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.

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SALAGEN NEWS HIGHLIGHTS

Published Studies Related to Salagen (Pilocarpine)

Reducing the incidence of 131I-induced sialadenitis: the role of pilocarpine. [2008.04]
The goal of this study was to reduce the salivary symptoms of pain and xerostomia caused by 131I therapy for papillary and follicular thyroid carcinoma... CONCLUSION: Under the conditions of the study, pilocarpine [generic for Salagen] did not reduce the occurrence of radiation sialadenitis or stomatitis. The occurrence, however, was lower than had previously been reported in the literature, possibly because of the concurrent stringent application of physiologic sialogogues (candy, gum, fluids), dexamethasone, and dolasetron mesylate, a serotonin receptor antagonist.

Protection of salivary function by concomitant pilocarpine during radiotherapy: a double-blind, randomized, placebo-controlled study. [2008.01.01]
CONCLUSIONS: Concomitant administration of pilocarpine [generic for Salagen] during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores. In a subgroup of patients with a mean dose above 40 Gy, pilocarpine administration resulted in sparing of parotid gland function. Therefore, pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable.

Protection of Salivary Function by Concomitant Pilocarpine During Radiotherapy: A Double-Blind, Randomized, Placebo-Controlled Study. [2007.09.13]
CONCLUSIONS: Concomitant administration of pilocarpine [generic for Salagen] during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores. In a subgroup of patients with a mean dose above 40 Gy, pilocarpine administration resulted in sparing of parotid gland function. Therefore, pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable.

Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjogren's syndrome in Taiwan--a double-blind, placebo-controlled trial. [2006.10]
BACKGROUND/PURPOSE: Sjogren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant symptoms of dry mouth and dry eye. As genetic predisposition and ethnicity may alter the effectiveness of drug treatment, evaluation of the efficacy and safety of the secretagogue pilocarpine [generic for Salagen] hydrochloride in the treatment of xerostomia in patients with SS in different populations is needed... CONCLUSION: The results of this study suggest that therapy with 5 mg pilocarpine four times daily is effective, safe and well tolerated for the relief of oral symptoms in patients with SS in Taiwan.

The effect of timolol-dorzolamide and timolol-pilocarpine combinations on ocular blood flow in patients with glaucoma. [2006.06]
PURPOSE: To investigate the effect of timolol-dorzolamide and timolol-pilocarpine [generic for Salagen] fixed combinations on retrobulbar vessel blood flow. DESIGN: Prospective, randomized, masked, crossover clinical trial... CONCLUSIONS: The timolol-dorzolamide combination increases the end diastolic velocity in central retinal artery, despite a lower intraocular pressure decrease, suggesting an effect on retinal circulation.

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Clinical Trials Related to Salagen (Pilocarpine)

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

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.

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 SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions [Completed]
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7. 5 mg, to SALAGEN® Tablets, 7. 5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

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