Fastzol: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Pantoprazole.

Description

Each vial contains: Pantoprazole sodium sesquihydrate (lyophilized) equivalent with pantoprazole 40 mg.

Indications/Uses

Duodenal ulcer, gastric ulcer, moderate to severe reflux esophagitis; pathologic hypersecretory state which is related to Zollinger-Ellison syndrome or other malignancy conditions.

Dosage/Direction for Use

Duodenal ulcer, gastric ulcer, moderate to severe reflux esophagitis: 1 vial IV daily.
Long-term therapy of Zollinger-Ellison syndrome and other pathologic hypersecretory condition: Initially 80 mg IV daily. Doses >80 mg daily should be given in 2 divided doses.

Contraindications

A history of hypersensitivity.

Special Precautions

Patients who can't receive oral therapy. Not indicated for mild gastrointestinal complaints, ie. nervous dyspepsia. Rule out any possibility of a diagnosis of malignant gastric ulcer or esophageal malignancy prior treatment. In elderly and patients with impaired kidney function, dosage should not exceed 40 mg daily. Dosage should be adjusted to 20 mg in patients with severe liver dysfunction. Prothrombine time should be monitored in patients who are receiving concomitant therapy with coumarin anticoagulants. Children. Pregnancy, lactation.

Adverse Reactions

Leucopenia, thrombocytopenia; upper abdominal pain, diarrhea, constipation, flatulence, rarely, nausea, vomiting, dry mouth; thrombophlebitis at injection site, peripheral edema; severe liver damage leading to jaundice with or without liver dysfunction; anaphylactic reactions; increased liver enzyme (transaminase, γ GT), increased triglyceride; increased body temperature; arthralgia, myalgia; headache, dizziness, visual disturbances; depression; interstitial nephritis; allergic reactions (ie. rash, pruritus), urticaria, angioedema, Steven-Johnson syndrome, erythema multiforme, photosensitivity.

View ADR Reporting Link

Drug Interactions

Coumarin anticoagulants.

MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Regulatory Classification

Presentation/Packing

Form

Fastzol powd for inj 40 mg

Packing/Price

1's (Rp177,600/boks)

Fastzol

pantoprazole

Manufacturer:

Solas