Tekral Tablets NDC 64543-025-90 DESCRIPTION Each light yellow and light green bi-layered capsule shaped tablet that is scored on one side and debossed “TEKRAL” on the opposite side contains: Diphenhydramine Hydrochloride . 100 mg Pseudoephedrine Hydrochloride ………. 120 mg Tekral tablets are specially formulated to provide prolonged activity and contain active in
- A |
J |K |
U |V |
Nexium medication guideMEDICATION GUIDE
NEXIUM (nex-e-um) (esomeprazole magnesium) Delayed-Release Capsules
NEXIUM (nex-e-um) (esomeprazole magnesium) For Delayed-Release Oral Suspension Read the Medication Guide that comes with NEXIUM before you start taking NEXIUM 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 What is the most important information I should
know about NEXIUM?
NEXIUM may help your acid-related symptoms, but
you could still have serious stomach problems. Talk
with your doctor.
NEXIUM can cause serious side effects, including:
• Diarrhea. NEXIUM 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 NEXIUM 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 NEXIUM. NEXIUM can have other serious side effects. See “What are the possible side effects of NEXIUM?”
What is NEXIUM?
NEXIUM is a prescription medicine called a proton pump
inhibitor (PPI). NEXIUM reduces the amount of acid in your • for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). NEXIUM may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), 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 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics • for the long-term treatment of conditions where your stomach makes too much acid, including Zollinger- Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more For children and adolescents 1 year to 17 years of age, NEXIUM may be prescribed for up to 8 weeks for short-term In children ages 1 month to less than 1 year of age, NEXIUM is only used to treat GERD with acid-related damage to the esophagus (erosive esophagitis) for up to 6 weeks. It is not known if NEXIUM is effective in children under 1 Who should not take NEXIUM?
Do not take NEXIUM if you:
• are allergic to esomeprazole magnesium or any of the ingredients in NEXIUM. See the end of this Medication Guide for a complete list of ingredients in NEXIUM. • are allergic to any other Proton Pump Inhibitor (PPI) What should I tell my doctor before taking NEXIUM?
Before you take NEXIUM, tell your doctor if you:
• have been told that you have low magnesium levels • are pregnant or plan to become pregnant. It is not known if NEXIUM can harm your unborn baby. • are breastfeeding or planning to breastfeed. It is not known if NEXIUM passes into your breastmilk. You and your doctor should decide if you will take NEXIUM or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you Tell your doctor about all of the medicines you take,
including prescription and non-prescription drugs, vitamins and herbal supplements. NEXIUM may affect how other medicines work, and other medicines may affect how NEXIUM works. Especially tell your doctor if you take: • St.John’s Wort (Hypericum perforatum) • Rifampin (Rimactane, Rifater, Rifamate) How should I take NEXIUM?
• Take NEXIUM exactly as prescribed by your doctor. • Do not change your dose or stop NEXIUM without • Take NEXIUM at least 1 hour before a meal. • Swallow NEXIUM capsules whole. Never chew or
• If you have difficulty swallowing NEXIUM capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Do not crush or chew the granules. Be sure to swallow the applesauce right • If you forget to take a dose of NEXIUM, 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 • If you take too much NEXIUM, call your doctor or local poison control center right away, or go to the • See the “Instructions for Use” at the end of this Medication Guide for instructions how to take NEXIUM For Delayed-Release Oral Suspension, and how to mix and give NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension, through a nasogastric tube or gastric tube. What are the possible side effects of NEXIUM?
NEXIUM can cause serious side effects, including:
• See “What is the most important information I
should know about NEXIUM?”
• Chronic (lasting a long time) inflammation of
the stomach lining (Atrophic Gastritis). Using
NEXIUM 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. This
problem can be serious. 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. Tel your doctor right away if you have any of these • jerking movements or shaking (tremors) Your doctor may check the level of magnesium in your body before you start taking NEXIUM or during treatment if you will be taking NEXIUM for a long period of time. The most common side effects with NEXIUM may include: Serious allergic reactions. Tell your doctor if you get any
Your doctor may stop NEXIUM if these symptoms happen. Tel your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side 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 NEXIUM?
• Store NEXIUM at room temperature between 68°F to • Keep the container of NEXIUM closed tightly. Keep NEXIUM and all medicines out of the reach of
General information about NEXIUM
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use NEXIUM for a condition for which it was not prescribed. Do not give NEXIUM to other people, even if they have the same This Medication Guide summarizes the most important information about NEXIUM. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about NEXIUM that is What are the ingredients in NEXIUM?
Active ingredient: esomeprazole magnesium trihydrate Inactive ingredients in NEXIUM Delayed-Release
Capsules (including the capsule shells): glyceryl
monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, triethyl citrate, gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl Inactive granules in NEXIUM For Delayed-Release
Oral Suspension: dextrose, xanthan gum, crospovidone,
citric acid, iron oxide, and hydroxypropyl cellulose. Instructions for Use
For instructions on taking Delayed-Release Capsules, see
the section of this leaflet called “How should I take
Take NEXIUM For Delayed-Release Oral Suspension as • NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 • You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your • If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor. • If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a container, then add the contents of a foil packet containing the dose • If you or your child are instructed to use more than one foil packet for the prescribed dose, follow the mixing instructions provided by your pharmacist or • Stir and take dose within 30 minutes. If not used within 30 minutes, throw away this dose and mix a • If any medicine remains after drinking, add more • For young children, you can give the dose with an oral syringe. Rinse the oral syringe with water after NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below: • Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give NEXIUM • Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check • Do not give the granules if they have dissolved or • Attach the syringe to the NG tube. Give the medicine in the syringe through the NG tube into the stomach. • After giving the granules, flush the NG tube with NEXIUM For Delayed-Release Oral Suspension: • NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 • Use only a catheter tipped syringe to give NEXIUM • If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose • If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose • Shake the syringe right away and then leave it for 2 • Shake the syringe and give the medicine through the NG or gastric tube (French size 6 or larger) into the • Refill the syringe with the same amount of water (either 5 mL or 15 mL of water depending on your • Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach. This Medication Guide has been approved by the U.S. Food NEXIUM is a registered trademark of the AstraZeneca group 2012 AstraZeneca Pharmaceuticals LP. All rights reserved
|HF1A_161109KS~ FINAL 16A |HF1A_161109Y-~ FINAL 16A |HF1A_161109CZ~ FINAL 16A |HF1A_161109Mk~ FINAL 16A 16A I SUNDAY, NOVEMBER 9, 2003 THE AMERICAS I MORE COVERAGE, 17-24A THE OPPENHEIMER REPORT New Latin American poll spells trouble for U.S. TAINTING AMERICA WHAT’S THE REASON? RESENTMENT ‘‘significant increase’’ in Latin IN MY OPINION OPPENHEI