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CSM Warnings
CSM Warnings
The words low Na+ added after some preparations indicate a sodium
content of less than 1 mmol per tablet or 10ml dose.
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.
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;
Be discontinued in the absence of benefit;
Be reviewed as clinically appropriate;stepping down thereapy should be
considered when good long-term asthma control has been achieved
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
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.
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:
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
Inhaled insulin
Not to be used for the routine treatment of type 1 or 3 diabetes. May be
used:
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:
Thiazolidinediones
Pioglitazone or rosiglitazone as second-line therapy added to either
metformin or a sulphonylurea is not recommened except for:
Osteoporosis
Those at risk of osteoporosis should maintain an adequate intake
ofcalcium and vitamin D and any defieciency should be corrected by
increasing dietary intake or taking supplements.
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:
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).
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.
Thiamine
Although potentially serious allergic adverse reactions may rarely occur
during, or shortly after, parenteral administration, the CHM has
recommended that:
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
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:
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.
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 highest SPF should be
prescribed.