Side effects, dosage, uses, and more

1. Prescription famotidine oral tablet is available as a generic drug and as a brand-name drug. Brand name: Pepcid.
2. Prescription famotidine also comes as a liquid suspension you take by mouth, and in an injectable form that’s only given by a healthcare provider. Famotidine also comes in over-the-counter forms.
3. Famotidine oral tablet is used to relieve symptoms of acid reflux and heartburn. It does this by reducing the amount of acid in your stomach.

Prescription famotidine oral tablet is available as a generic drug and as a brand-name drug. The brand name is Pepcid. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Prescription famotidine is also available as an oral suspension and an injectable form, which is only given by a healthcare provider. Famotidine also comes as an over-the-counter (OTC) drug. It comes as an OTC oral tablet and an OTC chewable oral tablet. This article focuses on the prescription oral tablet.

Why it’s used

Famotidine is used to relieve symptoms of acid reflux and heartburn. It does this by reducing the amount of acid in your stomach. It treats the following conditions:

• Gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into your esophagus (the tube that connects your mouth to your stomach). This may cause a burning feeling in your chest or throat, a sour taste in your mouth, or burping.
• Acid-related damage to the lining of your esophagus. When stomach acid splashes up and into the lower portion of your esophagus, it can cause damage to the tissue cells in your esophagus.
• Duodenal ulcers. The duodenal area is the part of your intestine where food passes when it leaves the stomach.
• Stomach ulcers. Also known as gastric ulcers, these are painful sores in the stomach lining.
• Conditions where your stomach makes too much acid. These conditions include Zollinger-Ellison syndrome.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

How it works

Famotidine belongs to a class of drugs called histamine-2 receptor blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Famotidine works by blocking the histamine 2 (h3) receptor in your stomach. This receptor helps release acid in your stomach. By blocking this receptor, this drug lowers the amount of acid released in your stomach.

Famotidine oral tablet can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking famotidine. This list does not include all possible side effects.

For more information on the possible side effects of famotidine, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common adult side effects for this drug are slightly different from the more common side effects for children.

• Adult side effects can include:
  • headache
  • dizziness
  • constipation
  • diarrhea
• Children under one year of age may also experience:
  • agitation, unusual restlessness, or crying for no clear reason

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Heart rate and rhythm problems. Symptoms can include:
  • dizziness
  • fainting
  • shortness of breath
  • irregular heart rate and rhythm
• Severe muscle problems. Symptoms can include:
  • unusual muscle pain that you cannot explain
  • weakness
  • fever
• Neurological problems. Symptoms can include:
  • agitation
  • anxiety
  • depression
  • trouble sleeping
  • seizures
  • sexual problems, such as decreased sex drive
• Liver problems. Symptoms can include:
  • unexplained or unusual weakness
  • decrease in appetite
  • pain in your abdomen (stomach area)
  • change in the color of your urine
  • yellowing of your skin or the whites of your eyes
• Skin problems. Symptoms can include:
  • blisters
  • rash
  • mouth sores or ulcers

Famotidine oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Before taking famotidine, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

The famotidine dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using famotidine to treat
• your age
• the form of famotidine you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Forms and strengths

Generic: Famotidine

• Form: oral tablet
• Strengths: 20 mg, 40 mg

Brand: Pepcid

• Form: oral tablet
• Strengths: 20 mg, 40 mg

Dosage for duodenal ulcer

Adult dosage (ages 18 years and older)

• Short-term dosage: 40 mg taken once per day at bedtime for up to eight weeks. Your doctor may divide your dose into 20 mg taken two times per day.
• Long-term dosage: 20 mg taken once per day at bedtime.

Child dosage (ages 0–17 years, 40 kg [88 lbs.] or greater)

• Short-term dosage: 40 mg taken once per day at bedtime for up to eight weeks. Your doctor may divide your dose into 20 mg taken two times per day.
• Long-term dosage: 20 mg taken once per day at bedtime.
• Dosage changes: Your doctor may adjust your dosage and length of treatment based on how well you respond to the drug.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with moderate or severe kidney disease: Your doctor may decrease your dose of this drug by half or they may have you take one dose every 48 hours instead of every day.

Dosage for gastric ulcer

Adult dosage (ages 18 years and older)

• Short-term dosage: 40 mg taken once per day at bedtime for up to eight weeks.

Child dosage (ages 0–17 years, 40 kg [88 lbs.] or greater)

• Short-term dosage: 40 mg taken once per day at bedtime for up to eight weeks.
• Dosage changes: Your doctor may adjust your dosage and length of treatment based on how well you respond to the drug.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with moderate or severe kidney disease: Your doctor may decrease your dose of this drug by half. Or they may have you take one dose 48 hours instead of every day.

Dosage for gastroesophageal reflux disease

Adult dosage (ages 18 years and older)

• Gastroesophageal reflux disease (GERD) symptoms: 20 mg taken two times per day for up to six weeks.
• Esophagitis (irritated esophagus with sores) with GERD symptoms: 20 to 40 mg taken two times per day for up to 12 weeks.

Child dosage (ages 0–17 years, 40 kg [88 lbs. ] or greater)

• Gastroesophageal reflux disease (GERD) symptoms: 20 mg taken two times per day for up to six weeks.
• Esophagitis (irritated esophagus with sores) with GERD symptoms: 20 to 40 mg taken two times per day for up to 12 weeks.
• Dosage changes: Your doctor may adjust your dosage and length of treatment based on how well you respond to the drug.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with moderate or severe kidney disease: Your doctor may decrease your dose of this drug by half. Or they may have you take one dose every 48 hours instead of every day.

Dosage for pathological hypersecretory conditions

Adult dosage (ages 18 years and older)

• Typical starting dose: 20 mg taken every 6 hours.
• Dose increases: Your doctor may increase your dose based on your symptoms.
• Maximum dose: People with severe disease may need 160 mg taken every 6 hours.

Child dosage (under 0–17 years)

This drug hasn’t been studied in children under 18 years of age for the treatment of this condition.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with moderate or severe kidney disease: Avoid using famotidine tablets for treating pathological hypersecretory conditions. The doses required for treating this condition may be higher than the maximum doses recommended in people with kidney disease.

Famotidine oral tablet comes with several warnings.

Allergy warning

Famotidine can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling in your eye(s) or face
• swelling of your throat or tongue
• rash
• hives

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it or other histamine receptor blockers (such as cimetidine, ranitidine, or nizatidine). Taking it again could be fatal (cause death).

Ranitidine, brand name Zantac, is now marketed as Zantac 360, which contains a different active ingredient (famotidine). Famotidine is in the same class as ranitidine and works the same way but has not been found to contain unacceptable levels of NDMA.

Warnings for people with certain health conditions

For people with moderate or severe kidney disease: If you have kidney problems, you may not be able to clear this drug from your body. This may increase the levels of this drug in your body. The increased levels may cause more side effects, such as confusion and an irregular heart rhythm called QT prolongation.

Warnings for other groups

For pregnant women: There haven’t been enough studies done in humans to show if famotidine poses a risk to a human fetus. Research in animals has not shown a risk to the fetus when the mother takes the drug. However, animal studies don’t always predict the way humans would respond.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used in pregnancy if clearly needed.

For women who are breastfeeding: Famotidine may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children:

• Famotidine may be used in children with peptic ulcer disease (such as duodenal or gastric ulcer) and gastroesophageal reflux disease (GERD).
• This drug hasn’t been studied in children under 18 years of age for the treatment of pathological hypersecretory conditions or reducing the risk of duodenal ulcer recurrence.
• Famotidine tablets are not recommended for use in children weighing less than 40 kg (88 lbs.). This is because the strengths of these tablets are greater than the recommended dose for these children. For these children, consider using another form of famotidine (such as the oral suspension).

Famotidine oral tablet is used for long-term treatment of Zollinger-Ellison syndrome and maintaining healing of ulcers. Famotidine oral tablet is used for short-term treatment of gastroesophageal reflux disease (GERD) and duodenal and gastric ulcers. Famotidine comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your acid reflux, heartburn, or ulcer symptoms may not get better or may get worse.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• agitation
• confusion
• seizures
• severe muscle pain

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You should have less pain and your symptoms should improve.

Keep these considerations in mind if your doctor prescribes famotidine oral tablet for you.

General

• You can take famotidine with or without food.
• Take this drug at the time(s) recommended by your doctor.
• You can cut or crush the tablet.
• Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Storage

Store the oral tablets at 77°F (25°C). They may be stored for a short time from 59°F to 86°F (15°C to 30°C). Keep them away from light.Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Your diet

Certain foods and beverages may irritate your stomach. This irritation could make your symptoms worse. Your doctor may suggest that you avoid spicy, acidic, and fatty foods while you take this drug. (Acidic foods include tomatoes and citrus fruits.) They may also ask you to avoid beverages with caffeine.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Top famotidine alternatives and how to switch your Rx

Famotidine doesn’t work for everyone. OTC antacids, h3 blockers, and proton pump inhibitors are some famotidine alternatives. Get the full list here.

Compare famotidine alternatives | OTC antacids | h3 blockers | PPIs | Natural alternatives | How to switch meds

Most people have heard of the brand-name stomach medications Pepcid or Pepcid AC. The generic form of Pepcid is famotidine. Famotidine is an FDA-approved over-the-counter (OTC) medication that is used to treat heartburn, indigestion, and stomach pain. It is specifically indicated for gastroesophageal reflux disease (GERD) and gastric or duodenal ulcer.

The cells in the stomach that are responsible for producing acid are called parietal cells. These cells produce acid when stimulated by three things: the vagus nerve, gastrin, and histamine. Famotidine blocks the histamine receptor; specifically histamine type 2 receptors. By doing this, it decreases the amount of acid these cells can secrete into the stomach. 

There are several heartburn medications available. Some are more effective than others and some cause side effects and drug interactions that may make an alternative necessary.

What can I take instead of famotidine?

If looking to switch from famotidine to another drug within the same class of medications (h3 blockers or h3 receptor antagonists), there is Tagamet (cimetidine) and Axid (nizatidine). Zantac (ranitidine) had been a viable alternative for years, however, a couple years ago this was removed from the market due to a potential carcinogen being discovered in the manufacturing process (this has not been found with famotidine). Cimetidine and nizatidine are fairly equivalent in their efficacy with acid reflux and stomach ulcer healing as compared to famotidine. However, nizatidine is often not as readily available as the others.

If the issue is that famotidine is not working as well as you would have liked, it may be time to jump up to a more potent class of acid reducers, which would be the proton pump inhibitors (or PPIs). These include Prilosec (omeprazole), Nexium (esomeprazole), Protonix (pantoprazole), Aciphex (rabeprazole), Prevacid (lansoprazole), Dexilant (dexlansoprazole), and Zegerid (omeprazole-sodium bicarbonate). These medications are stronger acid reducers, and usually work better to treat stubborn acid reflux symptoms. PPIs also will be better at healing duodenal or gastric ulcers. They work by inhibiting the final common pathway in the production of stomach acid by the parietal cell, the proton pump (hence their name). The h3 blockers just stop one step on the way to the acid production.

If it is just a quick fix you are looking for mild, occasional heartburn symptoms, try one of the fast-acting antacids, such as Tums (calcium carbonate), Rolaids (calcium carbonate-magnesium hydroxide), or Gaviscon (aluminum hydroxide-magnesium carbonate). These medications are fairly inexpensive and work faster than the h3 blockers or the PPIs to curb heartburn symptoms. However, they are not indicated to heal ulcers.

Top 3 famotidine alternatives

1. Over-the-counter antacids

These include Tums, Rolaids, Alka Seltzer, Maalox, and Gaviscon. These medications are safe, inexpensive, act fast, and can be taken several times a day if needed. The downside is that their effects often don’t last that long, and they are not indicated for erosive esophagitis or peptic ulcer disease.

RELATED: Pepto Bismol vs. Tums

2. h3 blockers

These are the same class as famotidine, and include alternatives cimetidine and nizatidine. These alternatives are equally effective as famotidine for the most part, are available OTC, and are usually inexpensive. The potential downside is they will likely present the same issues as your original reasons for switching medications in the first place.

3. Proton pump inhibitors

The proton pump inhibitors include Prilosec (omeprazole), Nexium (esomeprazole), Protonix (pantoprazole), Aciphex (rabeprazole), Prevacid (lansoprazole), Dexilant (dexlansoprazole), and Zegerid (omeprazole-sodium bicarbonate). These medications are stronger acid reducers, and usually work better to treat stubborn acid reflux symptoms, and also will be better at healing gastric or duodenal ulcers. The downside is that they can be more expensive OTC alternatives compared to the other medications discussed. 

RELATED: Famotidine vs. omeprazole

Natural alternatives to famotidine

GERD is a condition where there are probably more natural remedies than any other gastrointestinal condition (save constipation perhaps). I tell my patients with mild reflux symptoms that I am fine with using natural remedies and lifestyle changes, so long as they have no condition that requires a prescription medication. This would include Barrett’s esophagus and reflux induced esophagitis. These conditions would require PPIs, usually long term.

Baking soda, which is sodium bicarbonate, a basic compound, can neutralize the acid in the stomach. A tablespoon in a glass of water when heartburn occurs, can be very effective as a fast-acting antacid.

Aloe vera juice can also help to coat the esophagus and stomach. This is sold in many super markets. It can be purchased as a juice in a bottle, or as a capsule. About 4 ounces twice a day is usually sufficient. 

Many of my patients with reflux or indigestion have had a good response to apple cider vinegar. A teaspoon or tablespoon as needed when symptoms occur, or on a daily basis can help relieve indigestion symptoms quickly. This likely works by a negative feedback to tell the stomach to stop producing acid.

Always ask your healthcare provider before using supplements to treat heartburn or any other condition as supplements can affect your other medications or health conditions, causing potential for serious side effects.

RELATED: The best diet for acid reflux

How to switch to a famotidine alternative

It’s always a good idea to taper any long-term medication prior to discontinuing. Although it may not be necessary, it certainly won’t hurt. The same is true with famotidine. Even though it does not necessarily require a taper for safety reasons, tapering famotidine will prevent any rebound acid reflux from occurring (although this is less necessary than with the PPIs, where tapering is strongly recommended). As you are tapering off the famotidine, you can try the alternative medication, whether it is another h3 blocker, a stronger PPI medication, or a fast-acting antacid. Remember, if you have any questions about switching medications, or if you experience worsening symptoms despite switching, contact your healthcare provider for medical advice.

Famotidine tablets 20 mg Kievmedpreparat

• Indications
• Contraindications
• Dosage and Administration
• Adverse reactions
• Overdose
• Interaction with other medicinal products and other forms of interaction
• Pharmacological properties
• Expiry date
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

Composition:

active ingredient: 1 tablet contains famotidine in terms of 100% substance 20 mg;

excipients: lactose, monohydrate; potato starch; povidone; calcium stearate; silicon dioxide colloidal anhydrous.

Dosage form

Tablets.

Pharmacotherapeutic group

Agents for the treatment of peptic ulcer and gastroesophageal reflux disease. H2 receptor antagonists. ATC code A02B A03.

Clinical characteristics

Indications

• Benign gastric ulcer.
• Peptic ulcer of the duodenum (treatment and prevention of recurrence).
• Hypersecretory conditions such as Zollinger-Ellison syndrome.
• Treatment of gastroesophageal reflux disease (reflux esophagitis).
• Prevention of the development of symptoms and erosions or ulceration associated with gastroesophageal reflux disease.

Contraindications

Hypersensitivity to any component of the drug and other histamine H2 receptor antagonists.

Childhood, pregnancy or lactation (due to lack of necessary clinical experience).

Dosage and administration

The drug is most effective in the evening before bedtime. When taking famotidine twice a day, one dose should be taken in the morning, the other in the evening before bedtime.

Peptic ulcer of the duodenum and stomach (benign)

40 mg in the evening before bed for 4-8 weeks.

Prevention of recurrence of duodenal ulcer

To prevent recurrence after achieving a therapeutic effect, administer at a maintenance dose: 20 mg once a night for 1-4 weeks.

Gastroesophageal reflux disease (reflux esophagitis)

20 mg or 40 mg (depending on the severity of the disease) 2 times a day. Treatment lasts for 6-12 weeks.

For gastroesophageal reflux disease associated with erosive esophagitis or ulcers, 40 mg twice a day for 6-12 weeks.

For the prevention of recurrence of symptoms and erosions or ulceration associated with gastroesophageal reflux disease (maintenance therapy). Assign 20 mg 2 times a day.

Zollinger-Ellison syndrome

Select the dose of the drug individually. Patients who have not previously been prescribed antisecretory drugs should be given an initial dose of 20 mg 4 times a day (every 6 hours). For patients who have previously used other histamine H2 receptor antagonists, a higher initial dose of 40 mg every 6 hours can be immediately prescribed. Then the dose is adjusted depending on the level of secretion of gastric juice, as well as the clinical condition of the patient. Treatment should be carried out as long as clinical symptoms of the disease are observed.

If necessary, increase the daily dose gradually, depending on the individual, until the optimal dose is reached.

According to the literature, the highest doses of famotidine taken by patients with severe forms of the disease were up to 160 mg every 6 hours.

Dosing in renal failure

If creatinine clearance is less than 30 ml/min, serum creatinine level is more than 3 mg/100 ml, the daily dose of the drug should be reduced to 20 mg or the interval between doses should be increased to 36-48 hours .

Discontinue treatment with the drug gradually due to the risk of rebound syndrome with abrupt withdrawal.

Dosage for the Elderly

Dosage adjustment is not necessary for the elderly, except in patients with renal insufficiency.

Adverse reactions

Adverse events are listed below and classified by organ system. However, their causal relationship with famotidine therapy has not been established.

* Gynecomastia is extremely rare and is reversible if treatment is stopped. If any serious adverse reactions develop, treatment with Famotidine should be discontinued.

Overdose

Symptoms: Vomiting, restlessness, tremors, hypotension, tachycardia and collapse may occur.

Treatment: stop the drug, induce vomiting and/or gastric lavage. If necessary, appropriate symptomatic and supportive treatment can be used: intravenous diazepam in case of convulsions, atropine in case of bradycardia and lidocaine in case of ventricular arrhythmia. effective hemodialysis.

Use during pregnancy or lactation.

Pregnancy.

Famotidine crosses the placenta. Adequate and well-controlled studies involving pregnant women have not been conducted.

Famotidine is not recommended during pregnancy.

Breastfeeding.

Famotidine passes into human breast milk, therefore breast-feeding should be discontinued while using Famotidine.

Children.

This drug should not be prescribed to children due to the lack of experience with its use in this category of patients.

Application features

Prior to treatment with famotidine, it is necessary to exclude the presence of malignant neoplasms in the stomach and duodenum. Treatment with this drug may mask the symptoms of gastric carcinoma.

In case of hepatic insufficiency, famotidine should be used with caution and at low doses.

Since cross-sensitivity between H2 receptor antagonists has been reported, the use of Famotidine in patients with hypersensitivity to other H2 receptor antagonists is contraindicated.

Treatment with Famotidine cannot be carried out without a doctor’s prescription or without proper medical examination if:

• the patient suffers from kidney or liver disease. In elderly patients or in patients with impaired liver or kidney function, mental disorders (confusion) may occur that require a dose reduction;
• the patient suffers from concomitant diseases or uses other drugs at the same time;
• in a middle-aged or elderly patient, complaints of digestive disorders first appeared or previous complaints changed;
• the patient has stomach complaints and has lost weight;
• black patient stool;
• the patient has swallowing disorders or chronic abdominal pain.

The drug should be used with caution in case of acute porphyria (including history) and immunodeficiency.

Symptoms of duodenal ulcer may disappear within 1-2 weeks; however, treatment should be continued until scarring is confirmed by endoscopic or x-ray findings.

It is necessary to regularly monitor the condition of patients (especially elderly patients and patients with a history of gastric and / or duodenal ulcers) who use the drug in combination with non-steroidal anti-inflammatory drugs.

In the case of complex treatment with antacids, the interval between the use of the drug and antacids should be at least 1-2 hours.

If a dose is missed, it should be taken as soon as possible; do not double the dose if it is time for the next dose.

Treatment with the drug should not be started without prior proper medical examination in the presence of heartburn, manifestations of a hyperacid state, stomach pain or a hyperacid state after eating in elderly patients.

Patients should be warned that each Famotidine 20 mg tablet contains lactose and should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Patients should be careful when performing potentially hazardous activities that require increased attention and speed of psychomotor reactions, since the drug can cause dizziness.

Interaction with other drugs and other types of interactions

The absorption of some drugs (eg ketoconazole, amoxicillin, iron preparations) depends on the acidity of gastric juice. Therefore, famotidine must be used at least 2 hours after taking such medicines. Simultaneous use with other H2 receptor antagonists can significantly reduce the effectiveness of tolazoline. Although there are no confirmed interactions between famotidine and tolazoline, the likelihood of their existence is high enough that the effect of tolazoline should be checked at the beginning and after completion of concomitant treatment. In the event of a decrease in the effect of tolazoline, its dose should be gradually increased or treatment with famotidine should be discontinued.

Food and antacids have no significant effect on famotidine treatment.

Famotidine does not affect the hepatic cytochrome P450 oxidase system, so the metabolism of oral anticoagulants, antipyrine, aminopyrine, theophylline, phenytoin, diazepam, ethanol and propranolol remains unchanged.

Probenecid may delay the release of famotidine.

Pharmacological properties

Pharmacodynamics.

Famotidine is a potent competitive inhibitor of the histamine H2 receptor. The main clinically significant pharmacological action of famotidine is the inhibition of gastric secretion. Famotidine reduces both the concentration of acid and the volume of gastric secretion, while the production of pepsin remains proportional to the volume of secreted gastric juice.

Famotidine inhibits basal and nocturnal gastric secretion, as well as secretion stimulated by the administration of pentagastrin, betazol, caffeine, insulin and the physiological vagus nerve reflex.

The duration of inhibition of secretion when using doses of 20 mg and 40 mg is from 10 to 12 hours. Single oral doses of 20 mg and 40 mg in the evening provide inhibition of basal and nocturnal acid secretion.

Nocturnal secretion of hydrochloric acid is inhibited by 86-94% for at least 10 hours. The same doses taken in the morning reduce the acid secretion stimulated by food. This inhibition is respectively 76-84% of the initial secretion 3-5 hours after ingestion, and 25% and 30% 8 and 10 hours after ingestion, respectively.

Famotidine has virtually no effect on fasting or postprandial gastrin levels. Famotidine has no effect on gastric emptying, exocrine pancreatic function, blood flow in the liver and in the portal system.

Pharmacokinetics.

The kinetics of famotidine is linear.

Suction. Famotidine is rapidly absorbed. Bioavailability when taken orally is 40-45%. Bioavailability does not change depending on the contents of the stomach, but slightly decreases when taking antacids.

In elderly patients, no clinically significant, age-related change in the bioavailability of famotidine has been identified.

First-pass biotransformation has little effect on drug bioavailability.

Distribution. After oral administration, peak plasma concentrations are reached within 1-3 hours. With repeated administration of the cumulative effect does not occur. Plasma protein binding is relatively low, amounting to 15-20%.

Half-life – 2.3-3.5 hours. In patients with severe renal insufficiency, the half-life of famotidine may exceed 20 hours.

Metabolism of the drug occurs in the liver. The only metabolite identified in humans is the sulfoxide.

Famotidine is excreted by the kidneys (65-70%) and by metabolism of 30-35% of the administered drug. Renal clearance is 250-450 ml/min, indicating some degree of tubular excretion. 25-30% of the dose taken orally and 65-70% of the intravenously administered dose is determined in the urine unchanged. A small part of the administered dose may be excreted in the form of sulfoxide.

Pharmaceutical characteristics

Basic physical and chemical properties: white or white with a creamy tint tablets, round shape, with a flat surface, with a bevel.

Shelf life

4 years.

Storage conditions

Store in the original container at a temperature not exceeding 25 °C. Keep out of the reach of children.

Packaging

10 tablets in a blister, 2 blisters in a pack.

Dispensing category

Prescription.

Producer

PJSC “Kyivmedpreparat”.

Location

Ukraine, 01032, Kyiv, st. Saksaganskogo, 139.

Diseases of the stomach and duodenum	ICD K29.9
Other acute gastritis	ICD K29.1
Other chronic pancreatitis	ICD K86. 1
Urticaria	ICD L50.9

What is happening with two classes of acid-lowering drugs » Pharmvestnik

The Ministry of Health suspended the use of ranitidine in Russia, after which only famotidine remained among the available representatives of the group. The situation with the assessment of the risks of long-term use of the second class of acid-lowering drugs also raises questions.

It all started with Bourget

The opportunity to treat acid-related diseases appeared in the 80s, when two new classes of drugs were approved about 10 years apart – h3-histamine receptor blockers and proton pump inhibitors (PPIs).

The first type of blocker, cimetidine, was approved in 1977, but was not used for long due to interactions with a large number of drugs. Later, ranitidine and famotidine entered the market.

In some countries, but not in Russia, nizatidine is approved.

Proton pump inhibitors were first in their class with omeprazole.

Then followed the processes inherent in all drugs after entering the market: pharmacovigilance, post-registration studies and meta-analyses. As early as 1990, meta-analysis helped to formulate the famous “Bourget’s rule”. For scarring of an ulcer, the pH of the stomach must be within certain values ​​for about 18 hours a day.

Proton pump inhibitors fit into this condition, making them first-line drugs after evidence of efficacy in acid-related diseases. However, no one was going to give up H2-blockers.

What happened to h3-blockers

The situation has changed quite recently. In 2019, potential carcinogens were found in ranitidine. And the number of studies with potential risks in long-term PPI use has not reached critical mass.

Impurities of potential carcinogens over the past four years have “hooked” sartans, quinapril, metformin, varenicline, and finally ranitidine, but only for h3-blockers the consequences were the most severe. In 2020, the U.S. regulator demanded that ranitidine be withdrawn from the market due to the findings of an increase in the level of potential carcinogens during drug storage.

In Russia, the Ministry of Health in 2021 suspended the use of all approved ranitidine. The commission of the department decided to exclude it from the minimum assortment and the list of vital and essential drugs.

After the “rantitidine” storm, only famotidine remained on the Russian market among H2-blockers. The drugs of the group are not included in the first line of therapy, but the Russian Gastroenterological Association recommends them, for example, for peptic ulcer disease, when PPIs are ineffective or there are contraindications to taking them, and for dysphagia.

However, out of 10 manufacturers of oral famotidine, only three meet the needs of the market in 2022, follows from the register of Roszdravnadzor.

What happened to the IPP

The situation with the IPP developed less dramatically, but required the participation of experts from specialized communities. Clinical studies in recent years have raised increasing concerns about the risks of PPI use. As a rule, they were associated with long-term use of the drugs of the group.

A recent evaluation of a cohort of 75,000 people showed an increased risk of infections, decompensation with cirrhosis of the liver, and death associated with liver damage when taking PPIs. The exception was patients with gastrointestinal bleeding – their mortality rate decreased.

In addition, proton pump inhibitors doubled the risk of COVID-19 (unlike h3-blockers), and administration during hospitalization increased the risk of severe clostridial infection.

One of the explanations of the phenomenon was given by prof. Andrey Karateev – increased acidity of the stomach is a barrier to the penetration of pathogenic microorganisms. Long-term antisecretory therapy inevitably increases the risk of infections. This also affects the exchange of calcium due to a decrease in its solubility, leads to a decrease in bone density and the risk of fractures.

A recent meta-analysis has proven the latter suggestion. When assessing the data of 900 thousand people, the risk of fractures increased even in children and young people when taking PPIs, but not h3-blockers.

Expert response

A critical mass of evidence prompted the American Gastroenterological Association (AGA) to issue a statement in 2022. Among the reasons for this situation, experts noted the widespread use of PPIs for indications where their benefits are not obvious.

Withdrawal of drugs (when they are no longer indicated) is an important strategy to reduce theoretical risks. PPIs are generally safe, experts say, but should not be used without the expected benefit. In the absence of clear indications, drugs should be canceled. The physician is responsible for assessing the need for PPIs.

Some proton pump inhibitors are available without a prescription. The expansion of indications and the emergence of generics have made drugs one of the most prescribed groups.