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Adverse Effects and Precautions Interactions Pharmacokinetics 678 Antimigraine Dru s Migraine. For comparison of the relative benefits of differ­ Migraine and clusterheadache. Pizotifen has been widely ent triptans in migraine, see under Sumatriptan, p. 680.1. �.���.��!��.�S........................................................................... .. used for the prophylaxis of migraine (p. 670.3) but evi­ (details are given in Volume B) Further references. ProprietaryPreparations dence for its efficacy is limited. It has also been tried in the 1. Ashcroft DM, Millson D. Naratriptan for the treatment of acute Single-ingrecfJent Preparations. Belg.: Nocertonet; Fr.: Nocer­ management of cluster headache (p. 670.1) to prevent migraine: meta-analysis of randomised controlled trials. Pharmacoepide­ tOne; Gr.: Nocertone. headache attacks during a cluster period. miol Drug Safety 2004; 11: 73-82. 2. Tfelt-Hansen PC. Published and not fully published double-blind, References. randomised, controlled trials with oral naratriptan in the treatment of I. Cleland PG, et al. Studies to assess if pizotifen prophylaxis improves migraine: a review based on the GSK Trial Register. J Headache Pain tBAN, riNN! migraine beyond the benefit offered by acute sumatriptan therapy 2011; 12: 399-403. Pizotifen alone. Bur Neuro/ 1997; 38: 31-8. 2. Barnes N, Millman G. Do pizotifen or propranolol reduce the frequency Adverse Effectsand Precautions of migraine headache? Arch DisChild 2004; 89: 684-5. As for Sumatriptan, p. 680.2 and p. 681.2. Adverse Effectsand Precautions Naratriptan should not be used in patients with severe As 'for the sedating antihistamines in general, see p. 613.1 hepatic (Child-Pugh class C) or renal (creatinine clearance and p. 613.3. less than 15 mL/minute) impairment. Naratriptan should be Increased appetite and weight gain may occur with used with caution in mild or moderate renal or hepatic pizotifen. Drowsiness may be troublesome. impairment. Patients with hypersensitivity to sulfonarnides may theoretically show a similar reaction to naratriptan. Incidence of adverse effects. Adverse effects were noted (For discussion of cross-reactivity in sulfonamides and sulfa in 22 of 47 patients with severe migraine given pizotifen drugs see Hypersensitivity under Sulfamethoxazole, l to 2 mg daily.1 These reactions included weight increase p. 365.3.) (15 patients), muscle pain or cramps (3 patients), heavy or restless legs (3 patients), fluid retention (3 patients), drow­ Medication-overuse headache. For a report of an associa­ siness (2 patients), more frequent milder headaches (2 tion between naratriptan and medication-overuse head­ patients), facial flushing (1 patient), reduced libido ache, see under Adverse Effects of Sumatriptan, p. 681.2. patient), exacerbation of epilepsy (l patient), and dream­(l ing (2 patients). Adverse effects necessitating withdrawal The Drug Database for Acute Porphyria, com­ Porphyria. occurred in 11 patients. piled by the Norwegian Porphyria Centre (NAPOS) and 1. Peet KMS. Use of pizotifen in severe migraine: a long·term study. Curr the Porphyria Centre Sweden, classifies naratriptan as pos­ Med Res bpin 1977; 5: 192-9. sibly porphyrinogenic; it should be used only when no safer alternative is available and precautions should be Pharmacopoeias. In Br. Porphyria. The Drug Database for Acute Porphyria, com­ considered in vulnerable patients.1 BP 2014: (Pizotifen Malate). A white or slightly yellowish­ piled by the Norwegian Porphyria Centre (NAPOS) and 1. The Drug Database for Acute Porphyria. Available at: http://www. white, odourless or almost odourless, crystalline powder. the Porphyria Centre Sweden, classifies pizotifen as possi­ drugs-porphyria.org (accessed 11/04/11) Very slightly soluble in water; slightly soluble in alcohol and bly porphyrinogenic; it should be used only when no safer in chloroform; sparingly soluble in methyl alcohol. Protect alternative is available and precautions should be consid­ Interactions from light. ered in vulnerable patients. 1 As for Sumatriptan, p. 681.3. 1. The Drug Database for Acute Porphyria. Available at: http:l/www. Uses and Administration drugs·porphyria.org (accessed 11/04/11) Pharmacokinetics Pizotifen is a sedating antihistamine (p. 610.1) that has strong serotonin antagonist and weak antimuscarinic Interactions After oral doses, peak plasma-naratriptan concentrations properties. It also antagonises the action of tryptamine. As for the sedating antihistamines in general, see p. 614.3. occur at 2 to 3 hours, and bioavailability is reported to be Pizotifen is used, usually as the malate, for the prophylaxis 63% in men and 74% in women. Plasma protein binding is of migraine and for the prevention of headache attacks Antihypertensives. After a report1 of loss of blood pressure about 29%. Naratriptan undergoes some hepatic metab­ during cluster periods. It is not effective in treating an acute control when treatment with pizotifen was started in a olism via a wide range of cytochrome P450 isoenzymes. It is attack. Doses of pizotifen malate are expressed in terms of patient receiving debrisoquine the manufacturer suggested mainly excreted in the urine with 50% of a dose being the base; pizotifen malate 1.45 mg is equivalent to about that since pizotifen had a similar chemical structure to the recovered as unchanged drug and 30% as inactive l mg of pizotifen. Pizotifen hydrochloride has also been used tricyclic antidepressants it might antagonise the actions of metabolites. The elimination half-life is 6 hours, and is in the management of migraine. adrenergic neurone blockers in a similar manner. significantly prolonged in patients with renal or hepatic The usual oral dose is the equivalent of 1.5 mg of I. Bailey RR. Antagonism of debrisoquine sulphate by pizotifen impairment. pizotifen daily either in three divided doses or as a single (Sandomigran). N Z Med J 1976; 1: 449. Distribution into milk has been found in studies in rats. dose at night. Gradual increase from an initial dose of 500 micrograms may help to avoid undue drowsiness. Doses Pharmacokinetics ����.��.!��.n.s.................................................... ......................... may vary from 500 micrograms up to a maximum of 4.5 mg Pizotifen is well absorbed from the gastrointestinal tract and ProprietaryPreparations (details are given in Volume B) daily; not more than 3 mg should be given as a single dose. For details of doses in children, see below. peak plasma concentrations occur about 5 hours after a Single-ingredient Preparations. Arg.: Naramig; Austral.: Nata­ single oral dose. Over 90% is bound to plasma proteins. mig; Austria: Antimigrint; Naramig; Belg.: Naramig; Braz.: Administration in children. For the prophylaxis of Pizotifen undergoes extensive metabolism. Over half of a Naramig; Naratrin; Amerge; Bagomigral; Migtal; Canad.: Chile: migraine and for the prevention of headache attacks dur­ dose is excreted in the urine, mainly as metabolites; a Miragran; Naramig; Cz.: Naramig; Denm.: Naragran; Naramig; ing cluster periods, children aged over 2 years may be significant proportion is excreted in the faeces. The primary Fin.: Naramig; Fr.: Naramig; Ger.: Formigran; Naramig; Gr.: given up to 1.5 mg daily of pizotifen orally, although the metabolite of pizotifen (N-glucuronide conjugate) has a Naramig; India: Naratrex; Irl. : Naramergt; Naramig; Naraverg; long elimination half-life of about 23 hours. Israel: Naramig; Mex.: Naramigt; Neth.: Migatane; Naramig; maximum single dose (at night) should not exceed l mg. Gradual increase from an initial dose of 500 micrograms Distribution into milk has been found in animal studies. Norw.: Naramig; NZ: Naramig; Port.: Naramig; Rus.: Naramig may help to avoid undue drowsiness. (Hapi!MHI'); S.Afr.: Naramig; Singapore: Naramig; Spain: Nara­ r mig; Swed.: Naramig; Switz.: Naramig; Turk. : Naramig; UK: ����. �.!���S................................................................. .......... .. Naramig; USA: Amerge. Abdominal migraine. Abdominal migraine is a recurrent ProprietaryPreparations (details are given in Volume B) disorder seen mainly in children and characterised by epi­ PharmacopoeialPreparations sodic midline abdominal pain lasting for up to 72 hours. Single-ingredient Preparations. Arg. : Sandomigran; Austral.: USP 36: Naratriptan Hydrochloride Oral Suspension; Naratriptan The pain is severe enough to disrupt normal activities and Sandomigran; Belg.: Sandomigran; Braz.: Sandomigran; Tablets. may be associated with pallor, anorexia, nausea, and Canad.: Sandomigran; Cz.: Sandomigran; Denm.: Sandomigrin; vomiting.1•2 Sleep, and sometimes vomiting, terminate the Fr.: Sanmigran; Gr.: Mosegor; Hong Kong: Sandomigran; Indon.: Lysagor; Ir1.: Sanomigran; Ital.: Sandomigran; Malay­ attack. Oxetorone Fumarate (USAN, riNNM) sia: Sandomigran; Neth.: Sandomigran; NZ: Sandomigran; Phi­ In one small study pizotifen was found to be effective for lipp.: Litec; Mor- Vita; Mosegor; Pol.: Polomigran; S.Afr.: San­ the prophylaxis of abdominal pain in children with domigran; Spain: Mosegor; Sandomigran; Swed.: Sandomigrin; abdominal migraine;3 however, a systematic review Switz.: Mosegort; Thai.: Anorsia; Bozo; Manzofen; Migrin; concluded that there was only weak evidence in favour of Mosegor; Moselar; Mozifen-EF; Pizomed; Zofen; Turk.: Sando­ such use in recurrent abdominal pain and suggested that migran; UK: Sanomigran. pizotifen should only be used in the context of clinical trials or in children with severe problems refractory to Multi-ingredient Preparations.Philip p.: Appetens; Mosegor Vita. conventional
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