um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for:
Ovarian cancer:After failure of platinum-based chemotherapy (
1.1).
AIDS-related Kaposis Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy (1.2).
Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (
1.3).
1.1 Ovarian Cancer
Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
1.2 AIDS-Related Kaposi's Sarcoma
Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
1.3 Multiple Myeloma
Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
INDICATIONSAND USAGE
Norethindrone acetate tablets are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate tablets are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
INDICATIONS AND USAGE
Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (rescue) of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
Prophylaxis
Prophylaxis therapy at birth with Infasurf is indicated for premature infants less than 29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
Treatment
Infasurf therapy is indicated for infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
1 INDICATIONS AND USAGE
Betamethasone dipropionate lotion (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.
Betamethasone dipropionate lotion USP (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1)
INDICATIONS AND USAGE
For use with automated plasmapheresis equipment only.
Use according to equipment manufacturers instructions.
This unit should be used for plasmapheresis only.
INDICATIONS AND USAGE
In Chronic Spasticity
Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis).
It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.
Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function.
Dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
If improvement occurs, it will ordinarily occur within the dosage titration (see
DOSAGE AND ADMINISTRATION
), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without Dantrium.
Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrium therapy.
In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him.
Brief withdrawal of Dantrium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of Dantrium on a long-term basis is justified if introduction of the drug into the patient's regimen:
produces a significant reduction in painful and/or disabling spasticity such as clonus, or
permits a significant reduction in the intensity and/or degree of nursing care required, or
rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
In Malignant Hyperthermia
Oral Dantrium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery.
Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium
(dantrolene sodium) Intravenous.
Oral Dantrium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
INDICATIONS AND USAGE
Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrobid and other antibacterial drugs, Macrobid 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrobid are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrobid, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrobid, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
INDICATIONS
CMV Retinitis
Foscarnet sodium injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with foscarnet sodium injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS.
Mucocutaneous Acyclovir Resistant HSV Infections
Foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (
1.1)
Maintenance of Healing of Erosive Esophagitis (
1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (
1.3)
Pantoprazole sodium delayed-release tablets, USP are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets, USP 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, USP 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, USP 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, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
RISPERDAL
is an atypical antipsychotic indicated for:
Treatment of schizophrenia (
1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (
1.2)
Treatment of irritability associated with autistic disorder (
1.3)
1.1	Schizophrenia
RISPERDAL
(risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults
[see
Clinical Studies (14.1)]
.
1.2	Bipolar Mania
Monotherapy
RISPERDAL
is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)
[see
Clinical Studies (14.2)]
.
Adjunctive Therapy
RISPERDAL
adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults
[see
Clinical Studies (14.3)]
.
1.3	Irritability Associated with Autistic Disorder
RISPERDAL
is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)
[see
Clinical Studies (14.4)]
.
INDICATIONS AND USAGE
Hydrochlorothiazide Tablet, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.Hydrochlorothiazide Tablet, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Hydrochlorothiazide Tablet, USP is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
1 INDICATIONS AND USAGE
Dapsone Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Dapsone Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1).
1
INDICATIONS AND USAGE
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).
PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, andis characterized by involuntary, sudden, and frequent episodes of laughing and/or crying.
PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.
PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
NUEDEXTA is a combination product containing dextromethorphan hydrobromide (anuncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of pseudobulbar affect (PBA). (1)
1 INDICATIONS AND USAGE
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2)
in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3)
as a single agent for the treatment of pancreatic cancer. (1.4)
1.1 Ovarian Cancer
Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
Oxcarbazepine tablets USP are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures.
1 INDICATIONS AND USAGE
Docetaxel Injection is a microtubule inhibitor indicated for:
Breast Cancer (BC):single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
Non-small Cell Lung Cancer (NSCLC):single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
Castration-Resistant Prostate Cancer (CRPC):with prednisone in metastatic castration-resistant prostate cancer (1.3)
Gastric Adenocarcinoma (GC):with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
Squamous Cell Carcinoma of the Head and Neck (SCCHN):with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1 Breast Cancer
Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2 Non-small Cell Lung Cancer
Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3 Prostate Cancer
Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4 Gastric Adenocarcinoma
Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5 Head and Neck Cancer
Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
1 INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
(1)
1 INDICATIONSAND USAGE
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use:
Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tabletsare 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, which can occur at any dosage or duration [see WARNINGS],reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia, or are not expected to be provide adequate analgesia
Oxycodone and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
1 INDICATIONS AND USAGE
BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
This indication is approved under accelerated approval based on response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
BLENREP is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1)
Uses
relieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 hours
1.2
Bipolar I Disorder
Acute Treatment of Manic and Mixed Episodes
ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults .
[see CLINICAL STUDIES ]
(14.2)
Maintenance Treatment of Bipolar I Disorder
ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults .
[see CLINICAL STUDIES ]
(14.2)