5.csm warnings- Essential FOR THE EXAM PDF

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ESSENTIAL FOR THE EXAMLow Na+The words low Na+ added after some preparations indicate a sodium content of lessthan 1 mmol per tablet or 10ml dose.Infliximab for Crohn’s diseaseInfliximab is recommended for Crohn’s disease (with or without fistulae) whentreatment with immunomodulating drugs and corti...

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ESSENTIAL FOR THE EXAM Low Na+ The words low Na+ added after some preparations indicate a sodium content of less than 1 mmol per tablet or 10ml dose. Infliximab for Crohn’s disease Infliximab is recommended for Crohn’s disease (with or without fistulae) when treatment with immunomodulating drugs and corticosteroids has failed or is not tolerated and when surgery is inappropriate. Treatment may be repeated if the condition responded to the initial course but relapsed subsequently. Inflixamab should be prescribed only by a gastroenterologist. Aminosalicylates (Sulfasalazine) Blood disorders Patients receiving aminosalicylates should report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during treatment. A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia. Laxative For children with chronic constipation, it may be necessary to exceed the licensed doses of some laxatives. Parents and careers of children should be advised to adjust the dose of laxative given in order to establish a regular pattern of bowel movements in which stools are soft, well-formed, and passed without discomfort. Clopidogrel Clopidogrel with aspirin appropriate for management of non-ST-segment elevation acute coronary syndrome in those at moderate to high risk of myocardial infarction or of death. Lipid-regulating drugs MUSCLE EFFECTS The CSM has advised that rhabdomyolsis associated with lipid-regulating drugs such as the fibrates and statins appears to be rare(apporx. 1 case every 100 000 treatment years) but may be increased in those with renal impairement and possibly in those with hypothyroidism. Concomitant treatment with drugs that increase plasma-statin concentration increase muscle-toxicity; concomitant treatment with a fibrate and a statin may also be associated with an increased risk of serious muscle toxicity. Formoterol and salmeterol To ensure safe use, the CHM has advised that for the management of chronic asthma, long-acting beta2 agonists (formoterol and salmeterol) should:   

Be added only if regular use of standard-dose inhaled steroids has failed to control asthma adequately; Not be initiated in patients with rapidly deteriorating asthma; Be introduced at a low dose and the effect properly monitored before considering dose increase;

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Be discontinued in the absence of benefit;

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Be reviewed as clinically appropriate;stepping down thereapy should be considered when good long-term asthma control has been achieved

Aminophylline, Fentanyl, Remifentanil To avoid excessive dosage in obese patients, dose should be calculated on the basis of ideal weight for height.

Antipychotics IM injection of antipychotics can differ from oral dose, im has increased absorbtion especially if the patient is very active. The dose for antipsychotic for emergency use should be reviewed at least daily. Injections for depot must be titrated according to the patients response. Lithium Patients on lithium require a lithium card Hyponatreamia and antidepressant therapy Hyponatreamia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormones) has been associated with all types of antidepressants; however, it has been reported more frequently with SSRIs than with other antidepressants. The CSM has advised that hyponatreamia should be considered in all patients who develop drowsiness, confusion, or convulsion while taking an antidepressant. SSRI’s for children Not recommended in children as it may provoke suicidal thoughts. Products unfavourable for under 18’s: citalopram, escitalopram, paroxetine, sertraline. Product that is favourable: FLUOXETINE. Drugs used in status epilepticus If seizures recur or fail to respond with 30 minutes: PHENYTOIN, PHENOBARBITAL, FOSPHENYTOIN should be used If these measures fail to control seizure with 60 minutes, anaesthesia with thiopental, midazolam, or in adults, a non-barbiturate anaesthetic such as propofol should be instituted with full intensive care. Fosphenytoin sodium Precriptions for fosphenytoin sodium should state the dose in terms of phenytoin sodium equivalent(PE); fosphenytoin sodium 1.5mg = phenytoin sodium 1mg Fibrotic reactions The CSM has advised that ergot-derived dopamine receptor agonists, bromocriptine, cabergoline, lisuride[discontinued], and pergolide, have been associated with pulmonary, retroperitoneal, and pericardial fibrotic reactions. Before starting treatment with these ergot derivatives it may be appropriate to measure the

erythrocyte sedimentation rate and serum creatine and to obtain a chest x-ray. Patients should be monitored for dyspnoea, persistent cough, chest pain, cardiac failure, and abdominal pain or tenderness. If long-term tests may also be helpful. Sudden onset of sleep Excessive daytime sleepiness and sudden onset of sleep can occur with co-careldopa, co-beneldopa, and dopamine receptor agonists. Driving warning, drowsiness warning. Nicotine and bupropion Only give 2 weeks supply after the stop date, or 3-4 weeks supply of bupropion. Patients are only allowed to claim NHS supplied smoking cessation thereapy within 6 months of an unsuccessful cessation attempt. Bupropion The CSM has issues a reminder that bupropion is contra-indicated in patients with a history of seizures or of eating disorders, CNS tumour, alcohol and benzodiazepine withdrawal. Increases the risk of seizures with ANTIDEPRESSANTS, ANTIMALARIALS(MEFLOQUINE AND CHLOROQUINE), ANTIPSYCHOTICS, QUINOLONES, SEDATING ANTIHISTAMINES, SYSTEMIC CORTICOSTEROIDS, THEOPHYLLINE, TRAMADOL. And conditions including diabetes, alcohol abuse, head trauma, and use of stimulated and anorectics. Methadone and buprenorphine For opiod dependence, should be administered under supervision for 3 months, until compliance is assured, Flucloxacillin Cholestatic jaundice and hepatitis may occur up to several weeks after treatment with flucloxacillin has been stoppened.Administration for more than 2 weeks and increasing age and risk factors. CSM has reminded that:  

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Flucloxacillin should not be used in patients with a history of hepatic dysfunction associated with flucloxacillin Flucloxacillin should be used with caution in patients with hepatic impairment; Careful enquiry should be made about hypersensitivity reactions to betalactam antibacterials

Linezolid Refer symptoms of visual impairment, and blood disorders Co-trimoxaole Drug of choice for:???? Pneumocystis jiroveci (Pneumocystis carinil) Toxoplasmosis and nocardiasis If no other alternative consider for: Acute exacerbations of chronic bronchitis Urinary tract infections Acute otitis media in children

Quinonlones (e.g ciprofloxacin) Tendon damage (including rupture) has been reported in patients receiving quinolones. Tendon rupture may occur within 48 hours of starting treatment.  

Quinolones are contra-indicated in patients with a history of tendon disorders related to quinolone use Elderly patients are more prone to tendonitis

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The risk of tendonitis rupture is increased by the concomitant use of corticosteroids

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If tendonitis is suspected, the quinolone should be discontinued immediately

Urineary tract infections Whenever possible specimen of urine should be collected for culture and sensitivity testing before starting antibacterial therapy. The antibacterial chosen should reflect current local bacterial sensitivity to antibacterials. Itraconazole Following rare reports of heart failure, the CSM has advised caution when prescribing itraconazole to patients at high risk of heart failure. Those at risk include:  

Patients receiving high doses and longer treatment courses Older patients and those with cardiac disease

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Patients receiving treatment with negative inotropic drugs, e.g calcium channel blockers

Inhaled insulin Not to be used for the routine treatment of type 1 or 3 diabetes. May be used:  

With evidence of poor glycaemic control despite other interventions and Who require insulin but are unable to use subcutaneous insulin because of either a diagnosed phobia of injections, or severe or persistent problems with injection sites.

Treatment should continue beyond 6 months only if there is evidence of improvement og HBA12. Insulin glargine Insulin glargine should be available as an option for patients with type 1 diabetes. Insuline glargine is not recommended for routine use in patients with type 2 diabetes who require insulin but it may be considered in type 2 diabetes for those:  

Who require assistance with injecting their insulin or Whose lifestyle is significantly restricted by recurrent symptomatic hypoglycaemia or

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Who would otherwise need twice-daily, basal insulin injections in combination with oral antidiabetic drugs

Thiazolidinediones Pioglitazone or rosiglitazone as second-line therapy added to either metformin or a sulphonylurea is not recommened except for:  

Patients who are unable to tolerate metformin and sulphonylurea in combination therapy, or Patients in whom either metformin or a sulphonylurea is contra-indicated.

In such case thiazolidinedione should replace whichever drug in the combination is poorly tolerated or contra-indicated. Carbimazole Doctors are reminded of the importance of recognising bone marrow suppression induced by carbimazzole and the need to stop treatment promptly. 1. Patient should be asked to report symptoms and signs suggestive of infection, especially sore throat. 2. A white blood cell count should be performed if there is any clinical evidence of infection 3. carbimazole should be stopped promptly if there is clinical or laboratory evidence of neutropenia Steroid SEs – risk of sever chickenpox/measles, immunosuppression, adrenal suppression, mood changes, gi affects. Osteoporosis Those at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D and any defieciency should be corrected by increasing dietary intake or taking supplements. Bisphosphonates (Alendranate, risadronate) Bisphosphonates are recommended as treatment options for the secondary prevention of osteoporotic fractures in susceptiblepostmenopausal women. In women who cannot take a bisphosphonate or who have suffered a fragility fracture despite treatment for a year and whose bone mineral density declines below the pre-treatment level, the selective oestrogen receptor modulator raloxifene is an alternative. The parathyroid hormone fragment teriparatide is recommended for women over 65 years who cannot take a bisphosphonate (or in whom bisphosphonates has failed to prevent a fracture) and have:  

either an extremely low bone mineral density or a very low bone mineral density, sufferent more than 2 fractures, and have other risk factors for fractures (e.g body mass index under 19kg/m2, premature menopause, prolonged immobility, history of mineral hip fracture under the age of 75 years)

Induction of labour Dinoprostone is preferable to oxytocin for induction in women with intact membranes, regardless or parity or cervical favourability. Parental progesterone-only contraceptive The CSM has advised that:  

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in adolescents, medroxyprogesterone acetate (Deop-provera) be under only when other methods of contraception are inappropriate. In all women, benfits of using medroxyprogesterone beyond 2 years should be evaluated again risks. In women with risk factors for osteoporosis a method of contraception other than medroxyprogesterone acetate should be considered.

Spermicial contraceptives Products such as petroleum jelly (Vaseline), baby oil and oil-based vaginal and rectal preparations are likely to damage condoms and contraceptive diaphragms made from latex rubber, and may render them less effective as a barrier method of contraception and as a protection from sexually transmitted diseases (including HIV). CRM guildelines on handling cytotoxic drugs: 1. Trained personnel should reconstitute cytotoxics; 2. Reconstitution should be carried out in designated area; 3. Protective clothing (including gloves) should be worn; 4. The eyes should be protected and means of first aid should be specified; 5. Pregnant staff should not handle cytotoxics 6. Adequate care should be taken in the disposal of waste material, including syringes, containers, and absorbent material. Most cytotoxic drugs are teratogenic and all may cause life-threatening toxicity; administration should, where possible be confined to those experienced in their use. Because of the complexity of dosage regimens in the treatment of malignant disease, dose statements have been omitted from some of the drug entries in this chapter. In all cases detailed specialist literature should be consulted. Presciptions should not be repeated except on the instructions of a specialist. Ciclosporin Because of differences in bioavailability, the brand of oral ciclosporin to be dispensed should be specified by the prescriber. Anastrozole The aromatase inhibitors anastrazole, exemestane, and letrozole, within their licensed indications, are recommended as options for the adjuvant treatment of early oestrogen-receptor-postitive invasive breast cancer in postmenopausal women.

Drugs with definite risk of haemolysis in most G6PD-deficient individuals (from Afriva, Asia, Oceania,? and from south Europe): Dapson and other sulphones, Methylthionium chloride, Nitrofurantion, Pamaquin, Primaquin, Quinolones, Sulphonamides. Possible risk: Aspirin, Chloroquine, Menadione, Probenecid, Quinidine, Quinine

Thiamine Although potentially serious allergic adverse reactions may rarely occur during, or shortly after, parenteral administration, the CHM has recommended that: 1. This should not preclude the use of parenteral thiamine in patients where this route of administration is required, particularly in patients at risk of WenickeKorsakoff syndrome where treatment with thiamine is essential; 2. Intravenous administration should be by infusion over 30 minutes; 3. Facilities for treating anaphylaxis (including resuscitation facilities) should be available when parental thiamine is administered. Pyridoxine Hydrochloride Pyridoxine is used to treat isoniazid neuropathy. However prolonged use of pyridoxine in dose of 10mg daily is considered safe but the long-term use of pyridoxine in a dose of 200mg or more daily has been associated with neuropathy. The safety of long-term pyroxidine supplements with doses above 10mg daily has not been established. NSAIDS and cardiovascular events COX-2 selective inhibitors are associated with an increased risk of thrombotic events (e.g MI and stroke) and should not be used in preference to non-selective NSAIDS except when specifically indicated (i.e for patients at a particularly high risk of developing gastroduodenal ulceration or bleeding) and after assessing their cardiovascular risk. Non-selective NSAIDs may also be associated with a small increased risk of thrombotic evens particularly when used at high doses and for long-term treatment. Diclofenac (150mg daily) and ibuprofen (2.4g daily) are associated with an increased risk of thrombotic events. The increased risk for diclofenac is similar to that of licensed doses of etoricoxib. Naproxen is associated with an increased risk of myocardial infarction. A small increased thrombotic risk cannot be excluded for other NSAIDs. The lowest effective dose of NSAID or COX-2 selective inhibitor should be prescribed for the shortest period to control symptoms and that the need for long-term treatment should be reviewed periodically. Piroxicam The CHMP has recommended restrictions on the use of piroxicam because of the increased risk of gastro-intestinal side effects and serious skin reactions. The CHMP has advised that

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Piroxicam should be initiated only by physicians experienced in treating inflammatory or degenerative rheumatic diseases Piroxicam should not be used as first-line treatment

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In adults, use of piroxicam should be limited only to the symptomatic relief of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis

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Piroxicam dose should not exceed 20mg daily

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Piroxicam should no longer be used for the treatment of acute painful and inflammatory conditions

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Treatment should be reviewed 2 weeks after initiating piroxicam and periodicallt therafter

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Concomitant administration of a gastro-protective agent should be considered

Topical preparations containing piroxicam are not affected by these restrictions Tiaprofenic acid May cause sever cystisis, stop treatment if symptoms occur. Methotrexate In view of reports of dycrasias (including fatalities) and liver cirrhosis with low-dose methotrexate, the CSM has advised: 

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Full blood count and renal and liver function tests before starting treatment and repeated weekly until theraphy stabilised, thereafter patients should be monitored every 2-3 months That patients should be advised to report all symptoms and signs suggestive of infection, especially sore throat.

Treatment with folinic acid(calcium folinate) may be required in acute toxicity. The patient must be warned to report immediately the onset of any feature of blood disorders (e.g sore throat, bruising, and mouth mulcers), liver toxicity (e.g nausea, vomiting, abdominal discomfort, and dark urine), and respiratory effects (e.g shortness of breath) Co-cyprindiol Venous thromboembolism occurs more frequently in women taking co-cyprindiol than those taking a low-dose combines oral contraceptive. The CSM has reminded prescribers that co-cyprindiol is licensed for use in women with severe acne which has not responded to oral antibacterials and for moderately severe hirsutism; it should not be used solely for contraception. It is contra-indicated in those with a personal or close family history of venous thromboembolism. Women with severe acne or hirsutism may have an inherently increased risk of cardiovascular disease. Contra-indicated in pregnancy and a predisposition to thrombosis. Sun-screen For optimum photoprotection, sunscreen preparations should be applied thickly and

frequently (approx 2 hourly). In photodermatoses, they should be used from spring to autumn. As maximum protection from sunlight is desirable, preparations with the highests SPF should be prescribed.

Enzyme inhibitors Enzyme inhibitors act mainly in the liver to inhibit the action of the cytochrome P450 enzyme. Inhibition of cytochrome P450 cause decreased metabolism of other drugs. In most cases this causes the drug to stay in the body for longer in its active form, and therefore have increased action. When enzyme inhibitors are taken at the same time as drugs with narrow therapeutic ranges (warfarin, theophylline, phenytoin) this significantly increases the risk of toxicity or adverse effects. The effects of enzyme inhibitors will be seen approximately 2-3 days. Important enzyme inhibitors are listed below: 1. Isoniazid 2. Cimetidine 3. Grapefruit juice 3. Dilsulfuram 4. Sulphonamides 5. Quinolones (Erythromycin and Ciprofloxacin) 6. Fluconazole 7. Sodium Valporate others include, omeprazole, verapamil, itraconazole, ketoconazole, fluoxetine, allopurinol, metronidazole, clarithromycin. 　 Enzyme inducers Enzyme inducers have the opposite effect from enzyme inhibitors, they induce enzyme activity in the liver, therefore more active drugs are being changed into their inactive form, this causes a decrease in the action of other medication being taken at the same time. As with enzyme inducers this is particularly important in drugs with low a therapeutic range, e.g Rifampicin may decrease the effectiveness of an anti-epileptic drug, therefore reducing its action and leading to an increase risk of convulsions in the patient. 1. Phenytoin

2. Carbamazepine 3. Rifampicin 4...