Teveten HCT

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anuria (not able to pass urine) or
• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Sulfa drug allergy (e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in these patients.

• Asthma, history of—May increase likelihood of having an allergic reaction.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetes or
• Electrolyte imbalances (e.g., high or low potassium, magnesium, or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Hypercalcemia (high calcium in the blood) or
• Kidney problems or
• Liver disease or
• Myopia, acute (changes in the eyeball causing vision problems) or
• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Teveten HCT, salt substitutes containing potassium should be avoided.

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—One tablet once a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Teveten HCT (eprosartan and hydrochlorothiazide), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Teveten HCT. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Teveten HCT.

Review Date: October 4, 2017

Rx Only

See full prescribing information for complete boxed warning.

• When pregnancy is detected, discontinue Teveten HCT as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

TEVETEN® HCT 600/12.5 mg and TEVETEN® HCT 600/25 mg (eprosartan mesylate-hydrochlorothiazide) combine an angiotensin II receptor (AT1 subtype) antagonist and a diuretic, hydrochlorothiazide. TEVETEN® (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, TEVETEN® is chemically described as the monomethanesulfonate of (E)-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimidazole-5-acrylic acid. Its empirical formula is C23H24N2O4S•CH4O3S and molecular weight is 520.625. Its structural formula is:

Eprosartan mesylate is a white to off-white free-flowing crystalline powder that is insoluble in water, freely soluble in ethanol, and melts between 248°C and 250°C. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. TEVETEN® HCT is available for oral administration in film-coated, non-scored, capsule-shaped tablet combinations of eprosartan mesylate and hydrochlorothiazide. TEVETEN® HCT 600/12.5 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 12.5 mg hydrochlorothiazide in a butterscotch-colored tablet. TEVETEN® HCT 600/25 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 25 mg hydrochlorothiazide in a brick-red tablet. Inactive ingredients of both tablets: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, crospovidone, magnesium stearate, and purified water. Ingredients of the OPADRY® 85F27320 butterscotch film coating: polyethylene glycol 3350, talc, polyvinyl alcohol, titanium dioxide, iron oxide black, and iron oxide yellow. Ingredients of the OPADRY® II 85F24297 pink film coating: polyethylene glycol 3350, titanium dioxide, talc, polyvinyl alcohol, iron oxide red, and iron oxide yellow.

TEVETEN® HCT is contraindicated in patients who are hypersensitive to this product or any of its components. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not co-administer aliskiren with Teveten HCT in patients with diabetes (see PRECAUTIONS, Drug Interactions).

Store at controlled room temperature 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

AbbVie Inc.

North Chicago, IL 60064 USA

© AbbVie Inc. 2014

Revised July, 2014

NDC 0074–3015–11

TEVETEN® HCT eprosartan mesylate/hydrochlorothiazide

NDC 0074–3020–11

TEVETEN® HCT eprosartan mesylate/hydrochlorothiazide

More frequent side effects include: dizziness. See below for a comprehensive list of adverse effects.