um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Allergic states
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Dermatologic diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome)
Endocrine disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
Gastrointestinal diseases
To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic disorders
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous
Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic diseases
For the palliative management of leukemias and lymphomas.
Nervous system
Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic diseases
Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases
To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases
Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
INDICATIONSAND USAGE
1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
Systemic dermatomyositis (polymyositis)
4. Dermatologic diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Serum sickness
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Drug hypersensitivity reactions
6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
7. Respiratory diseases
Symptomatic sarcoidosis
Loefflers syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic diseases. For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous states. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal diseases. To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous system. Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
INDICATIONS AND USAGE
Elliotts B Solution is indicated as a diluent for the intrathecal administration
of methotrexate sodium and cytarabine for the prevention or treatment of
meningeal leukemia or lymphocytic lymphoma.
1 INDICATIONS AND USAGE
Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP)in patients with open-angle glaucoma or ocular hypertension.
Latanoprost ophthalmic solution is a prostaglandin F2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and olderwith chronic kidney disease on dialysis. (1)
1 INDICATIONS AND USAGE
Tri-Lo-Mili (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraception
Tri-Lo-Mili (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance (
1)
INDICATIONS AND USAGE
Diltiazem hydrochloride tablets USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
1 INDICATIONS AND USAGE
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Szary syndrome (SS) after at least one prior systemic therapy.
POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Szary syndrome after at least one prior systemic therapy (1).
1 INDICATIONS AND USAGE
Glimepiride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
[see Clinical Studies (14.1)].
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1.1)
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(1.1)
1.1
Important Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
INDICATIONS AND USAGE
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the
BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes,
Streptococcus pneumoniae, other streptococci (except
E. faecalis), and
Staphylococcus aureus.
Skin and skin structure infections caused by
Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by
Staphylococcus aureus, streptococci (except
Enterococcus faecalis), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by
Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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.
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.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
). Salsalate, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
INDICATIONS AND USAGE
Diltiazem hydrochloride extended-release capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.
INDICATIONS AND USAGE
MSC128D - For collection of up to 200 mL of umbilical cord blood. Use aseptic technique.
INDICATIONS AND USAGE
Norethindrone acetate tablets, USP is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
INDICATIONS AND USAGE
Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2to16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
How to Use
Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.
Do not accept if tamper evident box seal is broken or missing.
The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.
1 INDICATIONS AND USAGE
Solifenacin Succinate Tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin Succinate Tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
(1)
1 INDICATIONS AND USAGE
Lacosamide injection is indicated for:
Treatment of partial-onset seizures in patients 17 years of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older.
Pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) injection. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Letrazole Tablets, USP are an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1)
Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2)
First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3)
1.1
Adjuvant Treatment of Early Breast Cancer
LetrozoleTablets, USPareindicatedforthe adjuvant treatment ofpostmenopausal women with hormonereceptorpositive earlybreast cancer.
1.2 Extended Adjuvant Treatment of Early Breast Cancer
LetrozoleTablets, USPareindicatedforthe extended adjuvant treatment of earlybreast cancerinpostmenopausal women,who havereceived 5years of adjuvant tamoxifen therapy. The effectiveness of LetrozoleTabletsin extended adjuvant treatment ofearlybreast canceris based onan analysisof disease-freesurvival in patients treated withLetrozoleTabletsforamedian of60 months [s
e
e
C
lini
c
al Studi
e
s
(
14.2
,
14.3
)
].
1.3 First and Second-Line Treatment of Advanced Breast Cancer
LetrozoleTablets, USPareindicatedfor first-linetreatment ofpostmenopausal women with hormonereceptorpositiveorunknown, locallyadvanced ormetastaticbreastcancer.LetrozoleTablets USP,are also indicated forthetreatment of advanced breast cancerin postmenopausal women with diseaseprogression followingantiestrogen therapy[s
e
e
C
lini
c
al Studi
e
s
(
14.4
,
14.5
)
]
.
1
INDICATIONS AND USAGE
FETZIMA is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (
14
)].
Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults (1).
Limitation of Use:
FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established (1).
1 INDICATIONS AND USAGE
COSOPT is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
COSOPT is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of COSOPT twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
1 INDICATIONS AND 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 tablets are 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)
INDICATIONS & USAGE
Torsemide tablet is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.
Torsemide tablets are indicated for the treatment of hypertension 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 (Demerol
) 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
Promethazine is useful 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.
INDICATIONS AND USAGE
Lactated Ringers Irrigation is indicated for all
general irrigation, washing and rinsing purposes which permit use of a
sterile, nonpyrogenic electrolyte solution.
INDICATIONS AND USAGE
Doxepin hydrochloride capsules are recommended for the treatment of:Psychoneurotic patients with depression and/or anxiety.Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.