um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Zidovudineoral solution is a nucleoside analogue reverse transcriptase inhibitor indicated for:
Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1)
Prevention of maternal-fetal HIV-1 transmission. (1.2)
1.1 Treatment of HIV-1
Zidovudine oral solution, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
1.2 Prevention of Maternal-Fetal HIV-1 Transmission
Zidovudine oral solution is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.3)]. The indication is based on a dosing regimen that included 3 components:
antepartum therapy of HIV-1-infected mothers
intrapartum therapy of HIV-1-infected mothers
post-partum therapy of HIV-1-exposed neonate
Points to consider prior to initiating zidovudine oralsolution inpregnant women for the prevention of maternal-fetal HIV-1 transmission include:
In most cases, zidovudine oral solution for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.
Prevention of HIV-1 transmission in women who have received zidovudine oral solution for a prolonged period before pregnancy has not been evaluated.
Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine oral solution during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks' gestation.
1 INDICATIONS AND USAGE
Glycopyrrolate Tablets, USP are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use
Glycopyrrolate Tablets, USP are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Glycopyrrolate tablets, USP are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1)
Limitations of Use:
Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)
INDICATIONS AND USAGE
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoincapsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (monohydrate/macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see
CLINICAL STUDIES
). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1 INDICATIONS AND USAGE
KITABIS 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)].
KITABIS 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
1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
INDICATIONS AND USAGE
Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:
Antihistaminic
For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
Motion Sickness
For active treatment of motion sickness.
Antiparkinsonism
For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
1 INDICATIONSAND USAGE
Tramadol hydrochloride tabletsare indicated in adults 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 and Precautions (5.1)]
, reserve tramadol hydrochloride 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.
Tramadol hydrochloride tabletsare an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (
1).
Limitations of Use (
1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (
5.1), reserve tramadol hydrochloride 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 & USAGE SECTION
Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration[see CLINICAL STUDIES (14)].
Indications and Usage
Dipyridamole Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately.In a study of about 1100 patients who underwent coronary arteriography and Dipyridamole Injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the totalnumber of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests were almost identical.
INDICATIONS AND USAGE
1.Reltone is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Reltone beyond 24 months is not established.
2.Reltone is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
INDICATIONS AND USAGE
Amphetamine sulfate tablets, USP is indicated for:
Narcolepsy
Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below.
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam is indicated for adjunctive therapyfor the treatment of:
Myoclonic seizures in patients12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGEFor the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
1 INDICATIONS AND USAGE
Efavirenz is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg
Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
INDICATIONS AND USAGE
DepoDur is an extended-release liposome injection of morphine sulfate intended for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur is administered prior to surgery or after clamping the umbilical cord during cesarean section. DepoDur is not intended for intrathecal, intravenous, or intramuscular administration. Administration of DepoDur into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.
1 INDICATIONS AND USAGE
Paroxetine tablets areindicatedinadultsforthetreatmentof:
Majordepressivedisorder(MDD)
Obsessivecompulsivedisorder(OCD)
Panicdisorder(PD)
Socialanxietydisorder(SAD)
Generalizedanxietydisorder(GAD)
Posttraumaticstressdisorder(PTSD)
Paroxetine tablets is a selective serotonin reuptake inhibitor (SSRI) indicated in adults forthetreatment of (1):
MajorDepressiveDisorder(MDD)
ObsessiveCompulsiveDisorder(OCD)
PanicDisorder(PD)
SocialAnxietyDisorder(SAD)
GeneralizedAnxietyDisorder(GAD)
PosttraumaticStressDisorder(PTSD)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial
[see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
1 INDICATIONS AND USAGE
Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below.
Additional important information regarding the use of Nevirapine tablets, USP for the treatment of HIV-1 infection:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [seeBoxed Warningand Warnings and Precautions (5.1)
].
The 14-day lead-in period with Nevirapine tablets, USP 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [seeDosage and Administration (2.4)and Warnings and Precautions (5.2)
].
If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.
Nevirapine tablets, USP are an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection (1)
Important Considerations:
Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks(1,5.1)
adult females with CD4+ cell counts greater than 250 cells/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3
The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash(2.4,5.2)
1 INDICATIONS AND USAGE
Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1.1)
1.1 Hypertension
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)].
INDICATIONS AND USAGE
Bisoprolol is indicated in the management of hypertension. It may be used alone
or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.
As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
Indications and Usage
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
Method
Perfect Use
Typical Use
NA - not available
Levonorgestrel implants
0.05
0.05
Male sterilization
0.1
0.15
Female sterilization
0.5
0.5
Depo-Provera
(injectable progestogen)
0.3
0.3
Oral contraceptives
5
Combined
0.1
NA
Progestin only
0.5
NA
IUD
Progesterone
1.5
2.0
Copper T 380A
0.6
0.8
Condom
(male) without spermicide
3
14
(female) without spermicide
5
21
Cervical cap
Nulliparous women
9
20
Parous women
26
40
Vaginal sponge
Nulliparous women
9
20
Parous women
20
40
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, jellies, and vaginal suppositories)
6
26
Periodic abstinence (all methods)
1-9Depending on method (calendar, ovulation, symptothermal, post- ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998
25
Withdrawal
4
19
No contraception (planned pregnancy)
85
85
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets is a non-ergot dopamine agonist indicated for the treatment of:
Parkinson's disease (PD) (1.1)
Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2)
1.1 Parkinsons Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
1 INDICATIONS AND USAGE
Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
Ursodiol tablets, USP are bile acids indicated for the treatment of patients with primary biliary cirrhosis (1)
1 INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.'s VIMPAT
(lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate oral solution 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 AND USAGE
Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.
1 INDICATIONS AND USAGE
Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. (1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)
Limitations of Use: The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL
patient albumin [1g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
INDICATIONS
InitialTreatmentofAdvancedOvarianCarcinoma
Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES).
There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival ( 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
SecondaryTreatmentofAdvancedOvarianCarcinoma
Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.