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Before Using
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:
Allergies
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.
Geriatric
Elderly people are especially sensitive to the effects of vardenafil, which may increase their chance of having side effects. Patients 65 years of age and older are started on a lower dose than younger adults. The dose may be increased by a doctor as needed and tolerated.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| 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. |
Breastfeeding
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.
Drug Interactions
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.
- Dronedarone
- Erythrityl Tetranitrate
- Isosorbide Dinitrate
- Isosorbide Mononitrate
- Nitroglycerin
- 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.
- Acecainide
- Amiodarone
- Asenapine
- Azimilide
- Bretylium
- Disopyramide
- Dofetilide
- Ibutilide
- Iloperidone
- Lapatinib
- Methadone
- Moricizine
- Nilotinib
- Procainamide
- Quinidine
- Ranolazine
- Sematilide
- Sotalol
- Tedisamil
- Tetrabenazine
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.
- Alfuzosin
- Amprenavir
- Bunazosin
- Doxazosin
- Indinavir
- Itraconazole
- Phenoxybenzamine
- Phentolamine
- Prazosin
- Tamsulosin
- Terazosin
- Trimazosin
- Urapidil
Other Interactions
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 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 ("crowded disc") or
- Smoking—These conditions may increase risk for a serious eye problem called NAION .
- Angina (reoccurring chest pain) or
- Arrhythmia (irregular heartbeat) or
- Heart attack (within the last 6 months) or
- Heart failure or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Liver disease (severe) or
- Kidney disease (severe) or
- Retinal disorders (rare hereditary eye problem) or
- Stroke (recent history of)—Vardenafil has not been studied in patients with these medical conditions and should not be used.
- 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 or
- Sickle-cell anemia—Vardenafil may cause this condition to become worse.
- Heart disease, underlying—Chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients.
- Liver disease, moderate—Chance of problems occurring may be increased. Lower starting doses may be used and doses increased as needed and as tolerated .
- Heart blood flow problems—These conditions may cause you to be more sensitive to vardenafil.
- NAION (serious eye condition) in one or both eyes, previously—May increase your chance of getting NAION again .
- QT prolongation (rare heart condition)—Vardenafil may cause this condition to become worse.
