Papaveretum Injection 15.4mg/Ml
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Papaveretum Injection BP 15.4mg in 1 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Hydrochloride Codeine Hydrochloride Papaverine Hydrochloride or
Papaveretum
BP 13.16mg in 1 ml
BP 1.04mg in 1 ml
BP 1.2mg in 1 ml
BP 15.4mg in 1 ml
3. PHARMACEUTICAL FORM
Solution for Injection
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
a. Pre- operative medication.
b. Enhancement of anaesthetics during operations.
c. For the relief of post-operative pain.
d. Relief of severe chronic pain.
4.2. Posology and method of administration
The dose is not usually repeated more often than 4 hourly.
As with most opioids the patients response varies widely. As such the dose may need to be adjusted individually according to the required degree of analgesia and side effects.
For pre-operative medication the route is subcutaneous or intramuscular. For all other indications the intravenous route may also be used but the dose should be reduced to 25-50% of the corresponding intramuscular or subcutaneous dose.
Adults:
7.7 - 15.4mg as a single dose
Elderly or ill patients
The initial dose should not exceed 7.7mg.
Children:
1 month to 1 year: 154 micrograms per kg body weight
1 year to 5 years: 1.93 - 3.85mg maximum single dose
6 years to 12 years: 3.85mg to 7.7mg maximum single dose
4.3. Contraindications
• Hypersensitivity to any of the product’s ingredients.
• Acute respiratory depression or Chronic Obstructive Airways Disease.
• Asthma attack.
• Acute alcoholism.
• Biliary colic.
• Head injuries or increased intracranial pressure.
• Heart failure secondary to lung disease.
• Phaeochromocytoma.
• Risk of paralytic ileus
• Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
• Coma.
4.4. Special warnings and special precautions for use
Administration during labour may cause respiratory depression in the new-born infant. In elderly or ill patients, Papaveretum should be administered with caution and in reduced doses.
Caution in use should also be exercised and a reduction in dose may be advisable in the following cases:
• Adrenocortical insufficiency
• Hypotension.
• Hypothyroidism or hyperthyroidism.
• Depressed respiratory reserve.
• Prostatic hypertrophy.
• Hepatic or renal impairment (avoid or reduce dose).
• Convulsive disorders.
• Shock.
• Supraventricular tachycardia.
4.5. Interactions with other medicinal products and other forms of interaction
• Alcohol: Enhanced sedative and hypersensitive effects
• Anti-depressants: Papaveretum must not be administered within two weeks of administration of Monoamine Oxidase inhibitors.
• Antipsychotics: Papaveretum may enhance sedative and hypotensive effects.
• Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use of Papaveretum.
• Ciprofloxacin: Papaveretum should not be used as a premedication when ciprofloxacin is used for surgical prophylaxis as serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery.
4.6. Pregnancy and lactation
There is inadequate evidence of safety of Papaveretum in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence.
The active constituents cross the placenta and are also secreted in breast milk. This should be borne in mind when considering its use in patients during pregnancy or lactation.
Effects on ability to drive and use machines
Papaveretum may cause drowsiness. If affected or if you are in any doubt that you may be affected do not drive or operate machinery until any effects have worn off.
Undesirable effects
• Hallucinations, confusion, mood changes. Dysphoria and dependence
• Headache, vertigo, dizziness and drowsiness
• Tolerance and dependence may occur with repeated administration.
• Sweating and postural hypotension
• Miosis
• Bradycardia, palpitations, tachycardia and facial flushing
• Respiratory depression
• Constipation, nausea, vomiting and a dry mouth
• Ureteric or biliary spasm
• Rashes and pruritis
• Decrease in libido or potency
• Difficulty in micturition
• Hypothermia
Overdose
Symptoms As with morphine overdose the symptoms may include pin point pupils, respiratory depression and coma.. Convulsions, especially in children and rhabdomyolysis leading to renal failure. Circulatory failure may occur in severe cases.
Treatment If respiration is dangerously depressed naloxone should be used. Artificial respiration may be necessary.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties
Papaveretum contains phenanthrene (morphine and codeine) and isoquinoline (papaverine) groups of the opium alkaloids. Morphine and Codeine exert a narcotic action on the central nervous system. Papaverine acts as a peripheral antispasmodic.
Is distributed throughout the body, but mainly in the kidneys, liver, lungs and spleen. It crosses the placenta and traces are found in sweat and milk. It is about 35% plasma protein bound. T>/„ is about 2 - 3 hours.
Codeine
It is widely distributed throughout the body. T/ is about 3 - 4 hours.
Papaverine
It is widely distributed throughout the body. T/ is about 100 minutes.
5.3. Preclinical safety data
No additional pre-clinical data of relevance to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Glycerol, Sodium, Metabisulphite and Water for Injections.
The pH may be adjusted, if necessary, using Hydrochloric Acid.
6.2. Incompatibilities
None stated.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Protect from light.
6.5. Nature and contents of container
Clear, colourless 1ml glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.
6.6. Instructions for use/handling
None stated.
MARKETING AUTHORISATION HOLDER
7.
Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals, Bampton Road,
Harold Hill,
Romford RM3 8UG
8. MARKETING AUTHORISATION NUMBER(S)
PL 1883/6181R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorised: 3 January 1983 Last renewal: 21 January 1999
10. DATE OF (PARTIAL) REVISION OF THE TEXT
June 2003