TRIAZOLAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R)

Disponible desde:

Hikma Pharmaceuticals USA Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam is contraindicated in: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10) and Clinical Considerations]. Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to triazolam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to triazolam during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions ( 5.10 )]. Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Oral administration of triazolam to pregnant rats and rabbits during the period of organogenesis caused skeletal developmental changes (variations and malformations) at maternally toxic doses in rats and at doses in rats and rabbits which are approximately equal to or greater than 200 times the maximum recommended human dose (MRHD) of 0.5 mg/day based on mg/m2 body surface area. Oral administration of triazolam to male and female rats before mating, and continuing during gestation and lactation did not result in embryotoxicity at doses up to approximately 100 times the MRHD based on mg/m2 body surface area, but did cause an increase in the number of stillbirths and postnatal pup mortalities at doses greater than or equal to approximately 40 times the MRHD based mg/m2 body surface area. 14 C-triazolam was administered orally to pregnant mice. Drug-related material appeared uniformly distributed in the fetus with 14 C concentrations approximately the same as in the brain of the mother. Risk Summary There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. There are no data on the presence of triazolam in human milk or the effects on milk production. Triazolam and its metabolites are present in the milk of lactating rats (see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for triazolam and any potential adverse effects on the breastfed infant from triazolam or from the underlying maternal condition. Clinical Considerations Infants exposed to triazolam through breast milk should be monitored for sedation, poor feeding and poor weight gain. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 28 hours (approximately 5 elimination half-lives) after triazolam administration in order to minimize drug exposure to a breast fed infant. Data Both triazolam and triazolam metabolites were detected in milk of rats. Lactating rats were orally administered 0.3 mg/kg 14 C-triazolam; drug and metabolite levels were determined in milk collected at 6 and 24 hours after administration. Safety and effectiveness of triazolam have not been established in pediatric patients. Elderly patients exhibit higher plasma triazolam concentrations due to reduced clearance as compared with younger subjects at the same dose. Because elderly patients are especially susceptible to dose related adverse reactions and to minimize oversedation, the smallest effective dose should be used [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. Triazolam tablets contain triazolam, a Schedule IV controlled substance. Triazolam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see Warnings and Precautions ( 5.2)] . The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Physical Dependence Triazolam may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see Warnings and Precautions ( 5.3)] . To reduce the risk of withdrawal reactions, use a gradual taper to discontinue triazolam or reduce the dosage [see Dosage and Administration ( 2.3), Warnings and Precautions (5.3)] . Tolerance Tolerance to triazolam may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of triazolam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Resumen del producto:

Triazolam Tablets, USP 0.125 mg tablets are supplied as a white, oval-shaped tablet with tablet identification “54 519” debossed on the one side and plain on the other side. NDC 0054-4858-25: Bottle of 100 Tablets 0.25 mg tablets are supplied as a light blue, oval-shaped tablet, scored on one side with tablet identification “54 620” debossed on the other side. NDC 0054-4859-25: Bottles of 100 Tablets NDC 0054-4859-29: Bottles of 500 Tablets Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Hikma Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Triazolam Tablets, USP CIV
(trye az’ oh lam)
Rx only
What is the most important information I should know about Triazolam
Tablets?
•
Triazolam is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol,
or other central nervous system (CNS) depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death. Get emergency help
right away if any of the following happens:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
triazolam tablets with opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including triazolam tablets which can lead to
overdose and serious side effects
including coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including triazolam tablets. These serious
side effects may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty breathing. Call your
healthcare provider or go to the nearest hospital emergency room right
away if you get any of these
serious side effects.
o
You can develop an addiction even if you take triazolam tablets as
prescribed by your healthcare
provider.
o
Take triazolam tablets exactly as your healthcare provider prescribed.
o
Do not share your triazolam tablets with other people.
o
Keep triazolam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Triazolam tablets can
cause physical dependence
and withdrawal reactions.
o
Do not suddenly stop taking triazolam tablets. Stopping triazolam
tablets suddenly can cause
serious and life-threatening side effects, including unusual
movements, responses, or expressions,
seizures, sudden and severe mental or nervous syste

Ficha técnica

TRIAZOLAM- TRIAZOLAM TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIAZOLAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIAZOLAM
TABLETS.
TRIAZOLAM TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1982
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.10) 1/2023
INDICATIONS AND USAGE
Triazolam is a benzodiazepine indicated for the short-term treatment
of insomnia (generally 7 to 10 days)
in adults. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT
PRESCRIBING OF
THESE DRUGS IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE
INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS
FOR SIGNS
AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (5.1, 7.1).
THE USE OF BENZODIAZEPINES, INCLUDING TRIAZOLAM, EXPOSES USERS TO
RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
TRIAZOLAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE,
AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF TRIAZOLAM AFTER
CONTINUED USE
MAY PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE
LIFE-THREATENING. TO
REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO
DISCONTINUE
TRIAZOLAM OR REDUCE THE DOSAGE (2.3, 5.3).
_Adults:_ Recommended dosage is 0.25 mg once daily before bedtime.
Maximum recommended
dosage is 0.5 mg once daily (2.1)
_Geriatric patients:_ Reduce starting dosage to 0.125 mg once daily.
May increase to 0.25 mg if no
response. Geriatric patients should not exceed 0.2