Proscan250 mg

Proscan 250 mg Tablets are indicated for use in combination with LHRH agonistic analogues (such as leuprolide acetate) for the treatment of metastatic prostatic carcinoma (stage D2). To achieve the benefit of the adjunctive therapy with Proscan 250 mg, treatment must be started simultaneously using both drugs ... Read moreProscan 250 mg Tablets are indicated for use in combination with LHRH agonistic analogues (such as leuprolide acetate) for the treatment of metastatic prostatic carcinoma (stage D2). To achieve the benefit of the adjunctive therapy with Proscan 250 mg, treatment must be started simultaneously using both drugs. Proscan 250 mg Tablets are also indicated as adjunctive therapy to orchiectomy, in order to achieve complete androgen blockade. Proscan 250 mg Tablets in combination with LHRH agonists are also indicated prior to and during definitive external beam radiotherapy for patients with bulky locally advanced Stage B2 and Stage C prostatic carcinoma.

Hormonal Chemotherapy

Proscan 250 mg is a nonsteroidal 'pure' antiandrogen which acts directly on the target tissues either by blocking androgen uptake or by inhibiting cytoplasmic and nuclear binding of androgen.

Oral (Adult)- Palliative treatment of prostatic carcinoma: 250 mg tid preferably at least 3 days before gonadorelin analogue treatment. May be taken with or without food.

The recommended dosage of Proscan 250 mg in combination with orchiectomy or in combination with an LHRH agonist is one 250 mg tablet three times a day at eight-hour intervals. In combination with an LHRH agonist, either the two agents may be initiated simultaneously, or Proscan 250 mg tablet therapy may be started 24 hours prior to initiation of the LHRH agonist. In the management of bulky locally advanced Stage B 2 and Stage C prostatic carcinoma, the recommended dosage is one 250 mg tablet, three times a day at eight-hour intervals. Proscan 250 mg should be started simultaneously or 24 hours prior to initiation of the LHRH agonist. Administration of Proscan 250 mg should begin eight weeks prior to external beam radiation therapy and continue through the course of radiation therapy.

Interactions between Proscan 250 mg Tablets and leuprolide have not occurred. In patients receiving long-term oral-anticoagulant therapy, increases in prothrombin time have been reported after Proscan 250 mg monotherapy was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Proscan 250 mg tablets are administered concomitantly. Cases of increased theophylline plasma concentrations have been reported in patients receiving concomitant theophylline and Proscan 250 mg tablets. Theophylline is primarily metabolized by CYP1A2, which is the primary enzyme responsible for the conversion of Proscan 250 mg to its active agent 2-hydroxyProscan 250 mg.

Proscan 250 mg tablets are contraindicated in patients who have shown hypersensitivity to Proscan 250 mg or any component of this preparation. Proscan 250 mg is contraindicated in patients with severe hepatic impairment. Proscan 250 mg has not been studied in women and is not indicated for this population, particularly for nonserious or non-threatening conditions.

Cardiovascular System: hypertension in 1% of patients. Rarely thrombophlebitis, pulmonary embolism, myocardial infarction.Central Nervous System: CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients. Rarely insomnia, tiredness, headache, dizziness, weakness, malaise, blurred vision and decreased libido have been reported.Endocrine System: gynecomastia in 9% of patients. Rarely breast tenderness sometimes accompanied by galactorrhoea.Gastrointestinal System: nausea/vomiting occurred in 11%; diarrhea 12%, anorexia 4%, and other gastrointestinal disorders occurred in 6% of patients. Increased appetite, indigestion and constipation have also been reported.Hematopoietic System: anaemia occurred in 6% of patients, leukopenia 3%, thrombocytopenia 1%.Liver and Biliary System: clinically evident hepatitis and jaundice occurred in <1% of patients.Skin: irritation at the injection site and rash occurred in 3% of patients. Photosensitivity reactions have been reported in five patients.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Periodic liver function tests and sperm count determinations must be performed in patients on long-term treatment with Proscan 250 mg. After long-term administration in rats, Proscan 250 mg produced testicular interstitial cell adenomas and dose-related increases in mammary gland adenomas or carcinomas. The relevance of these findings to humans is unknown. It should be noted that few cases of malignant breast neoplasms have been reported in male patients receiving Proscan 250 mg; causality has not been established. Since Proscan 250 mg tends to elevate plasma testosterone and estradiol levels, fluid retention may occur. Accordingly, Proscan 250 mg should be used with caution in those patients with cardiac disease.Hepatic Injury: Treatment with Proscan 250 mg should not be initiated in patients with serum transaminase levels exceeding 2 to 3 times the upper limit of normal. Since transaminase abnormalities, cholestatic jaundice, hepatic necrosis and hepatic encephalopathy have been reported with the use of Proscan 250 mg, periodic liver function tests must be performed in all patients. Appropriate laboratory testing should be done monthly for the first 4 months, and periodically thereafter and at the first symptom/sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained "flu-like" symptoms). If the patient has laboratory evidence of liver injury or jaundice, in the absence of biopsy-confirmed liver metastases, Proscan 250 mg therapy should be discontinued if the patient develops jaundice or if serum transaminase levels rise to 2 to 3 times the upper limit of normal, even in clinically asymptomatic patients. The hepatic injury is usually reversible after discontinuation of therapy and in some patients, after dosage reduction. However, there have been reports of death following severe hepatic injury associated with the use of Proscan 250 mg.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Hormonal Chemotherapy

In animal studies, Proscan 250 mg demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g. castration.

No studies have been conducted in pregnant or lactating women. Therefore, the possibility that Proscan 250 mg may cause fetal harm if administered to a pregnant woman, or may be present in the breast milk of lactating women must be considered.