17 PATIENT COUNSELING INFORMATION
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 determined [ see Warnings and Precautions (5.1), Drug Interactions (7.1)] .
Abuse, Misuse, and Addiction
Inform patients that the use of triazolam, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2), Drug Abuse and Dependence (9.2)].
Inform patients that the continued use of triazolam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of triazolam may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of triazolam may require a slow taper [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].
“Sleep-driving” 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 “sleep-driving” can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other CNS depressants [ see Warnings and Precautions (5.5) ]. 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.
Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.
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 triazolam [ see Warnings and Precautions (5.7) ] .
Patients with Depression
Advise patients, their families and caregivers to look out for any signs of suicidality or worsening depression, and to inform the patient’s prescriber or healthcare provider immediately [ see Warnings and Precautions (5.9) ] .
Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medicines, vitamins and herbal supplements [ see Drug Interactions (7.1) ] .
Advise patients to avoid eating grapefruit or drinking grapefruit juice while taking triazolam [ see Drug Interactions (7.1) ] .
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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.1)] .
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 [ see Use in Specific Populations (8.2) ] .
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
554403 Rev. 11/2021
|MEDICATION GUIDE |
Triazolam Tablets USP CIV (trye az’ oh lam)
|This Medication Guide has been approved by the U.S. Food and Drug Administration. ||Revised 11/2021 |
| What is the most important information I should know about Triazolam Tablets? |
- Triazolam tablets are 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:
Do not drive or operate heavy machinery until you know how taking triazolam tablets with opioids affects you.
- shallow or slowed breathing
- breathing stops (which may lead to the heart stopping)
- excessive sleepiness (sedation)
- Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including triazolam which can lead to overdose and serious side effects including coma and death.
- Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including triazolam. 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.
- You can develop an addiction even if you take triazolam tablets as prescribed by your healthcare provider.
- Take triazolam tablets exactly as your healthcare provider prescribed.
- Do not share your triazolam tablets with other people.
- Keep triazolam tablets in a safe place and away from children.
- Physical dependence and withdrawal reactions. Triazolam can cause physical dependence and withdrawal reactions.
- 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 system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
- Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
- Do not take more triazolam tablets than prescribed or take triazolam tablets for longer than prescribed.
- After taking triazolam tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with triazolam tablets. Reported activities include:
| || |
- driving a car (“sleep-driving”)
- making and eating food
- talking on the phone
| || Call your healthcare provider right away if you find out that you have done any of the above activities after taking triazolam tablets. |
| What are Triazolam tablets? |
|Triazolam is a prescription medicine used in adults for the short-term treatment of a sleep problem called insomnia. Triazolam tablets is usually taken for 7 to 10 days. |
- Triazolam is a federal controlled substance (CIV) because it can be abused or lead to dependence. Keep triazolam tablets in a safe place to prevent misuse and abuse. Selling or giving away triazolam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
- It is not known if triazolam is safe and effective in children.
- It is not known if triazolam is safe and effective for use longer than 2 to 3 weeks.
| Do not take triazolam tablets if you : |
- are allergic to triazolam, other benzodiazepines, or any of the ingredients in triazolam tablets. Severe allergic reactions including swelling of the tongue or throat, trouble breathing and throat closing have happened and may lead to death. Get medical help right away if you have an allergic reaction to triazolam tablets. See the end of this Medication Guide for a complete list of ingredients in triazolam tablets.
- take antifungal medicines including ketoconazole and itraconazole
- take a medicine to treat depression called nefazodone
- take medicines to treat human immunodeficiency virus (HIV)-1 infection called protease inhibitors.
| Before you take triazolam tablets, tell your healthcare provider about all of your medical conditions, including if you: |
- have a history of depression, mood problems, mental illness, suicidal thoughts or behavior
- have a history of drug or alcohol abuse or addiction
- have lung problems, breathing problems, or sleep apnea
- are pregnant or plan to become pregnant.
- If you become pregnant while taking triazolam tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for psychiatric medicines during pregnancy. You can register by calling 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
- Babies born to mothers who take benzodiazepine medicines, including triazolam tablets, late in pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, and low muscle tone (floppy baby syndrome), feeding problems and withdrawal symptoms.
- are breastfeeding or plan to breastfeed. It is not known if triazolam can pass through your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take triazolam tablets.
|Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
|Taking triazolam tablets with certain other medicines can cause side effects or affect how well triazolam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. |
| How should I take triazolam tablets? |
- Take triazolam tablets exactly as your healthcare provider tells you to take it.
- Take triazolam tablets right before you get into bed.
- Do not eat grapefruit or drink grapefruit juice during treatment with triazolam tablets.
- Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days of treatment with triazolam tablets. This may mean that there is another condition causing your sleep problem.
- If you take too much triazolam tablets, call your healthcare provider or have somebody drive you to the nearest hospital emergency room right away.
| What are the possible side effects of Triazolam tablets? |
| Triazolam tablets may cause serious side effects, including: |
- See “What is the most important information I should know about triazolam tablets?“
- Increased daytime anxiety.
- Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
- Memory loss
- Triazolam tablets can make you sleepy or dizzy and can slow your thinking and motor skills.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how triazolam tablets affect you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking triazolam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, triazolam tablets may make your sleepiness or dizziness much worse.
- Worsening depression . Call your healthcare provider right away if you have any thoughts of suicide or dying or worsening depression.
| The most common side effects of Triazolam tablets include: |
| || |
- difficulty with coordination
|Elderly people have an increased risk of dose related side effects during treatment with triazolam tablets. |
|These are not all the possible side effects of triazolam tablets. |
|Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| How should I store Triazolam Tablets, USP? |
- Store triazolam tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep triazolam tablets and all medicines out of the reach of children
| General information about the safe and effective use of triazolam tablets. |
|Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use triazolam tablets for a condition for which it was not prescribed. Do not give triazolam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about triazolam tablets that is written for healthcare professionals. |
| What are the ingredients in Triazolam Tablets, USP? |
|Active Ingredient: Triazolam, USP |
|Inactive Ingredients: 0.125 mg — lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium with sodium benzoate, colloidal silicon dioxide and magnesium stearate; 0.25 mg — lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, FD&C Blue No. 1, docusate sodium with sodium benzoate, colloidal silicon dioxide and magnesium stearate. |
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
If you would like more information, call 1-877-748-1970.
Triazolam 0.25mg (CIV) Tablet
| TRIAZOLAM |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:71335-1876(NDC:50742-646) |
|Route of Administration ||ORAL ||DEA Schedule ||CIV
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|TRIAZOLAM (TRIAZOLAM) ||TRIAZOLAM ||0.25 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| LACTOSE MONOHYDRATE || |
| MICROCRYSTALLINE CELLULOSE || |
| STARCH, CORN || |
| SODIUM STARCH GLYCOLATE TYPE A POTATO || |
| DOCUSATE SODIUM/SODIUM BENZOATE || |
| SILICON DIOXIDE || |
| MAGNESIUM STEARATE || |
| FD&C BLUE NO. 1 || |
|Product Characteristics |
|Color ||blue ||Score ||2 pieces |
|Shape ||OVAL (elliptical) ||Size ||8mm |
|Flavor || ||Imprint Code ||ING646 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:71335-1876-1 ||10 TABLET in 1 BOTTLE, PLASTIC ||None |
| 2 ||NDC:71335-1876-2 ||30 TABLET in 1 BOTTLE, PLASTIC ||None |
| 3 ||NDC:71335-1876-3 ||60 TABLET in 1 BOTTLE, PLASTIC ||None |
| 4 ||NDC:71335-1876-4 ||40 TABLET in 1 BOTTLE, PLASTIC ||None |
| 5 ||NDC:71335-1876-5 ||90 TABLET in 1 BOTTLE, PLASTIC ||None |
| 6 ||NDC:71335-1876-6 ||6 TABLET in 1 BOTTLE, PLASTIC ||None |
| 7 ||NDC:71335-1876-7 ||1 TABLET in 1 BOTTLE, PLASTIC ||None |
| 8 ||NDC:71335-1876-8 ||2 TABLET in 1 BOTTLE, PLASTIC ||None |
| 9 ||NDC:71335-1876-9 ||28 TABLET in 1 BOTTLE, PLASTIC ||None |
| 10 ||NDC:71335-1876-0 ||3 TABLET in 1 BOTTLE, PLASTIC ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA214219 ||10/20/2020 || |
|Labeler — Bryant Ranch Prepack
|Registrant — Bryant Ranch Prepack (171714327) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Bryant Ranch Prepack || ||171714327 ||REPACK (71335-1876), RELABEL (71335-1876) |
Revised: 12/2021 Bryant Ranch Prepack
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