Adult Dosing

Hypertension

Initial therapy

• Start: 5 mg/40 mg PO qd or 5 mg/80 mg PO qd (if patients require larger BP reductions)
• Titer the dose after atleast 2 wks
• Max: 80 mg/10 mg PO qd

Add-On therapy

• For patients not adequately controlled on amlodipine or telmisartan monotherapy
• Start: 5 mg/40 mg PO qd (If patient not tolerating 10 mg amlodipine therapy)

Replacement therapy

• Amlodipine/telmisartan tablets containing the same component doses once daily
• When substituted for individual components, increase amlodipine/telmisartan dose if blood pressure control has not been satisfactory
• Max: 80 mg/10 mg PO qd

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Hypertension (alone or in combination with other antihypertensive agents)
• Initial therapy to maintain BP

• Hypersensitivity to any of the ingredients of the product
• Pregnancy (Third trimester)
• Co-administration with aliskiren in patients with diabetes

• If pregnancy is detected during the drug as early as possible
• Drugs that acts on the renin-angiotensin system can cause injury/death to the developing fetus

Renal Dose Adjustment

• Mild-moderate impairment: No dose adjustments
• Severe impairment: Titrate slowly

Hepatic Dose Adjustment

• Hepatic impairment: Initial therapy is not recommended. Start with 2.5 mg amlodipine and titrate slowly

See Supplemental Patient Information

• Suspend therapy as early as possible if pregnancy is detected during therapy [US Black Box warning]
• Do not use drugs that act on the renin-angiotensin system in second or third trimester as they can cause injury or death to the developing fetus
• Symptomatic hypotension has been reported after administration of telmisartan especially in volume or salt-depleted patients. Correct this condition before starting treatment or closely monitor the patient with a reduced dose
• Use with caution in patients with severe aortic stenosis as acute hypotension has been reported with amlodipine therapy
• Periodically determine serum electrolyte levels as hyperkalemia has been reported with telmisartan use
• In impaired hepatic patients initiate telmisartan at low dose and titrate it slowly, start amlodipine at 2.5 mg. As the lowest dose of amlodipine/telmisartan is 5/40 mg, initial therapy with amlodipine/telmisartan is not recommended in hepatic impairment
• Closely monitor renal function for dual blockade of renin-angiotensin-aldosterone system during the therapy
• Amlodipine may develop increased frequency, duration, or severity of angina or acute myocardial infarction particularly in patients with severe obstructive coronary artery disease
• Cautiously use in cardiovascular disorder as events of heart failure occurred with amlodipine therapy

Cautions: Use cautiously in

• Severe Renal impairment
• Severe hepatic impairment
• Severe aortic stenosis
• Elderly patients
• CHF
• Severe volume depletion
• Renal artery stenosis
• Hyponatremia
• Severe CAD
• Post-MI

Supplemental Patient Information

• Female patients of childbearing age should be warned about the effects of the drug on the fetus; discuss other treatment options with female patients planning to become pregnant

Pregnancy Category:C (First trimester); D (Second and third trimester )

Breastfeeding: Safety unknown; prefer an alternative drug during breastfeeding as appropriate literature on the use of amlodipine as well as telmisartan is unavailable. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 14 December 2010). According to the manufacturer data, it is not known whether amlodipine and telmisartan are excreted in human milk. It is recommended to discontinue nursing while amlodipine is administered. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of telmisartan, taking into account the importance of the drug to the mother.

• CV: Severe hypotension, angina exacerbation, myocardial infarction, orthostatic hypotension, atrial fibrillation, bradycardia, CHF, syncope
• CNS: Dizziness, headache, somnolence, asthenia
• GU: Renal impairment/failure, frequent micturation, nocturia, UTI
• HEMA: Anemia, thrombocytopenia
• RESP: URTI, sinusitis, pharyngitis, cough
• GI: Vomiting, diarrhea, hepatitis, hepatic enzyme elevations, abdominal pain, nausea
• MUSC: Back pain
• METABOLIC: Hyperkalemia
• DERM: Rash, pruritus, flushing, alopecia, urticaria
• MISC: Angioedema, peripheral edema, fatigue

Amlodipine

• Calcium channel blocker; inhibits the transmembrane influx of calcium ions into coronary vascular smooth muscle and cardiac muscle
• Absolute bioavailability: 64-90%
• Extensively metabolized by liver; CYP450: CYP3A4
• Excreted in urine as 60% metabolite, 10% unchange
• Half life: 30-50 hrs; 56 hrs in impaired hepatic function

Telmisartan

• Angiotensin II receptor antagonist; antagonizes the effect of angiotensin II by blocking the angiotensin II in vascular smooth muscle and the adrenal gland, producing decreased BP
• 42-58% absorbed following oral administration
• Metabolized by liver
• Excreted in feces (97% unchanged); bile
• Half life: Approximately 24 hrs

US Trade Name(s)

• Twynsta

US Availability

amlodipine/telmisartan (generic)

• TABS:
• 5 mg/40 mg
• 10 mg/40 mg
• 5 mg/80 mg
• 10 mg/80 mg

Twynsta (amlodipine/telmisartan)

• TABS:
• 5 mg/40 mg
• 10 mg/40 mg
• 5 mg/80 mg
• 10 mg/80 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Antihypertensive Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Twynsta 80-5 MG TABS [Box] (BOEHRINGER INGELHEIM)
  30 mg = $129.99
  90 mg = $365.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Twynsta 40/10 (telmisartan 40 MG / Amlodipine 10 MG ) Oral Tablet (Boehringer Ingelheim Pharmaceuticals, Inc.)
• Twynsta 40/5 (telmisartan 40 MG / amlodipine 5 MG) Oral Tablet (Boehringer Ingelheim Pharmaceuticals, Inc.)
• Twynsta 80/10 (telmisartan 80 MG / amlodipine 10 MG) Oral Tablet (Boehringer Ingelheim Pharmaceuticals, Inc.)
• Twynsta 80/5 (telmisartan 80 MG / amlodipine 5 MG) Oral Tablet (Boehringer Ingelheim Pharmaceuticals, Inc.)