um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection
pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 10% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes;
(2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See
DOSAGE AND ADMINISTRATION
for additional information.
Central Venous Infusion
Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition.
Peripheral Parenteral Nutrition
For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.
1 INDICATIONS AND USAGE
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. (1)
INDICATIONS AND USAGE
Sedative
Anticonvulsant- For the treatment of generalized and partial seizures.
1
INDICATIONS & USAGE
Adrenalin is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use.
Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.
INDICATIONS AND USAGE
Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see
Clinical Trials).
The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see
WARNINGS).
1 INDICATIONS AND USAGE
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for:
The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high- dose cisplatin.
The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in 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 during the postoperative period, Granisetron Hydrochloride Injection, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for:
Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. (1)
Prevention and treatment of postoperative nausea and vomiting in adults. (1)
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents.
AngiographicallyDocumented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
INDICATIONS AND USAGE
Acromegaly
Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of GH and IGF-1 (somatomedin C) levels (see
DOSAGE AND ADMINISTRATION
). In patients with acromegaly, Octreotide Acetate Injection reduces GH to within normal ranges in 50% of patients and reduces IGF-1 (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Octreotide Acetate Injection to reduce blood levels of GH and IGF-1 (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Octreotide Acetate Injection; these trials were not optimally designed to detect such effects.
Carcinoid Tumors
Octreotide Acetate Injection is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Octreotide Acetate Injection studies were not designed to show an effect on the size, rate of growth, or development of metastases.
Vasoactive Intestinal Peptide Tumors (VIPomas)
Octreotide Acetate Injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide Acetate Injection studies were not designed to show an effect on the size, rate of growth, or development of metastases.
1 INDICATIONS AND USAGE
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Ritonavir tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
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.
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.
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.
INDICATIONS AND USAGE
Zovia 1/35 is 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 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
(A) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(B) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
(D) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
(E) Foams, creams, gels, vaginal suppositories, and vaginal film.
(F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
(G) With spermicidal cream or jelly.
(H) Without spermicides.
(I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
(J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
14
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 strengths are a high dose, extended-release, oral morphine formulation 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
Dutasteride Capsules are a 5 alpha-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 acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (
1.2)
Limitations of Use: Dutasteride Capsules are not approved for the prevention of prostate cancer. (
1.3)
1.1 Monotherapy
Dutasteride Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination With Alpha Adrenergic Antagonist
Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
Dutasteride Capsules are not approved for the prevention of prostate cancer.
1
INDICATIONS AND USAGE
UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
UPLIZNA is aCD19-directed cytolytic antibody indicated for the treatment of neuromyelitis opticaspectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1)
1 INDICATIONS AND USAGE
Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired); testicular failure due to conditions such as cryptor chidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome,
chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum concentrations and gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropic or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation.
These men have low testosterone serum-concentrations but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of Testosterone Topical Solution in men with age-related hypogonadism' (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of Testosterone Topical Solution in males < 18 years old have not been established [see Use in Specific Populations (8.4)].
Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Limitations of use:
Safety and efficacy of Testosterone Topical Solution in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of Testosterone Topical Solution in males < 18 years old have not been established. (8.4)
Indications and Usage:
Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.
1 INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to
Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.
Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to
Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. (
1)
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/L) due to
T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options. (
1,
5.1)
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/L) due to
T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options
[see
Warnings and Precautions (5.1)]
.
INDICATIONS AND USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy 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 toxemia.
Edema during pregnancy may arise from pathologic 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 (see PRECAUTIONS: Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
HYDROQUINONE USP, 4% SKIN BLEACHING CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsulesare indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsulesare not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules are an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia. (1)
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. (1)
1 INDICATIONS AND USAGE
ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
ONEXTON 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 of age and older. (1)
Uses
For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
1 INDICATIONS AND USAGE
Ammonia N 13 Injection USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N 13 Injection USP is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease (1).
1 INDICATIONS AND USAGE
Ogivri is a HER2/neu receptor antagonist indicated for:
The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3)
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1).
1.1	Adjuvant Breast Cancer
Ogivri is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer
as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
as part of a treatment regimen with docetaxel and carboplatin
as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product[see Dosage and Administration (2.1)].
1.2	Metastatic Breast Cancer
Ogivri is indicated:
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product[see Dosage and Administration (2.1)].
1.3
Metastatic Gastric Cancer
Ogivri is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].
INDICATIONS AND USAGE
VANOS (fluocinonide) Cream, 0.1%, 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 (See PRECAUTIONS: Pediatric Use
).
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g/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.