Futapan   Freeze Dried Powder for solution for I.V. Infusion

 Pantoprazole 40mg

 

Usage and indications:

  • Reflux oesophagitis
  • Gastric and duodenal ulcer
  • Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

Dosage and administration:

This medicine should be administered by a healthcare professional and under appropriate medical supervision.

Intravenous administration of Futapan 40mg is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Futapan 40mg i.v. should be discontinued and 40mg pantoprazole p.o. should be administered instead.

Recommended dose

Gastric and duodenal ulcer, reflux oesophagitis

The recommended intravenous dose is one vial of Futapan 40mg per day.

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80mg of Futapan i.v. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160mg pantoprazole is possible but should not be applied longer than required for adequate acid control.

In case a rapid acid control is required, a starting dose of 2 x 80mg Futapan i.v. is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.

Undesirable effects:

Blood and lymphatic system:

Very rare: Thrombocytopenia; leucopenia.

Immune system disorders:

Rare: Hypersensitivity (including anaphylactic reactions and anaphylactic shock).

Metabolism and nutritional disorders:

Rare: Hyperlipidaemias and lipid increases (triglycerides, cholesterol); weight changes

Not known: Hyponatraemia; hypomagnesaemia. 

Psychiatric disorders:

Uncommon: Sleep disorders.

Rare: Depression (and all aggravations).

Very rare: Disorientation (and all aggravations).

Not known: Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence).

Nervous system disorders:

Uncommon: Headache; dizziness.

Eye disorders:

Rare: Disturbances in vision/ blurred vision.

Gastrointestinal Disorders:

Uncommon: Diarrhoea; nausea /vomiting; abdominal distension and bloating; constipation; dry mouth; abdominal pain and discomfort. 

Hepatobiliary disorders:

Uncommon: Liver enzymes increased (transaminases, γ-GT).

Rare: Bilirubin increased

Not known: Hepatocellular injury; jaundice; hepatocellular failure.

Skin and sub-cutaneous tissue disorders:

Uncommon: Rash / exanthema / eruption; pruritus.

Rare: Urticaria; angioedema.

Not known: Stevens-Johnson syndrome; Lyell syndrome; erythema multiforme; photosensitivity.

Musculoskeletal, connective tissue disorders:

Rare: Arthralgia; myalgia.

Renal and urinary disorders:

Not known: Interstitial nephritis.

Reproductive system and breast disorders:

Rare: Gynaecomastia.

General disorders and administration site conditions:

Common: Injection site thrombophlebitis.

Uncommon: Asthenia, fatigue and malaise.

Rare: Body temperature increased; peripheral edema.

Warnings and precautions:

Bone Fracture

 Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk of osteoporosis-related fractures should be managed according to the established treatment guidelines.

  • Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesaemia) if taken for prolonged periods of time (in most cases, longer than one year). Magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.
  • Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesaemia generally requires magnesium supplements. Treatment in patients taking a PPI and who have hypomagnesaemia may also require stopping the PPI.
  • Use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor (PPI) therapy.

Case reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.

In two of these cases, delayed methotrexate elimination was observed when high-dose methotrexate was co-administered with PPIs, but was not observed when methotrexate was co-administered with ranitidine. However, no formal drug interaction studies of methotrexate with ranitidine have been conducted.

In presence of alarm symptoms

In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.

Further investigation is to be considered if symptoms persist despite adequate treatment.

Hepatic Impairment

In patients with severe liver impairment, the liver enzymes should be monitored during therapy.

In the case of a rise of the liver enzymes, the treatment should be discontinued.

Co-administration with atazanavir

Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400mg with 100mg of ritonavir. A pantoprazole dose of 20mg per day should not be exceeded.

Gastrointestinal infections caused by bacteria

Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria (e.g. Salmonella and Campylobacter).

Pack: Carton box containing clear colorless glass vial fitted with rubber stopper & crimp seal of aluminum contains 42.3mg powder.

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