um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE:
NATACYN
(natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including
Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the
invitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.
1 INDICATIONS AND USAGE
Famciclovir tablets, a prodrug of penciclovir, are a deoxynucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients (
1.1)
Herpes labialis (cold sores)
Treatment of recurrent episodes
Genital herpes
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV)-Infected Adult Patients
(
1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen
delayed-release tablets and other treatment options before deciding to use
naproxen delayed-release tablets. Use the lowest effective dose for the shortest
duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen delayed-release tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen delayed-release tablets are not recommended for initial treatment of
acute pain because the absorption of naproxen is delayed compared to absorption
from other naproxen-containing products (see CLINICAL
PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
LMD (dextran 40) is indicated for use in the adjunctive treatment of shock or impending shock due to hemorrhage, burns, surgery or other trauma. It is not indicated as a replacement for whole blood or blood components if they are available. It should not replace other forms of therapy known to be of value in the treatment of shock.
LMD is also indicated for use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation.
LMD is also indicated for use in prophylaxis of venous thrombosis and pulmonary embolism in patients undergoing procedures known to be associated with a high incidence of thromboembolic complications, such as hip surgery.
INDICATIONS AND USAGE
Hypertension
Trandolapril Tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.
INDICATIONS AND USAGE
Haloperidoltablets are indicated for use in the management of manifestations of psychotic disorders.
Haloperidoltablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidoltablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation).
Haloperidoltablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidoltabletsshould be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
USE
For preparation of the skin prior to injection.
1 INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria:
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see DOSAGE AND ADMINISTRATION (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablets, taken in combination with ethambutol, are indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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 & USAGE
Rifabutin Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
INDICATIONS AND USAGE
This product is indicated for the relief of mild to moderate pain, either when
pain is present alone or when it is accompanied by fever.
1 INDICATIONS ANDUSAGE
Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1).
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Do not use if atrophy is present at the treatment site. (1.2)
Do not use for rosacea or perioral dermatitis. (1.2)
1.1 Indication
Clobetasol Propionate Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.
Patients should be instructed to use Clobetasol Propionate Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol Propionate Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobetasol Propionate Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see
CLINICAL PHARMACOLOGY,
CONTRAINDICATIONS,
WARNINGS, and
PRECAUTIONS).
Allopurinol is indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
1 INDICATIONS AND USAGE
Valproic acid is 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 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, neurodevelopmental disorders neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings Precautions (5.2, 5.3, 5.4), Use in Specific populations (8.1). and Patient Counseling Information (17)].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications (4)].
INDICATIONS AND USAGE
Bisoprolol and hydrochlorothiazide is indicated in the management of hypertension.
INDICATIONS AND USAGE
Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescens*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)*
Conjunctivitis:
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
PREPARATION OF INTRAVENOUS SOLUTIONS
Carboplatin injection is a premixed aqueous solution of 10 mg/mL carboplatin.
Carboplatin aqueous solution can be further diluted to concentrations as low as 0.5 mg/mL with 5% Dextrose in Water (D5W) or 0.9% Sodium Chloride Injection, USP.
When prepared as directed, carboplatin aqueous solutions are stable for 8 hours at room temperature (25C). Since no antibacterial preservative is contained in the formulation, it is recommended that carboplatin aqueous solutions be discarded 8 hours after dilution.
1 INDICATIONS & USAGE
Hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth (1). The effectiveness of Hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation (14). There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use
: Hydroxyprogesterone caproate injection is not intended for use in women with multiple gestations or other risk factors for preterm birth. (1)
1 INDICATIONSAND USAGE
HIV-1 Treatment (1.1)
Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (1.2):
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2 )].
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride Injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
INDICATIONS AND USAGE
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa
Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of
Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of
Ps. aeruginosa.
It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
H. influenzae, specifically meningeal infections.
Escherichia coli, specifically urinary tract infections.
Aerobacter aerogenes, specifically bacteremia.
Klebsiella pneumoniae, specifically bacteremia.
NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B 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
Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology:
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology:
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS AND USAGE
1. Prevention of nausea and vomiting associated with highly
emetogenic cancer chemotherapy, including cisplatin
50 mg/m2.
2. Prevention of nausea and vomiting associated with initial and repeat
courses of moderately emetogenic cancer chemotherapy.
3. Prevention of 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.
4. 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 hydrochloride tablets, ondansetron orally disintegrating tablets,
and ondansetron hydrochloride oral solution are recommended even where the
incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE
TAZORAC (tazarotene) Gel 0.05% and 0.1%
are indicated for the topical treatment of patients with stable plaque psoriasis
of up to 20% body surface area involvement.
TAZORAC (tazarotene) Gel 0.1% is also indicated for
the topical treatment of patients with facial acne vulgaris of mild to moderate
severity.
The efficacy of TAZORAC Gel in the treatment of acne
previously treated with other retinoids or resistant to oral antibiotics has not
been established.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
1 INDICATIONS AND USAGE
Sorafenib tablets are a kinase inhibitor indicated for the treatment of
Unresectable hepatocellular carcinoma (1.1)
Advanced renal cell carcinoma (1.2)
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3)
1.1 Hepatocellular Carcinoma
Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
1.2 Renal Cell Carcinoma
Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
1.3 Differentiated Thyroid Carcinoma
Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.