Patient Medication Information: uses, side effects, how to take - Apo-Dexlansoprazole
What is APO-DEXLANSOPRAZOLE used for?
APO-DEXLANSOPRAZOLE is used in people 12 years of age and older to:
help heal the throat:
- damaged by acid backing up from the stomach to the throat (erosive reflux esophagitis).
- help maintain the healed throat.
relieve symptoms of non-erosive gastroesophageal reflux disease (GERD) such as:
- heartburn during the day and night.
- the burning, burping and sour taste.
How does APO-DEXLANSOPRAZOLE work?
APO-DEXLANSOPRAZOLE is a medicine called a proton pump inhibitor (PPI). PPIs reduce the amount of acid your stomach makes.
APO-DEXLANSOPRAZOLE delayed-release capsules contain enteric coated minitablets, tiny dissolving tablets that release medicine. The minitablets begin releasing the medicine approximately 2-4 hours after dosing and are designed to continue to work throughout the day.
What are the ingredients in APO-DEXLANSOPRAZOLE?
Medicinal ingredients: dexlansoprazole.
Non-medicinal ingredients:
Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1, FD&C Red #40, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hypromellose, iron oxide black, MAA and MMA copolymer, magnesium stearate, meglumine, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac glaze, talc, titanium dioxide and triethyl citrate.
APO-DEXLANSOPRAZOLE comes in the following dosage forms:
- Capsules, 30 mg or 60 mg.
Do not use APO-DEXLANSOPRAZOLE if:
- you are allergic to APO-DEXLANSOPRAZOLE or any of its ingredients. (See What are the ingredients in APO-DEXLANSOPRAZOLE?).
- you are currently taking a medication called rilpivirine
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-DEXLANSOPRAZOLE. Talk about any health conditions or problems you may have, including if you:
- are taking other medications. (See The following may interact with APO-DEXLANSOPRAZOLE).
- have liver problems.
are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
have signs of low magnesium in the body (hypomagnesemia) with symptoms such as:
- rapid or irregular heartbeat (palpitations).
- brain symptoms such as dizziness, seizures.
- muscle symptoms such as twitching, cramps, spasms (tetany).
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
Tell your doctor if you experience the following symptoms before taking APO-DEXLANSOPRAZOLE:
- unexplained weight loss.
- severe or persistent diarrhea.
- repeated vomiting.
- vomiting blood.
- dark stools.
- tiredness (anemia).
- difficulty in swallowing.
APO-DEXLANSOPRAZOLE may help your acid-related symptoms. However, you could still have serious stomach problems. Talk to your doctor if your symptoms continue.
You should take APO-DEXLANSOPRAZOLE exactly as prescribed. You will use the lowest dose and shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.
Depending on your condition, your doctor may tell you to use this type of medicine (proton pump inhibitors) for a longer period.
Using proton pump inhibitors for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.
Long term use of proton pump inhibitors may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor.
Using APO-DEXLANSOPRAZOLE for a long period of time may cause a growth in your stomach (polyp), especially after one year.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-DEXLANSOPRAZOLE:
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How to take APO-DEXLANSOPRAZOLE:
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Applesauce:
APO-DEXLANSOPRAZOLE capsules can be opened and the contents sprinkled on a tablespoon of applesauce. Swallow immediately. Granules should not be chewed.
Water with an Oral Syringe:
- 1. Open the capsule and empty the granules into a clean container with 20 mL of water.
- 2. Draw up the water and granules mixture into an oral syringe.
- 3. Swirl the syringe gently, and give the mixture into the mouth right away. Do not save the water and granule mixture for later use.
- 4. Refill the syringe with 10 mL of water, and swirl gently. Give the water into the mouth.
- 5. Repeat step 4.
Water through a Nasogastric Tube: If you have a nasogastric tube (size 16 French or larger)
- 1. Open the capsule and empty the granules into a clean container with 20 mL of water.
- 2. Draw up the water and granules mixture into a catheter-tip syringe.
- 3. Swirl the syringe gently and connect the syringe to the nasogastric tube. Right away, give the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use.
- 4. Refill the syringe with 10 mL of water, swirl gently, and flush the nasogastric tube with water.
- 5. Repeat step 4.
Usual dose:
The recommended dose is not the same for all conditions. Your doctor will have told you what dose to take for your condition. Follow your doctor’s directions carefully.
| Condition | Adult or Adolescent Dose | How Often | For How Long |
|---|---|---|---|
| Healing of erosive esophagitis. | 60 mg. | Once daily. | Up to 8 weeks. |
| Maintaining healed erosive esophagitis. | 30 to 60 mg. | Once daily. | Adults: Up to 6 months. Adolescents aged 12 to 17: Up to 4 months. |
| Symptoms of non- erosive GERD. | 30 mg. | Once daily. | 4 weeks. |
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-DEXLANSOPRAZOLE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at your regular time. Do not double doses.
What are possible side effects from using APO-DEXLANSOPRAZOLE?
Like all medications, APO-DEXLANSOPRAZOLE can cause side effects. Serious side effects are uncommon. These are not all the possible side effects you may feel when taking APO-DEXLANSOPRAZOLE. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects are:
- constipation.
- diarrhea.
- gas.
- headache.
- nausea.
- stomach pain.
Tell your doctor right away if you have any of these symptoms:
- New or worsening joint pain.
- Rash on your cheeks or arms that gets worse in the sun.
Your symptoms may get worse after stopping your medication. This may occur as your stomach may increase the production of acid.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Clostridium difficile colitis (Bowel inflammation): Symptoms include severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness. | ✓ | ||
Clostridium difficile colitis (Bowel inflammation): If you are currently taking or have recently taken antibiotics and you develop diarrhea, contact your doctor, even if the diarrhea is relatively mild. | ✓ | ||
| Convulsion or seizure. | ✓ | ||
Liver problems (hepatitis or cholestasis): Symptoms include dark-coloured urine and pale stools, yellow tinge to skin and eyes (jaundice), stomach pain. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Microscopic colitis (inflammation of the gut): symptoms include chronic watery diarrhea, abdominal pain, cramps or bloating weight loss, nausea, uncontrollable bowel movement, signs of dehydration such as: extreme thirst, less frequent urination, dark-coloured urine, fatigue, dizziness, confusion. The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. | ✓ | ||
| Severe Cutaneous Adverse Reactions (SCAR) (Severe Skin Reactions): Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). You may also experience fever, chills, body aches, shortness of breath, or enlarged lymph nodes. | ✓ | ||
| Serious skin reactions: Symptoms include widespread rash, itching, or hives. Peeling of the skin, blisters on the skin, mouth, nose, eyes and genitals are other symptoms. | ✓ | ||
| UNKNOWN | |||
| Tubulointerstitial nephritis (kidney problems): decreases in urination, blood in your urine. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store APO-DEXLANSOPRAZOLE at room temperature, 15°C to 30°C.
Keep out of reach and sight of children.
If you want more information about APO-DEXLANSOPRAZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.