Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given two times a day or three times a day.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
Discontinuation or Dosage Reduction of Lorazepam
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence).
Lorazepam® (lorazepam) Tablets are available in the following dosage strengths:
0.5 mg White color, round, flat face beveled edge compressed tablets, debossed “EP” and “904” on one side, and plain on the other side.
NDC# 69315-904-01 Bottles of 100 Tablets.
NDC# 69315-904-05 Bottles of 500 Tablets.
NDC# 69315-904-10 Bottles of 1000 Tablets.
1 mg White color, round, bisected flat face beveled edge compressed tablets, debossed “EP” above bisect and “905” below bisect on one side, and “1” on the other side.
NDC# 69315-905-01 Bottles of 100 Tablets.
NDC# 69315-905-05 Bottles of 500 Tablets.
NDC# 69315-905-10 Bottles of 1000 Tablets.
2 mg White color, round, bisected flat face beveled edge compressed tablets, debossed “EP” above bisect and “906” below bisect on one side, and “2” on the other side.
NDC# 69315-906-01 Bottles of 100 Tablets.
NDC# 69315-906-05 Bottles of 500 Tablets.
NDC# 69315-906-10 Bottles of 1000 Tablets.
Dispense in a tight container. light-resistant container as defined in the USP, using a child-resistant closure.
Keep this and all Medications out of the reach of children.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Excursions permitted to 59° to 86°F (15° to 30°C).
Manufactured and Distributed by
Leading Pharma, LLC
Fairfield, NJ 07004 USA
Rev. 07 01/23
What is the most important information I should know about lorazepam tablets?
- Lorazepam tablets are 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 tablets with opioids affects you.
- Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including lorazepam tablets 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 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.
- You can develop an addiction even if you take lorazepam tablets exactly as prescribed by your healthcare provider.
- Take lorazepam tablets exactly as your healthcare provider prescribed.
- Do not share your lorazepam tablets with other people.
- Keep lorazepam tabletsin a safe place and away from children.
- Physical dependence and withdrawal reactions. Lorazepam tablets can cause physical dependence and withdrawal reactions.
- Do not suddenly stop taking lorazepam tablets. Stopping Lorazepam 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 tablets than prescribed or take lorazepam tablets for longer than prescribed.
What is lorazepam tablets?
- Lorazepam tablets are 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 tablets is a federal controlled substance (CIV) because it contains lorazepam that can be abused or lead to dependence. Keep lorazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away lorazepam 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 lorazepam tablets are safe and effective for use in children less than 12 years of age.
- It is not known if lorazepam tablets are safe and effective for use for longer than 4 months.
Do not take lorazepam if you:
- are allergic to lorazepam, other benzodiazepines, or any of the ingredients in lorazepam tablets. See the end of this Medication Guide for a complete list of ingredients inlorazepam tablets.
Before you take lorazepam , 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.
- Taking lorazepam tablets late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with lorazepam tablets.
- There is a pregnancy registry for women who take lorazepam tablets during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with lorazepam tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/pregnancyregistry/.
- are breastfeeding or plan to breastfeed. Lorazepam passes into your breast milk.
- Breastfeeding during treatment with Lorazepam may cause your baby to have sleepiness, feeding problems, and decreased weight gain.
- Talk to your healthcare provider about the best way to feed your baby if you take lorazepam tablets.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking lorazepam tablets with certain other medicines can cause side effects or affect how well lorazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take lorazepam tablets?
- Take lorazepam tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much lorazepam tablets to take and when to take it.
- If you take too much lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of lorazepam tablets?
Lorazepam tablets may cause serious side effects, including:
- See “What is the most important information I should know about lorazepam tablets?”
- Lorazepam 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 lorazepam tablets affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking lorazepam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, lorazepam tablets may make your sleepiness or dizziness much worse.
- Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam.
The most common side effects of lorazepam include:
These are not all the possible side effects of lorazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or LEADING PHARMA, LLC AT 1-844-740-7500.
How should I store lorazepam tablets?
- Store lorazepam tablets in a tightly closed container at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C).
- Keep lorazepam tablets and all medicines out of the reach of children.
General information about the safe and effective use of lorazepam tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lorazepam tablets for a condition for which it was not prescribed. Do not give lorazepam tablets 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 tablets that is written for health professionals
What are the ingredients in lorazepam tablets?
A ctive ingredient: lorazepam
Inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.
Manufactured and Distributed by
Leading Pharma, LLC
Fairfield, NJ 07004 USA
Rev. 04 01/23
| LORAZEPAM |
| LORAZEPAM |
| LORAZEPAM |
|Labeler — Leading Pharma, LLC (079575060)|
|Registrant — Leading Pharma, LLC (079575060)|
|Leading Pharma, LLC||079575060||MANUFACTURE (69315-904) (69315-905) (69315-906)|
Revised: 05/2023 Leading Pharma, LLC
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