um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of 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.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetrontablets, USPare recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS
Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs.
Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see
PRECAUTIONS
below).
Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see
PRECAUTIONS
below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
INDICATIONS AND USAGE
Disulfiram is an aid in the management of selected chronic alcohol patients who
want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage.
Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.
1 INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. (
1)
Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1.1). Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.1).
1.1 Important Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
1 INDICATIONS AND USAGE
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): 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.
Limitations of use:
Safety and efficacy of JATENZO in males less than 18 years old have not been established [
see Use in Specific Populations (
8.4)
].
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (
1).
Limitations of use:
Safety and efficacy of JATENZO in males less than 18 years old have not been established (
1,
8.4).
1 INDICATIONS AND USAGE
SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)].
Limitations of Use
SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.
SUNOSI is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). (1)
Limitations of Use
SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities. (1)
1 INDICATIONS AND USAGE
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. (1.1)
Prostate cancer
for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. (1.2, 2.1)
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.2)
1.1 Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer
Rubraca is indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
1.2 BRCA-mutated Metastatic Castration-Resistant Prostate Cancer
Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca [see Dosage and Administration (2.1)].
This indication is approved under accelerated approval based on objective response rate and duration of response [seeClinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
INDICATION:
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
INDICATIONS AND USAGE
Dolgic Plus is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Levetiracetam is
indicated for
the treatment of partial-onset
seizures
in
patients
1
month
of
age
and
older
(
1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment of:
Partial
onset
seizures
in
patients
one month
of
age
and
older
with epilepsy
(
1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
(
1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy
(
1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (
1).
INDICATIONS AND USAGE
Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.
The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.
Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.
1 INDICATIONS AND USAGE
Montelukast Sodium Chewable Tabletsare 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 sodiumchewable tablets are
indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodiumchewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodiumchewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients2 years of age and older.
INDICATIONS AND USAGE
Fluocinonide Cream, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
INSULIN GLARGINE U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.
INSULIN GLARGINE U-300 is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. (1)
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis. (1)
Limitations of Use:
INSULIN GLARGINE U-300 is not recommended for the treatment of diabetic ketoacidosis.
1. INDICATIONS AND USAGE
Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
INDICATIONS AND USAGE
MYCOBUTIN Capsules are indicated for the prevention of disseminated
Mycobacterium avium
complex (MAC) disease in patients with advanced HIV infection.
1 INDICATIONS AND USAGE
Dorzolamide Hydrochloride Ophthalmic Solution, USP is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dorzolamide Hydrochloride Ophthalmic Solution, USP is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (
1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see
WARNINGS
].
Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen Tablets are indicated for relief of mild to moderate pain.
Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.
INDICATIONS AND USAGE
Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac is indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following:
Treatment of
gastroesophageal reflux disease (GERD). (
1.1)
Risk reduction
of NSAID-associated gastric ulcer. (
1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
(
1.3)
Pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
(
1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole magnesium delayed-release capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [
see Dosage and Administration (
2) and Clinical Studies (
14)
].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [
see Clinical Pharmacology (
12.4) and the prescribing information for clarithromycin
].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.
JAVYGTOR (sapropterin dihydrochloride) is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. (1)
1 INDICATIONS & USAGE
Oxaliplatin Injection, USP used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
Oxaliplatin Injection, USP is a platinum-based drug used in combination with infusional 5-fluorouracil /leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. (1)
treatment of advanced colorectal cancer. (1)
1 INDICATIONS AND USAGE
ZOMIG Nasal Spray is a 5HT1B/1D receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (1)
Important limitations:
Use only after a clear diagnosis of migraine has been established (1.2)
Not intended for the prophylactic therapy of migraine (1.2)
Not indicated for the treatment of cluster headache (1.2)
1.1 Acute Treatment of Migraine Attacks
ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.
1.2 Important Limitations
ZOMIG 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 ZOMIG, the diagnosis of migraine should be reconsidered before ZOMIG is administered to treat any subsequent attacks.
ZOMIG is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see Contraindications (4.6)].
Safety and effectiveness of ZOMIG have not been established for cluster headache, which is present in an older, predominantly male population.
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.
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
1. INDICATIONS AND USAGE
1.1. Read these instructions carefully before use.
1.2. Rx ONLY.
1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.
1.4. For the collection of 500 mL 10% Whole Blood.
1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit.
1.6. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10C (transport temperature).
1.7. For further processing, use standard component processing techniques.