um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)]
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is a combination of codeine phosphate, an opiate agonist antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold. (
1
)
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age (8.4))
INDICATIONS AND USAGE
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride 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 was 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.
1.1 Hypertension
Amlodipine besylate tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Promethazine Hydrochloride, is useful orally for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
The Estradiol Transdermal System is indicated for:
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
[Enter Generic Section here]
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure
[Enter Generic Section here]
1.4 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis
1 INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (
1
).
1 INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see Clinical Studies (
14)]
.
Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults
(
1)
.
For cauterization of skin or mucous membrane and for removing warts and granulated tissue.
1 INDICATIONS AND USAGE
Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery (1).
INDICATIONS AND USAGE:
This product is indicated for the topical treatment and removal of common warts and plantar warts.
1 INDICATIONS AND USAGE
Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following:
- Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic braintumors.
- Multiple myeloma in combination withprednisone.
- Relapsed or refractory Hodgkin's lymphoma in combination with other approveddrugs.
- Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approveddrugs.
Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma,
astrocytoma, ependymoma, and metastatic brain tumors (1)
Multiple myeloma-in combination with prednisone (1)
Relapsed or refractory Hodgkin's lymphoma in combination with other
approved drugs (1)
Relapsed or refractory Non-Hodgkin's lymphomas in combination with
other
approved drugs (1)
1 INDICATIONS AND USAGE
Bicalutamide 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
Bicalutamide 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other treatments. (1)
Panic Disorder:
Clonazepam 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 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, i.e., 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).
INDICATIONS AND USAGE
LOMAIRA tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
The limited usefulness of agents of this class, including phentermine (see
Clinical Pharmacology
), should be measured against possible risk factors inherent in their use such as those described below.
table
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USPare indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USPare indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
).
INDICATIONS AND USAGE
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.
RELPAX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of RELPAX Tablets have not been established for cluster headache, which is present in an older, predominantly male population.
INDICATIONS AND USAGE
Edema
Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Furosemide tablets, USP may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, 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 tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin tablets, 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- 1.5)
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)
due to Neisseria gonorrhoeae.Because of high rates of amoxicillin resistance, amoxicillin tablets, USP are not recommended for empiric treatment of gonorrhea. Amoxicillin tablets, 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 tablets, 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 tablets, 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
Enoxaparin Sodium Injection is a low molecular weight heparin [LMWH] indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (1.3)
Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (1.4)
1.1 Prophylaxis of Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies 14.1
].
in patients undergoing hip replacement surgery, during and following hospitalization.
in patients undergoing knee replacement surgery.
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
1.2 Treatment of Acute Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for:
the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin Sodium Injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
INDICATIONS AND USAGE
Flucytosine Capsules USP is indicated only in the treatment of serious infections caused by susceptible strains of
Candida and/or
Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine Capsules USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules USP (See
MICROBIOLOGY).
1INDICATIONS AND USAGE
Ursodiol tablets, USP 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
Ursodiol tablets, USP 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cirrhosis (1)
INDICATIONS AND USAGE
LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
Only accepted procedures for these techniques as described in standard textbooks are recommended.
INDICATIONS AND USAGE: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers , infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. If a water-washable preparation is desired, the cream is preferable. Gentamicin sulfate cream has been used successfully in infants over one year of age, as well as in adults and children.
1 INDICATIONS AND USAGE
Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).
1 INDICATIONS AND USAGE
MOVANTIK (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
MOVANTIK (naloxegol) is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain (1)
1 INDICATIONS AND USAGE
Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1)
Limitation of Use:
Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2)
1.1 Indication
Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.
1.2 Limitations of Use
Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.
INDICATIONS AND USAGE:
AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of AZASAN on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: AZASAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, nonsteroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with AZASAN. The combined use of AZASAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of AZASAN with these agents cannot be recommended.
INDICATIONS AND USAGE
Meprobamate tablets are indicated for the management of anxietydisorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usuallydo not require treatment with an anxiolytic.
The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient.