Senna 8.8mg/5ml Syrup

Manufacturer PATRIN PHARMA Active Ingredient Sennosides Liquid and Syrup(SEN oh sides) Pronunciation SEN oh sides
It is used to treat constipation.
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Drug Class
Laxative
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Pharmacologic Class
Stimulant laxative; Anthraquinone derivative
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Pregnancy Category
Category C (often considered B for short-term use, but C is safer for general classification due to limited controlled studies)
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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?

Senna is a type of laxative that helps you have a bowel movement by stimulating your intestines. It's often used for occasional constipation. It usually works within 6 to 12 hours, so it's best to take it at bedtime.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Do not take any other medications within 2 hours of taking this drug.
If you are taking this medication once a day, take it at bedtime.
Some medications require shaking before use. Check your medication to see if this is necessary.
When taking a liquid dose, measure it carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding the bathroom.
Protect the medication from heat.
Keep all medications in a safe and secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, follow these guidelines:

Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Drink plenty of fluids (water, juice) while taking senna to help prevent dehydration and aid the laxative effect.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) to help prevent future constipation.
  • Engage in regular physical activity, as exercise can help promote regular bowel movements.
  • Do not use senna for more than 7 days unless directed by a doctor, as prolonged use can lead to dependence or electrolyte imbalances.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mL (17.6 mg sennosides) orally once daily at bedtime
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

constipation: Initial: 10 mL (17.6 mg sennosides) orally once daily at bedtime. May increase to 20 mL (35.2 mg sennosides) once daily if needed. Do not exceed 20 mL (35.2 mg sennosides) in 24 hours.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution and under medical supervision)
Infant: Not established (use with extreme caution and under medical supervision, typically 1.25-2.5 mL for infants >6 months, consult physician)
Child: 2-6 years: 2.5-5 mL (4.4-8.8 mg sennosides) orally once daily at bedtime. Max 5 mL/day. 6-12 years: 5-10 mL (8.8-17.6 mg sennosides) orally once daily at bedtime. Max 10 mL/day.
Adolescent: 12 years and older: Same as adult dosing, 10 mL (17.6 mg sennosides) orally once daily at bedtime. Max 20 mL/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution. Monitor for electrolyte imbalances.
Severe: Use with caution, may exacerbate fluid and electrolyte imbalances. Consult physician.
Dialysis: Use with caution, monitor for electrolyte imbalances. Consult physician.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, but use with caution in patients with severe liver disease due to potential for electrolyte disturbances.

Pharmacology

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Mechanism of Action

Sennosides are prodrugs that are metabolized by colonic bacteria into active anthrones (e.g., rhein anthrone). These active metabolites stimulate colonic peristalsis by direct irritation of the smooth muscle of the colon and nerve plexuses, and also increase water and electrolyte secretion into the colon, leading to increased intraluminal pressure and a laxative effect.
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Pharmacokinetics

Absorption:

Bioavailability: Low (prodrug, active metabolites formed in colon)
Tmax: Not directly applicable for parent drug; active metabolites reach systemic circulation after 6-12 hours.
FoodEffect: Minimal or no significant effect on efficacy.

Distribution:

Vd: Not well-quantified for active metabolites due to limited systemic absorption.
ProteinBinding: Not well-quantified.
CnssPenetration: Limited

Elimination:

HalfLife: Not well-defined for active metabolites due to complex colonic metabolism and enterohepatic recirculation; systemic half-life of rhein is approximately 16 hours.
Clearance: Not well-quantified.
ExcretionRoute: Mainly fecal (unabsorbed sennosides and metabolites); small amounts of active metabolites excreted renally.
Unchanged: Minimal systemic absorption of unchanged sennosides.
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Pharmacodynamics

OnsetOfAction: 6-12 hours (due to time required for colonic metabolism and transit)
PeakEffect: Not distinctly defined, effect is a gradual onset leading to bowel movement.
DurationOfAction: Effect typically resolves after a single bowel movement, usually within 24 hours.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.

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. Contact your doctor or seek medical help if you experience:
- Stomach pain or cramps
or if any other side effects bother you or do not go away.

Reporting Side Effects
This list does not include all possible 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:

  • Severe or persistent abdominal pain or cramping
  • Rectal bleeding
  • Nausea or vomiting
  • No bowel movement after 2-3 days of use
  • Signs of dehydration (e.g., excessive thirst, dry mouth, decreased urination, dizziness)
  • Muscle weakness or cramps
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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 issues, including:
+ Bowel blockage
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that last longer than 2 weeks

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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.

Do not use this medication for a period exceeding 1 week unless your doctor has specifically instructed you to do so.

Additionally, refrain from using other laxatives or stool softeners concurrently with this drug, unless your doctor has advised you to do so.

If you experience rectal bleeding or fail to have a bowel movement after using this medication, it is crucial that you consult with your doctor.

If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This conversation will help determine the benefits and risks associated with using this medication, both for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe abdominal cramps
  • Diarrhea (potentially severe, leading to fluid and electrolyte loss)
  • Dehydration
  • Electrolyte imbalances (especially hypokalemia)
  • Nausea
  • Vomiting

What to Do:

Discontinue use immediately. Seek medical attention. Management is supportive, focusing on fluid and electrolyte replacement. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Digoxin (cardiac glycosides): Prolonged use of senna can lead to hypokalemia, which can potentiate the effects of digoxin, increasing the risk of digoxin toxicity (arrhythmias).
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Moderate Interactions

  • Diuretics (thiazide, loop): Concomitant use with senna can increase the risk of hypokalemia due to increased fluid and electrolyte loss.
  • Corticosteroids: Concomitant use can increase the risk of hypokalemia.
  • Antiarrhythmics (e.g., quinidine): Hypokalemia induced by senna can increase the risk of arrhythmias in patients taking antiarrhythmics.
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Minor Interactions

  • Other laxatives: Concurrent use may lead to excessive laxation and electrolyte imbalance.
  • Warfarin: While rare, excessive diarrhea can theoretically alter gut flora and vitamin K absorption, potentially affecting INR. Monitor INR if prolonged use.

Monitoring

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Baseline Monitoring

Assessment of constipation cause

Rationale: To rule out underlying medical conditions requiring different treatment.

Timing: Prior to initiation of therapy.

Fluid and electrolyte status

Rationale: To identify pre-existing imbalances, especially in vulnerable populations (elderly, renal impairment).

Timing: Prior to initiation, especially if prolonged use is anticipated.

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily during treatment

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 2-3 days of use, or persistent diarrhea/abdominal pain.

Hydration status

Frequency: Daily

Target: Adequate fluid intake, no signs of dehydration

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

Serum electrolytes (Potassium, Sodium)

Frequency: Periodically, if used for prolonged periods (weeks to months) or in patients at risk for electrolyte imbalance (e.g., on diuretics, cardiac conditions).

Target: Within normal limits

Action Threshold: Abnormal levels, especially hypokalemia.

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Symptom Monitoring

  • Severe or persistent abdominal pain or cramping
  • Rectal bleeding
  • Nausea or vomiting
  • Signs of dehydration (e.g., excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
  • Muscle weakness or cramps (signs of electrolyte imbalance)
  • No bowel movement after 2-3 days of use

Special Patient Groups

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Pregnancy

Generally considered safe for short-term use during pregnancy for occasional constipation, but bulk-forming laxatives are usually preferred first-line. Use under medical supervision.

Trimester-Specific Risks:

First Trimester: Low risk for short-term use.
Second Trimester: Low risk for short-term use.
Third Trimester: Low risk for short-term use.
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Lactation

Considered compatible with breastfeeding for short-term use. Minimal amounts of active metabolites are excreted into breast milk and are not expected to cause adverse effects in the infant.

Infant Risk: Low risk (L2)
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Pediatric Use

Use with caution and only under medical supervision, especially in infants and young children. Dosing must be carefully adjusted by age and weight. Not recommended for children under 2 years without physician consultation.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to fluid and electrolyte imbalances. Start with the lowest effective dose and monitor hydration status and electrolytes closely. Avoid prolonged use.

Clinical Information

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Clinical Pearls

  • Senna is intended for short-term relief of occasional constipation. Prolonged use (more than 7 days) can lead to laxative dependence, loss of normal bowel function, and electrolyte disturbances.
  • Advise patients to take senna at bedtime, as its onset of action is typically 6-12 hours.
  • Emphasize the importance of adequate fluid intake to prevent dehydration and enhance the laxative effect.
  • Educate patients on lifestyle modifications (dietary fiber, exercise) to manage chronic constipation, rather than relying solely on stimulant laxatives.
  • Warn patients about potential urine discoloration (yellow-brown to red-brown) which is harmless and due to senna metabolites.
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Alternative Therapies

  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Osmotic laxatives (e.g., polyethylene glycol, lactulose, magnesium hydroxide)
  • Stool softeners (e.g., docusate sodium)
  • Lubricant laxatives (e.g., mineral oil - generally not recommended due to aspiration risk and malabsorption)
  • Peripherally acting mu-opioid receptor antagonists (PAMORAs) for opioid-induced constipation (e.g., methylnaltrexone, naloxegol)
  • Guanylate cyclase-C agonists (e.g., linaclotide, plecanatide) for chronic idiopathic constipation
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Cost & Coverage

Average Cost: $5 - $20 per 237 mL bottle
Generic Available: Yes
Insurance Coverage: Often OTC, may not be covered by prescription plans. If covered, typically Tier 1 (generic).
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.