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Alternatives to Using an Unlicensed "Special" Version 5 Review Due (6 Months): March 2021

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Alternatives to using an Unlicensed "Special" Version 5 Review due (6 months): March 2021 If you have any comments on the content of this database please email [email protected] Before considering other formulations/preparations, first ensure that the drug is still needed and the patient is compliant. For general advice see UKMi Q&A:What are the therapeutic options for patients unable to take solid oral dosage forms? First Choice: Use a licensed medicine in a LAST RESORT: Use an unlicensed special Second Choice: Use a licensed medicine in an Drug suitable formulation (incl change to different (this is an expensive option, avoid where unlicensed manner 1 drug in same therapeutic class) possible) The standard tablets disperse with a fine sediment. They disperse in one to five minutes.Rinse equipment well to ensure the whole dose is given.2 250mg/5ml oral suspension included in Part VIIIB The MR capsules are generally not considered Acetazolamide No licensed liquid of Drug Tariff suitable for use, although some centres have Minimum quantity 100ml 3 opened them and flushed the contents down enteral feeding tubes2 - this should only be done on specialist advice. GREY if being used as mucolytic (use carbocisteine) RED for renal protection - refer back to specialist Effervescent tablets are preferred choice for enteral LICENSED 600mg effervescent tablets available Acetylcysteine feeding tubes. Stop the feed prior to administration Unlikely to need: licensed alternative available (prescribe as NACSYS) and restart afterwards.2 Note that 600mg capsules are also available and in drug tariff, but are not licensed. LICENSED 200mg oral powder sachets available, but very expensive. Consider if still needed. Do not crush tablets - risk of oesophageal damage. Alendronic acid LICENSED effervescent tablets and liquid No info on using effervescent tablets or liquid for Unlikely to need: licensed alternative available available. enteral feeding tubes.2 The tablets can be crushed and mixed with 100mg/5ml oral suspension water.The 100mg tablets will disperse within one included in Part VIIIB of Drug Tariff minute without crushing. The 300mg tablets take Minimum quantity 150ml 3 Allopurinol No licensed liquid longer to disperse and so should be crushed before OR dispersing in water. They should be crushed well as 300mg/5ml oral suspension included in Part VIIIB the drug is not very soluble. Give immediately.2 of Drug Tariff For enteral feeding tubes, administer after feed.2 Minimum quantity 100ml 3 LICENSED 5mg/5ml oral solution sugar free Amiloride HCI Unlikely to need: licensed alternative available available Tablets can be crushed and mixed with water. 50mg/5ml and 100mg/5ml oral suspension Without crushing they disperse in around 5 included in Part VIIIB of Drug Tariff. Amiodarone No licensed liquid minutes. Bitter taste; if taking orally mix with fruit Minimum quantity 100ml 3 juice. Give immediately.2 LICENSED oral solution available (100mg/ml - 2 Amisulpride Unlikely to need: licensed alternative available months expiry once opened) LICENSED oral solution available Use the oral solution. Absorption may be decreased (25mg/5ml and 50mg/5ml - some manufacturers by high-fibre feeds. If administered directly into the Amitriptyline only give 1 month expiry once opened) Unlikely to need: licensed alternative available jejunum (i.e. through an NJ, PEJ, or PEGJ tube), 10mg/5ml also available, but very expensive (DT monitor for increased systemic effects. 2 Aug 20) If necessary, most tablet brands disperse in water LICENSED oral solution (and suspension for easily in 1 to 5 minutes.2 5mg/5ml) available, but very expensive. Amlodipine Administration via NG/PEG tube – Flush the Unlikely to need: licensed alternative available (5mg/5ml and 10mg/5ml, sugar free - 1 month 2 expiry once opened, store in fridge) feeding tube after the dose with 20mL of water. Give immediately as the drug is light sensitive. First Choice: Use a licensed medicine in a LAST RESORT: Use an unlicensed special Second Choice: Use a licensed medicine in an Drug suitable formulation (incl change to different (this is an expensive option, avoid where unlicensed manner 1 drug in same therapeutic class) possible) No licensed liquid available The SPC for Eliquis tablets states that the tablets may be crushed and suspended in water, 5% dextrose in water, or apple juice or mixed with Licensed for administration through nasogastric apple puree and immediately administered orally. tubes – administration through other types of Alternatively, Eliquis tablets may be crushed and Apixaban enteral feeding tube would be outside the product Unlikely to need: licensed alternative available suspended in 60 mL of water and immediately license. Take care to ensure the whole dose is delivered through a nasogastric tube. administered, and flush well after each dose.2 Crushed Eliquis tablets are stable in water, 5% dextrose in water, apple juice, and apple puree for up to 4 hours. LICENSED orodispersible tablets available, but expensive. Aripiprazole Unlikely to need: licensed alternative available Licensed liquid also available but is even more expensive. Atorvastatin LICENSED chewable tablets available Unlikely to need: licensed alternative available 50mg/5ml oral suspension included in Part VIIIB of Drug Tariff Minimum quantity 100ml 3 No licensed liquid Cytotoxic drug DO NOT CRUSH. Note that 20mg/5ml, 25mg/5ml & 100mg/5ml also Azathioprine Note that preferred strength of unlicensed oral Tablets have a film coating that prevents in tariff, but are more expensive than the 50mg/5ml suspension locally is 50mg/5mL exposure to the cytotoxic medicine inside.2 strength. NB: Cytotoxic - Carers handling the suspension should wear gloves in case of contact with the medication 2.5mg/5ml oral suspension Disperse in water (disperses readily in 1-5mins). Bendroflumethazide No licensed liquid included in Part VIIIB of Drug Tariff Give immediately 2 Minimum quantity 150ml 3 8mg/5ml oral suspension Crush tablets and mix with water (the drug is very included in Part VIIIB of Drug Tariff Betahistine No licensed liquid soluble). Give immediately2 Minimum quantity 200ml 3 (costs >£100 for 200ml) The tablet is enteric coated and is designed to LICENSED suppositories available (5mg and Bisacodyl release the drug in the colon. Do not crush as it has Unlikely to need: licensed alternative available 10mg) or consider senna liquid an irritant effect on the stomach2 2.5mg/5ml oral solution Crush tablets finely and mix with water. The lower included in Part VIIIB of Drug Tariff No licensed liquid strength tablets will disperse in 1 to 5 mins without Minimum quantity 150ml 3 Consider switching to alternative betablocker as Bisoprolol crushing. The higher strength tablets should be appropriate for indication e.g.: atenolol (available crushed before mixing with water. Give Note that other strengths also in tariff, but as LICENSED liquid) immediately. Flush well after each dose.2 2.5mg/5ml oral solution is by far the most cost effective option. LICENSED oral solution (1mg/5ml) but extremely If necessary, the tablets can be crushed and mixed Bumetanide Unlikely to need: licensed alternative available expensive (approx. £200 for 150ml - Aug20 DT). with water, Give immediately.2 Licensed sublingual tablets (if the patient has a The sublingual tablets are not suitable to be Buprenorphine sufficiently moist mouth) and transdermal patches administered via enteral feeding tube as the drug Unlikely to need: licensed alternative available available undergoes extensive first pass metabolism. 2 The tablets can be crushed and dispersed in Candesartan No licensed oral liquid available water.2 No liquid in Drug Tariff No information on use with feeding tubes. If necessary, the tablets will disperse in water in 1 LICENSED oral solution available, but expensive to 5 minutes.2 (~£100 per 100ml) Concomitant food or milk can decrease captopril Captopril Recommended strength is 25mg/5mL - AMBER 2 absorption. If clinical effect is insufficient, consider Unlikely to need: licensed alternative available (5mg/5mL for inpatient initiation - RED) withholding enteral feed for half an hour before and Expires 21 days after opening, 100ml pack size half an hour after each dose. Flush well after each dose.2 10mg/5ml oral suspension included in Part VIIIB of Drug Tariff Carbimazole No licensed oral liquid available Crush tablets and mix with water. Give immediately2 Minimum quantity 150ml 3 (costs >£100 for 150ml) LICENSED sachets (750mg/10ml) and oral solution Carbocisteine Unlikely to need: licensed alternative available (250mg/5ml) available. The tablets can be dispersed in water. They disperse in one to five minutes. Use immediately.2&3 If administered directly into the jejunum (i.e. through an NJ, PEJ, or PEGJ tube), monitor for increased systemic effects. Carvedilol has a high 5mg/5ml oral suspension level of first pass metabolism, and such drugs, Carvedilol No licensed oral liquid available included in Part VIIIB of Drug Tariff when administered into the jejunum, can have Minimum quantity 100ml 3 increased absorption leading to greater clinical effects and adverse effects. Giving carvedilol with food may help to decrease the risk of orthostatic hypotension by reducing the rate at which the medication is absorbed.2 First Choice: Use a licensed medicine in a LAST RESORT: Use an unlicensed special Second Choice: Use a licensed medicine in an Drug suitable formulation (incl change to different (this is an expensive option, avoid where unlicensed manner 1 drug in same therapeutic class) possible) Licensed oral solution available, but not 500mg/5ml oral solution recommended locally due to bitter taste and included in Part VIIIB of Drug Tariff For enteral feeds: Local recommendation is to use necessity for large volumes. Local recommended 3 the unlicensed oral solution (recommended Minimum quantity 100ml preparation is 500mg/5mL oral solution Chloral hydrate strength is 500mg/5mL). It is light sensitive, so give (unlicensed) Note that 1mg/5ml oral solution also in tariff, but immediately. 2 (Licensed 143.3mg/5ml oral solution BP, 150ml = 500mg/5ml oral solution is most cost effective £244 DT Feb2020) option.
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  • Role of Betahistine in the Management of Vertigo

    Role of Betahistine in the Management of Vertigo

    Published online: 2019-01-04 THIEME Review Article 51 Role of Betahistine in the Management of Vertigo Anirban Biswas1 Nilotpal Dutta1 1Vertigo and Deafness Clinic, Kolkata, West Bengal, India Address for correspondence Anirban Biswas, MBBS, DLO, Vertigo and Deafness Clinic, BJ 252, Salt Lake, Kolkata 700091, West Bengal, India (e-mail: [email protected]). Ann Otol Neurotol ISO 2018;1:51–57 Abstract Though betahistine is the most commonly prescribed drug for vertigo, there are a lot of controversies on its efficacy as well as its proclaimed mechanism of action. There are authentic studies that have shown it to be no different from a placebo in Ménière’s disease. It is often promoted as a vestibular stimulant, but scientific evidence suggests that it is a vestibular suppressant. It is also not very clear whether it is an H3-receptor antagonist as most promotional literature shows it to be, or whether it is an inverse agonist of the H3 receptors. Owing to insufficient data on its efficacy in Ménière’s dis- ease, betahistine is not approved by the U.S. Food and Drug Administration (FDA). The much-advertised role of betahistine in augmenting histaminergic transmission and thereby inducing arousal, though beneficial is some ways in the restoration of balance after peripheral vestibulopathy, is yet not without systemic problems, and the pros and cons of histaminergic stimulation in the brain need to be assessed more by clinical studies in humans before imbibing it in clinical practice. The effect of increasing blood flow to the cochlea and the vestibular labyrinth and “rebalancing the vestibular nuclei” (as claimed in some literature) and whether they are actually beneficial to the patient with vertigo in the therapeutic doses are very controversial issues.