Mistacor AM

Treatment of essential HTN. Replacement therapy in patients receiving telmisartan & amlodipine besilate from separate tab. Add on therapy in patients whose BP is not adequately controlled on telmisartan or amlodipine monotherapy. Initial therapy in patients who are likely to need multiple drugs to achieve BP goals.

Adult Replacement/add-on therapy 1 tab once daily. Initial therapy Initially 40 mg/5 mg once daily or 80 mg/5 mg once daily. Dose may be titrated after at least 2 wk to max 80 mg/10 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine besilate, or dihydropyridine derivatives. Biliary obstructive disorders; severe hepatic impairment; cardiogenic shock. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Rare hereditary conditions that may be incompatible w/ an excipient. Pregnancy (2nd & 3rd trimester) & lactation.

Risk of symptomatic hypotension, especially after 1st dose, in patients who are vol &/or Na depleted. Dual blockade of the renin-angiotensin-aldosterone system is not recommended. Not recommended in patients w/ primary aldosteronism. Caution in patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No data to support use in unstable angina pectoris & during or w/in 1 mth of MI. Reports of pulmonary oedema w/ amlodipine in patients w/ NYHA III & IV heart failure of non-ischaemic aetiology. Risk of hyperkalaemia, especially in patients w/ renal impairment &/or heart failure. Risk of fatal MI & unexpected CV death may be increased in DM patients w/ additional CV risk. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Caution in patients w/ hepatic impairment. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ renal impairment. No experience regarding administration in patients w/ recent kidney transplant. May affect ability to drive or operate machines. Not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy. Not recommended in childn <18 yr.

Cystitis; depression, anxiety, insomnia; dizziness, somnolence, migraine, headache, paraesthesia, syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor; vertigo; bradycardia, palpitations; hypotension, orthostatic hypotension, flushing; cough; abdominal pain, diarrhea, nausea, vomiting, gingival hypertrophy, dyspepsia, dry mouth; pruritus, eczema, erythema, rash; arthralgia, muscle spasms, myalgia, back pain, pain in extremity; nocturia; erectile dysfunction; peripheral oedema, asthenia, chest pain, fatigue, oedema, malaise; increased hepatic enzymes, increased blood uric acid.

Increased BP-lowering effect w/ other antihypertensives; agents w/ BP-lowering potential (eg, baclofen, amifostine). Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics, or antidepressants. Reduction of antihypertensive effect w/ corticosteroids. Telmisartan: Increased plasma conc of digoxin. Reversible increase in serum lithium conc & toxicity. Synergistic effect on renal insufficiency & reduced antihypertensive effect w/ NSAIDs. Amlodipine: Potentially increased bioavailability w/ grapefruit & grapefruit juice in certain patients. Increased plasma conc w/ CYP3A4 inhibitors eg, diltiazem, ketoconazole, itraconazole, ritonavir. Reduced plasma conc w/ CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, phosphenytoin, primidone, rifampicin, Hypericum perforatum. Increased exposure of simvastatin; ciclosporin or tacrolimus. Additive BP-lowering effect w/ sildenafil.

Angiotensin II Antagonists / Calcium Antagonists

C09DB04 - telmisartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

Rx