um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Important limitations of use: Safety and efficacy of AXIRON in males <18 years old have not been established (8.4)
Important limitations of use
Safety and efficacy of AXIRON in males <18 years old have not been established [see Use in Specific Populations (8.4)].
INDICATIONS AND USAGE
Epilepsy
Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types.2. Generalized tonic-clonic seizures (grand mal).3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do notappear to be controlled by carbamazepine (see
PRECAUTIONS, General
).
Trigeminal Neuralgia
Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
INDICATIONS AND USAGE
Hypertension
Amlodipine besylate is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Chronic Stable Angina
Amlodipine besylate is indicated for the treatment of chronic stable angina. Amlodipine besylate may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs.
1 INDICATIONS AND USAGE
AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures.
AKTEN is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. (1)
1 INDICATIONS & USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection (1.1) Otitis media (1.2) Skin and skin structure infections (1.3) Bone infections (1.4) Genitourinary tract infections (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen
Levofloxacin in 5% Dextrose Injectionis indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible
Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant
Streptococcus pneumoniae [MDRSP]),
Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or
Mycoplasma pneumoniae [see Dosage and Administration (
2.1) and Clinical Studies (
14.2)]
.
MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC
2 mcg/mL), 2
nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
1 INDICATIONS & USAGE
Methylphenidate hydrochloride oral solutionisindicatedforthetreatmentof:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older
Narcolepsy
Methylphenidate hydrochloride oral solutionisacentralnervoussystem(CNS)stimulantindicatedforthetreatmentof:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older (1)
Narcolepsy (1)
1 INDICATIONS AND USAGE
Fluoxetine Tablets is indicated for the treatment of:
Major Depressive Disorder (MDD). The efficacy of
fluoxetine in MDD was established in one 5-week trial, three 6-week
trials, and one maintenance study in adults. The efficacy of fluoxetine
was also established in two 8- to 9-week trials in pediatric patients 8 to
18 years of age [see CLINICAL STUDIES (14.1)].
Obsessions and compulsions in patients with Obsessive
Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was
demonstrated in two 13-week trials in adults and one
13-week trial in pediatric patients 7 to 17 years of age [see CLINICAL STUDIES (14.2)].
Binge-eating and vomiting behaviors in patients with
moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia
Nervosa was demonstrated in two 8-week trials
and one 16-week trial in adults [see CLINICAL STUDIES (14.3)].
Panic Disorder, with or
without agoraphobia. The efficacy of fluoxetine in Panic Disorder was
demonstrated in two 12-week trials in adults [see CLINICAL STUDIES (14.4)].
Fluoxetine tablets is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
Major Depressive Disorder (MDD) (1)
Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study (14.1)
Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age (14.1)
Obsessive Compulsive Disorder (OCD) (1)
Adults: Efficacy was established in two 13-week trials (14.2)
Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age (14.2)
Bulimia Nervosa (1)
Adults: Efficacy was established in two 8-week trials and one 16-week trial (14.3)
Panic Disorder, with or without agoraphobia (1)
Adults: Efficacy was established in two 12-week trials (14.4)
1 INDICATIONS AND USAGE
ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). (
1)
Cold Agglutinin Disease
ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
1 INDICATIONS AND USAGE
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.
Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1)
Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea.
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to betablockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see
Clinical Studies (14)
].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
1 INDICATIONS AND USAGE
Adults
LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Adults
LIQREV is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)
INDICATIONS AND USAGE
CARAFATE(sucralfate)OralSuspensionisindicated intheshort-term(upto8 weeks)treatment of active duodenal ulcer.
CLINICAL STUDIES
In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL(clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:
Lesions
CLINDAGEL QD
N=162
Vehicle Gel QD
N=82
Inflammatory
51%
40% P<0.05
Noninflammatory
25%
12%
Total
38%
27%
There was a trend in the investigators global assessment of the results, which favoredCLINDAGEL QD over the vehicle QD.
In a contactsensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to CLINDAGEL. There was no signal for contact sensitization in the clinical trials under normal use conditions.
1. INDICATIONS AND USAGE
Jakafi is a kinase inhibitor indicated for treatment of:
intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. (1.1)
polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. (1.2)
steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older (1.3)
chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (1.4)
1.1
Myelofibrosis
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
1.2 Polycythemia Vera
Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
1.3 Acute Graft-Versus-Host Disease
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
1.4 Chronic
Graft-Versus-Host Disease
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
1	INDICATIONS AND USAGE
Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. (1.1)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2)
1.1	Treatment of Postmenopausal Osteoporosis
Ibandronate sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14)].
1.2	Important Limitations of Use
The safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONSAND USAGE
Oxycodone Hydrochloride Tablets is 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 and Precautions (5.1)], reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Oxycodone Hydrochloride Tabletsis
an opioid agonist indicated for the management of pain severe enough to
require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use
(1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Tablets for usein
patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
Have not been tolerated, or are not expected to
be tolerated,
Have not provided adequate analgesia or are not expectedto
provide adequate analgesia.
1 INDICATIONS AND USAGE
LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Patients must have viable retinal cells as determined by the treating physician(s).
LUXTURNA is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). (1)
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older (1.3).
1.1
Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced
Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients6 years of age and older.
1.3 Allergic
Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older.
1 INDICATIONS AND USAGE
INLYTA is a kinase inhibitor indicated:
in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1)
in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1)
as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2)
1.1	First-Line Advanced Renal Cell Carcinoma
INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC.
1.2	Second-Line Advanced Renal Cell Carcinoma
INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
INDICATIONS AND USAGE
Neoplastic Diseases
Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.
In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia.
Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkins lymphomas.
Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.
Psoriasis
Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid
Arthritis
Methotrexate is indicated in the management of selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Aspirin, (NSAIDs), and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. (See
PRECAUTIONS, Drug Interactions.) Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
1 INDICATIONS AND USAGE
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
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 a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
(1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks
(1)