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Nexium Reviews: Effectiveness, Side Effects, and Patient Experiences

by alexxlab

How effective is Nexium for treating acid reflux and GERD. What are the most common side effects reported by patients. Is long-term use of Nexium safe. What alternatives are available for managing heartburn symptoms.

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Overview of Nexium and Its Uses

Nexium (esomeprazole) is a proton pump inhibitor (PPI) medication used to treat conditions related to excess stomach acid. It is commonly prescribed for gastroesophageal reflux disease (GERD), erosive esophagitis, and stomach ulcers. Nexium works by reducing acid production in the stomach.

According to reviews on Drugs.com, Nexium has an average rating of 6.0 out of 10 based on 201 reviews. 50% of users reported a positive experience, while 37% reported a negative experience. The medication is used to treat several conditions:

  • GERD (154 reviews)
  • Barrett’s Esophagus (21 reviews)
  • Erosive Esophagitis (11 reviews)
  • Helicobacter Pylori Infection (8 reviews)
  • NSAID-Induced Gastric Ulcer (4 reviews)
  • Duodenal Ulcer Prophylaxis (3 reviews)

Effectiveness of Nexium for Acid Reflux and GERD

Many patients report that Nexium is effective at reducing acid reflux and GERD symptoms. One long-term user stated: “Been on Nexium for 6 years. Works good for reflux.” However, they noted that symptoms often return if the medication is stopped.

The effectiveness of Nexium can vary between individuals. While some find significant relief, others may experience limited benefits or require additional treatments. It’s important to work with a healthcare provider to determine if Nexium is the right choice for managing your specific symptoms.

How quickly does Nexium start working?

Nexium typically begins to reduce stomach acid within 1 hour of taking the medication. However, it may take 1-4 days of regular use to achieve full effect. Some patients report noticing improvements in heartburn symptoms within a few days of starting treatment.

Common Side Effects and Risks of Nexium

While Nexium is generally well-tolerated, some users report experiencing side effects. Common side effects may include:

  • Headache
  • Nausea
  • Diarrhea
  • Abdominal pain
  • Flatulence

More serious side effects have also been reported by some users. One reviewer mentioned: “I started taking Nexium 3 days ago and I am very depressed, rapid heartbeat that I thought I was having a heart attack. Shallow breathing too! Joint pains.”

Can Nexium cause severe allergic reactions?

While rare, severe allergic reactions to Nexium are possible. One user reported: “I had this medicine first time and I got severe allergic reaction and I’m in the hospital. Please don’t take this medication because I didn’t have any allergies from medication.” It’s crucial to seek immediate medical attention if you experience signs of an allergic reaction such as rash, itching, swelling, or difficulty breathing.

Long-Term Use of Nexium: Benefits and Concerns

Many patients use Nexium for extended periods to manage chronic acid reflux or GERD. While this can provide ongoing symptom relief, there are potential risks associated with long-term use of proton pump inhibitors like Nexium.

What are the risks of using Nexium long-term?

Long-term use of Nexium may be associated with certain health risks:

  1. Vitamin B12 deficiency: One user reported: “I was also diagnosed with severe vitamin B12 deficiency. I was getting muscle cramps, tingling and numbness in my hands and feet.”
  2. Increased risk of osteoporosis: Another reviewer stated: “After 3 years of using, I develop Osteoporosis. Because it stops producing acid then calcium production is impeded.”
  3. Increased risk of certain infections
  4. Potential for kidney problems

It’s important to discuss the benefits and risks of long-term Nexium use with your healthcare provider. Regular monitoring and periodic reassessment of the need for continued treatment may be necessary.

Alternatives to Nexium for Managing Heartburn

While Nexium can be effective for many people, some may prefer alternative treatments for managing heartburn and acid reflux symptoms. Options may include:

  • Other proton pump inhibitors (e.g., omeprazole, lansoprazole)
  • H2 blockers (e.g., famotidine, ranitidine)
  • Antacids
  • Lifestyle modifications (e.g., dietary changes, weight loss)
  • Natural remedies (e.g., apple cider vinegar, ginger)

One reviewer shared their experience with an alternative approach: “I stop taking it instead I drink a glass of water at bedtime and each time I get acid reflux/heartburn.”

How does Nexium compare to other heartburn medications?

Nexium (esomeprazole) is chemically similar to Prilosec (omeprazole). Both are proton pump inhibitors and work in similar ways. Some studies suggest that Nexium may be slightly more effective than omeprazole for certain conditions, but individual responses can vary. Other PPIs like lansoprazole (Prevacid) or pantoprazole (Protonix) may also be options. The choice between these medications often depends on factors such as cost, insurance coverage, and individual response to treatment.

Tips for Taking Nexium Effectively

To maximize the benefits of Nexium and minimize potential side effects, consider the following tips:

  1. Take Nexium at least 1 hour before meals
  2. Swallow capsules whole; do not crush or chew
  3. If using the powder form, mix it with water as directed
  4. Take the medication consistently at the same time each day
  5. Do not exceed the recommended dose without consulting your doctor
  6. Report any unusual side effects to your healthcare provider

Can Nexium be taken with other medications?

Nexium may interact with certain medications, including some blood thinners, antifungal drugs, and HIV medications. Always inform your healthcare provider about all medications, supplements, and herbal products you are taking. They can advise on potential interactions and adjust your treatment plan if necessary.

Patient Experiences and Quality of Life Improvements

Many patients report significant improvements in their quality of life after starting Nexium. One user shared: “Wow it is the best. Now I can sleep without getting a burning in my throat and eating tums and a bad taste in my mouth.”

However, experiences can vary widely. Some users find great relief, while others may experience limited benefits or troublesome side effects. It’s important to monitor your response to the medication and communicate openly with your healthcare provider about your experiences.

How long should Nexium be taken for optimal results?

The duration of Nexium treatment can vary depending on the condition being treated. For some acute conditions, a 4-8 week course may be sufficient. However, many patients with chronic GERD or other ongoing conditions may require long-term treatment. One reviewer noted: “They say it is only an 8 to 12 week treatment. They lied.” It’s crucial to follow your doctor’s recommendations and discuss any concerns about treatment duration.

Nexium and Pregnancy: Safety Considerations

For pregnant women experiencing severe heartburn or GERD, the use of Nexium may be considered. However, it’s essential to weigh the potential benefits against any risks carefully.

Is Nexium safe to use during pregnancy?

Nexium is classified as a Category C drug for pregnancy, meaning that animal studies have shown some risk to the fetus, but human studies are limited. The FDA advises that Nexium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnant women should consult with their healthcare provider to determine the safest approach for managing acid reflux symptoms during pregnancy.

Some studies suggest that using PPIs like Nexium during pregnancy may be associated with a small increased risk of certain birth defects. However, untreated severe GERD can also pose risks to both mother and baby. Your doctor can help you make an informed decision based on your individual circumstances.

Are there safer alternatives for managing heartburn during pregnancy?

For many pregnant women, lifestyle modifications and dietary changes may be sufficient to manage mild to moderate heartburn symptoms. These may include:

  • Eating smaller, more frequent meals
  • Avoiding trigger foods
  • Not lying down immediately after eating
  • Using pillows to elevate the head while sleeping

If these measures are insufficient, your doctor may recommend safer alternatives such as antacids or certain H2 blockers before considering Nexium or other PPIs.

Monitoring and Follow-up for Nexium Users

Regular monitoring is important for patients using Nexium, especially those on long-term treatment. This helps ensure the medication remains effective and allows for early detection of any potential side effects or complications.

What should be monitored during long-term Nexium use?

Healthcare providers may recommend periodic monitoring of:

  • Vitamin B12 levels
  • Magnesium levels
  • Bone density (especially in high-risk individuals)
  • Kidney function
  • H. pylori status (in relevant cases)

Additionally, patients should be aware of any changes in their symptoms or the development of new health issues. Regular check-ups allow for reassessment of the need for continued PPI therapy and exploration of potential step-down strategies or alternative treatments.

How often should Nexium users have follow-up appointments?

The frequency of follow-up appointments can vary based on individual circumstances. Generally, patients starting Nexium may have a follow-up within 4-8 weeks to assess initial response. For those on long-term therapy, annual check-ups are often recommended, though more frequent visits may be necessary for some patients. Always follow your healthcare provider’s recommendations for follow-up care.

Cost Considerations and Insurance Coverage for Nexium

The cost of Nexium can be a significant factor for many patients, especially those requiring long-term treatment. Understanding insurance coverage and exploring cost-saving options can help make treatment more accessible.

Is Nexium covered by insurance?

Coverage for Nexium varies among insurance plans. Many insurers cover Nexium, but it may require prior authorization or step therapy (trying less expensive alternatives first). Some plans may prefer the generic version, esomeprazole, which is typically less expensive. Check with your insurance provider to understand your specific coverage and any requirements for Nexium prescriptions.

Are there ways to reduce the cost of Nexium?

Several strategies can help reduce the cost of Nexium:

  1. Use generic esomeprazole instead of brand-name Nexium
  2. Ask your doctor about therapeutic alternatives that may be less expensive
  3. Look into patient assistance programs offered by the manufacturer
  4. Use pharmacy discount cards or comparison shop among different pharmacies
  5. Consider mail-order pharmacy options for long-term prescriptions

Discussing cost concerns with your healthcare provider can help identify the most cost-effective treatment plan that meets your medical needs.

Nexium Reviews & Ratings – Drugs.com

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Nexium
has an average rating of 6.0 out of 10 from a total of 201 reviews
on Drugs.com.
50% of reviewers reported a positive experience, while 37% reported a negative experience.

Condition Avg. Rating ReviewsCompare
GERD  154 reviews227 medications
Barrett’s Esophagus  21 reviews13 medications
Erosive Esophagitis  11 reviews103 medications
Helicobacter Pylori Infection  8 reviews64 medications
NSAID-Induced Gastric Ulcer  4 reviews6 medications
Duodenal Ulcer Prophylaxis  3 reviews30 medications
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Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. Reviews that appear to be created by parties with a vested interest are not published. This information is not intended to endorse any particular medication. While these reviews may be helpful, they are not a substitute for the expertise, knowledge, and judgement of healthcare professionals.

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  • Duodenal Ulcer Prophylaxis
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Effectiveness, Ease of Use, and Satisfaction

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Most voted positive review

41 People found this comment helpful

Been on Nexium for 6 years. Works good for reflux. Can’t stop taking it or symptom’s return worse than before. They say it is only an 8 to 12 week treatment. They lied. I was also diagnosed with severe vitamin B12 deficency. I was getting muscle cramps, tingling and numbness in my hands and feet. They never did a study on long term use of PPI’s, but they are now warning people about the vitamin de…

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Most voted negative review

10 People found this comment helpful

After 3 years of using. I develop Osteoporosis. Bcoz it stop producing acid then calcium production is impede. Acid is important in calcium production which important for strong bones. I stop taking it instead I drink a glass of water at bedtime and each time I get acid reflux/heartburn.

Shared reviews and ratings

SORT BY Condition: Heartburn

Overall rating 3.0

EffectivenessEase of UseSatisfaction

I started taking Nexium 3 days ago and i am very depressed, rapid heartbeat that i thought i was having a heart attach. Shallow breathing too! Joint pains. i am going to stick to my enzymes and hope that helps.

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Fill 3Created with Sketch. Condition: Heartburn

Overall rating 2.0

EffectivenessEase of UseSatisfaction

I got very very bad diarrhoea lost 3 days never take them again my brother had the same experience

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Fill 3Created with Sketch. Condition: Increased Stomach Acid from Systemic Mastocytosis

Overall rating 1.0

EffectivenessEase of UseSatisfaction

I had this medicine first time and I got severe allergic reaction and I’m in the hospital. Please don’t take this medication because I didn’t have any allergies from medication. I did have little bit seasonal allergies. Stay safe and consult to your doctor before having any on the counter medicines. I have three little kids and I put my life in risk.

1

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Fill 3Created with Sketch. Condition: eosinophilic inflammation of the esophagus

Overall rating 5.0

EffectivenessEase of UseSatisfaction

Wow it is the best . now I can sleep with out getting a burning in my throat and eating tums and a bad taste in my mouth

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Fill 3Created with Sketch. Condition: Heartburn

Overall rating 3.0

EffectivenessEase of UseSatisfaction

Took fo approximately a week. Afterwards, after every dose, racing heart and diarrhea. Sort of like a gastric dumping sensation. The last time I took it, I had immense itching all over my body and vomiting. Apparently, this drug is not for me.

2

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Fill 3Created with Sketch. Condition: Heartburn

Overall rating 5.0

EffectivenessEase of UseSatisfaction

I had heartburn all the time. No more. I take 40mg everyother day. No side affects.

1

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 1.7

EffectivenessEase of UseSatisfaction

I�ve been on Nexium for decades for GERD. I�ve gained a lot of weight and suffer most of side effects others have listed. I have osteoporosis. I have developed terrible bruising on both my legs to the point where I keep them covered all the time, even when swimming. Doctors cannot find out the cause of this bruising. I�m constantly fatigued and doctors tell me I have fibromyalgia but I�m now wondering if it�s the Nexium causing this bruising and fatigue. Over the years I�ve taken myself off the Nexium but then have an episode where I think I�m having a heart attack. So I have to go back on it, I�m a 67 year old woman, people tell me I look like I�m in my early 50�s but I now feel that Nexium has contributed to more health problems instead of helping. I�ve had the dye test and no problems with my heart. Constant headaches as well. Going back to my family doctor this week to have a serious discussion about this. I have 80% Blue Cross coverage for Nexium here in Atlantic Canada but pay over $300 a month for this coverage. So I end up paying one way or the other. I still work full-time to help pay for this. Recently had to cut my hours back to 24 hours a week. Recent test show I have no more GERD so why do I need this medication? I�m on Nexium 40. Feeling very helpless.Read More Read Less

4

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Fill 3Created with Sketch. Condition: Inflammation of the Stomach Lining caused by H. Pylori

Overall rating 4.7

EffectivenessEase of UseSatisfaction

I am epileptic I take phenytoin primidone and zonisamide and gerd my chest started hurting from inflammation of my stomach I been to ER to make sure it wasnâ??t my heart my heart is fine now taking nexium 40mg for about a week and Iâ??ve had anxiety Iâ??ve had headaches dizziness and blurred vision about an hour after taking nexium 40mg so I just now have called and told the doctor that prescribed it to me to see what I should do

1

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 3.0

EffectivenessEase of UseSatisfaction

I started taking Nexium for GERD 4 months ago. It controlled my GERD, but side effects for me have been hair loss, elevated blood pressure and sinus congestion. Stopped it for a week and developed rebound GERD that was awful and had to resume it. Now trying to taper off of it. Wish I had never, ever started it.

8

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Fill 3Created with Sketch. Condition: Excessive Production of Stomach Acid

Overall rating 4.0

EffectivenessEase of UseSatisfaction

I was on it for a month, just to try and reduce the amount of stomach acid. And about two weeks into it my intestines felt like they were going to fall out of my body, three weeks into it, my boobs grew and hurt so much. I dont know if that is common but that was what I had.

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 5.0

EffectivenessEase of UseSatisfaction

It’s pricey but absolutely worth it when severe acid reflux hit.

5

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 5.0

EffectivenessEase of UseSatisfaction

I have been on Nexium for over 15 years, I started with 40 MG and when the paid increased last year, I started buy it over the counter and got the 20 Mg instead of the 40. I take one every morning, I have not ever had any side effects at all. It works great for me and I will continue to take it as long as I need to. I find it very effective.

17

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Fill 3Created with Sketch. Condition: Excessive Production of Stomach Acid

Overall rating 1.0

EffectivenessEase of UseSatisfaction

Stay away from this drug. after years of taking I develop osteoporosis. acid is important for calcium production. so instead I take glass of water before bedtime. it works!

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Fill 3Created with Sketch. Condition: Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

Overall rating 4.0

EffectivenessEase of UseSatisfaction

I had Duodenum caused by Helicobacter Pylor. It had bothered me from age 18. Had been on ulcer diet off and on for years. Maalox and other over counter antacids. Doc then switched to Zantac. Did a better job, but still would still occur always at a certain time of the year ? Then went on the antibiotic treatment and also went to Nexium 40 mg once a day. Been on it for 15 years now. Doc said maybe for life. It works well, not much problems, but I do wonder about the long term use, as it has not been around long. I have often wondered about the acid it blocks, as there are good acid’s that we need for good health ? What do you think.Read More Read Less

2

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Fill 3Created with Sketch. Condition: Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

Overall rating 5.0

EffectivenessEase of UseSatisfaction

I have been taking this sence it came out. I used to take Zantac till my doctor said I need something stronger. 40 MG once a day. It has worked well for me. I have always been a little concerned about the acid it blocks. Don’t we sometimes need acid to digest food ? Now I hear all kinds of warnings. What the hell is up with that. Also what is a alternative ?

1

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 1.0

EffectivenessEase of UseSatisfaction

After 3 years of using. I develop Osteoporosis. Bcoz it stop producing acid then calcium production is impede. Acid is important in calcium production which important for strong bones. I stop taking it instead I drink a glass of water at bedtime and each time I get acid reflux/heartburn.

21

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Fill 3Created with Sketch. Condition: Condition in which Stomach Acid is Pushed Into the Esophagus

Overall rating 2.3

EffectivenessEase of UseSatisfaction

I have been on Nexium since it first came on the market.I started on Nexium 20mg but am now on 40mg. I have GERD, Hiatus Hernia, esophageal muscle spasms(which mimic a heart attack), a torturous esophagus(which it causing the food to block up. In the beginning it helped but as the years have gone on I will wake up choking with a sensation going up my throat.I have many of the side effects that I have read here but hadn’t know that it was the Nexium. I am having more pain and vomiting, excessive gas, tingling in my feet and hands, excessive weight gain, fluid retention(on fluid tablets to try and relieve the swelling), muscle jerking,nausea, vomiting,stomach pain, polyps. I eat small meals but even then it still blocks causing severe pain and then vomiting. I am being referred back to my GI specialist as my GP said the medication is not working as well as it should and that it needs reviewing. I am so glad that I am not the only one who has experienced these sided effects. Read More Read Less

32

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Overall rating 4.3

EffectivenessEase of UseSatisfaction

I’ve tried everything. Been taking 40 mgs for years. Really need to eat nothing 2-3 hrs before bed – it can’t work miracles.

18

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Fill 3Created with Sketch. Condition: Heartburn

Overall rating 5. 0

EffectivenessEase of UseSatisfaction

I have had chronic heartburn for months, it was waking me up at night and I was unable to bend down without pain. Since taking Nexium 40 tablets for only 5 days!!!!! the pain has gone.

2

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Fill 3Created with Sketch. Condition: Heartburn

Overall rating 3.0

EffectivenessEase of UseSatisfaction

I wish i had read all the reviews before taking this poison. It does what it says and stops the heartburn effectively but the side effects are not worth it. Severe weight gain literally overnight, i gained 5 lbs in 2 days and ate very little. headaches.. started getting severe headaches that lasted a few minutes at a time… joint and back pain… memory loss from what appears to be B12 blocking… calcium deficiency (it blocks calcium as well) I am stopping treatment with this garbage today. it takes 48 to leave your system so hopefully i start to see some improvement then. this garbage should be banned.Read More Read Less

3

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Dosage form

Ganaton ®

Tab. , coated film coated, 50 mg: 40 or 70 pcs.

reg. No.: LS-002513
dated 09.09.11
– Indefinitely

Re-registration date: 06/29/21

Release form, packaging and composition
drug Ganaton

®

Film-coated tablets white, round, biconvex, scored on one side and engraved “HC 803” on the other side.

Excipients : lactose monohydrate – 35 mg, corn starch – 15 mg, carmellose – 20 mg, colloidal anhydrous silicon dioxide – 4 mg, magnesium stearate – 1 mg.

The composition of the film shell: hypromellose 2910 – 4.4 mg, macrogol 8000 – 0.4 mg, titanium dioxide (E171) – 0.2 mg, carnauba wax – 0.025 mg.

10 pcs. – blister packs contour (4) – packs of cardboard with the control of the first opening.
14 pcs. – cellular contour packs (5) – packs of cardboard with control of the first opening.

Clinical and pharmacological group:

A drug that increases the tone and motility of the gastrointestinal tract. Acetylcholine release stimulator

Pharmacotherapeutic group:

Gastrointestinal motility stimulant – acetylcholine ejection stimulant

Pharmacological action

Itopride hydrochloride – gastroprokinetic for oral administration. The dosage form and composition of the tablets provide an immediate release of the active substance. Itopride is characterized by a dual mechanism of action: antagonism to D 2 – dopamine receptors and inhibition of acetylcholinesterase. As a result of the action of itopride, the concentration of acetylcholine increases, which leads to increased gastric motility, increased tone of the lower esophageal sphincter (LES), accelerated gastric emptying and improved gastroduodenal coordination.

Itopride hydrochloride also has an antiemetic effect due to interaction with D 2 – dopamine receptors located in the chemoreceptor trigger zone of the medulla oblongata. Itopride causes a dose-dependent suppression of apomorphine-induced emesis.

The effect of the drug in patients with functional dyspepsia leads to a decrease in the severity of symptoms (overall patient rating, postprandial heaviness in the abdomen, early satiety). The use of itopride by patients with diabetic gastroparesis contributed to the acceleration of the evacuation of liquid and solid food from the stomach. In patients with gastroesophageal reflux disease (GERD), itopride reduces the amount of transient relaxation of the lower esophageal sphincter and reduces the length of time with high acidity in the esophagus (pH<4).

Co-administration of itopride hydrochloride with alpha-lipoic acid has been shown to accelerate gastric emptying and decrease gastrin and motilin levels compared with itopride alone.

Itopride hydrochloride has a highly specific effect on the upper GI tract. Itopride hydrochloride accelerates gastric emptying. Itopride hydrochloride does not affect serum gastrin levels.

Pharmacokinetics

Absorption

Itopride hydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Relative bioavailability is 60%, which is associated with metabolism during the “first pass” through the liver. Food does not affect bioavailability. C max in plasma (0.28 mcg / ml) is achieved 0.5-0.75 hours after taking 50 mg of itopride hydrochloride.

With repeated oral administration of itopride hydrochloride at a dose of 50-200 mg 3 times / day for 7 days, the pharmacokinetics of the drug and its metabolites were linear, and cumulation was minimal.

Distribution

Itopride hydrochloride is 96% bound to plasma proteins, mainly to albumin. Binding to the alpha 1- acid glycoprotein is less than 15% of the total binding.

Itopride is actively distributed in tissues (V dβ = 6.1 l/kg) and is found in high concentrations in the kidneys, small intestine, liver, adrenal glands and stomach. Penetration into the brain and spinal cord is minimal. Itopride passes into breast milk.

Metabolism

Itopride undergoes active biotransformation in the human liver. Three metabolites have been identified, only one of which exhibits little activity that has no pharmacological significance (approximately 2-3% of that of itopride). The primary metabolite in humans is the N-oxide, which results from the oxidation of the tertiary amino-N-dimethyl group.

Itopride is metabolized by flavin-dependent monooxygenase (FMO3). The amount and potency of FMO isoenzymes in humans may differ depending on the genetic polymorphism, which in rare cases leads to the development of an autosomal recessive condition known as trimethylaminuria (fishy odor syndrome).

Based on in vivo pharmacokinetic studies of CYP-mediated reactions, itopride does not inhibit or induce CYP2C19 isoenzymesand CYP2E1. Itopride therapy does not affect CYP or uridine diphosphate glucuronyl transferase activity.

Elimination

Itopride hydrochloride and its metabolites are excreted primarily in the urine. Renal excretion of itopride and its N-oxide after a single oral dose of the drug at a therapeutic dose (50 mg) in healthy people was 3.7 and 75.4%, respectively. T 1/2 itopride hydrochloride is about 6 hours

Indications of the drug

Ganaton

®

  • treatment of gastrointestinal symptoms associated with impaired gastric motility or delayed emptying, such as:
    • bloating;
    • fast saturation;
    • feeling of fullness in the stomach after eating;
    • epigastric pain or discomfort;
    • decreased appetite;
    • heartburn;
    • nausea;
    • vomiting.
  • functional (non-ulcerative) dyspepsia or chronic gastritis.

Open list of ICD-10 codes

K29 Gastritis and duodenitis
K30 Functional dyspepsia (indigestion)
R10.1 Pain localized in the upper abdomen
R11 Nausea and vomiting
R12 Heartburn
R14 Flatulence and related conditions (including bloating, belching)
R63.0 Anorexia

Dosage regimen

Adults are prescribed orally 1 tab. drug Ganaton ® 50 mg 3 times daily before meals. The recommended daily dose is 150 mg. This dose may be reduced according to the age and symptoms of the patient.

In clinical studies, the duration of treatment with Ganaton ® was up to 8 weeks.

Side effects

The following side effects were observed in 998 patients using itopride at a standard daily dose of 150 mg or less in 4 placebo-controlled, 4 comparative and 13 uncontrolled interventional clinical studies with a frequency of [often (≥1 / 100 and < 1/10) and infrequently (≥1/1000 and <1/100)]. No adverse reactions were observed in the very common (≥1/10), rare (≥1/10000 and <1/1000) or very rare (<1/10000) frequency categories.

9 0548

Regulatory Medical Dictionary Classification Authority (MedDRA) Incidence Adverse Effects
Gastrointestinal Common
Uncommon		 Abdominal pain, diarrhea
Increased salivation
Laboratory and instrumental findings Uncommon Increased ALT activity, decreased white blood cell count
Nervous system disorders Uncommon Dizziness, headache
Skin and subcutaneous tissue disorders Uncommon Rash

available data to estimate their frequency is not possible.

From the side of the hematopoietic system: leukopenia and thrombocytopenia.

From the immune system: hypersensitivity reactions, including anaphylactoid reaction.

From the side of the endocrine system: increase in the level of prolactin in the blood.

From the nervous system: dizziness, headache, tremor.

From the gastrointestinal tract: diarrhea, constipation, abdominal pain, increased salivation and nausea.

From the side of the liver and biliary tract: jaundice.

From the side of the skin and subcutaneous tissues: rash, erythema and itching.

From the side of the genitals and mammary gland: gynecomastia.

Laboratory and instrumental data: increased activity of ACT, ALT, GGT, alkaline phosphatase and bilirubin levels.

Contraindications for use

  • hypersensitivity to itopride or any excipient;
  • gastrointestinal bleeding, mechanical obstruction or perforation of the gastrointestinal tract;
  • pregnancy;
  • breastfeeding period;
  • children under 16 years of age (due to lack of safety data).

Precautions

Itopride hydrochloride enhances the action of acetylcholine, which may cause cholinergic side effects. The drug should be administered with caution to patients in whom the occurrence of such reactions may aggravate the course of the underlying disease.

In elderly patients, itopride hydrochloride should be administered with caution, given the higher incidence of decreased liver and kidney function, the presence of concomitant diseases or other treatment.

Use in pregnancy and lactation

Pregnancy

There are currently limited data (less than 300 pregnancy outcomes) on the use of itopride in pregnant women. Animal studies showed no evidence of direct or indirect adverse effects of itopride indicative of reproductive toxicity. As a precaution, the use of itopride during pregnancy is contraindicated.

Breastfeeding period

Itopride is excreted in milk in animals, but at the moment there is not enough data on the excretion of itopride in human breast milk. When breastfeeding, the risk of the drug affecting the child cannot be excluded. The decision to stop breastfeeding or stop/discontinue taking the drug should be made based on an assessment of the benefits of breastfeeding for the child and the benefits of the drug for the mother.

Fertility

There are no data on the effect of itopride on human fertility. However, animal studies have not shown signs of a negative effect of the drug on fertility.

Use in children

Contraindicated in children under 16 years of age (due to lack of safety data).

Use in Elderly Patients

Itopride should be used with caution in elderly patients due to the frequent decrease in liver and kidney function, the presence of concomitant diseases or other treatment.

Special instructions

Itopride enhances the action of acetylcholine and may cause cholinergic side effects.

There are no data on long-term use of the drug.

Influence on the ability to drive vehicles and mechanisms

Studies on the effect of itopride on the ability to drive vehicles and mechanisms have not been conducted. However, during the period of treatment with the drug, care should be taken when performing potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, the work of a dispatcher and operator), because. the use of the drug may cause dizziness.

Overdose

Treatment: in case of overdose, gastric lavage and symptomatic therapy are indicated.

Drug interactions

Metabolic interactions are not expected as Itopride is primarily metabolized by flavin monooxygenase and not by the cytochrome CYP450 system.

With the simultaneous use of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride, no changes in protein binding were observed.

Itopride increases gastric motility, so it may interfere with the absorption of other drugs taken by mouth. Particular caution should be observed when using drugs with a low therapeutic index, as well as dosage forms with a slow release or enteric-coated drugs.

Antiulcer drugs such as cimetidine, ranitidine, teprenone and cetraxate do not interfere with the prokinetic action of itopride.

Anticholinergics may reduce the effect of itopride.

Storage conditions of the drug Ganaton

®

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life of the drug Ganaton

®

Shelf life – 3 years. Do not use after the expiration date.

Terms of sale

The drug is dispensed by prescription.

RU2225711 (v1.0)

Contacts for inquiries

125171 Moscow,
Leningradskoe sh., 16A, building 1
Tel.: +7 (495) 258-42-80
Fax: +7 (495) 258-42-81
russia@abbott.

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