Drugs List

Therapeutic Indications

Uses

Benign gastric and duodenal ulceration
Reflux oesophagitis
Zollinger-Ellison syndrome (and other hypersecretory conditions)

Administration

Administer by intravenous injection or infusion only.

Duration of administration should be 2 to 15 minutes, by slow injection or further diluted and administered as a short-term infusion.

Contraindications

Children under 18 years
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
History of torsade de pointes
Pregnancy
Severe hepatic impairment

Correct electrolyte disorders before treatment
Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient dizziness may affect ability to drive or operate machinery
Exclude malignancy, if alarm symptoms develop in presence of gastric ulcer
Measure magnesium levels before and periodically during prolonged treatment
Consider monitoring ECG in patients at risk of QT prolongation
Ensure adequate vitamin D & calcium in patients at risk of osteoporosis
Monitor serum electrolytes
Consider discontinuing if subacute cutaneous lupus erythematosus occurs
Increased risk of GI infection due to decreased gastric acidity
May interfere with certain laboratory measurements
Discontinue if there is a rise in liver enzymes
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs

Prolonged use (greater than 1 year) of proton pump inhibitors has been associated with hypomagnesaemia. Patient should seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking pantoprazole.

Prolonged use (greater than 1 year) of PPIs has been associated with an increased risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

Rebound acid hypersecretion and protracted dyspepsia may occur after stopping prolonged treatment with a PPI.

Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug. The MHRA have issued the following advice if a patient treated with a PPI develops lesions - especially in sun-exposed areas of the skin - and it is accompanied by arthralgia:

- advise them to avoid exposing the skin to sunlight.
- consider SCLE as a possible diagnosis.
- consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another.
- in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months.

Pregnancy and Lactation

Pregnancy

Pantoprazole should be used with caution during pregnancy.

The animal and limited human data suggests that pantoprazole represents a low risk in pregnancy.

Animal reproduction studies have revealed signs of slight foetotoxicity at doses above 5mg/kg.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pantoprazole should be used with caution during breastfeeding.

There is limited information about the safety of pantoprazole during breastfeeding in humans but excretion in breast milk has been reported.

Pantoprazole doses of 40mg daily produce low levels in milk and would not be expected to cause any adverse effects in breast fed infants (LactMed).

As with all the PPIs, pantoprazole is completely unstable in an acid milieu and when present in milk, it would be largely destroyed before absorption (Hale, 2014).

Schaefer recommends that if a PPI is indicated, omeprazole or pantoprazole should be chosen.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Agranulocytosis
Anaphylactic shock
Anaphylactoid reaction
Angioedema
Arthralgia
Asthenia
Bloating
Blurred vision
Confusion
Constipation
Depression
Diarrhoea
Disorientation
Dizziness
Dry mouth
Elevated triglyceride levels
Erythema multiforme
Fatigue
Fundic gland polyps (benign)
Gamma glutamyl transferase (GGT) increased
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hyperbilirubinaemia
Hyperlipidaemia
Hypersensitivity reactions
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Increase in plasma cholesterol
Increase of liver transaminases
Increased risk of fractures
Interstitial nephritis
Jaundice
Leukopenia
Lyell's syndrome
Malaise
Muscle spasm
Myalgia
Nausea
Pancytopenia
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Rash
Renal failure
Rise in body temperature
Severe hepatocellular damage
Sleep disturbances
Stevens-Johnson syndrome
Subacute cutaneous lupus erythematosus
Taste disturbances
Thrombocytopenia
Thrombophlebitis (injection site)
Upper abdominal pain
Urticaria
Visual disturbances
Vomiting
Weight changes

Presentation

Powder for solution for injection containing pantoprazole.

Drugs List

Therapeutic Indications

Uses

Benign gastric and duodenal ulceration
Reflux oesophagitis
Zollinger-Ellison syndrome (and other hypersecretory conditions)

Dosage

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

Pantoprazole injection should be used only when the oral route is not appropriate.

Data are available on intravenous use for up to 7 days. Transition from intravenous to oral formulation should be performed as soon as clinically justified.

Adults

Patients with Hepatic Impairment

Administration

Administer by intravenous injection or infusion only.

Duration of administration should be 2 to 15 minutes, by slow injection or further diluted and administered as a short-term infusion.

Contraindications

Children under 18 years
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
History of torsade de pointes
Pregnancy
Severe hepatic impairment

Correct electrolyte disorders before treatment
Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient dizziness may affect ability to drive or operate machinery
Exclude malignancy, if alarm symptoms develop in presence of gastric ulcer
Measure magnesium levels before and periodically during prolonged treatment
Consider monitoring ECG in patients at risk of QT prolongation
Ensure adequate vitamin D & calcium in patients at risk of osteoporosis
Monitor serum electrolytes
Consider discontinuing if subacute cutaneous lupus erythematosus occurs
Increased risk of GI infection due to decreased gastric acidity
May interfere with certain laboratory measurements
Discontinue if there is a rise in liver enzymes
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs

Prolonged use (greater than 1 year) of proton pump inhibitors has been associated with hypomagnesaemia. Patient should seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking pantoprazole.

Prolonged use (greater than 1 year) of PPIs has been associated with an increased risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

Rebound acid hypersecretion and protracted dyspepsia may occur after stopping prolonged treatment with a PPI.

Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug. The MHRA have issued the following advice if a patient treated with a PPI develops lesions - especially in sun-exposed areas of the skin - and it is accompanied by arthralgia:

- advise them to avoid exposing the skin to sunlight.
- consider SCLE as a possible diagnosis.
- consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another.
- in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months.

Pregnancy and Lactation

Pregnancy

Pantoprazole should be used with caution during pregnancy.

The animal and limited human data suggests that pantoprazole represents a low risk in pregnancy.

Animal reproduction studies have revealed signs of slight foetotoxicity at doses above 5mg/kg.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pantoprazole should be used with caution during breastfeeding.

There is limited information about the safety of pantoprazole during breastfeeding in humans but excretion in breast milk has been reported.

Pantoprazole doses of 40mg daily produce low levels in milk and would not be expected to cause any adverse effects in breast fed infants (LactMed).

As with all the PPIs, pantoprazole is completely unstable in an acid milieu and when present in milk, it would be largely destroyed before absorption (Hale, 2014).

Schaefer recommends that if a PPI is indicated, omeprazole or pantoprazole should be chosen.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking pantoprazole.

Side Effects

Abdominal distension
Agranulocytosis
Anaphylactic shock
Anaphylactoid reaction
Angioedema
Arthralgia
Asthenia
Bloating
Blurred vision
Confusion
Constipation
Depression
Diarrhoea
Disorientation
Dizziness
Dry mouth
Elevated triglyceride levels
Erythema multiforme
Fatigue
Fundic gland polyps (benign)
Gamma glutamyl transferase (GGT) increased
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hyperbilirubinaemia
Hyperlipidaemia
Hypersensitivity reactions
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Increase in plasma cholesterol
Increase of liver transaminases
Increased risk of fractures
Interstitial nephritis
Jaundice
Leukopenia
Lyell's syndrome
Malaise
Muscle spasm
Myalgia
Nausea
Pancytopenia
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Rash
Renal failure
Rise in body temperature
Severe hepatocellular damage
Sleep disturbances
Stevens-Johnson syndrome
Subacute cutaneous lupus erythematosus
Taste disturbances
Thrombocytopenia
Thrombophlebitis (injection site)
Upper abdominal pain
Urticaria
Visual disturbances
Vomiting
Weight changes

Effects on Laboratory Tests

Treatment with pantoprazole may increase Chromogranin A (CgA) levels and may therefore interfere with investigations for neuroendocrine tumours. To avoid this, stop pantoprazole treatment temporarily for at least five days before CgA measurements. After initial measurement, if CgA and gastrin levels have not returned to reference range, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2017

Reference Sources

CredibleMeds
Available at: https://www.crediblemeds.org/
Last accessed: 21 October, 2014

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary. 73rd ed. London: BMJ Group and Pharmaceutical Press; 2017.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

MHRA Drug Safety Update April 2012. Proton pump inhibitors in long-term use: increased risk of fracture.
Available at: https://www.mhra.gov.uk
Last accessed: 5 May 2017

MHRA Drug Safety Update September 2015. Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus.
Available at: https://www.mhra.gov.uk
Last accessed: 5 May 2017

Summary of Product Characteristics: Protium 40mg i.v. Powder for Solution for Injection. Takeda UK Ltd. Revised March 2017.

Summary of Product Characteristics: Pantoprazole 40mg powder for solution for injection. Sandoz Limited. Revised February 2017.

Summary of Product Characteristics: Pantoprazole 40mg powder for solution for injection. Ranbaxy (UK) Limited a Sun Pharmaceutical Company. Revised May 2018.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Pantoprazole Last revised: 5 May 2017
Last accessed: 5 May 2017