Famotidine 10mg Tablets

Manufacturer CAMBER CONSUMER CARE Active Ingredient Famotidine Tablets(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, Gastric acid secretion inhibitor
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Pharmacologic Class
Histamine H2-receptor antagonist (H2RA)
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Pregnancy 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. This can relieve symptoms like heartburn and indigestion.
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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. You can take this medication with or without food. However, before taking antacids with this medication, consult your doctor. It's essential to swallow the medication whole and not chew it.

To help prevent heartburn, take the medication before consuming foods or drinks that trigger heartburn. Adhere to the dosage schedule recommended by your doctor or as indicated on the packaging.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best disposal method, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missing 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 dosage schedule. Avoid taking two doses at the same time or taking extra doses. Since this medication is often taken as needed, do not take it more frequently than prescribed by your doctor.
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Lifestyle & Tips

  • Avoid foods and drinks that trigger your heartburn (e.g., spicy foods, fatty foods, caffeine, alcohol, citrus, chocolate).
  • Eat smaller, more frequent meals.
  • Avoid eating within 2-3 hours of bedtime.
  • Elevate the head of your bed if heartburn is worse at night.
  • Maintain a healthy weight.
  • Avoid tight-fitting clothing around your waist.
  • Quit smoking.

Dosing & Administration

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Adult Dosing

Standard Dose: For heartburn relief: 10 mg once daily as needed. For heartburn prevention: 10 mg 15-60 minutes before eating food or drinking beverages that cause heartburn.
Dose Range: 10 - 20 mg

Condition-Specific Dosing:

Maximum Daily Dose: Do not take more than 2 tablets (20 mg) in 24 hours.
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Pediatric Dosing

Neonatal: Not established (OTC formulation)
Infant: Not established (OTC formulation)
Child: Not recommended for children under 12 years of age unless directed by a doctor (OTC formulation).
Adolescent: 12 years and older: Same as adult dosing for OTC use.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for OTC 10mg, but caution with chronic use.
Moderate: For prescription use, dose reduction may be needed (e.g., 50% reduction or increased dosing interval). For OTC 10mg, consult a doctor.
Severe: For prescription use, dose reduction is required (e.g., 50% reduction or increased dosing interval). For OTC 10mg, consult a doctor.
Dialysis: For prescription use, administer after dialysis. For OTC 10mg, consult a doctor.

Hepatic Impairment:

Mild: No specific adjustment for OTC 10mg.
Moderate: No specific adjustment for OTC 10mg.
Severe: No specific adjustment for OTC 10mg, as hepatic metabolism is minimal. However, caution is advised in severe impairment due to potential for altered drug disposition.

Pharmacology

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Mechanism of Action

Famotidine is a competitive antagonist of histamine at the H2-receptors located on the gastric parietal cells. This action inhibits gastric acid secretion, both basal and stimulated (e.g., by food, histamine, or gastrin). It reduces both the volume and the 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 it is not clinically significant.

Distribution:

Vd: 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% unchanged)
Unchanged: 65-70%
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 1-3 hours
DurationOfAction: 10-12 hours (for acid suppression)

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 do not go away, 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Heartburn that lasts for more than 14 days, even with treatment.
  • Frequent chest pain.
  • Heartburn with lightheadedness, sweating, or shortness of breath.
  • Difficulty or pain swallowing food.
  • Vomiting blood or black, tarry stools (signs of bleeding).
  • Unexplained weight loss.
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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 that has lasted 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.
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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 your doctor's prescribed treatment duration and do not exceed it. If you have pre-existing kidney problems or are 65 years or older, consult your doctor, as you may be at a higher risk of experiencing certain side effects. These potential side effects include hallucinations (perceiving things that are not present), seizures, and feelings of agitation, confusion, sluggishness, or being out of sorts.

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

Before starting this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Tachycardia (fast heart rate)
  • Flushing
  • Headache
  • Vomiting
  • Diarrhea

What to Do:

If you suspect an overdose, contact a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Major Interactions

  • Atazanavir (reduced absorption)
  • Cefditoren (reduced absorption)
  • Dasatinib (reduced absorption)
  • Delavirdine (reduced absorption)
  • Erlotinib (reduced absorption)
  • Itraconazole (reduced absorption)
  • Ketoconazole (reduced absorption)
  • Ledipasvir/Sofosbuvir (reduced absorption)
  • Pazopanib (reduced absorption)
  • Rilpivirine (reduced absorption)
  • Sotorasib (reduced absorption)
  • Velpatasvir/Sofosbuvir (reduced absorption)
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Moderate Interactions

  • Iron salts (reduced absorption)
  • Mycophenolate (reduced absorption)
  • Ulipristal (reduced efficacy)

Monitoring

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Baseline Monitoring

Symptom assessment (frequency, severity of heartburn/indigestion)

Rationale: To establish baseline and evaluate treatment efficacy.

Timing: Before initiating therapy

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Routine Monitoring

Symptom relief

Frequency: Daily, as needed

Target: Reduction or elimination of heartburn/indigestion

Action Threshold: If symptoms persist or worsen after 14 days of continuous use, or if new symptoms appear, discontinue and consult a doctor.

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

Frequency: As needed, during therapy

Target: Absence or mild, tolerable effects

Action Threshold: If severe or persistent, consult a doctor.

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Symptom Monitoring

  • Persistent heartburn despite treatment
  • Difficulty or pain swallowing food
  • Vomiting blood or black, tarry stools (signs of gastrointestinal bleeding)
  • Unexplained weight loss
  • Chest pain with lightheadedness, sweating, or shortness of breath (may indicate heart problems)
  • Frequent chest pain

Special Patient Groups

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Pregnancy

Famotidine is classified as 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, but always consult a healthcare provider.

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. The American Academy of Pediatrics considers famotidine to be compatible with breastfeeding. Monitor the infant for potential adverse effects, though significant issues are rare.

Infant Risk: Low risk (L3 - Moderately Safe)
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Pediatric Use

For OTC 10mg tablets, not recommended for children under 12 years of age unless directed by a doctor. Prescription formulations are used in pediatric patients for conditions like GERD and PUD, with weight-based dosing.

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Geriatric Use

No specific dose adjustment is typically needed for age alone. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustment for higher, chronic prescription doses. Use with caution in patients with pre-existing renal impairment.

Clinical Information

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Clinical Pearls

  • Famotidine 10mg is primarily used for the relief and prevention of occasional heartburn and acid indigestion.
  • It is an over-the-counter (OTC) medication and should not be used for more than 14 days without consulting a doctor.
  • Symptoms of a more serious condition (e.g., difficulty swallowing, unexplained weight loss, blood in vomit/stools) should prompt immediate medical evaluation, as H2RAs can mask these symptoms.
  • Take 15-60 minutes before a meal to prevent heartburn, or as needed for relief.
  • Avoid taking with other acid-reducing medications (e.g., PPIs) unless specifically directed by a doctor.
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Alternative Therapies

  • Other H2-receptor antagonists (e.g., cimetidine, nizatidine, ranitidine - though ranitidine is largely withdrawn due to NDMA concerns)
  • Proton pump inhibitors (PPIs) (e.g., omeprazole, lansoprazole, esomeprazole) for more severe or frequent symptoms.
  • Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide) for immediate, short-term relief.
  • Alginates (e.g., Gaviscon) for reflux symptoms.
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets
Generic Available: Yes
Insurance Coverage: OTC (Over-the-Counter) - generally not covered by prescription insurance plans, but may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them 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. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.