um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Parkinson's Disease
Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).
Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
1 INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see
DOSAGE AND ADMINISTRATION (2)].
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
INDICATIONS AND USAGE
Mebendazole tablets are indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.
Efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below:
Pinworm (enterobiasis)
Whipworm (trichuriasis)
Common Roundworm (ascariasis)
Hookworm
Cure rates mean
95%
68%
98%
96%
Egg reduction mean
93%
99%
99%
INDICATIONS AND USAGE
Chloroquine phosphate tablets are indicated for the:
Treatment of uncomplicated malaria due to susceptible strains of
P. falciparum, P.malariae, P. ovale , and
P.vivax.
Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present.
Treatment of extraintestinal amebiasis.
Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites.
Limitations of Use in Malaria:
Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure).
Do not use chloroquine phosphate tablets for malaria prophylaxis in areas where chloroquine resistance occurs, Resistance to Chloroquine phosphate tablets is widespread in
P. falciparum,
and is reported in
P.vivax
(see
WARNINGS).
Concomitant therapy with an 8-aminoquinoline drug is necessary for treatment of the hypnozoite liver stage forms of
P.vivax
and
P.ovale
(see
DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
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 healwithin 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.
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
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents:
Community-Acquired Pneumonia:
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES).
Acute Exacerbations of Chronic Bronchitis:
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis:
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE AND ADMINISTRATION.
Pharyngitis/Tonsillitis:
Caused by
Streptococcus pyogenes (see
CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections:
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
Pediatric Patients:
Acute Bacterial Otitis Media:
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis:
Caused by
Streptococcus pyogenes (see
CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections:
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated,
have not provided adequate analgesia, or are not expected to provide adequate analgesia
INDICATIONS
CMV Retinitis
FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS.
Mucocutaneous Acyclovir Resistant HSV Infections
FOSCAVIR is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.
SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS.
INDICATIONS AND USAGE
Norethindrone acetate tablets, USP is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Norethindrone acetate tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an 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 lisinopril does not have a similar risk. (See
WARNINGS
.)
In considering use of lisinopril and hydrochlorothiazide tablets, 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, Head and Neck Angioedema.)
INDICATION AND USAGE
Hypertension.
1 INDICATIONS AND USAGE
Penciclovir cream 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.
Penciclovir cream 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older. (1)
1 INDICATIONS AND USAGE
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see Dosage and Administration (2)
].
Carisoprodol tablet is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks (1)
1 INDICATIONS AND USAGE
Lacosamide is indicated for:
Treatment of partial-onset seizures in patients 17 years of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide is indicated for the treatment of partial-onset seizures in patients 17 years of age and older.
Additional pediatric use information is approved for UCB, Inc.'s VIMPAT (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS & USAGE
Abacavir oral solution in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Abacavir oral solution,a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.
The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.
For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets USP are indicated for:
Pantoprazole sodium 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)
Pantoprazole sodium delayed-release tablets USP are 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 pantoprazole sodium delayed-release tablets USP may 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 tablets USP are 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
Pantoprazole sodium delayed-release tablets USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for:
Use in combination with flutamide for the management of locally confined carcinoma of the prostate (1.1)
Use as palliative treatment of advanced carcinoma of the prostate (1.2)
1.1 Stage B2-C Prostatic Carcinoma
ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see Dosage and Administration (2.1) and Clinical Studies (14.1)].
1.2 Prostatic Carcinoma
ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration (2.2) and Clinical Studies (14.2)].
In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial.
In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks.
The automatic safety feature of the syringe aids in the prevention of needlestick injury.
INDICATIONS AND USAGE
Gentamicin Sulfate Ophthalmic Ointment 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.
1
INDICATIONS AND USAGE
IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children
12 years of age with hemophilia B for:
On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)].
IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children
12 years of age with hemophilia B for:
On-demand treatment and control of bleeding episodes (1)
Perioperative management (1)
Routine prophylaxis to reduce the frequency of bleeding episodes (1)
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. (1)
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole tablets 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 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
Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that:
requires continuous, around-the-clock opioid administration for an extended period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids
Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see DOSAGE AND ADMINISTRATION). Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
Because serious or life-threatening hypoventilation could result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., prn), for the management of postoperative or acute pain, or in patients who are not opioid-tolerant or who require opioid analgesia for a short period of time (see BOX WARNING and CONTRAINDICATIONS).
An evaluation of the appropriateness and adequacy of treating with immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride is indicated for:
Treatment of adult patients and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)] .
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] .
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] .
Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) (1, 14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
1 INDICATIONS AND USAGE
Epinephrine is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.1)
1.1	Hypotension associated with Septic Shock
Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.