Floranex Tablets
It is used to keep the normal balance of bacteria in the gastrointestinal (GI) tract.
Drug Class
Probiotic; Gastrointestinal agent
Pharmacologic Class
Live microbial supplement; Gut flora modifier
Pregnancy Category
Not applicable (Generally regarded as safe - GRAS)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lactobacillus is a type of 'good' bacteria, also known as a probiotic. It helps keep your digestive system healthy by balancing the bacteria in your gut. It can be used to prevent or treat diarrhea, especially after taking antibiotics, and to support overall digestive and immune health.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort. If you need to, you can sprinkle the contents of the capsule onto soft food or a liquid, but do not chew the mixture.
Storing and Disposing of Your Medication
It's essential to store this medication properly. Some brands require refrigeration, while others should be kept at room temperature. If you're unsure about the storage requirements, consult your pharmacist. Be aware of the medication's expiration date or the length of time you can store it before it needs to be discarded.
Missing a Dose
If you 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 to make up for the missed one.
To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort. If you need to, you can sprinkle the contents of the capsule onto soft food or a liquid, but do not chew the mixture.
Storing and Disposing of Your Medication
It's essential to store this medication properly. Some brands require refrigeration, while others should be kept at room temperature. If you're unsure about the storage requirements, consult your pharmacist. Be aware of the medication's expiration date or the length of time you can store it before it needs to be discarded.
Missing a Dose
If you 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 to make up for the missed one.
Lifestyle & Tips
- Maintain a balanced diet rich in fiber (prebiotics) to support the growth of beneficial gut bacteria.
- Stay well-hydrated.
- Avoid excessive alcohol consumption, which can negatively impact gut flora.
- Store product as directed (some require refrigeration, others are shelf-stable).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 capsules/tablets daily, or as directed by a healthcare professional. Dosing varies significantly by product and CFU count.
Dose Range:
1000000000 - 50000000000 mg
Condition-Specific Dosing:
antibiotic-associated diarrhea prevention:
5-10 billion CFU daily, started with antibiotics and continued for at least 1 week after.
general gut health:
1-10 billion CFU daily.
Pediatric Dosing
Neonatal:
Not established for routine use; specific strains may be used in clinical settings for certain conditions (e.g., necrotizing enterocolitis prevention). Dosing typically 1-5 billion CFU.
Infant:
Dosing typically 1-5 billion CFU daily, depending on product and indication. Consult pediatrician.
Child:
Dosing typically 1-10 billion CFU daily, depending on product and indication. Consult pediatrician.
Adolescent:
Similar to adult dosing, 1-10 billion CFU daily, depending on product and indication.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; generally safe.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Lactobacillus species are beneficial bacteria that colonize the human gastrointestinal tract. Their mechanism of action involves: 1. Restoring and maintaining a healthy balance of gut microbiota. 2. Competitive exclusion of pathogenic bacteria by competing for nutrients and adhesion sites. 3. Production of antimicrobial substances (e.g., lactic acid, hydrogen peroxide, bacteriocins) that inhibit pathogen growth. 4. Modulation of the host immune system, including enhancing gut barrier function and influencing cytokine production. 5. Aiding in digestion and nutrient absorption.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (minimal systemic absorption of live bacteria)
Tmax:
Not applicable
FoodEffect:
Some strains may have improved survival when taken with food or shortly before a meal, while others are designed for acid resistance and can be taken without food. Follow product-specific instructions.
Distribution:
Vd:
Not applicable (primarily localized to GI tract)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (colonize and are excreted in feces)
Clearance:
Not applicable
ExcretionRoute:
Fecal
Unchanged:
100% (live organisms)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable effects, depending on condition and individual response.
PeakEffect:
Sustained with continued daily use.
DurationOfAction:
Effects diminish rapidly upon discontinuation, as the introduced bacteria are transient colonizers.
Safety & Warnings
Side Effects
Serious 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
Feeling dizzy, tired, or weak
Unusual thirst
Changes in urine output
Muscle pain
Bone pain
Weight loss
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:
Gas
Upset stomach or vomiting
Decreased appetite
Stomach cramps
Dry mouth
* Headache
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.
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
Feeling dizzy, tired, or weak
Unusual thirst
Changes in urine output
Muscle pain
Bone pain
Weight loss
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:
Gas
Upset stomach or vomiting
Decreased appetite
Stomach cramps
Dry mouth
* Headache
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.
Seek Immediate Medical Attention If You Experience:
- Increased bloating
- Excessive gas
- Mild abdominal discomfort
- Allergic reaction (rare: rash, itching, swelling, severe dizziness, trouble breathing)
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.
If the patient is a premature infant or has a weight of less than 1 kilogram (2.2 pounds).
To ensure safe treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances or health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
If the patient is a premature infant or has a weight of less than 1 kilogram (2.2 pounds).
To ensure safe treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances or health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you follow a lactose-free diet, consult your doctor, as some formulations of this drug may contain lactose. Additionally, if you have diabetes (high blood sugar), carefully review the labels of this medication, as some products may contain sugar. Be aware that different brands of this medication may be approved for use in children of varying ages, so it is crucial to discuss this with your doctor before administering it to a child. If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult your doctor to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe bloating
- Excessive flatulence
- Abdominal discomfort
What to Do:
Overdose is unlikely to be toxic. Discontinue use and symptoms should resolve. If symptoms are severe or persistent, consult a healthcare professional. Call 1-800-222-1222 for poison control if concerned.
Drug Interactions
Major Interactions
- Immunosuppressants (e.g., cyclosporine, tacrolimus, corticosteroids, chemotherapy): May increase theoretical risk of bacteremia or fungemia in severely immunocompromised patients, though rare and strain-dependent. Use with caution.
Moderate Interactions
- Antibiotics (e.g., amoxicillin, ciprofloxacin, doxycycline): May reduce the efficacy of Lactobacillus by killing the beneficial bacteria. Advise taking probiotics at least 2-3 hours apart from antibiotics.
Monitoring
Symptom Monitoring
- Improvement in gastrointestinal symptoms (e.g., diarrhea, constipation, bloating)
- Resolution of antibiotic-associated diarrhea
- Occurrence of new or worsening abdominal discomfort, gas, or bloating (potential side effects)
Special Patient Groups
Pregnancy
Generally considered safe during pregnancy. Many studies support its use for common pregnancy-related issues like constipation or vaginal health. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Generally considered safe during lactation. Minimal systemic absorption means negligible transfer to breast milk. May benefit maternal and infant gut health.
Infant Risk:
Lowest risk (L1)
Pediatric Use
Generally safe for children, with age-appropriate dosing. Specific strains are studied for conditions like infant colic, eczema prevention, and antibiotic-associated diarrhea. Always consult a pediatrician before administering to infants or young children.
Geriatric Use
Generally safe for older adults. May be beneficial for age-related changes in gut microbiota and conditions like constipation. No specific dose adjustments are typically needed.
Clinical Information
Clinical Pearls
- Probiotic efficacy is strain-specific; different Lactobacillus species and strains have different benefits.
- Advise patients to take probiotics at least 2-3 hours apart from antibiotics to maximize efficacy.
- Some individuals may experience mild gas or bloating initially as their gut adjusts; this usually subsides with continued use.
- Refrigeration may be required for some products to maintain viability of live cultures; check product label.
- Not all probiotic products are created equal; look for products with reputable manufacturers and clear CFU counts at expiration, not just at manufacture.
Alternative Therapies
- Dietary changes (e.g., increased fiber intake, fermented foods like yogurt, kefir, sauerkraut)
- Prebiotics (e.g., inulin, FOS) to nourish beneficial gut bacteria
- Antidiarrheals (e.g., loperamide) for symptomatic relief of diarrhea
- Laxatives for constipation
Cost & Coverage
Average Cost:
$10 - $50+ per 30-60 tablets/capsules
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance (considered a dietary supplement); some FSA/HSA eligible.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.