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Trandolapril And Verapamil Hydrochloride (Tarka)

Trade Name : Tarka

AbbVie Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 2180 mg/1mg/1

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trandolapril And Verapamil Hydrochloride (Tarka) which is also known as Tarka and Manufactured by AbbVie Inc.. It is available in strength of 2; 180 mg/1; mg/1 per ml. Read more

Trandolapril And Verapamil Hydrochloride (Tarka) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • TARKA (trandolapril/verapamil hydrochloride ER) combines a slow release formulation of a calcium channel blocker, verapamil hydrochloride, and an immediate release formulation of an angiotensin converting enzyme inhibitor, trandolapril.
  • Verapamil hydrochloride and trandolapril have been used individually and in combination for the treatment of hypertension. For the four dosing strengths, the antihypertensive effect of the combination is approximately additive to the individual components.
  • In controlled clinical trials, once daily doses of TARKA, trandolapril 4 mg/verapamil HCl ER 240 mg or trandolapril 2 mg/verapamil HCl ER 180 mg, decreased placebo-corrected seated pressure (systolic/diastolic) 24 hours after dosing by about 7-12/6-8 mmHg. Each of the components of TARKA added to the antihypertensive effect. Treatment effects were consistent across age groups (<65, u226565 years), and gender (male, female).
  • Blood pressure reductions were significantly greater for the TARKA 4/240 combination than for either of the components used alone.
  • The antihypertensive effects of TARKA have continued during therapy for at least 1 year.
  • TARKA is indicated for the treatment of hypertension.
  • This fixed combination drug is not indicated for the initial therapy of hypertension (see n
  • In using TARKA, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see ).
  • TARKA is contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil.
  • Because of the verapamil component, TARKA is contraindicated in:
  • Because of the trandolapril component, TARKA is contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor.
  • Do not co-administer aliskiren with TARKA in patients with diabetes (see ).
  • TARKA is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer TARKA within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see ).
  • No data
  • No data
  • TARKA has been evaluated in over 1,957 subjects and patients. Of these, 541 patients, including 23% elderly patients, participated in U.S. controlled clinical trials, and 251u00a0were studied in foreign controlled clinical trials. In clinical trials with TARKA, no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with verapamil or trandolapril. TARKA has been evaluated for long-term safety in 272 patients treated for 1 year or more. Adverse experiences were usually mild and transient.
  • Discontinuation of therapy because of adverse events in U.S. placebo-controlled hypertension studies was required in 2.6% and 1.9% of patients treated with TARKA and placebo, respectively.
  • Adverse experiences occurring in 1% or more of the 541 patients in placebo-controlled hypertension trials who were treated with a range of trandolapril (0.5-8 mg) and verapamil (120-240 mg) combinations are shown below.
  • Other clinical adverse experiences possibly, probably, or definitely related to drug treatment occurring in 0.3% or more of patients treated with trandolapril/verapamil combinations with or without concomitant diuretic in controlled or uncontrolled trials (Nu00a0=u00a0990) and less frequent, clinically significant events (in italics) include the following:
  • No specific information is available on the treatment of overdosage with TARKA.
  • The recommended usual dosage range of trandolapril for hypertension is 1 to 4 mg per day administered in a single dose or two divided doses. The recommended usual dosage range of Isoptin-SR for hypertension is 120 to 480 mg per day administered in a single dose or two divided doses.
  • The hazards (see ) of trandolapril are generally independent of dose; those of verapamil are a mixture of dose-dependent phenomena (primarily dizziness, AV block, constipation) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of trandolapril and verapamil will thus be associated with both sets of dose-independent hazards. The dose-dependent side effects of verapamil have not been shown to be decreased by the addition of trandolapril nor vice versa.
  • Rarely, the dose-independent hazards of trandolapril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with TARKA only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy at its respective maximally recommended dose and shortest dosing interval, or (b) the dose of one or the other monotherapy cannot be increased further because of dose-limiting side effects.
  • Clinical trials with TARKA have explored only once-a-day doses. The antihypertensive effect and or adverse effects of adding 4 mg of trandolapril once-a-day to a dose of 240u00a0mg Isoptin-SR administered twice-a-day has not been studied, nor have the effects of adding as little of 180 mg Isoptin-SR to 2 mg trandolapril administered twice-a-day been evaluated. Over the dose range of Isoptin-SR 120 to 240 mg once-a-day and trandolapril 0.5 to 8 mg once-a-day, the effects of the combination increase with increasing doses of either component.
  • For convenience, patients receiving trandolapril (up to 8 mg) and verapamil (up to 240u00a0mg) in separate tablets, administered once-a-day, may instead wish to receive tablets of TARKA containing the same component doses.
  • TARKA should be administered with food.
  • TARKA 2/180 mg tablets are supplied as pink, oval, film-coated tablets containing 2 mg trandolapril in an immediate release form and 180 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 182 on one side and plain on the other side.
  • NDC
  • TARKA 2/240 mg tablets are supplied as gold, oval, film-coated tablets containing 2 mg trandolapril in an immediate release form and 240 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 242 on one side and plain on the other side.
  • NDC
  • TARKA 4/240 mg tablets are supplied as reddish-brown, oval, film-coated tablets containing 4 mg trandolapril in an immediate release form and 240 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 244u00a0on one side and plain on the other side.
  • NDC
  • Dispense in well-closed container with safety closure.
  • Store at 15u00b0-25u00b0C (59u00b0-77u00b0F) see USP.
  • AbbVie Inc.
  • North Chicago, IL 60064, U.S.A.
  • September 2019
  • NDC 0074-3287-13
  • Tarkan
  • Trandolapril/Verapamil HCl ER
  • 2 mg / 180 mg
  • 100 Tablets
  • Rx only abbvie
  • NDC 0074-3288-13
  • NDC 0074-3289-13
  • Tarkan
  • Trandolapril/Verapamil HCl ER
  • 2 mg / 240 mg
  • 100 Tablets
  • Rx only abbvie
  • NDC 0074-3290-13
  • Tarkan
  • Trandolapril/Verapamil HCl ER
  • 4 mg / 240 mg
  • 100 Tablets
  • Rx only abbvie

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