What is Konvomep?
Konvomep is a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate.
Konvomep is used:
- in adults for up to 8 weeks for the healing of stomach ulcers.
- in critically ill adults to lower the risk of stomach bleeding.
It is not known if Konvomep is safe and effective in children.
What is the most important information I should know about Konvomep?
Konvomep may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Konvomep can cause serious side effects, including:
- A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Konvomep, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Konvomep. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
- Konvomep contains sodium bicarbonate. Long-term use of bicarbonate with calcium or milk can cause a condition called “milk-alkali syndrome”. Long-term use of sodium bicarbonate can cause a condition called “systemic alkalosis”. Talk to your doctor about any questions you may have. Too much sodium can cause swelling and weight gain. Tell your doctor if you are on a low-sodium diet or if you have Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs.
- Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
- Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have bone fracture, especially in the hip, wrist, or spine.
- Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Konvomep, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
Talk to your doctor about your risk of these serious side effects.
Konvomep can have other serious side effects. See “What are the possible side effects of Konvomep?”
Who should not take Konvomep?
Do not take Konvomep if you are:
- allergic to omeprazole, any other PPI medicine, or any of the ingredients in Konvomep. See below for a complete list of ingredients in Konvomep.
- taking a medicine that contains rilpivirine, used to treat HIV-1 (Human Immunodeficiency Virus).
What should I tell my healthcare provider before taking Konvomep?
Before taking Konvomep, tell your doctor about all of your medical conditions, including if you:
- have low magnesium, calcium, or potassium levels in your blood.
- have problems with the acid-base (pH) balance in your body.
- have heart failure.
- are on a low-sodium diet.
- have Bartter’s syndrome (a rare kidney problem).
- are pregnant or plan to become pregnant. It is not known if Konvomep will harm your unborn baby.
- are breastfeeding or plan to breastfeed. Konvomep can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take Konvomep.
Tell your doctor about all the medicines you take, including prescription and over-the counter medications, vitamins and herbal supplements. Especially tell your doctor if you take:
- St. John’s wort (Hypericum perforatum)
Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take Konvomep?
- Take Konvomep exactly as prescribed by your doctor.
- Konvomep is mixed (reconstituted) by a healthcare provider, and you will receive Konvomep as an oral suspension that can be taken by mouth or given through a nasogastric or orogastric tube.
- Shake the Konvomep oral suspension well before each use.
- Measure the Konvomep oral suspension with an accurate measuring device. Ask your pharmacist to recommend a measuring device and for instructions on how to measure the correct dose.
- If Konvomep is given through a nasogastric or orogastric tube, it is important to stop enteral feeding at least 3 hours before giving Konvomep. You can start enteral feeding again at least 1 hour after giving Konvomep.
- Do not change your dose or stop taking Konvomep without talking to your doctor.
- If you miss a dose of Konvomep, 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 at your regular time. Do not take two doses to make up for a missed dose.
- If you take too much Konvomep, call your doctor or Poison Control Center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
What are the possible side effects of Konvomep?
Konvomep may cause serious side effects, including:
- See “What is the most important information I should know about Konvomep?”
- Low vitamin B-12 levels in your body can happen in people who have taken Konvomep for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
- Low magnesium levels in your body can happen in people who have taken Konvomep for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet, or voice.
- Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
- Severe skin reactions. Konvomep can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
- 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 have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.
- abdominal pain
These are not all the possible side effects of Konvomep. Call your doctor for medical advice about side effects. You may report side effect to FDA at 1-800-FDA-1088. You may also report side effects to Azurity Pharmaceuticals, Inc. at 1-800-461-7449.
General information about the safe and effective use of Konvomep
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Konvomep for any condition for which it was not prescribed. Do not give Konvomep to other people, even if they have the same symptoms that you have. It may harm them.
You can also ask your doctor or pharmacist for information about Konvomep that is written for health professionals.
How should I store Konvomep?
- Store Konvomep oral suspension in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Keep the Konvomep container tightly closed. Protect the container from light.
- Do not freeze Konvomep.
- Throw away (discard) any unused Konvomep oral suspension after 30 days.
Keep Konvomep and all medicines out of the reach of children.
What are the ingredients in Konvomep?
Active ingredients: omeprazole and sodium bicarbonate
Inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, FD&C Red No. 40, poloxamer 188, purified water, simethicone emulsion, sodium citrate (dihydrate), sorbitol solution, strawberry flavor (natural and artificial flavors, propylene glycol and glycerin) and sucralose.
For more information, go to www.azurity.com or call 1-800-461-7449.