Famotidine 10mg/ml Inj, 2ml

Manufacturer FRESENIUS KABI Active Ingredient Famotidine Injection Solution(fa MOE ti deen) Pronunciation fa MOE ti deen
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.
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Drug Class
Antiulcer agent
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Pharmacologic Class
Histamine H2-receptor antagonist
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Pregnancy Category
Category B
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FDA Approved
Oct 1986
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DEA Schedule
Not Controlled

Overview

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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. This injection form is typically used in hospitals when you can't take medicine by mouth.
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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 promptly to receive guidance on the appropriate course of action.
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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 experiencing nighttime reflux.
  • Avoid smoking, as it can worsen acid reflux.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg IV every 12 hours
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

Duodenal Ulcer (short-term treatment): 20 mg IV every 12 hours
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome): 20 mg IV every 6 hours (up to 160 mg every 6 hours in severe cases)
GERD (erosive esophagitis): 20 mg IV every 12 hours
Stress Ulcer Prophylaxis: 20 mg IV every 12 hours
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Pediatric Dosing

Neonatal: 0.5 mg/kg IV once daily or every 12 hours (max 20 mg/dose)
Infant: 0.25-0.5 mg/kg IV every 8-12 hours (max 20 mg/dose)
Child: 0.25-0.5 mg/kg IV every 8-12 hours (max 20 mg/dose)
Adolescent: 20 mg IV every 12 hours (or adult dose)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed (CrCl > 50 mL/min)
Moderate: Reduce dose by 50% or extend dosing interval to 24 hours (CrCl 10-50 mL/min)
Severe: Reduce dose by 50% or extend dosing interval to 24 hours (CrCl < 10 mL/min)
Dialysis: Administer after dialysis; dose reduction by 50% or extend interval to 24 hours

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment (famotidine is minimally metabolized by the liver)

Pharmacology

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Mechanism of Action

Famotidine is a competitive inhibitor of histamine H2-receptors located on the gastric parietal cells. By binding to these receptors, it inhibits both basal and stimulated gastric acid secretion, including acid secretion stimulated by histamine, acetylcholine, and gastrin. It also reduces pepsin secretion.
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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 to 11-15 hours in severe renal impairment)
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (65-70% unchanged drug)
Unchanged: 65-70%
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Pharmacodynamics

OnsetOfAction: Within minutes (IV)
PeakEffect: 30 minutes - 1 hour (IV)
DurationOfAction: 10-12 hours

Safety & Warnings

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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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain
  • Black, tarry stools (melena)
  • Vomiting blood or material that looks like coffee grounds
  • Difficulty swallowing
  • Unexplained weight loss
  • Chest pain (especially if accompanied by shortness of breath, sweating, or pain radiating to arm/jaw - seek immediate medical attention as this could be a heart attack)
  • Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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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
A history of heartburn lasting 3 months or more
Current use of specific medications, such as:
+ Cefditoren
+ Dasatinib
+ Delavirdine
+ Fosamprenavir

Please note that this is not an exhaustive list of 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.
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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 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 (seeing or hearing things that are not there), 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, you may need to take them at a different time than this medication. Consult your doctor to determine the best schedule for your medications.

Some formulations of this medication may contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as high doses of benzyl alcohol can cause serious 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, plan to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hypotension
  • Tachycardia
  • Vomiting
  • Diarrhea
  • Respiratory distress
  • Ataxia
  • Tremors
  • Convulsions

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive. Gastric lavage may be considered if recent ingestion (for oral forms). Hemodialysis is not effective for famotidine removal.

Drug Interactions

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Moderate Interactions

  • Atazanavir
  • Cefditoren
  • Cefpodoxime
  • Dasatinib
  • Delavirdine
  • Erlotinib
  • Fosamprenavir
  • Indinavir
  • Iron salts (oral)
  • Itraconazole
  • Ketoconazole
  • Ledipasvir
  • Levoketoconazole
  • Mesalamine
  • Mycophenolate mofetil
  • Nilotinib
  • Nelfinavir
  • Posaconazole
  • Rilpivirine
  • Riociguat
  • Simeprevir
  • Sparsentan
  • Sunitinib
  • Tenofovir alafenamide
  • Velpatasvir
  • Voriconazole
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Minor Interactions

  • Probenecid (may decrease famotidine clearance)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: Famotidine is primarily renally eliminated; dose adjustment is required in renal impairment.

Timing: Prior to initiation, especially in elderly or patients with known renal issues.

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Routine Monitoring

Symptom relief (e.g., heartburn, dyspepsia)

Frequency: Daily

Target: Reduction or resolution of symptoms

Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment or alternative therapy.

Renal function (CrCl)

Frequency: Periodically, especially in prolonged therapy or if renal status changes

Target: Maintain appropriate CrCl for dosing

Action Threshold: Significant decline in CrCl warrants dose adjustment.

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Symptom Monitoring

  • Headache
  • Dizziness
  • Constipation
  • Diarrhea
  • Nausea
  • Vomiting
  • Fatigue
  • Muscle cramps
  • Rash
  • Signs of hypersensitivity (e.g., rash, pruritus, urticaria, angioedema)
  • Signs of CNS effects (e.g., confusion, hallucinations, seizures - rare, more common in elderly or renal impairment)

Special Patient Groups

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Pregnancy

Famotidine is Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. Human data are limited but do not suggest an increased risk of birth defects. Generally considered safe for use during pregnancy when clinically indicated.

Trimester-Specific Risks:

First Trimester: Low risk, no evidence of increased congenital anomalies.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Famotidine is excreted into breast milk. The amount is small, and adverse effects on the infant are unlikely. The American Academy of Pediatrics considers famotidine compatible with breastfeeding. Monitor breastfed infant for potential side effects (e.g., GI upset).

Infant Risk: Low risk (L2 - Likely compatible)
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Pediatric Use

Famotidine IV is approved for use in pediatric patients, including neonates, for the treatment of GERD and peptic ulcer disease. Dosing is weight-based and adjusted for age. Safety and efficacy have been established. Close monitoring for CNS effects (rare) is advised, especially in very young or those with renal impairment.

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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. Monitor renal function and be aware of potential for increased CNS side effects (e.g., confusion, dizziness) in this population.

Clinical Information

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Clinical Pearls

  • Famotidine IV is typically used in hospitalized patients who cannot tolerate oral medication or for conditions requiring rapid acid suppression (e.g., stress ulcer prophylaxis, acute GI bleeding).
  • Administer IV famotidine slowly over 2 minutes or dilute and infuse over 15-30 minutes to avoid transient bradycardia or hypotension.
  • Dose adjustment is crucial in patients with renal impairment to prevent accumulation and potential adverse effects.
  • Famotidine is generally well-tolerated with a low incidence of side effects.
  • Unlike cimetidine, famotidine has minimal interaction with the cytochrome P450 enzyme system, leading to fewer drug-drug interactions.
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Alternative Therapies

  • Other H2-receptor antagonists (e.g., Ranitidine, Cimetidine, Nizatidine - though Ranitidine IV is largely unavailable due to NDMA concerns)
  • Proton Pump Inhibitors (PPIs) (e.g., Omeprazole, Pantoprazole, Esomeprazole, Lansoprazole, Rabeprazole) - generally more potent acid suppressants, often preferred for severe or refractory conditions.
  • Antacids (for immediate, short-term symptom relief)
  • Sucralfate (mucosal protective agent)
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Cost & Coverage

Average Cost: Varies widely by supplier and quantity per 2ml vial (10mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for 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, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, as community drug take-back programs may be available. Some medications may include an additional patient information leaflet; check with your pharmacist for more information. If you have questions or concerns about this 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 details about the medication taken, the amount, and the time of the incident.