um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
ALDARA Cream is indicated for the topical treatment of:
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. (1.1)
Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. (1.2)
External genital and perianal warts/condyloma acuminata in patients 12 years or older. (1.3)
Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 212. (1.4, 8.4)
1.1 Actinic Keratosis
ALDARA Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
1.2 Superficial Basal Cell Carcinoma
ALDARA Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of ALDARA Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.
1.3 External Genital Warts
ALDARA Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older.
1.4 Limitations of Use
ALDARA Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].
1.5 Unevaluated Populations
The safety and efficacy of ALDARA Cream in immunosuppressed patients have not been established.
ALDARA Cream should be used with caution in patients with pre-existing autoimmune conditions.
The efficacy and safety of ALDARA Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
1 INDICATIONS AND USAGE
Succinylcholine Chloride Injection is indicated in adults and pediatric patients:
as an adjunct to general anesthesia
to facilitate tracheal intubation
to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients:
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)
INDICATIONS AND USAGE
Acromegaly
Octreotide acetate injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of GH and IGF-1 (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, octreotide acetate injection reduces GH to within normal ranges in 50% of patients and reduces IGF-1 (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of GH and IGF-1 (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide acetate injection; these trials were not optimally designed to detect such effects.
Carcinoid Tumors
Octreotide acetate injection is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth, or development of metastases.
Vasoactive Intestinal Peptide Tumors (VIPomas)
Octreotide acetate injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth, or development of metastases.
INDICATIONS AND USAGE
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci.
Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.
Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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.
Indicated surgical procedures should be performed.
1 INDICATIONS AND USAGE
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (
1,
14)
1 INDICATIONS AND USAGE
Testosterone gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of testosterone gel, 1.62% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel, 1.62% in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Indications and Usage (
1
), and Clinical Pharmacology (12.3
)].
Testosterone gel, 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1
)
Hypogonadotropic hypogonadism (congenital or acquired) (1
)
Limitations of use:
Safety and efficacy of testosterone gel, 1.62% in men with age-related hypogonadism have not been established. (1
)
Safety and efficacy of testosterone gel, 1.62% in males less than 18 years old have not been established. (1
, 8.4
)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1
, 12.3
)
1.3 Reduction of Mortality in Acute Myocardial Infarction
Zestril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see
Clinical Studies (14.3) ].
INDICATIONS AND USAGE
Ethacrynic Acid Tablets, USP are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.
Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.
Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.
Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties.
Methocarbamol does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. (1)
RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. (1)
INDICATIONS AND USAGE
Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for the production of subarachnoid block (spinal anesthesia).
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia.
INDICATIONS AND USAGE
Ranitidine capsules are indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
INDICATIONS AND USAGE
Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of:
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia,disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing Fluconazole in Sodium Chloride Injection, USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis - Fluconazole in Sodium Chloride Injection, USP is also indicated to decrease the incidence of candidiasis in patients undergoing bonemarrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identifycausative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these resultsbecome available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1)
Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2)
Efficacy was established in two 6-week trials in adult patients. (14.2)
1.1 Schizophrenia
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (
14.1
)].
The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2 Schizoaffective Disorder
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (
14.2
)].
The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
1 INDICATIONS AND USAGE
Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (
1)
1 INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug therapy.
Limitations of Use: The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
Omega-3-acid ethyl esters, USP is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia.
(1)
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.
(1)
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
(1)
1 INDICATIONS AND USAGE
Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Propafenone hydrochloride extended-release capsules are an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. (1)
Usage Considerations:
Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia
(PSVT) has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. (1)
In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride extended-release capsules with drugs that increase the atrioventricular nodal refractory period. (1)
The effect of propafenone on mortality has not been determined. (1)
Usage Considerations:
The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.
Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
The effect of propafenone on mortality has not been determined [see Boxed Warning].
1
INDICATIONS & USAGE
Heparin sodium is indicated for:
Prophylaxis and treatment of venous thromboembolism and pulmonary embolism;
Atrial fibrillation with embolization;
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].
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; Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac sodium delayed-release tablets are indicated:
for relief of the signs and symptoms of osteoarthritis
for relief of the signs and symptoms of rheumatoid arthritis
for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride injection, 10 mg/mL is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. (
1)
INDICATIONS AND USAGE
Herpes Simplex Infections in Immunocompromised Patients
Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients.
Initial Episodes of Herpes Genitalis
Acyclovir Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients.
Herpes Simplex Encephalitis
Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis.
Neonatal Herpes Simplex Virus Infection
Acyclovir Sodium Injection is indicated for the treatment of neonates and infants with herpes simplex infections.
Varicella-Zoster Infections in Immunocompromised Patients
Acyclovir Sodium Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.
INDICATIONS AND USAGE
Ephedrine Sulfate Injectionn, USP is indicated in the treatment of allergic disorders, such as bronchial asthma The drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotensionn frequently ooccurs. In Stokes-Adams syndromeme with complete heart block, ephedrine has a value similar to that of epinephrine. It is indicated as a central nervous system stimulant in narcolepsy and depressive states. It is also used in myasthenia gravis.