Fosinopril and hydrochlorothiazide (Oral route)
fos-IN-oh-pril SOE-dee-um, hye-droe-klor-oh-THYE-a-zide
ACE inhibitors can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .
ACE Inhibitor/Thiazide Combination
Uses of This Medicine:
Fosinopril and hydrochlorothiazide combination is used 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 .
Fosinopril works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax. Hydrochlorothiazide works by helping to reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine. Both of these medicines lower blood pressure and increase the supply of blood and oxygen to the heart .
This medicine is available only with your doctor's prescription .
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies have not been performed on the relationship of age to the effects of fosinopril and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fosinopril and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, which may require an adjustment of dose in patients receiving fosinopril and hydrochlorothiazide combination .
|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.|
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.
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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine 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.
- Alteplase, Recombinant
- Arsenic Trioxide
- Candesartan Cilexetil
- Olmesartan Medoxomil
Using this medicine 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.
- Amtolmetin Guacil
- Bupivacaine Liposome
- Choline Salicylate
- Enalapril Maleate
- Ethacrynic Acid
- Flufenamic Acid
- Gold Sodium Thiomalate
- Ibuprofen Lysine
- Mefenamic Acid
- Niflumic Acid
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angioedema, history of—May increase the risk of this condition occurring again .
- Anuria (not able to pass urine)—This medicine should not be used in patients with this condition .
- Asthma, bronchial—This medicine may cause sensitivity reactions .
- Congestive heart failure (severe) or
- Dehydration or
- Diarrhea or
- Hyponatremia (low sodium in the blood) or
- Kidney disease—These conditions may cause the blood pressure to fall too low with this medicine .
- Diabetes or
- Gout or
- Hypercholesterolemia (high cholesterol in the blood) or
- Hyperuricemia (high uric acid in the blood) or
- Liver disease or
- Systemic lupus erythematosus (SLE)—These conditions may be made worse .
Proper Use of This Medicine:
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. 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. Therefore, 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.
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—1 or 2 tablets once a day.
- Children—Use and dose must be determined by your doctor .
- For high blood pressure:
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects .
Stop using this medicine and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema .
Stop using this medicine and call your doctor right away if you have severe stomach pain. This could be a symptom of a condition called intestinal angioedema .
You may experience lightheadedness during the first few days with this medicine. If this becomes severe and you faint, stop using this medicine and talk to your doctor right away .
Tell your doctor immediately if you have any signs of infection such as chills, sore throat, or fever. These may be symptoms of an immune system condition called neutropenia .
If your symptoms do not improve within a few days or if they become worse, check with your doctor .
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor .
Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .
Check with your doctor right away if you have symptoms of jaundice (yellow skin or eyes) because these may be signs of a serious liver condition .
This medicine may increase the amount of potassium in your blood. Do not use salt substitutes containing potassium without first checking with your doctor .
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .
Side Effects of This Medicine:
- Less common
- Blurred vision
- chest pain or discomfort
- cold sweats
- decreased urination
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- fast, slow, or irregular heartbeat
- muscle cramps or pain
- numbness, tingling, pain, or weakness in hands or feet
- rapid breathing
- sunken eyes
- unusual tiredness or weakness
- weakness and heaviness of legs
- wrinkled skin
- More common
- Less common
- Body aches or pain
- difficult breathing
- ear congestion
- loss of voice
- muscle or bone pain
- nasal congestion
- nausea and vomiting
- runny nose
- sore throat
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:
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:
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.
Last Updated: 11/4/2014