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• Gastrobiotic indications
• Uses of Gastrobiotic in details
• Gastrobiotic description
• Gastrobiotic dosage
• Gastrobiotic interactions
• Gastrobiotic side effects
• Gastrobiotic contraindications

What is Gastrobiotic?

Gastrobiotic (Gastrobiotic) is an antibiotic that fights bacterial infection only in the intestines.

Gastrobiotic works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because Gastrobiotic treats only the intestinal tract, it will not treat infections of other parts of the body.

Gastrobiotic is used to treat travelers' diarrhea caused by E. coli in adults and children who are at least 12 years old. Most people get this infection by eating food or drinking fluids that have been contaminated with the E. coli bacteria.

Gastrobiotic is also used to treat irritable bowel syndrome in adults whose main symptom is diarrhea.

Gastrobiotic is also used to lower the risk of worsened brain function in adults with liver failure. Brain function can be affected when the liver stops working and cannot remove toxic substances from the body.

Gastrobiotic indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gastrobiotic and other antibacterial drugs, Gastrobiotic when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Travelers' Diarrhea

Gastrobiotic is indicated for the treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults and pediatric patients 12 years of age and older.

Limitations of Use

Gastrobiotic should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.

Hepatic Encephalopathy

Gastrobiotic is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

In the trials of Gastrobiotic for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.

Gastrobiotic has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction.

Irritable Bowel Syndrome With Diarrhea

Gastrobiotic is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

How should I use Gastrobiotic?

Use Gastrobiotic as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Gastrobiotic by mouth with or without food.
• Gastrobiotic works best if it is taken at the same time each day.
• Continue to take Gastrobiotic even if you feel well. Do not miss any doses.
• If you miss a dose of Gastrobiotic, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Gastrobiotic.

Uses of Gastrobiotic in details

Use: Labeled Indications

Hepatic encephalopathy: Reduction in the risk of overt hepatic encephalopathy recurrence in adults.

Irritable bowel syndrome without constipation: Treatment of moderate to severe irritable bowel syndrome without constipation in adults.

Travelers' diarrhea: Treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults and pediatric patients ≥12 years of age.

Limitations of use: Gastrobiotic should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea caused by pathogens other than E. coli.

Off Label Uses

Clostridioides (formerly Clostridium) difficile infection (second or subsequent recurrence)

Data from a randomized, double-blind, placebo-controlled pilot study support the use of Gastrobiotic to prevent recurrent diarrhea in patients with Clostridioides (formerly Clostridium) difficile infection.

Based on the International Society of Travel Medicine guidelines for prevention and treatment of travelers

Gastrobiotic description

Gastrobiotic is a semisynthetic, rifamycin-based non-systemic antibiotic, meaning that the drug will not pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. It has multiple indications and is used in treatment of traveller's diarrhea caused by E. coli; reduction in risk of overt hepatic encephalopathy recurrence; as well as diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women and men. It is marketed under the brand name Gastrobiotic by Salix Pharmaceuticals.

Gastrobiotic dosage

Gastrobiotic Dosage

Generic name: Gastrobiotic 200mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Dosage for Travelers’ Diarrhea

The recommended dose of Gastrobiotic is one 200 mg tablet taken orally three times a day for 3 days.

Dosage for Hepatic Encephalopathy

The recommended dose of Gastrobiotic is one 550 mg tablet taken orally two times a day.

Dosage for Irritable Bowel Syndrome with Diarrhea

​The recommended dose of Gastrobiotic is one 550 mg tablet taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.

Administration

Gastrobiotic can be taken with or without food.

More about Gastrobiotic (Gastrobiotic)

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Professional resources

• Gastrobiotic (AHFS Monograph)
• Gastrobiotic (FDA)

Related treatment guides

• Irritable Bowel Syndrome
• Hepatic Encephalopathy
• Traveler's Diarrhea

Gastrobiotic interactions

See also:
What other drugs will affect Gastrobiotic?

Effects Of Gastrobiotic On Other Drugs

Substrates of Cytochrome P450 enzymes

Gastrobiotic is not expected to inhibit cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and CYP3A4 in clinical use based on in vitro studies.

An in vitro study has suggested that Gastrobiotic induces CYP3A4. However, in patients with normal liver function, Gastrobiotic at the recommended dosing regimen is not expected to induce CYP3A4. It is unknown whether Gastrobiotic can have a significant effect on the pharmacokinetics of concomitant CYP3A4 substrates in patients with reduced liver function who have elevated Gastrobiotic concentrations.

Effects Of Other Drugs On Gastrobiotic

In vitro studies suggested that Gastrobiotic is a substrate of P-glycoprotein, OATP1A2, OATP1B1 and OATP1B3. Concomitant cyclosporine, an inhibitor of P-glycoprotein and OATPs, significantly increased the systemic exposure to Gastrobiotic.

Cyclosporine

Co-administration of cyclosporine, with Gastrobiotic resulted in 83-fold and 124-fold increases in Gastrobiotic mean Cmax and AUC∞ in healthy subjects. The clinical significance of this increase in systemic exposure is unknown.

Gastrobiotic side effects

See also:
What are the possible side effects of Gastrobiotic?

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Travelers' Diarrhea

The safety of Gastrobiotic 200 mg taken three times a day was evaluated in patients with travelers' diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with Gastrobiotic. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.

Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.

The adverse reaction that occurred at a frequency ≥ 2% in Gastrobiotic-treated patients (n=320) at a higher rate than placebo (n=228) in the two placebo-controlled trials of TD was:

• headache (10% Gastrobiotic, 9% placebo)

Hepatic Encephalopathy

The data described below reflect exposure to Gastrobiotic in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of Gastrobiotic 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n=140) and in a long term follow-up study (n=280). The population studied had a mean age of 56 (range: 21 to 82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. The most common adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in Gastrobiotic-treated subjects than in the placebo group in the 6-month trial are provided in Table 1.

Table 1: Most Common Adverse Reactions* in HE Trial

Irritable Bowel Syndrome with Diarrhea

The safety of Gastrobiotic for the treatment of IBS-D was evaluated in 3 placebo-controlled studies in which 952 patients were randomized to Gastrobiotic 550 mg three times a day for 14 days. Across the 3 studies, 96% of patients received at least 14 days of treatment with Gastrobiotic. In Trials 1 and 2, 624 patients received only one 14-day treatment. Trial 3 evaluated the safety of Gastrobiotic in 328 patients who received 1 open-label treatment and 2 double-blind repeat treatments of 14 days each over a period of up to 46 weeks. The combined population studied had a mean age of 47 (range: 18 to 88) years of whom approximately 11% of the patients were ≥ 65 years old, 72% were female, 88% were White, 9% were Black and 12% were Hispanic.

The adverse reaction that occurred at a frequency ≥ 2% in Gastrobiotic-treated patients at a higher rate than placebo in Trials 1 and 2 for IBS-D was:

• nausea (3% Gastrobiotic, 2% placebo)

The adverse reactions that occurred at a frequency ≥ 2% in Gastrobiotic-treated patients (n=328) at a higher rate than placebo (n=308) in Trial 3 for IBS-D during the double-blind treatment phase were:

• ALT increased (Gastrobiotic 2%, placebo 1%)
• nausea (Gastrobiotic 2%, placebo 1%)

Less Common Adverse Reactions

The following adverse reactions, presented by body system, were reported in less than 2% of patients in clinical trials of TD and IBS-D and in less than 5% of patients in clinical trials of HE:

Hepatobiliary disorders: Clostridium colitis

Investigations: Increased blood creatine phosphokinase

Musculoskeletal and connective tissue disorders: myalgia

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Gastrobiotic. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to Gastrobiotic.

Infections and Infestations

Cases of C. difficile-associated colitis have been reported.

General

Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.

Gastrobiotic contraindications

See also:
What is the most important information I should know about Gastrobiotic?

Gastrobiotic works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because Gastrobiotic affects only the intestinal tract, it will not treat infections of other parts of the body.

You should not use take this medication if you are allergic to Gastrobiotic or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).

Before you take Gastrobiotic, tell your doctor if you have severe liver disease, diarrhea with fever, or diarrhea that is watery or has blood in it.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Gastrobiotic will not treat a viral infection such as the common cold or flu, or any form of diarrhea that is caused by a virus.

Call your doctor if your symptoms do not improve after 24 hours, or if they get worse while taking Gastrobiotic. Gastrobiotic does not treat all bacterial forms of traveler's diarrhea.

Active ingredient matches for Gastrobiotic:

Rifaximin in Egypt.

References

1. DailyMed. "RIFAXIMIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "Rifaximin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Rifaximin". http://www.drugbank.ca/drugs/DB01220 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology