Intimate 10 mg (5pcs)

Tadalafil is indicated for the treatment of erectile dysfunction (ED).

PHARMACOLOGY OF TADALAFIL

When sexual stimulation causes the local release of nitric oxide in the corpus cavernosum, nitric oxide then activates the enzyme guanylyl cyclase, which results in increased levels of cGMP. The increased levels of cGMP in the corpus cavernosum produce smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. PDES degrades cGMP in the corpus cavernoma, and the inhibition of POES by Tadalaft maintains increased levels of cGMP in the corpus cavernosum. Tadatafil has no effect on penile blood flow in the absence of sexual stimulation.

INDICATION Intimate' is indicated for the treatment of erectile dysfunction 1E01 Intimate' is indicated for the treatment of the signs and symptoms of benign prostate hyperplasia Intimate' is indicated for the treatment of freebie dysfunction and the signa of benign prostatic hyperplasia (ED/BPH).

INTIMATE 10 DOSAGE & ADMINISTRATION 

Erectile Dysfunction for 

Intimate 10mg Use as Needed 

• The recommended starting dose of IntimateTM 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. 

Intimate 10mg For Once Daily  Use 

• The recommended starting dose of IntimateTM for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. 

• The IntimateTM 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 

Intimate for once daily use for BPH 

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

Intimate for once daily use for ED+BPH 

The recommended dose of Intimate 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): IntimateTM  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 Intimatel-May be taken without regard to food. C

ONTRAINDICATIONS 

Nitrates 

Administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates.

Hypersensitivity Reactions 

Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis. 

INTIMATE 10 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 myocar-

• Dial 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. 

PREGNANCY & LACTATION

It is not indicated for use in newborn, children or women.

WARNINGS AND PRECAUTIONS 

Cardiovascular 

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. 

Potential for Drug Interactions When Taking TADALAFIL for Once Daily Use 

Physicians should be aware that TADALAFIL for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4). 

Prolonged Erection 

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. TADALAFIL should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). 

Eye & Sudden Hearing Loss 

Physicians should advise patients to stop use of all PDE5 inhibitors, including TADALAFIL, and seek medical attention in the event of a sudden loss of vision in one or both eyes & sudden decrease or loss of hearing. 

Alpha blockers and Antihypertensives 

Physicians should discuss with patients the potential for TADALAFIL to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications. Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. 

Renal Insufficiency, Hepatic Impairment, Consumption of alcohol.

INTIMATE 10 OVERDOSAGE 

Adverse events were similar to those seen at lower doses. In case of overdose, standard supportive measure should be adopted as required.

STORAGE

Store below 30°C. Protect from light and moisture. Keep out of reach of children.

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