um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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 for Oral Suspension, USP is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs
2 mcg/mL), H. influenzae(including -lactamase-producing strains), or M. catarrhalis(including -lactamase-producing strains) characterized by the following risk factors:
antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age 2 years or younger
- daycare attendance
[see CLINICAL PHARMACOLOGY, Microbiology (12.4)].
NOTE: Acute otitis media due to S. pneumoniaealone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, USP is not indicated for the treatment of acute otitis media due to S. pneumoniaewith penicillin MIC
4 mcg /mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae(penicillin MIC
2 mcg/mL) and the -lactamase-producing organisms listed above.
Amoxicillin and clavulanate potassium for oral suspension, USP is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs 2 mcg/mL), H. influenzae (including beta-lactamaseproducing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors. (1)
antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years or younger 2) daycare attendance.
1 INDICATIONS AND USAGE
Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. (1.1)
1.1	Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant[see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)], and heart transplant [see Clinical Studies (14.3)], and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)]in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Monotherapy epilepsy: Initial monotherapy in patients
2 years of age with partial onset or primary
generalized tonic-clonic seizures (
1.1)
Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with
partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age with seizures associated with
Lennox-Gastaut syndrome (LGS) (
1.2)
1.1 Monotherapy Epilepsy
Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials
[see Clinical Studies (
14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome
[see Clinical Studies (
14.2)].
INDICATIONS & USAGE SECTION
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.
INDICATIONS AND USAGE
Edema
Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Oral Furosemide tablets may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Furosemide tablets alone.
INDICATIONS AND USAGE
CARDENE SR is indicated for the treatment of hypertension. CARDENE
SR may be used alone or in combination with other anti-hypertensive
drugs.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets and other treatment options before deciding to use Naproxen Delayed-Release Tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS:
Gastrointestinal Bleeding, Ulceration, and Perforation
).
Naproxen Delayed-Release Tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.
Naproxen Delayed-Release Tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY, DOSAGE AND ADMINISTRATION
).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac sodium extended-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
TAZORAC Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1)
TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2)
Limitations of Use
The safety of TAZORAC Gel use on more than 20% body surface area has not been established.(1.3)
1.1 Plaque Psoriasis
TAZORAC (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.
1.2 Acne Vulgaris
TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patientswith facialacne vulgaris of mild to moderate severity.
The efficacy of TAZORAC Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.
1.3 Limitations of Use
The safety of TAZORAC Gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (
5.1
) and Use in Specific Populations (
8.1
)].
1.4 Pharyngitis/Tonsillitis
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets are administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (
see
WARNINGS
), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia,
Have not been tolerated, or are not expected to be tolerated.
INDICATIONS:
Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne
rosacea and seborrheic dermatitis.
Cardiac Arrhythmias
Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.
1.
Supraventricular arrhythmia
s
Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff-Parkinson-White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia.
2.
Ventricular tachycardias
With the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some
sympathetic drive for maintenance of myocardial tone (see
DOSAGE AND ADMINISTRATION
).
Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias.
Intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well-being of the patient and do not respond to conventional measures.
3.
Tachyarrhythmias of digitalis intoxication
Intravenous propranolol is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur (see
OVERDOSAGE
).
4.
Resistant tachyarrhythmias due to excessive catecholamine action during anesthesia
Intravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when propranolol is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure (see
WARNINGS
).
1 INDICATIONS AND USAGE
Cilostazol tablets, USP are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
Cilostazol tablets, USP are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance (1)
INDICATIONS AND USAGE
Betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
INDICATIONS AND USES:
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged and ingrown nails.
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride Injection, is 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
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
Skin Repair Cream (5% Dimethicone)
Drug Facts
Active ingredient
Dimethicone 5.0%
Purpose
Skin Protectant
Uses
temporarily protects and helps relieve chapped or cracked skin
Warnings
For external use only
Do not use on
deep or puncture wounds
animal bites
serious burns
When using this product
do not get into eyes
Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
gently cleanse and dry affected area
apply liberally to affected area as needed.
Inactive ingredients
Aleurites moluccana seed oil,
Aloe barbadensis (
Aloe vera) leaf juice, butylene glycol, caprylyl glycol,
Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5),
Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E),
Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine
1INDICATIONS & USAGE
Indomethacin Capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis
Indomethacin Capsules, USP are non steroidal anti-inflammatory drug indicated for (
1
)
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis.
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis).
Acute gouty arthritis
1	INDICATIONS AND USAGE
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Guanfacine extended-release tablets are a central alpha2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications (1, 14).
INDICATIONS AND USAGE
Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
1 INDICATIONS AND USAGE
Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Clolar is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. (1)
Indications and Usage
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Piroxicam is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
Piroxicam is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA) (1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD)
(
1.1)
prevention of seasonal affective disorder (SAD)
(
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see
Clinical Studies (
14.1)
].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see
Clinical Studies (
14.2)
].
1 INDICATIONS AND USAGE
Warfarin sodium tablets are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.