um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone (1.1).
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3).
Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4).
Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).
Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
1.1 Multiple Myeloma
Lenalidomide capsules in combination with
dexamethasone are indicated for the treatment of adult patients with multiple
myeloma (MM).
Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).
1.2 Myelodysplastic Syndromes
Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
1.3 Mantle Cell Lymphoma
Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
1.4 Follicular Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
1.5 Marginal Zone Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
1.6 Limitations of Use
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].
1 INDICATIONSANDUSAGE
Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy.
Drospirenone and ethinyl estradiol tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy.
(1)
1 INDICATIONS AND USAGE
Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer (1).
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging (1).
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
1 INDICATIONS AND USAGE
Tinidazole Tablets is a nitroimidazole antimicrobial indicated for:
Trichomoniasis (1.1)
Giardiasis: in patients age 3 and older (1.2)
Amebiasis: in patients age 3 and older (1.3)
Bacterial Vaginosis: in non-pregnant, adult women (1.4,
8.1)
1.1 Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by
Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies (14.1)].
1.2 Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by
Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age
[see Clinical Studies (14.2)].
1.3 Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage [see Clinical
Studies (14.3,
14.4)].
1.4 Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis,
Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women
[see Use in Specific
Populations (8.1) and Clinical Studies (14.5)].
Other pathogens commonly associated with vulvovaginitis such as
Trichomonas vaginalis, Chlamydia trachomatis, Neisseria
gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets 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.
INDICATIONS AND USAGE:
A wide range of dermatological clinical conditions benefit from NEXAVIR
therapy. The common denominator in these varied conditions is the presence of inflammation and edema. Favourable responses to the administration of NEXAVIR
in patients with acne vulgaris
5,6,7,8, herpes zoster, "poison ivy" dermatitis, pityriasis rosea, seborrheic dermatitis, urticaria and eczema
9,10,11, severe sunburn
12 and rosacea
13 have been reported.
INDICATIONS AND USAGE
Therapy
Buffered penicillin G potassium for injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered penicillin G potassium for injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued.
CLINICAL INDICATION
INFECTING ORGANISM
Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis
Streptococcus pyogenes (group A beta-hemolytic streptococcus), other beta-hemolytic streptococci including groups C, H, G, L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains)
Anthrax
Bacillus anthracis
Actinomycosis (cervicofacial disease and thoracic and abdominal disease)
Actinomyces Israelil
Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin)
Clostridium species
Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state)
Corynebacterium diphtheriae
Erysipelothrix endocarditis
Erysipelothrix rhusiopthiae
Fusospirochetosis (severe infections of the oropharynx [Vincents], lower respiratory tract and genital area)
Fusobacterium species and spirochetes
Listeria infections including meningitis and endocarditis
Listeria monocytogenes
Pasteurella infections including bacteremia and meningitis
Pasteurella multocida
Haverhill fever
Streptobacillus moniliformis
Rat-bite fever
Spirillum minus or Streptobacillus moniliformis
Disseminated gonococcal infections
Neisseria gonorrhoeae (penicillin-susceptible)
Syphilis (congenital and neurosyphilis)
Treponema pallidum
Meningococcal meningitis and/or septicemia
Neisseria meningitidis
Gram-negative bacillary infections (bacteremias)
Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, salmonella, shigella and Proteus mirabilis, Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G potassium 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.
INDICATIONSAND USAGE
Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
Indications and Usage
Fem pH
is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.
INDICATIONS AND USAGE
Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see
CLINICAL PHARMACOLOGY - Susceptibility Testing
).
Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with oxacillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin for 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
Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL
STUDIES (14)].
Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. (1)
1 INDICATIONS AND USAGE
Vigabatrin tablets are 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; Vigabatrin tablets are not indicated as a first line agent (1.1)
1.1 Refractory Complex Partial Seizures (CPS)
Vigabatrin tablets are 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)]. Vigabatrin tablets are not indicated as a first line agent for complex partial seizures.
Indications and Usage
Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.
Naproxen as naproxen sodium tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
1. Indications and Usage Section
Gabapentin tablets 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 epilepsyINDICATIONS AND USAGE
Gabapentin tablets 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
1 INDICATIONS AND USAGE
Extended phenytoin sodium capsules, USP are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (
1)
INDICATIONS AND USAGE
Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indictated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
1
INDICATIONS AND USAGE
CELEXAis indicated for the treatment of major depressive disorder (MDD)in adults[see Clinical Studies (
14
)].
CELEXA is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults(
1
).
1 INDICATIONS AND USAGE
TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.
TOSYMRA is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only if a clear diagnosis of migraine has been established (1)
Not indicated for the preventive treatment of migraine (1)
Not indicated for the treatment of cluster headache (1)
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
TOSYMRA is not indicated for the preventive treatment of migraine.
TOSYMRA is not indicated for the treatment of cluster headache.
INDICATIONS AND USAGE
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Topiramate extended-release capsules are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older (1.3)
1.1	Monotherapy Epilepsy
Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2	Adjunctive Therapy Epilepsy
Topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older.
1.3	Migraine
Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS AND USAGE
Meloxicam is a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1 INDICATIONS AND USAGE
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study
(adults and elderly) [see Clinical Studies (14)].
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
INDICATIONS AND USAGE
Lortab 2.5/500 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) are indicated for the relief of moderate to moderately severe pain.
1 INDICATIONS AND USAGE
Sildenafil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
1 INDICATIONS AND USAGE
Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see
Dosage and Administration(2.1)].
Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [
see Dosage and Administration (1)
].