Lorazepam (Page 2 of 2)

ADVERSE REACTIONS

Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.

In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria, slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactic/oid reactions; dermatological symptoms, allergic skin reactions, alopecia; SIADH, hyponatremia, thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT Phone # 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

OVERDOSAGE

In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. Therefore, in the management of overdosage, it should be borne in mind that multiple agents may have been taken.

Symptoms

Overdosage of benzodiazepines is usually manifested by varying degrees of CNS depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death.

Management

General supportive and symptomatic measures are recommended; vital signs must be monitored and the patient closely observed. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit drug absorption. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. 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 CONTRAINDICATION, WARNINGS, and PRECAUTIONS should be consulted prior to use.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

BOTTLES:

Dispense in a tight, 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. 05 09/20

MEDICATION GUIDE Lorazepam Tablets, CIV (lor az’ e pam)

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

  • Lorazepam 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.
  • Lorazepam 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 affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Lorazepam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Lorazepam may make your sleepiness or dizziness much worse.
  • Do not take more Lorazepam than prescribed.

What is Lorazepam?

  • Lorazepam 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 is a federal controlled substance (CIV) because it can be abused or lead to dependence. Keep Lorazepam in a safe place to prevent misuse and abuse. Selling or giving away Lorazepam 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 is safe and effective in children less than 12 years of age.
  • It is not known if Lorazepam is 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 . See the end of this Medication Guide for a complete list of ingredients in Lorazepam

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. Lorazepam may harm your unborn baby. You and your healthcare provider should decide if you should take Lorazepam while you are pregnant.
  • are breastfeeding or plan to breastfeed. Lorazepam 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 . You should not breastfeed while taking Lorazepam

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

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

How should I take Lorazepam?

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

What should I avoid while taking Lorazepam?

  • Lorazepam can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how Lorazepam affects you.
  • You should not drink alcohol while taking Lorazepam . Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Lorazepam?

Lorazepam may cause serious side effects, including:

  • See “What is the most important information I should know about Lorazepam?”
  • Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including Lorazepam .
  • Abuse and dependence. Taking Lorazepam can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Withdrawal symptoms. You may have withdrawal symptoms if you stop taking Lorazepam suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping Lorazepam to avoid withdrawal symptoms.

The most common side effects of Lorazepam include:

  • sedation
  • dizziness
  • weakness
  • unsteadiness

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

  • Store Lorazepam in a tightly closed container at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C).
  • Keep Lorazepam and all medicines out of the reach of children.

General information about the safe and effective use of Lorazepam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lorazepam for a condition for which it was not prescribed. Do not give Lorazepam 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 that is written for health professionals

What are the ingredients in Lorazepam?

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. 02 09/20

lorazepam 0.5mg 100tabs
(click image for full-size original)

lorazepam 0.5mg 500tabs
(click image for full-size original)
lorazepam 0.5mg 1000tabs
(click image for full-size original)
lorazepam 1mg 100tabs
(click image for full-size original)
lorazepam 1mg 500tabs
(click image for full-size original)
lorazepam 1mg 1000tabs
(click image for full-size original)
lorazepam 2mg 100tabs
(click image for full-size original)
lorazepam 2mg 500tabs
(click image for full-size original)
lorazepam 2mg 1000tabs
(click image for full-size original)
LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-904
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code EP;904
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-904-01 100 TABLET in 1 BOTTLE None
2 NDC:69315-904-05 500 TABLET in 1 BOTTLE None
3 NDC:69315-904-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 10/01/2007
LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-905
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code EP;905;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-905-01 100 TABLET in 1 BOTTLE None
2 NDC:69315-905-05 500 TABLET in 1 BOTTLE None
3 NDC:69315-905-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 10/01/2007
LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-906
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code EP;906;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-906-01 100 TABLET in 1 BOTTLE None
2 NDC:69315-906-05 500 TABLET in 1 BOTTLE None
3 NDC:69315-906-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 10/01/2007
Labeler — Leading Pharma, LLC (079575060)
Registrant — Leading Pharma, LLC (079575060)
Establishment
Name Address ID/FEI Operations
Leading Pharma, LLC 079575060 MANUFACTURE (69315-904) (69315-905) (69315-906)

Revised: 12/2020 Leading Pharma, LLC

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.