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 aliskiren, amlodipine, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren, amlodipine, and hydrochlorothiazide combination in the elderly.
|All Trimesters||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.
- Arsenic Trioxide
- St John's Wort
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.
- Enalapril Maleate
- Ibuprofen Lysine
- Magnesium Salicylate
- Mefenamic Acid
- Salicylic 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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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 (swelling of the face, mouth, arms, legs, or throat), history of—May increase the risk of this condition occurring again.
- Anuria (not able to pass urine) or
- Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) or
- Kidney disease, moderate or
- Sulfa drug allergy (e.g., sulfamethoxazole, sulfasalazine, Azulfidine®, Bactrim®, Septra®)—Should not be used in patients with these conditions.
- Asthma, history of—May increase likelihood of having an allergic reaction.
- Diabetes or
- Kidney problems—May increase risk of having high potassium in the blood.
- Electrolyte imbalances (e.g., high or low levels of calcium, magnesium, potassium, or sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Glaucoma, secondary angle closure or
- Gout or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Liver disease or
- Myopia (changes in the eyeball causing vision problems), acute or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- 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.