um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [
see Clinical Studies (
14)
].
Important Limitations of Use
Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [
see Warnings and Precautions (
5.3)
].
Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (
1,
14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (
1)
1	INDICATIONS AND USAGE
VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. (1)
1 INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections -caused by betalactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media -caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis -caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections -caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections -caused by betalactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium for Oral Suspension should not be used.
Usage
To reduce the development of drugresistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a betalactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicatingno beta-lactamase production, Amoxicillin and Clavulanate Potassium for Oral Suspensionshould not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain theeffectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspensionshould be used only to treat or prevent infections that are proven or stronglysuspected to be caused by bacteria. (1)
Doxepin HCl capsules are recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety.
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin HCl capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin HCl capsules is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.
INDICATIONSAND USAGE:
The injection form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
INDICATIONS AND USAGE
Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
1 INDICATIONS AND USAGE
DYSPORT is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for:
the treatment ofcervical dystonia in adults(1.1)
the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age (1.2)
The treatment of spasticity in patients 2 years of age and older (1.3)
1.1 Cervical Dystonia
DYSPORT is indicated for the treatment of cervical dystonia in adults.
1.2 Glabellar Lines
DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years of age.
1.3 Spasticity
DYSPORT is indicated for the treatment of spasticity in patients 2 years of age and older.
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution, USP 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See
CONTRAINDICATIONS, WARNINGS
and
ADVERSE REACTIONS
).
1 INDICATIONS AND USAGE
Divalproex sodium delayed-release capsules (sprinkle) are anti-epileptic drug indicated for:
Monotherapy and adjunctive
therapy of complex partial seizures and simple and complex absence
seizures; adjunctive therapy in patients with multiple seizure types that
include absence seizures (1)
1.1 Epilepsy
Divalproex sodium delayed-release capsules (sprinkle) are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules (sprinkle) are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see WARNINGS AND PRECAUTIONS
(5.2, 5.3, 5.4), USE IN SPECIFIC POPULATIONS (8.1), AND PATIENT COUNSELING INFORMATION (17)].
1 INDICATIONS AND USAGE
CUVPOSA is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
CUVPOSA is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). (1)
1 INDICATIONS AND USAGE
Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.
Limitations of Use:
The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3)
1.1 Treatment of Chronic Iron Overload Due to Blood
Transfusions (Transfusional Iron Overload)
Deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2	Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
1.3 Limitations of Use
The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.
1 INDICATIONS AND USAGE
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for
Treatment of schizophrenia (
1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (
14.1)
Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (
14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (
1.2)
Efficacy was established in two 6-week trials in adult patients. (
14.2)
1.1 Schizophrenia
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia
[see
Clinical Studies (14.1)]
.
The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2 Schizoaffective Disorder
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy
[see
Clinical Studies (14.2)]
.
The efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults.
1 INDICATIONS AND USAGE
Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].
Desonate is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. (1)
INDICATIONS AND USAGE
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenza and Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2)
Limitations of Use:
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Prevention of Postmenopausal Osteoporosis (1.3)
Limitations of Use:
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Estradiol and norethindrone acetate tablets are indicated for:
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1.3 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1 INDICATIONS AND USAGE
Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:
Pantoprazole is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (
1.1)
Maintenance of Healing of Erosive Esophagitis (
1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (
1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE
a) Acute Nonlymphocytic Leukemias
TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS).
The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent remission induction and longer duration of remission than thioguanine alone.
b) Other Neoplasms
TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkins lymphoma, multiple myeloma, or solid tumors. Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN (busulfan), and therefore busulfan is usually regarded as the preferred drug.
1	INDICATIONS AND USAGE
Vilazodone hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .
Vilazodone hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults (1).
1 INDICATIONS AND USAGE
Atropine Sulfate Ophthalmic Solution, 1% is indicated for:
Atropine Sulfate Ophthalmic Solution, 1% is a muscarinic antagonist indicated for:
Mydriasis (1.1)
Cycloplegia (1.2)
Penalization of the healthy eye in the treatment of amblyopia (1.3)
1.1 Mydriasis
1.2 Cycloplegia
1.3 Penalization of the healthy eye in the treatment of amblyopia
1 INDICATIONS AND USAGE
Imiquimod cream is indicated for the topical treatment of:
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults (1.1)
External genital and perianal warts/condyloma acuminata in patients 12 years old or older (1.3) Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 2 to12 (1.4, 8.4)
1.1 Actinic Keratosis
Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
1.3 External Genital Warts
Imiquimod Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older.
1.4 Limitations of Use
Imiquimod Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].
1.5 Unevaluated Populations
The safety and efficacy of Imiquimod Cream in immunosuppressed patients have not been established.
Imiquimod Cream should be used with caution in patients with pre-existing autoimmune conditions.
The efficacy and safety of Imiquimod Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
INDICATIONS & USAGE SECTION
Herpes Zoster Infections
Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes
Acyclovir tabletis indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox
Acyclovir tabletis indicated for the treatment of chickenpox (varicella).
INDICATIONS AND USAGE
HYDROQUINONE 4% CREAM
is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
1 INDICATIONS AND USAGE
Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Usage Considerations:
The use of
propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use
propafenone hydrochloride extended-release capsules to control ventricular rate during AF.
Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
The effect of propafenone on mortality has not been determined [see Boxed Warning].
Propafenone hydrochloride extended-release capsules are an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. (1)
Usage Considerations:
Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. (1)
In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride extended-release capsules with drugs that increase the atrioventricular nodal refractory period. (1)
The effect of propafenone on mortality has not been determined. (1)