Famotidine (oral): Difference between revisions

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|drugClass=gastric acid secretion inhibitor
|drugClass=gastric acid secretion inhibitor
|indicationType=treatment
|indicationType=treatment
|indication=[[heartburn]]
|indication=[[heartburn]],gastric hypersecretion, [[gastric ulcer]],[[astroesophageal reflux]],
[[indigestion]]
|adverseReactions=[[constipation]] ,[[diarrhea, dizziness]] , [[headache]]
|adverseReactions=[[constipation]] ,[[diarrhea, dizziness]] , [[headache]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
Line 18: Line 19:


* Duodenal ulcer  
* Duodenal ulcer  
* Esophagitis - Gastroesophageal reflux disease,  
* Esophagitis - [[gastroesophageal reflux]] disease,  
* Gastric hypersecretion
* Gastric hypersecretion
* Gastric ulcer,
* [[Gastric ulcer]]
* Gastroesophageal reflux disease
* [[Gastroesophageal reflux]] disease
* Indigestion
* [[Indigestion]]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
==Dosing==
 
* To relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
 
* To prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
 
* Do not use more than 2 tablets in 24 hours
 
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of famotidine in adult patients.
|offLabelAdultNoGuideSupport===Indications==
|offLabelAdultNoGuideSupport===Indications==


* Esophagitis, Maintenance
* Esophagitis, Maintenance
* Gastritis
* [[Gastritis]]
* Gastrointestinal hemorrhage
* [[Gastrointestinal hemorrhage]]
* Stress ulcer
* [[Stress ulcer]]
* Urticaria
* [[Urticaria]]
|fdaLIADPed===Indication==
|fdaLIADPed===Indication==


* Duodenal ulcer  
* [[Duodenal ulcer]]
* Esophagitis - Gastroesophageal reflux disease,  
* Esophagitis - [[gastroesophageal reflux]] disease,  
* Gastric hypersecretion
* Gastric hypersecretion
* Gastric ulcer,
* [[Gastric ulcer]]
* Gastroesophageal reflux disease
* [[Gastroesophageal reflux]] disease
* Indigestion
* [[Indigestion]]
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Famotidine in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Famotidine in pediatric patients.
|offLabelPedNoGuideSupport===Indications==
|offLabelPedNoGuideSupport===Indications==
* Stress ulcer; Prophylaxis
* Stress ulcer; Prophylaxis
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|warnings='''Allergy alert''': Do not use if you are allergic to famotidine or other acid reducers


=====Body as a Whole=====
'''Do not use'''


if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
if you have kidney disease, except under the advice and supervision of a doctor
with other acid reducers


'''Ask a doctor before use if you have'''


=====Cardiovascular=====
* Had heartburn over 3 months. This may be a sign of a more serious condition.


* Heartburn with [[lightheadedness]], sweating, or [[dizziness]]


* [[Chest pain]] or shoulder pain with [[shortness of breath]]; sweating; pain spreading to arms, neck or shoulders; or [[lightheadedness]]


=====Digestive=====
* Frequent chest pain


* Frequent wheezing, particularly with heartburn


* Unexplained weight loss


=====Endocrine=====
* [[Nausea]] or [[vomiting]]
* Stomach pain


'''Stop use and ask a doctor if'''


* Your heartburn continues or worsens
* You need to take this product for more than 14 days


=====Hematologic and Lymphatic=====
'''If pregnant or breast-feeding''',


* Ask a health professional before use.


'''Keep out of reach of children'''.


=====Metabolic and Nutritional=====
* In case of overdose, get medical help or contact a Poison Control Center right away.
|clinicalTrials='''Common'''
* Gastrointestinal: [[constipation]], [[diarrhea]]
* Neurologic: [[dizziness]], [[headache]]


'''Serious'''
* Dermatologic: Stevens-Johnson syndrome (very rare ), toxic epidermal necrolysis (very rare )
* Gastrointestinal: necrotizing enterocolitis in fetus OR newborn
* Immunologic: [[anaphylaxis]] (infrequent ), [[angioedema]] (infrequent )
* Musculoskeletal: [[rhabdomyolysis]]
* Neurologic: [[seizure]] (rare )
* Respiratory: [[Interstitial pneumonia]] (infrequent ), [[nosocomial pneumonia]]
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.




=====Musculoskeletal=====






=====Neurologic=====






=====Respiratory=====






=====Skin and Hypersensitivy Reactions=====






=====Special Senses=====




|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


=====Urogenital=====
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Famotidine in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of Famotidine during labor and delivery.
|useInNursing=There is no FDA guidance on the use of Famotidine  with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of Famotidine with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of Famotidine  with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of  Famotidine with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of Famotidine with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of Famotidine in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Famotidine in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of Famotidine in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of Famotidine in patients who are immunocompromised.




|administration=* Oral


=====Miscellaneous=====


|monitoring=There is limited information regarding <i>Monitoring</i> of Famotidine in the drug label.




<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description


<!--Use in Specific Populations-->
<!--IV Compatibility-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Famotidine in the drug label.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
|overdose====Acute Overdose===
|administration=* Oral


* Intravenous
====Signs and Symptoms====
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
There is limited information regarding <i>Chronic Overdose</i> of Famotidine in the drug label.


<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
|overdose====Acute Overdose===


====Signs and Symptoms====
|mechAction=*


* Description


====Management====
|structure=


* Description


===Chronic Overdose===
|PD=There is limited information regarding <i>Pharmacodynamics</i> of  in the drug label.


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of Famotidine in the drug label.


<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


<!--Structure-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Famotidine in the drug label.
|structure=*


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Famotidine in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
|howSupplied=*
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of Famotidine in the drug label.


<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
|alcohol=* Alcohol-Famotidine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
|brandNames=7 SELECT ACID CONTROLLER
|brandNames=7 SELECT ACID CONTROLLER
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 14:23, 12 January 2015

Famotidine (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Famotidine (oral) is a gastric acid secretion inhibitor that is FDA approved for the treatment of heartburn,gastric hypersecretion, gastric ulcer,astroesophageal reflux, indigestion. Common adverse reactions include constipation ,diarrhea, dizziness , headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosing

  • To relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
  • To prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
  • Do not use more than 2 tablets in 24 hours

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of famotidine in adult patients.

Non–Guideline-Supported Use

Indications

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Famotidine in pediatric patients.

Non–Guideline-Supported Use

Indications

  • Stress ulcer; Prophylaxis

Contraindications

There is limited information regarding Famotidine (oral) Contraindications in the drug label.

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. if you have kidney disease, except under the advice and supervision of a doctor with other acid reducers

Ask a doctor before use if you have

  • Had heartburn over 3 months. This may be a sign of a more serious condition.
  • Frequent chest pain
  • Frequent wheezing, particularly with heartburn
  • Unexplained weight loss

Stop use and ask a doctor if

  • Your heartburn continues or worsens
  • You need to take this product for more than 14 days

If pregnant or breast-feeding,

  • Ask a health professional before use.

Keep out of reach of children.

  • In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

Common

Serious

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Famotidine (oral) in the drug label.

Drug Interactions

There is limited information regarding Famotidine (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Famotidine (oral) in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Famotidine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Famotidine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Famotidine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Famotidine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Famotidine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Famotidine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Famotidine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Famotidine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Famotidine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Famotidine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Famotidine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Famotidine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Famotidine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

There is limited information regarding Chronic Overdose of Famotidine in the drug label.

Pharmacology

There is limited information regarding Famotidine (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

There is limited information regarding Famotidine (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Famotidine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Famotidine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Famotidine in the drug label.

How Supplied

Storage

There is limited information regarding Famotidine (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Famotidine (oral) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Famotidine (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Famotidine in the drug label.

Precautions with Alcohol

  • Alcohol-Famotidine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

7 SELECT ACID CONTROLLER

Look-Alike Drug Names

There is limited information regarding Famotidine (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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{{#subobject: 

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