Rifakem 550 Mg Tablet (10 Tab)

RIFAKEM 550 MG TABLET

RIFAKEM 550 MG Tablet, manufactured by Alkem Laboratories Ltd., is an antibiotic primarily used for treating bacterial infections in the intestines. Its active ingredient is Rifaximin.

• Name

  • Brand Name: Rifakem 550 MG Tablet
  • Common Name: Rifaximin

• Composition

  • Active Ingredient: Rifaximin 550 mg

• Uses RIFAKEM 550 MG Tablet is prescribed for various conditions by targeting harmful gut bacteria and reducing their growth. It is used to treat:

  • Irritable Bowel Syndrome with Diarrhea (IBS-D) in adults.
  • Hepatic Encephalopathy (HE) in adults, a condition where the liver fails to remove harmful toxins from the blood, leading to brain damage. It helps reduce the risk of overt HE recurrence.
  • Infectious Diarrhea, including traveler's diarrhea caused by non-invasive strains of Escherichia coli.
  • Small Intestinal Bacterial Overgrowth (SIBO).

• Dosage and Administration The dosage and duration of treatment are determined by a doctor based on the patient's condition and response to the medicine.

  • General Administration: Swallow the tablet whole with a glass of water. Do not crush, chew, or break it. It can be taken with or without food, preferably at the same time each day.
  • Typical Dosage for Hepatic Encephalopathy: 550 mg twice a day.
  • Typical Dosage for IBS-D: 550 mg three times a day for 14 days. A recurrence of symptoms can be retreated up to two times.
  • Typical Dosage for Traveler's Diarrhea: 200 mg three times a day for 3 days (though the tablet itself is 550mg, this is a general rifaximin dosage for traveler's diarrhea).

• Side Effects Most side effects are temporary and generally resolve over time. However, consult a doctor if they persist or worsen.

  • Common Side Effects: Nausea, abdominal pain, dizziness, fatigue, peripheral oedema (swelling of extremities like hands or feet), skin rash, headache, ascites (fluid buildup in the abdomen), increased liver enzymes (ALT), joint pain, and depression. Urine may turn reddish, which is a normal and harmless effect of this medicine.
  • Serious Side Effects (Seek immediate medical attention if experienced):
    • Severe watery or bloody diarrhea, possibly with stomach cramps and fever, which can occur during or up to two months after treatment. This could indicate Clostridium difficile-associated diarrhea.
    • Allergic reactions such as hives, rash, itching, difficulty breathing or swallowing, or swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs.
    • Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

• Precautions

  • Allergies: Do not take if allergic to rifaximin, any other rifamycin antibiotics (e.g., rifampicin, rifabutin, rifapentine), or any other ingredients of the tablet.
  • Liver Impairment: Use with caution in patients with severe liver impairment, as systemic absorption of rifaximin may increase.
  • Diarrhea with Fever or Blood: Not recommended for diarrhea complicated by fever or blood in the stool.
  • Bowel Obstruction: Contraindicated in patients with bowel obstruction.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy due to limited safety information. It is unknown if rifaximin passes into human milk, so breastfeeding should be avoided while taking this medicine.
  • Drug Interactions:
    • May interact with anticoagulants like warfarin, potentially requiring dosage adjustments.
    • May affect the efficacy of oral contraceptives (e.g., ethinylestradiol), potentially reducing their effectiveness.
    • Caution is advised with certain P-glycoprotein efflux transporter inhibitors (e.g., verapamil, midazolam, nelfinavir, carvedilol, berotralstat) as they can increase rifaximin levels.
  • Alcohol: No specific interaction is reported, but it is generally advised to limit or avoid alcohol consumption to prevent unpleasant side effects.
  • Children: Not recommended for children under 18 years of age.
  • Driving and Machinery: Generally does not affect the ability to drive, but if dizziness occurs, avoid driving or operating machinery.
  • Complete Course: It is crucial to complete the full course of medication, even if symptoms improve, to prevent the infection from returning and developing antibiotic resistance.

• Storage Store RIFAKEM 550 MG Tablet at room temperature, ideally between 20°C to 25°C or below 30°C. Keep the product in its original packaging, protected from light and moisture, and out of the reach of children. Always check the expiry date before use.

What is RIFAKEM 550 MG TABLET used for?

RIFAKEM 550 MG TABLET contains the active ingredient Rifaximin, an antibiotic primarily used to treat bacterial infections in the intestines. It is prescribed for several conditions, including irritable bowel syndrome with diarrhea (IBS-D) in adults, the prevention of recurring hepatic encephalopathy (a brain condition due to severe liver disease), and traveler's diarrhea caused by non-invasive strains of Escherichia coli (E. coli).

How does RIFAKEM 550 MG TABLET work?

Rifaximin works by inhibiting bacterial RNA synthesis, specifically by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase. This action prevents bacteria from reproducing and growing. Since it is poorly absorbed into the bloodstream, its antibacterial effects are mostly localized within the gastrointestinal tract, minimizing systemic side effects. For hepatic encephalopathy, it reduces ammonia-producing bacteria in the gut, thereby lowering blood ammonia levels that can affect brain function.

What is the usual dosage for RIFAKEM 550 MG TABLET?

The dosage depends on the condition being treated:

• For Irritable Bowel Syndrome with Diarrhea (IBS-D): The typical dosage for adults is 550 milligrams (mg) three times a day for 14 days. If symptoms recur, retreatment with the same dosage regimen may be considered up to two additional times.
• For Preventing Hepatic Encephalopathy: The recommended dose for adults is 550 mg two times a day.
• For Traveler's Diarrhea: While Rifaximin 200 mg is commonly used for traveler's diarrhea (200 mg three times a day for 3 days), the 550 mg tablet is generally reserved for IBS-D and hepatic encephalopathy. Always follow your doctor's specific instructions for dosage and duration.

What are the possible side effects of RIFAKEM 550 MG TABLET?

RIFAKEM 550 MG TABLET is generally well-tolerated. Common side effects may include nausea, stomach pain, dizziness, headache, excessive tiredness, muscle tightening, joint pain, gas (flatulence), feeling of incomplete bowel emptying, urgent need to empty bowels, constipation, fever, vomiting, bloating, and swelling in the hands, feet, or torso.

Serious side effects, though rare, should be reported to your doctor immediately. These include severe diarrhea (watery or bloody, possibly with stomach cramps and fever, which could indicate Clostridioides difficile-associated diarrhea), allergic reactions such as hives, rash, itching, difficulty breathing or swallowing, and swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs.

Is RIFAKEM 550 MG TABLET safe during pregnancy or breastfeeding?

There is limited data on the use of rifaximin in pregnant women, so the drug-associated risk is not definitively known. Animal studies have shown teratogenic effects, including maxillofacial, cardiac, ocular, and spine malformations in rabbits and ocular malformations in rats. Therefore, pregnant patients should be advised of the potential harm to the fetus.

It is not known whether rifaximin is excreted in human milk. Due to the minimal systemic absorption of rifaximin, infant exposure is expected to be low. However, the decision to breastfeed during therapy should consider the potential risks to the infant versus the benefits of treatment to the mother; an alternative drug may be preferred, especially when nursing a newborn or preterm infant.

Can RIFAKEM 550 MG TABLET be taken with other medications?

Rifaximin has minimal systemic absorption, leading to a low potential for drug interactions. However, caution is advised with certain medications. It may interact with P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, carvedilol, clarithromycin, crizotinib, verapamil, ritonavir), which can increase the systemic absorption of rifaximin. If you are taking warfarin, your doctor may need to adjust its dose as rifaximin can affect its activity. Co-administration with the cholera vaccine or BCG intravesical live is generally avoided due to potential reduced efficacy of these agents. Always inform your doctor and pharmacist about all prescription, nonprescription, vitamin, nutritional supplement, and herbal products you are taking or plan to take.

What precautions should be taken while taking RIFAKEM 550 MG TABLET?

You should not take RIFAKEM 550 MG TABLET if you are allergic to rifaximin, any other rifamycin antibiotics (like rifampin or rifabutin), or any other ingredients in the tablet. It is also contraindicated if you have an intestinal blockage. Inform your doctor if you have severe liver impairment, as you may require close monitoring. This medicine is not effective for diarrhea accompanied by fever, blood in the stool, or diarrhea caused by pathogens other than E. coli. If your diarrhea worsens or does not improve within 1-2 days, or if you develop fever or bloody stools, contact your doctor immediately. Ensure you drink plenty of fluids to prevent dehydration if you have diarrhea. In rare cases, severe skin reactions like Stevens-Johnson syndrome have been reported; seek immediate medical attention if you notice a severe skin rash, peeling, blistering, or mouth sores. Your urine may turn a reddish color, which is a normal and harmless effect. RIFAKEM 550 MG TABLET is generally not recommended for children and adolescents under 18 years of age, as its safety and efficacy in these age groups have not been established for all indications.

What happens if a dose of RIFAKEM 550 MG TABLET is missed?

If you miss a dose of RIFAKEM 550 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should RIFAKEM 550 MG TABLET be stored?

RIFAKEM 550 MG TABLET should be stored at room temperature, typically between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit), in a dry place, away from light and moisture. Keep this medicine out of the sight and reach of children and pets. Do not use the medicine after the expiration date printed on the packaging.