ETHEX Corporation - Products & Technology

Pharmacists will substitute brand drugs with non-brand drugs when they provide a safe and effective option to the brand-name product and the pharmacist has satisfied state law procedures. Typically, non-brand products are less expensive than their brand-name counterparts. The Good Manufacturing Practices standards for all prescription pharmaceutical products are the same.

Where can I find a complete listing of the ingredients and attributes of ETHEX's products?

Every ETHEX product is packaged with informative inserts. Additionally, you can find this information by visiting the specific product's information page on our Web site. Each product has its own product insert, which can be downloaded.

Does ETHEX offer a Patient Assistance Program/Indigent Patient Program?

ETHEX does not offer a Patient Assistance Program/Indigent Patient Program. As a multisource pharmaceutical distributor, EHTEX provides quality products that are typically available to patients for less than their brand-name counterparts. ETHEX does participate in several state run discount pharmaceutical programs. To view a complete list of the state run discount pharmaceutical programs that ETHEX participates in, please click on the link below.

What is stability of the product?

Stability of the product is related to the expiration date, which delineates the period of time for which the product has been tested and demonstrates compatibility with the potency of the label claim.

What is the difference between active and inactive ingredients?

Active ingredients are those which are intended to have a pharmacologic activity. Inactive ingredients are added for the purpose of formulation compatibility and proper drug delivery (i.e. binding ingredients, disintegrants, etc.). Inactive ingredients can also include flavors, color dyes, and are intended not to offer any pharmacologic activity.

What makes a product Kosher?

Kosher products are prepared under conditions which satisfy the requirements of Jewish dietary laws.

Does ETHEX offer any Kosher prenatal vitamins?

Yes, ETHEX offers the following Kosher prenatal vitamins:

Advanced NatalCare - Kosher
Advanced - RF NatalCare - Kosher
NutriNate Chewable - Kosher
Ultra NatalCare - Kosher, dairy

Are material safety data sheets (MSDS) available for all ETHEX products?

Material safety data sheets (MSDS) are not required for each prescription pharmaceutical. Instead they are supplied to the pharmacist with labeling or "package inserts" that describes the warnings and precautions that are associated with the use of the drug.

Where can I find the indications for ETHEX products?

Please consult the product insert that is contained in the product packaging. PDF copies of all ETHEX product inserts are also available on the product pages of the ETHEX website.

Which ETHEX Prenatal Vitamins contain stool softeners?

Iron is commonly included in prenatal vitamins as a woman's requirements increase during pregnancy due to increased red blood cell formation. Unfortunately, for many women, iron may have the unpleasant side effect of causing constipation. ETHEX has included a laxative agent in the following prenatal vitamin products:

Advanced NatalCare® (kosher) - 50mg Docusate Sodium
New Formula Anemagen™ OB - 25mg Docusate Calcium
CareNate™ 600 - 50mg Docusate Sodium
NatalCare® Gloss Tabs - 50mg Docusate Sodium
Cal-Nate™ - 50mg Docusate Sodium
Prenatal MR 90 Fe™ - 50mg Docusate Sodium
Ultra NatalCare® (kosher) - 50mg Docusate Sodium

Why doesn't the ETHEX NitroQuick® fit into the nitroglycerin container I bought at my pharmacy?

Our product has not been designed to fit in other containers, for the simple reason that the product should not be removed from the original container and changed to another container. ETHEX does not support the use of any container that requires the patient to remove NitroQuick® from the original container. Please note:

Our Patient Information Booklet states "To protect against loss of potency, NitroQuick® Tablets should be stored in the original bottle and the bottle kept tightly closed. NitroQuick® Tablets should not be placed in a pillbox or any other container. Do not place other medication in the NitroQuick® bottle."
Nitroglycerin is an inherently unstable chemical. It is especially susceptible to loss of potency when exposed to heat, light or moisture. The bottle that your NitroQuick® came in complies with U.S. Pharmacopoeia guidance. Manufacturers of nitroglycerin sublingual tablets use these types of bottles. That is why your pharmacist dispensed the product in its original container.
ETHEX has not performed any stability tests on containers available from third parties that are advertised as being "nitroglycerin tablet containers." Therefore, we can't tell you whether or not your product will still be effective if you put the tablets into one of these containers. There are literally 100's of these containers on the market, which would make it logistically unfeasible to do stability on all of them. In addition, we don't have any control over the specifications and quality control for the manufacture of these containers.

Once I open a bottle of NitroQuick®, how long do I have before I should no longer use it?

With proper use and storage of the product in accordance with the manufacturer's recommendations printed on the label and in the Package Insert, customers can expect acceptable product potency following routine opening and closing of the container up to the expiration date as shown on the NitroQuick® Tablet bottle. NitroQuick® should be discarded if it was improperly stored, or if the expiration date on the package has been exceeded.

How should I carry NitroQuick®, if I can't carry it in my pocket?

As you may know, nitroglycerin products like NitroQuick® need to be handled carefully to ensure that the product maintains its potency. It is particularly important that NitroQuick® be protected from heat, light and moisture. Unlike many medications you have probably had dispensed in the past, you may have noticed that NitroQuick® is dispensed in its original, unopened container. Since we only have stability data on our packaging, and since nitroglycerin is inherently unstable, ETHEX does not recommend repackaging this product, including removing the product and putting it into another container. Keep the bottle loose and away from your body to protect the medication from body heat. NitroQuick® bottles should not be kept in trouser or shirt pockets. Here are some possible ideas:

The product could be carried in a briefcase, pocketbook, tote bag, or overcoat. Some people wear a "fanny-pack" in order to keep the product with them at all times.
We realize that patients don't want to carry a bottle of 100 pills with them. For this reason, we make a convenience package of 25 pills in the 0.4 mg strength.
There are containers that are designed to hold the 25 tablet bottles. These containers are designed to be worn as a pendant, or can clip onto something, such as a belt loop or key chain. There are two kinds of containers. The first is the "NitroHolster", which is a durable, clear, flexible plastic holder which firmly holds one 25 tablet bottle of NitroQuick®. Please visit http://www.mikuskamfg.com/nitroholster.html for more information about this novel product.

The second type of containers are typically described as being airtight and waterproof, and are typically plastic or metal containers. Shown below are some websites where these containers can be found:

http://www.911medalert.com
http://www.apothecaryproducts.com
http://www.medids.com
http://www.onlythebestgifts.com/pillfob.html

Your pharmacist may carry these types of containers, but if they don't, they generally have access to order them. Containers such as these are also available through the Internet. Ask your pharmacist about the availability of these containers, or search for these types of containers on the Internet, using key words such as "nitroholster", "nitroglycerin container" or "pill fob". NEVER REMOVE THE NITROQUICK® TABLETS FROM THE ORIGINAL CONTAINER, UNLESS THE TABLET IS BEING IMMEDIATELY USED. If you choose to use one of these described containers, always put the original NitroQuick® bottle, with the lid securely closed on the bottle, into the container. Never pour your NitroQuick® Tablets into one of these containers.

My NitroQuick® isn't working because I'm not getting a headache, or I'm not getting the tingling sensation under my tongue.

Judging the ability of a sublingual tablet to relieve angina by the presence of a tingling or burning sensation after a tablet has been dissolved under the tongue is not completely reliable since some patients may be unable to detect these effects. Newer stabilized sublingual tablets are making such potency testing less useful, since the stabilized tablets may be less likely to produce these detectable effects (ref.: USP DI 2002; 22nd Ed. "Drug Information for the Healthcare Professional")

Why isn't there cotton in the bottle, or a safety seal or plastic shrink wrap around the lid of my NitroQuick® bottle?

There are several reasons why our bottles come without cotton, and no seal inside or outside the lid.

Nitroglycerin products are inherently unstable. They are especially susceptible to loss of potency when exposed to heat or light. Sealing a bottle or carton necessitates that heat be applied to the bottle or carton. This could affect the potency of the product.
Cotton, rayon, or any other material in the bottle could affect the stability of the nitroglycerin. This could affect the potency of the product.
Most importantly, unlike many other medications, NitroQuick® Tablets are used by patients who need to get to the product immediately. A person suffering an angina attack may not have time to remove a safety seal, or try to remove cotton from a very small opening, in order to get to the medicine.

What is the normal color for ETHEX Morphine Sulfate Concentrated Oral Solution, 20mg/1mL?

It is normal for ETHEX's morphine solution to vary in color from pink or light red to orange or amber-pink. Since our formulation contains ascorbic acid, this product tends to golden with age. This color change can occur even in a closed or sealed bottle, and is not indicative of the product's potency. Typically, the color of the product will be consistent within the same lot/ expiration date. Significant color change will usually occur only over a period of many months, provided the product is stored as recommended.

Opened bottles of Morphine Sulfate Concentrated Oral Solution, 20mg/1mL, should be discarded after 90 days. Morphine is easily oxidized, which can decrease the product's potency when the bottle has been opened for a period longer than 90 days.

If you have any questions, or if you encounter product that does not seem to fall within the noted color specifications, please contact ETHEX Customer Service at 1-800-321-1705.

Does ETHEX provide Material Safety Data Sheets (MSDS) on our products?

The Occupational Safety and Health Administration’s (OSHA) revised Hazard Communication Standard (HCS) 29 CFR §1910.1200(b)(6)(vii)(2000) states that HCS requirements do not apply to any drug as defined in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) when it is in solid, final form for direct administration to the patient; drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment; and drugs intended for personal consumption by employees while in the workplace.

Therefore, pursuant to the HCS of 29 CFR §1910.1200(b)(6)(vii)(2000), Material Safety Data Sheets (MSDS) are not required for finished drug products manufactured by KV Pharmaceuticals, Inc. and distributed by ETHEX Corporation.

Metoprolol Succinate Extended-Release Tablets
Frequently Asked Questions

What are Metoprolol Succinate Extended-release Tablets prescribed to treat?

Metoprolol Succinate Extended-release Tablets are used in the treatment of high blood pressure (hypertension) and may be used alone or in combination with other high blood pressure medications. Metoprolol Succinate Extended-release Tablets are also used to relieve chest pain (angina) and may be used in certain patients with congestive heart failure (CHF), along with other medications.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

How should this medicine be used?

Metoprolol Succinate Extended-release Tablets comes as a tablet to take by mouth. ETHEX’s long-acting product is usually taken once a day and you should try to take it at the same time each day. The amount that you will take will depend on your diagnosis and response to treatment. You should take Metoprolol Succinate Extended-release Tablets exactly as directed by your physician.

Metoprolol Succinate Extended-release Tablets are scored and can be divided; however, the whole or half tablet should be swallowed whole and not crushed or chewed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Metoprolol Succinate Extended-release Tablets help control your condition but will not cure it. Continue to take Metoprolol Succinate Extended-release Tablets even if you feel well. Do not stop taking the medication without talking to your doctor. Patients should not stop taking Metoprolol Succinate Extended-release Tablets suddenly because of the possibility of serious side effects, such as chest pain or a heart attack. If your doctor decides you should stop taking Metoprolol Succinate Extended-release Tablets, your doctor or health care provider may instruct you to slowly reduce your dose over a period of time before stopping it completely.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not stop taking the medication without talking to your doctor.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

What special dietary instructions should I follow?

Take Metoprolol Succinate Extended-release Tablets with or immediately following a meal. Try to take it at the same time each day. Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow the diet directions carefully.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

What side effects can this medication cause?

Although Metoprolol Succinate Extended-release Tablets are usually well tolerated, side effects can occur. Some of the most common side effects may be:

  • Drowsiness
  • Dizziness
  • Blurred vision
  • Nausea
  • Diarrhea
  • Decreased libido
  • Depression
  • Shortness of breath

If you experience any of the following symptoms, notify your physician:

  • Slow pulse rate
  • Skin rash
  • Fever
  • Sore throat
  • Unusual bleeding or bruising

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

What special precautions should I follow when taking Metoprolol Succinate Extended-release Tablets?

Before taking Metoprolol Succinate Extended-release Tablets,

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Tell your doctor and pharmacist if you are allergic to metoprolol or any other drugs.

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Tell your doctor and pharmacist what prescription and over-the-counter medications, including vitamins and herbal products, you are taking, especially medications for migraine headaches, asthma, allergies, colds, or pain; other medications for heart or high blood pressure; and reserpine.

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Tell your doctor if you have or have ever had asthma or other lung disease; heart, liver, or kidney disease; diabetes; circulation problems; severe allergies; or thyroid problems.

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Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Metoprolol Succinate Extended-release Tablets, discuss treatment options with your doctor.

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If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Metoprolol Succinate Extended-release Tablets.

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You should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. Remember that alcohol can add to the drowsiness caused by this drug.

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In diabetic patients, Metoprolol Succinate Extended-release Tablets may cause blood sugar levels to rise. Also, this medicine may cover up signs of low blood sugar (hypoglycemia), such as change in pulse rate.

Please refer to the Metoprolol Succinate Extended-release Tablets Product Insert Sheet for additional information.

Why are ETHEX Metoprolol Succinate Extended-release Tablets a different color/tablet size than the branded version?

Your prescription was filled with an ETHEX product, rather than a product sold by a brand company or another generic company. The ETHEX product may look different in shape, size or color than the product you previously received; however, it has been found to be “therapeutically equivalent” to the brand product by the U.S. Food and Drug Administration (FDA) based on the type and amounts of active ingredient(s) it contains, as well as how it is expected to work. Drugs may differ from the brand in certain ways, such as their shape, release mechanisms, packaging, excipients (colors, flavors, and preservatives), expiration date/time and minor aspects of labeling, but still be found therapeutically equivalent to the brand by the FDA. When your doctor considers such differences to be important, your prescription can be written in such a way that only a product from a particular company will be given to you. But when your doctor does not write your prescription in this way, your pharmacist may provide you with a product considered to be an appropriate substitute for the one named on your prescription.

Are ETHEX Metoprolol Succinate Extended-release Tablets dye free?

Yes

Are Metoprolol Succinate Extended-release Tablets covered by my insurance?

Check with your pharmacist to determine whether your specific insurance plan covers Metoprolol Succinate Extended-release Tablets. As a generic medication, this may be available at a lower co-pay than a brand name medication.