um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Felodipine Extended-release Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 felodipine. 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 1 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 (eg, on angina, heart failure, or diabetic kidney disease).
These considerations may guide selection of therapy.
Felodipine Extended-release Tablets, USP may be administered with other antihypertensive agents.
1 INDICATIONS AND USAGE
Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist.
Aprepitant capsules are indicated
in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)
for prevention of postoperative nausea and vomiting (PONV) in adults (1.2)
Limitations of Use: (1.3)
Aprepitant has not been studied for treatment of established nausea and vomiting.
Chronic continuous administration of aprepitant is not recommended.
1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
Aprepitant capsules, in combination with other antiemetic agents, are indicated in patients 12 years of age and older for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
1.2 Prevention of Postoperative Nausea and Vomiting (PONV)
Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting.
1.3 Limitations of Use
Aprepitant has not been studied for the treatment of established nausea and vomiting.
Chronic continuous administration of aprepitant is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
INDICATIONS AND USAGE
ALFENTA (alfentanil hydrochloride) 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).SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTA.
INDICATIONS
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam 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.
1 INDICATIONS AND USAGE
ZYVOX is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. ZYVOX is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [
see
Warnings and Precautions (5.4)
].
ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (
1.1); Community-acquired pneumonia (
1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (
1.2); Uncomplicated skin and skin structure infections (
1.2); Vancomycin-resistant
Enterococcus faecium infections. (
1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.4)
1.1
Pneumonia
Nosocomial pneumonia caused by
Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or
Streptococcus pneumoniae [
see
Clinical Studies (14)
].
Community-acquired pneumonia caused by
Streptococcus pneumoniae, including cases with concurrent bacteremia, or
Staphylococcus aureus (methicillin-susceptible isolates only) [
see
Clinical Studies (14)
].
1.2
Skin and Skin Structure Infections
Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by
Staphylococcus aureus (methicillin-susceptible and -resistant isolates),
Streptococcus pyogenes, or
Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers [
see
Clinical Studies (14)
].
Uncomplicated skin and skin structure infections caused by
Staphylococcus aureus (methicillin-susceptible isolates only) or
Streptococcus pyogenes [
see
Clinical Studies (14)
].
1.3
Vancomycin-resistant
Enterococcus faecium Infections
Vancomycin-resistant
Enterococcus faecium infections,
including cases with concurrent bacteremia [
see
Clinical Studies (14)
].
1.4
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX 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.
The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:
Arthritis
Simple Backache
Strains
Sprains
Bruises
Indications And Usage
Lidocaine hydrochloride injection administered intravenously or intramuscularly, is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.
INDICATIONS AND USAGE
Anxiety Disorders
Alprazolam Tablets, USP (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short- term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients:
Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability);
Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat');
Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to Alprazolam tablets, USP.
Panic Disorder
Alprazolam Tablets, USP is also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see
CLINICAL STUDIES).
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.
Demonstrations of the effectiveness of Alprazolam tablets, USP by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
In this dosage form, 5% Dextrose Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTORTM.
1 INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (1.1)
Epilepsymonotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine orally disintegrating tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine orally disintegrating tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.2)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
INDICATIONS AND USAGE
Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
1 INDICATIONS AND USAGE
Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors (1)
Multiple myeloma-in combination with prednisone (1)
Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs (1)
Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs (1)
Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
Multiple myeloma in combination with prednisone.
Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
INDICATIONS AND USAGE
Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING,
WARNINGS and PRECAUTIONS: Pediatric Use
).
1 INDICATIONS AND USAGE
Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. (1)
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Monotherapy epilepsy: Initial monotherapy
in patients
2 years of age with partial onset or primary
generalized tonic-clonic seizures (1.1)
Adjunctive therapy epilepsy: Adjunctive
therapy for adults and pediatric patients (2 to 16 years of age) with
partial onset seizures or primary generalized tonic-clonic seizures, and
in patients 2 years of age with seizures associated with
Lennox-Gastaut syndrome (LGS) (1.2)
1.1 Monotherapy Epilepsy
Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (
1.1)
1.1 Oral Contraceptive
Norgestimate and Ethinyl Estradiol Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)]
.
INDICATIONS AND USAGE
Griseofulvin Oral Suspension, USP is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis
Tinea pedis Tinea cruris Tinea barbae Tinea capitis
Tinea unguium when caused by one or more of the following species of fungi:
Epidermophyton floccosum
Microsporum audouinii
Microsporum canis
Microsporum gypseum
Trichophyton crateriform
Trichophyton gallinae
Trichophyton interdigitalis
Trichophyton megnini
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton schoenleini
Trichophyton sulphureum
Trichophyton tonsurans
Trichophyton verrucosum
Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection.
Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.
Griseofulvin is not effective in the following:
Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Sporotrichosis Chromoblastomycosis Coccidioidomycosis North American Blastomycosis Cryptococcosis (Torulosis) Tinea versicolor Nocardiosis
The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.
1. Indications & Usage
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
1 INDICATIONS AND USAGE
Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1)
Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. (1.2)
1.1 Plaque Psoriasis
Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.
1.2 Acne Vulgaris
Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
1 INDICATIONSAND USAGE
Neostigmine Methylsulfate Injection, USP is a cholinesterase inhibitor indicated for the reversal of theeffects of non-depolarizing neuromuscular blocking agents after surgery.
Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.