um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2)
o
Posaconazole oral suspension: adults and pediatric patients 13 years of age and older
Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older. (1.3)
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (
14.2
)] as follows:
Posaconazole oral suspension: adults and pediatric patients 13 years of age and older
1.3 Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole
Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older.
1 INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)
].
Important Limitations of Use
Pioglitazone tablets, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease
[see Warnings and Precautions (5.3)].
Pioglitazone hydrochloride is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1, 14) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
1 INDICATIONS AND USAGE
BONJESTAis indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
BONJESTAhas not been studied in women with hyperemesis gravidarum.
BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (1)
Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
Indications and Usage
10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid.
10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.
1 INDICATIONS AND USAGE
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS)
(1.1, 1.2)
1.1 Parkinsons Disease
Ropinirole tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
INDICATIONS AND USAGE
Tolterodine tartratetablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Warnings
For external use only
When using this product avoid contact with the eyes.
Directions
Apply to affected area no more than 3 to 4 times daily.
Inactive ingredients
Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)
1 INDICATIONS & USAGE
Levonorgestrel Tablet, 1.5 mg is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel Tablet is not indicated for routine use as a contraceptive.
Levonorgestrel Tablet is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel Tablet is not intended for routine use as a contraceptive. (1)
1.1 Mania
Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).
The efficacy of divalproex sodium extended-release tablets are based in part on studies of divalproex sodium tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1)].
The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium extended-release tablets for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
1 INDICATIONS AND USAGE
Ondansetron oral solution
is indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron
oral solution
is also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2. (
1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (
1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (
1)
postoperative nausea and/or vomiting. (
1)
1 INDICATIONS AND USAGE
Lacosamide oral solution is indicated for:
Treatment of partial-onset seizures in patients 1 monthof age and older (1.1)
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2)
1.1 Partial-Onset Seizures
Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Primary Generalized Tonic-Clonic Seizures
Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USPand other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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.
Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Capsules, USPare a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1- 1.5)
In combination for treatment of H. pyloriinfection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the Ear, Nose, and Throat
Due to Streptococcus species (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Due to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Due to Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
Due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin capsules, USPare not recommended for empiric treatment of gonorrhea. Amoxicillin capsules, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin capsules, USP, in combination with clarithromycin plus lansoprazole as triple therapy,are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin capsules, USP, in combination with lansoprazole delayed-release capsules as dual therapy,are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE:
Erythromycin Topical Solution is indicated for the topical treatment of acne vulgaris.
INDICATIONS AND USAGE SECTION
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, seasonal or perennial allergic rhinitis and serum sickness.
Dermatologic Diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycisis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
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, congenital (erythroid) hypoplastic anemia (Diamon-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous
Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic Diseases
For palliative management of leukemias and lymphomas.
Nervous System
Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic Diseases
Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal Diseases
To induce a 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, ankylosing spondylitis, 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.
INDICATIONS AND USAGE
Tenex (guanfacine hydrochloride) is indicated in the
management of hypertension. Tenex may be given alone or in combination
with other antihypertensive agents, especially thiazide-type
diuretics.
INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders
3rd edition (DSM-III) category of major depressive disorder (see
CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Etomidate is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see
CLINICAL PHARMACOLOGY
) should be weighed against the high frequency of transient skeletal muscle movements (see
ADVERSE REACTIONS
).
Intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION
).
In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See
WARNINGS
.)
In considering use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See
WARNINGS, Head and Neck Angioedema
.)
INDICATIONS
Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.
1 INDICATIONSAND USAGE
Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients (1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients (1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
Prevention of CMV Disease: Valganciclovir tablets, USP are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)].
1.2 Pediatric Patients
Prevention of CMV Disease: Valganciclovir for oral solution is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
BELSOMRA (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (1).
1 INDICATIONS AND USAGE
Oxaprozin tablets is a non-steroidal anti-inflammatory drug indicated for:
Relief of signs and symptoms of Osteoarthritis (OA) (1)
Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1)
Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See section.)
DOSAGE AND ADMINISTRATION
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets 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)
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 Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.