um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fexofenadine hydrochloride is an H1-receptor antagonist indicated for:
Relief of symptoms associated with seasonal allergic rhinitis in patients
2 years of age (1.1)
Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients
6 months of age (1.2)
1.1 Seasonal Allergic Rhinitis
Fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
1.2 Chronic Idiopathic Urticaria
Fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
1INDICATIONS AND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
(1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
(1)
postoperative nausea and/or vomiting.
(1)
INDICATIONS AND USAGE
Famotidine is indicated in:
1. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
Short-term treatment of active duodenal ulcer.
2. Controlled studies in adults have not extended beyond one year.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
3. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
Short-term treatment of active benign gastric ulcer.
4. Famotidine is indicated for short-term treatment of patients with symptoms of GERD (see Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see ).
Short-term treatment of gastroesophageal reflux disease (GERD).
).
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
5. (see )
Treatment of pathological hypersecretory conditions (e. g., Zollinger-Ellison Syndrome, multiple endocrine adenomas )
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
.
1 INDICATIONS AND USAGE
Zolpidem Tartrate is a GABA
A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep (
1)
Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking (
1)
Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Limitations of Use: Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
1 INDICATIONS & USAGE
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.
1 INDICATIONS AND USAGE
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1)
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1)
1 INDICATIONS AND USAGE
Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
1 INDICATIONS AND USAGE
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1)
Use in combination with cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (1.2)
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid are to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
1 INDICATIONS AND USAGE
Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:
Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. (1.1)
Liver Transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5)
Limitations of Use (1.3)
Safety and efficacy have not been established in the following:
Kidney transplant patients at high immunologic risk (1.3)
Recipients of transplanted organs other than kidney or liver (1.3, 5.7)
Pediatric patients (less than 18 years) (1.3)
1.1 Prophylaxis of Organ Rejection in Kidney Transplantation
Everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see Clinical Studies (14.1)]. Everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus and cyclosporine is recommended for all patients receiving these products [see Dosage and Administration (2.2, 2.3)].
1.2 Prophylaxis of Organ Rejection in Liver Transplantation
Everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see Warnings and Precautions (5.5), Clinical Studies (14.2)]. TDM of everolimus and tacrolimus is recommended for all patients receiving these products [see Dosage and Administration (2.3, 2.5)].
1.3 Limitations of Use
The safety and efficacy of everolimus has not been established in the following populations:
Kidney transplant patients at high immunologic risk
Recipients of transplanted organs other than kidney and liver [see Warnings and Precautions (5.7)]
Pediatric patients (less than 18 years).
1 INDICATIONS AND USAGE
Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (
1.1)
To assess the presence and extent of malignant breast disease in adult patients (
1.2)
To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (
1.3)
To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) (
1.4)
1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)
Gadobutrol injection is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
1.2 MRI of the Breast
Gadobutrol injection is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease.
1.3 Magnetic Resonance Angiography (MRA)
Gadobutrol injection is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease.
1.4 Cardiac MRI
Gadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
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 WARNING box, before selecting clindamycin, 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 and other antibacterial drugs, clindamycin hydrochloride 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 & USAGE
Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
1 INDICATIONS AND USAGE
Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. (1.1)
Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. (1.2, 1.3)
1.1 Prophylaxis of Deep Vein Thrombosis
Fondaparinux sodium injectionis indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing hip fracture surgery, including extended prophylaxis;
in patients undergoing hip replacement surgery;
in patients undergoing knee replacement surgery;
in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
1.2 Treatment of Acute Deep Vein Thrombosis
Fondaparinux sodium injectionis indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
1.3 Treatment of Acute Pulmonary Embolism
Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
INDICATIONS AND USAGE
Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
INDICATIONS AND USAGE
Betamethasone Dipropionate Ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
1	INDICATIONS AND USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.s Rizatriptan Benzoate Tablets.
However, due to Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet is administered to treat any subsequent attacks.
Rizatriptan benzoate tabletsare not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tabletsare not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age.(1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
INDICATIONS AND USAGE
Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
1. INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the:
Treatment of uncomplicated malaria due to
Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax
in adult and pediatric patients. (
1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (
1.1)
Treatment of rheumatoid arthritis in adults. (
1.2)
Treatment of systemic lupus erythematosus in adults. (
1.3)
Treatment of chronic discoid lupus erythematosus in adults. (
1.4)
Limitations of Use (1.1):
Hydroxychloroquine sulfate Tablets is
not recommended for the:
Treatment of complicated malaria.
Treatment of chloroquine or hydroxychloroquine-resistant strains of
Plasmodium species.
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the
Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of
P. vivax or
P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of
P. vivax and
P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
Hydroxychloroquine sulfate tablet in indicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due to
Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax,
and
Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablet is
not recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of
Plasmodium species
[see Microbiology (
12.4)].
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the
Plasmodium
species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of
P. vivax
or
P. ovale
because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of
P. vivax
and
P. ovale
infections, concomitant therapy with an 8-aminoquinoline drug is necessary
[see Microbiology (
12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention
1.
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
INDICATIONS AND USAGE
Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension.
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia
Fluoxetine is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
INDICATIONS & USAGE
Meprobamate tablets 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 do not require treatment with an anxiolytic.
The effectiveness of meprobamate tablets 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 INDICATIONSAND USAGE
Monotherapy
Fulvestrant injection is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Combination Therapy
Fulvestrant injection is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1)
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)