HIGHLIGHT
Mistacor AM

Mistacor AM

telmisartan + amlodipine

Manufacturer:

Sandoz

Distributor:

Sandoz
Concise Prescribing Info
Contents
Per 40 mg/5 mg tab Telmisartan 40 mg, amlodipine besilate 5 mg. Per 40 mg/10 mg tab Telmisartan 40 mg, amlodipine besilate 10 mg. Per 80 mg/5 mg tab Telmisartan 80 mg, amlodipine besilate 5 mg. Per 80 mg/10 mg tab Telmisartan 80 mg, amlodipine besilate 10 mg
Indications/Uses
Treatment of essential HTN. Replacement therapy in patients receiving telmisartan & amlodipine besilate. 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.
Dosage/Direction for Use
Adult Replacement therapy: 1 tab once daily. Add on therapy: 10 mg amlodipine, may be switched to 40 mg/5 mg once daily. Initial therapy: Initially 40 mg/5 mg once daily or 80 mg/5 mg once daily in patients requiring large BP reductions for 2 wks, max: 80 mg/10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders; severe hepatic impairment; cardiogenic shock; DM or renal impairment (GFR <60 mL/min/1.73 m2). Incompatible hereditary conditions. Pregnancy (2nd & 3rd trimester) & lactation.
Special Precautions
Hepatic impairment. Patients w/ biliary obstructive disorders or hepatic insufficiency. Renovascular HTN. Renal impairment & kidney transplant. Intravascular hypovolemia. Dual blockade of renin-angiotensin-aldosterone system. Severe CHF or underlying renal disease including renal artery stenosis. Primary aldosteronism. Aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Unstable angina pectoris, acute MI. Heart failure. Hyperkalemia. DM. May affect ability to drive or operate machines. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
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.
Drug Interactions
May potentiate hypotensive effects w/ baclofen, amifostine; aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Reduction of antihypertensive effect w/ corticosteroids.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
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.
Presentation/Packing
Form
Mistacor AM 40 mg/10 mg tab
Packing/Price
7's
Form
Mistacor AM 40 mg/5 mg tab
Packing/Price
10's
Form
Mistacor AM 80 mg/10 mg tab
Packing/Price
10's
Form
Mistacor AM 80 mg/5 mg tab
Packing/Price
7's
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