Side effects zantac 150: Zantac (Ranitidine) Side Effects | NDMA Contamination

13.03.202128.07.2023 by alexxlab

Содержание

Zantac (Ranitidine) Side Effects | NDMA Contamination

Common side effects of Zantac (ranitidine) include headaches, diarrhea and nausea. These side effects are mild and temporary. Rare, serious Zantac side effects include liver failure, acute porphyria attacks in patients with acute porphyria and pneumonia.

What Are the Common Side Effects of Zantac (Ranitidine)?

Zantac made with ranitidine is no longer available on the U.S. market. The market withdrawal doesn’t affect Sanofi’s new Zantac 360 made with famotidine, and the information about side effects on this page is specifically for Zantac made with ranitidine.

The most common side effects of Zantac are mild and infrequent. They also don’t last very long. Because ranitidine is no longer available on the market, there is no new information on Zantac made with ranitidine and its side effects.

Zantac side effects may include:

Stomach pain
Constipation
Diarrhea
Headache
Drowsiness
Fatigue
Dizziness
Insomnia
Nausea
Vomiting
Rash
Dark urine
Shortness of breath
Chest pain
Jaundice
Fever

In clinical trials, the rate of Zantac side effects was very similar to those reported by people who took a placebo, or an inactive medicine, according to French researchers who published their work in Drug Safety.

Researchers in another study by Glaxo Wellcome looked at data from controlled clinical trials with more than 26,000 patients who took the drug for four weeks or more. They also looked at postmarketing surveillance studies and adverse event reports. Researchers “confirmed the excellent safety profile of ranitidine.”

But after the Valisure pharmacy alerted the FDA that batches of ranitidine contained high levels of N-nitrosodimethylamine, or NDMA, several manufacturers voluntarily recalled their ranitidine products.

On April 1, 2020, the FDA requested manufacturers immediately withdraw all prescription and over-the-counter ranitidine drugs from the market. While initial FDA testing found NDMA in ranitidine in low levels, new FDA testing confirmed that NDMA levels increase in ranitidine over time.

Headache is the most common ranitidine side effect reported in clinical trials.

Serious and Rare Zantac Side Effects

According to the drug’s insert, serious Zantac side effects are rare. If you suffer any of the following side effects, talk to your health care provider.

Serious side effects of Zantac (ranitidine) include:

Clay-colored stools
Coughing up mucus
Dark urine
Easy bruising or bleeding
Irregular heartbeat
Loss of appetite
Severe blistering, peeling, and red skin rash with headache
Vision problems
Weakness
Yellowing of the eyes or skin

Central Nervous System

Rare cases of mental confusion, depression, agitation and hallucinations and reversible blurred vision have been reported. These mental issues have been reported most often in severely ill, elderly patients. Some people also reported vertigo, dizziness and involuntary motor disturbances.

Cardiovascular Side Effects

Cardiovascular issues with Zantac are extremely rare but have occurred. French researcher T. Vial and colleagues reported the risk was about 1 in 1 million patients.

These include abnormal heart rhythms that mostly occur during rapid intravenous treatment with ranitidine. They usually subside after stopping the drug. Other cardiac events include hypertension and premature ventricular beats.

Gastrointestinal Issues

Along with constipation, diarrhea and abdominal pain, researchers also received rare reports of pancreatitis.

Liver Failure and Hepatitis

People have reported rare instances of liver failure and hepatitis. Some of these people also suffered jaundice. If this happens, discontinue Zantac immediately and speak to a health care professional. According to the drug’s label, these conditions are usually reversible. In rare cases, people died because of liver injury.

Blood Disorders

Some people who took Zantac suffered blood count changes including low white blood cells and low platelets. Rare cases of low red blood cell counts, with or without bone marrow problems, and very rare cases of acquired immune hemolytic anemia have been reported.

Gynecomastia, Impotence and Decreased Sex Drive

According to the drug’s label, controlled studies in animals and humans didn’t show that Zantac caused impotence or abnormal enlargement of the breasts called gynecomastia. But men taking the drug have reported cases of impotence and decreased sex drive when taken at high doses for a long period of time. These were comparable to the general population.

Both males and females have reported rare instances of gynecomastia and galactorrhea, a milky nipple discharge.

How Often Do Serious Side Effects Occur?

Researcher J.G. Mills and colleagues reported on rare, serious side ranitidine effects and how often they occurred out of almost 24,000 people in clinical trials. Only about 1.65 percent of people suffered serious reactions.

Frequency (%) of Serious Side Effects in 23,672 People

Abdominal pain 0.13
Nausea and vomiting 0.08
Hemorrhage 0. 09
Chest pain 0.05
Pneumonia 0.05
Headache 0.06
Malaise/fatigue 0.04
Ischemic heart disease 0.06
Cardiac infarction 0.03
Lung neoplasm 0.01
Hypertension 0.04
Phlebitis (inflammation of a vein) 0.01
Backache 0.04
Mental disorder 0.08
Renal problems 0.07
Skin and soft tissue problems 0.08
Injury and poisoning 0.05
Infectious disease 0.02
Cerebrovascular disease 0.04

NDMA Contamination Side Effects

NDMA is a chemical that was once used in the production of rocket fuel, lubricants and other industrial products. It is also found in small amounts in food, soil, air and water and is a byproduct of water chlorination, according to the Environmental Protection Agency.

The chemical is known to cause cancer in animals and may cause cancer in humans. Some people who developed cancer filed lawsuits against Zantac drugmakers. The main cancer in Zantac lawsuits is bladder cancer, but other cancers such as stomach cancer, colon cancer, prostate cancer, kidney cancer, liver cancer and breast cancer have been linked to NDMA.

The EPA lists several symptoms of overexposure to NDMA.

Potential Side Effects of NDMA Toxicity

Abdominal cramps
Diarrhea
Enlarged liver
Fever
Headache
Jaundice
Nausea
Reduced function of liver, kidneys and lungs
Vomiting

The FDA has determined the safe dietary daily intake limit for NDMA consumption is 96 ng. In September 2019, the pharmacy Valisure told the FDA that it had tested brand name and generic Zantac and found NDMA levels as high as 3,267,968 ng per tablet.

According to Valisure, ranitidine contains molecules that may actually create NDMA when exposed to conditions that mimicked the human stomach.

In December 2019, the FDA announced it had not found that ranitidine forms NDMA in typical human stomach conditions. The agency told manufacturers to test all batches of ranitidine and instructed them not to sell batches that contain NDMA levels over 96 ng.

However, further FDA testing and evaluation confirmed that NDMA levels increase in ranitidine under normal storage conditions and especially when stored at higher temperatures, such as those during distribution and consumer handling. And the older the ranitidine product is, the greater the level of NDMA, the FDA found.

“These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” the FDA said in an April 1, 2020, news release.

As a result, the FDA requested immediate market withdrawal of all ranitidine products, meaning neither new nor existing prescription or OTC ranitidine products will be available for use in the U. S.

Is Zantac Safe for Pregnant Women and Children?

In general, Zantac is safe for pregnant women and children. But researchers have not established safety and effectiveness in babies less than one month old in clinical trials, according to ranitidine’s medication label.

Zantac and Pregnancy

The FDA categorized Zantac as Pregnancy Category B. This means it is unlikely to affect an unborn baby. But mothers-to-be should talk to their health care providers about whether they should use it during pregnancy or breastfeeding.

Pregnancy

In animal studies, researchers administered doses up to 160 times the human dose to rabbits and rats and found no evidence of harm to the fetus or fertility. But there have been no tests in pregnant women. The drug label recommends using the drug with caution and only if clearly needed.

Because ranitidine can travel through breast milk, nursing mothers should use caution.

Children and Babies

Zantac side effects in children one month to 16 years of age are similar to those found in adults, according to clinical trial data on the drug label.

Studies have previously shown that acid-reducing drugs such as Zantac are well tolerated by babies.

But emerging evidence suggests gastric acid inhibiting drugs may increase the risk of infections, bacterial overgrowth and other problems in children and babies, according to a study published by Mark Safe and colleagues in World Journal of Gastrointestinal Pharmacology and Therapeutics.

Before Taking Ranitidine

Ranitidine is generally safe, but not everyone should take it. People with preexisting conditions or who take certain medications should talk to their health care provider before taking the drug. Before taking ranitidine, tell your health care provider or pharmacist about any medical conditions you have or medications you take.

Warnings and Precautions

Tell your health care provider if you are allergic to ranitidine or any of the drugs in the same class called h3 blockers.
Tell your health care provider about all the medication, vitamins and supplements you take, especially if you take blood thinners such as warfarin. You may need to adjust your dose.
Tell your health care provider if you have ever had kidney or liver disease, phenylketonuria or porphyria. Zantac may trigger an acute porphyria attack.
Tell your health care provider if you have chest pain that isn’t like typical heartburn pain, especially if it is accompanied by nausea, sweating or dizziness. These symptoms could mean a heart problem.

Long Term Use & Withdrawal

In general, Zantac is safe for long-term use. But drugs that affect acid production like h3 blockers and proton pump inhibitors may affect how some vitamins like B12 are absorbed. A B12 deficiency can lead to anemia, dementia, neurological damage and other problems, some of which are irreversible.

A study by researcher Jameson R. Lam and colleagues found that people who took h3 blockers like Zantac for two or more years were more likely to have B12 deficiency than those who did not. The effect was greater in people who took proton pump inhibitors.

Zantac Withdrawal

People who used 300 mg of ranitidine for two months suffered indigestion that lasted about two days after stopping treatment.

Research has also tied long-term use of Zantac to withdrawal symptoms, mainly indigestion.

One study by British researcher A.D. Smith and colleagues found that people who used 300 mg of ranitidine for two months suffered indigestion after stopping treatment. The symptoms lasted for about two days on average and were the most severe on the second day after stopping the drug.

Ranitidine – StatPearls – NCBI Bookshelf

Indications

On April 1, 2020, The FDA announced that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market due to contamination with nitrosodimethylamine (NDMA). This article is only of historical interest.

Ranitidine was FDA-approved for both adults and children aged 1 month to 16 years. Ranitidine, over-the-counter for self-care use without a prescription, was only FDA-approved in children older than 12 years.

FDA-Approved Ranitidine Indications

Benign gastric ulcer disease, short-term, and maintenance
Duodenal ulcer disease, short-term, and maintenance
Erosive esophagitis
Hypersecretory conditions (e.g., Zollinger-Ellison, systemic mastocytosis, multiple endocrine adenoma syndrome)
Gastroesophageal reflux disease (GERD)
Non-ulcer dyspepsia, indigestion, heartburn, and sour stomach

Non-FDA-Approved Ranitidine Indications

Anaphylaxis[1][2]
NSAID-induced ulcer prophylaxis[3]
Stress ulcer prophylaxis[4]
Taxane-related urticaria prophylaxis[5]
Aspiration prophylaxis during obstetric anesthesia[6]

Mechanism of Action

Mechanism

Ranitidine is a competitive inhibitor of histamine h3-receptors. The reversible inhibition of h3-receptors in gastric parietal cells results in a reduction in both gastric acid volume and concentration. Ranitidine’s acid-lowering effect is more pronounced for basal and nocturnal acid secretion than it is for food-stimulated acid secretion. Additional indirect effects of ranitidine are decreased pepsin secretion and increased nitrate-reducing bacterial flora.

Pharmacokinetics and Pharmacodynamics

When dosed orally, ranitidine has a bioavailability of 50%, which is relatively unaffected by food. The peak levels occur 2 to 3 hours post-administration for oral administration and occur 15 minutes after intramuscular administration. Ranitidine is primarily excreted unchanged in the urine, with a half-life ranging from 2.5 to 3 hours, and because of the renal elimination, the half-life may increase to 4 to 5 hours in patients with kidney dysfunction.

Administration

Oral

Ranitidine is available as tablets, capsules, or oral syrup. Ranitidine solution or the dissolved tablet may be mixed with select enteral tube feeding solutions. [7]

Intramuscular (IM)

Administer as an undiluted solution.

Intravenous (
IV)

Intermittent IV bolus: Dilute with a compatible IV solution prior to use to a maximum concentration of 2.5 mg/mL. Then the solution may be administered at a maximum rate of 10 mg per minute.

Intermittent IV infusion: Dilute with a compatible IV solution prior to use to a maximum concentration of 0.5 mg/mL. Then the solution may be administered at a maximum rate of 2.5 to 3.5 mg per minute.

Continuous IV infusion: Dilute 150 mg ranitidine in 250 mL of a compatible IV solution. This solution then may be administered at a rate of 6.25 mg per hour. For patients with Zollinger-Ellison disease, a faster infusion rate may be required. Dilute prior to use to a maximum concentration of 2.5 mg/mL. Then the infusion may be started at a rate of 1 mg/kg per hour to a maximum dose of 2.5 mg/kg per hour. Ranitidine may be added to total parenteral nutrition. However, its stability varies greatly depending on the specific ingredients, concentrations, and packaging of the final product. [8]

Adverse Effects

The initial clinical trials for ranitidine reported the following adverse effects following oral or parenteral administration (frequency not defined):

Central nervous system (CNS): Malaise, dizziness, somnolence, insomnia, vertigo, mental confusion, agitation, and hallucinations.
Cardiovascular: Tachycardia, bradycardia, asystole, atrioventricular block, and premature ventricular beats. Bradycardia may be more frequent with rapid intravenous administration and in patients with cardiac rhythm disturbances.
Gastrointestinal (GI): Constipation, diarrhea, nausea, vomiting, abdominal discomfort, pancreatitis.
Hepatic: Hepatocellular, cholestatic, or mixed hepatitis; hepatic failure
Musculoskeletal: Myalgia, arthralgia
Hematologic: Leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, agranulocytosis
Endocrine: Decreased libido, impotence, galactorrhea, gynecomastia
Integumentary: Rash, alopecia, vasculitis
Respiratory: Pneumonia
Renal: Increased serum creatinine, acute interstitial nephritis
Other: Hypersensitivity reactions, anaphylaxis

Transient pain at the site of intramuscular (IM) injection has been reported. Transient local burning or itching has been reported with intravenous (IV) administration of ranitidine.

The 2015 Beers Criteria list identifies ranitidine as a therapy that may potentially trigger or exacerbate delirium in adults older than 65 years of age. Caution should be used when treating the elderly with ranitidine. [9]

Long-term use of ranitidine for greater than 2 years may also be associated with vitamin B12 deficiency. [10]

Pregnancy

Ranitidine is known to cross the placenta; however, it is still commonly used when pregnant patients require acid-suppressing therapy. Of note, increasing studies are revealing a correlation between acid-suppressing therapy use during pregnancy and the development of childhood asthma. [11] Likewise, ranitidine is excreted into breastmilk, and the risks and benefits of use should be discussed prior to initiating therapy.

Contraindications

Ranitidine is contraindicated in patients who have previously experienced a hypersensitivity reaction to ranitidine or any of the product components. Small case series and analyses demonstrate conflicting results regarding cross-sensitivity among h3-receptor antagonists; caution is advised. Due to differences and similarities between the chemical structures, there is speculation that some h3 blockers have less risk of cross-reactivity than others. [12][13][14]

Furthermore, patients with any history of acute porphyria should avoid ranitidine because it may trigger porphyric events.

Clinicians urge patients to seek professional medical care and contraindicate the over-the-counter product when they have difficulty or pain when swallowing food or have blood in vomit or stool. Concurrent use is contraindicated with other acid reducers, kidney disease, or in patients younger than 12 years old.

Monitoring

Efficacy Parameters

Patients should notice an improvement in symptoms. Laboratory signs of improvement would include an increase in gastric pH. For GI bleeding, the goal gastric pH is typically greater than 4. The goal gastric acid secretion in Zollinger-Ellison disease is less than 10 mEq per hour.

Additional Monitoring

For patients receiving ranitidine IV at total daily doses greater than 400 mg, daily monitoring of liver function tests (aspartate aminotransferase and alanine aminotransferase) may be warranted. For acutely ill patients, serum creatinine may also be measured to provide information for renal dose adjustments as well as to monitor for potential nephrotoxicity. When there is a concern of GI bleeding, further monitoring may include occult blood tests, hemoglobin, and hematocrit.

Toxicity

Severe toxicity to ranitidine is rare, and there currently is no antidote for ranitidine overdose. Patients may present with CNS depression or severe hypotension. Supportive treatment and monitoring based on the presenting symptoms may be warranted.

Enhancing Healthcare Team Outcomes

Guidelines and Recommendations

The 2015 American Academy of Allergy, Asthma, and Immunology (AAAAI), and American College of Allergy, Asthma, and Immunology (ACAAI) anaphylaxis practice parameter describe inadequate evidence for the use of h3-blockers in the treatment of anaphylaxis; however, h3-blockers can be considered adjunct therapy after the administration of epinephrine. [1][2] (Level II)

The 2009 American College of Gastroenterology guideline for the prevention of NSAID-related ulcer complications conclude that double-strength h3-blockers may reduce the risk of NSAID-induced endoscopic peptic ulcers. However, this guideline also concludes that h3 blockers are inferior to proton pump inhibitors for this indication.[3] (Level II)

The 2016 Surviving Sepsis Campaign guidelines recommend h3-blockers or proton pump inhibitors be used in patients with risk factors for stress ulcer prophylaxis.[4] (Level II)

The 2016 American Society of Anesthesiologists guideline for obstetric anesthesia suggest consideration of non-particulate antacids, h3 blockers and/or metoclopramide to prevent aspiration.[6] (Level II)

Review Questions

Access free multiple choice questions on this topic.
Comment on this article.

References

1.: Lieberman P, Nicklas RA, Oppenheimer J, Kemp SF, Lang DM, Bernstein DI, Bernstein JA, Burks AW, Feldweg AM, Fink JN, Greenberger PA, Golden DB, James JM, Kemp SF, Ledford DK, Lieberman P, Sheffer AL, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang D, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph C, Schuller DE, Spector SL, Tilles S, Wallace D. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010 Sep;126(3):477-80.e1-42. [PubMed: 20692689]
2.: Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of anaphylaxis: an updated practice parameter. J Allergy Clin Immunol. 2005 Mar;115(3 Suppl 2):S483-523. [PubMed: 15753926]
3.: Lanza FL, Chan FK, Quigley EM., Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009 Mar;104(3):728-38. [PubMed: 19240698]
4.: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. [PubMed: 28101605]
5.: Bookman MA, Kloth DD, Kover PE, Smolinski S, Ozols RF. Intravenous prophylaxis for paclitaxel-related hypersensitivity reactions. Semin Oncol. 1997 Dec;24(6 Suppl 19):S19-13-S19-15. [PubMed: 9427258]
6.: Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. [PubMed: 26580836]
7.: Crowther RS, Bellanger R, Szauter KE. In vitro stability of ranitidine hydrochloride in enteral nutrient formulas. Ann Pharmacother. 1995 Sep;29(9):859-62. [PubMed: 8547732]
8.: Allwood MC, H M. Factors influencing the stability of ranitidine in TPN mixtures. Clin Nutr. 1995 Jun;14(3):171-6. [PubMed: 16843929]
9.: By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. [PubMed: 26446832]
10.: Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013 Dec 11;310(22):2435-42. [PubMed: 24327038]
11.: Lai T, Wu M, Liu J, Luo M, He L, Wang X, Wu B, Ying S, Chen Z, Li W, Shen H. Acid-Suppressive Drug Use During Pregnancy and the Risk of Childhood Asthma: A Meta-analysis. Pediatrics. 2018 Feb;141(2) [PubMed: 29326337]
12.: Song WJ, Kim MH, Lee SM, Kwon YE, Kim SH, Cho SH, Min KU, Kim YY, Chang YS. Two cases of h(2)-receptor antagonist hypersensitivity and cross-reactivity. Allergy Asthma Immunol Res. 2011 Apr;3(2):128-31. [PMC free article: PMC3062792] [PubMed: 21461253]
13.: Demirkan K, Bozkurt B, Karakaya G, Kalyoncu AF. Anaphylactic reaction to drugs commonly used for gastrointestinal system diseases: 3 case reports and review of the literature. J Investig Allergol Clin Immunol. 2006;16(3):203-9. [PubMed: 16784015]
14.: Park KH, Pai J, Song DG, Sim DW, Park HJ, Lee JH, Jeong KY, Pan CH, Shin I, Park JW. Ranitidine-induced anaphylaxis: clinical features, cross-reactivity, and skin testing. Clin Exp Allergy. 2016 Apr;46(4):631-9. [PubMed: 26764898]

: Disclosure: Katie Morgan declares no relevant financial relationships with ineligible companies.
: Disclosure: Rajni Ahlawat declares no relevant financial relationships with ineligible companies.

Zantac. Effervescent tablets Reference book of medicines. Kyzyl (Republic of Tyva)

//= $single_post[“name_eng”] ?>
//= $single_post[“name_eng”] ?>

Packaging

Effervescent tablets

Pharmacological action

Reduces basal and stimulated secretion of hydrochloric acid caused by baroreceptor irritation, food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin. Duration of action after a single dose 12 hours

Indications for use

Treatment and prevention:

– exacerbations of peptic ulcer of the stomach and duodenum;

– ulcers of the stomach and duodenum associated with the use of NSAIDs;

– reflux esophagitis, erosive esophagitis;

– Zollinger-Ellison syndrome;

– treatment and prevention of postoperative, “stress” stomach ulcers;

– prevention of recurrence of bleeding from the upper gastrointestinal tract;

– prevention of aspiration of gastric juice during operations under general anesthesia (Mendelssohn’s syndrome).

Presentation form

Effervescent tablets 150 mg; tuba 10 box (box) 1;

Tablets for the preparation of an effervescent drink 300 mg; polypropylene tube 15 carton pack 1;

Tablets for the preparation of an effervescent drink 300 mg; tuba 10 box (box) 1;

Tablets for the preparation of an effervescent drink 150 mg; polypropylene tube 15 carton pack 1;

Pharmacodynamics

Reduces basal and stimulated secretion of hydrochloric acid caused by irritation of baroreceptors, food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin. Duration of action after a single dose 12 hours

Pharmacokinetics

Oral bioavailability is approximately 50%, Cmax in plasma is reached 2-3 hours after ingestion. Plasma protein binding does not exceed 15%. Partially metabolized in the liver. It is excreted mainly by the kidneys in unchanged form by tubular secretion, a small amount – with feces. The metabolism of ranitidine does not differ between parenteral and oral administration and proceeds with the formation of small amounts of N-oxide (6%), S-oxide (2%), desmethylranitidine (2%) and furoic acid analogue (1-2%). It has the effect of “first pass” through the liver. Poorly passes through the BBB, passes through the placenta, passes into breast milk (the concentration in breast milk of women during lactation is higher than in plasma).

Use during pregnancy

During pregnancy and lactation, it should be used only in cases where the potential benefit to the mother outweighs the possible risk to the fetus or child (ranitidine passes through the placenta, passes into breast milk).

Contraindications for use

Hypersensitivity to ranitidine or any other component of the formulation; pregnancy, lactation; children’s age (up to 12 years).

With caution: renal and / or liver failure, cirrhosis of the liver with a history of portosystemic encephalopathy, acute porphyria (including history).

Side effects

From the nervous system and sensory organs: headache, fatigue, dizziness, drowsiness, insomnia, vertigo, anxiety, depression; rarely – confusion, hallucinations (especially in elderly and debilitated patients), reversible blurred vision, impaired accommodation of the eye.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): arrhythmia, tachycardia / bradycardia, AV blockade, lowering blood pressure; reversible leukopenia, thrombocytopenia, granulocytopenia; rarely – agranulocytosis, pancytopenia, sometimes with bone marrow hypoplasia, aplastic anemia; sometimes – immune hemolytic anemia.

From the digestive tract: nausea, vomiting, constipation / diarrhea, abdominal discomfort / pain; rarely – pancreatitis. Sometimes – hepatocellular, cholestatic or mixed hepatitis with / without jaundice (in such cases, taking ranitidine should be stopped immediately). These effects are usually reversible, but in rare cases, death is possible. Rare cases of liver failure have also been reported.

From the musculoskeletal system: rarely – arthralgia, myalgia.

Allergic reactions: skin rash, bronchospasm, fever, eosinophilia; rarely – erythema multiforme, anaphylactic shock, angioedema.

Others: rarely – alopecia, vasculitis; in some cases – gynecomastia, decreased potency and / or libido. With prolonged use, the development of B12-deficiency anemia is possible.

Method of administration and dosage

Effervescent tablets: dissolve in water before taking (not less than 75 ml for a 150 mg tablet and not less than 150 ml for a 300 mg tablet).

Patients with renal insufficiency with Cl creatinine

Peptic ulcer of the stomach and duodenum: for the treatment of exacerbations, 150 mg 2 times a day (morning and evening) or 300 mg 1 time per day (at night) are prescribed. If necessary – 300 mg 2 times a day. The duration of the course of treatment is 4–8 weeks. For the prevention of exacerbations, 150 mg is prescribed once a day (at night).

Ulcers associated with taking NSAIDs: appoint 150 mg 2 times a day (morning and evening) or 300 mg 1 time per day (at night) for 8-12 weeks. Prevention of the formation of ulcers when taking NSAIDs – 150 mg 2 times a day (morning and evening).

Postoperative ulcers: 150 mg 2 times a day (morning and evening) for 4-8 weeks.

Gastroesophageal reflux disease: 150 mg 2 times a day (morning and evening) or 300 mg 1 time per day (at night). If necessary, the dose can be increased to 150 mg 4 times a day. The course of treatment is 8–12 weeks.

Zollinger-Ellison Syndrome: The initial dose is 150 mg 3 times a day. If necessary, the dose may be increased.

Prevention of recurrent bleeding: 150 mg 2 times a day (morning and evening).

Prevention of the development of Mendelssohn’s syndrome: prescribed at a dose of 150 mg 2 hours before anesthesia, and preferably 150 mg the evening before.

Overdose

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic and supportive therapy. With the development of seizures – diazepam IV, with bradycardia or ventricular arrhythmias – atropine, lidocaine. effective hemodialysis.

Interaction with other drugs

When used in recommended doses, ranitidine does not suppress the cytochrome P450-oxygenase system of the liver and does not enhance the activity of drugs that are inactivated by this system, incl. diazepam, lidocaine, phenytoin, propranolol, theophylline and warfarin.

Smoking reduces the effectiveness of ranitidine.

Ranitidine increases the AUC and the concentration of metoprolol in the blood serum (by 80 and 50%, respectively), while the T1 / 2 of metoprolol increases from 4.4 to 6.5 hours.

Due to the increase in the pH of the contents of the stomach, while taking itraconazole and ketoconazole, the absorption may decrease.

It inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, calcium antagonists.

Drugs that depress the bone marrow increase the risk of neutropenia.

When used simultaneously with antacids, sucralfate in high doses, ranitidine absorption may be impaired, so the interval between taking these drugs should be at least 2 hours.

Precautions

Treatment with ranitidine may mask symptoms associated with gastric carcinoma, so patients with gastric ulcer should be excluded from the possibility of malignancy prior to treatment.

Ranitidine is excreted through the kidneys, so the plasma concentration of the drug increases in severe renal failure (in this case, the dose should be adjusted).

During treatment, you should avoid eating foods, drinks and other drugs that can cause irritation of the gastric mucosa.

Storage conditions

List B.: At a temperature not exceeding 30 °C (do not freeze).

Shelf life

24 months

Zantac. Oral tablets Directory of drugs. Kyzyl (Republic of Tyva)

//= $single_post[“name_eng”] ?>
//= $single_post[“name_eng”] ?>

Packaging

Oral tablets

Pharmacological action

Indications for use

Treatment and prevention:

– exacerbations of peptic ulcer of the stomach and duodenum;

– ulcers of the stomach and duodenum associated with the use of NSAIDs;

– reflux esophagitis, erosive esophagitis;

– Zollinger-Ellison syndrome;

– treatment and prevention of postoperative, “stress” stomach ulcers;

– prevention of recurrence of bleeding from the upper gastrointestinal tract;

– prevention of aspiration of gastric juice during operations under general anesthesia (Mendelssohn’s syndrome).

Presentation form

Film-coated tablets 150 mg; blister 10 box (box) 2;

Coated tablets 150 mg; blister 15 box (box) 4;

Film-coated tablets 300 mg; blister 10 box (box) 1;

Film-coated tablets 300 mg; blister 15 box (box) 2;

Coated tablets 150 mg; blister 10 cardboard pack 2;

Film-coated tablets 300 mg; blister 10 cardboard pack 2;

Film-coated tablets 150 mg; blister 10 cardboard pack 2;

Film-coated tablets 300 mg; blister 10 cardboard pack 1;

Film-coated tablets 150 mg; blister 10 cardboard pack 2;

Film-coated tablets 300 mg; blister 10 cardboard pack 1;

Pharmacodynamics

Reduces basal and stimulated secretion of hydrochloric acid caused by irritation of baroreceptors, food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin).

Reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin. Duration of action after a single dose of 12 hours.

Pharmacokinetics

When administered orally, bioavailability is approximately 50%, Cmax in plasma is reached 2-3 hours after administration. Plasma protein binding does not exceed 15%. Partially metabolized in the liver.

The metabolism of ranitidine does not differ between parenteral and oral administration and proceeds with the formation of small amounts of N-oxide (6%), S-oxide (2%), desmethylranitidine (2%) and furoic acid analogue (1-2%). It has the effect of “first pass” through the liver. Poorly passes through the BBB, passes through the placenta, passes into breast milk (the concentration in breast milk of women during lactation is higher than in plasma).

Use during pregnancy

Use during pregnancy and lactation only if the potential benefit to the mother outweighs the possible risk to the fetus or child (ranitidine crosses the placenta, passes into breast milk)