PROTOCID

Description

PROTOCID Injection: Uses, Dosing, and Important Information

PROTOCID Injection, containing Pantoprazole Sodium Sesquihydrate, is a medication primarily used to reduce stomach acid. It is manufactured by Acme Laboratories Ltd. and available in Nepal.

What is PROTOCID Injection Used For?

PROTOCID Injection is used to treat various conditions caused by excessive stomach acid, including:

• Peptic Ulcer Disease: Healing ulcers in the stomach and the first part of the small intestine.
• H. pylori Infection: As part of a treatment plan to eliminate this bacteria, which often causes ulcers.
• Gastro-Oesophageal Reflux Disease (GERD): Managing symptoms like heartburn and acid reflux, especially erosive esophagitis (inflammation of the esophagus due to acid).
• Zollinger-Ellison Syndrome: A rare condition characterized by very high stomach acid production.
• Oesophagitis: Inflammation of the esophagus.
• Acid-Related Dyspepsia: Indigestion caused by stomach acid.
• NSAID-Associated Ulceration: Preventing or treating ulcers caused by non-steroidal anti-inflammatory drugs.
• Ulcers Resistant to H2 Receptor Antagonists: For ulcers that don’t respond to other types of acid-reducing medications.
• Gastrointestinal (GI) Bleeding from Stress: Helping to prevent or treat bleeding in the digestive tract in stressful situations.
• Prophylaxis for Acid Aspiration Syndrome: Reducing the risk of stomach acid entering the lungs during the induction of anesthesia.

How to Use PROTOCID Injection (Dosing Information)

Important Note: Always follow your doctor’s specific instructions for PROTOCID Injection. The doses listed below are general guidelines.

Adult Dosing

• Erosive Esophagitis Associated with GERD:
  • Treatment: 40 mg by mouth (PO) once daily for 8–16 weeks.
  • Maintenance of healing: 40 mg PO once daily.
  • Alternative (IV): 40 mg intravenously (IV) once daily for 7–10 days, particularly if oral administration isn’t feasible.
• Short-Term Treatment of GERD (when oral therapy isn’t appropriate or possible):
  • 40 mg IV infusion over 15 minutes once daily for 7–10 days. Transition to oral therapy once the patient is able to swallow.
• Zollinger-Ellison Syndrome:
  • Oral: 40 mg PO once daily; some patients may require up to 240 mg/day.
  • Intravenous: 80 mg IV infusion every 8–12 hours for up to 7 days. Switch to oral therapy when the patient can swallow.
• Peptic Ulcer Disease:
  • Duodenal Ulcer: 40 mg PO once daily for 2–4 weeks.
  • Gastric Ulcer: 40 mg PO once daily for 4–8 weeks.
• Elderly Patients: No dosage adjustment is typically needed.
• Hepatic Impairment (Liver Problems): The maximum dose is 20 mg/day, or 40 mg on alternate days.

Child Dosing (Erosive Esophagitis Associated with GERD)

• Under 5 years: Safety and effectiveness have not been established.
• 5 years and older:
  • Weight 15 kg to less than 40 kg: 20 mg PO once daily for up to 8 weeks.
  • Weight 40 kg or greater: 40 mg PO once daily for up to 8 weeks.

Renal Impairment (Kidney Problems)

• No dosage adjustment is typically needed.

How PROTOCID is Administered

• Controlled-Release Tablets (if applicable): Should be taken on an empty stomach, about 1 hour before meals. Swallow the tablet whole; do not chew or crush it.
• Normal-Release Tablets (if applicable): May be taken with or without food.

Intravenous (IV) Preparation & Administration

Preparation:

• GERD with a history of erosive esophagitis (15-minute infusion): Reconstitute one vial with 10 mL of normal saline (NS), then further dilute with 100 mL of D5W, NS, or Lactated Ringer’s (LR) solution to a final concentration of 0.4 mg/mL.
• Zollinger-Ellison syndrome (15-minute infusion): Reconstitute each vial with 10 mL of NS. Then, combine 2 vials and further dilute with 80 mL of D5W, NS, or LR to a total volume of 100 mL (final concentration 0.8 mg/mL).
• Zollinger-Ellison syndrome (2-minute injection): Reconstitute with 10 mL of NS to a final concentration of 4 mg/mL.

Administration:

• 15-minute infusion: Infuse no faster than 3 mg/min (7 mL/min) for GERD and no more than 6 mg/min (7 mL/min) for pathologic hypersecretory conditions.

Important Considerations and Warnings

Do Not Use If:

• You are concurrently using rilpivirine, atazanavir, or nelfinavir.
• You are breastfeeding (lactation).

Precautions:

• Your doctor should rule out gastric malignancy (stomach cancer) before you start this medication.
• Consider zinc supplementation during IV therapy if you are prone to zinc deficiency.
• Discuss with your doctor if you are pregnant.
• Monitoring: Your magnesium levels should be monitored before starting PROTOCID and periodically during prolonged use.

Possible Drug Interactions:

PROTOCID Injection can interact with other medications, potentially leading to:

• Increased risk of digoxin-induced cardiotoxic effects.
• Increased risk of hypomagnesaemia (low magnesium) when used with diuretics.
• May increase INR and prothrombin time of warfarin (a blood thinner).
• May increase serum concentration of methotrexate and saquinavir.
• Delayed absorption and decreased bioavailability when used with sucralfate.
• Decreased absorption of antifungals like ketoconazole and itraconazole.
• Potentially Fatal: May significantly decrease serum levels and pharmacological effects of rilpivirine, atazanavir, and nelfinavir.

Possible Side Effects:

Common (1–10% of patients):

• Headache (>4%)
• Abdominal pain (4%)
• Diarrhea (4%)
• Pruritus (itching) (4%)
• Rash (4%)
• Chest pain (4%)
• Vomiting (>4%)
• Facial swelling (<4%)
• Generalized swelling (<2%)
• Constipation (<4%)
• Flatulence (<4%)
• Hyperglycemia (high blood sugar) (1%)
• Nausea (1%)
• Photosensitivity (increased sensitivity to light) (<2%)

Less Common (Frequency Not Defined, but potentially serious):

• Angioedema (severe swelling under the skin)
• Atrophic gastritis (inflammation of the stomach lining)
• Anterior ischemic optic neuropathy (an eye condition)
• Hepatocellular damage leading to hepatic failure (liver damage resulting in liver failure)
• Interstitial nephritis (kidney inflammation)
• Pancreatitis (inflammation of the pancreas)
• Pancytopenia (deficiency of all blood cell types)
• Rhabdomyolysis (breakdown of muscle tissue)
• Risk of anaphylaxis (a severe, life-threatening allergic reaction)
• Stevens-Johnson syndrome (a severe skin reaction)
• Fatal toxic epidermal necrolysis (a very severe and potentially fatal skin reaction)
• Erythema multiforme (a skin condition)

How PROTOCID Injection Works (Mechanism of Action)

Pantoprazole, the active ingredient in PROTOCID Injection, is a proton pump inhibitor (PPI). It works by blocking the final step of acid secretion in the stomach. It does this by inhibiting the H+/K+ ATPase enzyme system, also known as the “proton pump,” which is found in the parietal cells of the stomach lining. This action effectively reduces both the normal (basal) and stimulated production of stomach acid.

Disclaimer: This information about PROTOCID Injection is for general knowledge and should not be used for self-diagnosis, medical advice, or treatment. It is not a substitute for professional medical judgment. Always consult with a healthcare professional for any health concerns or before making any decisions related to your health or treatment.