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Oramorph 10mg

Each 5 ml of Oramorph Oral Solution contains 10 mg of Morphine Sulfate.

Excipient(s) with known effect: Each 5 ml also contains 1500 mg sucrose, 500 mg corn syrup (contains glucose), 0.525 ml Ethanol (96%), 9 mg methyl parahydroxybenzoate (E218) and 1 mg propyl parahydroxybenzoate (E216).

For the full list of excipients, see Section 6.1.

$200.00

Pharmaceutical form
Oral solution.
A clear, colorless oral solution.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain in adults, adolescents (aged 13-18 years) and children (aged 1-12 years).
4.2 Posology and method of administration
Posology
Adults:
Recommended dose 10-20 mg (5-10 ml) every 4 hours.
Maximum daily dose: 120 mg per day
Paediatric population:
Children 13-18 years:
Recommended dose 5-20 mg (2.5 – 10 ml) every 4 hour
Maximum daily dose: 120 mg per day
Children 6-12 years:
Recommended dose 5-10 mg (2.5-5 ml) every 4 hours
Maximum daily dose: 60 mg per day
Children 1-5 years:
Recommended dose 5 mg (2.5 ml) every 4 hours
Maximum daily dose: 30 mg per day
Children under 1 year:
Not recommended
Dosage can be increased under medical supervision according to the severity of the pain and the patient’s previous history of analgesic requirements.
Special populations:
Reductions in dosage may be appropriate in the elderly and in patients with chronic hepatic disease (for acute hepatic disease see section 4.3), renal impairment, severe hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, shock or where sedation is undesirable.
Discontinuation of therapy
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Oramorph in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Method of Administration

For oral use.
When patients are transferred from other morphine preparations to Oramorph Oral preparations dosage titration may be appropriate.
Morphine sulfate is readily absorbed from the gastro-intestinal tract following oral administration. However, when oral Oramorph preparations are used in place of parenteral morphine, a 50 % to 100 % increase in dosage is usually required in order to achieve the same level of analgesia.
4.3 Contraindications

Oramorph is contraindicated in:

• patients known to be hypersensitive to morphine sulfate or to any other component of the product
• respiratory depression
• obstructive airways disease
• paralytic ileus (see section 4.4)
• acute hepatic disease
• acute alcoholism
• head injuries (see section 4.4)
• coma (see section 4.4)
• increased intracranial pressure (see section 4.4)
• convulsive disorders
• patients with known morphine sensitivity
• concurrent administration with monoamine oxidase inhibitors or within two weeks of discontinuation of their use (see section 4.5)
• patients with phaeochromocytoma. Morphine and some other opioids can induce the release of endogenous histamine and thereby stimulate catecholamine release
• acute asthma exacerbations (see section 4.4 for information relating to use in controlled asthma)

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