um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [
see
Warnings and Precautions (5.4)
].
Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (
1.1); Community-acquired pneumonia (
1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (
1.2); Uncomplicated skin and skin structure infections (
1.2); Vancomycin-resistant
Enterococcus faecium infections. (
1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.4)
1.1	Pneumonia
Nosocomial pneumonia caused by
Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or
Streptococcus pneumoniae [
see
Clinical Studies (14)
].
Community-acquired pneumonia caused by
Streptococcus pneumoniae, including cases with concurrent bacteremia, or
Staphylococcus aureus (methicillin-susceptible isolates only) [
see
Clinical Studies (14)
].
1.2	Skin and Skin Structure Infections
Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by
Staphylococcus aureus (methicillin-susceptible and -resistant isolates),
Streptococcus pyogenes, or
Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers [
see
Clinical Studies (14)
].
Uncomplicated skin and skin structure infections caused by
Staphylococcus aureus (methicillin-susceptible isolates only) or
Streptococcus pyogenes [
see
Clinical Studies (14)
].
1.3	Vancomycin-resistant
Enterococcus faecium Infections
Vancomycin-resistant
Enterococcus faecium infections,
including cases with concurrent bacteremia [
see
Clinical Studies (14)
].
1.4	Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid 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 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.
The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
1 INDICATIONS AND USAGE
VANOS Cream 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. (1.2)
1.1 Indications
VANOS (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 VANOS Cream 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.
VANOS Cream 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
PRED MILD is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).
1 INDICATIONS AND USAGE
Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. (
1)
1 INDICATIONS AND USAGE
Oxybutynin chloride is a
muscarinic antagonist indicated for the treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency, and frequency.
(1)
Oxybutynin chloride
extended-release tablets are also indicated for the treatment of pediatric
patients aged 6 years and older with symptoms of detrusor overactivity
associated with a neurological condition (e.g., spina bifida).
(1)
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
INDICATIONS AND USAGE
Granisetron hydrochloride tablets USP are indicated for the prevention of:
Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
1 INDICATIONS AND USAGE
GLIADEL Wafer is indicated for the treatment of patients with:
newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and
recurrent glioblastoma as an adjunct to surgery.
GLIADEL Wafer is an alkylating drug indicated for the treatment of:
newly-diagnosed high-grade glioma as an adjunct to surgery and radiation (1) and
recurrent glioblastoma as an adjunct to surgery (1)
INDICATIONS AND USAGE: This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).
Triamterene and hydrochlorothiazide
may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary.
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 satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological 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. 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 provide relief and may be appropriate.
1 INDICATIONS AND USAGE
JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JANUMET XR is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Not for the treatment of type 1 diabetes. (1)
Has not been studied in patients with a history of pancreatitis. (1, 5.2)
Limitations of Use
JANUMET XR should not be used in patients with type 1 diabetes mellitus.JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR. [See Warnings and Precautions (5.2).]
INDICATIONS AND USAGE
Cimetidine tablets USP are indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see
DOSAGE AND ADMINISTRATION,
Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg at bedtime for periods of up to five years.
Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.
Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established [see
DOSAGE AND ADMINISTRATION,
Erosive Gastroesophageal Reflux (
GERD)].
The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
1INDICATIONS AND USAGE
Xiidra (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). (1)
INDICATIONS AND USAGE
Sumatriptan Succinate Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan Succinate Tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of Sumatriptan Succinate Tablets have not been established for cluster headache, which is present in an older, predominantly male population.
INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. It may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery.
The antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine concomitantly with morphine may be indicated.
Atropine relaxes the upper GI tract and colon during hypotonic radiography.
In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. It is also used as an antidote for mushroom poisoning due to muscarine in certain species such as Amanita muscaria.
1 INDICATIONS AND USAGE
Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.
(1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)], or lung transplant [see Clinical Studies (14.4)] in combination with other immunosuppressants.
INDICATIONS AND USAGE
Fluocinonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients
who weigh 60 kg (
1.3)
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)
].
3. 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 Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
%ofWomenExperiencinganUnintendedPregnancy
intheFirstYearofContinuousUse
Method
LowestExpected*
Typical**
(Nocontraception)
(85)
(85)
Oralcontraceptives
3
combined
0.1
N/A***
progestinonly
0.5
N/A***
Diaphragmwithspermicidalcreamorjelly
6
20
Spermicidesalone(foam,creams,gels,vaginalsuppositoriesandvaginalfilm)
6
26
VaginalSponge
nulliparous
9
20
parous
20
40
Implant
0.05
0.05
Injection:depotmedroxyprogesteroneacetate
0.3
0.3
IUD
progesteroneT
1.5
2
copperT380A
0.6
0.8
LNg20
0.1
0.1
Condomwithoutspermicides
female
5
21
male
3
14
CervicalCapwithspermicidalcreamorjelly
nulliparous
9
20
parous
26
40
Periodicabstinence(allmethods)
1to9
25
Withdrawal
4
19
Femalesterilization
0.5
0.5
Malesterilization
0.1
0.15
Adapted from RA Hatcher et al, Reference 7.
* The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
** This term represents "typical" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
***N/A - Data not available.
1 INDICATIONS AND USAGE
Fentanyl Citrate Injection is indicated in adult and pediatric patients ages 2 years and older for:
use as a narcotic analgesic supplement in general anesthesia.
administration with a neuroleptic for the induction of anesthesia and as an adjunct in the maintenance of general anesthesia.
use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures [see Dosage and Administration (2.1)].
Fentanyl Citrate Injection is an opioid agonist indicated for:
use as an opioid analgesic supplement in general anesthesia.
administration with a neuroleptic for the induction of anesthesia and as an adjunct in the maintenance of general anesthesia.
use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. (1)
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65
[see
Clinical Studies (14)].
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; on the go; excessive talking; blurting answers; cant wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate hydrochloride extended-release tablets is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.
(1)
1.1 Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
1.2 Need for Comprehensive Treatment Program
Methylphenidate hydrochloride extended-release tablets is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patients symptoms.
1 INDICATIONS AND USAGE
ZIRGAN (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).
ZIRGAN is a topical ophthalmic antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers). (1)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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.
Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see
CLINICAL PHARMACOLOGY
Susceptibility Testing
)
.
Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.
INDICATIONS AND USAGE
Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.