Prescription Drug Information: Lorazepam (Page 3 of 3)

HOW SUPPLIED

2 mg per mL Lorazepam Oral Concentrate, USP

NDC 50383-705-30: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL [0.5 mg], 0.5 mL [1 mg], 0.75 mL [1.5 mg] and 1 mL [2 mg] on the dropper).

PROTECT FROM LIGHT

Store at Cold Temperature-Refrigerate 2°-8°C (36°-46°F)

Dispense only in the bottle and only with the calibrated dropper provided.

Discard opened bottle after 90 days.

Manufactured by:

Akorn Operating Company LLC

Lake Forest, IL 60045

Rev. 705:02 03/21

Medication Guide

MEDICATION GUIDE

Lorazepam Oral Concentrate

What is the most important information I should know about Lorazepam Oral Concentrate?

Lorazepam Oral Concentrate is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system 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:
shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (sedation)

Do not drive or operate heavy machinery until you know how taking Lorazepam Oral Concentrate with opioids affects you.

Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including Lorazepam Oral Concentrate 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 Lorazepam Oral Concentrate. 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 Lorazepam Oral Concentrate exactly as prescribed by your healthcare provider.
Take Lorazepam Oral Concentrate exactly as your healthcare provider prescribed.
Do not share your Lorazepam Oral Concentrate with other people.
Keep Lorazepam Oral Concentrate in a safe place and away from children.
Physical dependence and withdrawal reactions. Lorazepam Oral Concentrate can cause physical dependence and withdrawal reactions.
Do not suddenly stop taking Lorazepam Oral Concentrate. Stopping Lorazepam Oral Concentrate 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 Lorazepam Oral Concentrate than prescribed or take Lorazepam Oral Concentrate for longer than prescribed.

What is Lorazepam Oral Concentrate?

Lorazepam Oral Concentrate is a prescription medicine used:
to treat anxiety disorders
for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression
Lorazepam Oral Concentrate is a federal controlled substance (CIV) because it contains lorazepam that can be abused or lead to dependence. Keep Lorazepam Oral Concentrate in a safe place to prevent misuse and abuse. Selling or giving away Lorazepam Oral Concentrate 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 Lorazepam Oral Concentrate is safe and effective for use in children less than 12 years of age.
It is not known if Lorazepam Oral Concentrate is safe and effective for use for longer than 4 months.

Do not take Lorazepam Oral Concentrate if you:

are allergic to lorazepam, other benzodiazepines, or any of the ingredients in Lorazepam Oral Concentrate. See the end of this Medication Guide for a complete list of ingredients in Lorazepam Oral Concentrate.

Before you take Lorazepam Oral Concentrate, tell your healthcare provider about all of your medical conditions, including if you:

have or have had depression, mood problems, or suicidal thoughts or behavior
have a history of drug or alcohol abuse or addiction
have lung disease or breathing problems (such as COPD, sleep apnea syndrome)
have liver or kidney problems
have or have had seizures
are pregnant or plan to become pregnant. Lorazepam Oral Concentrate may harm your unborn baby. You and your healthcare provider should decide if you should take Lorazepam Oral Concentrate while you are pregnant.
are breastfeeding or plan to breastfeed. Lorazepam Oral Concentrate passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Lorazepam Oral Concentrate. You should not breastfeed while taking Lorazepam Oral Concentrate.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Lorazepam Oral Concentrate with certain other medicines can cause side effects or affect how well Lorazepam Oral Concentrate or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take Lorazepam Oral Concentrate?

Take Lorazepam Oral Concentrate exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Lorazepam Oral Concentrate to take and when to take it.
If you take too much Lorazepam Oral Concentrate, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Lorazepam Oral Concentrate?

Lorazepam Oral Concentrate may cause serious side effects, including:

See “What is the most important information I should know about Lorazepam Oral Concentrate?”
Lorazepam Oral Concentrate 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 Lorazepam Oral Concentrate affects you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Lorazepam Oral Concentrate without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Lorazepam Oral Concentrate may make your sleepiness or dizziness much worse.
Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including Lorazepam Oral Concentrate.

The most common side effects of Lorazepam Oral Concentrate include:

These are not all the possible side effects of Lorazepam Oral Concentrate. 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 Lorazepam Oral Concentrate?

Store Lorazepam Oral Concentrate at cold temperature – refrigerate at 2°C to 8°C (36°F to 46°F). Discard opened bottle after 90 days. Protect from light.
Keep Lorazepam Oral Concentrate and all medicines out of the reach of children.

General information about the safe and effective use of Lorazepam Oral Concentrate Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lorazepam Oral Concentrate for a condition for which it was not prescribed. Do not give Lorazepam Oral Concentrate to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Lorazepam Oral Concentrate that is written for health professionals.

What are the ingredients in Lorazepam Oral Concentrate?

Active ingredient: lorazepam

Inactive ingredients: polyethylene glycol and propylene glycol.

Manufactured by:

Akorn Operating Company LLC

Lake Forest, IL 60045

Revised: March 2021

This Medication Guide has been approved by the U.S. Food and Drug Administration

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Carton
(click image for full-size original)

NDC 50383-705-30

AKORN

Lorazepam Oral Concentration, USP

2 mg per mL

Each mL contains: Lorazepam 2 mg

See Package Insert For Complete Prescribing Information.

Pharmacist: Please see side panel for dispensing information

Store at Cold Temperature- Refrigerate 2° -8°C (36° -46°F).

Rx only

30 ml Bottle and Dropper

LORAZEPAM
lorazepam concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-705
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50383-705-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (50383-705-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200169 01/30/2012
Labeler — Akorn (117696873)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Akorn 117696873 MANUFACTURE (50383-705), PACK (50383-705)

Revised: 03/2022 Akorn

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