um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONSAND USAGE
Ketamine hydrochloride injection is indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
for the induction of anesthesia prior to the administration of other general anesthetic agents.
as a supplement to other anesthetic agents.
Ketamine hydrochloride is a general anesthetic indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)
for the induction of anesthesia prior to the administration of other general anesthetic agents (1)
as a supplement to other anesthetic agents (1).
INDICATIONS & USAGE
Benzonatate is indicated for the symptomatic relief of cough.
1 INDICATIONS AND USAGE
Natazia is indicated for use by women to prevent pregnancy.
The efficacy of Natazia in women with a body mass index (BMI) of > 30
kg/m2 has not been evaluated.
Natazia is an estrogen/progestin COC indicated for use by women to prevent
pregnancy. (1)
The efficacy of Natazia in women with a body mass index (BMI) of >30
kg/m2 has not been evaluated. (1, 8.8)
1. INDICATIONS AND USAGE
Sildenafil tablets are 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-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)
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-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)].
1 INDICATIONS AND USAGE
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)] .
Bosentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise
ability and to decrease clinical worsening. Studies establishing
effectiveness included predominantly patients with WHO Functional Class
II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH
associated with connective tissue diseases (21%), and PAH associated with
congenital heart disease with left-to-right shunts (18%) (1).
Urinary Tract Infections:
For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli
,
Klebsiella
species,
Enterobacter
species,
Morganella morganii
,
Proteus mirabilis
and
Proteus vulgaris
. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
1 INDICATIONS AND USAGE
VAZCULEP is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
VAZCULEP injection is an -1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. (1)
1
INDICATIONS AND USAGE
Adrenalin is a non-selective alpha and beta adrenergic agonist indicated for:
Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1)
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2)
1.1 Anaphylaxis
Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
1.2 Hypotension associated with Septic
Shock
Adrenalinis indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
INDICATION
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
Indications and Usage
The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression.
Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus.
Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated:
1. The acutely disturbed or hysterical patient.
2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens.
3. As pre- and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis.
Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS
)
.
In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate.
Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent.
The effectiveness of hydroxyzine in 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 & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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 for oral suspension is 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 byHaemophilus influenzae(including -lactamase producing strains),Haemophilus parainfluenzae(including -lactamase producing strains),Streptococcus pneumoniae(penicillin-susceptible strains only), andMoraxella catarrhalis(including -lactamase producing strains) (seeCLINICAL STUDIES).
Acute Exacerbations of Chronic Bronchitis caused byHaemophilus influenzae(including -lactamase producing strains),Haemophilus parainfluenzae(including -lactamase producing strains),Streptococcus pneumoniae(penicillin-susceptible strainsonly), andMoraxella catarrhalis(including -lactamase producing strains). Acute Maxillary Sinusitis caused byHaemophilus influenzae(including -lactamase producing strains),Streptococcus pneumoniae(penicillin-susceptible strains only), andMoraxella catarrhalis(including -lactamase producing strains).
NOTE:For information on use in pediatric patients, seePediatric UseandDOSAGE ANDADMINISTRATION. Pharyngitis/Tonsillitis caused byStreptococcus pyogenes(seeCLINICAL STUDIES).
NOTE:Cefdinir is effective in the eradication ofS. pyogenesfrom the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever followingS. pyogenespharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused byStaphylococcus aureus(including -lactamase producing strains) andStreptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused byHaemophilus influenzae(including -lactamase producing strains),Streptococcus pneumoniae(penicillin-susceptible strains only), andMoraxella catarrhalis(including -lactamase producing strains).Pharyngitis/Tonsillitis caused byStreptococcus pyogenes(seeCLINICAL STUDIES).
NOTE:Cefdinir is effective in the eradication ofS. pyogenesfrom the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever followingS. pyogenespharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused byStaphylococcus aureus(including -lactamase producing strains) andStreptococcus pyogenes.
Indications And Usage
Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride injection, USP in these patients.
Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated bupivacaine hydrochloride injection, USP concentrations are:
local infiltration
0.25%
peripheral nerve block
0.25% and 0.5%
retrobulbar block
0.75%
sympathetic block
0.25%
lumbar epidural
0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)
caudal
0.25% and 0.5%
epidural test dose
(see PRECAUTIONS)
(See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride injection, USP.
1 INDICATIONS AND USAGE
Flurbiprofen tablets are indicated:
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of rheumatoid arthritis (1)
Relief of the signs and symptoms of osteoarthritis (1)
INDICATIONS AND USAGE
Hypertension:
Diltiazem hydrochloride extended-release capsules is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Chronic Stable Angina:
Diltiazem hydrochloride extended-release capsules is indicated for the treatment of chronic stable angina.
1 INDICATIONS AND USAGE
Oral transmucosal fentanyl citrate is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking oral transmucosal fentanyl citrate.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)].
As a part of the TIRF REMS, oral transmucosal fentanyl citrate may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of oral transmucosal fentanyl citrate, patient and prescriber enrollment are not required.
Oral transmucosal fentanyl citrate is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking oral transmucosal fentanyl citrate.
Limitations of Use
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine or dental pain. (4)
As a part of the TIRF REMS, oral transmucosal fentanyl citrate may be dispensed by outpatient pharmacies only to outpatients enrolled in the program. (5.7) For inpatient administration of oral transmucosal fentanyl citrate, patient and prescriber enrollment are not required.
INDICATIONS AND USAGE
Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
1 INDICATIONS AND USAGE
Ranolazine extended-release tablets are indicated for the treatment of chronic angina.
Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers.
Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. (1)
1 INDICATIONS AND USAGE
CAPLYTA is indicated for the treatment of:
Schizophrenia in adults [see Clinical Studies (14.1)].
Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2)].
CAPLYTA is an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults. (1)
Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. (1)
INDICATIONS AND USAGE
Seizure Disorders: Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.
Panic Disorder: Clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam orally disintegrating tablets was established in two 6- to 9- week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see
CLINICAL PHARMACOLOGY:
Clinical Trials
).
Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The effectiveness of clonazepam orally disintegrating tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
TAZORAC Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1)
TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. (1.2)
1.1	Plaque Psoriasis
TAZORAC (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis.
1.2	Acne Vulgaris
TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
INDICATIONS AND USAGE
Cromolyn Sodium Ophthalmic Solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
1 INDICATIONS AND USAGE
Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid
arthritis including acute flares of chronic disease
Moderate to severe ankylosing
spondylitis
Moderate to severe
osteoarthritis
Acute painful shoulder
(bursitis and/or tendinitis)
Acute gouty arthritis (1)
Indomethacin capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute
flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis
1.1 Partial Onset Seizures
Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.
1 INDICATIONS & 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-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)].
Sildenafil is 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-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)