Tarka

DRUG DESCRIPTION

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 Component

Verapamil hydrochloride is chemically described as benzeneacetonitrile, ?[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3, 4-dimethoxy-?-(1-methylethyl) hydrochloride. Its empirical formula is C27H38N2O4 HCl and its structural formula is:

Verapamil hydrochloride Structural Formula Illustration

Verapamil hydrochloride is an almost white crystalline powder, with a molecular weight of 491.08. It is soluble in water, chloroform, and methanol. It is practically free of odor, with a bitter taste.

Trandolapril Component

Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. It is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its empirical formula is C24H34N2O5 and its structural formula is:

Trandolapril is a white or almost white powder with a molecular weight of 430.54. It is soluble ( ? 100 mg/mL) in chloroform, dichloromethane, and methanol.

TARKA tablets are formulated for oral administration, containing verapamil hydrochloride as a controlled release formulation and trandolapril as an immediate release formulation. The tablet strengths are trandolapril 2 mg/verapamil hydrochloride ER 180 mg, trandolapril 1 mg/verapamil hydrochloride ER 240 mg, trandolapril 2 mg/verapamil hydrochloride ER 240 mg, and trandolapril 4 mg/verapamil hydrochloride ER 240 mg. The tablets also contain the following ingredients: corn starch, dioctyl sodium sulfosuccinate, ethanol, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium alginate, sodium stearyl fumarate, synthetic iron oxides, talc, and titanium dioxide.

What are the possible side effects of trandolapril and verapamil (Tarka)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath;
  • feeling like you might pass out;
  • chest pain, slow heart rate; or
  • jaundice (yellowing of the skin or eyes).

Less...

Read All Potential Side Effects and See Pictures of Tarka

What are the precautions when taking trandolapril and verapamil er (Tarka)?

Before taking this product, tell your doctor or pharmacist if you are allergic to trandolapril or verapamil; or to other ACE inhibitors (such as benazepril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as second- or third-degree atrioventricular block, sick sinus syndrome unless you have a pacemaker, Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome), a history of an allergic reaction that included swelling of the...

Read All Potential Precautions of Tarka


Tarka Consumer (continued)

SIDE EFFECTS: Dizziness may occur as your body adjusts to the medication. Dry cough, slow heartbeat, constipation, and nausea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling ankles/feet, unusual tiredness, shortness of breath, fast/irregular/very slow heartbeat, fainting, muscle weakness.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to trandolapril or verapamil; or to other ACE inhibitors (such as benazepril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as second- or third-degree atrioventricular block, sick sinus syndrome unless you have a pacemaker, Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome), a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as renal artery stenosis), collagen vascular disease (such as lupus, scleroderma), loss of too much body water (dehydration), certain types of heart problems (such as aortic stenosis, heart failure), certain muscle/nerve disorders (muscular dystrophy, myasthenia gravis), untreated salt imbalance (such as high potassium, low sodium).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Losing too much body water (such as too much sweating, diarrhea, or vomiting) can lower your blood pressure and worsen dizziness. Tell your doctor if you have prolonged diarrhea or vomiting. Drink enough fluids during exercise. Consult your doctor for more details.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This product may increase your potassium levels, which could cause side effects. Consult your doctor or pharmacist before using potassium supplements or salt substitutes that contain potassium.

If you have diabetes, this product may cause low blood sugar levels (hypoglycemia) when you first start using it. Check your blood sugar levels regularly as directed by your doctor. Treat symptoms of low blood sugar quickly. Tell your doctor immediately if you have signs of low blood sugar such as nervousness, hunger, and shaking.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

Verapamil passes into breast milk. It is unknown if trandolapril passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Tarka Patient Information Including Side Effects

Brand Names: Tarka

Generic Name: trandolapril and verapamil (Pronunciation: tran DOL a pril and ver AP a mil)

  • What is trandolapril and verapamil (Tarka)?
  • What are the possible side effects of trandolapril and verapamil (Tarka)?
  • What is the most important information I should know about trandolapril and verapamil (Tarka)?
  • What should I discuss with my healthcare provider before taking trandolapril and verapamil (Tarka)?
  • How should I take trandolapril and verapamil (Tarka)?
  • What happens if I miss a dose (Tarka)?
  • What happens if I overdose (Tarka)?
  • What should I avoid while taking trandolapril and verapamil (Tarka)?
  • What other drugs will affect trandolapril and verapamil (Tarka)?
  • Where can I get more information?

What is trandolapril and verapamil (Tarka)?

Trandolapril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.

Verapamil is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

The combination of trandolapril and verapamil is used to treat high blood pressure (hypertension).

Trandolapril and verapamil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of trandolapril and verapamil (Tarka)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath;
  • feeling like you might pass out;
  • chest pain, slow heart rate; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough;
  • headache;
  • runny or stuffy nose, sore throat;
  • constipation, diarrhea;
  • dizziness;
  • back pain;
  • joint pain; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trandolapril and verapamil (Tarka)?

Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Trandolapril and verapamil could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Do not use salt substitutes or potassium supplements while taking trandolapril and verapamil, unless your doctor has told you to.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking trandolapril and verapamil. Drink plenty of water each day while you are taking this medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms, so you may not know when your blood pressure is high. You may need to use blood pressure medication for the rest of your life.

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