Meds and you

27 September 2013

Phenobarbitone, paracetamol, codeine, caffeine and diphenhydramine

The combination of phenobarbitone, paracetamol, codeine, caffeine and diphenhydramine is a potent analgesic. An analgesic is a substance which reduces or eliminates pain.

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The combination of phenobarbitone, paracetamol, codeine, caffeine and diphenhydramine is the active ingredient found in Propain Forte (Nappi Code: 757667-007))

General information
The combination of phenobarbitone, paracetamol, codeine, caffeine and diphenhydramine is a potent analgesic. An analgesic is a substance which reduces or eliminates pain.

In South Africa this combination is registered for the treatment of mild to moderate pain and pain associated with anxiety and tension. It is also effective in reducing fever.

Phenobarbitone is a barbiturate that depresses the central nervous system. It is effective in reducing anxiety, thereby relieving tension related pain.

Paracetamol is the analgesic of choice for mild to moderate pain and to reduce fever. It is suited for both adults and children and, as it does not cause stomach irritation, it is safe to use by those who suffer from peptic ulcers and those who cannot take aspirin.

When taken by mouth it is rapidly absorbed into the body and will be effective within 30 minutes. Paracetamol is safe for occasional use by those being treated with anticoagulants.

Codeine is most often prescribed to treat mild to severe pain, but is also effective in treating diarrhoea. Because of this, this combination may cause constipation in some.

Diphenhydramine, a centrally acting antihistamine, is assists with the reduction of smooth muscle contraction, tremors and spasms. Diphenhydramine may cause extreme sedation, and because of this users should be careful when driving or attempting dangerous activities. It should furthermore not be combined with alcohol, as alcohol may significantly enhance these medications’ sedative effects.

Caffeine appears to have analgesic effects for some types of pain. Caffeine alone or and in combination with other analgesics has been found to be effective in relieving mild to moderate tension and vascular headaches. It is also effective in reducing drowsiness and impaired mental alertness caused by some of the other ingredients in this combination.

It should be noted that pain is a symptom and not a disease, and although this combination may be useful for short-term pain management, long-term relief often requires treatment of the underlying cause. None of the ingredients in this combination cure the underlying condition responsible for pain or fever, but simply keep the symptoms under control.

This combination should be used with caution in those patients with a history of alcohol or drug abuse, as a definitive risk of dependency does exist.

A combination product such as this is helpful in reducing the number of tablets taken for pain management.

How does this combination work?
Paracetamol blocks the production of chemicals in the body that are responsible for pain and fever, while codeine exerts its effect by acting on parts of the central nervous system which process pain signals. Phenobarbitone is effective in reducing anxiety, thereby relieving tension-related pain while diphenhydramine reduces the activity of a chemical messenger in the brain called acetylcholine and thereby relieves muscle spasms and tremors. The combination of caffeine with these analgesics in this combination probably reinforces their effect by causing a pleasant general sense of well-being.

Fast facts

Drug schedule: schedule 5
Available as: this combination is available as tablets and capsules.
What does it do? This combination reduces or eliminates pain.
Overdose risk: high
Dependence risk: high
Is this combination available as a generic? no
Is this combination available on prescription only? no

User information

Onset of effect: within 90 minutes
Duration of action: up to 8 hours
Dietary advice: this combination should best be taken with meals to avoid gastric upset.
Stopping this medicine: treatment with this combination can be safely stopped if no longer needed. If it has been used for extended periods of time your doctor may need to gradually reduce your dose.
Prolonged use: prolonged use is not advised tolerance and dependence may occur.

Special precautions
Consult your doctor before using this drug if:

  • you have a kidney or liver disease

  • you are epileptic

  • you have a respiratory disorder

  • you have a history of alcohol or substance abuse

  • you have Porphyria

  • you have a head injury

  • you have an enlarged prostate

  • you have heart disease

  • you have difficulty urinating

  • you have an obstructive bowel disorder

  • you have a thyroid disorder

  • you have a stomach ulcer or a history of stomach ulcers

  • you have myasthenia gravis

  • you have glaucoma

  • you have diabetes

  • you have asthma

Pregnancy: avoid. Potential risk to the foetus has been reported. Consult your doctor before use, or if you are planning to fall pregnant.
Breastfeeding: avoid. This medication is passed through breast milk and may affect your baby adversely. Consult your doctor before use.
Porphyria: avoid. This medication may cause serious adverse effects. Consult your doctor before use.
Infants and children: this medication is not intended for use in children.
The elderly: caution is advised in the elderly as this drug may increase the likelihood of adverse effects.
Driving and hazardous work: caution is advised as use of this medication may lead to dizziness, light-headedness and/or sedation. Avoid such activities until you know how this medication affects you.
Alcohol: avoid concomitant use of alcohol with this medication.

Possible side effects

Side Effect
Frequency
Consult your doctor

Common
Rare
Only if severe
In all cases
drowsiness, dizziness
X

X

headache

X
X

dry mouth
X

X

slurred speech

X

X
weakness

X

X
visual impairment

X
X

nausea/vomiting

X
X

diarrhoea
X

X

fast, irregular heart rate

X

X
bruising/bleeding

X

X
swelling

X

X
skin rash

X

X
chills/fever

X

X
difficulty breathing

X

X
constipation
X

X

euphoria

X

X
change in mood

X

X
anxiety

X

X
rash/itchy skin

X

X
seizures

X

X
yellow-tinged skin and eyes

X

X
loss of balance

X

X
loss of coordination

X

X
sun sensitivity

X
X

nightmares

X
X

Interactions

alcohol (and other suppressants of the CNS) enhanced CNS effects i.e. sedation
atropine and related drugs increased risk of constipation, urinary retention, etc.
drugs for diarrhoea risk of severe constipation
carbamazepine increased risk of carbamazepine toxicity
monoamine oxidase inhibitors increase risk of low blood pressure
tricyclic Antidepressants increased occurrence of diphenhydramine related side-effects
drugs that may cause hearing loss signs of hearing damage may be masked
propranolol, etc. lower beta-blocker effect
Felodipine lower felodipine efficacy
nimodipine lower nimodipine efficacy
corticosteroids reduced corticosteroid effect
digoxin reduced digoxin effect
griseofulvin reduced griseofulvin effect
oral contraceptives that contains oestrogen possible pill failure

Disease interactions
See special precautions.

Overdose action
An overdose of this medication can be fatal. Seek immediate emergency medical attention.

Recommended dosage
Adults: 1-2 tablets/capsules 4 hourly if needed, but not exceeding 8 tablets/capsules in a 24 hour period

This material is not intended to substitute medical advice, but is for informational purposes only. Please consult a physician for specific treatment and recommendations.
 
 

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