Papaveretum And Hyoscine Injection 15.4mg & 400mcg In 1ml
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Papaveretum and Hyoscine Injection 15.4mg & 400 micrograms/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
13.16mg in 1 ml 1.04mg in 1ml 1.2mg in 1ml 15.4mg in 1ml
0.4mg in 1ml
Morphine Hydrochloride BP Codeine Hydrochloride BP Papaverine Hydrochloride BP or
Papaveretum BP Hyoscine Hydrobromide BP
3. PHARMACEUTICAL FORM
Solution for Injection
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Pre- operative medication.
For subcutaneous or intramuscular injection.
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 preoperative medication the route is by subcutaneous or intramuscular injection 45-60 minutes before anaesthesia.
Adults:
7.7 - 15.4mg as a single dose
Elderly or ill patients
The initial dose should not exceed 7.7mg.
Children:
Under 1 month:
1 month to 1 year: 1 year to 5 years:
115.5 micrograms per kg body weight. 154 micrograms per kg body weight 1.93 - 3.85mg maximum single dose
4.3. Contraindications
• Asthma attack
• Acute alcoholism.
• Biliary colic.
• Coma,
• Head injuries or increased intracranial pressure.
• Heart failure secondary to lung disease.
• Hypersensitivity to opium alkaloids.
• Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
• Obstructive airways disease.
• Phaeochromocytoma.
• Porphyria
• Respiratory depression.
• Risk of paralytic ileus
4.4. Special warnings and special precautions for use
Administration during labour may cause respiratory depression in the newborn infant. It is wise to administer with caution and in reduced doses to the elderly.
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 and Hyoscine Injection may enhance sedative and hypotensive effects and produce an increased antimuscarinic effect.
• Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use of Papaveretum and Hyoscine Injection.
• Antihistamines: May produce an increase in antimuscarinic effect.
• Antimuscarinics: May produce an increase in antimuscarinic effect.
• 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.
• Nitrates: Sublingual nitrates may be ineffective due to the loss of saliva.
As with all drugs during pregnancy care should be taken in assessing the potential risk to benefit ratio.
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.
4.7. 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.
4.8. 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
4.9. 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
5. PHARMACOLOGICAL PROPERTIES
5.1. 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.
Hyoscine is an antimuscarinic with central and peripheral actions. It acts as a hypnotic and reduces secretions.
Morphine
It 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. is about 2 - 3 hours.
Codeine
It is widely distributed throughout the body. T/2 is about 3 - 4 hours.
Papaverine
It is widely distributed throughout the body. T>/2 is about 100 minutes.
Hyoscine
The major portion of a dose is metabolised in the body with 4 - 5% of the unchanged drug appearing in the urine. The major metabolite is the glucuronide.
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.
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals, Bampton Road,
Harold Hill,
Romford RM3 8UG
8. MARKETING AUTHORISATION NUMBER(S)
PL 1883/6182R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorised: 3 February 1983
Last renewal: 18 September 1998
10. DATE OF (PARTIAL) REVISION OF THE TEXT
July 2003