Restora Capsules
It is used to keep the normal balance of bacteria in the gastrointestinal (GI) tract.
Drug Class
Probiotic, Dietary Supplement
Pharmacologic Class
Live Biotherapeutic Product, Gut Flora Modulator
Pregnancy Category
Not formally categorized (Generally considered safe, consult physician)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Restora Capsules contain beneficial live bacteria (probiotics) that help maintain a healthy balance of microorganisms in your digestive system. This can support digestion, nutrient absorption, and immune health.
How to Use This Medicine
Taking Your Medication
To use 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, taking it with food may help. Swallow the medication whole - do not chew or crush it. However, some products can be opened and mixed with a spoonful of applesauce. Check with your pharmacist to see if this is an option for your specific medication.
Storing and Disposing of Your Medication
Different brands of this medication have varying storage requirements. Some need to be refrigerated, while others should be stored at room temperature. If you're unsure about how to store your medication, consult your pharmacist. It's also important to know how long you can store the medication before it expires. Keep all medications in a safe place, out of the reach of children and pets.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use 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, taking it with food may help. Swallow the medication whole - do not chew or crush it. However, some products can be opened and mixed with a spoonful of applesauce. Check with your pharmacist to see if this is an option for your specific medication.
Storing and Disposing of Your Medication
Different brands of this medication have varying storage requirements. Some need to be refrigerated, while others should be stored at room temperature. If you're unsure about how to store your medication, consult your pharmacist. It's also important to know how long you can store the medication before it expires. Keep all medications in a safe place, out of the reach of children and pets.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Maintain a balanced diet rich in fiber (prebiotics) to support probiotic growth.
- Stay well-hydrated.
- Avoid excessive alcohol consumption.
- Store in a cool, dry place, as directed on the label (some probiotics require refrigeration).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 capsules daily, or as directed by a healthcare professional
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
general_gut_health:
1 capsule daily
antibiotic_associated_diarrhea_prevention:
2 capsules daily, separated from antibiotic dose
Pediatric Dosing
Neonatal:
Not established (Consult pediatrician)
Infant:
Not established (Consult pediatrician)
Child:
Dosing varies by age and specific product, typically 1 capsule daily for older children (consult pediatrician)
Adolescent:
1 capsule daily, or as directed by a healthcare professional
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required
Moderate:
No specific adjustment typically required
Severe:
No specific adjustment typically required
Dialysis:
No specific considerations, as systemic absorption is minimal
Hepatic Impairment:
Mild:
No specific adjustment typically required
Moderate:
No specific adjustment typically required
Severe:
No specific adjustment typically required
Pharmacology
Mechanism of Action
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Their mechanisms include: 1. Modulating the gut microbiota composition. 2. Producing antimicrobial substances (e.g., bacteriocins, short-chain fatty acids). 3. Competing with pathogens for nutrients and adhesion sites. 4. Enhancing gut barrier function. 5. Modulating local and systemic immune responses. 6. Producing vitamins and enzymes.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (minimal systemic absorption of live organisms)
Tmax:
Not applicable (colonization of gut, not systemic absorption)
FoodEffect:
May be taken with or without food; some strains may benefit from food for survival through gastric acid
Distribution:
Vd:
Not applicable (primarily localized to gastrointestinal tract)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (eliminated via feces as part of gut transit)
Clearance:
Not applicable
ExcretionRoute:
Fecal
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Gradual (days to weeks for colonization and observable effects)
PeakEffect:
Continuous with consistent use
DurationOfAction:
Dependent on continued administration; effects diminish upon discontinuation
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help 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
+ 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. Although 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 for advice:
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 not mentioned here. 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.
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 medical help 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
+ 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. Although 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 for advice:
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 not mentioned here. 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:
- Persistent or severe abdominal pain, bloating, or gas.
- New or worsening diarrhea.
- Signs of infection such as fever, chills, or unusual fatigue (especially if immunocompromised).
- Allergic reactions (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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 your medication, as some products may contain sugar. If you are pregnant, planning to become pregnant, or are breast-feeding, discuss this with your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive gas
- Bloating
- Mild abdominal discomfort
- Loose stools
What to Do:
Symptoms are generally mild and self-limiting. Reduce dose or temporarily discontinue use. If symptoms are severe or persistent, consult a healthcare professional. For severe reactions or concerns, call emergency services or a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Immunocompromised patients (e.g., severe critical illness, central venous catheters, recent surgery, organ transplant recipients) - potential risk of bacteremia/fungemia with live organisms. Consult physician.
Moderate Interactions
- Antibiotics: May reduce the efficacy of probiotics by killing the live bacteria. Administer probiotics at least 2-3 hours before or after antibiotic doses.
- Antifungals: May reduce the efficacy of yeast-based probiotics (e.g., Saccharomyces boulardii).
Confidence Interactions
Monitoring
Symptom Monitoring
- Gastrointestinal discomfort (bloating, gas, mild abdominal cramps)
- Changes in bowel habits (diarrhea, constipation)
- Signs of infection (fever, chills, persistent malaise) - rare, but important in immunocompromised individuals
Special Patient Groups
Pregnancy
Generally considered safe during pregnancy, but always consult with a healthcare provider before starting any new supplement.
Trimester-Specific Risks:
First Trimester:
Low risk, generally considered safe.
Second Trimester:
Low risk, generally considered safe.
Third Trimester:
Low risk, generally considered safe.
Lactation
Generally considered safe during lactation, but always consult with a healthcare provider.
Infant Risk:
Low risk; probiotics are often used in infants for various conditions.
Pediatric Use
Use in children should be under the guidance of a pediatrician, especially for infants and very young children. Dosing may need adjustment based on age and weight.
Geriatric Use
Generally safe for older adults. May be beneficial for age-related changes in gut microbiota. No specific dose adjustments typically required.
Clinical Information
Clinical Pearls
- Probiotics are living organisms; proper storage (e.g., refrigeration for some products) is crucial for maintaining viability.
- When taking antibiotics, separate probiotic doses by at least 2-3 hours to maximize probiotic survival.
- Consistency is key; benefits are typically seen with regular, long-term use.
- Different probiotic strains offer different benefits; 'Restora Capsules' likely contains specific strains targeted for general gut health.
- Patients with compromised immune systems or those with central venous catheters should consult a physician before using probiotics due to a rare risk of infection.
Alternative Therapies
- Dietary changes (e.g., increased fiber intake, fermented foods like yogurt, kefir, sauerkraut)
- Lifestyle modifications (stress reduction, regular exercise)
- Specific medications for underlying GI conditions (e.g., antidiarrheals, laxatives, IBS medications)
Cost & Coverage
Average Cost:
Variable ($15-$40) per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance (considered a dietary supplement)
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.