Floranex 1gm Granules
It is used to keep the normal balance of bacteria in the gastrointestinal (GI) tract.
Drug Class
Probiotic; Antidiarrheal (adjunctive); Digestive aid
Pharmacologic Class
Live Biotherapeutic Product; Gut Flora Modifier
Pregnancy Category
Category B (Generally considered safe, but consult healthcare provider)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lactobacillus is a type of 'good bacteria' (probiotic) that helps keep your digestive system healthy. It can be used to restore the natural balance of bacteria in your gut, especially after taking antibiotics, or to help with digestive issues like diarrhea or bloating.
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 the medication as directed, and follow these guidelines:
* Mix the medication with cold or room-temperature cereal, food, or milk. Avoid mixing it with warm or hot food or drinks.
Storing and Disposing of Your Medication
To ensure the medication remains effective, store it properly. Some brands require refrigeration, while others should be stored 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication as directed, and follow these guidelines:
* Mix the medication with cold or room-temperature cereal, food, or milk. Avoid mixing it with warm or hot food or drinks.
Storing and Disposing of Your Medication
To ensure the medication remains effective, store it properly. Some brands require refrigeration, while others should be stored 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 hydrated.
- Avoid excessive alcohol consumption.
- Manage stress, as it can impact gut health.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram (granules) orally 1-2 times daily, or as directed by a healthcare professional. Often taken with or after meals.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
Antibiotic-associated diarrhea prevention:
1 gram orally 1-2 times daily, starting with antibiotic therapy and continuing for at least 1 week after discontinuation.
General digestive health:
1 gram orally once daily.
Pediatric Dosing
Neonatal:
Not established (use with caution and under medical supervision, specific strains may be used for certain conditions like necrotizing enterocolitis prevention)
Infant:
Not established (consult pediatrician; specific strains and doses are used for conditions like colic or diarrhea)
Child:
0.5 - 1 gram orally 1-2 times daily, or as directed by a pediatrician. Dose may vary based on CFU count and specific product.
Adolescent:
1 gram orally 1-2 times daily, or as directed by a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; not systemically absorbed.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Lactobacillus species are beneficial bacteria that naturally reside in the human gastrointestinal tract. When administered as a probiotic, they exert their effects primarily within the gut lumen. Their mechanism of action includes: 1) Restoring and maintaining a healthy balance of gut microbiota, especially after disturbances (e.g., antibiotic use, illness). 2) Competitive exclusion of pathogenic bacteria by competing for nutrients and adhesion sites on the intestinal epithelium. 3) Production of antimicrobial substances (e.g., lactic acid, hydrogen peroxide, bacteriocins) that inhibit the growth of harmful microorganisms. 4) Modulation of the host immune system, including enhancing gut barrier function and influencing local and systemic immune responses. 5) Production of short-chain fatty acids (SCFAs) which serve as an energy source for colonocytes and contribute to gut health.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (not absorbed systemically)
Tmax:
Not applicable (not absorbed systemically)
FoodEffect:
Often recommended to take with or after food to protect the bacteria from stomach acid, or as directed by product label.
Distribution:
Vd:
Not applicable (primarily confined to the GI tract)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (eliminated via fecal excretion as part of gut flora turnover)
Clearance:
Not applicable
ExcretionRoute:
Fecal
Unchanged:
Not applicable (colonizes the gut, then shed)
Pharmacodynamics
OnsetOfAction:
Days to weeks for full colonization and clinical effect, though some symptomatic relief (e.g., for diarrhea) may be observed sooner.
PeakEffect:
Variable, depends on the condition being treated and individual gut flora.
DurationOfAction:
Effects persist as long as administration continues; colonization may last for a period after discontinuation, but typically requires ongoing intake for sustained benefit.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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, 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent abdominal pain
- High fever or chills (especially if immunocompromised)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Worsening of original symptoms or development of new, concerning symptoms.
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 discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Remember to always check with your doctor before starting, stopping, or changing the dose of any medication to confirm it is safe to do so in conjunction with this medication.
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 discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Remember to always check with your doctor before starting, stopping, or changing the dose of any medication to confirm it is safe to do so in conjunction with this medication.
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, notify your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive bloating
- Increased flatulence
- Mild abdominal discomfort
- Diarrhea (rare, usually mild)
What to Do:
Overdose is unlikely to cause severe toxicity. Discontinue use and symptoms should resolve. If symptoms are severe or persistent, consult a healthcare professional. For general poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Patients with severe acute pancreatitis (risk of bacteremia/fungemia, though specific to certain probiotic strains and severe conditions)
- Severely immunocompromised patients (e.g., those with central venous catheters, recent organ transplant, severe critical illness) due to theoretical risk of bacteremia/fungemia, though rare.
Major Interactions
- Immunosuppressants (e.g., corticosteroids, chemotherapy, TNF-alpha inhibitors): May theoretically increase the risk of probiotic-related infection in highly susceptible individuals, or reduce probiotic efficacy.
Moderate Interactions
- Antibiotics: Antibiotics can kill Lactobacillus bacteria. To maximize efficacy, it is generally recommended to take Lactobacillus at least 2-3 hours before or after antibiotic doses.
Monitoring
Routine Monitoring
Symptom resolution (e.g., diarrhea frequency, abdominal discomfort)
Frequency: Daily to weekly, as clinically indicated
Target: Improvement or resolution of target symptoms
Action Threshold: Lack of improvement or worsening of symptoms; new onset of adverse effects.
Symptom Monitoring
- Abdominal discomfort or bloating (especially at initiation)
- Flatulence
- Diarrhea or constipation (monitor for improvement or worsening)
- Signs of infection (rare, e.g., fever, chills, if immunocompromised)
Special Patient Groups
Pregnancy
Generally considered safe during pregnancy. Studies have not shown adverse effects. However, always consult a healthcare provider before starting any new supplement during pregnancy.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Generally considered safe during breastfeeding. Lactobacillus is naturally present in breast milk and is beneficial for infant gut health. No known adverse effects on the infant.
Infant Risk:
Low risk (L1)
Pediatric Use
Commonly used in children for various conditions like antibiotic-associated diarrhea, colic, and acute gastroenteritis. Dosing should be age-appropriate and guided by a pediatrician. Caution is advised in very premature infants or those with compromised immune systems due to theoretical risk of infection.
Geriatric Use
Generally safe and well-tolerated in older adults. No specific dose adjustments are typically needed. May be beneficial for age-related changes in gut flora or for managing antibiotic-associated diarrhea.
Clinical Information
Clinical Pearls
- Advise patients to take Lactobacillus granules with or after food to help the bacteria survive stomach acid, unless otherwise specified by the product.
- If taking antibiotics, instruct patients to separate Lactobacillus doses by at least 2-3 hours from antibiotic doses to minimize inactivation of the probiotic.
- Store according to product instructions (some require refrigeration, others are shelf-stable) to maintain viability of the live cultures.
- Inform patients that mild bloating or gas may occur initially as the gut flora adjusts, but this usually subsides.
- Emphasize that while generally safe, immunocompromised individuals should consult their physician before using probiotics due to a rare risk of infection.
Alternative Therapies
- Dietary fiber (prebiotics) to support native gut flora
- Dietary modifications (e.g., BRAT diet for diarrhea)
- Antidiarrheal medications (e.g., loperamide) for symptomatic relief of diarrhea
- Laxatives for constipation (if used for constipation relief)
Cost & Coverage
Average Cost:
Highly variable, typically $10 - $50 per 30-day supply (granules/sachets)
Generic Available:
Yes
Insurance Coverage:
Usually not covered by insurance as it's often considered a dietary supplement. May be covered in specific medical cases (e.g., prescription for IBS, AAD) depending on the plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the medication taken, the amount, and the time it happened.