Drugs List

Therapeutic Indications

Uses

Hypertension - mild to moderate

Administration

For oral administration, to be taken with a sufficient amount of liquid.

Contraindications

Children under 16 years
Bradycardia with pulse rate at rest < 50 beats per minute
Breastfeeding
Galactosaemia
History of angioneurotic oedema
Malignant arrhythmia
Non-paced sinus node dysfunction
Pregnancy
Renal impairment - glomerular filtration rate below 30ml/minute
Renal impairment - serum creatinine above 160 micromol/l
Second degree atrioventricular block
Severe cardiac failure
Severe hepatic disorder
Sinoatrial exit block
Third degree atrioventricular block

Precautions and Warnings

Children aged 16 to 18 years
Elderly
Depression
Epileptic disorder
First degree atrioventricular block
Glaucoma
Glucose-galactose malabsorption syndrome
Intermittent claudication
Lactose intolerance
Moderate cardiac failure
Parkinson's disease
Peripheral arterial circulatory disorder
Raynaud's syndrome
Recent myocardial infarction
Renal impairment - glomerular filtration rate 30-60ml/minute
Renal impairment - serum creatinine 105-160 micromol/l
Severe ischaemic heart disease
Unstable angina

If renal function impaired, reduce dose to lowest to maintain control
Monitor hypotensive effect in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not all available products are licensed for all age groups
Contains lactose
Gradually withdraw over 2 weeks
Stop betablocker a few days before moxonidine when withdrawing combination
Advise patient to moderate alcohol intake during treatment

When moxonidine in used in patients with first degree atrioventricular block, special care should be taken to avoid bradycardia.

Pregnancy and Lactation

Pregnancy

Moxonidine is contraindicated during pregnancy.

Moxonidine should not be used during pregnancy unless clearly necessary.

Schaefer (2015) suggests that moxonidine should not be used during pregnancy. However, if it is used during the first trimester, a follow up sonography should be offered.

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

Moxonidine is contraindicated during breastfeeding.

Moxonidine is excreted into breast milk and therefore should not be used during breastfeeding due to lack of safety data. The manufacturers suggest that if the use of moxonidine is considered essential, then breastfeeding should be stopped.

There is one report of daily administration of 200 micrograms of moxonidine during the first postpartum days, a maximum of 2.7 microgram/L was measured in the milk of five mothers. This equated to a milk to plasma ratio of 1 to 2. If treatment has begun, then weaning is not necessary, but therapy should be changed (Schaefer, 2015).

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 thoughts
Allergic skin reactions
Angioedema
Anorexia
Anxiety
Asthenia
Atrioventricular block
Back pain
Bradycardia
Cholestasis
Constipation
Depression
Diarrhoea
Dizziness
Drowsiness
Dry eyes
Dry mouth
Dyspepsia
Eye irritation
Fluid retention
Gastro-intestinal disturbances
Gynaecomastia
Headache
Hepatitis
Hypotension
Impaired circulation to the extremities
Impotence
Incontinence
Insomnia
Nausea
Neck pain
Nervousness
Oedema
Orthostatic hypotension
Pain in parotid gland
Paraesthesia in extremities
Pruritus
Rash
Raynaud's syndrome
Reduced libido
Sedation
Sleep disturbances
Somnolence
Syncope
Tinnitus
Urinary retention
Vasodilatation
Vertigo
Vomiting
Weakness of legs

Presentation

Oral formulations of moxonidine

Drugs List

Therapeutic Indications

Uses

Hypertension - mild to moderate

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Administration

For oral administration, to be taken with a sufficient amount of liquid.

Contraindications

Children under 16 years
Bradycardia with pulse rate at rest < 50 beats per minute
Breastfeeding
Galactosaemia
History of angioneurotic oedema
Malignant arrhythmia
Non-paced sinus node dysfunction
Pregnancy
Renal impairment - glomerular filtration rate below 30ml/minute
Renal impairment - serum creatinine above 160 micromol/l
Second degree atrioventricular block
Severe cardiac failure
Severe hepatic disorder
Sinoatrial exit block
Third degree atrioventricular block

Precautions and Warnings

Children aged 16 to 18 years
Elderly
Depression
Epileptic disorder
First degree atrioventricular block
Glaucoma
Glucose-galactose malabsorption syndrome
Intermittent claudication
Lactose intolerance
Moderate cardiac failure
Parkinson's disease
Peripheral arterial circulatory disorder
Raynaud's syndrome
Recent myocardial infarction
Renal impairment - glomerular filtration rate 30-60ml/minute
Renal impairment - serum creatinine 105-160 micromol/l
Severe ischaemic heart disease
Unstable angina

If renal function impaired, reduce dose to lowest to maintain control
Monitor hypotensive effect in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not all available products are licensed for all age groups
Contains lactose
Gradually withdraw over 2 weeks
Stop betablocker a few days before moxonidine when withdrawing combination
Advise patient to moderate alcohol intake during treatment

When moxonidine in used in patients with first degree atrioventricular block, special care should be taken to avoid bradycardia.

Pregnancy and Lactation

Pregnancy

Moxonidine is contraindicated during pregnancy.

Moxonidine should not be used during pregnancy unless clearly necessary.

Schaefer (2015) suggests that moxonidine should not be used during pregnancy. However, if it is used during the first trimester, a follow up sonography should be offered.

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

Moxonidine is contraindicated during breastfeeding.

Moxonidine is excreted into breast milk and therefore should not be used during breastfeeding due to lack of safety data. The manufacturers suggest that if the use of moxonidine is considered essential, then breastfeeding should be stopped.

There is one report of daily administration of 200 micrograms of moxonidine during the first postpartum days, a maximum of 2.7 microgram/L was measured in the milk of five mothers. This equated to a milk to plasma ratio of 1 to 2. If treatment has begun, then weaning is not necessary, but therapy should be changed (Schaefer, 2015).

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 thoughts
Allergic skin reactions
Angioedema
Anorexia
Anxiety
Asthenia
Atrioventricular block
Back pain
Bradycardia
Cholestasis
Constipation
Depression
Diarrhoea
Dizziness
Drowsiness
Dry eyes
Dry mouth
Dyspepsia
Eye irritation
Fluid retention
Gastro-intestinal disturbances
Gynaecomastia
Headache
Hepatitis
Hypotension
Impaired circulation to the extremities
Impotence
Incontinence
Insomnia
Nausea
Neck pain
Nervousness
Oedema
Orthostatic hypotension
Pain in parotid gland
Paraesthesia in extremities
Pruritus
Rash
Raynaud's syndrome
Reduced libido
Sedation
Sleep disturbances
Somnolence
Syncope
Tinnitus
Urinary retention
Vasodilatation
Vertigo
Vomiting
Weakness of legs

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: December 2016

Reference Sources

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 (online) London: BMJ Group and Pharmaceutical Press. Accessed on 15 November 2016.

Summary of Product Characteristics: Moxonidine 200 microgram film-coated tablets. Sandoz Limited. Revised March 2011.

Summary of Product Characteristics: Moxonidine 300 microgram film-coated tablets. Sandoz Limited. Revised March 2011.

Summary of Product Characteristics: Moxonidine 400 microgram film-coated tablets. Sandoz Limited. Revised March 2011.

Summary of Product Characteristics: Moxonidine 200 microgram Tablets. TEVA UK Limited. Revised December 2011.

Summary of Product Characteristics: Moxonidine 300 microgram Tablets. TEVA UK Limited. Revised December 2011.

Summary of Product Characteristics: Moxonidine 400 microgram Tablets. TEVA UK Limited. Revised December 2011.

Summary of Product Characteristics: Physiotens Tablets 200 micrograms. Mylan Products Limited. Revised October 2016.

Summary of Product Characteristics: Physiotens Tablets 300 micrograms. Mylan Products Limited. Revised October 2016.

Summary of Product Characteristics: Physiotens Tablets 400 micrograms. Mylan Products Limited. Revised October 2016.

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