um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
PEGASYS is an inducer of the innate immune response indicated for the treatment of
Chronic Hepatitis C (CHC) (
1.1)
Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs.
Pediatric Patients: In combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease
Chronic Hepatitis B (CHB) (
1.2)
Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection who have compensated liver disease and evidence of viral replication and liver inflammation
Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive CHB and evidence of viral replication and elevations in serum alanine aminotransferase (ALT)
1.1 Chronic Hepatitis C (CHC)
Adult Patients: PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with CHC and compensated liver disease.
For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS monotherapy is only indicated for the treatment of patients with CHC and compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.
Pediatric Patients: PEGASYS in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease.
Limitations of Use:
PEGASYS alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa.
PEGASYS is not recommended for treatment of patients with CHC who have had solid organ transplantation
[see
Use in Specific Populations (8.8)]
.
1.2 Chronic Hepatitis B (CHB)
Adult Patients: PEGASYS is indicated for the treatment of adults with HBeAg-positive and HBeAg-negative CHB infection who have compensated liver disease and evidence of viral replication and liver inflammation.
Pediatric Patients: PEGASYS is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (ALT).
1.1Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
INDICATIONS AND USAGE
Clindamycin HCl is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, 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.
1 INDICATIONS & USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (
1.1)
Otitis media (
1.2)
Skin and skin structure infections (
1.3)
Bone infections (
1.4)
Genitourinary tract infections (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of
Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and
Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus and
Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of
Staphylococcus aureus and
Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of
Escherichia coli, Proteus mirabilis, and
Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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 AND USAGE
Fluocinolone Acetonide Topical Solution USP, 0 .0 1 % is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsivedermatoses.
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafilis a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II to III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).(1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the:
short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
o The efficacy of omeprazole and sodium bicarbonate for oral suspension used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate for oral suspension may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the:
reduction of risk of upper GI bleeding in critically ill adult patients.
Omeprazole and sodium bicarbonate for oral suspension is a proton pump inhibitor (PPI)
Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for:
Treatment of active duodenal ulcer (1)
Treatment of active benign gastric ulcer (1)
Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) (1)
Maintenance of healing of EE (1)
Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for:
Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients (1)
INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Nifedipine Extended-Release Tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide tablets are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).
Triamterene and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets may enhance the actions of these drugs, dosage adjustments may be necessary.
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. Thiazides are indicated in pregnancy 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 & USAGE
Gabapentinis indicated for:
Management of post herpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Post herpetic neuralgia in adults (1) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Stavudine capsules , in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).
INDICATIONS AND USAGE
Carbidopa and levodopa extended release tablets are indicated in the treatment
of the symptoms of idiopathic Parkinsons disease (paralysis agitans),
postencephalitic parkinsonism, and symptomatic parkinsonism which may follow
injury to the nervous system by carbon monoxide intoxication and/or manganese
intoxication.
INDICATIONS AND USAGE
Albuterol Inhalation Aerosol is indicated in patients 12 years of age and older, for the prevention and relief of bronchospasm in patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm.
1
INDICATIONS AND USAGE
Donepezil hydrochloride is 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).
Donepezil hydrochloride tablets, are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
INDICATIONS AND USAGE
ORACEA is indicated for the treatment of only inflammatory
lesions (papules and pustules) of rosacea in adult patients. No meaningful
effect was demonstrated for generalized erythema (redness) of rosacea. ORACEA
has not been evaluated for the treatment of the erythematous, telangiectatic, or
ocular components of rosacea. Efficacy of ORACEA beyond 16 weeks and safety
beyond 9 months have not been established.
This formulation of doxycycline has not been evaluated in the treatment or
prevention of infections. ORACEA should not be used for treating bacterial
infections, providing antibacterial prophylaxis, or reducing the numbers or
eliminating microorganisms associated with any bacterial disease.
To reduce the development of drug-resistant bacteria as well as to maintain
the effectiveness of other antibacterial drugs, ORACEA should be used only as
indicated.
1 INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral Contraceptive
Drospirenone and ethinyl estradiol tablets USP, 3 mg/0.02 mg are indicated for use by women to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone and ethinyl estradiol tablets for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Drospirenone and ethinyl estradiol tablets have not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3 Acne
Drospirenone and ethinyl estradiol tablets are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1 INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for:
prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. (1.1)
treatment of acute, uncomplicated P. falciparum malaria. (1.2)
1.1 Prevention of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
1.2 Treatment of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
1 INDICATIONS AND USAGE
Oseltamivir Phosphate capsule USP is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (
1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (
1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (
1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (
1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (
1.3)
1.1 Treatment of Influenza
Oseltamivir Phosphate capsule USP is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir Phosphate capsule USP is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir Phosphate capsule USP is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Oseltamivir Phosphate Capsule USP
[see Microbiology (
12.4)].
Oseltamivir Phosphate capsule USP is not recommended for patients with end-stage renal disease not undergoing dialysis
[see Dosage and Administration (
2.4) and Use in Specific Populations (
8.6)].
1
INDICATIONS & USAGE
1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection is indicated for the 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 in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes.
Ondansetron is approved for patients aged 1 month and older.
INDICATIONS AND USAGE:
AllerNaze is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 12 years of age or older.
INDICATIONS AND USAGE
Parkinson's DiseasePramipexole dihydrochloride tablets are indicated for the
treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of pramipexole dihydrochloride tablets was demonstrated in
randomized, controlled trials in patients with early Parkinson's disease who
were not receiving concomitant levodopa therapy as well as in patients with
advanced disease on concomitant levodopa (see CLINICAL
STUDIES).
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns ; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
INDICATIONS & USAGE
To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.
INDICATIONS AND USAGE
Herpes Zoster Infections
Acyclovir capsules is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes
Acyclovir capsules is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox
Acyclovir capsules is indicated for the treatment of chickenpox (varicella).