Inturia 0.4 mg (Capsule (Modified Release))

Title

• Inturia Hydrochloride Capsules 0.4mg

Categories

• Medicine
• Pharmacy
• Healthcare

Description

• Indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH)
• Selective alpha1 adrenoceptor blocking agent
• Improves urine flow rate and reduces BPH symptoms
• Complete absorption (90%) following oral administration under fasting conditions
• Time to maximum concentration (Tmax) reached by four to five hours under fasting conditions and by six to seven hours when administered with food
• Extremely bound to human plasma protein (94% to 99%)
• Metabolized by cytochrome P 450 enzymes in the liver
• Elimination half-life in plasma ranges from five to seven hours
• Apparent half-life of approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population
• Dosage: 0.4 mg (one capsule) daily, to be taken after meal at night
• Dosage may be increased to 0.8 mg (two capsules) once daily after 2 to 4 weeks, if necessary
• Contraindicated in patients with hypersensitivity, history of orthostatic hypotension, and severe hepatic insufficiency
• Adverse reactions: dizziness, abnormal ejaculation, headache, asthenia, postural hypotension, palpitations
• Not recommended for use in pregnancy and lactation
• Rarely transient postural symptoms have occurred during orthostatic provocation testing after the first dose
• No data available on whether it adversely affects the ability to drive or operate machines
• Storage conditions: Store in a cool and dry place below 30°C, protected from light

Dimensions

• N/A

Color Options

• N/A

Functions

• Treats functional symptoms of Benign Prostatic Hyperplasia (BPH)
• Blocks alpha1 adrenoceptors to improve urine flow rate and reduce BPH symptoms
• Metabolized by cytochrome P 450 enzymes in the liver

Materials

• N/A

Technical Specifications

• Absorption: 90% following oral administration under fasting conditions
• Elimination half-life: ranges from five to seven hours in plasma
• Apparent half-life: approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population
• Dosage: 0.4 mg (one capsule) daily, to be taken after meal at night. Can be increased to 0.8 mg (two capsules) once daily after 2 to 4 weeks
• Storage conditions: Store in a cool and dry place below 30°C, protected from light

Design Elements

• Capsules

Usability Features

• Capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position
• Capsule should not be crunched or chewed

Indications

• Treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH)

Mode of Action

• Selective alpha1 adrenoceptor blocking agent
• Relaxes smooth muscle in the bladder neck and prostate
• Improves urine flow rate and reduces symptoms of BPH
• Metabolized by cytochrome P 450 enzymes in the liver
• Complete absorption (90%) following oral administration under fasting conditions
• Time to maximum concentration (Tmax): reached by four to five hours under fasting conditions and by six to seven hours when administered with food
• Extremely bound to human plasma protein (94% to 99%)
• Elimination half-life in plasma ranges from five to seven hours
• Apparent half-life of approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population

Dosage & Administration

• Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night
• Dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily
• Capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position
• Capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient

Interaction

• Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects
• No interactions observed when given concomitantly with atenolol, enalapril, or nifedipine
• Concomitant cimetidine may raise plasma levels of Inturia, but posology need not be changed
• No interactions seen at the level of hepatic metabolism during in vitro studies involving amitriptyline, salbutamol, glibenclamide, and finasteride
• Diclofenac and warfarin may increase the elimination rate of Inturia

Contraindications

• Hypersensitivity to Tamsulosin hydrochloride
• History of orthostatic hypotension
• Severe hepatic insufficiency
• Reduction in blood pressure can occur, leading to syncope
• Patients should avoid situations where injury could result

Side Effects

• Dizziness
• Abnormal ejaculation
• Headache
• Asthenia
• Postural hypotension
• Palpitations

Pregnancy & Lactation

• Not recommended for use

Precautions & Warnings

• Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose
• Use in patients with micturition syncope is not advised
• No data available on whether it adversely affects the ability to drive or operate machines
• Patients should be aware that dizziness can occur

Overdose Effects

• Acute hypotension likely to occur after overdosage, requiring cardiovascular support
• Renal function should be monitored
• Gastric lavage and activated charcoal may be administered in case of overdose

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

• Store in a cool and dry place below 30°C, protected from light

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