um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Doxepin HCl capsules are recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety.
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin HCl capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin HCl capsules is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.
1 INDICATIONS AND USAGE
Risperidone tabletsare an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescent aged 13-17 years ( )
1.1
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescent aged 10-17 years ( )
1.2
Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years ( )
1.3
1.1
Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia .
[see ]
Clinical Studies (14.1)
Adolescents
Risperidone tabletsare indicated for the treatment of schizophrenia in adolescents aged 1317 years
[see ].
Clinical Studies (14.1)
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone tabletsare indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults .
[see ]
Clinical Studies (14.2)
Combination Therapy
Adults
The combination of risperidone tablets with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder .
[see ]
Clinical Studies (14.3)
1.3
Irritability Associated with Autistic Disorder
Pediatrics
Risperidone tabletsare indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 516 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods .
[see ]
Clinical Studies (14.4)
INDICATIONS AND USAGE
Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension.
This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).
1 INDICATIONSAND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2.
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m2. (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1)
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. (1)
postoperative nausea and/or vomiting. (1)
INDICATIONS AND USAGE:
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
INDICATIONS AND USAGE
Diclofenac Sodium Ophthalmic Solution, 0.1% is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
1 INDICATIONS AND USAGE
Rivastigmine Transdermal System
is an acetylcholinesterase inhibitor indicated for treatment of:
Mild, moderate, and severedementia of the Alzheimers type (AD). (1.1)
Mild-to-moderate dementia associated with Parkinsons disease (PD). (1.2)
1.1 Alzheimers Disease
Rivastigmine Transdermal System
is indicated for the treatment of dementia of the Alzheimers type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severeAlzheimers disease.
1.2 Parkinsons Disease Dementia
Rivastigmine Transdermal System
is indicated for the treatment of mild-to-moderate dementia associated with Parkinsons disease (PDD).
1 INDICATIONS AND USAGE
Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone HCl tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone HCl tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone HCl tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
INDICATIONS AND USAGE
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella
spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*
NOTE: For information on use in pediatric patients (see
PRECAUTIONS - Pediatric Use
and
CLINICAL STUDIES
sections).
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp *
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*).
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection 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.
INDICATIONS AND USAGE
Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that:
requires continuous, around-the-clock opioid administration for an extended period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids
Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see DOSAGE AND
ADMINISTRATION). Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
Because serious or life-threatening hypoventilation could result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., prn), for the management of post-operative or acute pain, or in patients who are not opioid-tolerant or who require opioid analgesia for a short period of time (see BOX WARNING and CONTRAINDICATIONS).
An evaluation of the appropriateness and adequacy of treating with immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
1 INDICATIONS AND USAGE
Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Bimatoprost ophthalmic solution 0.03%is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1)
1
INDICATIONS AND USAGE
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Savella
is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (	1	).
Savella is not approved for use in pediatric patients (	1	).
1 INDICATIONS AND USAGE
Mycophenolic acid delayed-release tablets are
an antimetabolite immunosuppressant indicated for prophylaxis of organ
rejection in adult patients receiving kidney transplants and in pediatric
patients at least 5 years of age and older who are at least 6 months post
kidney transplant. (1.1)
Use in combination with
cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (1.2)
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
1 INDICATIONS & USAGE
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.(1)
1 INDICATIONS AND USAGE
GELNIQUE is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see
Clinical Studies 14
].
GELNIQUE is an antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
INDICATIONS AND USAGE
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
1 INDICATIONS AND USAGE
Valproic Acid Capsules are an anti-epileptic drug indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1)
1.1 Epilepsy
Valproic Acid Capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid Capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See
Warnings and Precaution (5.1)
for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17.3)].
INDICATIONS AND USAGE
Epinephrine Injection, USP is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (A-V) heart block with syncopal seizures (Stokes-Adams Syndrome).
In acute attacks of ventricular standstill, physical measures should be applied first. When external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective.
INDICATIONS & USAGE SECTION
For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:
Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
INDICATIONS AND USAGE
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of
Escherichia coli or
Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoincapsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see
CLINICAL STUDIES
). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
INDICATIONS & USAGE SECTION
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 may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is 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 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
To control severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
Methylphenidate HCl Extended-Release Tablets are 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; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate HCl 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 HCl Extended-Release Tablets are 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 patient's symptoms.