Prevacid SoluTab

(Lansoprazole OD)

The active ingredient in Prevacid SoluTab is lansoprazole, a proton-pump inhibitor (PPI). Lansoprazole helps reduce acid production in the stomach. Reducing acid in the stomach can facilitate the healing of ulcers and erosive esophagitis (irritation of the esophagus due to GERD). By improving healing, lansoprazole can help ease stomach pain, abdominal pain, irritation in the esophagus, and heartburn caused by these conditions.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prevacid SoluTab. However, the following is a synopsis of the general guidelines for the use of Prevacid SoluTab:

-Take Prevacid SoluTab 30 minutes before a meal, once or twice daily, as per your doctor’s instructions.

-Do not crush, chew, break, or cut the tablets.

-Place the tablet on your tongue and let it melt for 1 minute.

-You can swallow the remaining granules.

In the case of administration through an oral syringe, consider the following instructions:

-Place a 15mg Prevacid SoluTab tablet in an oral syringe. Draw up 4 mL of water.

-Or place a 30mg tablet in the syringe and draw up 10mL of water.

-Shake the syringe gently until the tablet has dispersed.

-Drink the entire contents of the syringe.

-Refill the syringe with 2mL of water, shake gently, and drink the remaining contents.

In the event of a missed dose, do not double the dose. Take your next dose at the scheduled time.

The most common side effects of Prevacid SoluTab seen in clinical trials as compared to placebo include:

-Bloating, gas, burping

-Abdominal pain

-Nausea, vomiting

-Diarrhea or constipation

-Headache

-Muscle pain

Some individuals may experience serious side effects while using Prevacid SoluTab. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Severe diarrhea.

-Heart palpitations, dizziness, twitching, muscle cramps, or seizures: this may indicate low magnesium levels.

-A skin rash, especially in sun-exposed areas, along with joint pain: This may indicate an immune condition called lupus erythematosus.

These are not all of the possible side effects of Prevacid SoluTab. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

People who take PPIs may be at increased risk of a Clostridium difficile infection. Persistent diarrhea should be reported to your doctor.

The use of Prevacid SoluTab may cause low magnesium and vitamin B12 levels.

Long-term use of Prevacid SoluTabs is associated with an increased risk of fundic gland polyps, which are often not symptomatic.

Before starting Prevacid SoluTab, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

-Have liver disease or kidney problems.

-Have stomach cancer.

-Are pregnant or breastfeeding.

-Have experienced unexplained weight loss.

-Have severe or persistent diarrhea or dark tarry stools.

-Have been vomiting repeatedly or vomiting blood.

-Have anemia.

-Have difficulty swallowing.

-Have osteoporosis (weak bones) or low vitamin B12: the use of lansoprazole for more than 1 year may increase the risk of broken bones and of vitamin B12 deficiency.

Prevacid SoluTab is contraindicated in people who have had an allergic reaction to lansoprazole or any of the inactive ingredients of the formulation, such as aspartame.

If used in a combination regimen with antibiotics like amoxicillin and clarithromycin for the treatment of H. Pylori, discuss the contraindications of these antibiotics with your doctor or pharmacist.

The decrease in stomach acid and improvement of symptoms can be noticed as soon as 1-3 hours after taking Prevacid but may take a few days for maximal effects.

When Prevacid SoluTab is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Other antacids, including other PPIs such as omeprazole.

-Non-steroidal antiinflammatory drugs (NSAIDs).

-Antiviral medications such as nelfinavir, saquinavir/ritonavir, or atazanavir, etc. Co-administration with rilpivirine is contraindicated.

-Antifungal medications like ketoconazole.

-Iron supplements.

-Any other medications, including pimozide, astemizole, terfenadine, cisapride, ampicillin, clopidogrel, digoxin, warfarin, methotrexate, sucralfate, tacrolimus, theophylline, warfarin, or fluvoxamine.

Prevacid SoluTab is available in 15mg and 30mg delayed-release orally-disintegrating tablet formulations.

Prevacid is also available in other dosage forms, including delayed-release capsules.

Prevacid SoluTabs should be stored at room temperature in a dry place, in the original packaging.

Prevacid SoluTabs are made by Takeda Pharmaceuticals America, Inc.

Lansoprazole is available as a generic, but the SoluTab formulation is only available as a brand name.

PPIs should be used at the lowest possible dose for the shortest possible duration until symptoms resolve. Long-term use of PPI can increase the risk of some vitamin deficiencies. Only use Prevacid SoluTab long-term if instructed by your doctor.

Lansoprazole is not known to be teratogenic, but there are no well-controlled studies done in pregnant women. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if lansoprazole is excreted into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.