Reguloid 0.52gm Capsules

Manufacturer RUGBY Active Ingredient Psyllium Capsules(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
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 capsules contain psyllium, a natural fiber that works by absorbing water in your intestines to form a soft, bulky stool. This helps to make bowel movements easier and more regular, relieving constipation. It can also help to firm up loose stools.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication with or without food, and swallow it whole with a full glass of water. It's essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

When taking multiple capsules as a single dose, swallow each capsule one at a time. This will help ensure you take the medication safely and effectively.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

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 scheduled dose, skip the missed dose and resume your regular dosing 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 water throughout the day, especially with each dose of Reguloid, to prevent choking or impaction.
  • Maintain a balanced diet rich in fiber from fruits, vegetables, and whole grains.
  • Engage in regular physical activity to promote healthy bowel function.
  • Do not take Reguloid if you have difficulty swallowing or have a history of esophageal narrowing or obstruction.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 to 6 capsules, 1 to 3 times daily, with at least 8 ounces (240 mL) of water or other liquid.
Dose Range: 0.52 - 3.12 mg

Condition-Specific Dosing:

constipation: Initial dose: 2 capsules once daily. May increase gradually to 6 capsules, 3 times daily as needed. Ensure adequate fluid intake.
bowel_regularity: 2 to 6 capsules, 1 to 3 times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6 to under 12 years: 1 to 3 capsules, 1 to 3 times daily, with at least 8 ounces (240 mL) of water or other liquid. Consult a physician for children under 6 years.
Adolescent: Adolescents 12 years and over: 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 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 ingested with sufficient water, the hydrophilic mucilage of psyllium absorbs water in the gastrointestinal tract, swelling to form a viscous, emollient gel. This increases the bulk of the stool, which stimulates peristalsis and facilitates the passage of softer, more easily eliminated feces. It also helps to normalize stool consistency in diarrhea by absorbing excess water.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal to none (not systemically absorbed)
Tmax: Not applicable (local action)
FoodEffect: Should be taken with a full glass of water, with or after meals, to minimize potential for esophageal or intestinal obstruction.

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

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

OnsetOfAction: 12 to 72 hours (1 to 3 days)
PeakEffect: Not applicable (gradual effect)
DurationOfAction: Effect persists as long as regular dosing is maintained.
Confidence: High

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:
- 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
- Difficulty 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 have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Stomach pain or cramps
- Bloating

Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 (may indicate bowel obstruction)
  • Rectal bleeding
  • No bowel movement after 7 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 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 first consulting your doctor.
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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), discuss this with your doctor, as some formulations of this medication may contain phenylalanine. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to weigh the benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bloating
  • Excessive gas
  • Abdominal discomfort or cramping
  • Potential for intestinal obstruction if not taken with sufficient fluid

What to Do:

If an overdose is suspected, especially if symptoms of obstruction (severe abdominal pain, vomiting, inability to pass gas or stool) occur, seek immediate medical attention. Ensure adequate fluid intake. For general overdose concerns, call a poison control center (1-800-222-1222).

Drug Interactions

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Major Interactions

  • Digoxin (oral)
  • Warfarin (oral)
  • Carbamazepine (oral)
  • Lithium (oral)
  • Salicylates (oral)
  • Tetracyclines (oral)
  • Vitamins (fat-soluble, oral)
  • Tricyclic antidepressants (oral)
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Moderate Interactions

  • Oral hypoglycemic agents (may slightly reduce glucose absorption)
  • Thyroid hormones (oral)

Monitoring

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Baseline Monitoring

Bowel habits (frequency, consistency)

Rationale: To establish baseline and assess effectiveness.

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

Bowel movement frequency and consistency

Frequency: Daily

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 7 days of use, or worsening constipation, abdominal pain, or bloating.

Fluid intake

Frequency: Daily

Target: At least 8 ounces (240 mL) of water per dose, and adequate daily hydration.

Action Threshold: Signs of dehydration or insufficient fluid intake with doses.

Abdominal comfort/distention

Frequency: Daily

Target: No significant abdominal pain, bloating, or distention.

Action Threshold: New or worsening abdominal pain, severe bloating, or distention.

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Symptom Monitoring

  • Relief of constipation
  • Regularity of bowel movements
  • Abdominal pain or cramping
  • Bloating or gas
  • Difficulty swallowing or choking sensation (if not taken with enough water)
  • Rectal bleeding
  • Nausea or vomiting

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 essential.

Trimester-Specific Risks:

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

Psyllium is considered compatible with breastfeeding as it is not systemically absorbed by the mother and therefore not excreted in breast milk. It poses no known risk to the nursing infant.

Infant Risk: Low risk
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Pediatric Use

Use in children under 6 years should only be under the direction of a physician. For children 6-12 years, use reduced doses as directed. Ensure adequate fluid intake to prevent choking or impaction. Not for use in infants.

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Geriatric Use

Generally safe for use in the elderly. However, older adults may be more susceptible to dehydration or impaction if fluid intake is insufficient. Monitor closely for adequate hydration and bowel function. Start with lower doses and gradually increase as needed.

Clinical Information

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Clinical Pearls

  • Always take psyllium with a full glass (at least 8 ounces) of water or other liquid to prevent the fiber from swelling in the throat or esophagus, which can cause choking or obstruction.
  • Do not take psyllium immediately before lying down.
  • Start with the lowest effective dose and gradually increase over several days to allow the body to adjust and minimize gas and bloating.
  • The full effect of psyllium may not be seen for 1 to 3 days.
  • Psyllium can be used for both constipation and to help firm up loose stools in some cases of diarrhea (e.g., irritable bowel syndrome with diarrhea predominance) by absorbing excess water.
  • Advise patients to separate psyllium administration from other oral medications by at least 1-2 hours before or 2-4 hours after to prevent reduced absorption of other drugs.
  • Not for use in patients with symptoms of appendicitis, fecal impaction, or intestinal obstruction.
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Alternative Therapies

  • Stool softeners (e.g., docusate sodium)
  • Osmotic laxatives (e.g., polyethylene glycol, lactulose, magnesium hydroxide)
  • Stimulant laxatives (e.g., bisacodyl, senna) - generally for short-term use
  • Dietary fiber supplementation (e.g., oat bran, flaxseed)
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Cost & Coverage

Average Cost: $5 - $20 per 100-200 capsules
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as it is an over-the-counter (OTC) product. May be eligible for FSA/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.