um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
1. HypertensionAmlodipine besylate is indicated for the treatment of hypertension. It may be used alone or incombination with other antihypertensive agents.2. Coronary Artery DiseaseCronic Stable AnginaAmlodipine besylate is indicated for the symptomatic treatment of chronic stable angina.Amlodipine besylate may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetals or Variant Angina)Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina.Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs.
1 INDICATIONS AND USAGE
MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
MULPLETA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. (1)
1 INDICATIONS AND USAGE
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic, and Bupivacaine Hydrochloride and Epinephrine Injection is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS].
Diclofenac is indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of the signs and symptoms of ankylosing spondylitis.
1 INDICATIONS AND USAGE
Quetiapine is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1)
Bipolar I disorder manic episodes (
1.2)
Bipolar disorder, depressive episodes (
1.2)
1.1 Schizophrenia
Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials
[see Clinical Studies (
14.1)]
.
1.2 Bipolar Disorder
Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years)
[see Clinical Studies (
14.2)]
.
Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder
[see Clinical Studies (
14.2)]
.
Quetiapine is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials
[see Clinical Studies (
14.2)]
.
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Norepinephrine Bitartrate in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)
INDICATIONS AND USAGE
Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see
DOSAGE AND ADMINISTRATION
and
CLINICAL PHARMACOLOGY
sections).
1 INDICATIONS AND USAGE
Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Triazolam tablets are a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
1. Indications and Usage
Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
INDICATIONS AND USAGE
Ketamine hydrochloride injection is indicated as the sole
anesthetic agent for diagnostic and surgical procedures that do not require
skeletal muscle relaxation. Ketamine hydrochloride injection is best suited
for short procedures but it can be used, with additional doses, for longer
procedures.
Ketamine hydrochloride injection is indicated
for the induction of anesthesia prior to the administration of other general
anesthetic agents.
Ketamine hydrochloride injection
is indicated to supplement low-potency agents, such as nitrous oxide.
Specific
areas of application are described in the CLINICAL
PHARMACOLOGY section.
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1)
Major Depressive Disorder (MDD)
Generalized Anxiety Disorder (GAD)
Social Anxiety Disorder (SAD)
Panic Disorder (PD)
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.2 Generalized Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.
1.3 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
1.4 Panic Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1 INDICATIONS AND USAGE
Mycophenolic acid delayed-release tabletsare antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1)
Use in combination with cyclosporine and corticosteroids. ( 1.1)
Limitations of Use:
Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2)
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid delayed-release tablet are to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
INDICATION AND USAGE
For
the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Keratolytic.
INDICATIONS AND USAGE
LARINTM Fe 1.5/30 isindicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
Lowest Expected*
Typical**
(No contraception)
(85)
(85)
Oral contraceptives combined progestin only
0.1 0.5
3 N/A***
N/A***
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge nulliparous parous
9 20
20 40
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD progesterone T copper T 380A LNg 20
1.5 0.6 0.1
2.0 0.8 0.1
Condom without spermicides female male
5 3
21 14
Cervical Cap with spermicidal cream or jelly nulliparous parous
9 26
20 40
Periodic abstinence (all methods)
1-9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
Adapted from RA Hatcher et al, Reference 7.
* The authors' best guess of the percentage of women expected to experience an accidental pregnancy among
couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
**This term represents typical couples who initiate use of a method (not necessarily for the first time),who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
***N/A--Data not available.
INDICATIONS AND USAGE
Clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see
CONTRAINDICATIONS,
WARNINGS
and
ADVERSE REACTIONS
).
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USPand other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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.Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin capsules, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1, 1.2, 1.3, 1.4, 1.5)
In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1
Infections of the Ear, Nose, and Throat
Due to Streptococcus species (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2
Infections of the Genitourinary Tract
Due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3
Infections of the Skin and Skin Structure
Due to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4
Infections of the Lower Respiratory Tract
Due to Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5
Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections in males and females)
Due to Neisseria gonorrhoeae.Because of high rates of amoxicillin resistance, amoxicillin capsules, USPare not recommended for empiric treatment of gonorrhea. Amoxicillin capsules, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6
Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin capsules, USP, in combination with clarithromycin plus lansoprazole as triple therapy,are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7
Dual Therapy for H. pylori with Lansoprazole
Amoxicillin capsules, USP, in combination with lansoprazole delayed-release capsules as dual therapy,are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1 INDICATIONS AND USAGE
OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
OSENI is a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. (1)
Limitations of Use
OSENI should not be used in patients with type 1 diabetes mellitus.
Pneumocystis Carinii Pneumonia:
For the treatment of documented
Pneumocystis carinii
pneumonia and for prophylaxis against
Pneumocystis carinii
pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
Pneumocystis carinii
pneumonia.
INDICATIONS AND USAGE
Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)
Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.
1 INDICATIONS AND USAGE
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see CLINICAL STUDIES (14)].
INDICATIONS AND USAGE
Trientine Hydrochloride Capsules are indicated in the treatment of patients with Wilsons disease who are intolerant of penicillamine. Clinical experience with Trientine Hydrochloride Capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patients dose have not been well defined. Trientine Hydrochloride Capsules and penicillamine cannot be considered interchangeable. Trientine Hydrochloride Capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, Trientine Hydrochloride Capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, Trientine Hydrochloride Capsules were reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine Hydrochloride Capsules are not indicated for treatment of biliary cirrhosis.
1 INDICATIONS AND USAGE
Cyclophosphamide for injection is an alkylating drug indicated for treatment of:
Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1)
Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. (1.2)
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
1.1
Malignant
Diseases
Cyclophosphamide for injection is indicated for the treatment of:
malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkins disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma
multiple myeloma
leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide for injection given during remission is effective in prolonging its duration)
mycosis fungoides (advanced disease)
neuroblastoma (disseminated disease)
adenocarcinoma of the ovary
retinoblastoma
carcinoma of the breast
Cyclophosphamide for injection, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
1.2
Minimal Change
Nephrotic Syndrome in Pediatric Patients
Cyclophosphamide for injection is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
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 a 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.
1 INDICATIONS AND USAGE
Tri-VyLibra is estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
Tri-VyLibrais also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2)
1.1 Oral Contraceptive
Tri-VyLibra tabletsareindicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
1.2 Acne
Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)].
INDICATIONS AND USAGE
Carisoprodol and Aspirin Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions.