um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established.
1 INDICATIONS AND USAGE
Eptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI). (1.1)
Treatment of patients undergoing PCI (including intracoronary stenting). (1.2)
1.1 Acute Coronary Syndrome (ACS)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
1.2 Percutaneous Coronary Intervention (PCI)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [seeClinical Studies (14.1,
14.2)].
1
INDICATIONS AND USAGE
MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. (1)
INDICATIONS AND USAGE
Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
Keep out of reach of children
Discontinue use of signs of irritation occur
Caution: For External Use only. Avoid contact with eyes.
no such information
Water/Aqua, Cyclomethicone, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Stearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Diisostearyl Polyglyceryl-3 Diisostearate, Trimethylsiloxysilicate, Cyclopentasiloxane, Glyceryl stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl
Butylcarbamate, Silica Silylate, Stearoyl inulin, panthenol, Sodium Chloride, Tocopheryl Acetate, Trisodium EDTA, Triethoxycaprylysilane, [May contain /+/- =: Titanium DIoxide/CI77891, Iron Oxides/CI77491/77492/77499].
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsulesare indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
[see
Clinical Studies (14)]
. Tamsulosin hydrochloride capsulesare not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules are an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia.
(1)
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
(1)
INDICATIONS AND USAGE
PREMASOL 10%
injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10%
injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).
Central Venous Nutrition
Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants, or those requiring long-term parenteral nutrition.
Peripheral Parenteral Nutrition
For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5-10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.
INDICATIONS AND USAGE
Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
INDICATIONS AND USE
Metformin HCL Tablets, USPare indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Releevia MC Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Releevia MC Patch is an external analgesic/counterirritant.
Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or 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.
The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others
Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets, USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1) Social Anxiety Disorder (SAD) (1.2)
1.1	Major Depressive Disorder
Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD).Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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.
1.2	Social Anxiety Disorder
Venlafaxine extended-release tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV.Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended-release tablets in the treatment of SAD was established in short-term SAD trials [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS
], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated,
have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (
1.1,
1.2)
1.1 Parkinsons Disease
Ropinirole tablets are indicated for the treatment of Parkinsons disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
1.	INDICATIONS AND USAGE
NALFON is indicated for:
Relief of mild to moderate pain in adults.
Relief of the signs and symptoms of rheumatoid arthrites.
Relief of the signs and symptoms of osteoarthritis.
NALFON is a nonsteroidal anti-inflammatory drug indicated for:
Relief of mild to moderate pain in adults. (
1)
Relief of the signs and symptoms of rheumatoid arthritis. (
1)
Relief of the signs and symptoms of osteoarthritis. (
1)
INDICATIONS & USAGE SECTION
Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain
INDICATIONS AND USAGE
Hypertension
Losartan potassium tablets USP are indicated for the treatment of hypertension. Losartan potassium may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy
Losartan potassium tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)
Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP 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 beconsidered in selecting ormodifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections (
1.1)
Acute bacterial otitis media (
1.2)
Sinusitis (
1.3)
Skin and skin structure infections (
1.4)
Urinary tract infections (
1.5)
1.1 Lower Respiratory Tract Infections
- caused by beta-lactamase-producing isolates of
Haemophilus
influenzae
and
Moraxella
catarrhalis.
1.2 Acute Bacterial
Otitis
Media
- caused by beta-lactamase-producing isolates of
H.
influenzae
and
M.
catarrhalis.
1.3 Sinusitis
- caused by beta-lactamase-producing isolates of
H.
influenzae
and
M.
catarrhalis.
1.4 Skin and Skin Structure Infections
- caused by beta-lactamase-producing isolates of
Staphylococcus
aureus,
Escherichia coli, and
Klebsiella
species.
1.5 Urinary Tract Infections
- caused by beta-lactamase-producing isolates of
E. coli,
Klebsiella
species, and
Enterobacter
species.
1.6 Limitations of Use
- When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP should not be used.
1. Indications and Usage
Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults.
1 INDICATIONS AND USAGE
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. (1)
Limitations of Use
:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Naproxen as naproxen or 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
Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.
Naproxen as naproxen and naproxen sodium tablets are also indicated:
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
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3)
1.1	Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)].
1.2	Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets should
only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see
DOSAGE AND ADMINISTRATION (2)
]
.
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
INDICATIONS AND USAGE
Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin hydrochloride capsules, USP are 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 colitis, as described in the
BOXED WARNING, before selecting clindamycin hydrochloride capsules, USP, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, 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
Naftifine hydrochloride cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.
Naftifine hydrochloride cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.(1)
1 INDICATIONS AND USAGE
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of:
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1)
Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2)
1.1 Myelodysplastic Syndromes (MDS)
Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
1.2 Juvenile Myelomonocytic Leukemia (JMML)
Azacitidine for injection is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed JMML.