um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
Note: -lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
Note: -lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor 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.
1	INDICATIONS AND USAGE
JARDIANCE is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. (1)
To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (1)
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 (1)
Limitations of Use
JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients
[see
Warnings and Precautions (5.1)	]	.
JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m	2	. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
1 INDICATIONS AND USAGE
XELSTRYM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14)].
Limitations of Use
Pediatric patients younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [USE IN SPECIFIC POPULATIONS (8.4)].
XELSTRYM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older (1)
Limitations of Use:
Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older (8.4)
INDICATIONS AND USAGE
Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS & USAGE
Quetiapineis an atypical antipsychotic indicated forthetreatmentof:
Schizophrenia
(1.1)
BipolarIdisordermanicepisodes
(1.2)
Bipolardisorder,depressiveepisodes
(1.2)
1.1 Schizophrenia
Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [
see
Clinical Studies (14.1)
].
1.2 Bipolar Disorder
Quetiapineis 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, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [
see
Clinical Studies
(14.2)
].
Quetiapine 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)
].
Quetiapineis indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [
see
Clinical Studies
(14.2)
].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (
1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (
1.2)
Esophageal candidiasis (
1.3)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (
1.4)
1.1 Invasive Aspergillosis
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were
Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of
Aspergillus other than
A. fumigatus [see Clinical Studies (
14.1,
14.5) and Microbiology (
12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following
Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
[see Clinical Studies (
14.2,
14.5) and Microbiology (
12.4)]
.
1.3 Esophageal Candidiasis
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older
[see Clinical Studies (
14.3,
14.5) and Microbiology (
12.4)]
.
1.4 Scedosporiosis and Fusariosis
Voriconazole tablets are indicated for the treatment of serious fungal infections caused by
Scedosporium apiospermum (asexual form of
Pseudallescheria boydii) and
Fusarium spp. including
Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy
[see Clinical Studies (
14.4) and Microbiology (
12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1 INDICATIONSAND USAGE
Lamotrigine tablets isindicated 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 antiepileptic drug. (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 tabletsin the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy:
Lamotrigine 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 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 tablets 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 tablets are is 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 (14.2)] .
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
1 INDICATIONS AND USAGE
Phentermine hydrochloride is 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
30 kg/m
2, or
27 kg/m
2 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
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.
Phentermine hydrochlorideis a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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
30 kg/m
2, or
27 kg/m
2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use.
image description
INDICATIONS:
Initial Treatment of Advanced Ovarian Carcinoma
Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see
CLINICAL STUDIES
).
There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (3 years)because of the small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma
Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
1 INDICATIONS AND USAGE
Metformin Hydrochloride Tablets are 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 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
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for:
the treatment of life-threatening ventricular arrhythmias(1.1)
the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2)
Limitations of Use
Sotalol hydrochloridehasnotbeenshowntoenhancesurvivalinpatientswithlifethreateningventriculararrhythmias(1.1)
Avoiduseinpatientswithminimallysymptomaticoreasilyreversible AFIB/AFL(1.2)
1.1 Life-Threatening Ventricular Arrhythmias
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Limitation of Use:
Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threateningventriculararrhythmias.
1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.
Limitation of Use:
Because sotalol hydrochloride/sotalol hydrochloride AF tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride AF tablets.
1 INDICATIONS AND USAGE
Lamivudine and zidovudine tablets, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
Lamivudine and zidovudine tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
INDICATIONS AND USAGE
ORBIVAN Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1
INDICATIONS AND USAGE
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
ENDARI is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. (1)
INDICATIONS AND USAGE
I. Vasospastic Angina
Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.
II. Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine Extended-release Tablet is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.)
III. Hypertension
Nifedipine Extended-release Tablet is indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
-
normal intact skin for local analgesia.
-
genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
1.3 Limitations of Use
Fenofibrate at a dose equivalent to 135 mg of Fenofibric Acid Delayed-Release Capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus
[see Warnings and Precautions (
5.1)]
.
INDICATIONS AND USAGE
Malaria
Hydroxychloroquine sulfate tablets areindicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
Hydroxychloroquine sulfate tablets areindicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
Hydroxychloroquine sulfate tablets arenot recommended for the treatment of complicated malaria.
Hydroxychloroquine sulfate tablets arenot effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see
CLINICAL PHARMACOLOGY
Microbiology
). Hydroxychloroquine sulfate tablets arenot recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Hydroxychloroquine sulfate tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
Hydroxychloroquine sulfate tablets donot prevent relapses of P. vivax or P.ovale because they are ot active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see
CLINICAL PHARMACOLOGY
Microbiology
).
Prior to prescribing Hydroxychloroquine sulfate tabletsfor the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria).
Lupus Erythematosus
Hydroxychloroquine sulfate tablets areindicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets areindicated for the treatment of acute and chronic rheumatoid arthritis in adults.