CSM Warnings - BNF NOTES PDF

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01 WARNINGS:Quinolones : ​TENDON DAMAGE● The CSM has warned that quinolones may ​induce convulsions in ○ patients with or without a history of convulsions; ○ patients taking ​NSAIDs ​at the same time may also induce them.Clomifene ​(Gonadotrophin replacement therapy):● The CSM has recommended that c...

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01.CSM WARNINGS: Quinolones : TENDON DAMAGE ● The CSM has warned that quinolones may i nduce convulsions in ○ patients with or without a history of convulsions; ○ patients taking NSAIDs at  the same time may also induce them.

Clomifene (Gonadotrophin replacement therapy): ● The CSM has recommended that clomifene (Gonadotrophin replacement therapy) should not normally be used for longer than 6  cycles (possibly increased risk of ovarian cancer).

Tiaprofenic acid: ● CSM has recommended that tiaprofenic acid should not be given to patients with urinary-tract disorders and should be stopped if urinary symptoms develop. ● UTI symptoms: ○ increased frequency, nocturia, urgency, pain on urinating, or blood in urine

MMR Vaccination and Bowel Disease or Autism ● No evidence of a link between MMR vaccination and bowel disease or autism. ● MMR vaccine is the safest and best way to protect children against measles, mumps, and rubella.

Eluxadoline ● Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking e  luxadoline.

Loperamide: ● Serious CVS events (such as QT prolongation,torsades de pointes, and cardiac arrest), including fatalities, have been reported in association with large overdoses of loperamide. ● Healthcare professionals are reminded that if symptoms of overdose occur, naloxone can be given as an antidote. ○ duration of action of loperamide is longer than that of naloxone so repeated treatment with naloxone might be indicated; ○ monitor closely for at least 48 hours to detect possible CNS depression.

PPIs: ● Very infrequent cases of subacute cutaneous lupus erythematosus  (SCLE) have been reported in patients taking PPIs. ○ advise to avoid exposing the skin to sunlight; ○ consider SCLE as a possible diagnosis; ○ consider discontinuing PPI treatment

Buscopan: ● The MHRA advises that hyoscine butylbromide injection can cause serious adverse effects including t achycardia,hypotension, and anaphylaxis; ● anaphylaxis is more likely to be fatal in patients with underlying coronary heart disease.

Obeticholic acid: ● Reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted.

Sotalol: ● Sotalol may prolong the Q  T interval, and it occasionally causes life threatening ventricular arrhythmias ● Particularly h  ypokalaemia and hypomagnesaemia should be corrected before sotalol started and during use/

DIRECT-ACTING ANTIVIRALS TO Tx CHRONIC HEPATITIS C: ● Risk of interaction with Vitamin K antagonist (warfarin) and changes in INR. ● Changes in liver function, secondary to hepatitis C treatment with direct acting antivirals, may affect the efficacy of vitamin K antagonists.

Warfarin: ● Reports of Calciphylaxis ○ commonly observed in patients with known risk factors such as end-stage renal disease. ● Report any painful skin rash;

Differences in strengths of Adrenaline: ● Association of Noradrenaline/Norepinephrine 0.08mg/ml (4mg in 50 ml) solution for infusion with potential risk of medical errors.

Adrenaline/epinephrine ● Intravenous route should be used with extreme care by specialists only. ● MHRA recommend that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times. ● Patients are advised to check the expiry date of the adrenaline auto-injectors and obtain replacements before they expire.

Braltus: ●

MHRA have received reports of r isk of inhalation of capsule from the mouthpiece into the back of the throat, resulting in coughing and risking aspiration or airway obstruction.

Formoterol and sameterol: Guidelines AsthMa Management BTS Beclometasone dipropionate ● Beclometasone dipropionate CFC-free pressurised metered-dose inhalers (Qvar ® and Clenil Modulite ®) are not interchangeable and should be prescribed by brand name;

Qvar: ● Qvar ® has extra-fine particles, is more  potent than traditional beclometasone dipropionate CFC containing inhalers, and is  approximately twice as potent as Clenil Modulite ®.

Fostair ● Fostair ® contains extra-fine particles of beclometasone dipropionate and is more potent than traditional beclometasone dipropionate CFC-free inhalers.

Over the counter cough and cold medicines preparation: ● Children under 6 years should not be given over-the counter cough and cold medicines containing chlorphenamine ,promethazine,pholcodine (cough suppressant). ● aged 6–12 years :treatment  should be restricted to 5 days or less. ● Should not be given more than 1 cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose. Chlorphenamine can be given for hayfever,allergies from 1 yrs but not for cough

Ephedrine, Xylometazoline HCl: ● non-prescription cough and cold medicines containing ephedrine can be considered for up to 5 days’ treatment in children aged 6–12 years after basic principles of best care have been tried; ● these medicines should not be used in children under 6 years of age

Hydroxyzine HCl: ● Risk of QT-interval prolongation and torsade de pointes ○ lowest effective dose for the shortest period of time should be prescribed.

Desensitising Vaccines: ● used by specialists and only for the following indications: ○ seasonal allergic hay fever (caused by pollen) that has not responded to anti-allergic drugs; ○ hypersensitivity to wasp and bee venoms. Desensitising vaccines should generally be avoided or used with particular care in patients with asthma.

Gabapentin: ● associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. ● Patients with c ompromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of central nervous system (CNS) depressants, and elderly people might be at higher risk of experiencing severe respiratory depression. ● Dose adjustments may be necessary in these patients.

Phenytoin: ● Risk of Death and severe harm from error with injectable phenytoin.

Sodium Valproate: ● Use of valproate in pregnancy is C/I for migraine prophylaxis [unlicensed] and bipolar disorder; ● must only be considered for epilepsy if there is no suitable alternative treatment (see Pregnancy). ● C/I in women and girls of child-bearing potential ● Valproate is highly teratogenic and evidence supports that use in pregnancy leads to neurodevelopmental disorders (approx. 30–40% risk) and congenital malformations (approx. 10% risk).

Thiopental sodium: ● should only be administered by, or under the direct supervision of, personnel experienced in its use, with adequate training in anaesthesia and airway management, and when resuscitation equipment is available.  enzos overdosed. ● It is advised that flumazenil is available when b

Clozapine: ● Associated with varying degrees of impairment of intestinal obstruction, peristalsis, faecal impaction and paralytic ileus.

Olanzapine(depot inj): ● When prescribing, dispensing or administering, check that this is the correct preparation ● this preparation(inj) is used for maintenance treatment and should not be used for the rapid control of an acute episode.

Co-beneldopa, Co-careldopa Apomorphine: ● Associated with i mpulse control disorders, including pathological gambling, binge eating, and hypersexuality.

Bromocriptine and Cabergoline and Pergolide: ● Associated with pulmonary,retroperitoneal, and pericardial fibrotic reactions. ● Exclude cardiac valvulopathy with echocardiography before starting Tx with these ergot derivatives for Parkinson’s disease or chronic endocrine disorders(excludes suppression of lactation); ● May also be appropriate to m  easure the ESR and serum creatinine and to obtain a chest X-ray. ● Patients should be monitored for d  yspnoea, persistent cough, chest pain, cardiac failure, and abdominal pain or tenderness. ● If long-term Tx is expected, then lung-function tests may also be helpful. Pramipexole, Rotigotine: IMPULSE

Domperidone: ● associated with a small increased risk of serious cardiac side-effects(QT prolongation) ● should only be used for the relief of the symptoms of N+V; ● Lowest dose used (max tx should not normally exceed 1 week);

Metoclopramide: ● Risk of neurological adverse effects such as EPSE(young adults) and tardive dyskinesia outweigh the benefits in long-term or high-dose. ● Restrict the dose and duration of use. ● Risk of neurological effects To help minimise the risk of potentially serious neurological adverse effects, the following restrictions to indications, dose, and duration of use have been made: In adults >18, metoclopramide should only be used for prevention of PONV ● radiotherapy-induced nausea and vomiting, ● delayed (but not acute) chemotherapy-induced nausea and vomiting, ● symptomatic treatment of nausea and vomiting, including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics); Metoclopramide ● should only be prescribed for short term use (up to 5 days); ● Usual dose is 10 mg, repeated up to 3 times daily; max. daily dose is 500 micrograms/kg; ● IV doses should be administered as a slow bolus over at least 3 minutes; ● Oral liquid formulations should be given via an appropriately designed, graduated oral syringe to ensure dose accuracy. This advice does not apply to unlicensed uses of metoclopramide (e.g. palliative care).

Antimuscarinics: ● Used for premedication to general anaesthesia only under the direct supervision of, personnel experienced in their use.

Methoxyflurane ● Only self-administered under the supervision of personnel experienced in its use, using a hand-held Penthrox inhaler device.

Codeine: ● A significant risk of serious and life threatening adverse reactions has been identified in children with obstructive sleep apnoea who received codeine after t onsillectomy or adenoidectomy:

Varenicline: ● Patients should be advised to discontinue treatment and seek prompt medical advice if they develop agitation, depressed mood, or suicidal thoughts. ● Patients with a history of psychiatric illness should be monitored closely while taking varenicline.

Methadone oral solution 1 mg/mL is 2.5 times the strength of Methadone Linctus (2 mg/5mL). Gentamicin: ● Reports of Histamine-related adverse drug reactions with some batches ● Monitor patients for signs of histamine-related adverse reactions; ● Particular caution is required in patients taking concomitant drugs known to cause h  istamine release,(allergies) in children, and in patients with severe renal impairment.

Streptomycin: ● S/E increase after a cumulative dose of 100 g,which should only be exceeded in exceptional circumstances.

Benzyl Methyl Penicillin: Intrathecal injection of benzylpenicillin is not  recommended.

Co-fluampicil AND Flucloxacillin : HEPATIC DISORDERS  to two ● Cholestatic jaundice and hepatitis may occur very rarely, up months after treatment with flucloxacillin has been stopped. ● Administration for more than 2 weeks and increasing age are risk factors.

Co-trimoxazole: ● Drug of choice in the prophylaxis and treatment of Pneumocystis jirovecii (Pneumocystis carinii) pneumonia; ● Also indicated for nocardiasis, Stenotrophomonas maltophilia infection [unlicensed indication], and toxoplasmosis. ● should only be considered for use in acute exacerbations of chronic bronchitis and infections of the urinary tract when sensitivity to cotrimoxazole. ● should only be used in acute otitis media in children when there is good reason to prefer it. ● Also used for the treatment of infections caused by Burkholderia cepacia in cystic fibrosis [unlicensed indication].

Ketoconazole: ● Risk of hepatotoxicity associated with oral ketoconazole is greater than the benefit in treating fungal infections. ● Patients with a prescription of oral ketoconazole for fungal infections should be referred back to their doctors.

Itraconazole: C/I : HEART FAILURE Those at risk include: ● Patients receiving high doses and longer treatment courses; ● Older adults and those with cardiac disease; ● Patients with chronic lung disease (including chronic obstructive pulmonary disease) associated with pulmonary hypertension; ● Patients receiving treatment with negative inotropic drugs, e.g. CCB

Linezolid: ● Severe optic neuropathy may occur rarely, particularly if linezolid is used for longer than 28 days. ● Patients should be warned to report symptoms of visual impairment (including blurred vision, visual field defect, changes in visual acuity and colour vision) immediately; BLOOD DISORDERS ● Haematopoietic disorders (including thrombocytopenia, anaemia, leucopenia, and pancytopenia) have been reported in patients receiving  linezolid. ● Recommended that full blood counts are monitored weekly. Close monitoring is recommended in patients who: ● receive treatment for more than 10–14 days; ● have pre-existing myelosuppression; ● are receiving drugs that may have adverse effects on haemoglobin, blood counts, or platelet function; ● have severe renal impairment.

Chloroquine: ● Ocular toxicity if > 4 mg/kg daily

Quinine Sulphate: ● Dose-Dependent QTprolongation effects

Methylprednisolone: ● Methylprednisolone injectable meds containing lactose .; do not use in patients with cow’s milk allergy.

Canagliflozin: ● Risk of Lower limb amputation (mainly toes) ○ Significant lower limb complication (e.g. skin ulcer, osteomyelitis, or gangrene) ● Risk of DKA with Canagliflozin, Dapagliflozin or empagliflozin ○ Signs and symptoms of DKA:( rapid weight loss, nausea or vomiting, abdominal pain, fast and deep breathing, sleepiness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat).

Pioglitazone: ● C/I: HF ● Risk of bladder Cancer

NHS IMPROVEMENT PATIENT SAFETY ALERT: Risk of Severe harm and death due to withdrawing insulin from pen devices.

Bisphosphonates: ● Risk of Atypical Femoral fractures ○ The need to continue treatment for osteoporosis should be re-evaluated periodically based on an assessment of the benefits and risks of treatment for individual patients, particularly after 5 or more years of use. ● Risk of Osteonecrosis of external auditory canal. ○ Benign idiopathic osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonate treatment, mainly in patients receiving long-term therapy (2 years or longer).

Bisphosphonates and I.V Bisphosphonates ● Risk of Osteonecrosis of the jaw

Denosumab: ● Risk of Atypical femoral fractures in patients receiving denosumab for the long-term Tx (2.5 or more years) of postmenopausal osteoporosis. ● Risk of osteonecrosis of the jaw (ONJ) and hypocalcaemia

Carbimazole: ● Risk of neutropenia and Agranulocytosis

Finasteride: Cases of sucidal and depression. Stop the med asap.

Intrauterine Contraceptives, Levonorgestrel: Risk of perforation ● Risk of uterine perforation(hole) is increased when the device is  r in patients who are inserted up to 36 weeks postpartum o breastfeeding. ● Signs and symptoms include: ○ severe pelvic pain after insertion (worse than period cramps); ○ pain or increased bleeding after insertion which continues for more than a few weeks; ○ sudden changes in periods; ○ pain during intercourse; ○ unable to feel the threads.

Oxytocin: ● Risk of Prolonged IV. can cause---- HYPONATRAEMIA ● To avoid: Use electrolyte-containing diluent (i.e. not glucose), increase oxytocin concentration to reduce fluid, restrict fluid intake by mouth; monitor fluid and electrolytes.

Ciclosporin: ● Must be prescribed and dispensed by brand

Oral tacrolimus: ● Prescribe by brand name ● Risk of toxicity and graft rejection when not on same brand

Anti-lymphocytemonoclonal antibodies Alemtuzumab ● under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.

Bevacizumab and Sunitinib: ● Risk of osteonecrosis of the jaw

(EGFR) INHIBITORS: Pantimumab ● SERIOUS CASES OF KERATITIS AND ULCERATIVE KERATITIS (MAY 2012) ● Tx should be interrupted or discontinued if diagnosed. ● Must receive an antihistamine and a corticosteroid for at least one hour before infusion. ● Resuscitation facilities should be available and treatment should be initiated by a specialist.

Panitumumab: Nivolumab:

Also SEVERE SKIN REACTIONS

● Risk of organ transplant rejection. ● May increase the risk of rejection in organ transplant recipients. ● MHRA recommends considering the benefit of treatment with nivolumab versus the risk of possible organ transplant rejection for each patient.

Pembrolizumab ● Reports of organ transplant rejection

Pomalidomide, Dabrafenib, Bendamustine,Ibrutinib : ● Risk of Hep B reactivation.

Bendamustine ● Increased mortality seen in off-label use ● Monitor for any infections. Hep B Reactivation

Cladribine treated for luekaemia: ● Reports of multifocal encelpathy. ● Stop Tx if suspected

MTX: ● Note that the dose is a weekly dose. ● To avoid error with low-dose methotrexate, it is recommended that: ○ Administer folic acid ○ Only one strength of methotrexate tablet prescribed ○ Rx and the dispensing label clearly show the dose and frequency of methotrexate administration; ○ Patient is warned to report immediately the onset of any feature of blood disorders (e.g. sore throat, bruising, and mouth ulcers), liver toxicity (e.g. nausea, vomiting, abdominal discomfort, and dark urine), and respiratory effects (e.g. shortness of breath).

Vinblastine,Vinorelbine ● Tx is for IV only. ● Inadvertent intrathecal administration can cause severe neurotoxicity, which is usually fatal. ● Teenagers and children treated in a child unit may receive their vinca alkaloid dose in a syringe.

Pomalidomide: ● Risk of Hep B reactivation.

Bortezomib inj: ● For IV/subcutaneous administration only. ● Inadvertent intrathecal administration with fatal outcome has been reported.

Dabrafenib: ● Risk of Hep B Reactivation with BCR-ABL tyrosine kinase Inhibitors

Crizotinib: ● Risk of Cardiac Failure

Ibrutinib: ● Reports of Ventricular Tachyarrhythmia ● Risk of Hep B activation and infections

Ponatinib: Risk of vascular occlusive events Sunitinib: Risk of osteonecrosis of jaw Trametinib: Risk of G.I perforation and colitis Vemurafenib: (DRESS Syndrome)

EPOEITINS: ERYTHROPOIETINS— ● TUMOUR PROGRESSION AND SURVIVAL IN PATIENTS WITH CANCER RECOMBINANT HUMAN ERYTHROPOIETINS: ● VERY RARE RISK OF SEVERE CUTANEOUS ADVERSE REACTIONS

IRON RELATED: ● SERIOUS HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS IRON

Calcium gluconate: ● Repeated or prolonged administration is C/I in children under 18 years and in renal impairment owing to the risk o  f aluminium accumulation; ● in these patients the use of calcium gluconate injection packaged in plastic containers is recommended.

Potassium: ● Ready-mixed infusion solutions containing potassium should be used.

Pyridoxine: ● dose of 200 mg or more daily has been associated with neuropathy. ● The safety of long-term pyridoxine supplementation with doses above 10mg daily has not been established.

Thiamine IV: Serious allergic adverse reactions may rarely occur during, or shortly after, parenteral administration, the CHM has recommended that: ● This should not prevent the use of where this route of administration is required, ...