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Salagen (Pilocarpine Hydrochloride) - Summary

 
 



SALAGEN SUMMARY

SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents.

SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.


See all Salagen indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Salagen (Pilocarpine)

A 12-week, double-masked, parallel-group study of the safety and efficacy of travoprost 0.004% compared with pilocarpine 1% in Chinese patients with primary angle-closure and primary angle-closure glaucoma. [2011.08]
OBJECTIVE: To examine the intraocular pressure-lowering efficacy and safety of travoprost 0.004% and pilocarpine 1% in Chinese patients with primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) after laser iridotomy in China... CONCLUSIONS: Travoprost 0.004% once daily provides effective IOP-lowering efficacy with significantly greater IOP reduction from baseline when compared with pilocarpine 1% 4 times daily at 4 PM over the 12-week period. Travoprost 0.004% once daily is safe and well tolerated in PAC or PACG patients.

A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA. [2011.05]
Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted... Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

Tramadol-induced oral dryness and pilocarpine treatment: effects on total protein and IgA. [2011.04]
Pilocarpine induces a profuse flow of saliva, and it may re-establish saliva production in cases of drug-induced oral dryness. The aim of the study (a sub-study to the previous trial investigating the pilocarpine fluid effects in individuals suffering from drug-induced dry mouth) was to search for saliva quality changes induced by the treatments.

A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA. [2011]
Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted... Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

Comparison of the effects of pilocarpine and cevimeline on salivary flow. [2009.05]
OBJECTIVE: The aim of the present study was to compare the effect of low-dose pilocarpine and cevimeline as stimulants for salivary flow in healthy subjects... CONCLUSION: Both drugs showed efficacy in increasing the salivary flow in healthy volunteers, but cevimeline was more effective than pilocarpine.

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Clinical Trials Related to Salagen (Pilocarpine)

Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients [Recruiting]
This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.

A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment [Completed]

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer [Recruiting]
RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids [Active, not recruiting]
RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition.

PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids.

Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions [Completed]
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGENŽ Tablets, 5 mg (MGI Pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

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Reports of Suspected Salagen (Pilocarpine) Side Effects

Hyperhidrosis (4)Drug Ineffective (3)Hemiparesis (3)Speech Disorder (3)Fatigue (3)Micturition Urgency (3)Infection (2)Sensory Loss (2)Optic Neuritis (2)Adverse Event (2)more >>


Page last updated: 2013-02-10

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