Polycarbophil

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Polycarbophil
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: Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Polycarbophil is a laxative that is FDA approved for the treatment of relieves occasional constipation to help restore and maintain regularity this product generally produces bowel movement in 12 to 72 hours. Common adverse reactions include epigastric fullness, flatulence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Relieves occasional constipation to help restore and maintain regularity

this product generally produces bowel movement in 12 to 72 hours take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See CHOKING warning.

  • FiberCon works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Polycarbophil in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Polycarbophil Contraindications in the drug label.

Warnings

  • Choking:
  • Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
  • Ask a doctor before use if you have
  • Abdominal pain, nausea, or vomiting
  • A sudden change in bowel habits that persists over a period of 2 weeks
  • Ask a doctor or pharmacist before use if you are
  • Taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.
  • When using this product
  • Do not use for more than 7 days unless directed by a doctor
  • Do not take more than 8 caplets in a 24 hour period unless directed by a doctor
  • Stop use and ask a doctor if
  • Rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.
  • 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

There is limited information regarding Clinical Trial Experience of Polycarbophil in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Polycarbophil in the drug label.

Drug Interactions

There is limited information regarding Polycarbophil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Polycarbophil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Polycarbophil Mechanism of Action in the drug label.

Structure

There is limited information regarding Polycarbophil Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Polycarbophil How Supplied in the drug label.

Storage

There is limited information regarding Polycarbophil Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

There is limited information regarding Polycarbophil 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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