Pethidine Amdipharm Mercury

Pethidine Amdipharm Mercury

pethidine

Manufacturer:

Amdipharm Mercury

Distributor:

DCH Auriga - Universal
Full Prescribing Info
Contents
Pethidine hydrochloride.
Description
Each 1ml contains 50mg of Pethidine Hydrochloride (100mg in 2ml).
Excipients/Inactive Ingredients: The other ingredients are sodium hydroxide or dilute hydrochloric acid in water for injections.
Action
Pethidine Injection is a type of medicine called an opioid analgesic. The word opioid means a substance similar to opium, for instance strong pain relievers such as morphine or codeine. An analgesic is a medicine that can be used to relieve pain.
Indications/Uses
Pethidine Injection is used to relieve moderate to severe pain, including pain associated with childbirth, before an operation and as a medicine given before administration of an anaesthetic.
Dosage/Direction for Use
Pethidine Injection may be administered by injection into a muscle (intramuscular) or into the tissue (subcutaneous) just below the skin or by slow injection into the vein (intravenous).
The patient should be lying down when the injection is given. The doctor will choose the most suitable dose depending on age and particular condition.
If thinking a dose of Pethidine Injection has been missed, tell the doctor or nurse immediately.
If there are any further questions on the use of this product, ask the doctor or pharmacist.
Use in Elderly Patients: Elderly patients may require reduced doses.
Use in children: In children, the dose is calculated according to the child's weight.
Overdosage
The symptoms and signs of taking too much of this medicine include shallow breathing, drowsiness, incoordination, coma, seizures, blue skin and lips, eye closure (miosis), shaking, cold, clammy skin, drop in body temperature, slow heartbeat and low blood pressure.
This medicine will be given in the hospital so it is unlikely too much will be received. The doctor has information on how to recognise and treat an overdose.
If feeling unwell after being given this medicine, or at all concerned too much has been given, tell the doctor or nurse immediately.
This is unlikely as the injection will be administered by a doctor or nurse. If concerned about the dose, discuss this with the doctor.
Contraindications
The patient should not be given this medicine if: The patient has known allergy (hypersensitivity) to Pethidine Hydrochloride or any of the other ingredients in this medicine (listed in Description).
The patient has any problems that affect the breathing including chronic bronchitis or asthma, shallow breathing or other breathing difficulties.
The patient is taking monoamine oxidase inhibitors (MAOIs) or has been taking them within the last two weeks. MAOIs (e.g. phenelzine or isocarboxazid) are medicines used to treat depression (see Interactions).
The patient is suffering from severe headaches or has suffered a head injury.
The patient suffers from alcoholism.
The patient suffers from a convulsive disorder (fits) such as epilepsy.
The patient has any liver or kidney problems.
The patient is suffering from a condition known as delirium tremens, caused by withdrawal from alcohol.
The heartbeat is faster than usual.
The patient suffers from a tumour of the adrenal gland known as phaeochromocytoma.
The patient suffers from diabetes.
Patients in a coma should not be given this medicine.
Special Precautions
If any of the following is/are applicable, please tell the doctor before being given Pethidine Injection.
Talk to the doctor before using Pethidine Injection if: The patient is in shock, the symptoms of which include sweating, a fast pulse and cold, clammy skin.
The patient has an underactive thyroid gland (which may cause tiredness, intolerance to cold, constipation and puffiness of the face).
The patient has underactive adrenal glands or suffers from problems related to the adrenal gland (the organ responsible for stress levels), including adrenocortical insufficiency (a lack of the hormones produced by the adrenal gland).
The patient suffers from fits.
The patient has problems with the heart causing an increased heart rate.
The patient suffers from any problem with the bowel, liver, kidneys or gall bladder.
The patient has any problems that affect the breathing.
The patient suffers from low blood pressure due to loss of blood or fluid.
The patient suffers from raised pressure in the brain.
The patient was born with sickle cell anaemia, where he/she has abnormally shaped red blood cells.
The patient is elderly and in a poor state of health.
The patient has an enlarged prostate gland causing difficulty in passing water (men only).
The patient has cancer.
The patient is dependent on alcohol.
The patient has weak muscular movement.
The patient has lung problems.
The patient is taking any medicine from the group of medicines known as benzodiazepines. Taking these medicines with Pethidine may result in sedation, difficulties in breathing (respiratory depression), coma and may be fatal. Even if benzodiazepines are prescribed, the doctor may need to change the dose, the duration of treatment or monitor the patient regularly.
Tolerance, dependence and withdrawal: Pethidine Injection can become less effective with repeated use. This is called tolerance and it means that the dose may have to be increased for Pethidine Injection to remain effective.
If Pethidine Injection is used repeatedly, it becomes habit-forming. This is called dependence and if Pethidine Injection treatment is suddenly stopped, unpleasant withdrawal symptoms, like nausea, vomiting, loss of appetite and restlessness may occur.
Important information about some of the ingredients of Pethidine Injection: This medicine contains less than 1mmol sodium (23mg) per dose, i.e. is essentially 'sodium-free'.
Driving and using machines: Pethidine Injection will cause drowsiness which could interfere with the ability to use machines.
Do not operate machinery whilst taking this medicine. When Pethidine Injection treatment has stopped, ask the doctor when it will be safe to use machines.
The medicine can affect the ability to drive as it may make the patient sleepy or dizzy.
The patient should not drive while taking this medicine until he/she knows how it affects him/her.
It is an offence to drive if this medicine affects the ability to drive.
However, the patient would not be committing an offence if: The medicine has been prescribed to treat a medical or dental problem; The patient has taken it according to the instructions given by the prescriber or in the information provided with the medicine; It was not affecting the ability to drive safely.
Talk to the doctor or pharmacist if unsure whether it is safe to drive while taking this medicine.
Use in Children: This product must be used with caution in newborn and premature babies.
If the the baby or child is being given Pethidine Injection, special care will be taken.
Use in the Elderly: If the patient is elderly or ill, special care will be taken.
Use In Pregnancy & Lactation
If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
As with all drugs, Pethidine Injection should only be given in pregnancy or when breast-feeding if absolutely necessary. Pethidine can pass into the baby through the blood.
It can be administered as pain relief during childbirth but it may cause breathing problems in newborns.
Ask the doctor or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, Pethidine Injection can cause side-effects, although not everybody gets them.
Repeated use of pethidine can result in tolerance and addiction.
All medicines can cause allergic reactions although serious allergic reactions are rare.
Any sudden wheeziness, tightness of the chest and difficulty in breathing, swelling of the eyelids, face or lips, skin rash (red spots), fever or itching (especially affecting the whole body) and collapse should be reported to a doctor immediately.
The following side effects have also been reported: Very common (may affect more than 1 in 10 people): feeling sick (nausea); being sick (vomiting); dry mouth; constipation; lightheadedness, dizziness, sleepiness; slowing of breathing or shallow breathing; sweating; flushing of the face; itching, rash causing redness of the skin; feeling faint on standing up from sitting; fits; trembling, uncoordinated muscle movements; headache; CNS excitation; fainting; low blood pressure, the symptoms of which include feeling dizzy or light-headed, feeling weak and fainting; high blood pressure; dilatation of blood vessels (vasodilatation).
Other side effects include: Not known: frequency cannot be estimated from the available data: addiction; confusion; feeling of unease (anxiety); nervousness; changes in mood; disturbances in eyesight; dry eye; pin-point pupils; delay in blinking reflex when things are close to the eye; sensation of spinning (vertigo); spasms in the lower abdomen; muscle twitching; reduced sex drive; difficulty achieving or maintaining an erection; hypothermia, the symptoms of which include shivering, drowsiness and feeling weak; weakness; seeing or hearing things that are not there (hallucinations); feeling overly happy (euphoria) or overly sad (dysphoria); irregular heartbeats, fast or slow heartbeats, loss of consciousness; difficulty in passing urine; feeling agitated; inability to empty the bladder completely (urinary retention); abdominal pain caused by kidney stones (renal colic); pain or irritation at the site of injection or local tissue, wheal, redness over the vein (after an injection into the vein).
If any of the side effects gets serious, or if any side effects not listed have been noticed, please tell the doctor or pharmacist.
Reporting of side effects: If any side effects are experienced, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.
Drug Interactions
Other medicines and Pethidine injection: Tell the doctor before being given this medicine if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pethidine Injection must not be used with drugs used to treat severe depression, such as rasagiline or moclobemide, or if within 2 weeks of discontinuing them. These drugs are known as Monoamine Oxidase Inhibitors (MAOIs).
A large number of drugs can interact with Pethidine Injection which can significantly alter their effects.
These drugs include: medicines to treat depression (e.g. tricyclic antidepressants such as amitriptyline); selegiline, a medicine used to treat Parkinson's disease; ritonavir, a medicine used to treat HIV; medicines for anxiety (anxiolytics) (e.g. benzodiazepines such as diazepam); medicines used to help to sleep (hypnotics); medicines to treat schizophrenia or other serious mental illness, such as phenothiazines (which may be present in various medicines including some for treating allergic disorders); sedatives, sleeping tablets or barbiturates (e.g. phenobarbital for epilepsy); domperidone and metoclopramide (used for disorders of the gastrointestinal tract); pain relievers and other opioid medicines.
Other medicines which may interact with Pethidine injection are: Cimetidine (for heart burn or stomach ulcer); anticholinergic drugs (e.g. for a stomach or intestine problem, for Parkinson's disease (a condition where the patient gets tremor, stiffness and shuffling), for a "weak" bladder, or as an inhaler for a breathing problem, for example ipratropium bromide, oxybutynin, orphenadrine and hyoscine hydrobromide); Halothane, a gas used in general anesthesia; medicines for depression (eg. tricyclic antidepressants such as amitriptyline); monoamine oxidase inhibitors (MAOIs) (e.g. phenelzine or isocarboxazid used to treat depression); ciprofloxacin, an antibiotic used to treat a number of bacterial infections; mexiletine, a medicine used to treat seriously irregular heartbeats; concomitant use of Pethidine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor does prescribe Pethidine together with sedative medicines the dose and duration of concomitant treatment should be limited by the doctor.
Please tell the doctor about all sedative medicines being taken and follow the doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated previously. Contact the doctor when experiencing such symptoms.
If already taking one of these medicines, speak to the doctor before being given Pethidine Injection.
Pethidine Injection with food, drink and alcohol: The patient must avoid drinking alcohol before or after being given Pethidine Injection.
Caution For Usage
For single use only.
Once the ampoule has been opened it should be used immediately. If only part of the contents of an ampoule is used, the remaining solution should be discarded.
Do not use the solution if the ampoule is damaged or if the contents are discoloured in any way or contains particles in it.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Keep the ampoules in the outer carton in order to protect from light. Do not store above 25°C.
MIMS Class
ATC Classification
N02AB02 - pethidine ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Soln for inj (amp) (clear, colourless, sterile solution for injection) 50 mg/mL x 10's. 100 mg/2 mL x 10's.
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