um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION).
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.
INDICATIONS
CLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.
1 INDICATIONS AND USAGE
Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older (1).
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Avoid any contact with the eyes and lips. (1.2)
1.1 Indication
Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
INDICATIONS AND USAGE
Prednisone tablets USP are indicated in the following conditions:
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Respiratory Diseases
Symptomatic sarcoidosis; Loeffler's syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Nervous System
Acute exacerbations of multiple sclerosis
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
INDICATIONS AND USAGE
Hydrocortisone valerate cream USP, 0.2% and hydrocortisone
valerate ointment USP, 0.2% are medium potency corticosteroids indicated for the
relief of the inflammatory and pruritic manifestations of corticosteroid
responsive dermatoses in adult patients.
INDICATIONS & USAGE
Tramadol hydrochloride and acetaminophen tablets is indicated for the short-term (five days or less) management of acute pain.
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] Clopidogrel tablets, have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)
For patients with ST-elevation myocardial infarction (STEMI), Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate
of myocardial infarction (MI) and stroke in patients with nonST-segment
elevation ACS (unstable angina [UA]/nonST-elevation myocardial
infarction [NSTEMI]), including patients who are to be managed medically
and those who are to be managed with coronary revascularization.
Clopidogrel tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate
of myocardial infarction and stroke in patients with acute ST-elevation
myocardial infarction (STEMI) who are to be managed medically. Clopidogrel
should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke Clopidogrel tablets are indicated to reduce the rate of MI and stroke.
1 INDICATIONS AND USAGE
Methadone hydrochloride tablets are indicated for the:
1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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 long-acting opioids, [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (
2.1)].
Methadone hydrochloride tablets are an opioid agonist indicated for the:
1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
L
i
mitations 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 long-acting opioids, reserve methadone hydrochloride 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.
Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (2.1).
Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle - Package Insert Text:
Rx only
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Virasal is a topical preparation containing 27.5% salicylic acid in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Virasal is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is:
structure.jpg
CLINICAL PHARMACOLOGY
Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.
The virucidal complex incorporated into Virasals proprietary vehicle is designed to help reduce risk of reinfection at the wart site, as well as prevent viral contamination of the product under normal usage.
INDICATIONS AND USAGE
Virasal is indicated for the topical treatment and removal of common warts and plantar warts.
CONTRAINDICATIONS
Patients with diabetes or impaired blood circulation should not use Virasal.
Virasal also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.
PRECAUTIONS
Virasal is for external use only.
Do not permit Virasal to contact eyes or mucous membranes.
If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes.
Virasal should not be allowed to contact normal skin surrounding wart, since localized irritation may occur.
Treatment should be discontinued if excessive irritation occurs.
Virasal is flammable.
Keep away from fire or flame.
Keep bottle tightly capped when not in use.
ADVERSE REACTIONS
A localized irritant reaction may occur if Virasal is applied to the normal skin surrounding the wart.
Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.
DOSAGE AND ADMINISTRATION
Prior to applying Virasal, soak wart in warm water for five minutes.
Remove any loosened tissue by gently rubbing with a brush, wash cloth, or emery board.
Dry wart site thoroughly.
Using the brush applicator supplied, apply Virasal twice to entire wart surface, allowing the first application to dry before applying the second.
Continue treatment once or twice a day as directed by physician.
Be careful not to apply to surrounding skin.
Clinically visible improvement will normally occur during the first or second week of therapy.
Maximum resolution may be expected after four to six weeks of Virasal use.
HOW SUPPLIED
Virasal is supplied in 10ml amber bottles with a brush applicator (NDC 42783-312-10).
Store at controlled room temperature, 15 to 30C (59 to 86F).
Manufactured for:Elorac, Inc. Vernon Hills, IL 60061
U.S. Patent Pending
Revised 06/2011
221619
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin tablets are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin tablets are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3
12 years.
1INDICATIONS AND USAGE
VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age [see Clinical Studies (14.1, 14.2)
].
Additional important information regarding the use of VIRAMUNE XR for the treatment of HIV-1 infection:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [
see Boxed Warning and Warnings and Precautions (5.1)
].
The 14-day lead-in period with immediate-release VIRAMUNE dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [
see Dosage and Administration (2.5) and Warnings and Precautions (5.2)
].
If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.
VIRAMUNE XR is an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age. (1)
Important Considerations:
Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks. (1, 5.1)
adult females with CD4+ cell counts greater than 250 cells/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3
The 14-day lead-in period with immediate-release VIRAMUNE (200 mg once daily) must be strictly followed; it has been demonstrated to reduce the frequency of rash. (2.5, 5.2)
INDICATIONS AND USAGE: NuCort lotion is a topical corticosteroid and is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE:
Disulfiram is an aid in the management of selected chronic alcohol patients who
want to remain in a state of enforced sobriety so that supportive and psychotherapeutic
treatment may be applied to best advantage.
Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking
pattern of the chronic alcoholic.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are indicated for:
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.'s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
INDICATIONS AND USAGE:
Carefully consider the potential benefits and risks of Indomethacin Extended-release Capsules USP 75 mg and other treatment options before deciding to use Indomethacin Extended-release Capsules USP 75 mg. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (See
WARNINGS
).
Indomethacin Extended-release Capsules USP 75 mg has been found effective in active stages of the following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
Moderate to severe ankylosing spondylitis.
Moderate to severe osteoarthritis.
Acute painful shoulder (bursitis and/or tendinitis).
Indomethacin Extended-release Capsules USP 75 mg are not recommended for the treatment of acute gouty arthritis.
Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See
PRECAUTIONS, Drug Interactions
).