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PBS Information: MICARDIS is listed
on the PBS for General Benefit.
TWYNSTA: Restricted Benefit.
Hypertension in a patient who is not
adequately controlled with either of the
drugs in the combination.
New TWYNSTA® is a combination
of two powerful, long-acting agents --
MICARDIS® (telmisartan) and
amlodipine -- providing 24-hour power
for hypertensive patients uncontrolled
on either monotherapy.1--6
POWERED BY MICARDIS®
Before prescribing, please review
full Product Information available on
request from Boehringer Ingelheim.
MINIMUM PRODUCT INFORMATION (Combined). TWYNSTA® (telmisartan/
amlodipine as besylate) 40/5 mg, 40/10 mg, 80/5 mg and 80/10 mg tablets and
MICARDIS® (telmisartan) Tablets 40 mg and 80 mg. INDICATIONS: TWYNSTA:
Treatment of hypertension. Treatment should not be initiated with fixed-dose combination.
MICARDIS: Treatment of hypertension. Prevention of cardiovascular morbidity and
mortality in patients 55 years or older with coronary artery disease, peripheral artery
disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence
of end organ damage. DOSAGE AND ADMINISTRATION: TWYNSTA: One tablet daily,
taken with or without food. Patients receiving telmisartan and amlodipine as separate
tablets may be switched to TWYNSTA at same dose. Patients whose blood pressure
is not adequately controlled with amlodipine or telmisartan alone may be switched to
TWYNSTA. MICARDIS: Treatment of hypertension: Adults: 40 mg once daily. Increase to
80 mg once daily if necessary. The maximum antihypertensive effect is generally attained
four to eight weeks after the start of treatment. No dosing adjustment is necessary in
the elderly or in patients with renal impairment, including those on haemodialysis.
Telmisartan is not removed from blood by haemofiltration. In patients with mild to
moderate hepatic impairment, dosage should not exceed 40 mg once daily. Prevention of
cardiovascular morbidity and mortality: 80 mg once daily. It is not known whether doses
lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity and
mortality. When initiating therapy, monitoring of blood pressure is recommended, and
if appropriate, adjustment of medications that lower blood pressure may be necessary.
CONTRAINDICATIONS: TWYNSTA and MICARDIS: Hypersensitivity to any component
of the products, biliary obstructive disorders, severe hepatic impairment pregnancy,
lactation. TWYNSTA: hypersensitivity to dihydropyridine derivatives, cardiogenic shock.
MICARDIS: Rare hereditary conditions (fructose intolerance). PRECAUTIONS: TWYNSTA
and MICARDIS: kidney transplantation, intravascular volume and/or sodium depletion,
aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, concomitant
use of ACE inhibitors/angiotensin receptor antagonists and anti-inflammatory drugs
(NSAID or COX-2 inhibitor) and thiazide diuretics, children. TWYNSTA: Mild to moderate
hepatic impairment, renovascular hypertension, renal impairment and severe congestive
heart failure or underlying renal disease, including renal artery stenosis, unstable angina
pectoris, acute myocardial infarction, beta-blocker withdrawal should be gradual,
hyperkalaemia, adolescents under 18 years of age, caution when driving or operating
machines. MICARDIS: Primary aldosteronism, congestive heart failure, ischaemic
cardiovascular disease, renal artery stenosis, patients whose vascular tone and renal
function depend on the activity of the renin-angiotensin-aldosterone system, hepatic
and/or renal impairment, dual blockade of the renin-angiotensin-aldosterone system
(e.g. concomitant use with ramipril), fructose intolerance. INTERACTIONS: TWYNSTA and
MICARDIS: Other antihypertensive agents; digoxin; ramipril (higher risk of hyperkalaemia,
renal failure, hypotension and syncope observed in clinical trials, concomitant use should
be limited to individually defined cases with close monitoring of renal function); lithium,
NSAIDs (including aspirin, COX-2 inhibitors and non-selective NSAIDs), potassium-
sparing diuretics, potassium supplements, other agents that may cause increased serum
potassium levels, TWYNSTA: agents with blood pressure lowering potential, corticosteroids
(systemic route), grapefruit juice, CYP3A4 inhibitors (e.g. ketoconazole, itraconazole,
ritonavir), CYP3A4 inducers (e.g. rifampicin, St John's Wort). ADVERSE REACTIONS:
TWYNSTA: Common: Dizziness, peripheral oedema. Rare/Serious: depression, syncope,
peripheral neuropathy, tremor, others (see full PI). MICARDIS: upper respiratory tract
infections, urinary tract infections, abdominal pain, diarrhoea, dry mouth, dyspepsia,
flatulence, stomach discomfort, vomiting, anxiety, insomnia, depression, syncope, visual
disturbance, vertigo, back pain, arthralgia, muscle spasms, pain in extremity, myalgia,
tendon pain, chest pain, influenza-like illness, asthenia, hypotension, orthostatic
hypotension, bradycardia, tachycardia, dyspnoea, abnormal hepatic function/liver
disorder, renal impairment, hyperkalaemia, hypoglycaemia (in diabetic patients)*, anaemia,
eosinophilia, thrombocytopenia, anaphylactic reaction, hypersensitivity, drug eruption,
toxic skin eruption, hyperhidrosis, angioedema (with fatal outcome)*, pruritus, rash,
urticaria, erythema, eczema, decreased haemoglobin, increased blood uric acid, increased
blood creatinine, increased hepatic enzymes, increased blood creatine phosphokinase,
sepsis (including fatal outcomes) in high risk patients, others (see full PI). May 2011.
PBS DISPENSED PRICE: TWYNSTA® 40/5 mg $30.75, TWYNSTA® 40/10 mg
$37.60, TWYNSTA® 80/5 mg $38.01, TWYNSTA® 80/10 mg $44.34, June 2011.
MICARDIS® 40 mg $21.66, MICARDIS® 80 mg $28.91. February 2010. REFERENCES:
1. TWYNSTA® Approved Product Information, February 2011. 2. Neutel JM and Smith
DHG. J Clin Hypertens 2003;5:58--63. 3. MICARDIS® Approved Product Information,
January 2011. 4. Approved Product Information amlodipine, MIMS Annual 2011.
5. Littlejohn TW et al. J Clin Hypertens (Greenwich) 2009;11:1--7 (Erratum 2009;11:
458). 6. White WB et al. Blood Press Monit 2010;15:205--12. TWYNSTA® and
MICARDIS® are registered trademarks of Boehringer Ingelheim Pty Limited,
ABN 52 000 452 308, 78 Waterloo Road, North Ryde NSW 2113. OHW BITW0021R AP 06/11
*Please note changes
in Product Information.
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