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Quinine bisulfate oral

Presentation

Oral formulations of quinine bisulfate

Drugs List

  • quinine bisulfate 300mg tablets
  • Therapeutic Indications

    Uses

    Cramps in legs - nocturnal
    Treatment of chloroquine resistant malaria

    Treatment of chloroquine resistant malaria

    Prevention / relief of nocturnal cramps in adults and the elderly, when cramps cause regular disruption to sleep.

    For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted.
    Guidelines for Malaria Prevention from the Health Protection Agency specifically developed for travellers from the United Kingdom may be obtained from the Public Health England website:https://www.gov.uk/government/publications/malaria-prevention-guidelines-for-travellers-from-the-uk

    Dosage

    If quinine resistance is known or suspected in the patient then supplementary treatment with an additional antimalarial is recommended.

    Quinine bisulfate contains less quinine than other quinine salts which may affect the choice of treatment including dosing regimens.

    Adults

    Treatment of chloroquine resistant malaria
    600 mg every 8 hours for 7 to 10 days.

    Night leg cramps
    300 mg at night (before retiring to bed).

    A reduction in the frequency of leg cramps make take up to 4 weeks. Patients should be monitored closely during the early stages of therapy for the occurrence of adverse effects and to determine efficacy of treatment. Treatment should be interrupted every 3 months to determine the need for continued therapy with quinine.

    Elderly

    (See Dosage; Adult)

    Children

    Children under 12
    10 mg/kg (maximum 600 mg) every 8 hours for 7 days

    Night leg cramps
    Not suitable for this indication in children

    Patients with Renal Impairment

    Lower doses or extended dose intervals should be considered in patients with renal impairment.

    The Renal Drug Handbook suggests the following doses of quinine for the treatment of malaria:

    GFR 20 to 50 ml/minute: 5 to 7 mg/kg every 8 hours.

    GFR 10 to 20 ml/minute: 5 to 7 mg/kg every 8 to 12 hours.

    GFR less than 10 ml/minute: 5 to 7 mg/kg every 24 hours.

    The Renal Drug handbook suggests for night cramps to dose as in normal renal function.

    Additional Dosage Information

    Equivalent quinine dosing
    300 mg quinine sulfate = 248 mg quinine anhydrous base
    300 mg quinine bisulfate = 178 mg quinine anhydrous base
    200 mg quinine sulfate = 165 mg quinine anhydrous base

    Quinine bisulfate contains less quinine than other quinine salts which may affect the choice of treatment including dosing regimens.

    Contraindications

    Haemoglobinuria
    Long QT syndrome
    Myasthenia gravis
    Optic neuritis
    Tinnitus
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Atrial fibrillation
    Atrioventricular block
    Breastfeeding
    Cardiac conduction defects
    Electrolyte imbalance
    G6PD deficiency
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of torsade de pointes
    Pregnancy
    Renal impairment
    Severe cardiac disorder

    Correct electrolyte disorders before treatment
    Reduce dose and/or alter dose interval in patients with hepatic impairment
    Reduce dose and/or alter dose interval in patients with renal impairment
    Advice available from specialist unit for the use of this drug
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating therapy enquire about previous hypersensitivity reactions
    Some formulations contain sucrose
    Consider monitoring ECG in patients at risk of QT prolongation
    In treatment of night cramps, reassess need for therapy every 3 months
    Monitor serum electrolytes
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Discontinue, in treatment of night cramps, if symptoms of cinchonism occur

    Quinine should be used with caution in patients with atrial fibrillation or other serious heart disease as it may cause hypoprothrombinaemia.

    Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency as there may be a risk of haemolysis in these patients.

    Patients who have previously experienced adverse reactions to quinine including that in tonic water or other beverages should not be prescribed quinine.

    Pregnancy and Lactation

    Pregnancy

    Quinine should be used with caution in pregnancy.

    Quinine should be used only for the treatment of chloroquine-resistant malaria as the potential risk to the foetus due to treatment is much less than risks due to severe disease. Pregnant women treated with quinine are at risk of hypoglycaemia caused or exacerbated by quinine-induced hyperinsulinaemia.

    High doses of quinine have been used to attempt induction of abortion and may cause congenital abnormalities of the CNS and extremities, and high doses have been associated with deafness and photosensitivity in the neonate. However, standard malaria treatment doses are considered to be safe in pregnancy.

    Quinine is contraindicated in the treatment of nocturnal leg cramps during pregnancy.

    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

    Quinine should be used with caution in breastfeeding.

    Quinine is excreted in human breast milk. There is a potential risk of thrombocytopenia in neonates. Therefore quinine should only be used in breastfeeding if the benefits outweighs the risks.

    Newborns at risk of glucose-6-phosphate dehydrogenase deficiency should not be breastfed until this disease can be ruled out.

    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 pain
    Acute renal failure
    Agranulocytosis
    Altered colour perception
    Angioedema
    Asthma
    AV conduction disorders
    Blindness
    Blood disorders
    Blurred vision
    Bronchospasm
    Cardiovascular effects
    Cinchonism
    Circulatory failure
    Confusion
    Diarrhoea
    Dyspnoea
    Eczematous reactions
    Erythema
    Exacerbation of myasthenia gravis
    Fever
    Haemoglobinuria
    Haemolysis
    Haemolytic uraemic syndrome
    Headache
    Hearing disturbances
    Hot and flushed skin
    Hypersensitivity reactions
    Hypoglycaemia
    Hypoprothrombinaemia
    Hypotension
    Intravascular coagulation
    Lichen planus
    Muscle weakness
    Nausea
    Oedema
    Oliguria
    Pancytopenia
    Photosensitivity
    Prolongation of QT interval
    Pruritus
    Rash
    Renal impairment
    T-wave changes
    Thrombocytopenia
    Thrombocytopenic purpura
    Tinnitus
    Urticaria
    Vertigo
    Visual disturbances
    Visual field defects
    Vomiting
    Widened QRS complex

    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: June 2015

    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, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 03 June 2015.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 03 June 2015.

    Summary of Product Characteristics: Quinine bisulfate Tablets 300mg. Kent pharmaceuticals. Revised April 2012.
    Summary of Product Characteristics: Quinine bisulfate Tablets 300mg. Teva UK Ltd. Revised August 2012.

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

    MHRA Drug Safety Update June 2010
    Available at: https://www.mhra.gov.uk
    Last accessed: 3 June 2015.

    UK Drugs in Lactation Advisory Service.
    Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
    Last accessed: 3 June 2015.

    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
    Quinine Last revised: 10 March 2015
    Last accessed: 3 June 2015.

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