um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli, Klebsiella species,
Enterobacter species,
Morganella morganii, Proteus mirabilis and
Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets offer some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets, USP are not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae
or
Haemophilus influenzae when a physician deems that
sulfamethoxazole and trimethoprim tablets, USP could offer some advantage over the use of a single antimicrobial agent.
Shigellosis
For the treatment of enteritis caused by susceptible strains of
Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis jiroveci
Pneumonia
For the treatment of documented
Pneumocystis jiroveci pneumonia and for prophylaxis against
P.
jiroveci
pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
P. jiroveci pneumonia.
Traveler's Diarrhea in Adults
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic
E. coli.
1 INDICATIONS AND USAGE
IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents 12 years of age weighing
30 kg for the treatment of:
Visceral leishmaniasis caused by
Leishmania donovani [see Clinical Trials (
14.1)]
.
Cutaneous leishmaniasis caused by
Leishmania braziliensis,
Leishmania guyanensis, and
Leishmania panamensis [see Clinical Trials (
14.2)]
.
Mucosal leishmaniasis caused by
Leishmania braziliensis [see Clinical Trials (
14.3)]
.
Limitations of Use:
Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data
[see Clinical Trials (
14.1,
14.2)]
.
There may be geographic variation in clinical response of the same
Leishmania species to IMPAVIDO
[see Clinical Trials (
14.1,
14.2)]
.
The efficacy of IMPAVIDO in the treatment of other
Leishmania species has not been evaluated.
IMPAVIDO is an antileishmanial drug indicated in adults and adolescents 12 years of age weighing 30 kg (66 lbs) for treatment of:
Visceral leishmaniasis due to
Leishmania donovani (
1).
Cutaneous leishmaniasis due to
Leishmania braziliensis, Leishmania guyanensis, and
Leishmania panamensis (
1).
Mucosal leishmaniasis due to
Leishmania braziliensis (
1).
Limitations of use:
Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same
Leishmania species to IMPAVIDO (
1,
14). The efficacy of IMPAVIDO in the treatment of other
Leishmania species has not been evaluated.
INDICATION AND USAGE
Indicated for the treatment of plaque psoriasis.
INDICATION AND USAGE
Nifedipine extended-release tablets are indicated for the
treatment of hypertension. It
may be used alone or in
combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1).
INDICATIONS AND USAGE
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder.
In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of NUVIGIL in long-term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe NUVIGIL for an extended time in patients should periodically re-evaluate long-term usefulness for the individual patient.
1 INDICATIONS AND USAGE
Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per spray)is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
Azelastine hydrochloride nasal solution (nasal spray) is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
1 INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and
older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1 Invasive Aspergillosis
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive
aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number
of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus
[see Clinical Studies (14.1, 14.5)
and Microbiology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia
in non-neutropenic patients and the following
Candida infections: disseminated infections in skin and infections in
abdomen, kidney, bladder wall, and wounds
[see Clinical Studies (14.2, 14.5) and Microbiology (12.4)].
1.3 Esophageal Candidiasis
Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal
candidiasis (EC) in adults and pediatric patients 2 years of age and older
[see Clinical Studies (14.3, 14.5) and Microbiology
(12.4)].
1.4 Scedosporiosis and Fusariosis
Voriconazole tablets are indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum
(asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients
(2 years of age and older) intolerant of, or refractory to, other therapy
[see Clinical Studies (14.4) and Microbiology (12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to
therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other
laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted
accordingly.
DermaSilkRx Penetral Cream
Drug Facts
Active ingredient
Capsicum Oleoresin 0.0625% (containing capsaicin 0.025%)
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, and sprains.
Warnings
For external use only
This is not a face cream. Do not apply to the face.
Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
Do not bandage tightly.
Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation.
Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.
When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using product immediately and get medical attention if experiencing burning, pain, swelling, or blistering of the skin. Rare cases of severe burning or blistering have been reported.
If pregnant, breast-feeding, or any medical conditions exist, ask a health professional before use.
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.
Directions
Rotate pumps spout counter-clockwise slightly to unlock; clockwise to lock.
Before using on children under 18 years of age consult a physician.
Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.
Gently massage into the skin until fully absorbed.
Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
WARNING: FLAMMABLE PRODUCT
Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.
Inactive ingredients
Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.
Questions or comments?
Call toll-free 1-800-317-2910 or visit us at
www.dermasilkrx.com
1 INDICATIONS AND USAGE
Lamotrigine tablets are indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic
seizures.
generalized seizures of Lennox-Gastaut
syndrome. (
1.1)
Epilepsymonotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (
1.1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (
1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC)
seizures.
generalized seizures of Lennox-Gastaut
syndrome.
Monotherapy
Lamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (
14.1)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
1	INDICATIONS AND USAGE
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
1 INDICATIONS AND USAGE
Oxycodone hydrochloride tablets 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 and Precautions (
5.1)]
, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (
1)
Limitations of Use (
1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid
analgesics or non-opioid combination products):
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
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourette's Disorder
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourette's disorder (14.5)
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
INDICATIONS AND USAGE
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below:
Infections of the ear, nose, and throat - due to
Streptococcus spp. (- and - hemolytic strains only),
S. pneumoniae,
Staphylococcus spp., or
H. influenzae.
Infections of the genitourinary tract - due to
E. coli, P. mirabilis, or E. faecalis.
Infections of the skin and skin structure - due to
Streptococcus spp. (- and -hemolytic strains only),
Staphylococcus spp., or
E. coli.
Infections of the lower respiratory tract - due to
Streptococcus spp. (- and -hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to
N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Amoxicillin/Clarithromycin/Lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
Dual Therapy
Amoxicillin/Lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert,
MICROBIOLOGYsection.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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.
Indicated surgical procedures should be performed.
1 INDICATIONS AND USAGE
TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults and in pediatric patients:
weighing at least 35 kg coadministered with atazanavir or
weighing at least 40 kg coadministered with darunavir. (1.1)
Limitations of Use:
TYBOST is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of TYBOST is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir. (1.2, 5.4)
Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain TYBOST interactions. TYBOST and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications. (1.2, 5.3, 7, 12.3)
1.1
Indications
Adult Patients:
TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults [see Dosage and Administration (2.1)].
Pediatric Patients:
TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients
[see Dosage and Administration (2.2)]:
weighing at least 35 kg coadministered with atazanavir or
weighing at least 40 kg coadministered with darunavir.
1.2	Limitations of Use
TYBOST is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of TYBOST is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir [see Warnings and Precautions (5.4)].
Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain TYBOST interactions. TYBOST and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications [see Warnings and Precautions (5.3), Drug Interactions (7), and Clinical Pharmacology (12.3)].
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.