um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Useand
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
INDICATIONS AND USAGE
HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.
Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9.
Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.
INDICATIONS AND USAGE
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by
Streptococcuspneumoniae and
Streptococcuspyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to
Streptococcuspneumoniae,
Haemophilusinfluenzae,
Staphylococcus aureus, Streptococcus pyogenes, and
Moraxellacatarrhalis
Skin and skin structure infections caused by
Staphylococcus aureus and/or
Streptococcus pyogenes
Bone infections caused by
Staphylococcus aureus and/or
Proteusmirabilis
Genitourinary tract infections, including acute prostatitis, caused by
Escherichiacoli,
Proteusmirabilis, and
Klebsiellapneumoniae
Note
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP 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.
Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age.
Contraindicated in pediatric patients under 12 years of age.
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine with Codeine Oral Solution for use in adult
patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
1INDICATIONS AND USAGE
Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy. (1)
1 INDICATIONS AND USAGE
COLCRYS (colchicine, USP) tablets are an alkaloid indicated for:
Prophylaxis and Treatment of Gout Flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.
1.1 Gout Flares
COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares:
COLCRYS is indicated for prophylaxis of gout flares.
Treatment of Gout Flares:
COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2 Familial Mediterranean fever (FMF)
COLCRYS (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).
INDICATIONS AND USAGE
Metolazone tablets, USP, are indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets (UCB).
Usage In Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
INDICATIONS AND USAGE
Metolazone tablets are indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets in the treatment of hypertension. See package circular for MYKROX Tablets.
Usage In Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS).Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
1.	INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1)
INDICATIONS AND USAGE
Mexiletine Hydrochloride Capsules USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
INDICATIONS AND USAGE:
Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
Indications and Usage
Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.
Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Nalbuphine Hydrochloride Injection 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
1 INDICATIONS AND USAGE
Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.
Olux-E Foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older. (1)
1 INDICATIONS AND USAGE
Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
Tobramycin inhalation solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. (1) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV1) less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia. (1)
1 Indications And Usage
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults 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. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION (2.2)].
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION (2.2), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1, 5.4, 5.5, 5.7, 5.9)].
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic, and Bupivacaine Hydrochloride and Epinephrine Injection is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults 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. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9)
INDICATIONS AND USAGE
Doxycycline hyclate tabletsareindicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
1 INDICATIONS AND USAGE
Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of
Staphylococcus aureus (S. aureus) and
Streptococcus pyogenes (S. pyogenes).
1 INDICATIONS AND USAGE
FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve FIORICET with CODEINE for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate 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.
FIORICET with CODEINE is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve FIORICET with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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.
INDICATIONS AND USAGE
PLASMA-LYTE R
Injection (Multiple Electrolytes Injection, Type 2, USP) is indicated as
a source of water and electrolytes or as an alkalinizing
agent.
INDICATIONS AND USAGE
Oxybutynin chloride extended release tablets are once-daily controlled-release tablets indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Pediatric use information for the treatment of patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida) is approved for Alza Corporation's oxybutynin chloride extended release tablets. However, due to Alza Corporation's marketing exclusivity rights, this drug product is not labeled for pediatric use.
Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Sulindac tablets are indicated for acute long-term use in the relief of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis*
Ankylosing spondylitis
Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
Acute gouty arthritis
1 INDICATIONS AND USAGE
Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride USP is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
1 INDICATIONS AND USAGE
Divalproex sodium is an anti-epileptic drug indicated for:
Treatment of manic episodes associated with bipolar disorder (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
1.1 Mania
Divalproex sodium delayed-release tablets, USP are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablets, USP was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].
The safety and effectiveness of divalproex sodium delayed-release tablets, USP for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets, USPfor extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed-release tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets, USP are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3 Migraine
Divalproex sodium delayed-release tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets, USP are useful in the acute treatment of migraine headaches.
1.4 Important Limitations
Because of the risk to the fetus ofdecreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see
Warnings and Precautions(5.2,
5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)].
Divalproex sodium delayed-release tablets, USP are contraindicated for prophylaxis of migraine headaches in women who are pregnant.