→Appendix 1: asenapine
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▶Common or very common Anxiety. appetite increased.
fatigue. muscle rigidity. nausea. oral disorders. taste
altered
▶Uncommon Bundle branch block. dysarthria. dysphagia.
hyperglycaemia. sexual dysfunction. syncope
▶Rare or very rare Accommodation disorder.
rhabdomyolysis
▶Rare or very rare Nephropathy
▶Frequency not known Abdominal discomfort. alopecia.
angioedema. appetite decreased. arrhythmias.
atrioventricular block. cardiomyopathy. cerebellar
syndrome. circulatory collapse. coma. delirium.
diarrhoea. dizziness. dry mouth. electrolyte imbalance.
encephalopathy. folliculitis. gastritis. goitre.
hyperglycaemia. hyperparathyroidism. hypersalivation.
hypotension. hypothyroidism. idiopathic intracranial
hypertension. leucocytosis. memory loss. movement
disorders. muscle weakness. myasthenia gravis. nausea.
neoplasms. nystagmus. peripheral neuropathy.
peripheral oedema. polyuria. QT interval prolongation.
reflexes abnormal. renal disorders. renal impairment.
rhabdomyolysis. seizure. sexual dysfunction. skin
reactions. skin ulcer. speech impairment. taste altered.
thyrotoxicosis. tremor. vertigo. vision disorders.
vomiting. weight increased
SIDE-EFFECTS, FURTHER INFORMATION Overdose
Signs
of intoxication require withdrawal of treatment and
include increasing gastro-intestinal disturbances
(vomiting, diarrhoea), visual disturbances, polyuria,
muscle weakness, fine tremor increasing to coarse tremor,
CNS disturbances (confusion and drowsiness increasing to
lack of coordination, restlessness, stupor); abnormal
reflexes, myoclonus, incontinence, hypernatraemia. With
severe overdosage seizures, cardiac arrhythmias (including
sino-atrial block, bradycardia and first-degree heart block),
blood pressure changes, circulatory failure, renal failure,
coma and sudden death reported.
For details on the management of poisoning, see
Lithium, under Emergency treatment of poisoning p. 1430.
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Use only if potential benefit outweighs risk—
toxicity in animal studies.
Avoid if possible, particularly in the first
trimester (risk of teratogenicity, including cardiac
abnormalities).
Dose adjustments Dose requirements increased during the
second and third trimesters (but on delivery return
abruptly to normal).
Monitoring Close monitoring of serum-lithium
concentration advised in pregnancy (risk of toxicity in
neonate).
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Avoid—no information available.
Present in milk and risk of toxicity in
infant—avoid.
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Manufacturer advises caution in
Nervous system
moderate impairment; avoid in severe impairment (risk of
increased exposure).
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Use with caution if eGFR less than
15 mL/minute/1.73 m2—no information available.
Caution in mild to moderate
impairment. Avoid in severe impairment.
Monitoring In renal impairment monitor serum-lithium
concentration closely and adjust dose accordingly.
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Manufacturer advises
effective contraception during treatment for women of
child bearing potential.
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▶Serum concentrations Lithium salts have a narrow
therapeutic/toxic ratio and should therefore not be
prescribed unless facilities for monitoring serum-lithium
concentrations are available.
Samples should be taken 12 hours after the dose to achieve
a serum-lithium concentration of 0.4–1 mmol/litre (lower
end of the range for maintenance therapy and elderly
patients).
A target serum-lithium concentration of 0.8–1 mmol/litre
is recommended for acute episodes of mania, and for
patients who have previously relapsed or have sub-
syndromal symptoms. It is important to determine the
optimum range for each individual patient.
g Routine serum-lithium monitoring should be
performed weekly after initiation and after each dose
change until concentrations are stable, then every
3 months for the first year, and every 6 months thereafter.
Patients who are 65 years and older, taking drugs that
interact with lithium, at risk of impaired renal or thyroid
function, raised calcium levels or other complications,
have poor symptom control or poor adherence, or whose
last serum-lithium concentration was 0.8 mmol/litre or
higher, should be monitored every 3 months. h
Additional serum-lithium measurements should be made
if a patient develops significant intercurrent disease or if
there is a significant change in a patient’s sodium or fluid
intake.
▶Manufacturer advises to assess renal, cardiac, and thyroid
function before treatment initiation. g An ECG is
recommended in patients with cardiovascular disease or
risk factors for it. Body-weight or BMI, serum electrolytes,
and a full blood count should also be measured before
treatment initiation.
▶Monitor body-weight or BMI, serum electrolytes, eGFR,
and thyroid function every 6 months during treatment,
and more often if there is evidence of impaired renal or
thyroid function, or raised calcium levels. h
Manufacturer also advises to monitor cardiac function
regularly.
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