Reguloid Psyllium Orange Powder

Manufacturer RUGBY LABORATORIES Active Ingredient Psyllium Powder(SIL i yum) Pronunciation SIL-ee-um
It is used to treat constipation.It is used to raise fiber in the diet.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Laxative, Bulk-forming
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Pharmacologic Class
Bulk-forming agent
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Pregnancy Category
Not formally categorized, generally considered safe (Category B equivalent)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Psyllium is a natural fiber supplement that helps to relieve constipation and promote regularity. It works by absorbing water in your intestines to form a soft, bulky stool that is easier to pass. It can also help lower cholesterol and manage blood sugar levels.
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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. Take your medication as directed, with or without food, and swallow it with a full glass of water. It's also important to drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

To prepare your medication, mix it with at least 8 ounces (240 mL) of water or another liquid. If the mixture becomes thick, add more liquid and stir well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on proper disposal. You may also want to explore local drug take-back programs.

Missing a Dose

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Drink plenty of fluids (at least 8 ounces with each dose, and 6-8 glasses throughout the day) to prevent choking and ensure the fiber works effectively.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Engage in regular physical activity to promote bowel regularity.
  • Do not take psyllium dry; always mix it thoroughly with the recommended amount of liquid.
  • Take other medications at least 2 hours before or 2 hours after psyllium to avoid interference with their absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 rounded teaspoon (approx. 5-7g) mixed in 8 ounces (240 mL) of water or other liquid, 1 to 3 times daily. Follow with an additional glass of liquid.
Dose Range: 5 - 21 mg

Condition-Specific Dosing:

constipation: Start with 1 dose daily, gradually increase to 3 doses daily as needed.
fiber_supplementation: 1 dose daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-11 years: Half the adult dose (approx. 2.5-3.5g) mixed in 8 ounces (240 mL) of water or other liquid, 1 to 3 times daily. Consult a physician for children under 6 years.
Adolescent: Adolescents 12 years and older: Adult dose.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations, as it is not systemically absorbed. Ensure adequate fluid intake.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Psyllium is a natural, bulk-forming laxative. It consists of the dried ripe seeds of Plantago psyllium or Plantago ovata. When mixed with water, the mucilage in psyllium swells to form a gel-like mass. This mass increases the bulk of the stool, which stimulates peristalsis and facilitates bowel movements. The increased bulk also helps to soften the stool by retaining water, making it easier to pass.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal to none (not systemically absorbed)
Tmax: Not applicable (not systemically absorbed)
FoodEffect: Can be taken with or without food, but generally recommended to take with a full glass of water.

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

HalfLife: Not applicable
Clearance: Not applicable
ExcretionRoute: Fecal
Unchanged: Nearly 100% (as fiber)
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Pharmacodynamics

OnsetOfAction: 12-72 hours (usually within 1-3 days)
PeakEffect: Not applicable (gradual effect)
DurationOfAction: As long as regular use continues

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Trouble swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While 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:

Stomach pain or cramps
Bloating

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:

  • Choking or difficulty swallowing (seek immediate medical attention)
  • Chest pain
  • Severe abdominal pain, nausea, or vomiting (do not take psyllium and consult a doctor)
  • Rectal bleeding
  • No bowel movement after 3 days of use
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 conditions, including:
+ Bowel blockage
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that last longer than 2 weeks
* Difficulty swallowing

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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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. To minimize potential interactions, try to take other medications at least 2 hours apart from this one, as it can interfere with the absorption of many other drugs.

Do not use this medication for more than 1 week without consulting your doctor. If you experience rectal bleeding or do not have a bowel movement after using this medication, promptly discuss these symptoms with your doctor. Additionally, avoid using other laxatives or stool softeners unless your doctor has advised you to do so.

To ensure safe use, it is crucial to take this medication with a sufficient amount of liquid. If not taken with enough liquid, the medication can swell and potentially block your throat or esophagus, leading to choking. If you have difficulty swallowing, do not take this medication. If you experience chest pain, vomiting, swallowing difficulties, or breathing problems after taking this medication, seek immediate medical attention.

If you have phenylketonuria (PKU), consult your doctor before taking this medication, as some products contain phenylalanine. It is also important to discuss your pregnancy status or plans with your doctor, as well as whether you are breastfeeding, to carefully weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bloating
  • Excessive gas
  • Abdominal cramping
  • Intestinal obstruction (rare, but serious, especially if not taken with enough water)

What to Do:

Discontinue use. Ensure adequate fluid intake. If symptoms are severe or persistent, seek medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Digoxin (may decrease absorption)
  • Warfarin (may decrease absorption)
  • Carbamazepine (may decrease absorption)
  • Lithium (may decrease absorption)
  • Tricyclic antidepressants (may decrease absorption)
  • Salicylates (may decrease absorption)
  • Vitamins (fat-soluble vitamins, B12 - may decrease absorption)
  • Minerals (calcium, iron, zinc - may decrease absorption)
  • Oral hypoglycemic agents (may decrease absorption, potentially affecting blood glucose control)

Monitoring

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily during initial use, then as needed

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 3 days of use, worsening constipation, or severe abdominal pain

Hydration status

Frequency: Daily

Target: Adequate fluid intake (at least 8 glasses of water per day)

Action Threshold: Signs of dehydration (e.g., dry mouth, decreased urination)

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Symptom Monitoring

  • Abdominal pain or cramping
  • Bloating
  • Gas
  • Nausea
  • Vomiting
  • Difficulty swallowing
  • Chest pain
  • Rectal bleeding
  • Lack of bowel movement after use

Special Patient Groups

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Pregnancy

Psyllium is generally considered safe and is often recommended as a first-line treatment for constipation during pregnancy due to its minimal systemic absorption. Adequate fluid intake is crucial.

Trimester-Specific Risks:

First Trimester: Low risk, generally considered safe.
Second Trimester: Low risk, generally considered safe.
Third Trimester: Low risk, generally considered safe.
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Lactation

Psyllium is considered compatible with breastfeeding (L1) as it is not systemically absorbed by the mother and therefore not excreted in breast milk. It is a safe option for lactating mothers experiencing constipation.

Infant Risk: None known
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Pediatric Use

Use in children under 6 years should be under the guidance of a healthcare professional. Ensure adequate fluid intake to prevent choking or impaction. Start with the lowest effective dose.

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Geriatric Use

Generally safe for elderly patients. However, ensure adequate fluid intake to prevent dehydration and potential impaction, as elderly individuals may have reduced thirst sensation or be on medications that cause dehydration. Start with lower doses and titrate as needed.

Clinical Information

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Clinical Pearls

  • Always mix psyllium powder with at least 8 ounces (240 mL) of water or other liquid and drink immediately. Follow with an additional glass of liquid to prevent choking or impaction.
  • Do not take psyllium dry, as it can swell and cause choking.
  • The full effect of psyllium may take 1 to 3 days to become apparent, so consistent daily use is important.
  • If using psyllium for cholesterol lowering or blood sugar management, consistent daily use is key, and it should be part of a comprehensive diet and lifestyle plan.
  • Advise patients to separate psyllium administration from other oral medications by at least 2 hours to prevent reduced absorption of other drugs.
  • Patients with a history of esophageal stricture, bowel obstruction, or difficulty swallowing should avoid psyllium.
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Alternative Therapies

  • Osmotic laxatives (e.g., polyethylene glycol 3350, lactulose, magnesium hydroxide)
  • Stool softeners (e.g., docusate sodium)
  • Stimulant laxatives (e.g., senna, bisacodyl - for short-term use)
  • Dietary fiber (e.g., fruits, vegetables, whole grains, legumes)
  • Probiotics
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Cost & Coverage

Average Cost: Varies widely (typically $10-$30) per container (e.g., 114 doses)
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as it is an over-the-counter (OTC) product, unless prescribed for specific medical conditions (e.g., IBS, diverticulosis) and covered by a flexible spending account (FSA) or health savings account (HSA).
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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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.