um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Morphine sulfate oral solution (10 mg per 5 mL and 20 mg per 5 mL) are formulations of morphine, an opioid analgesic, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.
Morphine sulfate is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain where an opioid analgesic is appropriate. (1)
Morphine sulfate 100 mg per 5 mL (20 mg/mL) solution is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. (1)
1 INDICATIONS AND USAGE
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
INDICATIONS AND USAGE
Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets, USP. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.
1 INDICATIONS AND USAGE
VISUDYNE (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis.
There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.
VISUDYNE (verteporfin for injection) therapy is a photoenhancer indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. (
1
)
Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine capsules, USP is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina), nifedipine capsules, USP has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine capsules, USP and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (SeeWARNINGS).
1 INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION.
ATROPINE SULFATE injection, for intravenous use
Initial U.S. Approval: 1960
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (
1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (
1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (
1.3)
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. (
1.4)
1.1 Partial Onset Seizures
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetirecetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1.4 Limitations of Use
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
INDICATIONS AND USAGE
For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma.
Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies.
1.1	Prevention of Cardiovascular Disease
In
hypercholesterolemic
patients
without
clinically
evident
coronary
heart
disease
(CHD), Pravastatin Sodium is indicated to:
reduce the risk of myocardial infarction (MI).
reduce the risk of undergoing myocardial revascularization procedures.
reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
In patients with clinically evident CHD, Pravastatin Sodium is indicated to:
reduce the risk of total mortality by reducing coronary death.
reduce the risk of MI
reduce the risk of undergoing myocardial revascularization procedures.
reduce the risk of stroke and stroke/transient ischemic attack (TIA).
slow the progression of coronary atherosclerosis.
1 INDICATIONS AND USAGE
Albendazole tablets are an anthelmintic drug indicated for:
Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium. (1.1)
Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus. (1.2)
1.1 Neurocysticercosis
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium.
1.2 Hydatid Disease
Albendazole tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus.
Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset
seizures, with and without secondary generalization, in adults and
pediatric patients 3 years and older with epilepsy (1)
Gabapentin capsules, are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
1 INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1)
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.
1 INDICATIONS AND USAGE
Medroxyprogesterone acetate
injectable suspension is
indicated
for use by females of reproductive potential to prevent pregnancy.
Limitations of Use:The use of
medroxyprogesterone acetate
injectable suspension is not recommended asa long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [seeDosage and Administration (2.1) and Warnings and Precautions (5.1)].
Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)
Limitations of Use:
The use of
medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1)
1 INDICATIONS AND USAGE
Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg
1
INDICATIONS & USAGE
Neostigmine Methylsulfate Injection, USP, is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery.
1 INDICATIONS AND USAGE
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Doxercalciferol is a synthetic vitamin D2 analog:
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USP are 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
ESTRACE (estradiol tablets USP) is indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies
.)The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
1 INDICATIONS AND USAGE
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam injection is indicated for adjunctive therapy for the treatment of:
oMyoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
oPrimary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (1.4)
1.1 Partial-Onset Seizures
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1.4 Limitations of Use
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1.1 Actinic Keratosis
Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
1.2 Superficial Basal Cell Carcinoma
Imiquimod Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of Imiquimod Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.
1.3 External Genital Warts
Imiquimod Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old and older.
1.4 Limitations of Use
Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy. [see USE IN SPECIFIC POPULATIONS (8.4)].
1.5 Unevaluated Populations
The safety and efficacy of Imiquimod Cream in immunosuppressed patients have not been established.
Imiquimod Cream should be used with caution in patients with pre-existing autoimmune conditions.
The efficacy and safety of Imiquimod Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
INDICATIONS AND USAGE
Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as
an adjunct for the prevention and treatment of wound sepsis in patients with
second and third degree burns.
1 INDICATIONS AND USAGE
Glimepiride tablets USP are 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 tablets USP are 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 USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
1 INDICATIONS AND USAGE
Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
Adjuvant Colon Cancer (1.1)
Patients with Dukes C colon cancer
Metastatic Colorectal Cancer (1.1)
First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
Metastatic Breast Cancer (1.2)
In combination with docetaxel after failure of prior anthracycline-containing therapy
As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
1.1 Colorectal Cancer
Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine tablets were non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent capecitabine tablets in the adjuvant treatment of Dukes C colon cancer.
Capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with capecitabine tablets monotherapy. Use of capecitabine tablets instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
1.2 Breast Cancer
Capecitabine tablets in combination with docetaxel are indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Capecitabine tablets monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
For dermatologic Use
RAYASAL is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis.
For Podiatric Use
RAYASAL is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.
INDICATION AND USAGE: Nestabs One is a prescription prenatal multi-vitamin/mineral supplement with DHA that can be taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers.
Nestabs One may also be useful in improving the nutritional status of women prior to conception. The usual dose is one softgel daily, or as directed by a physician.
INDICATIONS AND USAGE
Lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin for local analgesia.
genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see
WARNINGS).
1 INDICATIONS AND USAGE
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (
1)
INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
Addisonian (pernicious) anemia
Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy
Fish tapeworm infestation
Malignancy of pancreas or bowel
Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see
Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).