Leading Pharma vs. Actavis Lorazepam Ingredients

In our latest question and answer, the pharmacist discusses the difference between the ingredients in lorazepam products from two different manufacturers: Leading Pharma and Actavis.

Question

Do Leading Pharma generic lorazepam and Actavis Labs generic lorazepam have the same active ingredient in them? I worry about that when changing companies.

Asked by Moon On Jul 31, 2019

Answered by
Medical Content Reviewed By PharmacistAnswers Staff

On Jul 31, 2019
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Overview

Yes, Leading Pharma and Actavis lorazepam products both contain the exact same active ingredient, which is of course lorazepam.

Oftentimes, the only the difference between two products different generic products (for a specific brand name, like Ativan) are the inactive ingredients they use.

This is why generics often look different from their brand name counterparts (and other generic products for that matter).

Interestingly enough, in the case of Leading Pharma and Actavis lorazepam, not only do they contain the same active ingredient (lorazepam), they actually, both contain the same inactive ingredients as well.

They may differ slightly in how much of each inactive ingredient is contained in the tablets, but rest assured, the actual ingredients are the same.

It is important to note that that substitutable generic products must show equivalent (within a statistical margin) bioavailability (i.e. rate and extent of absorption) to the brand name product. So even if Leading Pharma and Actavis lorazepam did have different inactive ingredients, they would still need to have the same properties in regard to their rate and extent of absorption.


Comparison

As stated, lorazepam products from Leading Pharma and Actavis contain the same inactive ingredients, which doesn't always happen between generic products.

Below are the listed ingredients for each product in question.

Leading Pharma Lorazepam 1mg

The prescribing information for Leading Pharma lorazepam gives the following ingredient information:

What are the ingredients in Lorazepam?
Active ingredient:
lorazepam
Inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.
Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004
Leading Pharma Lorazepam Prescribing Information

To summarize:

Active Ingredient

  • Lorazepam 1 mg

Inactive Ingredients

  • Lactose
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polacrilin potassium

Leading Pharma Lorazepam 1mg Tablet Image

Leading Pharma Lorazepam 1mg Tablet

Actavis Pharma Lorazepam 1mg

The prescribing information for Actavis lorazepam gives the following ingredient information:

What are the ingredients in lorazepam tablets?
Active ingredient:
lorazepam, USP
Inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose and polacrilin potassium
Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA
Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA
Actavis Lorazepam Prescribing Information

To summarize:

Active Ingredient

  • Lorazepam 1 mg

Inactive Ingredients

  • Lactose anhydrous
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polacrilin potassium

Actavis Pharma Lorazepam 1mg Tablet Image

Actavis Lorazepam 1mg tablet

As you can see from the ingredient list of both products, they contain the same active and inactive ingredients. The only difference between them is that they have different imprints.


Inactive Ingredients

While we are on the subject of generic products, let's talk a bit more about exactly what inactive ingredients are.

Inactive ingredients, are, by definition, simply ingredients other than the active ingredient and are not intended to produce medicinal effects and do not interfere with the effectiveness of the active ingredient. Per the FDA:

An inactive ingredient is any component of a drug product other than the active ingredient.

Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions

Inactive ingredients are often referred to as excipients, and they play an important role in pharmaceutical manufacturing. They can act as:

  • Fillers
  • Lubricants
  • Binders
  • Disintegrating agents
  • Coloring agents
  • Flavoring agents
  • Preservatives

Even if generic products have different inactive ingredients than their brand name counterpart (or between generic products themselves), they all must have the same bioavailability, which is defined as the rate and extent of absorption. The bioavailability may not be exactly the same but needs to be within a statistically acceptable margin.

Going back to the lorazepam products in question, they contain the following inactive ingredients:

  • Lactose anhydrous
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polacrilin potassium

Lactose

Lactose, per the FDA, is defined as:

...is the carbohydrate normally obtained from whey. It may be anhydrous or contain one molecule of water of crystallization or be a mixture of both forms.
CFR - Code of Federal Regulations Title 21

Lactose, when used in pharmaceuticals, is used as a filler/bulking agent. It is an inactive ingredient of choice in many products as it is relatively inexpensive and is easily compressible.

The amount of lactose used in pharmaceutical products ls quite low and generally does not exacerbate symptoms in those who are lactose intolerant. Nevertheless, extremely sensitive individuals may be affected.

Magnesium Stearate

Magnesium stearate is an often used inactive ingredient due to its lubricating properties.

While it does provide bulk to a pharmaceutical product, like a tablet, it's mainly used because it helps improve the flow of ingredients in pharmaceutical equipment and prevents sticking.

Microcrystalline Cellulose

Microcrystalline cellulose is used as a bulking and flowing agent. Like lactose, it is easily compressible and dissolves easily.

Cellulose is not absorbed and is not known to cause adverse effects in the amounts used in pharmaceutical products.

Polacrilin potassium

Polacrilin potassium is used most often to aid in the disintegration of tablets. It can be used to improve the rate and extent of absorption of pharmaceutical products.


Summary

Leading Pharma and Actavis lorazepam products contain the same active ingredient (lorazepam) and the same inactive ingredients (lactose, magnesium stearate, microcrystalline cellulose and polacrilin potassium).

References
  1. Lorazepam Prescribing Information - Actavis. DailyMed
  2. Lorazepam Prescribing Information - Leading Pharma. DailyMed
  3. Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions. FDA
  4. CFR - Code of Federal Regulations Title 21. AccessFDA
  5. Effect of polacrilin potassium as disintegrant on bioavailability of diclofenac potassium in tablets: a technical note. PubMed

About the Pharmacist

Dr. Brian Staiger Pharm.D

Dr. Brian Staiger is a licensed pharmacist in New York State and the founder of PharmacistAnswers.com. He graduated from the University At Buffalo with a Doctor of Pharmacy degree in 2010. He has been featured in numerous publications including the Huffington Post as well as a variety of health and pharmacy-related blogs. Please feel free to reach out to him directly if you have any inquiries or want to connect! He's answered thousands of medication and pharmacy-related questions and he's ready to answer yours! Brian.Staiger@PharmacistAnswers.com Office: 716-389-3076

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