Protera I (10 Capsule)

PROTERA I (10 CAPSULE)

PROTERA I is a combination medicine manufactured by Lupin Ltd, primarily used to treat various gastrointestinal disorders.

• Name:

  • Brand Name: PROTERA I CAPSULE, PROTERA-I Capsule SR
  • Common Name: Pantoprazole and Itopride Capsules

• Composition:

  • Each capsule contains Pantoprazole 40 mg and Itopride 150 mg.

• Uses: PROTERA I is prescribed for the management and relief of symptoms associated with:

  • Gastroesophageal Reflux Disease (GERD): A condition where stomach acid frequently flows back into the food pipe, causing heartburn, irritation, and potential damage to the esophageal lining.
  • Peptic Ulcers: Sores that develop on the inner lining of the stomach and the upper part of the small intestine. It promotes healing by decreasing acid secretion.
  • Hyperacidity: Reduces excessive stomach acid production, providing relief from heartburn, indigestion, and stomach discomfort.
  • Functional Dyspepsia: Provides relief from acid-related symptoms such as heartburn, regurgitation, bloating, and improves gastrointestinal motility.

• Dosage and Administration:

  • PROTERA I CAPSULE should be taken as directed by a doctor.
  • It is generally advised to take the capsule whole with a glass of water, preferably 30-60 minutes before a meal, usually in the morning.
  • Do not crush, break, or chew the capsule.
  • The dosage and duration of treatment will depend on the patient's condition and response to the medicine.

• Side Effects:

  • Common Side Effects: Headache, nausea, stomach pain, dizziness, diarrhoea, flatulence (excessive gas), vomiting, abdominal pain, joint pain (arthralgia), and dry mouth. Most of these side effects are temporary and usually resolve over time.
  • Serious Side Effects (Rare): Allergic reactions (rash, swelling, difficulty breathing), liver problems, irregular heartbeat, worsening stomach pain (indicating inflamed liver or pancreas), back pain, fever, painful urination or blood in urine (kidney problems). Long-term use may also lead to osteoporosis (weakening of bones) and hypomagnesemia (low levels of magnesium).

• Precautions:

  • Allergies: Do not use if allergic to Pantoprazole, Itopride, or any ingredients in the medicine.
  • Pregnancy and Breastfeeding: Use with caution and consult a doctor, as safety data is limited and components may pass into breast milk.
  • Liver and Kidney Disease: Caution is advised for patients with a history of liver or kidney impairment.
  • Gastrointestinal Conditions: Inform your doctor if you have a history of gastrointestinal bleeding, mechanical perforation/obstruction, bowel obstruction, or movement disorders.
  • Bone Health: Long-term use (over one year) may increase the risk of bone fractures and low magnesium levels (hypomagnesemia). Regular monitoring and calcium/vitamin D supplements may be advised.
  • Driving and Operating Machinery: May cause dizziness or drowsiness; avoid these activities if affected.
  • Alcohol: Avoid consuming alcohol as it can worsen acidity and increase drowsiness.
  • Children: Not recommended for use in children below 16 or 18 years of age as safety and effectiveness have not been established.
  • Drug Interactions: Inform your doctor about all other medications you are taking, especially HIV medications, as some may interact. Avoid taking antacids within 1-2 hours of PROTERA I.
  • Other Warnings: Prolonged use may reduce the absorption of vitamin B12, calcium, and iron, and may increase the risk of gastrointestinal infections or stomach polyps.

• Storage:

  • Store in a cool and dry place, away from direct sunlight.
  • Keep out of sight and reach of children.
  • Typically stored at temperatures between 10ºC to 25ºC or below 30ºC, and protected from moisture and light.

What is PROTERA I (10 CAPSULE) used for?

PROTERA I (10 CAPSULE) is primarily used to treat gastroesophageal reflux disease (GERD), which involves acid reflux and heartburn. It is also prescribed for conditions such as acidity, erosive esophagitis, peptic ulcers, functional dyspepsia (indigestion), gastroparesis (delayed stomach emptying), and Zollinger-Ellison syndrome. This medicine can also help in the management of stomach ulcers caused by Helicobacter pylori bacteria.

How does PROTERA I (10 CAPSULE) work?

PROTERA I is a combination medication containing Pantoprazole and Itopride. Pantoprazole is a proton pump inhibitor (PPI) that works by reducing the amount of acid produced in the stomach. It achieves this by blocking the action of an enzyme called the gastric proton pump. Itopride is a prokinetic agent that enhances the contractions of the stomach and intestines, accelerating gastric emptying and improving gastric sensitivity and tone. It also has anti-emetic (anti-vomiting) properties. Together, these actions help prevent acid reflux and relieve symptoms of acidity and indigestion.

What is the usual dosage for PROTERA I (10 CAPSULE)?

The typical dosage is generally one capsule, containing Pantoprazole 40 mg and Itopride 150 mg, taken once daily. It should be taken approximately 30-60 minutes before a meal, preferably in the morning. The capsule should be swallowed whole with water and should not be chewed, crushed, or split to maintain its effectiveness. Always follow your doctor's specific instructions regarding dosage and duration of treatment.

What are the possible side effects of PROTERA I (10 CAPSULE)?

Common side effects may include headache, dizziness, nausea, vomiting, abdominal pain, diarrhea, flatulence (gas), and joint pain (arthralgia). Some serious but rare side effects could include anxiety, irregular heartbeat, severe diarrhea, seizures, muscle spasms, tremors, or lupus-like reactions and kidney damage. Long-term use of this medication may also increase the risk of bone fractures and lead to hypomagnesemia (low magnesium levels). If you experience any severe or persistent side effects, consult your doctor immediately.

Is PROTERA I (10 CAPSULE) safe during pregnancy or breastfeeding?

Pregnancy: Caution is advised during pregnancy, and PROTERA I should only be used if the potential benefits justify the potential risks to the fetus. It is recommended to consult your doctor if you are pregnant or planning a pregnancy, as some studies suggest it may be unsafe or could harm the fetus. Breastfeeding: This medicine is generally contraindicated or advised with caution during breastfeeding. It is recommended to consult your doctor, who will weigh the potential benefits against the potential risks for both the mother and the baby. Discontinuing breastfeeding may be advised while taking this medication as safety for the infant has not been fully established, particularly for Itopride.

Can PROTERA I (10 CAPSULE) be taken with other medications?

PROTERA I can interact with certain medications. It is crucial to inform your doctor about all prescription, non-prescription, and herbal medicines you are currently taking. Specific medications that may interact include antifungals (e.g., ketoconazole, itraconazole), anticancer agents (e.g., methotrexate, erlotinib), antiretrovirals (e.g., nelfinavir, atazanavir, rilpivirine), heart medications (e.g., digoxin), blood thinners (e.g., warfarin, clopidogrel), antidepressants (e.g., duloxetine), drugs for hypothyroidism (e.g., levothyroxine), statins (e.g., atorvastatin), ampicillin esters, and vitamin B12 supplements. While antacids may be taken with this medicine, if you are taking sucralfate, PROTERA I should be taken at least 30 minutes before it.

What precautions should be taken while using PROTERA I (10 CAPSULE)?

Before taking PROTERA I, inform your doctor if you have a history of gastrointestinal bleeding, mechanical perforation or obstruction, movement disorders (such as Parkinson's disease), liver disease, kidney problems, osteoporosis, hypomagnesemia (low magnesium levels), or autoimmune conditions like lupus. Avoid consuming alcohol, as it can worsen acidity and increase drowsiness. This medication may cause dizziness and sleepiness, so avoid driving or operating heavy machinery if you experience these effects. Long-term use requires regular monitoring for bone density and magnesium levels. It is generally not recommended for children under 12 or 16 years of age as its safety and effectiveness have not been established.

What happens if a dose of PROTERA I (10 CAPSULE) is missed?

If you miss a dose, 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 compensate for the missed one, as this can lead to an overdose.

How should PROTERA I (10 CAPSULE) be stored?

PROTERA I (10 CAPSULE) should be stored in a cool, dry place, ideally at room temperature (between 10°C to 25°C or below 30°C). Keep it in its original packaging, away from direct sunlight and moisture. Ensure it remains out of reach of children and pets.