um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Morphine Sulfate Extended-Release Tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Morphine Sulfate Extended-Release Tablets are NOT intended for use as a prn analgesic.
The Morphine Sulfate Extended-Release Tablets 100 and 200 mg tablet strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only.
Morphine Sulfate Extended-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
Morphine Sulfate Extended-Release Tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time.
Morphine Sulfate Extended-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see American Pain Society guidelines.)
1 INDICATIONS AND USAGE
Tacrolimus capsules, USP are a calcineurin-inhibitor immunosuppressant indicated for:
Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3)
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3)
Limitations of Use (1.4):
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who cannot tolerate capsules orally
Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established
1.1Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus capsules, USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [see Clinical Studies (14.1)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [see Dosage and Administration (2.6)].
1.2Prophylaxis of Organ Rejection in Liver Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus capsules be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [see Dosage and Administration (2.6)].
1.3Prophylaxis of Organ Rejection in Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [see Clinical Studies (14.3)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [see Dosage and Administration (2.6)].
1.4Limitations of Use
Tacrolimus capsules should not be used simultaneously with cyclosporine [see Dosage and Administration (2.5)].
Tacrolimus injection should be reserved for patients unable to take tacrolimus capsules orally [see Warnings and Precautions (5.11)].
Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus capsules with sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].
INDICATIONS AND USAGE
Citalopram tablets, USP are indicated for the treatment of depression.
The efficacy of citalopram in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R 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 least five of the following nine 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 antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Indications and Usage
Verapamil Hydrochloride Injection, USP is indicated for the following: Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Because a small fraction (less than 1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole - see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversioncapability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patients response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.
1 INDICATIONS AND USAGE
AIMOVIG is indicated for the preventive treatment of migraine in adults.
AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. (1)
1 INDICATIONS AND USAGE
Divalproex sodium delayed-release tablets, USP are an anti-epileptic drug indicated for:
Treatment
of manic episodes associated with bipolar disorder (1.1)
Monotherapy
and adjunctive therapy of complex partial seizures and simple and complex
absence seizures; adjunctive therapy in patients with multiple seizure
types that include absence seizures (1.2)
Prophylaxis
of migraine headaches (1.3)
1.1 Mania
Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablet, USP was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].
The safety and effectiveness of divalproex sodium delayed-release tablets, USP for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets, USP for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed-release tablets, USP 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. Divalproex sodium delayed-release tablets, USP are also 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 that 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.
1.3 Migraine
Divalproex sodium delayed-release tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets, USP are useful in the acute treatment of migraine headaches.
1.4 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)
].
Divalproex sodium delayed-release tablets, USP are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
1INDICATIONS AND 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 greater than or equal to 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)
1 INDICATIONS AND USAGE
Relapsed or Refractory Acute Myeloid Leukemia
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration (2.1), Clinical Pharmacology (12.1), and Clinical Studies (14.1)].
REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. (1)
INDICATIONS AND USAGE
Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Levorphanol Tartrate 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
1 INDICATIONS AND USAGE
VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma
in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma
in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. (
1)
1 INDICATIONS AND USAGE
SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
SUTAB is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with initial and repeat courses
of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of
the 32 mg single dose beyond 24 hours in these patients has not been
established.
Prevention of postoperative nausea and/or vomiting. As with other
antiemetics, routine prophylaxis is not recommended for patients in whom there
is little expectation that nausea and/or vomiting will occur postoperatively. In
patients where nausea and/or vomiting must be avoided postoperatively,
ondansetron injection, USP is recommended even where the incidence of
postoperative nausea and/or vomiting is low. For patients who do not receive
prophylactic ondansetron injection, USP and experience nausea and/or vomiting
postoperatively, ondansetron injection, USP may be given to prevent further
episodes (see CLINICAL TRIALS).
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used.
1 INDICATIONSAND USAGE
Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution 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
Oxycodone Hydrochloride Oral Solution is 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 Hydrochloride Oral Solution 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
1 INDICATIONS AND USAGE
Sertraline hydrochloride is indicated for the treatment of the following [See Clinical Studies (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. (1)
1 INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
Malignant Diseases: malignant lymphomas: Hodgkins disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1)
Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2)
Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
1.1 Malignant Diseases
Cyclophosphamide Capsules are indicated for the treatment of:
malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkins disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma
multiple myeloma
leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
mycosis fungoides (advanced disease)
neuroblastoma (disseminated disease)
adenocarcinoma of the ovary
retinoblastoma
carcinoma of the breast
Cyclophosphamide Capsules, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients
Cyclophosphamide Capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
Limitations of Use:
The safety and effectiveness of Cyclophosphamide Capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
1 INDICATIONS AND USAGE
Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.
Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. (1)
1 INDICATIONS AND USAGE
AKTEN
is indicated for ocular surface anesthesia during ophthalmologic procedures.
AKTEN
is a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. (
1)
INDICATIONS AND USAGE
Herpes Zoster Infections: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
Valganciclovir 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 is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
Prevention of CMV Disease: Valganciclovir is 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 is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
RYTARY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication (1)
1 INDICATIONS AND USAGE
Finasteride, is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to
(1.1):
Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride tablets, USP administered in combination with the alpha-blocker doxazosinis indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score)
(1.2).
Limitations of Use:
Finasteride tablets, USP are not approved for the prevention of prostate cancer
(1.3).
1.1 Monotherapy
Finasteride tablets, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms
- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets, USP areadministered in combination with the alpha-blocker doxazosinare indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride tablets, USP are not approved for the prevention of prostate cancer.