um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
Pantoprazole sodium is a proton pump inhibitor 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 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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 erosive esophagitis 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 syndrome.
1 INDICATIONS AND USAGE
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (
1)
1 INDICATIONS AND USAGE
AndroGel 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 AndroGel 1.62% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of AndroGel 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
)].
AndroGel 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 AndroGel 1.62% in men with age-related hypogonadism have not been established. (
1)
Safety and efficacy of AndroGel 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 INDICATIONS AND USAGE
Tadalafil tablets, USP are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile
dysfunction (ED) (1.1)
the signs and
symptoms of benign prostatic hyperplasia (BPH) (1.2)
ED and the
signs and symptoms of BPH (ED/BPH) (1.3)
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4).
1.1 Erectile Dysfunction
Tadalafiltablets,USP are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil tablets, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets, USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If tadalafil tablets, USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies (14.3)].
Essential hypertension
Verapamil hydrochloride is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma
Cold urticaria
Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
INDICATIONS & USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinol tablets are indicated in:
-the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
-the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present.
-the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
1 INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraception
Norgestimate and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets, USP are indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets, USP are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine tablets, USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS
,
PRECAUTIONS
,
DOSAGE AND ADMINISTRATION
, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 days.
INDICATIONS AND USAGE
The topical corticosteriods are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by betalactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections - caused by betalactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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.
Amoxicillin and clavulanate potassium tablet is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
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 INDICATIONS AND USAGE
Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for:
The treatment of inflammation and pain associated with ocular surgery. (1.1)
The treatment of endogenous anterior uveitis. (1.2)
1.1 Ocular Surgery
Difluprednate ophthalmic emulsion, 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2 Endogenous Anterior Uveitis
Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.
1 INDICATIONS AND USAGE
Colchicine is an alkaloid indicated for:
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
1.2 Familial Mediterranean Fever (FMF)
Colchicine tablets are indicated in adults and childrenfour years or older for treatment of familial Mediterranean fever (FMF).
1 INDICATIONS AND USAGE
CLOBEX (clobetasol propionate) Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. (1) Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Avoid any contact with the eyes and lips. (1.2)
1.1 Indication
CLOBEX Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Patients should be instructed to use CLOBEX Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration
(2)].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
CLOBEX Shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
INDICATIONS AND USAGE
Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
This product is not recommended for use in pediatric patients under 12 years of age.
1 INDICATIONS AND USAGE
Zolpidem Tartrate Tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Zolpidem Tartrate Tablets USP, a gamma-aminobutyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
suspension and other antibacterial drugs, cefdinir for oral suspension 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.
Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents:
Community-Acquired Pneumonia:
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see CLINICAL STUDIES).
Acute Exacerbations of Chronic Bronchitis:
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis:
Caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see PEDIATRIC USE and DOSAGE AND ADMINISTRATION .
Pharyngitis/Tonsillitis:
Caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections:
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients:
Acute Bacterial Otitis Media:
Caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis:
Caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections:
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment
of depression. The efficacy of trazodone HCl has been demonstrated in both
inpatient and outpatient settings and for depressed patients with and without
prominent anxiety. The depressive illness of patients studied corresponds to the
Major Depressive Episode criteria of the American Psychiatric Associations
Diagnostic and Statistical Manual, lll.a
Major Depressive Episode implies a prominent and relatively persistent
(nearly every day for at least two weeks) depressed or dysphoric mood that
usually interferes with daily functioning, and includes at least four of the
following eight symptoms: change in appetite, change in sleep, psychomotor
agitation or retardation, loss of interest in usual activities or decrease in
sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed
thinking or impaired concentration, and suicidal ideation or attempts.
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a betaadrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)