um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
For the management of schizophrenia.
Trifluoperazine HCl is effective for the short-term treatment of generalized
non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be
used in therapy for most patients with non-psychotic anxiety because certain
risks associated with its use are not shared by common alternative treatments
(i.e., benzodiazepines).
When used in the treatment of non-psychotic anxiety, trifluoperazine HCl
should not be administered at doses of more than 6 mg per day or for longer than
12 weeks because the use of trifluoperazine HCl at higher doses or for longer
intervals may cause persistent tardive dyskinesia that may prove irreversible
(see
WARNINGS
).
The effectiveness of trifluoperazine HCl as a treatment for non-psychotic
anxiety was established in a four-week clinical multicenter study of outpatients
with generalized anxiety disorder (DSM-III). This evidence does not predict that
trifluoperazine HCl will be useful in patients with other non-psychotic
conditions in which anxiety, or signs that mimic anxiety, are found (i.e.,
physical illness, organic mental conditions, agitated depression, character
pathologies, etc.).
Trifluoperazine HCl has not been shown effective in the management of
behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Adapalene and benzoyl peroxide gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
1 INDICATIONS AND USAGE
SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
SEGLENTIS contains tramadol hydrochloride, an opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate (1).
Limitations of Use (1):
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (5.1), reserve SEGLENTIS 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.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve SEGLENTIS 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.
INDICATIONS AND USAGE
Midazolam HCl Syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use (see WARNINGS).
Uses
For the treatment and / or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin
INDICATIONS AND USAGE
Cephalexin for Oral Suspension USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin for Oral Suspension USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin for Oral Suspension USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
Note Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for Oral Suspension USP and other antibacterial drugs, Cephalexin for Oral Suspension USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
INDICATION
Pyridostigmine bromide oral solution USP is useful in the treatment of myasthenia gravis.
1INDICATIONS AND USAGE
PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
INDICATIONS AND USAGE
Nystatin and Triamcinolone Acetonide Cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders
(previously known as Minimal Brain Dysfunction in Children). Other terms being
used to describe the behavioral syndrome below include: Hyperkinetic Child
Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral
Dysfunction.
Methylphenidate hydrochloride is indicated as an integral part of a total
treatment program which typically includes other remedial measures
(psychological, educational, social) for a stabilizing effect in children with a
behavioral syndrome characterized by the following group of developmentally
inappropriate symptoms: moderate-to-severe distractibility, short attention
span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this
syndrome should not be made with finality when these symptoms are only of
comparatively recent origin. Nonlocalizing (soft) neurological signs, learning
disability, and abnormal EEG may or may not be present, and a diagnosis of
central nervous system dysfunction may or may not be warranted.
Special Diagnostic ConsiderationsSpecific etiology of this syndrome is unknown, and there is no
single diagnostic test. Adequate diagnosis requires the use not only of medical
but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention
span, distractibility, emotional lability, impulsivity, and moderate-to-severe
hyperactivity; minor neurological signs and abnormal EEG. Learning may or may
not be impaired. The diagnosis must be based upon a complete history and
evaluation of the child and not solely on the presence of one or more of these
characteristics.
Drug treatment is not indicated for all children with this syndrome.
Stimulants are not intended for use in the child who exhibits symptoms secondary
to environmental factors and/or primary psychiatric disorders, including
psychosis. Appropriate educational placement is essential and psychosocial
intervention is generally necessary. When remedial measures alone are
insufficient, the decision to prescribe stimulant medication will depend upon
the physicians assessment of the chronicity and severity of the childs
symptoms.
1 INDICATIONSAND USAGE
Morphine Sulfate Injection 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 and Precautions (5.1
)], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
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 INDICATIONSAND USAGE
Aripiprazole tablets are indicated for the treatment of:
1.Schizophrenia [seeClinicalStudies(14.1)]
2.Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)]
3.Treatment of Tourettes Disorder [see Clinical Studies (14.5)]
Additional pediatric use information is approvedfor OtsukaAmericaPharmaceutical, Inc.sABILIFY(aripiprazole) product.However,due to OtsukaAmericaPharmaceutical,Inc.smarketingexclusivity rights, this drugproduct is not labeledwith that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulation is indicated for:
4.Schizophrenia(14.1)
5. Irritability Associated with Autistic Disorder (14.4)
6.Treatment of Tourettes disorder (14.5)
INDICATIONS AND USAGE:
To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.
1INDICATIONS AND USAGE
Ritalin LA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].
Ritalin LA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age. (1)
INDICATIONS AND USAGE
Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (coldsores) in adults and children 12 years of age and older.
INDICATIONS
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:"Lacking substantial evidence of effectiveness as a fixed combination":Urobiotic-250 is indicated in the therapy of a number of genitourinary infections caused by susceptible organisms. These infections include the following: pyelonephritis, pyelitis, ureteritis, cystitis, prostatitis, and urethritis. Since both Terramycin and sulfamethizole provide effective levels in blood, tissue, and urine, Urobiotic-250 provides a multiple antimicrobial approach at the site of infection. Both antibacterial components are active against the most common urinary pathogens, including Escherichia coli, Pseudomonas aeruginosa, Aerobacter aerogenes, Streptococcus faecalis, Streptococcus hemolyticus, and Micrococcus pyogenes. Urobiotic-250 is particularly useful in the treatment of infections caused by bacteria more sensitive to the combination than to either component alone. The combination is also of value in those cases with mixed infections, and in those instances where the causative organism is unknown pending laboratory isolation. Final classification of the less than effective indications requires further investigation. Clinical studies to substantiate the efficacy of Urobiotic 250 are ongoing. Completion of these ongoing studies will provide data for final classification of these indications.
1 INDICATIONSAND USAGE
Toremifene citrate tablets are estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Toremifene citrate tablets are estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac potassium tablets are indicated:
for treatment of primary dysmenorrhea
for relief of mild to moderate pain
for relief of the signs and symptoms of osteoarthritis
for relief of the signs and symptoms of rheumatoid arthritis
INDICATIONS
Tigan
is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
1INDICATIONS AND USAGE
Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1)
Use in combination with cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (1.2)
1.1Prophylaxis of Organ Rejection in Kidney Transplant
Myfortic (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Myfortic is to be used in combination with cyclosporine and corticosteroids.
1.2Limitations of Use
Myfortic delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
INDICATIONS
Sodium Sulfacetamide 9% and Sulfur 4.25% Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1
INDICATIONS AND USAGE
Yasmin is indicated for use by women to prevent pregnancy.
Yasmin is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets USP are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see
WARNINGS AND PRECAUTIONS (5.1)
].
1	INDICATIONS AND USAGE
DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see
CLINICAL STUDIES (14)
].
DETROL LA is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
INDICATIONS & USAGE SECTION
Anxiety Disorders
Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension(trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity(shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning(feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to alprazolam tablets.
Panic Disorder
Alprazolam tablets are also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam tablets by systematic clinical study are limited to4 months duration for anxiety disorder and 4 to10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.
Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see
CLINICAL STUDIES, Breast Carcinoma
).
Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.
INDICATIONS AND USAGE
Malaria
Hydroxychloroquine sulfate tablets, USP are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
Hydroxychloroquine sulfate tablets, USP are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
Hydroxychloroquine sulfate tablets, USP are not recommended
for the treatment of complicated malaria.
Hydroxychloroquine sulfate
tablets, USP are not effective against
chloroquine or hydroxychloroquine-resistant strains of Plasmodium
species (seeCLINICAL PHARMACOLOGY
Microbiology) . Hydroxychloroquine sulfate tablets,
USP are not 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, USP are not recommended
for malaria prophylaxis in geographic areas
where chloroquine resistance occurs.
Hydroxychloroquine sulfate
tablets, USP do not prevent
relapses of P. vivax
or P. ovale
because it is not 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 tablets, USP for 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, USP are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets, USP are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
Use(s)
To prevent or treat fainting