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Pregnancy and lactation:
is not indicated for use in newborns, children or women.
Undesirable effects
LEVITRAŽ was administered to over 7800 patients
during clinical trials worldwide. LEVITRAŽ was generally very well tolerated.
Adverse events were generally transient and mild to moderate in nature
In a study evaluating visual function with twice the maximum recommended dose of vardenafil,
some patients were found to have mild and transient impairment of colour discrimination in
the blue/green range and in the purple range one hour after dosing. These changes had improved
by six hours and no changes were present at 24 hours. The majority of these patients had no subjective visual symptoms.
Placebo controlled clinical trials:
When LEVITRAŽ was taken as recommended, the following
adverse drug reactions were reported in placebo controlled clinical trials:
Adverse Drug Reactions (ADRs) reported by
≥ 1 % of patients treated with LEVITRAŽ and more frequent on drug than placebo in fixed dose phase III trials of 5 mg, 10 mg, and 20 mg LEVITRAŽ
|
Body system |
Adverse drug reaction |
LEVITRAŽ |
Placebo |
|
Body as a whole
Cardiovascular
Digestive
Nervous System
Respiratory |
Headache
Flushing
Dyspepsia
Nausea
Dizziness
Rhinitis |
10.5%
11.6%
2.7%
1.2%
1.8%
4.4% |
2.1%
0.9%
< 0.1%
0.2%
0.4%
0.3% |
All clinical trials:
The following adverse drug
reactions were reported in patients given LEVITRAŽ in all clinical trials
worldwide (Status: June 2003)
|
|
Very
Common
(≥10%) |
Common
(>1%<10%) |
Uncommon
(>0.1%<1% |
Rare
(>0.01%<0.1%)* |
|
Digestive |
|
Dyspepsia
Nausea |
Abnormal liver
function tests
GGTP increased |
|
|
Nervous System |
|
Dizziness |
Somnolence |
Hypertonia |
|
Metabolic and
Nutritional |
|
|
Increased
creatine kinase |
|
|
Musculoskeletal |
|
|
Myalgia |
|
|
Cardiovascular |
Flushing |
|
Hypertension |
Hypotension
Syncope
Angina pectoris
Myocardial
ischemia
Postural
hypotension |
|
Respiratory |
|
Rhinitis |
Dyspnoea |
Epistaxis |
|
Body as a whole |
Headache |
|
Photosensitivity reaction
Face oedema
Back pain |
Anaphylactic reaction
(including laymgeal
oedema) |
|
Special senses |
|
|
Abnormal vision
Watery eyes |
Glaucoma |
|
Urogenital |
|
|
Priapism (including
prolonged
or painful erections) |
Erectile disturbance |
* For adverse reactions reported in < 1 %
of patients, only those which warrant special attention, because of their possible
association with serious disease states or of otherwise clinical relevance, and which have been reported in > 2 cases are listed.
In a phase I study with 40 mg (twice the maximum recommended dose) priapism was observed in 2 cases as ADR.
Post-Marketing
Myocardial infarction (MI) has been
reported in temporal association with the use of Vardenafil and sexual activity,
but it is not possible to determine whether MI is related directly to Vardenafil,
or to sexual activity, to the patent's underlying cardiovascular disease, or to a combination of these factors.
Overdose
In single dose volunteer studies,
Vardenafil was tested in doses up to and including 80 mg per day. Even the highest
dosage tested (80 mg per day) was tolerated without producing serious adverse side effects.
This was confirmed in a study with 40 mg once daily doses over 4 weeks. When 40 mg was
administered twice daily, cases of severe back pain were observed. No muscle or
neurological toxicity was identified, however. In cases of overdose, standard
supportive measures should be taken as required. Renal dialysis is not expected to
accelerate clearance as Vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
Instructions for use/handling
Do not store above 30°C
Presentation 4 tablets
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