Triazolam (Triazolam)

Trade Name : Triazolam

West-Ward Pharmaceuticals Corp.

TABLET

Strength 0.125 mg/1

TRIAZOLAM Benzodiazepine [EPC],Benzodiazepines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Triazolam (Triazolam) which is also known as Triazolam and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 0.125 mg/1 per ml. Read more

Triazolam (Triazolam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
See full prescribing information for complete boxed warning.
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (, ).

Reserve concomitant prescribing for use 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.

Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.

No data

2.2n- 8.5

Triazolam Tablets USP are available as a 0.125u00a0mg and 0.25 mg tablet.

u2022
3

Triazolam is contraindicated in:

4n- 5.7n- 17

No data

Persistent or Worsening Insomnia:
u201cSleep-drivingu201d and Other Complex Behaviors:
CNS Manifestations:
Effects on Driving and Operating Heavy Machinery:
Patients with Depression:
Tolerance/Withdrawal Phenomena:
Neonatal Sedation and Withdrawal Syndrome:

The following serious adverse reactions are discussed in greater detail in other sections:
Most common adverse reactions (incidence u22654% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia ().

Table 2 includes clinically significant drug interactions with triazolam n

4n- 5.7n- 7.1

Lactation:
8.2

No data

Manifestations of overdosage with triazolam include somnolence, confusion, impaired coordination, slurred speech, and ultimately, coma. Respiratory depression and apnea have been reported with overdosages of triazolam. Seizures have been reported after overdosages.
Death has been reported in association with overdoses of triazolam. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including triazolam, and alcohol; benzodiazepine and alcohol levels seen in some of these cases have been lower than those usually associated with reports of fatality with either substance alone.
Respiration, pulse, and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. An adequate airway should be maintained. Intravenous fluids may be administered.
Flumazenil may be useful in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including Contraindications and Warnings and Precautions should be consulted prior to use.
Hemodialysis and forced diuresis are probably of little value. As with the management of intentional overdosage with any drug, the physician should bear in mind that multiple agents may have been ingested by the patient.
In case of an overdosage, consult a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.

Triazolam Tablets USP contain triazolam, a triazolobenzodiazepine.
Triazolam USP is a white to off-white powder, soluble in chloroform; slightly soluble in alcohol; and practically insoluble in ether and in water. It has a molecular weight of 343.2.
The chemical name for triazolam is 8-chloro-6-(-chlorophenyl)-1-methyl-4-s-triazolo-[4,3-][1,4]benzodiazepine.
The structural formula is represented below:
Each triazolam tablet for oral administration, contains 0.125 mg or 0.25 mg of triazolam USP.
Inactive ingredients: - docusate sodium with sodium benzoate, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch; - docusate sodium with sodium benzoate, FD&C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

No data

Carcinogenesis:
No evidence of carcinogenic potential was observed in rats or mice administered triazolam in the diet for 24-months at doses greater than or equal to 900 times the MRHD of 0.5 mg, based on mg/m body surface area.
Mutagenesis:
Triazolam was not mutagenic in the Ames bacterial reverse mutation assay, and no DNA damage was observed in an alkaline elution assay in Chinese hamster lung fibroblast cells.
Impairment of Fertility:
Female rats were administered triazolam in the diet for 14 days before cohabitation, during gestation, and until 21 days post parturition, and male rats for 60 days before cohabitation. No effects on mating or fertility were observed in rats up to 5u00a0mg/kg/day which is approximately 100 times the MRHD of 0.5u00a0mg/day, based on mg/m2 body surface area.

Triazolam Tablets USP
0.125 mg tablets are supplied as a white, oval-shaped tablet with tablet identification u201c54 519u201d 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 u201c54 620u201d debossed on the other side.
NDC 0054-4859-25: Bottles of 100 TabletsNDC 0054-4859-29: Bottles of 500 Tablets
Storage
Store at 20u00ba to 25u00b0C (68u00ba to 77u00b0F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risks from Concomitant Use with Opioids:
Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when triazolam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been n
u201cSleep-drivingu201d and Other Complex Behaviors:
There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. Advise patients to report similar experiences to their healthcare provider immediately, since u201csleep-drivingu201d can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other CNS depressants Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative hypnotic. As with sleep-driving, patients usually do not remember these events.
Effects on Driving and Operating Heavy Machinery:
Caution patients against driving a motor vehicle or operating heavy machinery until the effects of taking triazolam are determined due to its CNS depressant effects. Also advise patients to avoid the use of alcohol or other CNS depressants while taking triazolamn
Patients with Depression:
Advise patients, their families and caregivers to look out for any signs of suicidality or worsening depression, and to inform the patientu2019s prescriber or healthcare provider immediately n
Concomitant Medications:
Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medicines, vitamins and herbal supplements n
Grapefruit Juice:
Advise patients to avoid eating grapefruit or drinking grapefruit juice while taking triazolam n n n
Pregnancy:
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using triazolam to monitor neonates for signs of sedation, respiratory depression, withdrawal, and feeding problems n
Lactation:
Advise mothers using benzodiazepines to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. A lactating woman may consider pumping and discarding breastmilk during treatment and for 28 hours after triazolam administration to minimize drug exposure to a breastfed infant n
Distr. by: n n Eatontown, NJ 07724
4076601//10
Revised October 2019

4076601//10
Revised October 2019

NDC 0054-4858-25: Bottle of 100 Tablets
0.125 mg
Rx Only

NDC 0054-4859-25: Bottles of 100 Tablets
0.25 mg
Rx Only

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Triazolam (Triazolam)

Trade Name : Triazolam

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Triazolam (Triazolam)

Trade Name : Triazolam

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?