um-ids/dailymed-annotations huggingface dataset:
1.2 Adenocarcinoma of the Breast or Ovary
Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1 INDICATIONS AND USAGE
Gabapentin capsules are indicated for:
Management of postherpetic neuralgia in adults.
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
Gabapentin capsules are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
1 INDICATIONS AND USAGE
TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. (1.1)
Limitations of Use:
The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drugs efficacy is not ethical. (1.2)
TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. (1.2)
1.1	Treatment of Human Smallpox Disease
TPOXX is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg.
1.2	Limitations of Use
The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drugs efficacy is not ethical
[see Clinical Studies (14)].
TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should beconsidered in selecting ormodifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and Clavulanate Potassium Powder for Oral Suspension is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and Clavulanate Potassium Powder for Oral Suspension is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections (
1.1)
Acute bacterial otitis media (
1.2)
Sinusitis (
1.3)
Skin and skin structure infections (
1.4)
Urinary tract infections (
1.5)
1.1 Lower Respiratory Tract Infections
- caused by beta-lactamase-producing isolates of
Haemophilus
influenzae
and
Moraxella
catarrhalis.
1.2 Acute Bacterial
Otitis
Media
- caused by beta-lactamase-producing isolates of
H.
influenzae
and
M.
catarrhalis.
1.3 Sinusitis
- caused by beta-lactamase-producing isolates of
H.
influenzae
and
M.
catarrhalis.
1.4 Skin and Skin Structure Infections
- caused by beta-lactamase-producing isolates of
Staphylococcus
aureus,
Escherichia coli, and
Klebsiella
species.
1.5 Urinary Tract Infections
- caused by beta-lactamase-producing isolates of
E. coli,
Klebsiella
species, and
Enterobacter
species.
1.6 Limitations of Use
- When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension should not be used.
1 INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for use in the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:
Invasive aspergillosis (
1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (
1.2)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (
1.3)
1.1 Invasive Aspergillosis
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive apergillosis (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), and
Microbiology (12.4)]
.
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole for injection is indicated in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) 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) and
Microbiology (12.4)
].
1.3 Scedosporiosis and Fusariosis
Voriconazole for injection is indicated for the treatment of serious fungal infections caused by
Scedosporium apiospermum (asexual form of
Pseudallescheria boydii) and
Fusarium spp. including
Fusarium solani, in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see
Clinical Studies (14.3) and
Microbiology (12.4)
].
1.4 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.
Additional pediatric use information is approved for PF PRISM C.V.s VFEND (voriconazole) for injection. However, due to PF PRISM C.V.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS & USAGE
Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Travoprost Ophthalmic Solution USP, 0.004% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
INDICATIONS AND USAGE
Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules, USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
1 INDICATIONS AND USAGE
Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium Chloride Extended-release Tablets is a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
1 INDICATIONS AND USAGE
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
Naloxone HCl Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. (1)
Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. (1)
Naloxone HCl Nasal Spray is not a substitute for emergency medical care. (1)
1 INDICATIONS AND USAGE
Fluocinonide Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1)
Limitation of Use:
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
Avoid use on the face, groin, or axillae. (1.2)
Avoid use in perioral dermatitis or rosacea.
1.1 Indication
Fluocinonide Cream, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].
1.2 Limitation of Use
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide Cream, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
INDICATIONS AND USAGE
Diltiazem Hydrochloride Extended Release Tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Diltiazem Hydrochloride Extended Release Tablets are indicated for the management of chronic stable angina.
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 of 6 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 Disorder
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, 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) 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
Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
CONTRAINDICATIONS
Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.).
Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.
INDICATIONS
AND USAGE
Chlorhexidine Gluconate
Oral Rinse 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 has not been tested
among patients with acute necrotizing ulcerative gingivitis (ANUG).
For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.
1 INDICATIONS AND USAGE
Betamethasone dipropionate cream, 0.05% (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.
Betamethasone dipropionate cream, 0.05% (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1)
INDICATIONS AND USAGE
Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
INDICATIONS AND USAGE
Diethylpropion hydrochloride tablets USP, 25 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m
2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches
0.0254 = meters.
Body Mass Index (BMI), kg/m
2
Weight (pounds)
Height (feet, inches)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The usefulness of agents of this class (See
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride tablets USP, 25 mg are indicated for use as monotherapy only.
1
INDICATIONS AND USAGE
Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of:
rheumatoid arthritis (RA)
osteoarthritis (OA)
ankylosing spondylitis (AS)
tendinitis, bursitis
acute gout
primary dysmenorrhea (PD)
the relief of mild to moderate pain
[see Warnings and Precautions (
5
)].
Naproxen Sodium Controlled-Release Tabletsis a nonsteroidal anti-inflammatorydrug indicatedfor the treatment of:
rheumatoid arthritis (RA)(1)
osteoarthritis (OA)(1)
ankylosing spondylitis(AS)(1)
tendinitis, bursitis(1)
acute gout(1)
primary dysmenorrhea (PD)(1)
the relief of mild to moderate pain(1)
INDICATIONS AND USAGE
Metolazone tablets, USP, are indicated for the treatment of salt and water retention including:
edema accompanying
congestive heart failure;
edema accompanying
renal diseases, including the nephrotic syndrome and states of diminished
renal function.
Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROXTablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROXTablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROXTablets.
Usage In Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
1INDICATIONS AND USAGE
Ritalin and Ritalin-SR are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy. (1)
1 INDICATIONS AND USAGE
Sevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Sevelamer carbonate is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.(1)
1. INDICATIONS AND USAGE
Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1)
Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants (1.2)
Efficacy was established in two 6-week trials in adult patients (14.2)
1.1 Schizophrenia
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1)].
The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2 Schizoaffective Disorder
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2)].
The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.