Instructions for Use Please read carefully all instructions on your prescription before you start taking URO 500. URO 500 is for adult males and should not be taken by women or children. Take this medicine as directed by your healthcare practitioner. Ask your health care provider if you have any questions before taking URO 500. Do not take this medicine in larger or smaller doses or for longer or shorter periods than recommended. Take URO 500 after meal with water. It may take up to 3 weeks before it improves your prostate health. Keep using the medication as directed and tell your health care provider if you do not experience any benefit. Dosage Form: URO 500 is an easy to swallow gelatinous shell capsule. URO 500 is packed 30 capsules per container. Active Ingredients: URO 500 is made from extract of Croton membranaceus. Each capsule contains 10 mg of the extract of Croton membranaceus. Other Ingredients: URO 500 contains methyl paraben and corn starch as excipients. Phytochemical Composition: The class of phytochemical constituents found in URO 500 include alkaloids, coumarins, diterpenoids and phytosterols. However, the main chemical constituents found to be responsible for the pharmacological activity of URO 500 are julocrotine an alkaloid and scopoletin a coumarin. Possible Mechanism of Action of URO 500: Knowledge of the chemical constituents, pre-clinical studies and clinical observation following the administration of URO 500 suggest that the activity of URO 500 could be due to more than one mechanism of action. The possible mechanism of action may include two or more of the following: 1.5α-reductase inhibition 2.Alpha adrenergic receptor antagonism 3.Antioxidant action 4.Anti-atherogenic action 5α-reductase inhibition: The effect of 5α-reductase inhibition is to lower blood and tissue DHT levels and thereby reduce the size of the prostate. Julocrotine, one of the isolates of C. membranaceus which is the main medicinal plant material in URO 500, has been found to possess 5α-reductase inhibitory activity. Alpha adrenergic receptor antagonism: Adrenergic receptor antagonists (Alpha blockers) are known to start reducing symptoms of BPH within two weeks as compared to 5α-reductase inhibitors which might take more than 3 months. Alpha blockers relax the smooth muscles of the prostate capsule and the bladder neck by blocking the transmission of noradrenalin. Relaxing the muscles around the bladder neck helps relieve dysuria. The quick onset of action of URO 500 against urinary obstruction in BPH patients might be due to an alpha-adrenergic receptor antagonist effect. Scopoletin which is one of the phytochemical constituents in URO 500 is known to block peripheral adrenergic transmissions, and has also been found to have smooth muscle relaxant action Anti-oxidant action: Research findings suggest that oxidative stress may be one of the major factors responsible for the development of BPH. URO 500 as well as one of its constituents, scopoletin have been found to exhibit significant Anti-oxidant activity. Anti-atherogenic Action: It has been observed in preclinical studies that URO 500 has anti-atherogenic properties (prevents the formation of fatty deposits in the arteries) Safety In pre-clinical studies, the oral LD50 of URO 500 was found to be greater than 5000 mg/kg in rats and mice. When rats were administered with thirty times the therapeutic dose daily for six months, there were no reported adverse reactions or toxicological effects on internal organs upon histo-pathological analysis. Interactions Clinical administration of URO 500 with some herbal preparations has not resulted in any reported adverse effect. Concomitant use with other drugs other than herbal preparations has not been studied clinically. Thus, concomitant administration with other drugs and herbs must be done in consultation with your healthcare practitioner. Use URO 500 is used as a supplement for the maintenance of prostate health and improvement in urine flow especially in patients with benign prostatic hyperplasia and its associated symptoms including difficulty in initiating urinary flow, urine retention, frequent urination, terminal dribbling, incomplete emptying of the bladder, weak urine stream, incontinence, painful urination and nocturia. Dosage Take two capsules three times a day with water. Assess response after 6 to 12 weeks of treatment. Contraindication Hypersensitivity to Croton membranaceus extract or to any of the additives in URO 500. Overdose Undesirable reactions due to overdose of URO 500 has not been reported. Even though URO 500 is known to have a wide margin of safety, it is recommended that you adhere to the recommended dosage regimen. In case of overdose, consult your healthcare practitioner. Adverse Reactions No adverse reactions have been observed clinically. Storage Keep lid of container safely closed at all times. Store URO 500 at room temperature, and from moisture. Do not freeze. Caution Keep all medicines out of the reach of children.