Cevimeline (Saligren) is a medication used to relieve xerostomia in patients with Sjögren's syndrome. As a cholinergic agonist, it promotes salivary secretion by stimulating the M-type muscarinic receptors of the salivary glands.

Dosage and Administration, Recommended Dose of Cevimeline (Saligren)

Recommended Dose and Dosing Regimen

The standard adult treatment regimen for cevimeline is: 30 mg (calculated as cevimeline hydrochloride) orally three times a day, preferably taken after meals.

Administration Method

This product is a hard capsule formulation and must be swallowed whole; it should not be opened or chewed.

For the medication packaged in PTP (press-through pack) blisters, patients must be instructed to remove the capsule from the aluminum foil blister before taking it, to avoid accidental ingestion of the entire PTP blister which may cause severe complications such as esophageal mucosal injury or even perforation.

Dose Adjustment of Cevimeline (Saligren)

Adjustment Based on Adverse Reactions

If a patient experiences intolerable adverse reactions during treatment, especially common gastrointestinal reactions (e.g., nausea, abdominal pain, diarrhea) or adverse reactions involving other systems.

The primary measure is to assess the necessity of continued medication use, rather than simply reducing the dose.

In most cases, if adverse reactions are significant, discontinuation of the medication should be considered and managed under the guidance of a physician.

Effect of Co-administration with Food

Studies have shown that taking the medication after meals significantly delays the time to reach the peak plasma drug concentration compared with fasting administration, but has little effect on the overall extent of absorption (AUC).

Administration after meals is recommended to reduce gastrointestinal irritation and potentially improve tolerability.

Use in Special Populations of Cevimeline (Saligren)

Patients with Hepatic Impairment

The liver is the main site of cevimeline metabolism (primarily via CYP2D6 and CYP3A4 enzymes).

Hepatic impairment may slow down drug metabolism, leading to a sustained increase in plasma drug concentration and thus an elevated incidence of adverse reactions.

This medication should be used with caution in such patients, with enhanced monitoring.

Patients with Renal Impairment

The drug and its metabolites are mainly excreted via the kidneys.

Decreased renal function may cause drug accumulation in the body, which also increases plasma drug concentration and the risk of adverse reactions.

Caution is also required when using this medication in patients with renal impairment.

Geriatric Patients

Geriatric patients are often accompanied by age-related physiological decline in hepatic and renal function to varying degrees, with reduced drug clearance capacity, which may result in higher plasma drug concentrations and a longer duration of action.

Close monitoring for adverse reactions is required in geriatric patients.

Pregnant and Lactating Women

Pregnant women: This medication may be used only if the therapeutic benefit to the mother is judged to outweigh the potential risk to the fetus. Effects on fetal body weight have been observed in animal studies (rats).

Lactating women: The drug is excreted in rat milk, and whether it is excreted in human milk is unclear. The necessity of drug treatment should be weighed against the benefits of breastfeeding, and a careful decision should be made whether to continue breastfeeding or suspend medication.