Consumer medicine information

Quinate

Quinine sulfate

BRAND INFORMATION

Brand name

Quinate Tablets

Active ingredient

Quinine sulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Quinate.

What is in this leaflet

This leaflet answers some common questions about Quinate. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Quinate against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Quinate is used for

Quinate contains quinine (as quinine sulfate) as the active ingredient.

Quinate is used to treat malaria, an infectious disease spread by female mosquitoes. It belongs to a group of medicines called antimalarials.

This medicine works by stopping the growth of the organisms which cause malaria.

Ask your doctor if you have any questions about why Quinate has been prescribed for you.

Your doctor may have prescribed it for another purpose.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Quinate if you have ever had an allergic reaction to:

  • quinine sulfate
  • Any of the tablet ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take Quinate if you have had a reaction to it before.

Highly sensitive reactions to quinine can include bleeding or bruising more easily than normal, bloody diarrhoea and stomach pains.

Do not take Quinate if you have:

  • myasthenia gravis, a disease of the muscles.
  • Glucose-6-phosphate dehydrogenase, a genetic disorder mainly affecting red blood cells
  • Tinnitus, ringing in the ears
  • Optic neuritis, an inflammation of the optic nerve
  • A history of blackwater fever, a form of malaria characterized by kidney damage resulting in dark urine.

Do not take Quinate after the expiry date (EXP) printed on the label.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not take it if the bottle shows signs of tampering, or if the tablets don't look quite right.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • Heart problems.
  • Blood problems including anaemia and haemophilia.
  • Nervous system disorder.

Do not take Quinate if you are pregnant or plan to become pregnant unless you and your doctor have discussed the risks and benefits involved.

Do not take it if you are breast feeding or plan to breast feed.

It is not recommended for use while breastfeeding as it is found in breast milk.

If you have not told your doctor about any of these things, tell them before you take Quinate.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with Quinate. These include:

  • glycosides (e.g. digoxin and digitoxin), medicines used to heart failure.

It is recommended that regular bold tests be performed when glycosides and Quinate are taken at the same time.

  • antacids containing aluminium
  • Warfarin, a medicine used to prevent blood clots
  • Pancuronium, succinylcholine, and tubocurarine, medicines used for anaesthesia
  • mefloquine, a medicine used for treating malaria
  • Cimetidine, a medicine used for ulcers
  • muscle relaxant drugs
  • Urinary alkalinisers(e.g. sodium bicarbonate and acetazolamide), medicines used for bladder infections
  • Quinine-containing beverages eg. tonic water, bitter lemon.

These medicines may be affected by Quinate or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to be careful with or avoid while taking Quinate.

How to take it

How much to take

Your doctor will tell you how much Quinate to take.

The dose will depend on the condition being treated and your response to the treatment.

Follow all directions given to you by your doctor carefully.

These directions may differ from the information contained in this leaflet.

How to take it

Swallow the tablet whole with a full glass of water.

Do not chew the tablets.

Quinate has a special coating to mask the bitter taste of the tablet.

How long to take it

Continue taking Quinate for as long as your doctor tells you.

Do not stop taking it, or lower the dosage, even if you are feeling better, without first checking with your doctor.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much Quinate. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include:

  • tinnitus (ringing in the ears)
  • Dizziness.
  • Skin rash
  • Intestinal cramping and Vomiting
  • Headache
  • Fever
  • apprehension and confusion
  • Convulsions

While you are taking it

Things you must do

Take Quinate exactly as your doctor has prescribed.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Quinate, especially if you are being started on any new medicine.

Tell your doctor, surgeon or dentist that you are taking Quinate if you are about to undergo surgery or an operation requiring a general anaesthetic.

Tell your doctor immediately if you become pregnant while taking Quinate.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not take Quinate to treat any other complaints unless your doctor tells you to.

Do not stop taking it, or lower the dosage, even if you are feeling better, without first checking with your doctor

Things to be careful of

Be careful driving or operating machinery until you know how Quinate affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Quinate.

Like other medicines, Quinate may cause some unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or Pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following side effects and they worry you:

  • tinnitus (ringing in the ears)
  • headache
  • nausea
  • Slightly disturbed vision

These side effects are usually mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • Severely disturbed vision
  • Chest pain
  • Changes in the way your heart beats for example if you notice it beating faster.
  • Hypersensitivity, for example, flushing or rash of the skin, itching, fever, and swelling.
  • Shortness of breath, difficulty in breathing
  • Diarrhoea or cramps
  • Distinct reduction in the amount of urine or a reddish colour in the urine.

Stop taking Quinate and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any unexplained signs of bruising or swelling.

Some side effects can only be detected by your doctor. So it is important to visit your doctor for regular check-ups.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Some people may get other side effects while taking Quinate.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking it

Storage

Keep your tablets in the bottle until it is time to take them.

If you take the tablets out of the bottle they may not keep as well.

Keep your tablets in a cool dry place, protected from light, where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Quinate or you find that the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Quinate tablets are plain white, round, biconvex and film coated.

Available in bottles of 50 tablets.

Ingredients

Active ingredient:

Each tablet contains 300 mg of quinine sulfate.

Inactive ingredients:

  • Lactose monohydrate
  • magnesium stearate
  • maize starch
  • Povidone
  • sodium starch glycollate
  • Opadry complete film coating system White Y-1-7000

Quinate tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

BRAND INFORMATION

Brand name

Quinate Tablets

Active ingredient

Quinine sulfate

Schedule

S4

 

Name of the medicine

Quinine sulfate.

Excipients.

Lactose monohydrate, maize starch, povidone, sodium starch glycollate, magnesium stearate and Opadry complete film coating system white Y-1-7000.

Description

Molecular formula: (C20H24N2O2)2.H2SO4 (anhydrous). MW: 783.0. CAS: 6119-70-6.
Quinine sulfate is the sulfate of an alkaloid obtained from the bark of species of Cinchona. It contains not less that 99.0 per cent and not more that 101.0 per cent of total alkaloid salt, calculated as (C20H24N2O2)2.H2SO4, on the anhydrous basis. It is a white or almost white or colourless, fine, crystalline solid.
Quinate tablets contain 300 mg of quinine sulfate. They also contain the excipients lactose monohydrate, maize starch, povidone, sodium starch glycollate, magnesium stearate and Opadry complete film coating system white Y-1-7000.

Pharmacology

Quinine affects a large variety of biological systems. From a therapeutic viewpoint, the following are most relevant.

Central nervous system.

Quinine exerts a slight antipyretic effect, and an analgesic action resembling that of the salicylate group, especially on joint and muscle pain. Although quinine acts centrally, it is ineffective against severe pain.

Cardiovascular system.

Quinine acts in a similar qualitative manner on cardiac muscle as does its isomer quinidine, the antiarrhythmic drug. However, therapeutic doses of quinine have little or no effect on the normal cardiovascular system in humans.

Smooth muscle.

Quinine has a mild stimulatory effect on the pregnant uterus which is an oxytocic stimulation. It also passes the placental barrier. Quinine may also cause the smooth muscle in the spleen to contract producing lymphocytosis, sometimes observed after therapeutic doses of the drug.

Skeletal muscle.

Quinine has a dual action in skeletal muscle: it acts directly on the muscle fibre increasing the tension response, and also increases the refractory period; it affects neuromuscular transmission by increasing the threshold of excitability of the motor endplate.

Antimalarial action.

Quinine is also effective in malaria. Although the exact mechanism of action is not known, quinine appears to interfere with plasmoidal DNA.

Other actions.

Quinine has a strong prostaglandin antagonistic action and a weak agonistic activity. The antagonistic effect is clearly demonstrated at concentrations attained therapeutically. Quinine has a slight local anaesthetic activity. The anaesthesia may last for many hours or days.

Pharmacokinetics.

Absorption.

Absorption occurs readily when given orally, and occurs mainly in the upper small intestine. Plasma concentrations after single oral doses are approximately the same as after comparable intravenous doses. Peak plasma concentrations occur within one to three hours after a single oral dose. Quinine sulfate is 70% bound to plasma proteins.

Metabolism.

Metabolism occurs largely in the liver, with less than 5% excreted unaltered in the urine.

Elimination.

After cessation of quinine therapy, the plasma level falls rapidly, and only a negligible concentration is present after 24 hours. No accumulation in body tissues occurs with continued administration. The inactive metabolites are excreted mainly in the urine.

Indications

Treatment of malaria due to strains of Plasmodium falciparum resistant to chloroquine and the related 4-aminoquinolines.

Contraindications

Patients hypersensitive to quinine and patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Since thrombocytopenia, which may be fatal, and haemolytic uraemic syndrome with acute renal failure may follow the administration of quinine in highly sensitive patients, a history of this occurrence associated with previous quinine ingestion contraindicates its further use. Recovery usually occurs following withdrawal of the medication and appropriate therapy.
Myasthenia gravis (see Adverse Effects).
Tinnitus; optic neuritis or in patients with a history of blackwater fever.

Precautions

Haemolysis.

Quinine should be stopped immediately if haemolysis occurs and supportive measures instituted.

Prothrombin formation.

Quinine is capable of causing hypoprothrombinaemia, i.e. depresses the formation of prothrombin, and may enhance the effects of anticoagulants. The simultaneous administration of vitamin K counteracts the prolongation of the prothrombin time.

Atrial fibrillation.

Patients with atrial fibrillation should be digitalised before receiving quinine, because quinine may otherwise cause an increase in the ventricular rate.

Hypersensitivity reactions.

Hypersensitivity reactions, including cutaneous flushing, pruritus, rash (urticarial, papular, scarlatinal), fever, facial oedema, gastrointestinal distress, dyspnoea, tinnitus and impairment of vision have been reported with quinine. Extreme flushing of the skin with intense, generalised pruritus is the most frequently reported hypersensitivity reaction to the drug. Haemoglobinuria and asthma have also been reported rarely. If evidence of hypersensitivity occurs during quinine therapy, the drug should be discontinued.

Use in pregnancy.

(Category D)
The use of antimalarials in the treatment of life threatening malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified.
In high doses, quinine causes fetal injuries in the form of deafness, development disturbances and malformations of the extremities and cranium in both animals and humans. Its ability to induce uterine contractions also constitutes a risk of abortion.

Use in lactation.

Caution should be exercised when quinine is given to breastfeeding mothers because quinine is excreted in breast milk (in small amounts).

Interactions

Increased plasma levels of digoxin have been demonstrated in individuals after concomitant quinine administration. Increased plasma levels of digitoxin have been demonstrated in individuals after concomitant quinidine administration. It is therefore recommended that plasma levels of digoxin or digitoxin be determined periodically for those individuals taking either of these glycosides and quinine concomitantly.
Concurrent use of aluminium containing antacids may delay or decrease absorption of quinine.
Cinchona alkaloids, including quinine, have the potential to depress the hepatic enzyme system that synthesises the vitamin K dependent factors. The resulting hypoprothrombinaemic effect may enhance the action of warfarin and other anticoagulants.
Excessive quantities of quinine containing beverages should not be consumed while taking quinine as this may increase the risk of adverse reactions and toxicity.
The effects of neuromuscular blocking agents (particularly pancuronium, succinylcholine and tubocurarine) may be potentiated with quinine, and result in respiratory difficulties.
Concomitant use of quinine and mefloquine may produce additive effects and may result in ECG abnormalities or cardiac arrest and may increase the risk of seizures.
Cimetidine has been reported to decrease the clearance and prolong the elimination half-life of quinine following concomitant use in healthy adults. The clinical significance of this interaction is unknown.
In view of the known effects of quinine in patients with myasthenia gravis it may potentiate the effect of both depolarising and nondepolarising muscle relaxants.
Urinary alkalinisers (such as acetazolamide and sodium bicarbonate) may increase quinine blood levels with potential for toxicity.
Prothrombin formation may be prolonged and the effects of anticoagulants may be enhanced (see also Precautions).

Drug and laboratory interactions.

Quinine may produce an elevated value for urinary 17-ketogenic steroids when the Zimmerman method is used.

Adverse Effects

Cinchonism is the term given to a group of symptoms which usually occurs when quinine is given repeatedly in full doses. Cinchonism has certain features in common with salicylate poisoning. Mildest forms consist of tinnitus, headache, nausea and slightly disturbed vision. If the medication is continued or in overdose, symptoms involve the gastrointestinal tract, CNS and cardiovascular system and the skin. In some individuals, small doses of quinine cause toxic manifestations.
The following adverse reactions have been reported with quinine in therapeutic or excessive doses. Individual or multiple symptoms may represent cinchonism or hypersensitivity.

Haematological.

Acute haemolysis, thrombocytopenic purpura, agranulocytosis, hypoprothrombinaemia.

Central nervous system.

Visual disturbances, including blurred vision with scotomata, photophobia, diplopia, diminished visual fields and disturbed colour vision. Although visual disturbances are generally reversible following discontinuation of the drug, in severe cases, optic atrophy may result. Tinnitus, deafness and vertigo. Headache, nausea, vomiting, fever, apprehension, restlessness, confusion and syncope.

Dermatological/ allergic.

Cutaneous rashes (urticarial), the most frequent type of allergic reaction, papular or scarlatinal), pruritus, flushing of the skin, sweating, occasional oedema of the face.

Respiratory.

Asthmatic symptoms.

Cardiovascular.

Anginal symptoms, conduction disturbances, ventricular tachycardia, widening of the QRS complex and anginal symptoms have occurred with prolonged therapy in highly sensitive patients.

Gastrointestinal.

Nausea and vomiting (may be CNS related), epigastric pain, hepatitis.

Renal.

Anuria, uraemia and haemoglobinuria.
Quinine can cause thrombocytopenia which may be fatal. There have been reports of haemolytic uraemic syndrome and acute renal failure following a single dose of 300 mg of quinine. Acute haemolytic anaemia is rare and normally disappears on discontinuation of the drug.

Dosage and Administration

Adults.

Quinine sulfate 600 mg (adult < 50 kg: 450 mg) orally after a meal, eight hourly for 7 to 14 days and pyrimethamine 75 mg + sulfadoxine 1,500 mg as a single dose on the second day of the treatment.

Children.

Quinine sulfate 10 mg/kg bodyweight (up to 600 mg) orally, eight hourly for seven to ten days, in combination with appropriate single dose of pyrimethamine/ sulfadoxine.

Overdosage

The most common signs and symptoms of overdosage are tinnitus, dizziness, skin rash and gastrointestinal disturbances (intestinal cramping). With higher doses, cardiovascular and CNS effects may occur, including headache, fever, vomiting, apprehension, confusion and convulsions. Abortion, low blood pressure and renal failure are also possible results of overdosage. Other effects are listed in the Adverse Effects.
Fatalities have been reported from a single dose of 2 to 8 g of quinine and a single fatality reported with a 1.5 g dose (which may reflect an idiosyncratic effect). Several cases of blindness following large overdoses of quinine, with partial recovery of vision in each instance, have been reported. Tinnitus and impaired hearing may occur at plasma quinine concentrations of over 10 microgram/mL. This level would not be normally attained with the dose of one to two quinine tablets a day, but in hypersensitive patients, as little as 0.3 g of quinine may produce tinnitus.
Treatment for overdosage with Quinate should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient together with careful monitoring of ECG, respiratory status and central nervous system toxicity. There is no specific antidote for overdose with Quinate. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.
Patients should be warned of possible blindness but reassured that some recovery of sight frequently occurs. Stellate block has been used effectively for quinine associated blindness. Residual visual impairment occasionally yields to vasodilators.
Contact the Poisons Information Centre on 131 126 for management of overdose.

Presentation

White, round, biconvex film coated tablet. Available in HDPE bottles of 50.

Storage

Store below 30°C.

Poison Schedule

S4.