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FAM001159-0001 intervals of 4-7 days to usual dose of 75-100 mg Dolmatil® (Sanofi-Synthelabo) ~ 100 rag/5 mL, thioridazine 100 rag/ per course and max. 4 injections; max. duration of daily according to response; CHILD not recom- Tablets, both scored, sulpiride 200 rag, net price ’ net price 300 mL = £7.14. Label: 2 treatment 2 weeks---if maintenance treatment mended 100-tabpack=£13.85;400mg(f/c), 100-tab ! fNote. These suspensions should not be diluted but the necessary change to an oral antipsychotic 2-3 Short-term adjunctive management of severe pack = £36¯29. Label: 2 .: :~t~a preparations may be mixed with each other to days after last injection, or to a longer acting anti- anxiety, 15-20rag daily in divided doses; max. Sulpltil® (Pharmacia) I~ ~0iovid¢ intermediate strengths psychotic depot injection given concomitantly 40 mg daily; CHILD not recommended Tablets, scored, sulpiride 200 rag. Net price 28-tab "ff~-~p, brown, thioridazine (as hydrochloride) with last injection of zuclopenthixol acetate; By deep intramuscular injection, psychoses, mania, pack = £4.29; 112-tab pack = £12.85. Label: 2 ~ff.~5"~mg/5 mL, net price 300 mL = £1.98. Label: 2 CHILD not recommended prochlorperazine mesilate 12.5-25 mg 2-3 times Sulpor® (Rosemont) IPoMI Clopi~ol Acuphase® (Lundbeck) daily; CHILD not recommended Oral solution, sugar-free, lemon- and aniseed-fla. LUOPERAZINE Injection (oily), zuclopenthixol acetate 50 mg/mL. By rectum in suppositories, psychoses, mania, the voured, sulpiride 200 mg/5 mL, net price 150 mL (’~’n~ications: see under Dose; anti-emetic (section Net price I-mL amp = £5.20; 2-mL amp = £10.03 equivalent of prochlorperazine maleate 25 mg 2- = £27.00. Label: 2 3 times daily; CHILD not recommended ~,6) ... , .~autions: see notes anove ZUCLOPENTHIXOL THIORIDAZlNE Contra-indications: see notes above DIHYDROCHLORIDE Preparations , b’qdc;-effects: see notes above; extmpyramidal Indications: under specialist supervision, second. Indications: schizophrenia and other psychoses, Section 4.6 more frequent, especially at doses line treatment of schizophrenia in adults (see 6 mg daily; pancytopeniai thrombocy- particularly when associated with agitated, Contra-indicationa, below) aggressive, or hostile behaviour PROMAZINE HYDROCHLORIDE Cautions: see notes above; avoid in porphyria Cautions: see notes above; ECG screening and by mouth (reduce initial doses in elderly by Indications: see under Dose electrolyte measurement before treatment, after (section 9.8.2) each dose increase and at 6-month intervals; also Contra-indications: see notes above; apathetic or Cautions: see notes above; also cerebral arterio- Schizophrenia and other psychoses, short-term monitor for visual defects on prolonged use; withdrawn states sclerosis ldjunctiv¢ management of psychomotor agita- avoid in porphyria (section 9.8.2) Slde-effects: see notes above; urinary frequency Contr’a-indications: see notes above tion; excitement, and violent or dangerously Contra-indications: see notes above or incontinence; weight loss (less common than impulsive behaviour, initially 5 mg twice daily, or Side-effects: see notes above; also haemolytic weight gain) " " ’ CARDIOTOXIClTY, Thioridazine is associated with QT- 10rag daily in mod fled-release form, jncreased anaemia interval prolongation and increased risk of ventriculat 5 mg after 1 week, then at intervals of 3 days, Dose: initially 20-30mg daily in divided doses, Dose: by mouth, short-term adjunctive manage- arrhythmias. The CSM has advised that thioridazinc increasing to a max. of 150 mg daily if necessary; ~¢ording to the response; CHILD Lip to 12 years, ment of psychomotor agitation, 100-200mg 4 should be restricted to second-line treatment of schizo- usual maintenance dose 20-50 mg daily; ELDERLY phrenia in adults under specialist supervision. Thiorid. up to 5mg daily in divided doses, times daily; CHILD not recommended (or debilitated) initially quarter to half adult dose; Agitation and restlessness in elderly, 25-50 mg 4 azine is contra-indleated in patients with: according to response, age, and body- ¯ significant cardiac disease, such as angina, brady- CHILD not recommended times daily eardia, second- or third-degree heart block, cardiac adjunctive management Of severe By.intramuscular injection, short-term adjunctive failure; Clopixol® (Lundbeck) ~,Laaxiety, 2--4 mg daily in divided doses or 2--4 mg management of psychomotor agitation, 50mg ¯ history of ventricular arrhythraia; " Tablets, all fi’c, pink, zuclopenthixol (as dihydro- ,iSd,ai’iy in modified-release form, increased if nec- (25 mg in elderly or debilitated), repeated if nec- ¯ QT-interval prolongation or a family history of th~ chloride) 2 mg, net price 20.= 62p; 10 rag, 20 = essary after 6-8 hours; CHILD not recommended condition; - = "~ e~ay to 6mg daily; CHILD 3-5 years up to I mg £1.73; 25 mg, 20 = £3.47. Label: 2 ¯ uncorrected hypokalaemia or hypomagnesaemia; _~d~’!y, 6-12 years up to 4 mg daily Depot injection (zuclopenthixol decanoate): sec- ¯ concomitant use with other drugs known to cause tion 4.2.2 Promazine (Non-proprietary) . QT-interval prolongation; : :; ~’~;ifluop’erazine (Non-proprietary) Tablets ~, coated, promazine hydrochloride ¯ reduced cytochmme P450 21)6 activity; ,(Tablets, coated, trifluoperazine (as hydrochloride) ¯ concomitant use with drugs that inhibit or are metab- 25 mg, net price 20 = 49p; 50 mg, 20 = 87p. : -iil mg, net price 20 = 57p; 5 mg, 20 = 87p. Label: 2 Atypical antipsychotics ¯ olised by cytochrome P450 2D6. Label: 2 rJWailable from most genetic manufacturers The ’atypical antipsychotics’ amisulpride, cloz- Side-effects: see notes above; less sedating than Available from Biorex =pral solution, trifluoperazine (as hydrochlo~’ide) apine, olanzapine, quetiapine, risperidone, and chlorpromazine, and extrapyramidat symptoms Oral solution ~, pr0mazine hydrochloride ~mg/5 mL. Net price 200-mL = £11.07. Label: 2 zotepine may be better tolerated than other antipsy- and hypothermia rarely occur; more likely to 25 mg/5 mL, net price 150 mL = £ 1.60; 50 mg/ ~..rAy~lable from Rosemont (sugar-free) chotics; extrapyramidal symptoms and prolactin induce hypotension and increased risk of cardio- 5mL, 150mL =£2.06. Label: 2 oStelazine® (Goldshield) elevation may be less frequent than with older anti- toxicity and prolongation of QT interval (see i A’,;ailable from Rosemont Tablets, both blue, f/c, tfifluoperazine (as hydro- psychotics. above); pigmentary retinopathy (with reduced Injection, promazine hydrochloride 50 mg/mL. chl0ride) I mg, net price 20 = 61p; 5 mg, 20 = The atypical antipsychotics may be used as first- visual acuity, brownish colouring of vision, and Net price 1-mL amp = 30p ~: Label: 2 line treatment for schizophrenia, but clozapine is impaired night vision) occurs rarely with high Note. May be difficult to obtain licensed for the treatment of schizophrenia only in doses; sexual dysfunction, particularly retrograde ; dark blue, light blue, and white pellets, patients unresponsive to, or intolerant of, conven- ejaculation, may occur tional antipsychotic drugs. It can cause agranulo- SULPIRIDE Dose: 50-300 mg daily (initially in divided doses); £4.36; 10 mg, 30-cap pack = £2.83; cytosis and its use is restricted to patients registered max’. 600mg daily (in hospital patients only); Indications: schizophrenia !.mg~ 30-cap pack = £4.27. Label: 2, 25 with the Clozaril Patient Monitoring Service (see CHILD not recommended Cautions: see notes above; also excited, agitated, trifluoperazine (as under Clozapine, below). or aggressive patients (even low doses may mg/5 mL. Net price 200-mL Sertindole has been suspended following reports aggravate symptoms) Thioridazlne (Non-proprietary) 2 of arrhythmias and sudden cardiac death; it remains Contra-indications: see notes above; also por- Tablets, coated, thioridazine hydrochloride 25 mg~ available on a named-patient basis (from Lund- phyria (section 9.8.2) net price 20 = 35p; 50 mg, 20 = £1.02; 100 rag, 20 ZUCLOPENTHIXOL ACETATE beck~erdolect~) for patients already stabilised on Side-effects: see notes above; also hepatitis = £1.57. Label: 2 the drug in whom other antipsychotics are inappro- Available from Alpharma, DDSA (Rideril~), Hillemss, Indications: short-term management of acute psy- Dose: 200-400 mg twice daily; max. 800mg daily priate. IVAX .’ chosis, mania, or exacerbations of chronic psy- in predominantly negative symptoms, and 2.4 g Oral solution, thioridazine (as hydrochloride) CAUTIONS AND CONTRA-INDICATIONS. daily in mainly positive symptoms; ELDEaLY, 25 mg/5 mL. Net price 500-mL = £2.67. Label: 2 Cautions: see notes above; avoid in porphyria While most atypical antipsychotics have not gener- lower initial dose, increased gradually according Available from Hillcross, Rosemont c;: ally been associated with prolongation of the QT to response; CHILD under 14 years not recom- (section 9.8.2) Plelleril® (Novartis) IPoHI COntra-indications: see notes above interval, caution should be exercised if they are pre- mended Tablets, all f/c, thioridazine hydrochloride 10 mg, Side-effects: see notes above scribed with other drugs known to increase the QT net price 84-tab pack = £ 1.01 ; 25 mg, 84-tab pack ~DOse: by deep intramuscular injection into the glu- interval. Atypical antipsychotics should be used Sulpiride (Non-proprietary) = £1.66; 50mg, 84-tab pack = £3.23; 100 rag, 84- ,,teal muscle or lateral thigh, 50-150mg (elderly with caution in patients with cardiovascular disease, Tablets. sulpiride 200 mg, net price 100-tab pack = tab pack = £6.24. Label:
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  • Summary of Product Characteristics 1. Name Of

    Summary of Product Characteristics 1. Name Of

    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atracurium Hikma 10mg/ml Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 10 mg of atracurium besilate. Each 2.5ml ampoule contains 25mg of Atracurium Besilate Each 5ml ampoule contains 50mg of Atracurium Besilate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection or Infusion Clear and colourless solution pH: 3.25 – 3.65 Osmolality: 10 – 30 mOsmol/Kg 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atracurium Hikma is a highly selective, competitive or non-depolarising neuromuscular blocking agent. It is used as an adjunct to general anaesthesia or sedation in the intensive care unit (ICU), to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. 4.2 Posology and method of administration Administration by injection in adults Route of administration: Intravenous injection or continuous infusion. Atracurium Hikma is administered by intravenous injection. The dosage range recommended for adults is 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for about 15 to 35 minutes. Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6 mg/kg. Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect. Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the tetanic response to 95% of normal neuromuscular function.