Reguloid 43% Powder 369gm

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; Fiber supplement
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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?

Reguloid is a fiber supplement that helps make your stools softer and easier to pass, relieving constipation. It works by absorbing water in your intestines to add bulk to your stool. It can also help maintain regularity and may help lower cholesterol and 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. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.

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

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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are 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 your doctor recommends.
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Lifestyle & Tips

  • Always mix Reguloid powder with at least 8 ounces (a full glass) of water or other liquid. Stir well and drink immediately to prevent the powder from thickening and becoming difficult to swallow.
  • Drink plenty of fluids throughout the day (at least 6-8 glasses of water) to ensure the fiber works effectively and to prevent choking or impaction.
  • Start with a lower dose and gradually increase it over several days to allow your body to adjust and minimize gas or bloating.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Engage in regular physical activity to promote healthy bowel function.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 rounded teaspoon (approx. 5-7g psyllium) mixed in 8 oz (240 mL) of water or other liquid, 1 to 3 times daily. Follow specific product instructions.
Dose Range: 5 - 21 mg

Condition-Specific Dosing:

constipation: 1 rounded teaspoon 1-3 times daily
fiber_supplementation: 1 rounded teaspoon 1-3 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-11 years: 1/2 adult dose (approx. 2.5-3.5g) in 8 oz liquid, 1-3 times daily. Consult 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 adjustment needed; not systemically absorbed.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Psyllium is a natural, bulk-forming laxative. It is derived from the husks of Plantago ovata seeds. When mixed with water, it forms a gel-like substance that absorbs water in the intestine, increasing stool bulk and softening the stool. This increased bulk stimulates peristalsis, promoting bowel movements. It also acts as a soluble fiber, which can help lower cholesterol and regulate blood glucose levels.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (not absorbed systemically)
Tmax: Not applicable (not absorbed)
FoodEffect: Can be taken with or without food, but generally recommended with a full glass of water. Taking with meals may help with post-prandial glucose control.

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

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

OnsetOfAction: 12 to 72 hours (for laxative effect)
PeakEffect: Not well-defined for bulk-forming laxatives; continuous effect with regular use.
DurationOfAction: Maintains effect as long as taken regularly.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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. Your doctor can provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Choking or difficulty swallowing (if not mixed with enough liquid)
  • Severe abdominal pain, cramping, or bloating
  • Nausea or vomiting
  • 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 allergic reaction and its symptoms.
Certain health conditions, including:
+ Bowel obstruction
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that persist for more 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 prevent many drugs from being absorbed by the body.

Do not use this medication for more than 1 week without explicit instruction from 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 outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe abdominal bloating
  • Excessive gas
  • Abdominal cramping
  • Intestinal obstruction (rare, but possible with insufficient fluid intake)

What to Do:

Discontinue use. Ensure adequate fluid intake. If symptoms are severe or persistent, seek immediate medical attention or call a poison control center (1-800-222-1222).

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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Baseline Monitoring

Bowel habits and history of constipation

Rationale: To establish baseline and assess need for treatment.

Timing: Prior to initiation

Hydration status

Rationale: Adequate fluid intake is crucial to prevent impaction.

Timing: Prior to initiation

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Routine Monitoring

Frequency and consistency of bowel movements

Frequency: Daily or as needed

Target: Regular, soft, formed stools

Action Threshold: Lack of bowel movement for >3 days, hard stools, or abdominal discomfort

Adequacy of fluid intake

Frequency: Daily

Target: At least 8 glasses (2 liters) of water per day

Action Threshold: Signs of dehydration, persistent constipation despite psyllium use

Abdominal discomfort/bloating

Frequency: Daily

Target: Minimal to no discomfort

Action Threshold: Severe or persistent abdominal pain, bloating, or distension

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Symptom Monitoring

  • Relief of constipation
  • Reduced straining during bowel movements
  • Abdominal bloating or gas (especially initially)
  • Abdominal pain or cramping
  • Difficulty swallowing or choking sensation (if not mixed with enough liquid)
  • Rectal bleeding (seek medical attention)

Special Patient Groups

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Pregnancy

Psyllium is generally considered safe and effective for treating constipation during pregnancy. It is a bulk-forming laxative that is not absorbed systemically, minimizing fetal exposure.

Trimester-Specific Risks:

First Trimester: Low risk; often recommended for constipation.
Second Trimester: Low risk; often recommended for constipation.
Third Trimester: Low risk; often recommended for constipation.
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Lactation

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

Infant Risk: Very low risk (L1 - Safest)
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Pediatric Use

Generally safe for children over 6 years of age, but dosing should be adjusted (typically half the adult dose for children 6-11 years). Adequate fluid intake is critical. Consult a pediatrician for use in children under 6 years.

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Geriatric Use

Generally safe for older adults. Ensure adequate fluid intake to prevent impaction. Older adults may be more susceptible to dehydration or have pre-existing conditions that require careful monitoring. Start with a lower dose and increase gradually.

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of mixing psyllium powder with a full glass (at least 8 oz) of water or other liquid and drinking it immediately to prevent choking or esophageal obstruction.
  • Advise patients to increase fluid intake throughout the day when using psyllium to ensure its effectiveness and prevent adverse effects.
  • Inform patients that the laxative effect may not be immediate and can take 12 to 72 hours to occur.
  • Psyllium can be used long-term for chronic constipation or as a fiber supplement, but patients should be advised to consult a healthcare provider if constipation persists or worsens.
  • Counsel patients to take other oral medications at least 2 hours before or 2 hours after psyllium to avoid interference with absorption.
  • Initial use may cause increased gas or bloating, which usually subsides with continued use as the body adjusts.
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Alternative Therapies

  • Methylcellulose (e.g., Citrucel)
  • Polycarbophil (e.g., FiberCon)
  • 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 only)
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Cost & Coverage

Average Cost: $10 - $30 per 369gm container
Generic Available: Yes
Insurance Coverage: Generally OTC, not typically covered by insurance unless prescribed for specific medical conditions (e.g., IBS, diverticulosis) and a prescription is submitted.
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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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.