um-ids/dailymed-annotations huggingface dataset:
Sunscreen Active Ingredient (SPF 10): Titanium Dioxide, Octinoxate/Ethylhexyl Methoxycinnamate.
Sunscreen
Keep out of reach of children
Discontinue use of signs of irritation occur
Caution: For External Use only. Avoid contact with eyes.
no such information
Water/Aqua, Cyclomethicone, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Stearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Diisostearyl Polyglyceryl-3 Diisostearate, Trimethylsiloxysilicate, Cyclopentasiloxane, Glyceryl stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl
Butylcarbamate, Silica Silylate, Stearoyl inulin, panthenol, Sodium Chloride, Tocopheryl Acetate, Trisodium EDTA, Triethoxycaprylysilane, [May contain /+/- =: Titanium DIoxide/CI77891, Iron Oxides/CI77491/77492/77499].
INDICATIONS AND USAGE
VASOCON REGULAR is indicated for use as a topical ocular vasoconstrictor.
1 INDICATIONS AND USAGE
Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcusaureus (S. aureus) and Streptococcuspyogenes (S. pyogenes).
Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)
1 INDICATIONS AND USAGE
Pantoprazole sodium
delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tabletsare indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tabletsmay be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tabletsare indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tabletsare indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
Meloxicam oral suspension is a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older (1.3)
1.1 Osteoarthritis (OA)
Meloxicam oral suspension is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam oral suspension is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam oral suspension is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (
1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (
1.2)
in combination with cisplatin for the treatment of non-small cell lung cancer. (
1.3)
as a single agent for the treatment of pancreatic cancer. (
1.4)
1.1 Ovarian Cancer
Gemcitabine for Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine for Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine for Injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine for Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection is indicated for patients previously treated with fluorouracil.
1 I
NDICATIONS AND USAGE
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the sixweek studies (adults and elderly), and at the end of the six month study (adults and elderly)
[see Clinical Studies (14)].
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
INDICATIONS AND USAGE
LEVEMIR is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.
INDICATIONS AND USAGE:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, vancomycin 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.
Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by
S. viridans
or
S. bovis.
For endocarditis caused by enterococci (e.g.,
E. faecalis)
, vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by
S. epidermidis
or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
The parenteral form of vancomycin may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by
C. difficile
and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications.
Vancomycin is not effective by the oral route for other types of infection.
1 INDICATIONS AND USAGE
Tri-Lo-EstaryllaTM
(norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraception
Tri-Lo-EstaryllaTM
(norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)].
1 INDICATIONS AND USAGE
Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. (1)
Use with caution if the diagnosis of cyanide poisoning is uncertain. (1)
INDICATIONS & USAGE
ENTOCORT EC is indicated for
the treatment of mild to moderate active Crohn's disease involving the iluem and/or the ascending colon and
the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.
1 INDICATIONS AND USAGE
Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2).
1.1 Postmenopausal Osteoporosis
Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1)].
1.2 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS & USAGE
Tobramycin for Injection, USP is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli, and Klebsiella spp
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus (penicillinase- and non-penicillinase-producing strains)
Serious central-nervous-system infections (meningitis) caused by susceptible organisms
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp
Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S. aureus
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia spp, and Citrobacter spp
Aminoglycosides, including tobramycin for injection USP, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin for Injection, USP may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with Tobramycin for Injection, USP may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Tobramycin for Injection, USP should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the Warnings box above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, Tobramycin for Injection, USP 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.
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.
1.1 Major Depressive Disorder
Bupropion hydrochloride extended-release tablets (XL) are 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)
].
INDICATIONS
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets, USP and other antibacterial drugs, Neomycin Sulfate Tablets, USP 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.
Suppression of Intestinal Bacteria
Neomycin Sulfate Tablets, USP are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g. preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base
(see
DOSAGE AND ADMINISTRATION section).
Hepatic Coma (Portal-Systemic Encephalopathy)
Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
1 INDICATIONS & USAGE
Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)].
The following points should be considered when initiating therapy with lamivudine tablets (HBV): Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. Lamivudine tablets (HBV) have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus. Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
Lamivudine tablets (HBV) are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. (1)
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine hydrochloride capsulesfor long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsulesfor extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (
see
DOSAGE AND ADMINISTRATION
).
1.3 Adjunctive Treatment of Major Depressive Disorder
ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode .
[see CLINICAL STUDIES ]
(14.3)
1 INDICATIONS AND USAGE
LUNESTA (eszopiclone) is indicated for the treatment of insomnia.
In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration.
The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
LUNESTA is indicated for the treatment of insomnia.
LUNESTA has been shown to decrease sleep latency and improve sleep maintenance (1)
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. (See CLINICAL PHARMACOLOGY, for details and limitations of survival trials.) In using enalapril maleate, 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 enalapril maleate does not have a similar risk. (See WARNINGS.) In considering use of enalapril maleate, 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, .)
Heart Failure, Mortality Trials
Head and Neck Angioedema
1 INDICATIONS AND USAGE
TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
TOBRAMYCIN INHALATION SOLUTION PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa (1).
INDICATIONS AND USAGE
BENZONATATE is indicated for the symptomatic relief of cough.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets, USP are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil hydrochloride tablets, USP are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1)
INDICATIONS AND USAGE
Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with age-related hypogonadism (also referred to as late-onset
hypogonadism) have not been established.