ACITOP I.V

Description

ACITOP I.V Injection: Uses, Dosage, and Important Information

ACITOP I.V Injection, which contains Pantoprazole Sodium Sesquihydrate, is a proton pump inhibitor (PPI) manufactured by Aristo Pharmaceuticals Ltd. It’s available in Nepal and is used to reduce stomach acid, particularly when oral medication isn’t an option.

What is ACITOP I.V Injection Used For?

ACITOP I.V Injection is used to treat conditions involving excessive stomach acid, including:

• Peptic ulcer disease (ulcers in the stomach or small intestine)
• H. pylori infection (often part of a combination therapy with antibiotics)
• Gastro-oesophageal reflux disease (GERD), including erosive esophagitis (damage to the esophagus from acid reflux)
• Zollinger-Ellison syndrome (a condition causing very high acid production)
• Oesophagitis (inflammation of the esophagus)
• Acid-related dyspepsia (indigestion)
• NSAID-associated ulceration (ulcers caused by certain pain relievers)
• Ulcers resistant to H2 receptor antagonists (another type of acid-reducing drug)
• Gastrointestinal (GI) bleeding from stress
• Prophylaxis for acid aspiration syndrome during the start of anesthesia (to prevent stomach acid from entering the lungs during surgery)

How to Use ACITOP I.V Injection

ACITOP I.V Injection is administered intravenously (into a vein) by a healthcare professional. Oral doses are listed below for when a patient can transition from IV to oral therapy.

Intravenous (IV) Dosage

• Erosive Esophagitis Associated with GERD: 40 mg via IV infusion over 15 minutes once daily for 7-10 days. Patients typically switch to oral therapy once they can swallow.
• Short-term Treatment of GERD (when oral therapy isn’t possible): 40 mg via IV infusion over 15 minutes once daily for 7-10 days. Switch to oral therapy as soon as the patient is able to swallow.
• Zollinger-Ellison Syndrome: 80 mg via IV infusion every 8-12 hours for up to 7 days. Patients typically switch to oral therapy once they can swallow.

IV Preparation and Administration:

• For GERD with a history of erosive esophagitis (15-minute infusion):
  • Reconstitute the vial with 10 mL of Normal Saline (NS).
  • Then, dilute further with 100 mL of Dextrose 5% in Water (D5W), NS, or Lactated Ringer’s (LR) solution to reach a final concentration of 0.4 mg/mL.
  • Infuse over 15 minutes, with the rate not exceeding 3 mg/min (7 mL/min).
• For Zollinger-Ellison syndrome (15-minute infusion):
  • Reconstitute each vial with 10 mL NS.
  • Combine 2 vials and dilute further with 80 mL D5W, NS, or LR to a total volume of 100 mL (concentration 0.8 mg/mL).
  • Infuse over 15 minutes, with the rate not exceeding 6 mg/min (7 mL/min).
• For Zollinger-Ellison syndrome (2-minute injection):
  • Reconstitute with 10 mL NS to a final concentration of 4 mg/mL.

Oral Dosage (for transition from IV)

• Erosive Esophagitis Associated with GERD:
  • Treatment: 40 mg orally once daily for 8-16 weeks.
  • Maintenance of healing: 40 mg orally once daily.
• Zollinger-Ellison Syndrome: 40 mg orally once daily; some patients may receive up to 240 mg/day.
• Peptic Ulcer Disease:
  • Duodenal ulcer: 40 mg orally once daily for 2-4 weeks.
  • Gastric ulcer: 40 mg orally once daily for 4-8 weeks.

Note on Oral Tablet Administration: If transitioning to oral tablets, controlled-release forms should be taken on an empty stomach, 1 hour before meals, swallowed whole (do not chew or crush). Normal release tablets can be taken with or without food.

Dosage Adjustments

• Elderly: No dosage adjustment is usually needed.
• Hepatic impairment (liver problems): The maximum dose is 20 mg per day or 40 mg on alternate days.
• Renal impairment (kidney problems): No dosage adjustment is usually needed.

Pediatric Dosage (Oral – for transition from IV, where applicable)

• Erosive Esophagitis Associated with GERD:
  • Under 5 years: Safety and effectiveness are not established.
  • 5 years and older:
    • 15 kg to <40 kg: 20 mg orally once daily for up to 8 weeks.
    • 40 kg or greater: 40 mg orally once daily for up to 8 weeks.

Important Considerations

Do Not Use If You Are:

• Taking rilpivirine, atazanavir, or nelfinavir (certain antiviral medications), as ACITOP can significantly reduce their effectiveness. This interaction can be potentially fatal.
• Breastfeeding, as it’s not known if pantoprazole passes into breast milk, and its use is not recommended during lactation.

Use With Caution If:

• Gastric malignancy (stomach cancer) needs to be ruled out. ACITOP can mask the symptoms of stomach cancer, so your doctor will ensure this is considered.
• You are prone to zinc deficiency. Your doctor might consider zinc supplementation during IV therapy if you’re at risk.
• You are pregnant. Discuss the benefits and risks with your doctor.
• You are on prolonged use of ACITOP. Your doctor may monitor your magnesium levels periodically.

Potential Drug Interactions:

ACITOP can interact with several medications. It’s crucial to inform your doctor or pharmacist about all prescription, over-the-counter, and herbal supplements you are taking.

• Increased risk of side effects with:
  • Digoxin: May increase the risk of heart-related side effects.
  • Diuretics (water pills): May increase the risk of low magnesium levels (hypomagnesaemia).
  • Warfarin (blood thinner): May increase INR and prothrombin time, which could raise the risk of bleeding.
  • Methotrexate and Saquinavir: May increase their levels in the blood.
• Decreased absorption and/or effectiveness of:
  • Sucralfate: Absorption of ACITOP may be delayed and its effectiveness decreased; administer these drugs about 2 hours apart.
  • Ketoconazole, Itraconazole: The absorption of these antifungal medications may be reduced.
  • Rilpivirine, Atazanavir, Nelfinavir: As mentioned, this is a potentially fatal interaction due to a significant decrease in the levels and effects of these antiviral drugs. Concomitant use is contraindicated.

Possible Side Effects

Common side effects (1-10%) may include:

• Headache
• Abdominal pain
• Diarrhea
• Constipation
• Rash
• Pruritus (itching)
• Vomiting
• Nausea
• Flatulence (gas)
• Chest pain
• Facial edema (swelling in the face)
• Generalized edema (widespread swelling)
• Hyperglycemia (high blood sugar)
• Photosensitivity (increased sensitivity to sunlight)

Less common but potentially serious side effects (frequency not defined) include:

• Angioedema (severe allergic swelling)
• Atrophic gastritis (a condition where the stomach lining thins)
• Anterior ischemic optic neuropathy (a type of vision loss)
• Hepatocellular damage leading to hepatic failure (liver damage that can lead to liver failure)
• Interstitial nephritis (inflammation of the kidneys)
• Pancreatitis (inflammation of the pancreas)
• Pancytopenia (a deficiency of all blood cell types)
• Rhabdomyolysis (breakdown of muscle tissue)
• Risk of anaphylaxis (a severe, life-threatening allergic reaction)
• Stevens-Johnson syndrome, fatal toxic epidermal necrolysis, erythema multiforme (severe, potentially life-threatening skin reactions)

How ACITOP I.V Injection Works

Pantoprazole is a type of medication called a proton pump inhibitor (PPI). It works by blocking the final step of acid secretion in the stomach. Specifically, it inhibits the H+/K+ ATPase enzyme system (often called the “proton pump”) located in the gastric parietal cells. By doing this, ACITOP significantly reduces both the continuous, background acid production and the acid production that’s stimulated by food or other factors.

Disclaimer: This information about ACITOP I.V Injection is for general knowledge only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.