Adult Dosing

Hypertension

• 1 tab PO daily
• Note: Not for initial therapy; titrate individual components. Should be administered with food

Pediatric Dosing

• Safety and effectiveness in pediatric patients < 18yrs have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Hypertension

• Hypersensitivity to any ACE inhibitor or verapamil
• Hx. of ACEI-associated angioedema
• Severe left ventricular (LV) dysfunction or LV dysfunction treated with beta-blockers
• Moderate to severe heart failure
• Pregnancy
• Hypotension
• Cardiogenic shock
• Sick sinus syndrome, 2nd or 3rd degree AV block, unless paced
• Atrial flutter or fibrillation and an accessory bypass tract
• Co-administration of aliskiren in patients with diabetes

• Discontinue trandolapril/verapamil when pregnancy is detected as ACE inhibitors can cause injury and even death to the developing fetus when used in pregnancy during 2nd and 3rd trimesters

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Discontinue drug if laryngeal edema, angioedema, or jaundice occurs
• Monitor liver function
• Monitor for neutropenia in collagen vascular and/or renal disease and for hyperkalemia in diabetics
• Black patients may have higher risk of angioedema than non-black patients. Control mild heart failure (eg, with digitalis, diuretics)

Use cautiously in

• Renal impairment
• Hepatic impairment
• CHF
• Cerebrovascular or ischemic heart disease
• Renal artery or aortic stenosis
• Dialysis (esp. high-flux membrane)
• Salt/volume depletion
• Black patients
• Antigen desensitization treatment
• Surgery
• AV conduction or neuromuscular transmission disorders
• Hypertrophic cardiomyopathy
• Hyponatremia
• LDL apheresis with dextran
• Smoking habit changes
• Elderly patients

Supplemental Patient Information

• Advise patients not to use trandolapril/verapamil if they are pregnant as it could harm the unborn baby
• Instruct patient to contact physican if pregnancy is detected before taking the drug
• Contact physican if signs of an allergic reaction like hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat occurs

Pregnancy Category:C (1st trimester) and D (2nd and 3rd trimesters)

Breastfeeding: Safety unknown for trandolapril; alternate drug might be preferred, especially while nursing a newborn baby. According to manufacturer's data, trandolapril should not be administered to nursing women. Verapamil is poorly excreted in breast milk; would not be expected to cause any adverse effects in breastfed infants, especially if the infant is >2 months. Verapamil information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT) Verapamil is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 10 December 2010 ). However, manufacturer advices not to administer trandolapril/verapamil to nursing mothers

• RESP: Cough, bronchitis, dyspnea
• GI: Constipation, nausea, GI upset, elevated liver enzymes, paralytic ileus
• CV: Chest pain, bradycardia, AV Block First Degree, hypotension, pulmonary edema
• CNS: Dizziness
• GU: Endometriosis, hematuria, nocturia, polyuria, proteinuria
• MUSC: Joint pain, back pain
• MISC: Fatigue, pain in extremities, neonatal harm or death

trandolapril

• ACE Inhibitor; inhibits conversion of angiotensin I to the potent vasoconstrictor angiotensin II, promoting vasodilation. Also increases plasma renin and stimulates aldosterone secretion, inducing diuresis
• Metabolized by liver; active metabolite-trandoprilat
• Bioavailability: 10% as trandolapril and 10% as trandolaprilat
• Excreted in feces: 66%; urine: 33%
• Half-life: 6 hrs (trandopril), 10 hrs (trandoprilat)

verapamil

• Calcium Channel Blocker; decreases conduction of sinoatrial and atrioventricular (AV) nodes by inhibiting calcium influx into cardiac and vascular smooth muscle cells, inhibiting excitatory contraction. These effects prolong AV node conduction rate and decrease myocardial oxygen consumption
• Well absorbed following oral administration
• Bioavailability: 20%-35%
• Extensively metabolized by liver; CYP450: 3A4 substrate/inhibitor
• Renally excreted: 70% (3-4% unchanged); Bile/feces: 9-16%
• Half life: Single doses: 2.8-7.4 hrs; Repeated dosing: 4.5-12 hrs

US Trade Name(s)

• Tarka

US Availability

trandolapril/verapamil (generic)

• 1 mg (IR TABS); 240 mg (ER TABS)
• 2 mg (IR TABS); 180 mg (ER TABS)
• 2 mg (IR TABS); 240 mg (ER TABS)
• 4 mg (IR TABS); 240 mg (ER TABS)

Tarka (trandolapril/verapamil)

• 1 mg (IR TABS); 240 mg (ER TABS)
• 2 mg (IR TABS); 180 mg (ER TABS)
• 2 mg (IR TABS); 240 mg ER TABS)
• 4 mg (IR TABS); 240 mg (ER TABS)

Canadian Trade Name(s)

• Tarka

Canadian Availability

Tarka (trandolapril/verapamil

• 1 mg (IR TABS); 180 mg (ER TABS)
• 2 mg (IR TABS); 180 mg ER TABS)
• 1 mg (IR TABS); 240 mg (ER TABS)
• 2 mg (IR TABS); 240 mg (ER TABS)
• 4 mg (IR TABS); 240 mg (ER TABS)

UK Trade Name(s)

• Tarka

UK Availability

Tarka (trandolapril/verapamil)

• 2 mg (IR TABS); 180 mg (ER TABS)

Australian Trade Name(s)

• Tarka

Australian Availability

Tarka (trandolapril/verapamil)

• 2 mg (IR TABS); 180 mg (ER TABS)

Tarka (trandolapril/verapamil)

• 2 mg (IR TABS); 180 mg (ER TABS)

[Outline]

Cardiovascular

Antihypertensive Combinations

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

• Tarka 2-240 MG TBCR [Bottle] (ABBOTT)
  30 mg = $113.99
  90 mg = $319.98
• Trandolapril-Verapamil HCl 4-240 MG TBCR [Bottle] (GLENMARK PHARMACEUTICALS)
  30 mg = $89.99
  90 mg = $249.97
• Tarka 1-240 MG TBCR [Bottle] (ABBOTT)
  30 mg = $105.99
  90 mg = $285.96
• Tarka 2-180 MG TBCR [Bottle] (ABBOTT)
  30 mg = $113.99
  90 mg = $329.97
• Trandolapril-Verapamil HCl 2-240 MG TBCR [Bottle] (GLENMARK PHARMACEUTICALS)
  30 mg = $89.99
  90 mg = $249.97
• Tarka 4-240 MG TBCR [Bottle] (ABBOTT)
  30 mg = $115.99
  90 mg = $334.98
• Trandolapril-Verapamil HCl 2-180 MG TBCR [Bottle] (GLENMARK PHARMACEUTICALS)
  30 mg = $89.99
  90 mg = $249.97

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.

• 24 HR trandolapril 2 MG / Verapamil hydrochloride 240 MG Extended Release Tablet (Glenmark Generics Inc., USA)
• Tarka 1/240 24HR Extended Release Tablet (Abbott Laboratories)
• Tarka 2/180 24HR Extended Release Tablet (Abbott Laboratories)
• Tarka 2/180 24HR Extended Release Tablet (Physicians Total Care, Inc.)
• Tarka 2/240 24HR Extended Release Tablet (Abbott Laboratories)
• Tarka 2/240 24HR Extended Release Tablet (Physicians Total Care, Inc.)
• Tarka 4/240 24HR Extended Release Tablet (Abbott Laboratories)
• Tarka 4/240 24HR Extended Release Tablet (Physicians Total Care, Inc.)
• Trandolapril 2 MG / Verapamil hydrochloride 180 MG 24 HR Extended Release Tablet (Glenmark Generics Inc., USA)
• Trandolapril 4 MG / Verapamil hydrochloride 240 MG Extended Release Tablet (Glenmark Generics Inc., USA)