Famotidine 40mg/5ml Oral Susp 150ml

Manufacturer UPSHER-SMITH Active Ingredient Famotidine Oral Suspension(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 medication that helps reduce the amount of acid your stomach makes. It's used to treat conditions like heartburn, ulcers, and acid reflux (GERD). By lowering stomach acid, it helps relieve symptoms and allows ulcers to heal.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, if you plan to take antacids, consult your doctor first to ensure safe use.

When taking the liquid form of this medication, make sure to shake the bottle well before use. Measure your dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Discard any unused medication after 1 month. Keep all medications in a safe location, out of the reach of children and pets. Do not dispose of unused or expired medications by flushing them down the toilet or pouring them down the drain, unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. Since this medication is often taken as needed, be sure to follow your doctor's instructions regarding the frequency of use and do not take it more often than prescribed.
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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, citrus, chocolate, peppermint).
  • 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.
  • Maintain a healthy weight.
  • Quit smoking, as it can worsen acid reflux.

Dosing & Administration

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Adult Dosing

Standard Dose: For active duodenal ulcer: 40 mg once daily at bedtime or 20 mg twice daily. For GERD: 20 mg twice daily. For Zollinger-Ellison Syndrome: 20 mg every 6 hours, may be increased up to 160 mg every 6 hours.
Dose Range: 20 - 160 mg

Condition-Specific Dosing:

Active Duodenal Ulcer: 40 mg once daily at bedtime or 20 mg twice daily for 4-8 weeks.
Benign Gastric Ulcer: 40 mg once daily at bedtime for 6-8 weeks.
GERD: 20 mg twice daily for up to 6 weeks. For erosive esophagitis: 20-40 mg twice daily for up to 12 weeks.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome): Initial: 20 mg every 6 hours; dosage may be increased to 160 mg every 6 hours.
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Pediatric Dosing

Neonatal: Not established (limited data, generally not recommended)
Infant: Not established (limited data, generally not recommended)
Child: GERD: 0.5 mg/kg/day divided twice daily (max 40 mg/day). Peptic Ulcer: 0.5 mg/kg/day divided twice daily (max 40 mg/day).
Adolescent: Similar to adult dosing for GERD/PUD: 20 mg twice daily or 40 mg once daily at bedtime.
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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 36-48 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 50% of the usual dose or extend dosing interval to every 36-48 hours. Administer after dialysis session.

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. It inhibits basal, nocturnal, and stimulated gastric acid secretion (e.g., by food, betazole, pentagastrin, caffeine, insulin) and pepsin secretion. It reduces both the volume and acid content of the gastric secretion.
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Pharmacokinetics

Absorption:

Bioavailability: 40-45%
Tmax: 1-3 hours
FoodEffect: Food may slightly increase absorption but is not clinically significant; can be taken with or without food.

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 (primarily renal excretion)
ExcretionRoute: Renal (65-70% of IV dose, 25-30% of oral dose as unchanged drug)
Unchanged: 25-30% (oral), 65-70% (IV)
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Headache

Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor.

Reporting Side Effects

You can 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 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 chest pain (could be heart-related, seek immediate medical attention)
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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 longer
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 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. Do not initiate, discontinue, or modify the dosage of any medication without first 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 pre-existing kidney problems or are 65 years or older, it is crucial to discuss your condition with your doctor, as you may be at a higher risk of experiencing certain side effects. These potential side effects include hallucinations (seeing or hearing things that are not real), seizures, and changes in mood or behavior, such as feeling agitated, confused, sluggish, or disoriented.

This medication may interfere with the absorption of other oral medications, reducing their effectiveness. If you take other medications by mouth, your doctor may advise you to take them at a different time than this medication to minimize potential interactions.

If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tachycardia (fast heart rate)
  • Hypotension (low blood pressure)
  • Flushing
  • Respiratory distress

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention. Treatment is symptomatic and supportive. Gastric lavage or activated charcoal may be considered.

Drug Interactions

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Moderate Interactions

  • Cefditoren
  • Cefpodoxime
  • Dasatinib
  • Delavirdine
  • Erlotinib
  • Fosamprenavir
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Ledipasvir/Sofosbuvir
  • Mesalamine
  • Mycophenolate Mofetil
  • Nilotinib
  • Posaconazole
  • Rilpivirine
  • Riociguat
  • Sunitinib
  • Telaprevir
  • Voriconazole
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Minor Interactions

  • Antacids (administer famotidine 1-2 hours before antacids)
  • Iron salts (reduced absorption)

Monitoring

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Baseline Monitoring

Renal function (CrCl)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom resolution (e.g., heartburn, dyspepsia, abdominal pain)

Frequency: Daily/as needed

Target: Reduction or absence of symptoms

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

Renal function (CrCl)

Frequency: Periodically, especially in elderly or those with pre-existing renal impairment, or if dose is adjusted.

Target: Maintain appropriate CrCl for dosing

Action Threshold: Significant decline in CrCl may necessitate further dose reduction.

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Symptom Monitoring

  • Resolution of heartburn
  • Decrease in abdominal pain
  • Reduction in acid regurgitation
  • Improvement in dyspepsia
  • Monitoring for potential adverse effects such as headache, dizziness, constipation, diarrhea, nausea.

Special Patient Groups

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Pregnancy

Famotidine is Pregnancy Category B. Studies in animals 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 compatible.
Second Trimester: Low risk, generally considered compatible.
Third Trimester: Low risk, generally considered compatible.
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Lactation

Famotidine is excreted in human breast milk. While the amount is small and adverse effects in breastfed infants are unlikely, caution is advised. The decision to continue or discontinue nursing or the drug should consider the importance of the drug to the mother.

Infant Risk: Low risk (L3 - Moderately safe). Monitor infant for potential side effects like drowsiness or gastrointestinal upset, though unlikely.
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Pediatric Use

Dosing is weight-based for children and infants. Safety and efficacy in neonates and infants under 1 year are not well-established. Use with caution and only if clearly indicated, under medical supervision.

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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.

Clinical Information

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Clinical Pearls

  • Famotidine is generally well-tolerated with a low incidence of side effects.
  • For occasional heartburn, over-the-counter (OTC) formulations are available at lower strengths.
  • Administer famotidine at bedtime for nocturnal acid suppression.
  • If taking antacids, separate administration by 1-2 hours from famotidine to avoid reduced absorption of famotidine.
  • Patients with renal impairment require dose adjustment to prevent accumulation and potential side effects.
  • Long-term use of H2-blockers may rarely be associated with vitamin B12 deficiency, especially in elderly patients or those with pre-existing risk factors.
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Alternative Therapies

  • Other H2-receptor antagonists (e.g., Ranitidine, Cimetidine, Nizatidine)
  • Proton Pump Inhibitors (PPIs) (e.g., Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole) - generally more potent for acid suppression.
  • Antacids (for immediate, short-term relief)
  • Sucralfate (for ulcer treatment, forms a protective barrier)
  • Prokinetics (e.g., Metoclopramide - for motility issues, not primary acid suppression)
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Cost & Coverage

Average Cost: Varies, typically $20-$50 per 150ml bottle
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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. 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 this medication, don't hesitate to reach out to 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. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.