telmisartan and amlodipine

T

tel-mi-SAR-tan, am-LOE-di-peen BES-i-late

Oral route(Tablet)

When pregnancy is detected, discontinue telmisartan/amlodipine besylate as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

Twynsta

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

Uses For telmisartan and amlodipine

Telmisartan and amlodipine is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Telmisartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

telmisartan and amlodipine is available only with your doctor's prescription.

Before Using telmisartan and amlodipine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For telmisartan and amlodipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to telmisartan and amlodipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of telmisartan and amlodipine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telmisartan and amlodipine combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require starting at a lower dose in these patients.

Pregnancy Pregnancy Category Explanation 1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 2nd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking telmisartan and amlodipine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using telmisartan and amlodipine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Atazanavir Benazepril Conivaptan Dantrolene Droperidol Enalapril Enalaprilat Lisinopril Moexipril Perindopril Quinapril Ramipril Simvastatin Telaprevir Trandolapril

Using telmisartan and amlodipine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Carteolol Carvedilol Celecoxib Celiprolol Clopidogrel Dalfopristin Diclofenac Diflunisal Digoxin Dilevalol Diltiazem Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Ibuprofen Imatinib Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Lithium Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pindolol Piroxicam Propranolol Quinupristin Rifapentine Ritonavir Salsalate Sotalol St John's Wort Sulindac Talinolol Tertatolol Timolol Tolmetin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

Kidney Problems or Congestive heart failure—Use with caution. May make these conditions worse. Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of telmisartan and amlodipine may be increased. Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks. Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of telmisartan and amlodipine

telmisartan and amlodipine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of telmisartan and amlodipine, treatment for your high blood pressure may include weight control and a change 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 telmisartan and amlodipine 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 telmisartan and amlodipine with or without food.

Dosing

The dose of telmisartan and amlodipine 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 telmisartan and amlodipine. 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—At first, one tablet containing 40 milligrams (mg) or 80 mg of telmisartan and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg of telmisartan and 10 mg of amlodipine once a day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of telmisartan and amlodipine, 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.

Precautions While Using telmisartan and amlodipine

It is very important that your doctor check your progress at regular visits to make sure telmisartan and amlodipine is working properly. Blood tests may be needed to check for unwanted effects.

Using telmisartan and amlodipine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using telmisartan and amlodipine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur after the first dose of telmisartan and amlodipine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to telmisartan and amlodipine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).

Check with your doctor right away if you become sick while taking telmisartan and amlodipine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving telmisartan and amlodipine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

telmisartan and amlodipine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bloating or swelling of the face, arms, hands, lower legs, or feet body aches or pain chills cough difficulty with breathing ear congestion fever headache loss of voice nasal congestion rapid weight gain runny nose sneezing sore throat tingling of the hands or feet unusual tiredness or weakness unusual weight gain or loss Less common Bladder pain bloody or cloudy urine blurred vision chest pain diarrhea difficult, burning, or painful urination dizziness frequent urge to urinate general feeling of discomfort or illness joint pain loss of appetite lower back or side pain muscle aches and pains nausea nervousness pounding in the ears shivering slow or fast heartbeat sweating trouble with sleeping vomiting Rare Abdominal or stomach pain arm, back, or jaw pain black, tarry stools bleeding gums blistering, peeling, or loosening of the skin blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest tightness or heaviness cold sweats confusion constipation cough or hoarseness dark urine difficult or labored breathing difficulty with swallowing dilated neck veins dry mouth extreme fatigue fast, irregular, pounding, or racing heartbeat or pulse feeling of warmth flushed, dry skin fruit-like breath odor hives increased hunger increased sweating increased thirst increased volume of pale, dilute urine indigestion irregular heartbeat irritation in the mouth joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lightheadedness, dizziness, or fainting loss of consciousness muscle cramps or stiffness pale, bluish-colored, or cold hands or feet pinpoint red spots on the skin rash redness and swelling of the gums redness, soreness, or itching skin severe or sudden headache sudden loss of coordination sudden slurring of speech swollen glands tightness in the chest trembling or shaking of the hands or feet troubled breathing unexplained weight loss unsteadiness, trembling, or other problems with muscle control or coordination unusual bleeding or bruising vomiting of blood waking to urinate at night weakness in the arms, hands, legs, or feet weight gain yellow eyes or skin Incidence not known Decreased urine output nervousness puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach belching difficulty with moving heartburn indigestion pain or tenderness around the eyes and cheekbones sleepiness or unusual drowsiness Rare Abnormal dreams abnormal ejaculation ankle, knee, or great toe joint pain anxiety bad, unusual, or unpleasant (after) taste bleeding after defecation blistering, crusting, irritation, itching, or reddening of the skin bloody nose burning feeling in the chest or stomach burning, dry, or itching eyes changes in vision cold and clammy skin continuing ringing or buzzing or other unexplained noise in the ears cough producing mucus cracked, dry, or scaly skin decreased sexual performance or desire depression discharge or excessive tearing dry mouth dryness of the eyes dryness of the skin earache excess air or gas in the stomach or intestines feeling of constant movement of self or surroundings feeling of unreality feeling of warmth full feeling hair loss or thinning of the hair headache, severe and throbbing hearing loss hives or welts hyperventilation inability to have or keep an erection increased appetite irritability lack of feeling or emotion lack or loss of strength loose stools loss of memory pinpoint red or purple spots on the skin redness of the face, neck, arms, and occasionally, upper chest redness of the skin redness or swelling in the ear redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid restlessness tenderness in the stomach area toothache unable to sleep uncomfortable swelling around the anus Incidence not known Decreased interest in sexual intercourse swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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telmisartan and amlodipine

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