Omeprazole (Page 10 of 11)

14.5 Pathological Hypersecretory Conditions

In open studies of 136 patients with pathological hypersecretory conditions, such as Zollinger-Ellison (ZE) syndrome with or without multiple endocrine adenomas, omeprazole delayed-release capsules significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia, and pain. Doses ranging from 20 mg every other day to 360 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery, and below 5 mEq/hr in patients with prior gastric surgery.

Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients [see Dosage and Administration (2)]. Omeprazole was well tolerated at these high dose levels for prolonged periods (> 5 years in some patients). In most ZE patients, serum gastrin levels were not modified by omeprazole. However, in some patients serum gastrin increased to levels greater than those present prior to initiation of omeprazole therapy. At least 11 patients with ZE syndrome on long-term treatment with omeprazole developed gastric carcinoids. These findings are believed to be a manifestation of the underlying condition, which is known to be associated with such tumors, rather than the result of the administration of omeprazole [see Adverse Reactions (6)].

14.6 Pediatric GERD

Symptomatic GERD

The effectiveness of omeprazole for the treatment of nonerosive GERD in pediatric patients 2 to 16 years of age is based in part on data obtained from pediatric patients in an uncontrolled Phase III studies [see Use in Specific Populations (8.4)].

The study enrolled 113 pediatric patients 2 to 16 years of age with a history of symptoms suggestive of nonerosive GERD. Patients were administered a single dose of omeprazole (10 mg or 20 mg, based on body weight) for 4 weeks either as an intact capsule or as an open capsule in applesauce. Successful response was defined as no moderate or severe episodes of either pain-related symptoms or vomiting/regurgitation during the last 4 days of treatment. Results showed success rates of 60% (9/15; 10 mg omeprazole) and 59% (58/98; 20 mg omeprazole), respectively.

Healing of Erosive Esophagitis

In an uncontrolled, open-label dose-titration study, healing of erosive esophagitis in pediatric patients 1 to 16 years of age required doses that ranged from 0.7 to 3.5 mg/kg/day (80 mg/day). Doses were initiated at 0.7 mg/kg/day. Doses were increased in increments of 0.7 mg/kg/day (if intraesophageal pH showed a pH of < 4 for less than 6% of a 24-hour study). After titration, patients remained on treatment for 3 months. Forty-four percent of the patients were healed on a dose of 0.7 mg/kg body weight; most of the remaining patients were healed with 1.4 mg/kg after an additional 3 months’ treatment. Erosive esophagitis was healed in 51 of 57 (90%) children who completed the first course of treatment in the healing phase of the study. In addition, after 3 months of treatment, 33% of the children had no overall symptoms, 57% had mild reflux symptoms, and 40% had less frequent regurgitation/vomiting.

Maintenance of Healing of Erosive Esophagitis

In an uncontrolled, open-label study of maintenance of healing of erosive esophagitis in 46 pediatric patients, 54% of patients required half the healing dose. The remaining patients increased the healing dose (0.7 to a maximum of 2.8 mg/kg/day) either for the entire maintenance period, or returned to half the dose before completion. Of the 46 patients who entered the maintenance phase, 19 (41%) had no relapse. In addition, maintenance therapy in erosive esophagitis patients resulted in 63% of patients having no overall symptoms.

15 REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically— Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol, 20, No. 2, NCCLS, Wayne, PA, January 2000.

16 HOW SUPPLIED/STORAGE AND HANDLING

Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:

Bottles of 30 (NDC 60505-0145-0)
Bottles of 100 (NDC 60505-0145-2)
Bottles of 1000 (NDC 60505-0145-1)
Blisters of 70 (NDC 60505-0145-3)
Blisters of 100 (NDC 60505- 0145-7)

Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:

Bottles of 30 (NDC 60505-0065-0)
Bottles of 100 (NDC 60505-0065-2)
Bottles of 500 (NDC 60505-0065-5)
Bottles of 1000 (NDC 60505-0065-1)
Bottles of 5000 (NDC 60505 -0065-8)
Blisters of 70 (NDC 60505-0065-3)
Blisters of 100 (NDC 60505-0065-7)
Package of 12 Bottles each containing 30 Capsules (NDC 60505-3952-3)

Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:

Bottles of 30 (NDC 60505-0146-0)
Bottles of 90 (NDC 60505-0146-9)
Bottles of 100 (NDC 60505-0146-2)
Bottles of 500 (NDC 60505-0146-1)

Storage

Store omeprazole delayed-release capsules in a tight container protected from light and moisture.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

“See FDA-Approved Medication Guide”

Omeprazole delayed-release capsule should be taken before eating. Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see Warnings and Precautions (5.3)].

Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.6)].


APOTEX INC.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP 10 mg, 20 mg and 40 mg

Manufactured by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revised: May 2014

Revision: 18

MEDICATION GUIDE

Omeprazole Delayed-Release Capsules, USP

(oh mep’ ra zole)

Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about omeprazole delayed-release capsules?

Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Omeprazole delayed-release capsules can cause serious side effects, including:

  • Diarrhea. Omeprazole may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.

Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

  • Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take omeprazole delayed-release capsules.

Omeprazole can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?”

What are omeprazole delayed-release capsules?

Omeprazole delayed-release capsules is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Omeprazole delayed-release capsules are used in adults:

  • for up to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
  • with certain antibiotics to treat an infection caused by bacteria called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
  • for up to 8 weeks for healing stomach ulcers.
  • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.

  • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) . If needed, your doctor may decide to prescribe another 4 weeks of omeprazole delayed-release capsules.
  • to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules is safe and effective when used for longer than 12 months (1 year) for this purpose.
  • for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

For children and adolescents 2 to 17 years of age, omeprazole delayed-release capsules are used:

  • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
  • to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose.

It is not known if omeprazole delayed-release capsules are safe and effective for the treatment of gastroesophageal reflux disease (GERD) in children under 1 year of age.

Who should not take omeprazole delayed-release capsules?

Do not take omeprazole delayed-release capsules if you:

  • are allergic to omeprazole delayed-release capsules or any of the ingredients in omeprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in omeprazole delayed-release capsules.
  • are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What should I tell my doctor before taking omeprazole delayed-release capsules?

Before you take omeprazole delayed-release capsules, tell your doctor if you:

  • have been told that you have low magnesium levels in your blood
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if omeprazole will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Omeprazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take omeprazole delayed-release capsules.

Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, anti-cancer drugs, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works.

Especially tell your doctor if you take:

  • atazanavir (Reyataz)
  • nelfinavir (Viracept)
  • saquinavir (Fortovase)
  • cilostazol (Pletal)
  • ketoconazole (Nizoral)
  • voriconazole (Vfend)
  • an antibiotic that contains ampicillin, amoxicillin or clarithromycin
  • products that contain iron
  • warfarin (Coumadin, Jantoven)
  • digoxin (Lanoxin)
  • tacrolimus (Prograf)
  • diazepam (Valium)
  • phenytoin (Dilantin)
  • disulfiram (Antabuse)
  • clopidogrel (Plavix)
  • St. John’s Wort (Hypericum perforatum)
  • rifampin (Rimactane, Rifater, Rifamate),
  • erlotinib (Tarceva)
  • methotrexate

    Ask your doctor or pharmacist for a list of these medicines if you are not sure.

How should I take omeprazole delayed-release capsules?

  • Take omeprazole delayed-release capsules exactly as prescribed by your doctor.
  • Do not change your dose or stop omeprazole delayed-release capsules without talking to your doctor.
  • Take omeprazole delayed-release capsules at least 1 hour before a meal.
  • Swallow omeprazole delayed-release capsules whole. Do not chew or crush omeprazole delayed-release capsules.
  • If you have trouble swallowing omeprazole delayed-release capsules, you may take as follows:
    • Place 1 tablespoon of applesauce into a clean bowl.
    • Carefully open the capsule and empty the contents (pellets) onto the applesauce. Mix the pellets with the applesauce.
    • Swallow the applesauce and pellet mixture right away with a glass of cool water. Do not chew or crush the pellets. Do not store the applesauce and pellet mixture for later use.
  • If you forget to take a dose of omeprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
  • If you take too much omeprazole delayed release capsules, tell your doctor right away.

What are the possible side effects of omeprazole delayed-release capsules?

Omeprazole can cause serious side effects, including:

  • See “What is the most important information I should know about omeprazole?”
  • Chronic (lasting a long time) inflammation of the stomach lining (Atrophic Gastritis). Using omeprazole delayed-release capsules for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.
  • Low magnesium levels in your body. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

  • seizures
  • dizziness
  • abnormal or fast heart beat
  • jitteriness
  • jerking movements or shaking (tremors)
  • muscle weakness
  • spasms of the hands and feet
  • cramps or muscle aches
  • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.

The most common side effects with omeprazole delayed-release capsules in adults and children include:

  • headache
  • stomach pain
  • nausea
  • diarrhea
  • vomiting
  • gas

    In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:

  • respiratory system events
  • fever

    Other side effects:

    Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole:

  • rash
  • face swelling
  • throat tightness
  • difficulty breathing

Your doctor may stop omeprazole if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that do not go away. These are not all the possible side effects with omeprazole delayed-release capsules.

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 omeprazole delayed-release capsules?

  • Store omeprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the container of omeprazole delayed-release capsules closed tightly.

Keep omeprazole delayed-release capsules and all medicines out of the reach of children.

General information about omeprazole delayed-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about omeprazole delayed-release capsules.

For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information contact Apotex Corp., Drug Safety at 1-800-706-5575.

Instructions for Use

For instructions on taking omeprazole delayed-release capsules, please see “How should I take omeprazole delayed-release capsules?

What are the ingredients in omeprazole delayed-release capsules?

Active ingredient in omeprazole delayed-release capsules: omeprazole

Inactive ingredients in omeprazole delayed-release capsules: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, red iron oxide and titanium dioxide. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.

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

Manufactured by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

May 2014

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