um-ids/dailymed-annotations huggingface dataset:
INDICATIONSAND USAGE
Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains).
Serious central-nervous-system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp.
Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp, (indole-positive and indole- negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
Aminoglycosides, including tobramycin sulphate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram- negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulphate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the
WARNINGS
box above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Seizure Disorders
Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful.
Some loss of effect may occur during the course of clonazepam treatment (see
PRECAUTIONS: Loss of Effect
).
Panic Disorder
Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam tablets was established in two 6 to 9 week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see
CLINICAL PHARMACOLOGY, Clinical Trials
).
Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).
1 INDICATIONS AND USAGE
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated,
de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (
1)
INDICATIONS AND USAGE
Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Cilostazol Tablets, USP are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
1. INDICATIONS AND USAGE
CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. (1)
CASODEX 150 mg daily is not approved for use alone or with other treatments. (1)
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
INDICATIONS AND USAGE
Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see
PRECAUTIONS
).
Diagnosis
Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
1 INDICATIONS AND USAGE
YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). (1)
1 INDICATIONS AND USAGE
Scopolamine transdermal system is indicated in adults for prevention of:
nausea and vomiting associated with motion sickness
post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery
.
Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of:
nausea and vomiting associated with motion sickness. (
1)
post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. (
1)
1	INDICATIONS AND USAGE
Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure
(IOP) in patients with open angle glaucoma or ocular hypertension.
Travoprost ophthalmic solution (ionic buffered solution) 0.004% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
(1)
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
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are 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 Tablets 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
Epilepsy
Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
Generalized tonic-clonic seizures (grand mal).
Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see
PRECAUTIONS, General
).
Trigeminal Neuralgia
Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
1.1 Major Depressive Disorder
Escitalopram tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablets, USP are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1
INDICATIONS AND USAGE
URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis(PBC).
URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis.(1)
INDICATIONS AND USAGE
Fludarabine Phosphate for Injection, USP is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate for Injection, USP in previously untreated or non-refractory patients with CLL have not been established.
1 INDICATIONS AND USAGE
GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14)].
GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (1)
Limitations of Use
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients (1)
Has not been studied in patients with a history of pancreatitis (1)
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 (1)
Limitations of Use
GLYXAMBI is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)].
GLYXAMBI has not been studied in patients with a history of pancreatitis.
It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI [see Warnings and Precautions (5.1)].
GLYXAMBI is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. GLYXAMBI is likely to be ineffective in this setting based upon its mechanism of action.
1 INDICATIONS AND USAGE
Hydrocodone bitartrate extended-release capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Hydrocodone bitartrate extended-release capsules are not indicated as an as-needed (prn) analgesic.
Hydrocodone bitartrate extended-release capsules are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1)
Hydrocodone bitartrate extended-release capsules are not indicated as an as-needed (prn) analgesic. (1)
Rugby Cream Uses
temporarily relieves minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
sprains
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1)
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
1 INDICATIONS AND USAGE
Albuterol sulfate inhalation aerosol is a beta
2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1 Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
INDICATIONS AND USAGE
Leucovorin calcium rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
INDICATIONS AND USAGE
Oxazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Anxiety associated with depression is also responsive to Oxazepam therapy.
This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients.
Alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy.
The effectiveness of Oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
NOVOCAIN is indicated for the production of local
or regional analgesia and anesthesia by local infiltration and peripheral
nerve block techniques.The routes of administration
and concentrations are: for local infiltration use 0.25% to 0.5% (via
dilution) and for peripheral nerve blocks use 0.5% (via dilution),
1%, and 2%. (See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the
accepted procedures and techniques for the administration of NOVOCAIN.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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.