Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
For the relief of moderate to severe pain.
The dosage is usually tailored to the individual patient and to the severity of the pain.
The usual initial dosage is 50 mg every four hours after meals followed by one to two 50 mg capsules every three to four hours.
The maximum dose is 600 mg daily.
Children under 12 years: It is recommended that another dosage form i.e. tablets, be used as appropriate for this age group.
Since impaired renal or hepatic function is often associated with ageing, elderly patients may require smaller doses of pentazocine.
For oral use.
The symptoms and clinical signs of pentazocine overdose will resemble those of morphine and other opioids. They may therefore include somnolence, respiratory depression, hypotension, hypertension, tachycardia, hallucinations, or seizures. Circulatory failure and deepening coma may occur in more severe cases as may convulsions, particularly in patients who have also ingested other CNS depressants such as alcohol, sedatives/hypnotics or antihistamines. Adequate measures to maintain ventilation and general circulatory support should be employed and consideration given to gastric lavage and gastric aspiration.
For respiratory depression due to overdosage or unusual sensitivity to pentazocine, parenteral naloxone is a specific and effective antagonist. Initial doses of 0.4 to 0.2 mg of naloxone are recommended, repeated at 2-3 minute intervals if needed, up to a total of 10 mg. Anti-convulsant therapy may be necessary.
Shelf life: 60 months.
Store below 25°C.
Blisters: Store in the original package in order to protect from light and moisture.
Bottles: Keep the bottle tightly closed in order to protect from light and moisture.
Pentazocine Capsules are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) or high density polyethylene containers (HDPE) with polyethylene snap closures, and PVC/foil blisters, in pack sizes of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, and 500 capsules.
No special requirements.
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