um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Hydrochlorothiazide tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide tablets, USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide tablets, USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, PREGNANCY). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
INDICATIONS AND USAGE
Treatment of Anaerobic Infections
Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole.
Metronidazole is effective in
Bacteroides fragilis
infections resistant to clindamycin, chloramphenicol and penicillin.
Intra-abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by
Bacteroides
species including the
B. fragilis
group (B. fragilis, B. distasonis, B. ovatus,
B. thetaiotaomicron, B. vulgatus).
Clostridium
species,
Eubacterium
species,
Peptococcus
species, and
Peptostreptococcus
species.
Skin and Skin Structure Infections
caused by
Bacteroides
species including
B. fragilis
group,
Clostridium
species,
Peptococcus
species,
Peptostreptococcus
species and
Fusobacterium
species.
Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by
Bacteroides
species including the
B. fragilis
group,
Clostridium
species,
Peptococcus
species,
Peptostreptococcus
speciesand Fusobacterium species.
Bacterial Septicemia
caused by
Bacteroides
species including the
B. fragilis
group and
Clostridium
species.
Bone and Joint Infections, as adjunctive therapy, caused by
Bacteroides
species including the
B. fragilis
group.
Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by
Bacteroides
species including the
B. fragilis
group.
Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by
Bacteroides
species including the
B. fragilis
group.
Endocarditis
caused by
Bacteroides
species including the
B. fragilis
group.
Prophylaxis
The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated.
Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see
DOSAGE AND ADMINISTRATION
).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole 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.
1 INDICATIONS AND USAGE
Testosterone topical solution USP is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism
(congenital or acquired) (1)
Hypogonadotropic hypogonadism
(congenital or acquired) (1)
Limitations of use:
Safety and efficacy of testosterone topical solution USP in men with "age-related hypogonadism" have not been established. (1)
Safety and efficacy of testosterone topical solution USP in males <18 years old have not been established (8.4)
Testosterone topical solution USP is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary
hypogonadism (congenital or acquired):
testicular failure due to
conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing
testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or
toxic damage from alcohol or heavy metals. These men usually have low
serum testosterone concentrations and gonadotropins (FSH, LH) above the
normal range.
Hypogonadotropic hypogonadism
(congenital or acquired):
gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic
injury from tumors, trauma, or radiation. These men have low testosterone
serum concentrations but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of testosterone topical solution USP in men
with "age-related hypogonadism" (also referred to as "late-onset
hypogonadism") have not been established.
Safety and efficacy of testosterone topical solution USP in
males <18 years old have not been established [see USE IN SPECIFIC
POPULATIONS (8.4)] .
INDICATIONS AND USAGE
SupplementationofthedietwithvitaminsA,CandD.
Multi-VitaminDropswithFluoride0.25mgalsoprovidesfluorideforcariesprophylaxis.
TheAmericanAcademyofPediatricsrecommendsthatchildrenuptoage16,inareaswheredrinkingwatercontainslessthanoptimallevelsoffluoride,receivedailyfluoridesupplementation.
The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg
(See
Dosage and Administration
).
Multi-VitaminDropswithFluoride0.25mgsupplysignificant amountsofvitaminsA,CandDtosupplementthediet,andtohelpassurethatnutritionaldeficienciesofthesevitaminswillnotdevelop.
Thus,inasingleeasy-to-usepreparation,childrenobtainessentialvitaminsandfluoride.
INDICATIONS AND USAGE
MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. 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 MARCAINE in these patients.
MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated MARCAINE 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
0.5% with epinephrine 1:200,000
dental block
0.5% with epinephrine 1:200,000
(See DOSAGE AND ADMINISTRATION for additional information).
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
1 INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. (1)
INDICATIONS AND USAGE
Terazosin hydrochloride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.
Terazosin hydrochloride is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
Indication
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception
INDICATIONS AND USAGE
Major Depressive Disorder
Sertraline is indicated for the treatment of major depressive disorder in adults.
The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied.
The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloridefor extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
Premenstrual Dysphoric Disorder (PMDD)
Sertraline hydrochlorideis indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults.
The efficacy of sertraline hydrochloridein the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY).
The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.
The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS & USAGE
Metronidazole gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole gel USP, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. (1)
1 INDICATIONS AND USAGE
Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics (1.1).
Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).
1.1 Hypertension
Ramipril capsulesUSP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
1.3
Heart Failure Post-Myocardial Infarction
Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure [see
Clinical Studies (14.3)
].
INDICATIONS & USAGE
Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.
Antihistaminic
For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
Motion Sickness
For active treatment of motion sickness.
Antiparkinsonism
For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows:
parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
1 INDICATIONS AND USAGE
NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetal's or Variant Angina)
Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
1.1 Hypertension
NORVASC is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
NORVASC is indicated for the symptomatic treatment of chronic stable angina. NORVASC may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
NORVASC is indicated for the treatment of confirmed or suspected vasospastic angina. NORVASC may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, NORVASC is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the:
treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (
1)
treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older (
1)
Escitalopram tablets are indicated for the treatment of:
major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.
1 INDICATIONS AND USAGE
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Isotretinoin capsules are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1)
Limitations of Use:
If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy. (1)
Limitations of Use:
If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)].
INDICATIONS AND USAGE
Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults.
Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. (1)
1 INDICATIONS AND USAGE
Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is indicated for use by females of reproductive potential to prevent pregnancy.
Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)
Limitations of Use:
The use of MPA Injectable Suspension, USP 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)
Limitations of Use:
The use of MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated,
have not provided adequate analgesia, or are not expected to provide adequate analgesia
MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- (Dimethicone 5.0%)
Drug Facts
Active ingredient
Dimethicone 5.0%
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve chapped or cracked skin
Beneficial for face, hands, body and legs.
Warnings
For external use only
Do not use on
deep or puncture wounds
animal bites
serious burns
When using this product
avoid contact with eyes.
Stop use and ask a doctor if
condition worsens
symptoms last for more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
apply cream liberally as needed
Other information
protect from freezing
avoid excessive heat
Inactive ingredients
Purified Water, Cocos Nucifera (Coconut oil), Olea Europaea (Olive Oil ), Cetyl Alcohol, Glyceryl
stearate, Stearic Acid, Peg 100 stearate,Propanediol, Glycol Distearate,1,2- Hexanediol, Caprylyl
Glycol, Hydroyacetophenone, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Sinensis (Orange) Peel Oil,
Citrus Reticulata (Tangerine) Peel Oil, Hexyldecanol, Bisabolol, Cetylhydroxyproline Palmitamide,
Brassica Campestris (Rapeseed) Sterols, Yeast Ferment Extract, Hydrolyzed Soy Protein, 7-
Dehydrocholestrol, Caprylic/Capric Triglcerides, Glycerin, Phospholipids, Tocopherol Acetate,
Algae Extract, Eugenia Caryophyllus (Clove) Flower Extract, Camellia Sinensis (Green Tea) Leaf
Extract, Isopropyl Myristate, Methyldihydrojasmonate, Ethylene Brassylate, Vanilla Planifolia Extract,
Carthamus Tinctorius (Safflower) Oleosomes, Manuka Honey, Cholecalciferol, Phytonadione, Jojoba
Esters, Zea Mays (Corn) Oil
INDICATIONS AND USAGE:
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4Sodium Fluoride 1.1% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (SeeWARNINGS for exception.)