DAYGRA 100 - Film coated tablet
Box of 1 blister of 4 film coated tablets.
Sildenafil citrate equivalent to sildenafil 100 mg.
Film coated tablet
Each film coated tablet contains:
Active ingredient: Sildenafil citrate equivalent to sildenafil 100 mg.
For the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection, in men.
DOSAGE AND ADMINISTRATION
This drug is taken by mouth about 1 hour before sexual intercourse. Do not take more often than once daily.
Adults: The usual dose is 50 mg daily. The dose may be adjusted depending on response. The maximum recommended dose is 100 mg daily.
DAYGRA 100 is not suitable for use in patients over 65 years of age, patients with hepatic or renal impairment, patients using other medications such as inhibitors of cytochrome P450 isoenzyme CYP3A4, ritonavir, alpha blockers.
Patients with hypersensitivity to any component of this product.
Patients who are taking nitric oxide donors, organic nitrates or organic nitrites.
Patients with severe hepatic impairment, hypotension, recent history of stroke or myocardial infarction, unstable angina, heart failure, retinal disorders such as retinitis pigmentosa.
WARNINGS AND PRECAUTIONS
Erectile dysfunction should be diagnosed and potential underlying causes should be determined before treatment with sildenafil.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiovascular risk associated with sexual intercourse.
Caution is required in patients with hepatic or severe renal impairment, and dosage reduction of sildenafil may be necessary.
Care is also needed in patients with anatomical deformation of the penis or haematological disorders that may predispose them to priapism.
If you have heart problems severe enough to make sexual activity a danger, you should avoid using sildenafil.
Use it cautiously if you've had a stroke, life-threatening heart irregularities, severe high or low blood pressure, heart failure, unstable angina (within the past 6 months).
The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied, and the use of such combinations is not recommended.
Care is needed in patients with bleeding disorders, active peptic ulceration.
Use in pregnancy and lactation: Sildenafil is not indicated for use in women.
Use in children: Sildenafil is not indicated for use in children.
Use in the elderly: Since sildenafil clearance is reduced in elderly patients, a lower initial dose should be considered.
Effects on the ability to drive or operate machinery: Patients who experience dizziness or visual disturbances should not drive or operate hazardous machinery.
Sildenafil may potentiate the hypotensive effects of organic nitrates or organic nitrites, and is therefore contraindicated in patients receiving such drugs.
Sildenafil may also enhance the hypotensive effect of nicorandil and use of the two drugs together should be avoided.
Symptomatic hypotension may also occur when sildenafil are given with alpha blockers.
Drugs that inhibit the cytochrome P450 isoenzyme CYP3A4, such as cimetidine, delavirdine, erythromycin, itraconazole, ketoconazole, and HIV-protease inhibitors, may reduce the clearance of sildenafil.
Plasma concentrations of sildenafil are significantly increased by ritonavir.
Grapefruit juice may increase plasma concentrations of sildenafil.
Inducers of CYP3A4, such as rifampicin, are likely to decrease plasma concentrations of sildenafil.
ADVERSE DRUG REACTIONS
The adverse events were generally transient and mild to moderate in nature.
Adverse effects most commonly reported from sildenafil are headache and flushing.
There may be visual disturbances, dizziness, and nasal congestion. Priapism has also occurred.
Other adverse effects reported include skin rashes, vomiting, pain and redness of the eyes, epistaxis, syncope, cerebrovascular haemorrhage, and transient ischaemic attack.
Heart attack, stroke, heart irregularities, dangerous surges in blood pressure, and sudden death have all been reported after use of sildenafil, usually in men with existing cardiac risk factors.
Stop use and ask a doctor if: you develop cardiac symptoms (such as dizziness, nausea, and chest pain) during sexual activity, or any of adverse effects become severe.
Inform your physician in case of any adverse reaction related to drug use.
PHARMACOLOGY AND PHARMACOKINETICS
- Sildenafil, an oral therapy for erectile dysfunction (ED), is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
- The physiologic mechanism of erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
- Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
- Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
- Sildenafil is rapidly absorbed after a dose by mouth, with a bioavailability of about 40%. Peak plasma concentrations are attained within 30 to 120 minutes. The rate of absorption is reduced when sildenafil is given with food.
- Sildenafil is widely distributed into tissues and is about 96% bound to plasma proteins.
- It is metabolised in the liver mainly by cytochrome P450 isoenzymes CYP3A4. The major metabolite, N-desmethylsildenafil, also has some activity. The terminal half-lives of sildenafil and the N-desmethyl metabolite are about 4 hours.
- Sildenafil is excreted as metabolites, mainly in the faeces, and to a lesser extent the urine. Clearance may be reduced in the elderly and in patients with hepatic or severe renal impairment.
Symptoms: Symptoms of overdose may include dizziness, fainting, or prolonged erection.
- In cases of overdose, standard supportive measures should be adopted as required.
- As sildenafil is highly bound to plasma proteins and not eliminated in the urine, its clearance is not accelerated by renal dialysis.
PRESENTATION: Box of 1 blister of 4 film coated tablets.
STORAGE: Store at the temperature not more than 30oC, in a dry place, protect from light.
SHELF-LIFE: 48 months from manufacturing date.
KEEP OUT OF REACH OF CHILDREN
READ CAREFULLY THE LEAFLET BEFORE USE
FOR MORE INFORMATION, CONSULT YOUR PHYSICIAN.
Manufactured by: GLOMED PHARMACEUTICAL Co., INC
Address: 35 Tu Do Boulevard, Vietnam – Singapore Industrial Park, Thuan An District, Binh Duong Province.
Tel: (0650)3768824 - (0650)3768825 Fax: (0650)3769095