COMPOSITION :
Each f/c tablet contains : Vardenafil Hydrochloride Trihydrate equivalent to Vardenafil 10 mg.
DESCRIPTION :
Sala (Vardenafil) is a drug for erectile dysfunction. It acts by inhibiting phosphodiesterase type-5. It is rapidly absorbed and
maximum plasma concentrations are reached within 30 - 120 minutes. Vardenafil is highly bound to plasma proteins
(approximately 95%). The half life of Vardenafil is reached to 4 - 5 hours. It is excreted as metabolites mainly in the faeces and
to a lesser extent in the urine.
INDICATIONS :
Sala is used in the treatment of erectile dysfunction.
DOSAGE AND ADMINISTRATION :
Sala could be taken with or without food, but preferable not after heavy meals because the rate of absorption is reduced.
- Adults : The usual dose of Sala is 10 mg once daily and the maximum dose is 20 mg once daily, taken about 25 - 60 minutes
before sexual activity.
- Elderly patients (≥ 65 years old) : Dose adjustment is not required. However an increase to a maximum 20 mg dose should
be carefully considered.
- Patients with mild to moderate hepatic impairment : An intial dose is 5 mg once daily, which may be increased if
necessary to a maximum dose 10 mg once daily.
- Patients with renal impairment : Dose adjustment is not required in patients with mild to moderate renal impairment but in
case of severe renal impairment (creatinine clearance < 30 ml / min) a starting dose of 5 mg should be considered and
according to the tolerability the dose may be increased to 10 mg and 20 mg.
RESTRICTIONS ON USE :
Contraindications
- Hypersensitivity to Vardenafil.
- Patients use nitrates, amyl nitrite, ritonavir or indinavir.
- Patients more than 75 years of age who are using ketoconazole or itraconazole.
- Patients have severe heart or liver problems, low blood pressure, if there is a history of degenerative eye diseases or patients
have kidney dialysis.
- Children and adolescents under 18 years.
- Consumption of alcohol and grapefruit juice should be avoided during use of Vardenafil.
Precautions
- Patients suffer from cardiac arrythmia or congenital cardiac disease.
- Patients with physical condition affecting the shape of the penis or illness that can cause persist erection ( priapism ).
- Patients have stomach ulcer, bleeding disorder or using any other treatment for erection difficulties and sudden decrease or
loss of vision.
Effects on the capacity to drive vehicles or use machines
Vardenafil may cause dizziness or affect the vision, if this happened, patients should not drive vehicles or use machines.
DRUG INTERACTIONS :
- Using nitrates, medicines for angina or amyl nitrite with Vardenafil could seriously affect the blood pressure.
- Problems appear if Vardenafil used with quinidine, procainamide, amiodarone or sotalol, ritonavir, indinavir, ketoconazole,
itraconazole, erythromycin and alpha-blockers drugs.
ADVERSE EFFECTS :
Most of Vardenafil side effects are mild or moderate.
- Very common side effect : Headache.
- Common side effects : Flushing, indigestion, dizziness and runny nose.
- Uncommon side effects : Sleep disorder, paraesthesia, visual disturbance, tinnitus, vertigo, tachycardia, sinus congestion,
gastritis, abdominal pain, nausea, vomiting, diarrhea, dry mouth, increase in liver enzymes, muscle pain, back pain, rash,
increase erection and feeling unwell.
OVERDOSAGE :
In case of Vardenafil overdose, severe back pain have been reported. The treatment of overdose involves appropriate
supportive therapy . Renal dialysis is not expected to accelerate clearance of the drug.
STORAGE INSTRUCTIONS :
Store below 30oC , in a dry place.
PRESENTATIONS :
Sala tablets : Pack of 4 tablets and hospital packs of different sizes.