um-ids/dailymed-annotations huggingface dataset:
Treatment
CEFOTAN (cefotetan for Injection, USP) is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms:
Urinary Tract Infections
caused by
E. coli, Klebsiella
spp (including
K. pneumoniae
),
Proteus mirabilis,
Proteus
vulgaris
,
Providencia rettgeri
, and
Morganella morganii
).
Lower Respiratory Tract Infections
caused by
Streptococcus pneumoniae
,
Staphylococcus aureus(methicillin-susceptible),
Haemophilus
influenzae,
Klebsiella
species (including
K. pneumoniae
),
E. coli
,
Proteus mirabilis
, and
Serratia marcescens.*
Skin and Skin Structure Infections due to Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin susceptible), Streptococcus pyogenes, Streptococcus species, Escherichia coli, Klebsiella pneumoniae, Peptococcus niger*, Peptostreptococcus species.
Gynecologic Infections caused by Staphylococcus aureus (methicillin susceptible), Staphylococcus epidermidis (methicillin susceptible, Streptococcus species, Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides fragilis, Prevotella melaninogenica
Bacteroides vulgatus, Fusobacterium species*, and gram- positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species).
Cefotetan, like other cephalosporins, has no activity against
Chlamydia trachomatis.
Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and
C. trachomatis
is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
Intra-abdominal lnfections caused by E. coli, Klebsiella species (including K. pneumoniae), Streptococcus species, Bacteroides fragilis, Prevotella melaninogenica, Bacteroides vulgatus and Clostridium species (other than Clostridium difficile [see WARNINGS])*.
Bone and Joint Infections
caused by
Staphylococcus
aureus (methicillin susceptible)*.
* Efficacy for this organism in this organ system was studied in fewer than ten infections in clinical studies
Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use CEFOTAN concomitantly with an aminoglycoside. Cefotetan combinations with aminoglycosides have been shown to be synergistic in vitro against many Enterobacteriaceae and also some other gram- negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition.
NOTE: Increases in serum creatinine have occurred when CEFOTAN was given alone. If CEFOTAN and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.
INDICATIONS AND USAGE
LORTAB Elixir (hydrocodone bitartrate and acetaminophen oral
solution) is indicated for the relief of moderate to moderately severe pain.
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Alfuzosin hydrochloride extended-release tablets USP, is an alpha adrenergic antagonist, indicated for treatment of signs and symptoms of benign prostatic hyperplasia. (1)Important Limitations of Use:Alfuzosin hydrochloride is not indicated for the treatment of hypertension. (1.1)Alfuzosin hydrochloride is not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
1.1 Important Limitations of Use
Alfuzosin hydrochloride is not indicated for the treatment of hypertension.
Alfuzosin hydrochloride is not indicated for use in the pediatric population.
1 INDICATIONS AND USAGE
Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (1.1)
1.1 Parkinson's Disease
Ropinirole extended-release tablets are indicated for the treatment of Parkinsons disease.
INDICATIONS & USAGE SECTION
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetrontablets, USPare recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS & USAGE
Postherpetic Neuralgia
Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3
12 years.
1 INDICATIONS AND USAGE
Oxycodone hydrochloride 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 and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
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 & Usage
COVARYXT and COVARYX H.S. are indicated in the treatment of
Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)
COVARYXT and COVARYX H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOXED WARNINGS).
1 INDICATIONS AND USAGE
APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require anopioid 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 andPrecautions (5.1)
], reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioidanalgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
APADAZ is a combination of benzhydrocodone, a prodrug of the opioid agonist hydrocodone, and acetaminophen, andis indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioidanalgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve APADAZ foruse 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.
1 INDICATIONS AND USAGE
INVOKANA (canagliflozin) is indicated:
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).
to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.
INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease (1)
To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria (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)
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
INVOKANA 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)].
INVOKANA 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. INVOKANA is likely to be ineffective in this setting based upon its mechanism of action.
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin capsules, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin capsules, USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
1 INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:
The treatment of inflammation following cataract surgery. (
1)
The temporary relief of ocular itching due to seasonal allergic conjunctivitis. (
1)
1 INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
AZITHROMYCIN is a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria:
Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.1	Sexually Transmitted Diseases
Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
1.2	Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].
Treatment of Disseminated MAC Disease
Azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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.
INDICATIONS & USAGE
Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
1.1 Adjuvant Treatment
Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
Anastrozole is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (1.1) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2) Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole (1.3)
1.2 First-Line Treatment
Anastrozole is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3 Second-Line Treatment
Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole.
INDCIATIONS AND USAGE
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
These include allergic conjunctivitis, acne rosacea, superficial punctate keratits, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivities when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies.
INDICATIONS AND USAGE:
Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus ani.
INDICATIONS AND USAGE
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03%
for children aged 2 to 15 years, is indicated as second-line
therapy for the short-term and non-continuous chronic treatment of
moderate to severe atopic dermatitis in non-immunocompromised adults and
children who have failed to respond adequately to other topical prescription
treatments for atopic dermatitis, or when those treatments are not
advisable.
PROTOPIC Ointment is not indicated for children younger than
2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS:
Pediatric
Use).
1 INDICATIONS AND USAGE
RYKINDO is indicated:
for the treatment of schizophrenia in adults
as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults
RYKINDO is an atypical antipsychotic indicated:
for the treatment of schizophrenia in adults. (1)
as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1)
INDICATIONS AND USAGE
Olopatadine hydrochloride ophthalmic solution, USP 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Uses
surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healhcare personnel handwash: helps reduce bacteria that potentially can cause disease
patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
skin wound and general skin cleansing
1 INDICATIONS AND USAGE
Sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)
].
Sodium phenylacetate and sodium benzoate injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. (1)
INDICATIONS AND USAGE
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.
Micronized colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, micronized colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.
LDL-Cholesterolmg/dL (mmol/L)
Definite Atherosclerotic DiseaseCoronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
Two or More Other Risk FactorsOther risk factors for coronary heart disease (CHD) include: age (males: 45 years; female: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).
Initiation Level
Goal
No
No
190(4.9)
<160(<4.1)
No
Yes
160(4.1)
<130(<3.4)
Yes
Yes or No
130(3.4)
100(2.6)
INDICATION Darvon-N is indicated for the relief of mild to moderate pain.
1 INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride extended-release capsules areindicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsulesshould be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. (1)
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) (1)
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity or cerebral palsy (1)
1 INDICATIONS AND USAGE
Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
INDICATIONS AND USAGE
KADIAN Capsules are an extended-release
oral formulation of morphine sulfate indicated for the management of moderate to
severe pain when a continuous, around-the-clock opioid analgesic is needed for
an extended period of time (see CLINICAL PHARMACOLOGY).
KADIAN
Capsules are NOT intended for use as
a prn analgesic.
KADIAN is not indicated for pain in the immediate
postoperative period (the first 12-24 hours following surgery), or if the pain
is mild or not expected to persist for an extended period of time. KADIAN is only indicated for postoperative use if the patient is
already receiving the drug prior to surgery or if the postoperative pain is
expected to be moderate to severe and persist for an extended period of time.
Physicians should individualize treatment, moving from parenteral to oral
analgesics as appropriate. (See American Pain Society guidelines.)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen tablets are indicated:For relief of mild to moderate painFor relief of signs and symptoms of juvenile arthritisFor relief of the signs and symptoms of rheumatoid arthritisFor relief of the signs and symptoms of osteoarthritisFor treatment of primary dysmenorrheaFor acute or long-term use in the relief of signs and symptoms of the following:Ankylosing spondylitisAcute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)Acute gouty arthritis