um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime for oral suspension and other antibacterial drugs, Cefixime for oral suspension 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.
Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:
Cefixime for oral suspension, USP is a cephalosporin antibacterial drug indicated for
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)
1.1 Uncomplicated Urinary Tract Infections
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis
1.2 Otitis Media
Otitis media caused by 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
Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime for oral suspension is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinaseand non-penicillinase-producing isolates).
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of
fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Tri-Mili is estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
Tri-Miliis also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Tri-Mili should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2)
1.1 Oral Contraceptive
Tri-Mili tabletsareindicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
1.2 Acne
Tri-Mili is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Mili should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Levetiracetam in Sodium Chloride Injection is indicatedfor adjunct therapy in adults(16 years of age) with the following seizure types when oral administration is temporarily not feasible:
Partial-onset seizures (1.1)
Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures (1.3)
1.1 Partial-Onset Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.
1.4 Limitations of Use
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia
[see Clinical Studies (
14.1)]
.
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
[see Clinical Studies (
14.2)]
.
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression)
[see Clinical Studies (
14.2)]
.
Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) (
1,
14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression), in adults, and pediatric patients (10 to 17 years) as monotherapy(
1,
14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (
1,
14.2)
INDICATIONS & USAGE
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see Clinical Pharmacology). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
INDICATIONS AND USAGE
Tizanidine is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1);adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS & USAGE
Diclofenac potassium for oral solutionisindicatedfortheacutetreatmentofmigraineattackswithorwithoutaurainadults(18yearsofageorolder).
LimitationsofUse
Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.
Diclofenac potassium for oral solution isanon-steroidalanti-inflammatorydrug(NSAID)indicatedforthe acute treatment of migraine attacks with or without aura in adults 18yearsofageorolder (1)
LimitationsofUse (1):
Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine
Safety and effectiveness of diclofenac potassium for oral solution not established for cluster headache, which is present in an older, predominantly male population
1 INDICATIONS AND USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for injection has not been studied for treatment of
established nausea and vomiting.
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia
(1.1).
For treatment of adult patients with severe hypertriglyceridemia
(1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus
(5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets USP are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see
Warnings and Precautions (5.1)].
INDICATIONS AND USAGE
Uro-MP Capsules are indicated for the treatment of symptoms of irritative voiding.
Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections.
Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see
CLINICAL PHARMACOLOGY,
CONTRAINDICATIONS,
WARNINGS, and
PRECAUTIONS).
Allopurinol tablets are indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
1 INDICATIONS AND USAGE
Acetaminophen Injection is indicated for
the management of mild to moderate pain in adult and pediatric patients 2 years and older
the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
the reduction of fever in adult and pediatric patients 2 years and older.
Acetaminophen Injection is indicated for the
Management of mild to moderate pain in adult and pediatric patients 2 years and older (1)
Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older (1)
Reduction of fever in adult and pediatric patients 2 years and older (1)
1 INDICATIONS AND USAGE
EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
EPIDUO gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
1 INDICATIONS AND USAGE
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. (1)
Phentermine hydrochloride tablets USP are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight
(pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
INDICATIONS AND USAGE
Prevention of Malaria:
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see
CLINICAL STUDIES
).
Treatment of Malaria:
Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
INDICATIONS AND USAGE
Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects).
Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.
1 INDICATIONS AND USAGE
BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (1)
1 INDICATIONS AND USAGE
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
INDICATIONS & USAGE SECTION
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
1 INDICATIONS AND USAGE
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1)
1 INDICATIONS AND USAGE
CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). (1)
USES
Helps treat and prevent diaper dermatitis
Temporarily protects and helps relieve chapped or cracked skin and lips
1 INDICATIONS AND USAGE
Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and 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 morphine sulfate suppositories 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
Morphine sulfate suppositories is an opioid agonist indicated for the management of acute and chronic 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, reserve morphine sulfate suppositories 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
1 INDICATIONS AND USAGE
Urocit-K is a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones (1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2)
Uric acid lithiasis with or without calcium stones (1.3)
1.1 Renal tubular acidosis (RTA) with calcium stones
Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)].
1.2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology
Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)].
1.3 Uric acid lithiasis with or without calcium stones
Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)
].