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  • ORAMORPH®
    / BioAvenir


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Oral Drops

    20ml

    BOTTLE

    not in the basket chart

    Related information


    Dosage

    The dosage has to be adapted to the severity of pain and to the individual sensitivity of the patient.
    The recommended range of the single and daily doses for children and adults is stated in the following table based on a single dose of 0.2 to 0.3 mg morphine sulphate/kg body weight.
    Children under 3 years contra indicated.
    Children 3-5 years (12.5 – 18 kg): 0.125-0.25 ml, i. e. 2-4 drops, corresponding to 2.5-5 mg morphine sulphate, every 4-6 hours.
    Children 6-12 years (20 – 40 kg): 0.25-0.5 ml, i. e. 4-8 drops, corresponding to 5-10 mg morphine sulphate, every 4-6 hours.
    Adolescents 13-18 years / Adults (40-50 kg):  0.5-1.0 ml, i. e. 8-16 drops, corresponding to 10-20 mg morphine sulphate, every 4-6 hours.
    Adults: 0.5-3 ml, i. e. 8-48 drops, corresponding to 10-60 mg morphine sulphate, every 4-6 hours.
    The dose is removed from the 20 ml bottle by counting the drops (1 drop = 1.25 mg morphine sulphate).
    In case of decreasing effect the single doses can be repeated after 4-6 hours. The maximum daily doses should not exceed the single doses by more than 4- to 6-fold.
    If higher daily doses are needed other appropriate dosage strengths have to be considered alternatively or in combination with Oramorph.
    When patients are transferred from other morphine preparations to Oramorph oral solution dosage titration may be appropriate.
    A calibrated oral dosing pipette is supplied with this dosage form for accurate and convenient dose adjustment. The required dose may be added to a soft drink immediately prior to administration.
    Morphine Sulphate is readily absorbed from the gastro-intestinal tract following oral administration. However, when Oramorph oral solution is 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. 
    Renal or hepatic impairment
    In patients with impaired liver or kidney function and in those with suspected delayed gastrointestinal passage Oramorph should be dosed with special caution.
    Elderly patients
    Elderly patients (usually 75 years and older) and patients with poor overall physical condition may be more sensitive to morphine. Therefore, the adjustment of dose has to be done more carefully and / or the dosage intervals have to be extended. As appropriate, lower dosage strengths have to be given instead.
    Special recommendations concerning dose adjustment
    For initial dose adjustment pharmaceutical forms with lower active ingredient content may be applied, possibly also in addition to an existing therapy with prolonged-release tablets.
    In principle, the administered dose should be sufficiently high and at the same time the lowest dose needed for pain relief in the individual case should be aimed at.
    For treatment of chronic pain dosing following a fixed time schedule is preferred.
    In patients receiving another additional analgesic treatment (e. g. surgery, plexus blockage) the dose should be readjusted following the respective measure.
    Method and duration of administration
    The oral drops, solution are administered with a sufficient quantity of liquid. The medication can be taken independently of meals. The physician decides about the duration of the treatment in dependence on the pain.
    By no means Oramorph be given longer than absolutely necessary. If prolonged analgesic treatment with Oramorph appears necessary based on the nature and severity of the disease, careful and regular monitoring within short time intervals should be installed (if required by means of temporary suspension of the medication) to evaluate if and to what extent the therapeutic necessity persists. If needed, more suitable pharmaceutical forms should be applied instead. In case of chronic pain conditions, a fixed dosage regimen is preferred.
    Since the risk of occurrence of withdrawal symptoms is increased in case of abrupt discontinuation of therapy the dose should be reduced stepwise after termination of treatment.


    Indications

    For the relief of moderate to severe pain.  


    Contra-Indications

    Patients with:
    – hypersensitivity to morphine or to any of the excipients of Oramorph.
    – paralytic ileus
    – acute abdomen.
    – respiratory depression
    – obstructive airways disease
    – head injuries
    – delayed gastric emptying
    – acute hepatic disease
    – Acute alcoholism
    – Coma
    – Convulsive disoreders
    – Raised intracranial pressure
    Concomitant use with MAO’s inhibitors or within two weeks of dicontinuation of their use.
    Morphine and some other opioids can induce the release of endogenous histamine and thereby stimulate catecholamine release making them unsuitable for use in patients with phaeochromocytoma.
    Patients with  acute asthma exacerbations.
    Pregnancy and lactation.


    Special Precautions

    Especially careful monitoring by the physician and possibly dose reduction is needed in case of:
    – opioid dependence
    – disturbances of consciousness
    – conditions associated with a disturbance of the respiratory centre and of the respiratory function or where there is reduced respiratory reserve (such as kyphoscoliosis, emphysema and severe obesity)
    – cor pulmonale
    – conditions with increased intracranial pressure unless ventilation is performed
    – hypotension in the setting of hypovolaemia
    – prostatic hyperplasia with residual urine (risk of bladder rupture due to urinary retention)
    – obstruction or spasms of urinary tracts
    – diseases of biliary ducts
    – obstructive and inflammatory bowel diseases (paralytic ileus)
    – chronic hepatic and renal disease
    – myxoedema
    – adrenocortical insufficiency
    – phaeochromocytoma
    – pancreatitis
    – hypothyroidism
    – epilepsia or increased propensity to seizures.
    In case of an opioid overdose respiratory depression is the most important risk.
    The use of morphine can be associated with physical dependence. Abrupt discontinuation after repeated use or application of an opioid antagonist can provoke typical signs of withdrawal (withdrawal syndrome).
    When a patient no longer requires therapy with morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
    Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required.
    Therapeutic administration in patients with chronic pain is associated with a markedly reduced risk of psychological dependence and has to be assessed in a different light.
    Compared to patients not undergoing surgery the use of Oramorph® 20 mg/ml solution is associated with an increased risk of ileus or respiratory depression during the postoperative phase and should therefore be administered with caution in patients before and after surgery.
    Due to the analgesic effect of morphine serious intraabdominal complications such as bowel perforation can be masked.
    In case of pre-existing adrenocortical insufficiency (e. g. Morbus Addison) plasma concentrations of cortisol should be monitored and possibly corticoids should be substituted.
    The administration of morphine may result in severe hypotension in individuals whose ability to maintain homeostatic blood pressure has already been compromised by depleted blood volume or the concurrent administration of drugs such as phenothiazine or certain anaesthetics.
    Hypersensitivity and anaphylactic reaction have both occurred with the use of Oramorph. Care should be taken to elicit any history of allergic reactions to opiates.
    Oramorph must not be used in children under 3 years of age.
    Due to its mutagenic properties, morphine should be given to males with procreative potential and to females with childbearing potential only if effective contraceptive measures are guaranteed.
    The use of Oramorph can lead to positive results of doping tests.


    Side Effects

    Confusion, Insomnia, Dizziness , Headache, Involuntary muscle contractions, Somnolence ,Constipation, Nausea , Abdominal pain Anorexia Dry mouth Vomiting  Hyperhidrosis, Rash, Asthenic conditions, Pruritus. See prescribing information for full details.


    Drug interactions

    The following interactions of this medicinal product have to be considered: Concomitant application of morphine and other medicines with centrally sedating effects such as tranquilisers, anaesthetics, hypnotics and sedatives, neuroleptics, barbiturates, tricyclic antidepressants, antihistamines / antiemetics, and other opioids or alcohol can result in an increase of the adverse effects of morphine at the usually recommended dose. This applies especially to the possibility of respiratory depression, sedation, hypotension and even coma.
    Morphine may possibly increase plasma concentrations of esmolol. Interactions have been reported in those subjects taking Oramorph and voriconazole. Interactions have been reported in those taking Oramorph and gabapentin. Both interactions suggest an increase in opioid adverse events when co-prescribed, the mechanism of which is not known. Caution should be taken where these medicines are co-prescribed.
    Mixed agonist/antagonist opioid analgesics (e.g. buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.
    Medicines with anticholinergic effect (e. g. psychotropic drugs, antihistamines, antiemetics, drugs for the treatment of Morbus Parkinson) can enhance anticholinergic adverse effects of opioids (e. g. constipation, dry mouth or disturbances of micturition).
    Cimetidine and other drugs impairing liver metabolism can lead to higher morphine plasma concentrations due to the inhibition of its metabolism. Opioid analgesics including morphine may antagonise the actions of domperidone and metoclopramide on gastro-intestinal activity.
    Concomitant use of ritonavir should be avoided as the plasma concentration of morphine may be increased.
    The absorption of mexiletine may be delayed by concurrent use of morphine.
    Monoamine oxidise inhibitors are known to interact with narcotic analgesics producing CNS excitation or depression with hyper- or hypotensive crisis.
    Morphine can enhance the effect of muscle relaxants.
    Concomitant application of rifampicin can lead to a decrease in the effect of morphine.    


    Pregnancy and Lactation

    Pregnancy
    Morphine may be used during pregnancy only if the benefit for the mother clearly outweighs the risk for the foetus.
    Withdrawal symptoms have been reported in neonates following prolonged morphine application during pregnancy. See prescribing information for full details.
    Lactation
    Morphine is excreted in human milk where concentrations higher than in maternal plasma are reached. Since clinically relevant concentrations can be reached in infants breast feeding is discouraged. See prescribing information for full details.


    Overdose

    Symptoms of intoxication
    The sensitivity towards morphine varies greatly from patient to patient. Therefore, symptoms of intoxication can occur in adults after application of single doses which correspond to a subcutaneous and intravenous dose of about 30 mg. In patients with carcinoma these doses are frequently exceeded without provoking serious adverse reactions.
    The manifestation of an opioid intoxication comprises the triad of miosis, respiratory depression and coma. At first pinpoint pupils are observed; however, in case of marked hypoxia the pupils are dilated. Respiration is markedly reduced (breath rate of 2-4 per minute). The patient becomes cyanotic.
    Morphine over dosage leads to giddiness and stupor up to coma. The blood pressure remains normal initially, but decreases markedly with progression of intoxication. Persistent decrease in blood pressure can result in shock. Tachycardia, bradycardia and rhabdomyolysis can occur. The body temperature decreases. The skeletal muscles relax; occasionally generalised seizures can develop, especially in children. Death occurs mostly due to respiratory insufficiency or due to complications such as pulmonary oedema.
    Therapy of intoxication
    In unconscious patients with respiratory arrest ventilation, intubation and intravenous administration of opioid antagonists (e. g. 0.4- 2 mg naloxon intravenously) are indicated. In case of persistent respiratory insufficiency the single dose has to be repeated 1 to 3 times in 3-minute intervals until the respiratory rate is back to normal and the patient responds to painful stimuli.
    The patient has to be strictly monitored (at least for 24 hours) since the duration of action of the opioid antagonist is shorter (naloxone 2-3 hours) compared to that of morphine so that recurrence of the respiratory insufficiency has to be expected.
    The single dose of the opioid antagonist is 0.01 mg per kg body weight in children. Additionally measures to prevent a decrease in body temperature and to supplement volume may be necessary.


    Important notes

    Effects on ability to drive and use machines
    Morphine can impair the attentiveness and the capability to react to such an extent that the ability to drive or to use machines is impaired or inexistent.
    This is to be expected especially upon initiation of treatment, dose increase and change in medication as well as in combination with alcohol or the use of sedatives.
    The assessment of the individual situation in each case has to be done by the treating physician. During a stable therapeutic regimen driving is not prohibited generally.
    Shelf life
    The shelf life is 3 years.
    After opening of the bottle Oramorph  is stable for 90 days.
    Storage
    Do not store above 25°C. Store the bottle in the outer carton in order to protect from light.


    Manufacturer
    L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. Italy
    Licence holder
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