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
1
INDICATIONS AND USAGE
ACIPHEX delayed-release tablets is a proton-pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance of Healing of Erosive or Ulcerative GERD (1.2).
Treatment of Symptomatic GERD (1.3).
Healing of Duodenal Ulcers (1.4).
Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (1.7).
1.1
Healing of Erosive or Ulcerative GERD
in Adults
ACIPHEX delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.
1.2
Maintenance of Healing of Erosive or Ulcerative GERD
in Adults
ACIPHEX delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance).Controlled studies do not extend beyond 12 months.
1.3
Treatment of Symptomatic GERD
in Adults
ACIPHEX delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4
Healing of Duodenal Ulcers
in Adults
ACIPHEX delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5
Helicobacter pylori
Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
in
Adults
ACIPHEX delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen,are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [
see
Clinical Pharmacology(12.2)
and the full prescribing information for clarithromycin].
1.6
Treatment of Pathological Hypersecretory Conditio
ns, Including Zollinger-Ellison
Syndrome
in Adults
ACIPHEX delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7
Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
ACIPHEX delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.