Famotidine 20mg/50ml Inj, 50ml

Manufacturer BAXTER HEALTHCARE CORP 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
Mar 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 given directly into a vein, usually in a hospital or clinic setting.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication is administered as an intravenous injection, which means it is given as a shot into a vein.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.

Missing a Dose

If you miss a dose, contact your doctor immediately to find out what to do next. They will provide guidance on how to get back on schedule with your medication.
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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.
  • Quit smoking, as it can worsen acid reflux.
  • Maintain a healthy weight.

Dosing & Administration

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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 every 6 hours
Stress Ulcer Prophylaxis: 20 mg IV every 12 hours
GERD/PUD (short-term treatment): 20 mg IV every 12 hours
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Pediatric Dosing

Neonatal: Not established (limited data, generally avoided)
Infant: 0.5 mg/kg IV once daily (up to 20 mg/day) for GERD/PUD, max 20 mg/dose
Child: 0.5 mg/kg IV once daily (up to 20 mg/day) for GERD/PUD, max 20 mg/dose; for pathological hypersecretory conditions, 0.5 mg/kg IV every 6-8 hours (max 40 mg/dose)
Adolescent: Same as adult dosing (20 mg IV every 12 hours)
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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 dose after dialysis; reduce dose by 50% or extend dosing interval to every 36-48 hours

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Famotidine is a competitive inhibitor of histamine H2-receptors. It inhibits basal and nocturnal gastric acid secretion and, to a lesser extent, pepsin secretion. It also inhibits gastric acid secretion stimulated by food, betazole, and pentagastrin. By blocking H2-receptors on gastric parietal cells, it reduces the volume and acid content of gastric secretions.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Rapid (within minutes after IV administration)
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: 1.3 L/kg (adults)
ProteinBinding: 15-20%
CnssPenetration: Limited (low lipid solubility)

Elimination:

HalfLife: 2.5-3.5 hours (prolonged in renal impairment)
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (65-70% as unchanged drug)
Unchanged: 65-70%
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Pharmacodynamics

OnsetOfAction: Within 1 hour (IV)
PeakEffect: 1-3 hours (IV)
DurationOfAction: 10-12 hours (IV)

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

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain
  • Difficulty swallowing
  • Vomiting blood or material that looks like coffee grounds
  • Black, tarry stools
  • Unexplained weight loss
  • Chest pain (especially if accompanied by shortness of breath or pain radiating to arm/jaw, 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
If you have experienced 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 consulting your doctor first.
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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 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 issues 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 ensure optimal effectiveness.

Some formulations of this product 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.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is symptomatic and supportive.

Drug Interactions

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Moderate Interactions

  • Cefditoren
  • Cefpodoxime
  • Dasatinib
  • Delavirdine
  • Erlotinib
  • Iron salts (oral)
  • Itraconazole
  • Ketoconazole
  • Ledipasvir
  • Nilotinib
  • Posaconazole
  • Rilpivirine
  • Sunitinib
  • Voriconazole
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Minor Interactions

  • Atazanavir
  • Dabigatran etexilate
  • Mycophenolate mofetil

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: Famotidine is primarily renally excreted; dose adjustment is necessary in renal impairment.

Timing: Prior to initiation

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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

Adverse effects (e.g., headache, dizziness, constipation/diarrhea)

Frequency: Daily

Target: Absence or mild, tolerable effects

Action Threshold: Severe or persistent adverse effects may require discontinuation or dose adjustment

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Symptom Monitoring

  • Headache
  • Dizziness
  • Constipation
  • Diarrhea
  • Nausea
  • Vomiting
  • Fatigue
  • Muscle cramps
  • Rash
  • Signs of hypersensitivity (e.g., angioedema, bronchospasm)

Special Patient Groups

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Pregnancy

Famotidine is generally considered safe for use during pregnancy when clinically indicated. Animal studies have not shown harm to the fetus, and human data are reassuring, though controlled studies are limited.

Trimester-Specific Risks:

First Trimester: Low risk, generally considered compatible.
Second Trimester: Low risk, generally considered compatible.
Third Trimester: Low risk, generally considered compatible.
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Lactation

Famotidine is excreted into breast milk. While the amount is small, caution is advised. Monitor the infant for potential adverse effects (e.g., changes in feeding, drowsiness). Use with caution, or consider alternative agents if possible.

Infant Risk: Low to moderate risk (L3 - Moderately safe; monitor infant)
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Pediatric Use

Dosing varies significantly by age and weight. Neonatal use is not well-established. Close monitoring for adverse effects is crucial, especially in younger children due to potential for CNS effects (though rare). Renal dose adjustments are critical in pediatric patients with impaired renal function.

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Geriatric Use

No specific dose adjustment is required based on age alone, but dose reduction is recommended for elderly patients with moderate to severe renal impairment due to decreased renal clearance. Elderly patients may be more susceptible to CNS adverse effects (e.g., confusion, dizziness), though these are rare.

Clinical Information

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Clinical Pearls

  • Famotidine IV is often used in hospitalized patients for stress ulcer prophylaxis or when oral administration is not feasible.
  • Ensure proper dilution and administration rate for IV infusion (over 15-30 minutes) to avoid transient adverse effects like hypotension.
  • Renal dose adjustment is crucial to prevent accumulation and potential adverse effects.
  • Famotidine is generally well-tolerated with a low incidence of side effects.
  • Consider drug interactions with medications that require an acidic gastric environment for absorption, even with IV famotidine, as it reduces overall acid production.
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Alternative Therapies

  • Other H2-receptor antagonists (e.g., Ranitidine, Cimetidine, Nizatidine - though Ranitidine is largely off-market due to NDMA concerns)
  • Proton Pump Inhibitors (PPIs) (e.g., Omeprazole, Pantoprazole, Esomeprazole, Lansoprazole, Rabeprazole) - generally more potent for acid suppression.
  • Antacids (for immediate, short-term relief)
  • Sucralfate (mucosal protectant)
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Cost & Coverage

Average Cost: $10 - $50 per 20mg/50ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, 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. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended method, as some medications may require specific disposal procedures. Additionally, you can inquire about drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. 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 contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.