um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONSAND USAGE
Pregabalin capsule is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pregabalin capsule is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
(1)
Postherpetic neuralgia (PHN)
(1)
Adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older
(1)
Fibromyalgia
(1)
Neuropathic pain associated with spinal cord injury
(1)
INDICATIONS AND USAGE
Metaxalone tabletsare indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
1
INDICATIONS AND USAGE
Zingo is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 318 years of age.
Zingo is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults.
Zingo is an amide local anesthetic indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children 318 years of age. (1)
Zingo is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults. (1)
Important Limitations:
For use on intact skin only (1, 2)
For external use only (5)
1 INDICATIONS & USAGE
Aripiprazole oral tablets are indicated for the treatment of:
Schizophrenia
[see CLINICAL STUDIES (
14.1
)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (
14.1)
1 INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
Malignant Diseases: malignant lymphomas: Hodgkins disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1)
Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2)
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults of other renal disease has not been established.
1.1 Malignant Diseases
Cyclophosphamide is indicated for the treatment of:
malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkins disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma
multiple myeloma
leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
mycosis fungoides (advanced disease)
neuroblastoma (disseminated disease)
adenocarcinoma of the ovary
retinoblastoma
carcinoma of the breast
Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
INDICATIONS AND USAGE
Anxiety Disorders
ALPRAZOLAM Tablets (alprazolam) 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 of six 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.
Panic Disorders
ALPRAZOLAM is 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, ie, 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 by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 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 Section
1 INDICATIONS AND USAGE
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
INDICATIONS & USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50mg/m
2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE
Halobetasol Propionate Ointment,0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies
(see
Clinical Trials
under
CLINICAL PHARMACOLOGY
). It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS, and
WARNINGS).
1 INDICATIONS AND USAGE
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Taclonex Scalp Topical Suspension is a vitamin D analog
andcorticosteroid combination product indicated for the topical treatmentof
moderate to severe psoriasis vulgaris of the scalp in adults18 years and older
(1.1)
Limitations of Use:
Do not use on the face, axillae or groin (1.2)
Do no use if atrophy is present at the treatment site (1.2)
1.1 Indication
Taclonex Scalp Topical Suspension is indicated for the
topical treatment of moderate to severe psoriasis vulgaris of the scalp in
adults 18 years and older.
1.2 Limitations of Use
Taclonex Scalp Topical Suspension should not be used
on the face, axillae or groin
Taclonex Scalp Topical Suspension should not be used
if there is atrophy at the treatment site
1 INDICATIONS AND USAGE
Lo-Zumandimine is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral Contraceptive
Lo-ZumandimineTM is
indicated for use
by females of reproductive potential to
prevent
pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Lo-Zumandimine is
also indicated for the treatment of
symptoms of
premenstrual dysphoric disorder (PMDD) in
females of reproductive potential
who choose to use an
oral contraceptive as their
method of contraception. The effectiveness of Lo-Zumandimine for
PMDD when used for
more than
three menstrual cycles has not
been evaluated.
The
essential features of PMDD
according to
the Diagnostic and
Statistical Manual-4th edition
(DSM-IV) include markedly depressed
mood, anxiety or
tension, affective lability, and
persistent anger or
irritability. Other features include decreased interest in
usual activities, difficulty concentrating, lack
of energy, change in
appetite or
sleep, and feeling out of
control. Physical
symptoms associated
with PMDD include
breast tenderness, headache, joint and muscle pain, bloating and
weight gain. In this
disorder, these symptoms occur regularly during the
luteal phase and
remit within a
few
days following onset of menses; the
disturbance markedly interferes with work or
school, or
with usual social activities and
relationships with others. Diagnosis is
made by
healthcare providers according to
DSM-IV criteria, with symptomatology assessed prospectively over at
least two menstrual cycles.
In making the
diagnosis, care should be taken to
rule out
other cyclical mood disorders.
Lo-Zumandimine has not
been evaluated for the
treatment of
premenstrual syndrome (PMS).
1.3 Acne
Lo-Zumandimine isindicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.Lo-Zumandimine should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1 INDICATIONS AND USAGE
LYBALVI is indicated for the treatment of:
Schizophrenia in adults
Bipolar I disorder in adults
Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
Maintenance monotherapy treatment
LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of:
Schizophrenia in adults (1)
Bipolar I disorder in adults (1)
Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
Maintenance monotherapy treatment
1 INDICATIONS & USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
(1)
INDICATIONS & USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in PregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (seePRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
INDICATIONSAND USAGE
Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinsons disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Carbidopa tablets are for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa.
Carbidopa tablets are for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication.
Carbidopa tablets are used with carbidopa-levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular (on-off) responses to levodopa have not been shown to benefit from the addition of carbidopa.
Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, supplemental pyridoxine (vitamin B6), can be given to patients when they are receiving carbidopa and levodopa concomitantly or as carbidopa-levodopa.
Although the administration of carbidopa tablets permits control of parkinsonism and Parkinsons disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.
Certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently. This was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
In deciding whether to give carbidopa tablets with carbidopa-levodopa or with levodopa to patients who have nausea and/or vomiting, the physician should be aware that, while many patients may be expected to improve, some may not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone, about half the patients with nausea and/or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
1 INDICATIONS AND USAGE
Fluoxetine tablets are indicated for the treatment of:
Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age
[see
Clinical Studies (14.1)].
Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age
[see
Clinical Studies (14.2)].
Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults
[see
Clinical Studies (14.3)].
Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults
[see
Clinical Studies (14.4)].
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
Major Depressive Disorder (MDD) (
1)
Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study (
14.1)
Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age (
14.1)
Obsessive Compulsive Disorder (OCD) (
1)
Adults: Efficacy was established in two 13-week trials (
14.2)
Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age (
14.2)
Bulimia Nervosa (
1)
Adults: Efficacy was established in two 8-week trials and one 16-week trial (
14.3)
Panic Disorder, with or without agoraphobia (
1)
Adults: Efficacy was established in two 12-week trials (
14.4)
INDICATIONS AND USAGE
Ranitidine tablets USP are indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mgtwice dailyd.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg4 times dailyd.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
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.)
Nephropathy in Type 2 Diabetic Patients
Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).
INDICATIONS AND USAGE:
Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.