um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS & USAGE
Paroxetine is indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD)
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)
1 INDICATIONS AND USAGE
Fluoxetine oral solution, USP is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see
Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see
Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see
Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia
[see
Clinical Studies (14.4)].
Fluoxetine oral solution, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD)
(1).
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
(1).
Acute and maintenance treatment of Bulimia Nervosa
(1).
Acute treatment of Panic Disorder, with or without agoraphobia
(1).
1. Indications and Usage
Duloxetine delayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.1 Travelers Diarrhea
XIFAXAN
200 mg is indicated for the treatment of patients (
12 years of age) with travelers diarrhea caused by
noninvasive strains of Escherichia coli
[
see
Warningsand
Precautions (5), Clinical
Pharmacology (12.4) and
ClinicalStudies(14.1)].
Limitations of Use
XIFAXAN
should not be used in patients with diarrhea complicated by
fever or blood in the stool or diarrhea due to pathogens other
than Escherichia coli.
INDICATIONS AND USAGE Parenteral
Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates.
Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see
CLINICAL PHARMACOLOGY
).
Preanesthetic.
Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
1 INDICATIONS AND USAGE
TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.
TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. (1)
INDICATIONS AND USAGE
Metastatic Prostate Cancer
NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).
For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration.
Equipment
Required supplies needed to compound this kit
Equipment
Item
Quantity
Cyclobenzaprine HCl (Included)
3 grams
Magnesium Oxide Heavy Powder (Included)
60 grams
Lactose Monohydrate Spray Dried Powder ( Included)
60 grams
Riboflavin Powder (Included)
0.15 grams
Red 1 Capsules ( Required Not Included)
300 Capsules
INDICATIONS AND USAGE
Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
INDICATIONS AND USAGE
TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular 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 superficial ocular 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:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Active Ingredients
Purpose
Avobenzone 3.0%
Sunscreen
Octinoxate 7.5%
Sunscreen
Octisalate 5.0%
Sunscreen
image of back
Warnings
-for external use only
-when using this product keep out of eyes
-rinse with water to remove
-stop use and ask a doctor if rash or irritation develops and lasts
-keep out of reach of children
-do not use on infants under 6 months of age
Uses
-helps prevent sunburn
-for skin that burns easily
-provides moderate protection against sunburn
-higher SPF gives more sunburn protection
Directions
-for external use only
-when using this product keep out of eyes
-rinse with water to remove
-stop use and ask doctor if rash or irritation develops and lasts
-keep out of reach of children
-do not use on infants under 6 months of age
Inactive Ingredients: Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sea Water (Maris Aqua), Dimethicone, Behenyl Alcohol, Stearyl Alcohol, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Batyl Alcohol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Phytosterols, Silicornia Herbacea Extract, Niacinamide, Hydrolyzed Oat Protein, Alpinia Galang Leaf Extract, Quartz, Disodium Adenosine Triphosphate, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Cholesteryl Nonanoate, Cimicifuga Racemosa Root Extract, Copper Gluconate, PEG-20 Phytosterol, Actinidia Polygama Fruit Extract, Acetyl Heptapeptide-Gold, Cholesteryl Oleate, Dimethylmethoxy Chromanyl Palmitate, Corallina Officinalis Extract, Carbomer, Cholsteryl Stearate, Acrylates Copolymer, Boswellia Serrata Extract, Ammonium Acryloyldimethltaurate/Beheneth-25 Methacrylate Crosspolymer, Phormidium Persicinum Extract, Caprylyl Glycol, Dextran, Magnesium Asparate Glyceryl Stearate, Disodium EDTA, Xanthan Gum, BHT, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbia Acid, Methylparaben, Mica, Titanium Dioxide (CI 77891), Red (CI 14700), Yellow 5 (CI 19140), Gold
1 INDICATIONS AND USAGE
Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (
14.1
)].
1. INDICATIONS AND USAGE
Celecoxib capsules is indicated
Celecoxib capsules is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
1 INDICATIONS AND USAGE
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1).
1 INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome (1.1).
Epilepsymonotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (1.1)
Bipolar Disorder
: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures
primary generalized tonic-clonic (PGTC) seizures
generalized seizures of Lennox-Gastaut syndrome
Monotherapy
Lamotrigine orally disintegrating tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine orally disintegrating tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
INDICATIONSAND USAGE
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.
Edema:
Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is particularly useful when an agent with greater diuretic potential is desired.
Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Furosemide Injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.
If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Furosemide Injection is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.
1 INDICATIONS AND USAGE
Clobazam tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
INDICATIONS AND USAGE
Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See
CLINICAL PHARMACOLOGY-Susceptibility Test Methods
).
Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with oxacillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin for Injection, USP 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Metformin hydrochloride is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1)
1
INDICATIONS AND USAGE
JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH) (1).
Limitations of Use
The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH) (1).
The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined (1).
1.1	Homozygous Familial Hypercholesterolemia
JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Limitations of Use
The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.
1 INDICATIONS AND USAGE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate 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.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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
Ranolazine extended-release tablet is indicated for the treatment of chronic angina.
Ranolazine extended-release tablet may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine extended-release tablet is an antianginal indicated for the treatment of chronic angina. (1)
1 INDICATIONS AND USAGE
REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes
Limitations of Use: REBINYN is not indicated for immune tolerance induction in patients with hemophilia B.
REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes
Limitations of Use: REBINYN is not indicated for immune tolerance induction in patients with hemophilia B (1).
1 INDICATIONS AND USAGE
Desmopressin acetate nasal solution (nasal spray) is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older.
Limitations of Use:
Desmopressin acetate nasal solution (nasal spray) is not indicated for:
Treatment of nephrogenic diabetes insipidus,
Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1) ],
Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)].
Use in patients with an impaired level of consciousness,
Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)].
Desmopressin acetate nasal solution (nasal spray) is a vasopressin analog indicated as antidiuretic replacement therapy in the management of central diabetes insipidus for adults and pediatric patients 4 years of age and older (1)
Limitations of Use:
Desmopressin acetate nasal solution (nasal spray) is not indicated for:
Treatment of nephrogenic diabetes insipidus (1)
Treatment of primary nocturnal enuresis (1, 5.1)
Use in patients with conditions that compromise intranasal route of administration (1, 5.2)
Use in patients with an impaired level of consciousness (1)
Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg (1,3)
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)