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PENTAZOCINE is a brand name for Pentazocine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the relief of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The dosage is usually tailored to the individual patient and to the severity of the pain.
Adults:
The usual initial dose is two 25 mg tablets (50 mg) every four hours after meals, followed by 25 mg to 100 mg of pentazocine every three to four hours.
Elderly:
Since impaired renal or hepatic function is often associated with ageing, elderly patients may require smaller doses of pentazocine. Paediatric population: (6 - 12 years) one 25 mg tablet every 3 - 4 hours as necessary. Pentazocine tablets are not recommended for children under 6 years of age.
No data are available. Method of administration For oral use.
In chronic usage, care should be exercised to avoid any unnecessary increase in dosage since prolonged use of high dosage of pentazocine may produce dependence. At normal therapeutic doses, side-effects are generally of a minor nature.
Sedation, the most common side effect, is less than that associated with morphine. The most frequent side effects are light-headedness, dizziness, nausea, vomiting and sweating.
The following side effects have also been reported:
Blood and lymphatic system disorders: transient eosinophilia, depression of white blood cell count Immune system disorders: oedema of the face, flushing of the skin including facial plethora, skin rashes, urticaria, dermatitis including pruritus, chills and allergic reactions.
4) Nervous system disorders: hallucinations may occur occasionally, dysphoria, headache, disorientation mood changes, nightmares, insomnia, paraesthesia, syncope, euphoria, grand mal convulsions, raised intracranial pressure, confusion, muscle tremor, thought disturbances.
Eye disorders: miosis, disturbances of vision. Cardiac disorders: tachycardia, bradycardia, palpitations. Vascular disorders: transient hypertension, hypotension, circulatory depression Respiratory, thoracic and mediastinal disorders: respiratory depression.
Gastrointestinal disorders: dry mouth, constipation, biliary tract spasm, Skin and subcutaneous system disorders: toxic epidermal necrolysis. Renal and urinary disorders: urinary retention, ureteric tract spasm. Pregnancy, puerperium and perinatal conditions: alterations in rate or strength uterine contractions during labour.
Reproductive system and breast disorders: decreased libido or potency. General disorders and administration site conditions: hypothermia, drug withdrawal syndrome (uncommon). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Pentazocine can both depress as well as elevate blood pressure possibly through the release of endogenous catecholamines. Particular caution should be observed therefore in using it in the presence of phaeochromocytoma, in the acute phase following myocardial infarction when it may increase pulmonary and systemic arterial pressure and vascular resistance, and in other clinical situations where alteration of vascular resistance and blood pressure might be particularly undesirable.
Caution should be observed in patients with severe renal or hepatic impairment and in elderly patients, who may additionally be especially sensitive to the effects of opioids, as both conditions may lead to an increase in bioavailability of pentazocine and call for a reduction in dosage.
Administer with caution to patients previously on large doses of narcotics. Caution should also be observed in patients who are prone to seizures and in the presence of other opioids or opioid-dependence since the weak opioid antagonistic effects of pentazocine may provoke withdrawal symptoms.
Caution should also be observed in patients with hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy and in patients with inflammatory or obstructive bowel disorders, cholecystitis, pancreatitis or other unidentified abdominal pain.
After long term treatment (> 3 months) of analgesics, with use every second day or more frequently, headache may develop or aggravate. Headache caused by overuse of analgesics (MOH-medication-overuse headache) should not be treated by increasing the dose.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Pentazocine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Pentazocine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
1 • Pentazocine should not be administered to patients with established respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion • Acute alcoholism • Acute bronchial asthma • Heart failure, secondary to chronic lung disease • Porphyria • Raised intracranial pressure, head injuries or pathological brain conditions where clouding of the sensorium is undesirable.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Some opioids can cause CNS excitation or depression. Pentazocine, like most other strong analgesics, should not be used in patients who are receiving monoamine oxidase inhibitors or who have received them within the past 14 days.
5) Opioids can be taken after two weeks of MAOI's discontinuation Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with pentazocine.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure,increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 7 mg of sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.