Psyllium

Psyllium
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]

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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

Psyllium is a laxative that is FDA approved for the treatment of constipation. Common adverse reactions include borborygmi and flatulence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within 12 to 72 hours

Dosage

• 5 capsules one to three times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Indications

• Constipation
• Gastrointestinal symptom, Orlistat-induced
• Hypercholesterolemia

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

• For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within 12 to 72 hours

Dosage

Children 12 years and over

• 5 capsules one to three times daily

Children under 12 years

• Consult a doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Psyllium 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.

DO NOT USE

• When abdominal pain, nausea or vomiting are present unless directed by a doctor
• If constipation lasts more than seven days
• If you have difficulty swallowing

ASK A DOCTOR BEFORE USE IF YOU HAVE

• Noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

• You experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

There is limited information regarding Psyllium Pharmacology in the drug label.

Mechanism of Action

Structure

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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