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Country of origin : Argentina

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phenazopyridine hydrochloride

Tablets, film coated 200mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
WHO
Manufacturer #16399
It is a Laboratory of medicinal specialties, founded in the 1950s, with 100% national capital and a 2nd generation family directory. At present, the laboratory has more than 100 permanent collaborators. The company’s vision is to develop pharmaceutical products with excellent quality, strengthen its participation in the domestic market and grow in the external market.

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Phenazopyridine hydrochloride

Phenazopyridine hydrochloride is an analgesic pain reliever. It is used to treat pain, burning, increased urination, or the urge to urinate frequently. It has a local analgesic effect on the mucosa of the urinary tract and for this reason, it is used to treat the pain, irritation, or urgency caused by urinary tract infections, surgery, or injury to the urinary tract. In conjunction with antibiotics or similar medication for treating infections, it used at the beginning to provide immediate symptomatic relief. However, it is important to note that it does not treat infections or injury but will only provide symptomatic relief. Patients are recommended to take it with the first two days of frontline antibacterial treatment. If It is used for a longer course, there is a risk of masking symptoms. Since it masks symptoms, It can be used for relief from the same symptoms caused by other complications, when the infection is caused by in-dwelling Foley catheter usage, in endoscopic procedures, or after prostate, urethral, or urinary bladder surgery which causes irritation in the epithelial lining of the urinary tract. Since the use of Phenazopyridine HCl relieves only symptoms, the patient should not confuse it with the cure for infection and delay definitive diagnosis but get tested for causative conditions. It is recommended to discontinue the use, once the symptomatic relief is found and focus on the real underlying causes and find the treatment that cures the underlying condition or cause. Phenazopyridine hydrochloride is sold under the brand names Pyridium, Prodium, Pyridiate among others. Bernhard Joos, the founder of Cilag first discovered and synthesized Phenazopyridine hydrochloride in 1914. The first known application in the treatment of jaundice. Pyridium Corp filed for the first patent in the USA in 1936. Phenazopyridine hydrochloride has not been found to be safe and effective by the USFDA, and so the labeling has not been approved.

DOSAGE AND ADMINISTRATION

Phenazopyridine hydrochloride is sold as 100mg and 200mg tablets. The usual recommended adult dose is 2 tablets, taken orally 3 times a day after meals and if taking the 200 mg, the dose is one tablet, take orally 3 times a day after meals. when being used concomitantly with an antibacterial agent, the treatment should not exceed 2 days. If symptomatic relief is achieved, stop using and continue with treatment of cause of infection.

The price of Phenazopyridine Hydrochloride

A supply of 10 Phenazopyridine hydrochloride 200mg tablets costs around USD1.3 in India. The same supply in the international market costs around USD 33.33.

How does it work?

Phenazopyridine's mechanism of action has not been fully understood. However, it is understood to have a direct topical analgesic effect on the mucosa lining of the urinary tract. Phenazopyridine HCl is excreted in the urine. there it exerts a topical analgesic effect on the mucosa of the urinary tract which relieves pain, burning, urgency, and frequency.

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