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.
Vardenafil is not indicated for use in children. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vardenafil in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
- Erythrityl Tetranitrate
- Isosorbide Dinitrate
- Isosorbide Mononitrate
- Pentaerythritol Tetranitrate
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
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
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:
- Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.
- Age greater than 50 years or
- Coronary artery disease or
- Diabetes or
- Hyperlipidemia (excess of lipids in the blood) or
- Hypertension (high blood pressure) or
- Low cup to disc ratio (eye condition also called "crowded disc") or
- Smoking—These conditions may increase risk for a serious eye problem called non-arteritic ischemic optic neuropathy or NAION.
- Angina (reoccurring chest pain) or
- Arrhythmia (irregular heartbeat) or
- Heart attack (within the last 6 months) or
- Heart failure, severe or
- Hypertension (high blood pressure), uncontrolled or
- Hypotension (low blood pressure) or
- Kidney disease, severe or
- Liver disease, severe or
- Retinal disorders (eye problem) or
- Retinitis pigmentosa (an inherited eye disorder) or
- Stroke, recent history of—Should not be used in patients with these conditions.
- Bleeding disorders or
- Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.
- Bone marrow cancer or
- Leukemia (blood related cancer) or
- Multiple myeloma (blood related cancer) or
- Sickle-cell anemia (blood disorder)—Vardenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.
- Fructose intolerance—The orally disintegrating tablet contains sorbitol, which can make this condition worse.
- Heart blood flow problems—These conditions may cause you to be more sensitive to vardenafil.
- Heart disease, underlying—Chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients.
- Kidney disease or
- Liver disease—Chance of problems occurring may be increased. Lower starting doses may be used and doses increased as needed and as tolerated.
- NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.
- Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
- QT prolongation (rare heart condition), or history of—Use with caution. May make this condition worse.