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Pethidine Tablets and Injections

(Pethidine hydrochloride BP 50 mg Tablet)

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PETHIDINE INJECTION. BP 25, 50,100 mg/mL
1 mL Ampoules containing 25 mg Pethidine Hydrochloride.
1 mL Ampoules containing 50 mg Pethidine Hydrochloride.
2 mL Ampoules containing 100 mg Pethidine Hydrochloride.
Note: Pethidine is an analgesic (or pain-reliever) given to women to ease the pains labour.

How does it work?

Pethidine is a type of medicine called an opioid painkiller.

Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.

Pethidine mimics the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.

Pethidine is used to relieve moderate to severe pain, for example during childbirth or before and during an operation.

Pethidine is available as tablets and injections. For pain relief during childbirth it is given as an injection either under the skin (subcutaneously) or into the muscle (intramuscularly).

What is it used for?drug banner

Relieving moderate to severe pain, for example pain during childbirth, or before and during a surgical operation.

Warning!

This medicine may cause drowsiness. If affected do not drive or operate machinery. Alcohol should be avoided.

If you have been given pethidine tablets it is important that you don’t take more than the dose your doctor has recommended.

This medicine is not suitable for prolonged use. If you have continuing pain your doctor will usually change you onto a different painkiller. If this medicine is taken for prolonged periods of time the body can become tolerant to it and it may become less effective at relieving pain. This means that with time, higher doses may be needed to control pain. With prolonged use the body may also become dependent on the medicine and withdrawal symptoms may then occur if the medicine is then stopped suddenly.

Use with caution in Elderly people.

Newborn babies and premature infants.
Weak or debilitated people.
Decreased kidney function.
Decreased liver function.
People with decreased lung function or breathing difficulties, for example asthma.
Irregular heartbeats (arrhythmias), in particular a type of abnormally fast heartbeat called supraventricular tachycardia.
History of convulsions (fits), eg epilepsy.
Low blood pressure (hypotension).
People with decreased production of natural steroid hormones by the adrenal glands (adrenocortical insufficiency).
Reduced blood flow to vital internal organs (shock).
Disorders affecting the bile ducts or gall bladder.
Inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
Enlarged prostate gland (prostatic hypertrophy).
Underactive thyroid gland (hypothyroidism).
People with a history of drug abuse or dependence.

Not to be used in

Severely decreased liver function.
Severely decreased kidney function.
Slow, shallow breathing (respiratory depression).
Obstructive airways disease.
People having an acute asthma attack.
Head injury.
Increased pressure in the brain (raised intracranial pressure).
People who are intoxicated with alcohol (acute alcoholism).
Serious medical condition caused by withdrawal from alcohol (delirium tremens).
People with inactivity of the intestine that stops material passing through the gut (paralytic ileus).
Unresponsive unconscious states (comatose states).
Tumour of the adrenal gland (phaeochromocytoma).
People who have taken a type of medicine called a monoamine-oxidase inhibitor (MAOI) in the last 14 days (see last section of this factsheet for examples).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

Pethidine crosses the placenta, but it has been widely used during pregnancy for many years without apparent ill consequence. Nevertheless, it should be used with caution during pregnancy and only if the benefit to the mother outweighs any possible risk to the developing baby. Seek further medical advice from your doctor.

Pethidine also passes into breast milk. It should be used with caution in breastfeeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the baby. Seek medical advice from your doctor.

Pethidine is widely used for pain relief during labour. However, it actually provides limited pain relief and can cause drowsiness, nausea and vomiting in the mother. It also crosses the placenta to the baby and can cause drowsiness and breathing difficulties in the baby after the birth. These problems are less likely if the injection is given shortly before delivery of the baby. An antidote to pethidine may be needed if the baby has breathing problems after the birth. This is given by injection. Pethidine may also affect the baby's sucking reflex, which can make it difficult for the baby to feed. Drowsiness in the baby and difficulties with breastfeeding can last for several days after the birth.

Label warnings

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Nausea and vomiting.
Constipation.
Drowsiness.
Dry mouth.
Headache.
Dizziness or spinning sensation.
Confusion.
Rash or itching.
Sweating.
Feeling weak.
Pinpoint pupils (miosis).
Increased blood flow to the skin on the face (facial flushing).
Problems with urinating.
Feeling of well-being (euphoria) or changes in mood.
False perceptions of things that are not really there (hallucinations).
Slow, shallow breathing (respiratory depression).
Awareness of your heartbeat (palpitations).
Increased or decreased heart rate (tachycardia or bradycardia).
Low blood pressure (hypotension).
Feeling cold.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine should not be taken by people who are taking or have taken one of the following medicines in the last 14 days, as the combination could cause serious, potentially life-threatening side effects:

linezolid, which is an antibacterial monoamine oxidase inhibitor antidepressants (MAOIs), eg moclobemide, phenelzine, tranylcypromine or isocarboxazid monoamine oxidase type B inhibitors, eg rasagiline, selegiline (used to treat Parkinson’s disease).

The sedative effect of this medicine will be increased if this medicine is taken with any of the following, which can also cause drowsiness:

alcohol
antipsychotics, eg chlorpromazine, haloperidol
barbiturates, eg phenobarbital, amobarbital
benzodiazepines, eg diazepam, temazepam
certain antiepileptics, such as sodium valproate
other strong opioid painkillers, eg morphine, codeine
sedating antihistamines, eg chlorphenamine, hydroxyzine
sleeping tablets, eg zopiclone
tricyclic antidepressants, eg amitriptyline.

Pethidine may oppose the effects of the following medicines on the gut:

domperidone
metoclopramide.

There may be an increased risk of a rare side effect called the serotonin syndrome if pethidine is taken with duloxetine or sibutramine.

Pethidine should not be used in combination with the anti-HIV medicine ritonavir, because ritonavir increases the breakdown of pethidine into a toxic substance and therefore increases the chance of side effects. The anticonvulsant phenytoin may also have this effect and pethidine should therefore be used with caution in people taking phenytoin.

There may be an increased risk of side effects if cimetidine is taken with pethidine.

If pethidine is used in combination with antipsychotic medicines such chlorpromazine, prochlorperazine and thioridazine there may be an increased risk of side effects such as a severe drop in blood pressure.
Other medicines containing the same active ingredient

Pethidine as a single ingredient is only available generically (ie without a brand name), as tablets and injections.


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