um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Triamterene capsulesare indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.
Triamterene capsulesmay be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.
Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman 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 developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see
PRECAUTIONS
below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
1 INDICATIONS AND USAGE
Anagrelide capsules USP are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events [see Clinical Studies (14), Dosage and Administration (2)].
Anagrelide is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. (1)
INDICATIONS & USAGE
POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks.
The routes of administration and indicated concentrations for mepivacaine are:
See
DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine.
INDICATIONS
Indications and Usage:
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Upper respiratory tract infections caused by Streptococcus
pyogenes, Streptococcus
pneumoniae and Hemophilus
influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by Streptococcus
pyogenes, Streptococcus
pneumoniae, Mycoplasma
pneumoniae (Eaton agent, and Klebsiellasp.)
Skin and soft tissue infections caused by Streptococcus
pyogenes, Staphylococcus
aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)
Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis of ornithosis caused by Chlamydia
psittaci.
Infections caused by Chlamydia
trachomatis such as uncomplicated urethral, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.
Granuloma inquinale caused by Calymmatobacterium
granulomatis.
Relapsing fever caused by Borrelia sp.
Bartonellosis caused by Bartonella
bacilli-formis.
Chancroid caused by Hemophilus ducreyi.
Tularemia caused by Francisella tularensis.
Plaque caused by Yersinia
pestis.
Cholera caused by Vibrio
cholerae.
Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).
Infections due to Campylobacter
fetus.
As adjunctive therapy in intestinal amebiasis caused by Entamoeba
histolytica.
Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter
aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
syphilis and yaws caused by Treponema pallidumand pertenue, respectively,
Vincents infection caused by Fusobacterium fusiforme,
infections caused by Neisseria gonorrhoeae,
anthrax caused by Bacillus anthracis,
infections due to Listeria monocytogenes,
actinomycosis caused by Actinomyces species,
infections due to Clostridium species.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs, cefazolin 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.
Cefazolin for Injection is indicated for the treatment of the following infections when caused by susceptible bacteria.
Cefazolin for Injection, USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Respiratory tract infections (1.1); urinary tract infections (1.2); skin and skin structure infections (1.3); biliary tract infections (1.4); bone and joint infections (1.5); genital infections (1.6); septicemia (1.7); endocarditis (1.8); and perioperative prophylaxis (1.9).
1.1 Respiratory Tract Infections
Respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus
and Streptococcus pyogenes.
Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.
1.2 Urinary Tract Infections
Urinary tract infections due to Escherichia coli and Proteus mirabilis.
1.3 Skin and Skin Structure Infections
Skin and skin structure infections due to S. aureus, S. pyogenes, and Streptococcus agalactiae.
1.4 Biliary Tract Infections
Biliary infections due to E. coli, various isolates of streptococci, P. mirabilis, and S. aureus.
1.5 Bone and Joint Infections
Bone and joint infections due to S. aureus.
1.6 Genital Infections
Genital infections due to E. coli and P. mirabilis.
1.7 Septicemia
Septicemia due to S. pneumoniae, S. aureus, P. mirabilis, and E. coli.
1.8 Endocarditis
Endocarditis due to S. aureus
and S. pyogenes.
1.9 Perioperative Prophylaxis
The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).
The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).
If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted.
INDICATIONS AND USAGE
Fluconazole Tablets USP are indicated for the treatment of:
1.Vaginal candidiasis (vaginal yeast infections due to Candida).
2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole Tablets USP were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3.Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole Tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS AND USAGE
Metolazone tablets are indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Mykrox
tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox
tablets are to be substituted for Zaroxolyn
tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see
PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
INDICATIONS AND USAGE
Phenytoin Oral Suspension is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections).
DOSAGE AND ADMINISTRATION
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection,USP is indicated in PET (positron emission tomography) for:
1. Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
2. 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.
3. Assessment of patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function.
Fludeoxyglucose F 18 Injection, USP is not indicated for distinguishing epileptogenic foci from brain tumors or other brain lesions which may cause seizures.
INDICATIONS AND USAGE
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
1INDICATIONS AND USAGE
Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated,
de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated,
de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (
1)
1 INDICATIONS AND USAGE
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
PROTONIX is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
PROTONIX is 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
PROTONIX is indicated for maintenance of healing of erosive esophagitis 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
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
Aripiprazole orally disintegrating tablets are indicated for the treatment of:
Schizophrenia
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole orally disintegrating tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
1 INDICATIONS AND USAGE
GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
GEODON is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of GEODON to prolong the QT interval and may consider the use of other drugs first (1)
GEODON capsules are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
GEODON for injection is indicated for the:
acute treatment of agitation in schizophrenic patients in adults. (1)
Schizophrenia
GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
GEODON is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].
GEODON is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
Acute Treatment of Agitation in Schizophrenia
GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation [see Clinical Studies (14.1)].
Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
INDICATIONS AND USAGE:
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adults patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4Sodium Fluoride 5000 ppm Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (SeeWARNINGS for exception.)
INDICATIONS AND USAGE
Herpes Zoster Infections:
Acyclovir oral suspension, USP is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes:
Acyclovir oral suspension, USP is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox:
Acyclovir oral suspension, USP is indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
CLARINEX-D 12 HOUR is a combination product containing an H1-receptor antagonist and a sympathomimetic amine indicated for:
Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. (1)
1.1	Seasonal Allergic Rhinitis
CLARINEX-D 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see Clinical Pharmacology (12)].
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and
Serratia marcescens.