um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Omeprazole and Sodium bicarbonate capsules are indicated in adults for the:
short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
Omeprazole and sodium bicarbonate capsules are a proton pump inhibitor (PPI).
Omeprazole and sodium bicarbonate capsules are indicated in adults for:
Treatment of active duodenal ulcer (1)
Treatment of active benign gastric ulcer (1)
Treatment of erosive esophagitis (EE) due to acid-mediated
gastroesophageal reflux disease (GERD) (1)
Maintenance of healing of EE (1)
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition,2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see
Boxed CONTRAINDICATIONS AND WARNINGS
).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see
WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure
).
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 Parkinson's Disease
Ropinirole tablets are indicated for the treatment of Parkinsons disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
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, 600 mg/42.9 mg per 5 mL 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-lactamaseproducing strains) characterized by the following risk factors:
antibacterial drug 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. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with 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 beta-lactamaseproducing organisms listed above.
Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL 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
RETHYMIC
is indicated for immune reconstitution in pediatric patients with congenital athymia.
RETHYMIC is indicated for immune reconstitution in pediatric patients with congenital athymia. (
1)
Limitations of Use:
RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).
Limitations of Use
RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).
INDICATIONS AND USAGE
Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see
CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).
1 INDICATIONS AND USAGE
Otrexup is a folate analog metabolic inhibitor indicated for the:
Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1).
Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).
Limitation of Use
Otrexup is not indicated for the treatment of neoplastic diseases (1.3).
1.1 Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis
Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
1.2 Psoriasis
Otrexup is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis flare is not due to an undiagnosed concomitant disease affecting immune responses.
1.3 Limitation of Use
Otrexup is not indicated for the treatment of neoplastic diseases.
1 INDICATIONS AND USAGE
Propafenone HCl Extended Release Capsules, USP 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.
Usage Considerations:
The use of propafenone ER 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 ER 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].
Propafenone HCl Extended Release Capsules, USP is 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 ER capsules with drugs that increase the atrioventricular nodal refractory period.
(1)
The effect of propafenone on mortality has not been determined.
(1)
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS
], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated
have not provided adequate analgesia, or are not expected to provide adequate analgesia
INDICATIONS AND USAGE
Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
INDICATIONS AND USAGE
Clobetasol Propionate Ointment USP, 0.05% 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
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
1 INDICATIONSAND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pregabalin capsules are indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)(1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients17 years of age and older (1)
Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1)
1 INDICATIONS AND USAGE
1.1 Hyperlipidemia and Mixed Dyslipidemia
CRESTOR is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate.
1.2 Hypertriglyceridemia
CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.3 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
CRESTOR is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.4 Homozygous Familial Hypercholesterolemia
CRESTOR is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.5 Slowing of the Progression of Atherosclerosis
CRESTOR is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
1.6 Limitations of Use
The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined.
CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias.
INDICATIONS & USAGE
Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.
1 INDICATIONS AND USAGE
LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. (1)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)
Hypothyroidism
LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
Limitations of Use:
LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4)].
LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
1 INDICATIONS AND USAGE
Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)].
The following points should be considered when initiating therapy with Lamivudine tablets (HBV):
Due to high rates of resistance development in treated patients, initiation of treatment with Lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus.
Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
Lamivudine tablets (HBV) are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. (1)
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
Indications & Usage
Carefully consider the potential benefits and risks of etodolac extended-release tablets, USP and other treatment options before deciding to use etodolac extended-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Etodolac extended-release tablets, USP are indicated:
*
For relief of signs and symptoms of juvenile arthritis
*
For relief of the signs and symptoms of rheumatoid arthritis
*
For relief of the signs and symptoms of osteoarthritis
1 INDICATIONS AND USAGE
SUPRAX (cefixime) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections:
Uncomplicated Urinary Tract Infections (1.1)
Otitis Media (1.2)
Pharyngitis and Tonsillitis (1.3)
Acute Exacerbations of Chronic Bronchitis (1.4)
Uncomplicated Gonorrhea (cervical/urethral) (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SUPRAX and other antibacterial drugs, SUPRAX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1 Uncomplicated Urinary Tract Infections
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.
1.2 Otitis Media
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator [see Clinical Studies (14)].
1.3 Pharyngitis and Tonsillitis
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. SUPRAX is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of SUPRAX in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
1.6 Usage
To reduce the development of drug resistant bacteria and maintain the effectiveness of SUPRAX and other antibacterial drugs, SUPRAX 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patients clinical condition allows (see
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS, and
WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION).
1 INDICATIONS & USAGE
Heparin Sodium Injection is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolismPrevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic diseaseAtrial fibrillation with embolizationTreatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)Prevention of clotting in arterial and cardiac surgeryProphylaxis and treatment of peripheral arterial embolismAnticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures
Heparin Sodium Injection is an anticoagulant indicated for (1) Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease 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 Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures