Domadol Inj by sdsdfqw21

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									                  SCHEDULING STATUS S5

                  PROPRIETARY NAME (and dosage form):                                    Hepatic impairment:
                  DOMADOL 50 MG (Injection)                                              The elimination of DOMADOL may be prolonged. The usual
                  DOMADOL 100 MG (Injection)                                             initial dose should be used but in severe hepatic impairment, the
                                                                                         dosage interval should be increased to 12 hours.
                  COMPOSITION:
                  DOMADOL 50 MG contains tramadol hydrochloride 50 mg.                   Duration of treatment:
                  DOMADOL 100 MG contains tramadol hydrochloride 100 mg.                 Under no circumstances should DOMADOL injectable be given
                                                                                         for longer than absolutely necessary. If the nature and severity of
                  PHARMACOLOGICAL CLASSIFICATION:                                        the disease require long-term pain treatment with DOMADOL
                  A.2.9. Other analgesics                                                injectable, evaluation should be carried out initially and at regular
                                                                                         intervals to assess efficacy, adverse events, and the need for
                  PHARMACOLOGICAL ACTION:                                                further treatment.
                  Tramadol hydrochloride is a centrally-acting synthetic opioid
                  analgesic binding to specific opioid receptors. It is a non-           SIDE EFFECTS AND SPECIAL PRECAUTIONS:
                  selective, pure agonist at mu (µ), delta (d) and kappa (k) opioid      Side effects:
                  receptors with a higher affinity for the µ receptor. Other             Cardiac disorders
                  mechanisms, which may contribute to its analgesic effect, are          Less frequent: Tachycardia.
                  inhibition of neuronal re-uptake of noradrenaline and                  The following have been reported but the frequencies are
                  enhancement of serotonin release.                                      unknown:
                  Tramadol hydrochloride does not promote histamine release.             Bradycardia, cardiovascular collapse.

                  Pharmacokinetics:                                                      Vascular disorders
                  Tramadol hydrochloride is readily absorbed following oral              The following have been reported but the frequencies are
                  administration. Oral bioavailability is approximately 68% after a      unknown:
                  single dose and increases to 90% at steady state. Onset of             Flushing, postural hypotension.
                  action is dose dependent but generally occurs within one hour of
                  dosing, peaking within 2 to 3 hours. Duration of analgesia is          Nervous system disorders
                  about 6 hours. The rate or extent of absorption is not significantly   Frequent: Drowsiness, dizziness, headache.
                  affected by co-administration with food.                               Less frequent:     Confusion, hallucinations, seizures (see
                  The bioavailability of tramadol hydrochloride after intramuscular      WARNINGS), amnesia, paraesthesia, syncope.
                  injection or intravenous administration is the same; the mean          The following have been reported but the frequencies are
                  peak serum concentration is achieved after 45 minutes.                 unknown:
                  Tramadol hydrochloride is primarily metabolised in the liver           Fatigue, sedation.
                  (90%) with one of its metabolites, mono-O-desmethyltramadol
                  (M1), being 2 to 4 times as potent as the parent compound.             Gastrointestinal disorders
                  Tramadol hydrochloride has a linear pharmacokinetic profile            Frequent:      Nausea, vomiting, dry mouth, dyspepsia,
                  within the therapeutic dosage range.                                   constipation, diarrhoea, anorexia, abdominal pain.
                  Tramadol hydrochloride and its metabolites are excreted mainly
                  in the urine. The elimination half-life is 5 to 7 hours, but is        Renal and urinary disorders
                  prolonged in impaired hepatic and renal function.                      Less frequent: Urinary retention, urinary frequency.
                  Tramadol hydrochloride crosses the blood-brain and placental
                  barrier. Small amounts are excreted in breast milk unchanged or        Hepato-biliary disorders
                  as the metabolite M1.                                                  The following has been reported but the frequency is unknown:
                                                                                         Increase in liver enzymes.
                  INDICATIONS:
                  DOMADOL is indicated for the management of moderate to                 Eye disorders
                  moderately severe pain.                                                Less frequent: Blurred vision.
                  CONTRA-INDICATIONS:                                                    Skin and subcutaneous disorders
                  Hypersensitivity to tramadol hydrochloride or opioids.                 Frequent: Sweating (especially when IV administration is too
                  Acute intoxication with alcohol, hypnotics, analgesic opioids or       rapid), skin rashes, pruritus.
                  psychotropic medicines (due to the risk of respiratory                 Less frequent: Urticaria, vesicles.
                  depression).                                                           The following have been reported but the frequencies are
                  Patients taking monoamine oxidase (MAO) inhibitors or within           unknown:
                  two weeks of their discontinuation (see INTERACTIONS).                 Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome.
                  Narcotic withdrawal treatment.
                  Respiratory depression especially in the presence of cyanosis          General disorders
                  and excessive bronchial secretions.                                    The following have been reported but the frequencies are
                  Increased intracranial pressure or central nervous depression          unknown:
                  due to head injury or cerebral disease.                                Angioedema, bronchospasm, anaphylaxis, and anaphylactoid
                  Pregnancy and lactation.                                               reactions. These reactions may occur after the first dose.
                  WARNINGS:                                                              Special precautions:
                  Avoid the use of DOMADOL in patients with a history of addiction,      The administration of DOMADOL concurrently with other central
                  as physical dependence of the morphine-type may develop.               nervous system medicines is likely to intensify and prolong CNS
                  Reinstatement of physical dependence in patients that have             effects (see INTERACTIONS). Patients should be warned not to
                  previously been dependent may occur with DOMADOL.                      operate machinery or drive a car while using DOMADOL.
                  Use with caution in patients with a history of epilepsy or those       The possibility of respiratory depression cannot be excluded if the
                  susceptible to seizures (e.g. patients taking neuroleptics and         recommended dose is exceeded or other centrally depressant
                  other drugs that reduce the seizure threshold).                        medicines are given concomitantly.
                  Use with caution in patients with renal or hepatic impairment and      DOMADOL injection should not be used for the treatment of
                  avoid if severe.                                                       minor pain.

                  INTERACTIONS:                                                          KNOWN SYMPTOMS OF OVERDOSAGE AND
                  Monoamine oxidase inhibitors (MAOIs): Because of its                   PARTICULARS OF ITS TREATMENT:
                  inhibitory effect on serotonin uptake, DOMADOL should not be           Symptoms of overdose:
                  used concomitantly with MAOIs or within 14 days after                  (See SIDE EFFECTS AND SPECIAL PRECAUTIONS)
                  discontinuing such treatment (see CONTRA-INDICATIONS).                 Symptoms of overdosage are typical of opioids, and include
                  Central nervous system (CNS) depression-producing                      pinpoint pupils, slow heartbeat, slow or troubled breathing,
                  medications, including alcohol and anaesthetics: Caution is            weakness, seizures, cold, clammy skin.
                  recommended because concurrent use may potentiate the CNS
                  depressant effects. The duration of anaesthesia may be                 Treatment of overdose:
                  prolonged when DOMADOL is combined with barbiturates.                  Supportive measures such as maintaining the patency of the
                  Carbamazepine: Serum concentrations of DOMADOL are                     airway and maintaining cardiovascular function should be
                  reduced by carbamazepine, resulting in diminished analgesic            instituted. Treatment of restlessness is symptomatic and
                  activity of DOMADOL.           Inhibitors of CYP3A4 such as            supportive.
                  ketoconazole and erythromycin may inhibit the metabolism of            Naloxone should be used to reverse some, but not all, symptoms
                  DOMADOL.                                                               caused by overdosage with DOMADOL. Administration of
                  Incompatibilities:                                                     naloxone should be done with caution because it may precipitate
                  DOMADOL injection solution is incompatible with the following          seizures.
                  injection solutions if mixed in the same syringe: Diclofenac,          Diazepam has been found to be effective in treating convulsions
                  indomethacin, phenylbutazone, diazepam, flunitrazepam,                 caused by DOMADOL toxicity.
                  midazolam, and glyceryl trinitrate.                                    Haemodialysis is not recommended in overdose, since it
                                                                                         removes less than 7% of the administered dose of DOMADOL in
                  PREGNANCY AND LACTATION:                                               a 4-hour dialysis period.
                  Safety in pregnancy and lactation has not been established (see
                  CONTRA-INDICATIONS).                                                   IDENTIFICATION:
                                                                                         DOMADOL 50 MG Injection is a clear colourless solution, free
                  DOSAGE AND DIRECTIONS FOR USE:                                         from particles.
                  The dosage should be adjusted to the intensity of pain and the         DOMADOL 100 MG Injection is a clear colourless solution, free
                  individual's response to the analgesic action of DOMADOL.              from particles.
                  DOMADOL should not be used for the treatment of minor pain.
                                                                                         PRESENTATION:
                  Adults and children over the age of 14 years:                          DOMADOL 50 MG Injection is packed in a 1 ml transparent, glass
                  Parenteral administration:                                             ampoule with a blue ring at the constriction. Five ampoules are
                  IV: 1 ampoule (100 mg injected slowly or diluted in solution for       packed in a blister strip with clear PVC on one side and printed
                  infusion and infused).                                                 aluminium foil on the other side. Each blister is packed in an inner
                  IM: 1 ampoule (100 mg).                                                carton. Five inner cartons are packed in an outer carton.
                  SC: 1 ampoule (100 mg).                                                DOMADOL 100 MG Injection is packed in a 2 ml transparent,
                  Intravenous injection must be given slowly over 2 to 3 minutes.        glass ampoule with a blue ring at the constriction. Five ampoules
                  A total daily dose of more than 400 mg per day must not be             are packed in a blister strip with clear PVC on one side and
                  exceeded.                                                              printed aluminium foil on the other side. Each blister is packed in
                  For postoperative pain, administer an initial bolus of 100 mg.         an inner carton. Five inner cartons are packed in an outer carton.
                  During the 90 minutes following the initial bolus further doses of
                  50 mg may be given every 30 minutes, up to a total dose of 250         STORAGE INSTRUCTIONS:
                  mg including the initial bolus. Subsequent doses should be 50          Store below 25ºC.
                  mg or 100 mg 4 to 6 hourly up to a total daily dose of 600 mg. For     KEEP OUT OF REACH OF CHILDREN.
                  less severe pain administer 50 mg or 100 mg 4 to 6 hourly.
                                                                                         REGISTRATION NUMBER:
                  Elderly:                                                               DOMADOL 50 MG: 40/2.9/0190
                  The usual doses may be used except in patients 75 years of age         DOMADOL 100 MG: 40/2.9/0191
                  and over. A downward adjustment of the dose and/or
                  prolongation of the interval between doses are recommended.

                  Renal impairment:
                  The elimination of DOMADOL may be prolonged. The usual
                  initial dose should be used, but for patients with creatinine
                  clearance < 30 ml/min, the dosage interval should be increased to
                                                                                         ADRINA BUILDING, 1ST FLOOR, 32 KLINKENBERG STREET
                  12 hours.                                                              VAN DER HOFF PARK, POTCHEFSTROOM, 2531




             Magnification: 100%
             Actual Size: 115 mm x 240 mm
             South Africa Export




Company Name : UNICHEM LABORATORIES LTD.                                                                                       Date: 19-08-2008
Agency Name: ANKUR - GERMINATING IDEAS
Product: PackInsert Domadol 100 (AFR) Packing: 2 ml                                                                            Size:
Item Code: PSD2467-00                 Location: Ghaziabad, India                                                               Layout No.:
Specification:                                                                                                                 Colours :
Varnish:                                                                                                                       Country: For South Africa Exports
Colour Codes:
Comments:                             Barcode:                                                                                 Pharmacode:
Prepared By:                          Checked By:                                                                              Approved By:



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