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Overview

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Name

Famotidine

Precaution

- **Pregnancy and Breastfeeding**: **Famotidine** is classified as **Pregnancy Category B** by the FDA, meaning that studies in animals have shown no evidence of harm to the fetus, but there are no well-controlled studies in pregnant women. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is excreted into breast milk in small amounts, so caution is advised when using it in breastfeeding women. If the benefits outweigh the risks, use in lactating women may be considered. - **Renal Impairment**: **Famotidine** is primarily excreted by the kidneys. In patients with **renal impairment**, particularly those with **creatinine clearance (CrCl)** less than 30 mL/min, the dose should be reduced to avoid drug accumulation and potential toxicity. Patients with severe renal dysfunction should be closely monitored for adverse effects, especially in prolonged therapy. - **Hepatic Impairment**: Though **famotidine** is not extensively metabolized by the liver, caution is still needed in patients with significant **hepatic impairment**, especially for long-term use or high doses. Liver function should be monitored periodically during treatment. - **Gastrointestinal Disorders**: Use with caution in patients with a history of **gastrointestinal bleeding** or **gastric ulcer**, as famotidine reduces gastric acidity and could mask symptoms of bleeding or ulcer-related complications. Famotidine should be used judiciously in patients with a history of **recurrent peptic ulcers** or **gastritis**. - **Elderly Patients**: Elderly patients may have altered renal function, so dose adjustments may be necessary to avoid drug accumulation. They are also at a higher risk for potential **drug interactions**, especially if they are on multiple medications.

Indication

- **Peptic Ulcer Disease (PUD)**: **Famotidine** is commonly prescribed for the treatment of **duodenal ulcers** and **gastric ulcers**. It works by inhibiting **gastric acid secretion**, thus allowing ulcers to heal. For duodenal ulcers, the typical course of therapy lasts up to 4 to 8 weeks. - **Gastroesophageal Reflux Disease (GERD)**: Famotidine is used for **GERD** to reduce gastric acid secretion, which helps alleviate the symptoms of heartburn, acid regurgitation, and discomfort associated with reflux disease. It is effective in managing both the acute symptoms and long-term management of GERD. - **Zollinger-Ellison Syndrome**: **Famotidine** is used in the treatment of **Zollinger-Ellison syndrome**, a rare condition characterized by **gastrinoma** and excessive gastric acid secretion. The drug helps to reduce acid output and manage symptoms related to this syndrome. - **Off-Label Uses**: Famotidine has been used off-label for **prevention of stress ulcers** in critically ill patients, although this is not its primary indication. It has also been explored in the context of **drug-induced gastrointestinal distress** or **preoperative use** for reducing gastric acidity prior to surgery, particularly in patients at high risk for aspiration. - **Evidence-Based Context**: Famotidine's efficacy in reducing gastric acid secretion and promoting ulcer healing has been demonstrated in multiple clinical trials, making it a first-line treatment for **PUD** and **GERD**. It is often preferred over older **H2 blockers** due to its higher potency and fewer side effects.

Contra indication

- **Hypersensitivity**: **Famotidine** is contraindicated in patients who have a known hypersensitivity to the drug or any of its components, including reactions such as **angioedema** or **rash**. - **Severe Renal Impairment**: In patients with **severe renal impairment** (CrCl less than 10 mL/min), **famotidine** should be avoided, or used with extreme caution, due to the potential for drug accumulation and increased risk of **adverse effects**. In these cases, dose reduction or alternative therapies may be considered. - **Liver Disease**: Although famotidine is not extensively metabolized by the liver, caution is still advised for patients with **severe liver disease**. Use should be closely monitored, especially for those on prolonged therapy. - **Pregnancy and Breastfeeding**: Famotidine should be used in **pregnant** or **breastfeeding women** only if the potential benefits outweigh the potential risks. It is classified as **Category B** for pregnancy, and while it is generally considered safe for breastfeeding, it is always best to use it with caution during lactation.

Side Effect

- **Common Side Effects**: - **Headache**: A mild and common side effect of famotidine, often transient and manageable. - **Dizziness**: Some patients may experience dizziness or lightheadedness, particularly in elderly patients. - **Constipation**: Famotidine may cause mild constipation in some individuals, although this is less common. - **Diarrhea**: Diarrhea is another gastrointestinal side effect, though it is generally mild and resolves with continued use. - **Serious Side Effects**: - **Severe Allergic Reactions**: Rare but serious allergic reactions, including **angioedema** (swelling of the face, lips, or throat), **urticaria** (hives), and difficulty breathing, may occur. Immediate medical attention is required. - **Arrhythmias**: Famotidine has been rarely associated with **arrhythmias**, including **bradycardia** and **tachycardia**. Monitoring heart function is recommended, especially in patients with underlying heart conditions. - **Liver Enzyme Elevation**: Some patients may experience elevations in liver enzymes, especially with prolonged use, requiring **liver function monitoring**. - **CNS Effects**: Confusion, hallucinations, or agitation, particularly in elderly patients or those with renal impairment, have been reported but are rare. - **Long-Term Side Effects**: Chronic use of **famotidine** at high doses may lead to **vitamin B12 deficiency** and potential **bone fractures** due to prolonged acid suppression, although this is not a common occurrence.

Pregnancy Category ID

2

Mode of Action

**Famotidine** is a **histamine H2-receptor antagonist**, meaning it blocks the action of histamine on the **H2 receptors** located on the **parietal cells** in the stomach lining. Histamine normally stimulates the **H2 receptors**, leading to an increase in **gastric acid secretion**. By inhibiting this receptor, famotidine effectively **reduces gastric acid production**, which aids in the healing of ulcers and alleviates symptoms associated with **GERD** and other acid-related conditions. - **Pharmacodynamics**: The primary effect of famotidine is a **decrease in gastric acid secretion**, resulting in a **lower pH** in the stomach. This promotes the healing of gastric and duodenal ulcers, reduces acid reflux, and relieves discomfort associated with acid indigestion. - **Pharmacokinetics**: **Famotidine** is rapidly absorbed after oral administration, with peak plasma concentrations occurring within **1-3 hours**. It has a **half-life of 2.5 to 3.5 hours**, which allows for twice-daily dosing. Famotidine is **excreted primarily by the kidneys**, and its clearance may be reduced in patients with **renal impairment**.

Interaction

- **Antacids**: The coadministration of **famotidine** with **antacids** can alter the absorption of the drug, as antacids can increase the pH of the stomach, affecting the bioavailability of famotidine. To minimize this interaction, it is advised to take **famotidine** at least **1 hour before** or **after** an antacid. - **Warfarin**: There is a potential interaction between **famotidine** and **warfarin**, as famotidine may enhance the anticoagulant effect of **warfarin**, increasing the risk of bleeding. Frequent **monitoring of INR (International Normalized Ratio)** is recommended for patients taking both medications. - **Ketoconazole**: **Famotidine** can decrease the absorption of **ketoconazole** by raising gastric pH. This can reduce the effectiveness of ketoconazole, particularly in patients who are using it to treat fungal infections. The administration of ketoconazole should be done at least **2 hours before** famotidine. - **Theophylline**: There is a potential interaction between **famotidine** and **theophylline** in which famotidine may increase the serum concentration of theophylline. Monitoring for **toxicity** is recommended when these drugs are used together. - **Alcohol**: Alcohol may exacerbate the **gastrointestinal side effects** of famotidine, such as **gastric irritation** or **nausea**. While there is no direct contraindication, it is advised to limit alcohol consumption during therapy. - **Cimetidine and Ranitidine**: Combining famotidine with other **H2 receptor antagonists** like **cimetidine** or **ranitidine** is generally unnecessary and not recommended, as it may lead to increased risk of **adverse effects** due to additive pharmacologic actions.

Pregnancy Category Note

Information not available

Adult Dose

- **Peptic Ulcer Disease (PUD)**: The typical dose for adults is **20 mg twice daily** for **duodenal ulcers** or **40 mg once daily** at bedtime for **gastric ulcers**. The duration of therapy usually lasts between **4 to 8 weeks**. - **Gastroesophageal Reflux Disease (GERD)**: For GERD, **20 mg twice daily** is often prescribed, though some patients may require higher doses depending on the severity of symptoms. - **Zollinger-Ellison Syndrome**: For this condition, higher doses of **40 mg every 6 hours** may be required. Treatment should be adjusted based on symptom relief and acid output monitoring. - **Prevention of Stress Ulcers**: **20 to 40 mg once daily** is typically used for ulcer prevention in critically ill patients.

Child Dose

- **Pediatrics (Children 1-16 years)**: The typical dose for pediatric patients with **peptic ulcers** or **GERD** is **0.5 mg/kg** given twice daily, with a maximum dose of **40 mg/day**. Dosing adjustments may be required for children with **renal impairment**. The safety and efficacy of famotidine in children younger than 1 year have not been established.

Renal Dose

- **Mild Renal Impairment (CrCl 30-60 mL/min)**: No adjustment is necessary, but patients should be monitored. - **Moderate Renal Impairment (CrCl 10-30 mL/min)**: The dose should be reduced to **20 mg once daily**. - **Severe Renal Impairment (CrCl <10 mL/min)**: In this population, **famotidine** should be used with caution, and the dose should be reduced to **20 mg once daily**, or alternative therapies may be considered.

Administration

Information not available