| | Detailed Information: | Composition:
Each film coated tablet contains 10 mg or 20 ing tadalafil.
Properties:
Tadalafil is a potent selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type -5- (PDE5) when sexual stimulation causes local release of (NO), inhibition of (PDE5) by tadalafil causes increased levels of (cGMP) in the corpus cavemosum, resulting in smooth muscle relaxation and inflow of blood into the penile tissues, therapy producing an erection. Tadalafil has no effect in the absence of sexual stimulation. Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing.
Pharmacokinetics:
Tadalafil is rapidly absorbed after oral administration and the mean maximum observed plasma concentration is achieved at median time of 1 hour, it is distributed into tissues and 94% of tadalafil in plasma is bound to proteins. Tadalafil is metabolized by the (cytochrome P4503A4) and is converted to an active metabolite, the mean oral clearance is 2.5L / hours and the mean half-life is 17.5 hours. Tadalafil is excreted as inactive metabolites predominantly in the faeces. Pharmacokinetics in special populations:
Geriatrics: clearance of tadalafil is reduced but it is not clinically significant and does
not warrant a dose adjustment.
Renal impairment: in mild, moderate and severe renal impairment, the
Pharmacokinetics of single oral dose of tadalafil were not altered.
Hepatic impairment: no dose adjustment is required.
Indications:
Cyvel is used for the treatment of erectile dysfunction (various degrees of impotence
associated with diabetes, history of prostate surgery.
Contraindications:
Patients who are using organic nitrates either regularly and or intermittently in any form.
Patients with a known hypersensitivity to tadalafil or to any of the excipients
Patients with cardiovascular disease
Concomitant use of potent cytochrome P4503A4 inhibitors (erythromydn and itraconazole)
women and individuals below 18 years of age.
Side Effects:
May cause: headach, back pain, dyspepsia, nasal congestion, flashing and dizziness.
Precautions:
The evalution of erectile dysfunction should include a determination of potential underlying causes and identification of appropriate treatment following complete medical assessment.
Cyvel should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia) or in patients with anatomical deformation of the penis. Caution is required in patients with sever renal or hepatic impairment. Pregnancy and lactation: Cyvel is not indicated for use in women.
Drug Interactions:
Clarithromydn, erythromydn, ketoconazole, ritonavir and grapefruit juice increase the plasma concentration of tadalafil.
Rifampicin reduced the plasma concentration of tadalafil.
Avoid concomitant use of tadalafil with nitrate.
Dosage and Administration:
The recommended dose is 20 mg, taken prior to antidpated sexual activity, the maximum recommended dosing frequency is once per day. Cyvel may be taken between 30 minutes and 36 hours prior to antidpated sexual activity.
The dose may be lowered to 10mg based on individual response and tolerability.
Cyvel may be taken without regard to food.
Dosage adjustment is not required in elderly patients, patients with renal impairment, and patients with mild to moderate hepatic impairment.
Overdosage:
Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be abopted as required
Presentation:
- A box contains 4 tablets 10 mg.
- A box contains 4 tablets 20 mg. |
