Levitra ODT

Levitra ODT

vardenafil

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Vardenafil HCl trihydrate
Indications/Uses
Dosage/Direction for Use
Adult men 10 mg as needed approx 25-60 min before sexual activity. Max: 10 mg/day.
Administration
May be taken with or without food: Place tab on the tongue & allow to dissolve, then swallow. Do not chew/crush.
Contraindications
Hypersensitivity. Co-administration w/ nitrates or nitric oxide donors eg, amyl nitrite. Patients who have loss of vision in 1 eye because of non-arteritic anterior ischemic optic neuropathy. Men for whom sexual activity is inadvisable (eg, patients w/ severe CV disorders). Severe hepatic impairment (Child-Pugh C), end-stage renal disease requiring dialysis, hypotension (BP <90/50 mmHg), recent history of stroke or MI (w/in the last 6 mth), unstable angina, known hereditary retinal degenerative disorders eg, retinitis pigmentosa. Concomitant use w/ ketoconazole & itraconazole (oral form) in men >75 yr; HIV PIs eg, ritonavir & indinavir; guanylate cyclase stimulators eg, riociguat.
Special Precautions
Consider CV status of patients prior to treatment initiation. Use w/ caution in patients w/ pre-existing CV risk factors; patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma, leukaemia); patients w/ bleeding disorders or active peptic ulceration. Risk of QTc interval prolongation. Reports of visual defects & non-arteritic anterior ischaemic optic neuropathy. Not recommended in combination w/ other treatments for erectile dysfunction. Concomitant use of α-blockers & vardenafil should only be initiated if patient has been stabilised on α-blocker therapy. Vardenafil dose adjustment might be necessary w/ concomitant moderate CYP3A4 inhibitors. Avoid combination w/ grapefruit or grapefruit juice. Contains aspartame which may be harmful to patients w/ phenylketonuria. Rare hereditary problems of fructose intolerance. May affect ability to drive & use machines. Not indicated as a starting dose in patients w/ mild hepatic impairment (Child-Pugh A) or severe renal impairment (CrCl <30 mL/min). Not for use in patients w/ moderate (Child-Pugh B) hepatic impairment. Not indicated for use in women & individuals <18 yr. Elderly.
Adverse Reactions
Headache. Dizziness; flushing; nasal congestion; dyspepsia.
Drug Interactions
Increased plasma levels w/ CYP3A4 inhibitors (eg, indinavir, ritonavir, ketoconazole & itraconazole in oral form, erythromycin, grapefruit juice). Possible potentiation of hypotensive effects of nitrates (eg, nitroglycerin, nicorandil). Additive BP-lowering effect w/ α-blockers; riociguat.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE09 - vardenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Levitra ODT orodispersible tab 10 mg
Packing/Price
4's
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