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TRIAZOLAM Tablets, C-IV (GREENSTONE LLC)

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TRIAZOLAM Tablets, C-IV (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

  • ...
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1 INDICATIONS AND USAGE

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

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2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dosage is 0.25 mg once daily before bedtime. A dosage of 0.125 mg once daily may be sufficient for...

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3 DOSAGE FORMS AND STRENGTHS

  • Tablets: 0.125 mg white, imprinted with "G3717"
  • Tablets: 0.25 mg powder blue, scored, imprinted with "G3718"
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4 CONTRAINDICATIONS

Triazolam is contraindicated in:

  • Patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. Reactions consistent with angioedema (...
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5 WARNINGS AND PRECAUTIONS

5.1 Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including triazolam, and opioids may result in profound...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

  • Risks from Concomitant Use with Opioids [see

    6.1 Clinical...

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7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with Triazolam

Table 2 includes clinically significant drug interactions with triazolam...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Triazolam contains triazolam, a Schedule IV controlled substance.

...
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10 OVERDOSAGE

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...

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11 DESCRIPTION

Triazolam is a triazolobenzodiazepine.

Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21.

The chemical name for triazolam...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Triazolam is a benzodiazepine. Triazolam exerts its effect for the short-term treatment of insomnia through binding...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Triazolam is supplied as a 0.125 mg white tablet or a 0.25 mg powder blue, scored tablet in the following strengths and package configurations:

...
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MEDICATION GUIDE
Triazolam
tablets, CIV
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised 2/...
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