um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
CYTRA-K CRYSTALS is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. CYTRA-K CRYSTALS is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. CYTRA-K CRYSTALS alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.
INDICATIONS AND USAGE
Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See
CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS.
)
1 INDICATIONS AND USAGE
Esomeprazole strontium is a proton pump inhibitor indicated for adults for:
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) in Adults
Healing of Erosive Esophagitis
Esomeprazole strontium is 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 strontium may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults
Esomeprazole strontium is 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 either 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 in Adults
Triple Therapy (esomeprazole strontium plus amoxicillin and clarithromycin): esomeprazole strontium, in combination with amoxicillin and clarithromycin, is 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 [seeDosage 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 [seeClinical Pharmacology (12.4)and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults
Esomeprazole strontium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
INDICATIONS & USAGE
To control severe nausea and vomiting. For the treatment of schizophrenia.
Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac Sodium Extended-release Tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1.INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)
]
CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
7.Osteoarthritis (OA) (1.1)
8.Rheumatoid Arthritis (RA) (1.2)
9.Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
10.Ankylosing Spondylitis (AS) (1.4)
11.Acute Pain (AP) (1.5)
12.Primary Dysmenorrhea (PD) (1.6)
1.1Osteoarthritis (OA)
CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)
]
1.2Rheumatoid Arthritis (RA)
CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)
]
1.3 Juvenile Rheumatoid Arthritis (JRA)
CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)
]
1.4Ankylosing Spondylitis (AS)
CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)
]
1.5Acute Pain (AP)
CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)
]
1.6Primary Dysmenorrhea (PD)
CELEBREX is indicated for the treatment of PD [see Clinical Studies (14.5)
]
1 INDICATIONS AND USAGE
Potassium chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Potassium chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. (1)
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants.
SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.
INDICATIONS AND USAGE
Intramuscular
Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinoloneacetonideinjectable suspension, USP) is indicated for intramuscular use as follows:
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliativeerythroderma, mycosis fungoides, pemphigus, severe erythemamultiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurativethyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosingspondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Intra-Articular
The intra-articular or soft tissue administration of Kenalog-40 Injection is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis, or osteoarthritis.
INDICATIONS AND USAGE
Hydrocortisone acetate and pramoxine hydrochloride suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
INDICATIONS AND USAGE:
A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract.
For pre and postoperative states when mydriasis is required.
Use as an optical aid in some cases of axial lens opacities.
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy:
initial monotherapy in patients
2 years of age with partial onset
or primary generalized tonic-clonic seizures (1.1);
adjunctive therapy for adults and pediatric patients (2 to 16 years of
age) with partial onset seizures or primary generalized tonic-clonic
seizures, and for patients 2 years of age with seizures associated
with Lennox-Gastaut syndrome (1.2)
Prophylaxis
of migraine in patients 12 years of age and other (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1.3Migraine
Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium extended-release tablets are useful in the acute treatment of migraine headaches. Because it may be a hazard to the fetus, divalproex sodium extended-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment [see Warnings and Precautions (5.2), Patient Counseling Information (17.3)].
1INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia, bipolar mania or autistic disorder.(1.1,1.2,1.3)
1.1Schizophrenia
AdultsRisperidone oral solution is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
AdolescentsDue to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
1.2Bipolar Mania
Monotherapy - Adults and PediatricsRisperidone oral solution is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
Combination Therapy
AdultsThe combination of risperidone oral solution with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3Irritability Associated with Autistic Disorder
PediatricsDue to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder. Information regarding the treatment of pediatric patients with irritability associated with autistic disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
INDICATIONS AND USAGE
Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrolene Sodium for Injection should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
Dantrolene Sodium for Injection is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
1.3 Limitations of Use
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
1 INDICATIONS AND USAGE
Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Norepinephrine Bitartrate in Dextrose Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)
1 INDICATIONS AND USAGE
Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older (1.1).
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Do not use if atrophy is present at the treatment site. (1.2)
Do not use for rosacea or perioral dermatitis. (1.2)
1.1 Indication
Clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.
Patients should be instructed to use clobetasol propionate lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see DOSAGE AND ADMINISTRATION (2)].
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4)].
1.2 Limitations of Use
Clobetasol propionate lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobetasol propionate lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
1.1 Gout Flares
Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares:
Colchicine Tablets, USP are indicated for prophylaxis of gout flares.
Treatment of Gout Flares:
Colchicine Tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2 Familial Mediterranean Fever (FMF)
Colchicine Tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
1 INDICATIONS AND USAGE
Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (
1)
1 INDICATIONS AND USAGE
VIOKACE tablets, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
VIOKACE is a combination of porcine-derived lipases, proteases, and amylases.
VIOKACE, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. (1)