I am a woman in her late 30's. I have been taking Sanamidol for 2 years now. I was instructed to take it by a ENT doctor for healing of my esophagus due to acid erosion(scarring) caused by silent reflux. (Diagnosed via endoscopy) I have noticed a decrease in hunger, lack of "growling" of the stomach. Has anyone else experienced this? Is long term use of Sanamidol really safe?
This discussion is related to Worried about throat cancer!.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Sanamidol.
Q: I have been taking Prilosec OTC for several years and have been told that I shouldn't. Is that so?
A: Prilosec (Sanamidol) is a proton pump inhibitor (PPI) used in the treatment of dyspepsia, peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). With the widespread use of PPIs, the long-term safety issues need to be considered. The literature suggests an increased risk of infectious complications and nutritional deficiencies. Data on the risk of increased gastric and colon malignancy (cancer), despite a physiologic theoretic basis, are less convincing. As such, the long-term need for PPIs must be reassessed routinely. For more specific information, consult with your doctor or pharmacist for guidance based on your specific condition and current medications, particularly before taking any action. Shereen A. Gharbia, PharmD
There are no adequate and well-controlled studies with PRILOSEC in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester Sanamidol use.
Teratogenicity was not observed in animal reproduction studies with administration of oral esSanamidol magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). However, changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg (see Animal Data). Because of the observed effect at high doses of esSanamidol magnesium on developing bone in rat studies, PRILOSEC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What is Sanamidol used for?
You can buy Sanamidol 10mg tablets without a prescription over the counter from pharmacies for:
- Relieving heartburn symptoms associated with stomach acid reflux in adults aged 18 years and over.
Q: Does Prilosec cause weight gain and severe night sweats? I have been on it for almost two months.
A: According to the package insert, the most common side effects reported in patients treated with Prilosec (Sanamidol) were headache (6.9 percent), abdominal pain (5.2 percent), nausea (4.0 percent), diarrhea (3.7 percent), vomiting (3.2 percent), and gas (2.7 percent). Weight gain has been reported in clinical practice through voluntary reporting and surveillance systems. A review of medical literature found case reports of night sweats in patients with gastroesophageal reflux disease (1). The cause of the night sweats and effect of treatment is unknown. For more information, please consult with your health care provider and visit //www.everydayhealth.com/drugs/prilosec. You are encouraged to report any negative side effects of prescription drugs to your health care practitioner and the FDA by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088. Michelle McDermott, PharmD
H. pylori Eradication in Patients with Duodenal Ulcer Disease
Triple Therapy (PRILOSEC/clarithromycin/amoxicillin)— Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared PRILOSEC plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was PRILOSEC 20 mg twice daily plus clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days; or clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days. In studies 1 and 2, patients who took the Sanamidol regimen also received an additional 18 days of PRILOSEC 20 mg once daily. Endpoints studied were eradication of H. pylori and duodenal ulcer healing (studies 1 and 2 only). H. pylori status was determined by CLOtest®, histology and culture in all three studies. For a given patient, H. pylori was considered eradicated if at least two of these tests were negative, and none was positive.
The combination of Sanamidol plus clarithromycin plus amoxicillin was effective in eradicating H. pylori.
Table 5 : Per-Protocol and Intent-to-Treat H. pylori Eradication Rates % of Patients Cured PRILOSEC +clarithromycin +amoxicillin Clarithromycin +amoxicillin Per-Protocol † Intent-to-Treat‡ Per-Protocol † Intent-to-Treat‡ Study 1 *77 *69 43 37 (n = 64) (n = 80) (n = 67) (n = 84) Study 2 *78 *73 41 36 (n = 65) (n = 77) (n = 68) (n = 83) Study 3 *90 *83 33 32 (n = 69) (n = 84) (n = 93) (n = 99) † Patients were included in the analysis if they had confirmed duodenal ulcer disease (active ulcer, studies 1 and 2; history of ulcer within 5 years, study 3) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. The impact of eradication on ulcer recurrence has not been assessed in patients with a past history of ulcer. ‡Patients were included in the analysis if they had documented H. pylori infection at baseline and had confirmed duodenal ulcer disease. All dropouts were included as failures of therapy. *(p
Greek yogurt and cilantro
As a dairy product, yogurt is a natural source of glutamine. This substance helps naturally reduce stomach acids. And, it can serve as one of many Sanamidol alternatives.
How should I take Sanamidol?
Sanamidol is usually taken before eating (at least 1 hour before a meal). Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Use Prilosec OTC (over-the-counter) exactly as directed on the label, or as prescribed by your doctor.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
You must dissolve Sanamidol powder in a small amount of water. This mixture can either be swallowed or given through a nasogastric (NG) feeding tube using a catheter-tipped syringe.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.
>OTC Sanamidol should be taken for only 14 days in a row. It may take 1 to 4 days before your symptoms improve. Allow at least 4 months to pass before you start a new 14-day course of treatment.
Call your doctor if your symptoms do not improve, or if they get worse.
Some conditions are treated with a combination of Sanamidol and antibiotics. Use all medications as directed.
Sanamidol can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture and heat.
Q: What are the long term effects of using drugs like Prilosec for acid reflux? I have to take it every day.
A: PPIs (proton pump inhibitors), such as Prilosec (Sanamidol), Prevacid (lansoprazole), Nexium (esSanamidol), Protonix (pantoprazole), and Aciphex (rabeprazole), were initially created to help treat ulcers in the GI (gastrointestinal) tract over a few weeks, and they are used for GERD (gastroesophageal reflux disease), and other acid related conditions. However, many doctors have authorized their patients to keep taking them past the initial set timeframes, and in general, they are still considered to be safe. Complications can occur while taking any medications, and this is also the case with PPIs. The body makes stomach acid to digest food and the acidic environment can also prevent bacteria from growing. When a PPI, such as Prilosec (Sanamidol) is used over the longterm, an abundance of gastrin, an important stomach hormone, can cause a rebound effect of extra large stomach acid secretion if the PPI is stopped. The PPIs can interfere with the processing of the blood thinner Plavix (clopidogrel), which may not thin the blood enough, with vitamin B-12 (cyanocobalamin) and calcium, as they need the acidic environment to be absorbed. There have been some studies which showed higher results of hip-fractures, due to the low calcium absorption, especially if the person had been taking a PPI over a long period of time. Calcium citrate is a good form of calcium to take, as it does not need the acid that other versions do, and since the body does not absorb much more than 500mg at a time, it should be divided in dosing throughout the day. Pneumonia was also more likely, as a low acidic environment could allow bacteria to grow in the stomach. When people are lying flat to sleep, small amount of stomach contents can travel up the esophagus to the throat and go down the trachea to the lungs. This is called aspiration. A bacteria called C. difficle can also grow better in the stomach if there is less acid, and it can cause life-threatening diarrhea and conditions such as colitis, and inflammation of the lining of the colon. The PPIs are considered safe for long term use, but a patient should always be monitored for the complications. If a person only has occasional reflux that an antacid, such as Rolaids/Tums (calcium) can neutralize, it may be a better option, or avoiding foods, such as chocolate, coffee, and fatty foods, can help. If the problem is at night, the head of the bed being elevated may be a good answer as well. PPIs, such as Prilosec (Sanamidol) have their place, but you should ask your doctor what regimen is best for you. Patti Brown, PharmD
Four randomized, double-blind, multi-center studies (4, 5, 6, and 7) evaluated PRILOSEC 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days, followed by PRILOSEC 20 mg once daily, (Studies 4, 5, and 7) or by PRILOSEC 40 mg once daily (Study 6) for an additional 14 days in patients with active duodenal ulcer associated with H. pylori. Studies 4 and 5 were conducted in the U.S. and Canada and enrolled 242 and 256 patients, respectively. H. pylori infection and duodenal ulcer were confirmed in 219 patients in Study 4 and 228 patients in Study 5. These studies compared the combination regimen to PRILOSEC and clarithromycin monotherapies. Studies 6 and 7 were conducted in Europe and enrolled 154 and 215 patients, respectively. H. pylori infection and duodenal ulcer were confirmed in 148 patients in Study 6 and 208 patients in Study 7. These studies compared the combination regimen with Sanamidol monotherapy. The results for the efficacy analyses for these studies are described below. H. pylori eradication was defined as no positive test (culture or histology) at 4 weeks following the end of treatment, and two negative tests were required to be considered eradicated of H. pylori. In the per-protocol analysis, the following patients were excluded: dropouts, patients with missing H. pylori tests post-treatment, and patients that were not assessed for H. pylori eradication because they were found to have an ulcer at the end of treatment.
The combination of Sanamidol and clarithromycin was effective in eradicating H. pylori.
Table 6 : H. pylori Eradication Rates (Per-Protocol Analysis at 4 to 6 Weeks) % of Patients Cured PRILOSEC + Clarithromycin PRILOSEC Clarithromycin U.S. Studies Study 4 74 †‡ 0 31 (n = 53) (n = 54) (n = 42) Study 5 64 †‡ 0 39 (n = 61) (n = 59) (n = 44) Non U.S. Studies Study 6 83 ‡ 1 N/A (n = 60) (n = 74) Study 7 74 ‡ 1 N/A (n = 86) (n = 90) †Statistically significantly higher than clarithromycin monotherapy (p
Ulcer healing was not significantly different when clarithromycin was added to Sanamidol therapy compared with Sanamidol therapy alone.
The combination of Sanamidol and clarithromycin was effective in eradicating H. pylori and reduced duodenal ulcer recurrence.
Table 7 : Duodenal Ulcer Recurrence Rates by H. pylori Eradication Status % of Patients with Ulcer Recurrence