Dipipanone with cyclizine 10mg + 30mg oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing 10 mg dipipanone hydrochloride and 30 mg cyclizine hydrochloride
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
Adults
The initial dose in all conditions is one tablet every 6 hours. Caution should be used when increasing this dose as it is difficult to accurately predict the initial central effects of dipipanone.
However, if this dose is inadequate (such as in severe intractable pain or when other potent opioids have been used) it may be increased by half a tablet every 6 hours.
It is rarely necessary to exceed a dose of 30 mg dipipanone given 6-hourly (that is 12 tablets in 24 hours).
Patients with Renal Impairment
Use of dipipanone with cyclizine is contraindicated in patients with severe renal impairment as it may precipitate coma.
In patients with mild to moderate renal impairment, dosage should be reduced and the patients' response monitored with regard to further dosage requirements.
Patients with Hepatic Impairment
Dipipanone with cyclizine is contraindicated in patients with severe hepatic impairment as it may precipitate hepatic encephalopathy.
Contraindications
Children under 18 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Alcoholism
Biliary colic
Breastfeeding
Excessive bronchial secretions
Galactosaemia
Head trauma
Labour
Pregnancy
Raised intracranial pressure
Renal colic
Respiratory depression
Severe hepatic impairment
Severe renal impairment
Ulcerative colitis
Precautions and Warnings
Debilitation
Elderly
Hypovolaemic shock
Adrenal insufficiency
Benign prostatic hyperplasia
Diabetes mellitus
Drug addiction
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of drug misuse
Hypotension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Opioid dependence
Phaeochromocytoma
Renal impairment
Respiratory impairment
Seizures
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine is subject to driving restrictions
Contains lactose
Tolerance and dependence may occur
May cause agitation and confusion in the elderly
May affect results of some laboratory tests
Withdraw gradually after long-term use
Pregnancy and Lactation
Pregnancy
Dipipanone with cyclizine is contraindicated in pregnancy.
There are no data available on the use of dipipanone and cyclizine in human pregnancy. It may be anticipated that if administered in the last trimester, it would precipitate withdrawal symptoms in the neonate.
Use during labour is not recommended because of the potential to cause respiratory depression in the neonate.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Dipipanone with cyclizine is contraindicated in breastfeeding.
There are no data available on the excretion of dipipanone, cyclizine or their metabolites in human milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving.
When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Side Effects
Agranulocytosis
Biliary spasm
Blurred vision
Cholestatic jaundice
Chorea
Confusion
Constipation
Convulsions
Dependence
Difficulty in micturition
Disorientation
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Dyskinesia
Dysphoria
Dystonia
Euphoria
Extrapyramidal effects
Facial flushing
Fixed drug eruption
Hallucinations
Hepatitis
Hypotension
Impaired consciousness
Insomnia
Miosis
Mood changes
Muscle spasm
Nausea
Nervousness
Orthostatic hypotension
Psychosis
Raised intracranial pressure
Rash
Renal spasm
Respiratory depression
Restlessness
Sedation
Speech disturbances
Subjective feelings of mental slowness or dullness
Sweating
Tachycardia
Tremor
Twitching
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Vomiting
Effects on Laboratory Tests
Protein estimation using the Lowry method are affected by opioids, which can react with the Folin-Ciocalteau reagent used during the process.
Urinary 17-ketosteroids values are affected by opioids, due to chemical structure effects in the zimmerman procedure.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2016
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on 05 September 2016].
Summary of Product Characteristics: Dipipanone 10mg and cyclizine 30mg Tablets. Concordia International. Revised October 2016.
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: Advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk/ Last accessed: 6 January 2015
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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