um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:
Tinea corporis
Tinea pedis
Tinea cruris
Tinea barbae
Tinea capitis
Tinea unguium when caused by one or more of the following species of fungi:
Epidermophyton
floccosum
Microsporum
audouinii
Microsporum
canis
Microsporum
gypseum
Trichophyton
crateriform
Trichophyton
gallinae
Trichophyton
interdigitalis
Trichophyton
megnini
Trichophyton
mentagrophytes
Trichophyton
rubrum
Trichophyton
schoenleini
Trichophyton
sulphureum
Trichophyton
tonsurans
Trichophyton
verrucosum
Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection.
Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.
Griseofulvin tablets, USP are
not
effective in the following:
Bacterial infections
Candidiasis (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis
The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.
INDICATIONS AND USAGE
Hydrocortisone valerate cream, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
INDICATIONS
CitraNatal B-Calm is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the
postnatal period for both lactating and nonlactating mothers. CitraNatal B-Calm may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
Ganciclovir for Injection, USP is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (1.1)
prevention of CMV disease in adult transplant recipients at risk for CMV disease. (1.2)
1.1 Treatment
of CMV Retinitis
Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
1.2 Prevention
of CMV Disease in Transplant Recipients
Ganciclovir for Injection, USP is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Hypothyroidism
SYNTHROID is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (ThyroidStimulating Hormone, TSH) Suppression
SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions
(5.4)].
SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
SYNTHROID is levothyroxine sodium (T4) indicated for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (ThyroidStimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
INDICATIONS AND USAGE
AUGMENTIN XR Extended Release Tablets are indicated for the
treatment of patients with community-acquired pneumonia or acute bacterial
sinusitis due to confirmed, or suspected -lactamaseproducing pathogens (i.e.,
H.influenzae, M.catarrhalis, H.
parainfluenzae, K.pneumoniae, or
methicillin-susceptible S.aureus) and S.pneumoniae with reduced susceptibility to penicillin
(i.e., penicillin MICs=2mcg/mL). AUGMENTIN XR is not indicated for the
treatment of infections due to S. pneumoniae with
penicillin MICs
4mcg/mL. Data are limited with regard to infections due to
S.pneumoniaewith penicillin MICs
4mcg/mL (see
CLINICAL STUDIES).
Of the common epidemiological risk factors for patients with resistant
pneumococcal infections, only age > 65 years was studied. Patients with other
common risk factors for resistant pneumococcal infections (e.g., alcoholism,
immune-suppressive illness, and presence of multiple co-morbid conditions) were
not studied.
In patients with community-acquired pneumonia in whom
penicillin-resistant S.pneumoniae is suspected,
bacteriological studies should be performed to determine the causative organisms
and their susceptibility when AUGMENTIN XR is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a
penicillin-susceptible strain of S.pneumoniae plus a
-lactamaseproducing pathogen can be treated with another AUGMENTIN (amoxicillin/clavulanate potassium) product containing lower
daily doses of amoxicillin (i.e., 500mg every 8 hours or 875mg every 12
hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTINXR and other antibacterial drugs, AUGMENTINXR 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
VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy (1).
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:
Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)]
Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)]
Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)]
Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]
1. Indications and Usage
Adults and Pediatric Patients
Upper Respiratory Tract Infections of the Ear, Nose, and Throat:
Amoxicillin capsules
are indicated in the treatment of infections due to susceptible (ONLY - lactamasenegative) isolates of Streptococcus species. (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
Infections of the Genitourinary Tract: Amoxicillin capsules
are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Adult Patients only
Helicobacter pylori Infection and Duodenal Ulcer Disease:
Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:
Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by 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 AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
1 INDICATIONS AND USAGE
Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (
1)
This is a prescription fluoride treatment foam used to help prevent dental decay.
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
1 INDICATIONS AND USAGE
Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [seeWarnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Acute Treatment of Agitation in Schizophrenia
Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation [see Clinical Studies (14.1)].
Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
Ziprasidone mesylate for injection is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone mesylate for injection to prolong the QT interval and may consider the use of other drugs first (5.3)
Ziprasidone mesylate for injection as an intramuscular injection is indicated for the:
Acute treatment of agitation in schizophrenic patients. (1)
INDICATIONS AND USAGE
5% Dextrose Injection USP is indicated for use in adults and pediatric patients as sources of calories and water for hydration.
This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for
INDICATIONS AND USAGE
of drug additives to be administered in this manner.
1
INDICATIONS AND USAGE
6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma.
The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.
1 INDICATIONS AND USAGE
Quetiapine fumarate tablet is an atypical antipsychotic indicated for the: Treatment of schizophrenia (
1.1
)
Adults: Efficacy was established in three 6-week clinical trials in patients with schizophrenia (
14.1
)
Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex
(
1.2
)
Adults: Efficacy was established in two 12-week monotherapy trials and in one 3-week adjunctive trial in patients with manic episodes associated with bipolar I disorder (
14.2
)
Acute treatment of depressive episodes associated with bipolar disorder (
1.2
)
Adults: Efficacy was established in two 8-week trials in patients with bipolar I or II disorder (
14.2
)
Maintenance treatment of bipolar disorder as an adjunct to lithium or divalproex
(
1.2
)
Adults: Efficacy was established in two maintenance trials in adults (
14.2
)
1.1 Schizophrenia
Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-
week trials in adults. The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials
[see Clinical Studies (
14.1
)].
Pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
1.2 Bipolar Disorder
Quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults.
[see Clinical Studies
(
14.2
)].
Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies
(
14.2
)].
Pediatric use information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric use information in patients (13 to 17 years of age) with schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for such use in those patients.
INDICATIONS & USAGE SECTION
1.1 Partial Onset Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
SUPRANE, a general anesthetic, is an inhalation agent indicated:
for induction and/or maintenance of anesthesia in adults (1.1)
for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation.
1.1 Induction of Anesthesia
SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.
1.2 Maintenance of Anesthesia
SUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.
After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [See Warnings and Precautions (5.3)
and
Clinical Studies (14.5)
].
1 INDICATIONS AND USAGE
EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.
EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitation of Use: The dosage of this product is for HIV-1 and not for HBV. (1)
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.
1 INDICATIONS AND USAGE
HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. (
1)
1
INDICATIONS AND USAGE
Adefovir Dipivoxil Tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function.
Adefovir Dipivoxil Tablets are nucleotide analogues indicated for the treatment of chronic hepatitis B in patients 12 years of age and older. (
1)