um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1)
Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.
INDICATIONS AND USAGE:
Chlorhexidine gluconate oral rinse USP, 0.12% is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse USP, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
INDICATIONS AND USAGE:
Cromolyn Sodium Oral Solution, Concentrate is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
INDICATIONS AND USAGE
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is
indicated for the treatment of the signs and symptoms of allergic
conjunctivitis.
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 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 tablets in the acute treatment of mood episodes has not been established.
1 INDICATIONS & USAGE
Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) (1.1) Social Anxiety Disorder (SAD) (1.2)
1.1	Major Depressive Disorder
Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2	Social Anxiety Disorder
Venlafaxine Extended-Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.
MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated MARCAINE concentrations are:
local infiltration
0.25%
peripheral nerve block
0.25% and 0.5%
retrobulbar block
0.75%
sympathetic block
0.25%
lumbar epidural
0.25%, 0.5%, and 0.75%
(0.75% not for obstetrical anesthesia)
caudal
0.25% and 0.5%
epidural test dose
0.5% with epinephrine 1:200,000
dental blocks
0.5% with epinephrine 1:200,000
(See DOSAGE AND ADMINISTRATION for additional information).
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin andother antibacterial drugs, Amoxicillin Tablets should be used only to treat infections that are proven orstrongly 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.
Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1
1.5)
In combination for treatment of
H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the ear, nose, and throat
due to
Streptococcus species.
(- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus
influenzae.
1.2 Infections of the genitourinary tract
due to
Escherichia coli,
Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the skin and skin structure
due to
Streptococcus spp.
(- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the lower respiratory tract
due to
Streptococcus spp.
(- and -hemolytic isolates only),
S. pneumoniae,
Staphylococcus spp., or
H. influenzae.
1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral infections)
due to
Neisseria
gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Tablets are not recommended for empiric treatment of gonorrhea. Amoxicillin Tablets use should be limited to situations where
N. gonorrhoeaeisolates are known to be susceptible to amoxicillin.
1.6 Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin Tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year historyof a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of
duodenal ulcer recurrence.
1.7 Dual therapy for H. pylori with lansoprazole
Amoxicillin Tablets, in combination with lansoprazoledelayed-release capsules as dual therapy, are indicated for the treatment of patients with
H. pyloriinfection 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 orsuspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has beenshown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see
DOSAGE AND ADMINISTRATION
and
CLINICAL PHARMACOLOGY
).
INDICATIONS AND USAGE
Methimazole tablets are indicated:
In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option.
To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance (1)
1 INDICATIONS AND USAGE
Phentermine Hydrochloride, USP 15 mg and 30 mg 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/m2, or27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the 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 hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
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Indications and Usage
Major indications for Griseofulvin Oral Suspension, USP are:
Tinea capitis (ringworm of the scalp)
Tinea corporis (ringworm of the body)
Tinea pedis (athlete's foot)
Tinea unguium (onychomycosis; ringworm of the nails)
Tinea cruris (ringworm of the thigh)
Tinea barbae (barbers itch)
Griseofulvin Oral Suspension, USP inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:
Trichophyton rubrum
Trichophyton tonsurans
Trichophyton mentagrophytes
Trichophyton interdigitalis
Trichophyton verrucosum
Trichophyton sulphureum
Trichophyton schoenleini
Microsporum audouini
Microsporum canis
Microsporum gypseum
Epidermophyton floccosum
Trichophyton megnini
Trichophyton gallinae
Trichophyton crateriform
Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical antifungal agents alone.
It is
not effective in:
Bacterial infections
Candidiasis (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis
1 INDICATIONS AND USAGE
Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1)
Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. (1.2)
1.1
Plaque Psoriasis
Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.
1.2
Acne Vulgaris
Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
INDICATIONS AND USAGE
Hypertension:
Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy:
Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see PRECAUTIONS, Race
and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race).
1 INDICATIONS AND USAGE
Doxorubicin hydrochloride liposomal infusion is an anthracycline topoisomerase inhibitor indicated for:
Ovarian cancer: After failure of platinum-based chemotherapy (1.1)
AIDS-related Kaposi's Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2)
Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3)
1.1 Ovarian Cancer
Doxorubicin hydrochloride liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
1.2 AIDS-Related Kaposi's Sarcoma
Doxorubicin hydrochloride liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
1.3 Multiple Myeloma
Doxorubicin hydrochloride liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
INDICATIONS AND USAGE
Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immunocompromised patients.
1 INDICATIONS AND USAGE
SYMFI LO
(efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
SYMFI LO is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. (1)
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)].
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1.1)
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(
1.1)
1.1
Important 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.
1 INDICATIONS AND USAGE
Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1,2.3
)and Warnings and Precautions (5.1)].
Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible. (1)
1 INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the:
Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax
in adult and pediatric patients. (1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1)
Treatment of rheumatoid arthritis in adults. (1.2)
Treatment of systemic lupus erythematosus in adults. (1.3)
Treatment of chronic discoid lupus erythematosus in adults. (1.4)
Limitations of Use (1.1):
Hydroxychloroquine sulfate tablets are not recommended for the:
Treatment of complicated malaria.
Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium
species.
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium
species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax or P. ovale
because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivax and P. ovale
infections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax,
and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablets are not recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium
species [see Microbiology (12.4)].
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium
species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax
or P. ovale
because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax
and P. ovale
infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention.1
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults.
1 INDICATIONS AND USAGE
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to
Staphylococcus aureus,
Streptococcus pneumoniae,
Haemophilus influenzae,
Moraxella catarrhalis, and
Pseudomonas aeruginosa.
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is a combination of ciprofloxacin, a fluoroquinolone antibacterial, and fluocinolone acetonide, a corticosteroid, indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to
Staphylococcus aureus,
Streptococcus pneumoniae,
Haemophilus influenzae,
Moraxella catarrhalis, and
Pseudomonas aeruginosa (
1)
1 INDICATIONS AND USAGE
VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
VALTOCO is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. (1)
INDICATIONS AND USAGE
Propylthiouracil is indicated:
in patients with Graves disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option
to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
7. Respiratory Diseases
Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis