Drugs List

Therapeutic Indications

Uses

Glaucoma
Oedema
Treatment of all forms of epilepsy

Administration

Intravenous or intramuscular injection. The direct intravenous route is the preferred as intramuscular route is painful due to the alkaline pH of the solution.

Care should be taken during intravenous administration to avoid extravasation and possible development of skin necrosis.

Contraindications

Adrenal insufficiency
Hepatic cirrhosis
Hyperchloraemic acidosis
Hypokalaemia
Hyponatraemia
Long term use in chronic non-congestive narrow angle glaucoma
Pregnancy
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Children under 18 years
Elderly
Breastfeeding
Diabetes mellitus
Disorder of acid-base balance
Electrolyte imbalance
Hepatic impairment
Obstructive pulmonary disease
Pulmonary emphysema
Renal impairment
Urolithiasis

Advise ability to drive/operate machinery may be affected by side effects
Diuresis is not dose-related
If extravasation occurs follow local policy & seek expert help immediately
Blood counts should be performed before and periodically during treatment
Monitor serum electrolytes before and during treatment
Consider AGEP if feverish generalised erythema occurs
Monitor fluid balance
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Patients on prolonged therapy should be regularly reviewed
Advise patients to report any unusual rash to the prescriber
Advise patients/carers to seek medical advice if suicidal intent develops
Discontinue if hypersensitivity reactions occur
Discontinue immediately if any severe fall in blood counts occur
Discontinue permanently if AGEP is diagnosed
Not licensed for all indications in all age groups

Pregnancy and Lactation

Pregnancy

Acetazolamide sodium parenteral is contraindicated in pregnancy.

The manufacturer notes that acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at parenteral doses in excess of ten times those recommended in human beings. As there are no adequate studies in pregnant women, this medication should not be used in pregnancy, especially during the first trimester.

Briggs notes animal data has shown toxicity in offspring but a comparison to the human dose has not been provided and most studies found no adverse effects. Limited human data does not suggest a risk of developmental toxicity and no reports linking the use of acetazolamide with congenital defects have been located.

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

Use acetazolamide sodium parenteral with caution in breastfeeding.

Acetazolamide has been detected in low levels in the milk of lactating women, although it is thought to be unlikely that this will lead to any harmful effects in the infant.

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

Abnormal liver function
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylaxis
Aplastic anaemia
Bone marrow depression
Cholestatic jaundice
Confusion
Convulsions
Crystalluria
Decreased appetite
Depression
Diarrhoea
Dizziness
Drowsiness
Electrolyte disturbances
Erythema multiforme
Fatigue
Fever
Flaccid paralysis
Flushing
Fulminant hepatic necrosis
Glycosuria
Haematuria
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hypoglycaemia
Hypokalaemia
Hyponatraemia
Irritability
Leukopenia
Melaena
Metabolic acidosis
Myopia
Nausea
Nephrolithiasis
Pain on intramuscular injection
Pancytopenia
Paraesthesia
Photosensitivity
Polyuria
Rash
Reduced libido
Renal colic
Renal failure
Renal lesions
Skin necrosis (application site)
Stevens-Johnson syndrome
Taste disturbances
Thirst
Thrombocytopenia
Thrombocytopenic purpura
Tingling in extremities
Tinnitus
Toxic epidermal necrolysis
Ureteral colic
Urticaria
Vomiting

Presentation

Injection of acetazolamide sodium.

Drugs List

Therapeutic Indications

Uses

Glaucoma
Oedema
Treatment of all forms of epilepsy

Dosage

Intravenous or intramuscular injection.

The direct intravenous route is the preferred route of administration. The intramuscular route is not recommended as it is painful due to the alkaline pH of the solution.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

Intravenous or intramuscular injection. The direct intravenous route is the preferred as intramuscular route is painful due to the alkaline pH of the solution.

Care should be taken during intravenous administration to avoid extravasation and possible development of skin necrosis.

Contraindications

Adrenal insufficiency
Hepatic cirrhosis
Hyperchloraemic acidosis
Hypokalaemia
Hyponatraemia
Long term use in chronic non-congestive narrow angle glaucoma
Pregnancy
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Children under 18 years
Elderly
Breastfeeding
Diabetes mellitus
Disorder of acid-base balance
Electrolyte imbalance
Hepatic impairment
Obstructive pulmonary disease
Pulmonary emphysema
Renal impairment
Urolithiasis

Advise ability to drive/operate machinery may be affected by side effects
Diuresis is not dose-related
If extravasation occurs follow local policy & seek expert help immediately
Blood counts should be performed before and periodically during treatment
Monitor serum electrolytes before and during treatment
Consider AGEP if feverish generalised erythema occurs
Monitor fluid balance
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Patients on prolonged therapy should be regularly reviewed
Advise patients to report any unusual rash to the prescriber
Advise patients/carers to seek medical advice if suicidal intent develops
Discontinue if hypersensitivity reactions occur
Discontinue immediately if any severe fall in blood counts occur
Discontinue permanently if AGEP is diagnosed
Not licensed for all indications in all age groups

Pregnancy and Lactation

Pregnancy

Acetazolamide sodium parenteral is contraindicated in pregnancy.

The manufacturer notes that acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at parenteral doses in excess of ten times those recommended in human beings. As there are no adequate studies in pregnant women, this medication should not be used in pregnancy, especially during the first trimester.

Briggs notes animal data has shown toxicity in offspring but a comparison to the human dose has not been provided and most studies found no adverse effects. Limited human data does not suggest a risk of developmental toxicity and no reports linking the use of acetazolamide with congenital defects have been located.

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

Use acetazolamide sodium parenteral with caution in breastfeeding.

Acetazolamide has been detected in low levels in the milk of lactating women, although it is thought to be unlikely that this will lead to any harmful effects in the infant.

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

Abnormal liver function
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylaxis
Aplastic anaemia
Bone marrow depression
Cholestatic jaundice
Confusion
Convulsions
Crystalluria
Decreased appetite
Depression
Diarrhoea
Dizziness
Drowsiness
Electrolyte disturbances
Erythema multiforme
Fatigue
Fever
Flaccid paralysis
Flushing
Fulminant hepatic necrosis
Glycosuria
Haematuria
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hypoglycaemia
Hypokalaemia
Hyponatraemia
Irritability
Leukopenia
Melaena
Metabolic acidosis
Myopia
Nausea
Nephrolithiasis
Pain on intramuscular injection
Pancytopenia
Paraesthesia
Photosensitivity
Polyuria
Rash
Reduced libido
Renal colic
Renal failure
Renal lesions
Skin necrosis (application site)
Stevens-Johnson syndrome
Taste disturbances
Thirst
Thrombocytopenia
Thrombocytopenic purpura
Tingling in extremities
Tinnitus
Toxic epidermal necrolysis
Ureteral colic
Urticaria
Vomiting

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 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

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

Summary of Product Characteristics: Diamox Sodium 500mg Powder for Solution for Injection. Mercury Pharmaceuticals Ltd. Revised January 2018.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 May 2018