um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
triCitrasol
Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol
to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan
2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol
and 6% solution of HES contains the following concentration depending upon the volume used:
Volume of triCitrasol
Volume of HES
Total Volume
Final Concentration of triCitrasol
30 mL
500 mL (measured from HES bag)
530 mL
2.6%
30 mL
558 mL (injected directly into HES bag)
588 mL
2.4%
The triCitrasol
/HES solution is stable for up to 24 hours at room temperature after mixing.
Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.
INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine in the treatment of major depressive disorder was established in6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see
CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least5 of the following9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Hypertension.
INDICATIONSAND USAGE
Nystatin and Triamcinolone AcetonideOintment, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Indication and Usage
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.
1	INDICATIONS AND USAGE
CYTOMEL is an L-triiodothyronine (T3) indicated for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (1.1)
Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer (1.2)
Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy (1.3)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)
1.1 Hypothyroidism
CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
1.2 Pituitary Thyroid-Stimulating Hormone(TSH) Suppression
CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
1.3 Thyroid Suppression Test
CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Limitations of Use
CYTOMEL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4)].
CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
1
INDICATIONS AND USAGE
Clindamycin phosphateand benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)
1 INDICATIONS AND USAGE
RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
INDICATIONS AND USAGE
Hypertension
VASOTEC is indicated for the treatment of hypertension.
VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-
type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive.
Heart Failure
VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see
CLINICAL PHARMACOLOGY,	Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), VASOTEC decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
In using VASOTEC consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that VASOTEC does not have a similar risk (see
WARNINGS, Neutropenia/Agranulocytosis).
In considering use of VASOTEC, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS, Head and Neck Angioedema
).
For Intravenous Injection
Mannitol Injection, USP is indicated for the following therapeutic uses:
The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.
The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.
The reduction of elevated intraocular pressure when it cannot be lowered by other means.
The promotion of urinary excretion of toxic substances.
INDICATIONS AND USAGE
Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Naltrexone has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
1 INDICATIONS AND USAGE
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.
SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis flares in adults. (1)
INDICATIONS AND USAGE
Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
INDICATIONS AND USAGE
Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Levetiracetam Tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
INDICATIONS & USAGE
Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.
Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)
1.1 Major Depressive Disorder
Bupropion hydrochloride extended-release tablets (XL) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies(14.1)].
1.2 Seasonal Affective Disorder
Bupropion hydrochloride extended-release tablets (XL) is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies(14.2)
].
INDICATIONS AND USAGE
Adapalene Topical Solution, 0.1% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
1.1 Major Depressive Disorder
Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Social Anxiety Disorder
Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [
see Clinical Studies (14.2)].
INDICATIONS AND USAGE
NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program.
The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.
INDICATIONS AND USAGE
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.
Tuberculosis
Rifampin is indicated in the treatment of all forms of tuberculosis.
A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide [e.g., RIFATER]5 is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.
Following the initial phase, treatment should be continued with rifampin and isoniazid [e.g., RIFAMATE]6
for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.
Meningococcal Carriers
Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See
WARNINGS).
Rifampin should not be used indiscriminately, and therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin 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.
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
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 is indicated for:
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
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of:
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1)
1.1 Myelodysplastic Syndromes (MDS)
Azacitidine for injection is indicated for treatment of adult patients with the following French-American- British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection). However, due to Celgene Corporation's marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.'s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets is administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine
[see
Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Rizatriptan benzoate tablets are a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (
1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (
1)
Not indicated for the prophylactic therapy of migraine (
1)
Not indicated for the treatment of cluster headache (
1)
1 INDICATIONS AND USAGE
Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients
(1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients
(1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis:
Valganciclovir tablets
are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies
(14.1)
].
Prevention of CMV Disease:
Valganciclovir tablets
are indicated for the prevention of CMV disease in kidney,heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)
].
1.2
Pediatric Patients
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age)andheart transplant patients
(1 month to 16 years of age) at high risk [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.