Famotidine 40mg/4ml Inj, 4ml
It is used to treat or prevent GI (gastrointestinal) ulcers.It is used to treat gastroesophageal reflux disease (GERD; acid reflux). It is used to treat heartburn and sour stomach.It is used to treat syndromes caused by lots of stomach acid.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiulcer agent
Pharmacologic Class
Histamine H2-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Sep 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Famotidine is a medicine that reduces the amount of acid your stomach makes. It's used to treat and prevent ulcers, heartburn, and other conditions caused by too much stomach acid. The injection form is typically used in hospitals when you can't take medicine by mouth.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via intravenous injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid foods and drinks that trigger heartburn or acid reflux (e.g., spicy foods, fatty foods, caffeine, alcohol, carbonated beverages).
- Eat smaller, more frequent meals.
- Avoid eating close to bedtime (within 2-3 hours).
- Elevate the head of your bed if you experience nighttime reflux.
- Quit smoking, as smoking can worsen acid reflux.
- Maintain a healthy weight.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg IV every 12 hours for most indications (e.g., duodenal ulcer, gastric ulcer, GERD). For pathological hypersecretory conditions, 20 mg IV every 6 hours.
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
duodenal_gastric_ulcer_gerd:
20 mg IV every 12 hours
pathological_hypersecretory_conditions:
20 mg IV every 6 hours, may increase up to 160 mg every 6 hours
prevention_stress_ulcers:
20 mg IV every 12 hours
Pediatric Dosing
Neonatal:
Not established (limited data, generally avoided)
Infant:
0.5 mg/kg IV once daily (max 20 mg/day) for GERD/peptic ulcer disease (1-12 months)
Child:
0.5 mg/kg IV once daily (max 20 mg/day) for GERD/peptic ulcer disease (1-16 years)
Adolescent:
20 mg IV every 12 hours (similar to adult dosing for GERD/peptic ulcer disease)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 60 mL/min)
Moderate:
Reduce dose by 50% or extend dosing interval to every 24 hours (CrCl 30-60 mL/min)
Severe:
Reduce dose by 50% or extend dosing interval to every 36-48 hours (CrCl < 30 mL/min)
Dialysis:
Administer after dialysis; dose reduction to 50% or interval extension to every 36-48 hours. Famotidine is removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended (Famotidine is minimally metabolized by the liver)
Pharmacology
Mechanism of Action
Famotidine is a competitive inhibitor of histamine at the H2-receptors of the gastric parietal cells. This inhibition leads to a reduction in both basal and stimulated gastric acid secretion, as well as pepsin secretion. It reduces the volume and acid content of gastric secretions.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IV administration)
Tmax:
Not applicable (IV administration, peak plasma concentration achieved rapidly after IV bolus)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
0.96-1.3 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Limited (can cross blood-brain barrier, but typically low CNS effects unless high doses or renal impairment)
Elimination:
HalfLife:
2.5-3.5 hours (prolonged in renal impairment)
Clearance:
Approximately 400 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
65-70% (IV dose)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (IV)
PeakEffect:
1-3 hours (acid suppression)
DurationOfAction:
10-12 hours (acid suppression)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Dizziness or fainting
Fast or abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Headache
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Dizziness or fainting
Fast or abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Headache
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Persistent or worsening abdominal pain
- Difficulty swallowing or painful swallowing
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools (melena)
- Unexplained weight loss
- New or worsening confusion, hallucinations, or unusual drowsiness (especially in elderly or those with kidney problems)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
If you have been experiencing heartburn for 3 months or more
If you are currently taking any of the following medications: cefditoren, dasatinib, delavirdine, or fosamprenavir
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
If you have been experiencing heartburn for 3 months or more
If you are currently taking any of the following medications: cefditoren, dasatinib, delavirdine, or fosamprenavir
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, and do not exceed the recommended timeframe without consulting your doctor.
If you have pre-existing kidney problems or are 65 years or older, it is crucial to discuss this with your doctor, as you may be at a higher risk of experiencing certain side effects. These include hallucinations (seeing or hearing things that are not real), seizures, and feelings of agitation, confusion, sluggishness, or being out of sorts.
This medication may interfere with the absorption of other oral medications. If you are taking other drugs by mouth, your doctor may advise you to take them at a different time than this medication to ensure optimal absorption.
Some formulations of this medication may contain benzyl alcohol. It is recommended to avoid products containing benzyl alcohol in newborns and infants, as high doses of benzyl alcohol can cause severe side effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss alternative options.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is essential to inform your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
If you have pre-existing kidney problems or are 65 years or older, it is crucial to discuss this with your doctor, as you may be at a higher risk of experiencing certain side effects. These include hallucinations (seeing or hearing things that are not real), seizures, and feelings of agitation, confusion, sluggishness, or being out of sorts.
This medication may interfere with the absorption of other oral medications. If you are taking other drugs by mouth, your doctor may advise you to take them at a different time than this medication to ensure optimal absorption.
Some formulations of this medication may contain benzyl alcohol. It is recommended to avoid products containing benzyl alcohol in newborns and infants, as high doses of benzyl alcohol can cause severe side effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss alternative options.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is essential to inform your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypotension (low blood pressure)
- Tachycardia (fast heart rate)
- Vomiting
- Diarrhea
- Respiratory distress
- CNS effects (e.g., ataxia, convulsions, restlessness, confusion)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive. Hemodialysis may be effective in removing famotidine from the blood.
Drug Interactions
Moderate Interactions
- Atazanavir
- Cefditoren
- Cefpodoxime
- Dasatinib
- Delavirdine
- Erlotinib
- Fosamprenavir
- Iron salts (oral)
- Itraconazole
- Ketoconazole
- Ledipasvir
- Levoketoconazole
- Mesalamine
- Mycophenolate mofetil
- Nilotinib
- Pazopanib
- Rilpivirine
- Sunitinib
- Velpatasvir
Minor Interactions
- Calcium carbonate (high doses)
- Dabigatran etexilate
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine)
Rationale: Famotidine is primarily renally eliminated; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical symptoms (e.g., heartburn, abdominal pain, dyspepsia)
Frequency: Daily or as needed
Target: Resolution or improvement of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment, alternative therapy, or further diagnostic workup.
Renal function (BUN, serum creatinine)
Frequency: Periodically, especially in elderly or patients with pre-existing renal impairment, or if dose changes
Target: Within patient's baseline or acceptable limits
Action Threshold: Significant decline in renal function warrants dose adjustment.
Mental status (especially in elderly or renally impaired)
Frequency: Periodically
Target: Normal cognitive function
Action Threshold: New onset of confusion, delirium, or hallucinations may indicate drug-related CNS effects, especially with renal impairment.
Symptom Monitoring
- Resolution of heartburn
- Decrease in abdominal pain
- Improvement in dyspepsia
- Absence of nausea/vomiting related to acid reflux
- Monitoring for signs of GI bleeding (e.g., melena, hematemesis) in high-risk patients
- Monitoring for CNS effects (e.g., confusion, dizziness, headache, hallucinations) especially in elderly or renally impaired patients
Special Patient Groups
Pregnancy
Famotidine is Pregnancy Category B. Studies in animals have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women, but human experience has not revealed evidence of harm. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and limited human experience.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Famotidine is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Lactation Risk Category L3 (Moderately Safe).
Infant Risk:
Potential for gastric acid suppression in infant, theoretical risk of CNS effects. Monitor infant for any unusual symptoms.
Pediatric Use
Use in pediatric patients (1-16 years) for GERD and peptic ulcer disease is generally accepted with appropriate dose adjustment based on weight and age. Safety and effectiveness in neonates and infants <1 month have not been established. Renal dose adjustment is critical in pediatric patients with impaired renal function.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients are more likely to have decreased renal function, which may require dose adjustment. They may also be more susceptible to CNS adverse effects (e.g., confusion, delirium) due to impaired renal clearance or polypharmacy.
Clinical Information
Clinical Pearls
- Famotidine IV is often used in hospitalized patients who are NPO (nothing by mouth) or cannot tolerate oral medications, for stress ulcer prophylaxis or treatment of acid-related disorders.
- Always adjust dose in patients with renal impairment to prevent accumulation and potential CNS side effects.
- Rapid IV bolus injection should be avoided; administer over at least 2 minutes to prevent transient bradycardia and hypotension.
- Famotidine is generally well-tolerated, but CNS effects (confusion, dizziness) are more common in elderly or renally impaired patients.
- Unlike cimetidine, famotidine has minimal interaction with the cytochrome P450 enzyme system, leading to fewer drug-drug interactions.
Alternative Therapies
- Other H2-receptor antagonists (e.g., Ranitidine [though largely withdrawn/recalled], Cimetidine, Nizatidine)
- Proton Pump Inhibitors (PPIs) (e.g., Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole, Rabeprazole) - generally more potent acid suppressors
- Antacids (for symptomatic relief)
- Sucralfate (mucosal protectant)
Cost & Coverage
Average Cost:
Varies widely by supplier and contract per 4ml vial (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.