Brand name: SB-Tad

Generic name with specification: Tadalafil USP.

Strength:  5 mg, 10 mg.

  Composition: Each film coated tablet contains Tadalafil USP 5 mg.

Each film coated tablet contains Tadalafil USP 10 mg.

INDICATION:

SB-Tad is indicated for the treatment of erectile dysfunction (ED).

SB-Tad is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

SB-Tad is indicated for the treatment of erectile dysfunction and the signs of benign prostatic hyperplasia (ED/BPH).

DOSAGE & ADMINISTRATION:

Erectile Dysfunction

For Use as Needed

• The recommended starting dose of SB-Tad for use as needed 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.

For Once Daily Use

• The recommended starting dose of SB-Tad for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The SB-Tad dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Patients with BPH or with ED and BPH

SB-Tad for once daily use for BPH

The recommended dose of SB-Tad for once daily use is 5 mg, taken at approximately the same time every day.

SB-Tad for once daily use for ED+BPH

The recommended dose of SB-Tad for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Renal Insufficiency

For Use as Needed

• Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.
• Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.
• Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended dose is 5 mg not more than once in every 72 hours.

For Once Daily Use

• Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.
• Severe (creatinine clearance <30 mL/min and on hemodialysis): SB-Tad for once daily use is not recommended.

Hepatic impairment

For Use as Needed

• Mild or moderate: The dose should not exceed 10 mg once per day.
• Severe: Not recommended.

For Once Daily Use

• Mild or moderate: Tadalafil for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if Tadalafil for once daily use is prescribed to these patients.
• Severe: Not recommended.

Geriatrics

No dose adjustment is required in patients >65 years of age.

USE WITH FOOD

SB-Tad may be taken without regard to food.

 

Side effects

Body as a whole: hypersensitivity reactions including rash, urticaria, facial edema, Stevens-Johnson syndrome, and exfoliative dermatitis.

Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations, and tachycardia, may occur. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), hypertension, and syncope.

Skin and subcutaneous tissues: hyperhidrosis (sweating).

Gastrointestinal: abdominal pain and gastroesophageal reflux.

Nervous system: migraine, transient global amnesia.

Respiratory system: epistaxis (nose bleed).

Special senses: blurred vision, nonarteritic anterior ischemic optic neuropathy, retinal vein occlusion, visual field defect.

Otologic: cases of sudden decrease or loss of hearing have been reported.

Contraindications

Concurrent use of organic nitrates, nitrates and nitric oxide donors. Men with cardiac disease for whom sexual activity is inadvisable. Recent MI (within 90 days) or stroke (within last 6 months), hypotension (<90/50 mm Hg), unstable angina, heart failure, uncontrolled arrhythmias or hypertension.

Pregnancy category:  B

Available packaging: 4’S, 4’S.

Unit Price: 18 tk, 25 tk.