CIALIS®
(tadalafil)
tablets
(tadalafil)
tablets
DESCRIPTION
CIALIS® (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic
guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the
empirical formula C22H19N3O4 representing a molecular weight of 389.41.
Mechanism of Action.
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CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet
contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose
sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.
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Effects on Vision — Single oral doses of phosphodiesterase inhibitors have demonstrated
transient dose-related impairment of color discrimination (blue/green), using the
Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This
finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the
retina. In a study to assess the effects of a single dose of tadalafil 40 mg on vision (N=59), no
effects were observed on visual acuity, intraocular pressure, or pupillometry. Across all clinical
studies with CIALIS, reports of changes in color vision were rare (<0.1%>
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Effects on Sperm Characteristics — Three studies were conducted in men to assess the
potential effect on sperm characteristics of tadalafil 10 mg (one 6 month study) and 20 mg (one 6
month and one 9 month study) administered daily. There were no adverse effects on sperm
morphology or sperm motility in any of the three studies. In the study of 10 mg tadalafil for 6
months and the study of 20 mg tadalafil for 9 months, results showed a decrease in mean sperm
concentrations relative to placebo, although these differences were not clinically meaningful.
This effect was not seen in the study of 20 mg tadalafil taken for 6 months. In addition there was
no adverse effect on mean concentrations of reproductive hormones, testosterone, luteinizing
hormone or follicle stimulating hormone with either 10 or 20 mg of tadalafil compared to
placebo.
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INDICATIONS AND USAGE
CIALIS is indicated for the treatment of erectile dysfunction.
CONTRAINDICATIONS
Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate,
either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies,
tadalafil was shown to potentiate the hypotensive effect of nitrates. This is thought to result from
the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway (see
Pharmacodynamics, Effects on Blood Pressure when CIALIS is Administered with Nitrates
under CLINICAL PHARMACOLOGY).
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Pregnancy, Nursing Mothers, and Pediatric Use
CIALIS is not indicated for use in newborns, children, or women.
Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. Tadalafil
and/or its metabolites were secreted into the milk in lactating rats at concentrations
approximately 2.4-fold greater than found in the plasma. Following a single-oral dose of
10 mg/kg, approximately 0.1% of the total radioactive dose was excreted into the milk within 3
20
hours.
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OVERDOSAGE
Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to
100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In
cases of overdose, standard supportive measures should be adopted as required. Hemodialysis
contributes negligibly to tadalafil elimination.
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DOSAGE AND ADMINISTRATION
The recommended starting dose of CIALIS in most patients is 10 mg, taken prior to anticipated
sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual
efficacy and tolerability. The maximum recommended dosing frequency is once per day in most
patients.
CIALIS was shown to improve erectile function compared to placebo up to 36 hours following
dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into
consideration.
CIALIS may be taken without regard to food.
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