Nexicure 20 mg & 40 mg Delayed-Release Capsules

Nexicure belongs to a group of medicines called proton pump inhibitors. Nexicure contains the active ingredient Esomeprazole. Nexicure works by decreasing the amount of acid that is made by the stomach. Nexicure used to treat:

1.GERD disease: This disease is caused by food and acid flowing from the stomach the wrong way up (reflux) back into the food pipe, also known as the esophagus. Reflux can cause a burning sensation in the chest that reaches up to the throat, also known as heartburn.

Nexicure is used to treat reflux esophagitis, and is also used to help prevent reflux esophagitis from coming back or recurring.

2.Peptic ulcer: Depending on the location of the ulcer, it is called a stomach or duodenal ulcer. Stomach ulcers occur in the stomach. Duodenal ulcers occur in the duodenum, which is the tube that leads out of the stomach. These ulcers can be caused by too much acid in the stomach.

Most people with peptic ulcers also have bacteria called Helicobacter pylori in their stomach. When treating peptic ulcers associated with H. pylori, Nexicure is used in combination with two antibiotics (clarithromycin and amoxicillin). When Nexicure is taken with antibiotics, the combination treatment will kill H. pylori and allow the ulcer to heal.

Nexicure is used to treat peptic ulcers, and is also used to help prevent peptic ulcers from coming back or recurring.

3.Chronic gastritis: The presence of Helicobacter pylori (H. pylori) may lead to gastritis, leading to pain, nausea, and vomiting. When Nexicure taken with antibiotics, they will help kill the H. pylori bacteria and allow the stomach to heal.

What you should know about Nexicure

This medication is well tolerated by the body, and most people do not feel or experience any serious side effects. The most common side effects are headache and gastrointestinal upset, and these often go away  with continued treatment.

The usual dose is once daily (however the doctor can increase the dose to twice daily), the dose is taken either 30 minutes before breakfast or 30 minutes before dinner, and the duration of treatment in most cases is between 4 to 8 weeks. Your doctor may ask you to continue taking this medication for longer periods. Always follow your doctor’s instructions.

Regular use of Nexicure for prolonged periods (once daily for more than 6 to 12 months) may lead to the following problems: ① increased risk of bone fractures, especially in elderly patients with osteoporosis ② decreased levels of magnesium in the blood, and this can lead to Heart rhythm disturbances, ③ deficiency of vitamin B in the body, which may lead to anemia.

Treatment with Nexicure may mask stomach cancer (a disease in which malignant (cancerous) cells form in the lining of the stomach)…Therefore, the presence of stomach cancer must be ruled out before starting treatment with Nexicure, noting that improvement in symptoms does not prevent the presence of stomach malignancy.

Long-term treatment with esomeprazole has been associated with atrophic gastritis (changes in the type of cells lining the stomach wall, which is characterized by chronic inflammation of the gastric mucosa).

Treatment with Nexicure, especially for a prolonged period of time, may be associated with an increased risk of diarrhea caused by C. difficile, a bacteria that causes severe diarrhea, and inflammation of the colon, a condition called pseudomembranous colitis.

Bone fracture: Long-term treatment may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.

High doses of esomeprazole reduce the anti-platelet activity of clopidogrel (Plavix).

Hypomagnesaemia has been reported rarely with prolonged treatment with proton pump inhibitors.

Avoid concomitant use of Nexicure with St. John’s wort or rifampin due to the possibility of a decrease in the effect of esomeprazole.

Tips for GERD & Peptic Ulcer Patients

Some important tips for patients with stomach ulcers and GERD ; In order to reduce the severity of symptoms and help fast recovery:

1. Do not drink too much tea, coffee, Cola, and Alcohol.
2. Divide your meals into easy-to-digest snacks.
3. Eat boiled and sautéed foods.
4. Avoid fatty, fried foods, hot and spicy sauces.
5. Avoid taking medicines on an empty stomach unless after consulting a doctor.
6. Do not sleep immediately after eating.
7. Take care of your psychological conditions and stay away from stress, and anxiety .
8. Make the pillow a little high when sleeping to avoid reflux of intestinal acid upwards.

1.INDICATIONS AND USAGE

1.1.Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Nexicure is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Nexicure may be considered.

Maintenance of Healing of Erosive Esophagitis

Nexicure is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

Nexicure is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.

1.2.Risk Reduction of NSAID-Associated Gastric Ulcer

Nexicure is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.3.H. pylori Eradication to Reduce the Risk of Duodenal Ulcer

Recurrence

Triple Therapy (Nexicure plus amoxicillin and clarithromycin): Nexicure, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.

1.4.Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Nexicure is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

2.DOSAGE AND ADMINISTRATION

Nexicure is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions.

The recommended dosages are outlined in table below.

Nexicure should be taken at least one hour before meals.

The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs.

Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.

Recommended Dosage Schedule for Nexicure

Administration Options

Delayed-Release Capsules – Route: Oral

Capsule can be swallowed whole. -or- Capsule can be opened and mixed with applesauce

Delayed-Release Capsules – Route: Nasogastric Tube

Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.

Nexicure Delayed-Release Capsules

Nexicure Delayed-Release Capsules should be swallowed whole.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Nexicure Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce.

• The granules should be mixed with the applesauce and then swallowed immediately.
• Do not store for future use.
• The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
• The granules should not be chewed or crushed.
• If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.

For patients who have a nasogastric tube in place, Nexicure Delayed-Release Capsules can be opened and the intact granules emptied into a 60 ml catheter tipped syringe and mixed with 50 ml of water. It is important to only use a catheter tipped syringe when administering Nexicure through a nasogastric tube.

Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach.

• After administering the granules, the nasogastric tube should be flushed with additional water.
• Do not administer the granules if they have dissolved or disintegrated.
• The mixture must be used immediately after preparation.

Side effects

common side effects (may affect 1 in 10 people who use this medicine)

• Headache.
• Diarrhea, stomach pain, constipation, wind (flatulence).
• Nausea or vomiting.

Nexicure is an equivalent alternative to the Esmorap brand. For more information, I advise you to read the patient information leaflet of Esmorap.

Product reference code: A02BC05.