um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
OMNITROPE is a recombinant human growth hormone indicated for:
Pediatric:
Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1)
Adult:
Treatment of adults with either adult onset or childhood onset GHD (1.2)
1.1 Pediatric Patients
Omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).
Omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications (4) and Warnings and Precautions (5.2)].
Omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.
Omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with Turner syndrome.
Omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS)
-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
1.2 Adult Patients
Omnitrope (somatropin) injection is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:
Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
INDICATIONS AND USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis
e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO
2 content is crucial
e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
1 INDICATIONS AND USAGE
QWO is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.
QWO is a combination of bacterial collagenases indicated forthe treatment of moderate to severe cellulite in the buttocks of adult women. (1)
1 INDICATIONS AND USAGE
STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). (1)
INDICATIONS:
Anesthetic for relief of pruritus, pruritic
eczemas, abrasions, minor burns, insect bites, pain,
soreness and discomfort due to pruritus ani, pruritus
vulvae, hemorrhoids, anal fissures, and similar conditions
of the skin and mucous membranes.
1 INDICATIONS AND USAGE
Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida
infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum
and Fusarium
species including Fusarium solani
, in patients intolerant of, or refractory to, other therapy (1.4)
1.1 Invasive Aspergillosis
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus[see Clinical Studies (14.1, 14.5) and Microbiology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4)].
1.3 Esophageal Candidiasis
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients (2 years of age and older) [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)].
1.4 Scedosporiosis and Fusariosis
Voriconazole is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)]
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet.
Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac Sodium Delayed-release Tablets, are indicated:
For relief of the signs and symptoms of osteoarthritisFor relief of the signs and symptoms of rheumatoid arthritisFor acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1.1 Refractory Complex Partial Seizures
(CPS)
Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (
5.1
)]. Vigabatrintablets are not indicated as a first line agent for complex partial seizures.
1 INDICATIONS AND USAGE
Famciclovir tablets, a prodrug of penciclovir, are a deoxynucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients (1.1)
Herpes labialis (cold sores)
Treatment of recurrent episodes
Genital herpes
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV)-Infected Adult Patients (1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1 INDICATIONS AND USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (
1.1,
1.2,
1.3)
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (
1.1,
1.2,
1.3)
Limitations of Use (
1.4):
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who can not tolerate capsules orally
Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids
[see Clinical Studies (
14.1)]
. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus
[see Dosage and Administration (
2.6)].
1.2 Prophylaxis of Organ Rejection in Liver Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus be used concomitantly with adrenal corticosteroids
[see Clinical Studies (
14.2)]
.
Therapeutic drug monitoring is recommended for all patients receiving tacrolimus
[see Dosage and Administration (
2.6)].
1.3 Prophylaxis of Organ Rejection in Heart Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids
[see Clinical Studies (
14.3)]
. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules
[see Dosage and Administration (
2.6)].
1.4 Limitations of Use
Tacrolimus Capsules should not be used simultaneously with cyclosporine
[see Dosage and Administration (
2.5)].
Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus with sirolimus has not been established in kidney transplant
[see Warnings and Precautions (
5.12)].
Intravenous use reserved for patients who cannot tolerate capsules orally.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of:
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
INDICATIONS AND USAGE
POLYTRIM Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the
following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
INDICATIONS AND USAGE
IMPORTANT NOTICE
Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.
Antepartum: Oxytocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.
Postpartum: Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
1 INDICATIONS AND USAGE
Warfarin sodium tablets are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are a vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1)
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)
1 INDICATIONS AND USAGE
Oxymorphone Hydrochloride Tablets are indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate.
Oxymorphone Hydrochloride Tablets are an opioid agonist indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. (1)
INDICATIONS AND USAGE
Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including: I.
Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).II.
Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.III.
Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.IV.
Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin B12 or folate. V.
Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of vitamin B12.Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation. Nascobal Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).
1 INDICATIONS AND USAGE
Oxycodone hydrochloride 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 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 tablets are 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 use in 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 expected to provide adequate analgesia.
1 INDICATIONS AND USAGE
Clozapine tablets are an atypical antipsychotic indicated for:
Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study.
(1.1,
14.1)
Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Efficacy was established in an active-controlled study.
(1.2,
14.2)
1.1 Treatment-Resistant Schizophrenia
Clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment
[see
Warnings and Precautions (5.1,
5.5)].
The effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine tablets and chlorpromazine in patients who had failed other antipsychotics
[see
Clinical Studies (14.1)].
1.2 Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder
Clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death.
The effectiveness of clozapine tablets in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the InterSePT trial
[see
Clinical Studies (14.2)].