Famotidine 10mg/ml Inj, 20ml
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; Gastric acid secretion inhibitor
Pharmacologic Class
Histamine H2-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Oct 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Famotidine is a medicine that helps reduce the amount of acid your stomach makes. It's often used to treat conditions like heartburn, ulcers, and acid reflux. 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 adhere to all guidelines provided. This drug is administered via intravenous injection.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid foods and drinks that trigger your symptoms (e.g., spicy foods, caffeine, alcohol, fatty foods).
- Eat smaller, more frequent meals.
- Avoid lying down immediately after eating.
- Elevate the head of your bed if you experience nighttime reflux.
- Quit smoking, as it can worsen acid reflux.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg IV every 12 hours
Dose Range:
20 - 40 mg
Condition-Specific Dosing:
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome):
20 mg IV every 6 hours, may increase up to 160 mg IV every 6 hours
Prevention of Upper GI Bleeding (Stress Ulcer Prophylaxis):
20 mg IV every 12 hours
GERD/Erosive Esophagitis:
20 mg IV every 12 hours
Pediatric Dosing
Neonatal:
0.5 mg/kg IV once daily or every 12 hours (max 20 mg/dose)
Infant:
0.5 mg/kg IV once daily or every 12 hours (max 20 mg/dose)
Child:
0.25-0.5 mg/kg IV every 12 hours (max 20 mg/dose)
Adolescent:
0.25-0.5 mg/kg IV every 12 hours (max 20 mg/dose) or adult dose if weight appropriate
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-90 mL/min)
Moderate:
Reduce dose by 50% or extend dosing interval to every 24 hours (CrCl 30-59 mL/min)
Severe:
Reduce dose by 50% or extend dosing interval to every 24 hours (CrCl < 30 mL/min)
Dialysis:
Administer after dialysis; dose reduction by 50% or extend interval to every 24-48 hours
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Famotidine is a competitive inhibitor of histamine H2-receptors. It reversibly binds to H2-receptors on the gastric parietal cells, leading to a reduction in both basal and stimulated gastric acid secretion, as well as pepsin secretion. This results in decreased gastric volume and acidity.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV)
Tmax:
Immediate (IV)
FoodEffect:
Not applicable for IV formulation
Distribution:
Vd:
0.96-1.3 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Limited
Elimination:
HalfLife:
2.5-3.5 hours (prolonged in renal impairment)
Clearance:
Not available
ExcretionRoute:
Renal (primary), Fecal (minor)
Unchanged:
65-70% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (IV)
PeakEffect:
1-3 hours (IV)
DurationOfAction:
10-12 hours
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
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, consult 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
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, consult 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:
- Severe or persistent stomach pain
- Difficulty swallowing
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools (signs of bleeding)
- Unexplained weight loss
- New or worsening confusion (especially in elderly or those with kidney problems)
- Unusual bruising or bleeding
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 allergic reaction and its symptoms.
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
A history of heartburn lasting 3 months or more
Current use of specific medications, such as 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 consulting your doctor first.
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 allergic reaction and its symptoms.
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
A history of heartburn lasting 3 months or more
Current use of specific medications, such as 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 consulting your doctor first.
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, discuss your condition with your doctor, as you may be at a higher risk of experiencing certain side effects. These include hallucinations (perceiving things that are not present), seizures, and feelings of agitation, confusion, sluggishness, or being out of sorts, which have been reported in individuals with kidney problems and older adults.
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 minimize potential interactions.
Some formulations of this product may contain benzyl alcohol. It is crucial to avoid products with benzyl alcohol in newborns and infants whenever possible, 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 breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.
If you have pre-existing kidney problems or are 65 years or older, discuss your condition with your doctor, as you may be at a higher risk of experiencing certain side effects. These include hallucinations (perceiving things that are not present), seizures, and feelings of agitation, confusion, sluggishness, or being out of sorts, which have been reported in individuals with kidney problems and older adults.
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 minimize potential interactions.
Some formulations of this product may contain benzyl alcohol. It is crucial to avoid products with benzyl alcohol in newborns and infants whenever possible, 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 breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypotension
- Tachycardia
- Vomiting
- Diarrhea
- Respiratory distress
- Seizures
- Ataxia
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is symptomatic and supportive.
Drug Interactions
Major Interactions
- Atazanavir (reduced absorption due to increased gastric pH)
- Delavirdine (reduced absorption due to increased gastric pH)
- Cefpodoxime (reduced absorption due to increased gastric pH)
- Dasatinib (reduced absorption due to increased gastric pH)
- Erlotinib (reduced absorption due to increased gastric pH)
- Ketoconazole (reduced absorption due to increased gastric pH)
- Itraconazole (reduced absorption due to increased gastric pH)
- Ledipasvir/Sofosbuvir (reduced absorption due to increased gastric pH)
- Rilpivirine (reduced absorption due to increased gastric pH)
Moderate Interactions
- Iron salts (reduced absorption due to increased gastric pH)
- Mycophenolate mofetil (reduced absorption of mycophenolic acid)
Minor Interactions
- Antacids (may reduce absorption of oral famotidine, not relevant for IV)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Famotidine is primarily renally eliminated; dose adjustment is required in renal impairment.
Timing: Prior to initiation
Routine Monitoring
Symptom relief (e.g., heartburn, dyspepsia, pain)
Frequency: Daily
Target: Resolution or significant improvement of symptoms
Action Threshold: Persistent or worsening symptoms may indicate inadequate dosing or alternative diagnosis
Renal function (CrCl, BUN, Creatinine)
Frequency: Periodically, especially in elderly or those with pre-existing renal impairment
Target: Stable renal function
Action Threshold: Deterioration of renal function may necessitate dose adjustment
Complete Blood Count (CBC)
Frequency: Rarely, if prolonged use or unexplained symptoms
Target: Within normal limits
Action Threshold: Rare reports of blood dyscrasias (e.g., agranulocytosis, thrombocytopenia)
Symptom Monitoring
- Headache
- Dizziness
- Constipation
- Diarrhea
- Nausea
- Vomiting
- Fatigue
- Rash
- Muscle cramps
- Confusion (rare, especially in elderly or renal impairment)
Special Patient Groups
Pregnancy
Famotidine is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, generally considered safe if indicated.
Second Trimester:
Low risk, generally considered safe if indicated.
Third Trimester:
Low risk, generally considered safe if indicated.
Lactation
Famotidine is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for potential adverse effects such as gastrointestinal disturbances (e.g., diarrhea, constipation) or central nervous system effects (e.g., drowsiness).
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Famotidine injection is used in pediatric patients, including neonates and infants, for conditions like GERD and peptic ulcer disease. Dosing is weight-based and requires careful calculation. Safety and efficacy data are more limited in very young infants compared to older children and adults.
Geriatric Use
Elderly patients are more likely to have decreased renal function, which can lead to increased plasma concentrations of famotidine. Dose adjustment is often necessary based on creatinine clearance to avoid accumulation and potential CNS side effects (e.g., confusion, delirium).
Clinical Information
Clinical Pearls
- Famotidine IV is often used for stress ulcer prophylaxis in critically ill patients or for acute management of upper GI bleeding.
- It is a good option for patients who are NPO (nothing by mouth) or cannot tolerate oral medications.
- Ensure proper dilution and administration rate for IV infusion to avoid adverse effects.
- Always check renal function before administering famotidine, especially in elderly or renally impaired patients, and adjust the dose accordingly.
- While generally well-tolerated, rare CNS effects (e.g., confusion, hallucinations) can occur, particularly in patients with renal impairment or advanced age.
Alternative Therapies
- Proton Pump Inhibitors (PPIs): Omeprazole, Pantoprazole, Esomeprazole (more potent and longer-acting acid suppression)
- Other H2-receptor antagonists: Cimetidine, Nizatidine (Ranitidine has been withdrawn from the market)
- Antacids (for immediate, short-term relief of symptoms)
- Sucralfate (mucosal protectant)
Cost & Coverage
Average Cost:
Varies widely, typically $5 - $20 per 20mg vial per 20mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact 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 occurred, as this will aid in providing appropriate care.