Reguloid Orange Powder 538gm

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
Bulk-forming laxative
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Pharmacologic Class
Bulk-forming agent
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Pregnancy Category
Category B
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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 make your bowel movements more regular and softer. It works by absorbing water in your intestines, which adds bulk to your stool and helps it pass more easily. It can also help with occasional diarrhea by absorbing excess water.
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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 your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.

Missing a Dose

If you take this medication regularly and miss a dose, take it 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, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids throughout the day (at least 6-8 glasses of water) to prevent constipation and potential choking/obstruction.
  • 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 with the recommended amount of liquid and drink immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Mix 1 rounded teaspoon (approx. 5g) in at least 8 ounces (240 mL) of water or other liquid, stir briskly and drink immediately. Take 1 to 3 times daily.
Dose Range: 5 - 15 mg

Condition-Specific Dosing:

constipation: 1 rounded teaspoon (approx. 5g) 1-3 times daily.
cholesterol_reduction: Consult physician for specific dosing, typically higher doses (e.g., 7g per dose, 2-3 times daily) with meals.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-11 years: Mix 1/2 rounded teaspoon in at least 8 ounces of water or liquid, 1 to 3 times daily. Not recommended for children under 6 years old without physician consultation.
Adolescent: Adolescents 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed, as psyllium is not systemically absorbed.

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, it forms a gelatinous mass that increases the bulk of the stool, promoting normal peristalsis and bowel evacuation. The increased bulk also helps to soften the stool, making it easier to pass. It can also help absorb excess water in cases of diarrhea.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal to none (not systemically absorbed)
Tmax: Not applicable (local action)
FoodEffect: Can be taken with or without food, but often recommended with meals for cholesterol-lowering effects.

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

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

OnsetOfAction: 12-72 hours (usually within 12-24 hours)
PeakEffect: May take several days for full effect on regularity
DurationOfAction: Variable, depends on continued use

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
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 for advice:

Stomach pain or cramps
Bloating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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:

  • Difficulty swallowing or breathing after taking the product
  • Chest pain
  • Vomiting
  • Severe abdominal pain or cramping
  • Inability to pass gas or stool
  • Rectal bleeding
  • Allergic reaction (e.g., rash, itching, swelling, severe dizziness)
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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 allergic reaction and its symptoms.
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 change 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 7 days unless specifically instructed to do so by your doctor. If you experience rectal bleeding or do not have a bowel movement after using this medication, consult your doctor promptly.

Unless advised by your doctor, avoid using other laxatives or stool softeners in conjunction with this medication. It is crucial to take this medication with a sufficient amount of liquid to prevent it from swelling and potentially blocking your throat or esophagus, which may lead 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. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bloating
  • Excessive gas
  • Abdominal cramping
  • Intestinal obstruction (in severe cases, especially without adequate fluid intake)

What to Do:

Discontinue use. Seek immediate medical attention if symptoms of obstruction occur (severe abdominal pain, vomiting, inability to pass gas/stool). Ensure adequate hydration. For less severe symptoms, supportive care.

Drug Interactions

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Moderate Interactions

  • Oral medications (e.g., digoxin, warfarin, carbamazepine, lithium, tricyclic antidepressants, salicylates, nitrofurantoin, oral contraceptives, vitamins, minerals, antidiabetic agents)

Monitoring

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily

Target: Regular, soft, formed stools

Action Threshold: Lack of bowel movement after 3 days, worsening constipation, or abdominal pain

Hydration status

Frequency: Daily

Target: Adequate fluid intake (at least 8 oz with each dose, and sufficient daily intake)

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

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Symptom Monitoring

  • Relief of constipation
  • Abdominal discomfort (bloating, gas, cramping)
  • Signs of esophageal or intestinal obstruction (e.g., difficulty swallowing, chest pain, vomiting, severe abdominal pain, inability to pass gas or stool)
  • Allergic reactions (e.g., rash, itching, difficulty breathing)

Special Patient Groups

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Pregnancy

Psyllium is generally considered safe and effective for treating constipation during pregnancy. It is a first-line recommendation due to its minimal systemic absorption.

Trimester-Specific Risks:

First Trimester: Low risk, commonly used.
Second Trimester: Low risk, commonly used.
Third Trimester: Low risk, commonly used.
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Lactation

Psyllium is considered safe for use during breastfeeding as it is not systemically absorbed by the mother and therefore not excreted into breast milk.

Infant Risk: Low risk (L1 - Safest)
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Pediatric Use

Use with caution and under medical supervision for children under 6 years of age. Ensure adequate fluid intake to prevent choking or obstruction. Dosing should be age-appropriate.

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Geriatric Use

Generally safe and effective. Elderly patients may be more susceptible to dehydration, so emphasize adequate fluid intake. Start with lower doses and titrate as needed. Monitor for signs of impaction or obstruction, especially in those with reduced mobility or pre-existing bowel conditions.

Clinical Information

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Clinical Pearls

  • Always mix psyllium with the full recommended amount of liquid (at least 8 ounces) and drink immediately to prevent the powder from gelling in the throat and causing choking.
  • Do not take psyllium dry.
  • Take other oral medications at least 2 hours before or 2 hours after psyllium to avoid interference with their absorption.
  • Increase fluid intake throughout the day when using psyllium to maximize its effectiveness and prevent adverse effects like bloating, gas, or obstruction.
  • Regular, daily use is often necessary for consistent bowel regularity and cholesterol-lowering effects.
  • If constipation persists or worsens after 7 days of use, consult a healthcare professional.
  • Psyllium can be used for both constipation and mild diarrhea, as it helps normalize stool consistency.
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Alternative Therapies

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

Average Cost: $10 - $30 per 538g container
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as it is an over-the-counter (OTC) product, unless specifically prescribed and covered by certain plans (e.g., FSA/HSA eligible).
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.