Drugs List

Therapeutic Indications

Uses

Malaria - prophylaxis
Malaria - suppression

For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted. Guidelines for Malaria Prevention from Public Health England specifically developed for travellers from the United Kingdom may be obtained from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/461295/2015.09.16_ACMP_guidelines_FINAL.pdf

Administration

Tablets should be taken with water, after food and at the same time each day.

Younger children can take the tablets crushed and mixed with milk, honey or jam if desired.

Contraindications

Within 3 days of oral typhoid vaccine

Precautions and Warnings

Pregnancy
Renal impairment - creatinine clearance < 60ml/minute/1.73m sq

Reduce dose in patients with renal impairment
Advice available from specialist unit for the use of this drug
Drugs for malaria prophylaxis are not prescribable on the NHS
Monitor the elderly for optimum dosing
Avoid antacids within 2 hours of dose
Pregnancy: Advise taking folate supplement as risk of neural tube defects
Advise of importance of avoiding mosquito bites
Advise patients on the importance of taking treatment regularly
Consult Dr. if illness occurs within 1 year of return from malarious area

Not prescribable on the NHS when used for malaria prophylaxis. If used for malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration.

In areas where drug-resistant malaria is prevalent or suspected, seek local medical advice on appropriate malaria prophylaxis. The use of proguanil alone may not provide an effective cover.

Warn travellers about the importance of avoiding mosquito bites, the importance of taking prophylaxis regularly and the importance of an immediate visit to a doctor if ill within 1 year and especially within 3 months of return.

Pregnancy and Lactation

Pregnancy

Use proguanil with caution in pregnancy.

Proguanil has been widely used during human pregnancy for over 40 years and a causal connection to any adverse effect on the mother or foetus has not been established.

If malaria is contracted during pregnancy there is an increased risk of maternal death, miscarriage, still-birth and low birth weight with associated possible neonatal death. Travel to malarious areas should be avoided during pregnancy but if unavoidable, pregnant women should receive prophylactic therapy.

Briggs (2015) indicates 5 mg/day of folic acid or 5 mg/week of folinic acid should be taken at least during the first trimester.

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

Proguanil is excreted in breast milk but at an amount too low to be harmful. The levels excreted are insufficient to provide the infant with protection against malaria. If appropriate, malaria prophylaxis medications should be administered to the infant.

Schaefer (2007) suggests that proguanil is well tested and well tolerated during breastfeeding.

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

Allergic reaction
Angioedema
Cholestasis
Constipation
Diarrhoea
Drug fever
Gastro-intestinal disturbances
Haematological changes in renal impairment
Hair loss
Mouth ulcers
Skin reactions
Stomatitis
Urticaria
Vasculitis (allergic)

Presentation

Oral formulations of proguanil hydrochloride.

Drugs List

Therapeutic Indications

Uses

Malaria - prophylaxis
Malaria - suppression

For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted. Guidelines for Malaria Prevention from Public Health England specifically developed for travellers from the United Kingdom may be obtained from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/461295/2015.09.16_ACMP_guidelines_FINAL.pdf

Dosage

Non-immune subjects entering a malarious area should begin daily treatment with proguanil one week (or at least 48 hours) before arrival. The daily dose should be continued throughout exposure to malaria risk and for 4 weeks after leaving the malarious area.

Adults

Children

Patients with Renal Impairment

Additional Dosage Information

Administration

Tablets should be taken with water, after food and at the same time each day.

Younger children can take the tablets crushed and mixed with milk, honey or jam if desired.

Contraindications

Within 3 days of oral typhoid vaccine

Precautions and Warnings

Pregnancy
Renal impairment - creatinine clearance < 60ml/minute/1.73m sq

Reduce dose in patients with renal impairment
Advice available from specialist unit for the use of this drug
Drugs for malaria prophylaxis are not prescribable on the NHS
Monitor the elderly for optimum dosing
Avoid antacids within 2 hours of dose
Pregnancy: Advise taking folate supplement as risk of neural tube defects
Advise of importance of avoiding mosquito bites
Advise patients on the importance of taking treatment regularly
Consult Dr. if illness occurs within 1 year of return from malarious area

Not prescribable on the NHS when used for malaria prophylaxis. If used for malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration.

In areas where drug-resistant malaria is prevalent or suspected, seek local medical advice on appropriate malaria prophylaxis. The use of proguanil alone may not provide an effective cover.

Warn travellers about the importance of avoiding mosquito bites, the importance of taking prophylaxis regularly and the importance of an immediate visit to a doctor if ill within 1 year and especially within 3 months of return.

Pregnancy and Lactation

Pregnancy

Use proguanil with caution in pregnancy.

Proguanil has been widely used during human pregnancy for over 40 years and a causal connection to any adverse effect on the mother or foetus has not been established.

If malaria is contracted during pregnancy there is an increased risk of maternal death, miscarriage, still-birth and low birth weight with associated possible neonatal death. Travel to malarious areas should be avoided during pregnancy but if unavoidable, pregnant women should receive prophylactic therapy.

Briggs (2015) indicates 5 mg/day of folic acid or 5 mg/week of folinic acid should be taken at least during the first trimester.

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

Proguanil is excreted in breast milk but at an amount too low to be harmful. The levels excreted are insufficient to provide the infant with protection against malaria. If appropriate, malaria prophylaxis medications should be administered to the infant.

Schaefer (2007) suggests that proguanil is well tested and well tolerated during breastfeeding.

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

Allergic reaction
Angioedema
Cholestasis
Constipation
Diarrhoea
Drug fever
Gastro-intestinal disturbances
Haematological changes in renal impairment
Hair loss
Mouth ulcers
Skin reactions
Stomatitis
Urticaria
Vasculitis (allergic)

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: October 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Summary of Product Characteristics: Paludrine 100 mg Tablets. Alliance Pharmaceuticals Limited. Revised December 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 September 2017