Salagen

Salagen

pilocarpine

Manufacturer:

Concordia Pharmaceuticals

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Pilocarpine HCl.
Description
Each tablet also contains the following inactive ingredients: Carnauba wax, hydroxypropyl methylcellulose, iron oxide, microcrystalline cellulose, stearic acid and titanium dioxide.
Pilocarpine HCl is (3S-cis)-2-(3H)-furanone,3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl)]monoHCl. It 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. It has a molecular weight of 244.72.
Action
Pharmacology: Pharmacodynamics: Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal, gastric, pancreatic and intestinal glands, and the mucous cells of the respiratory tract may be stimulated. When applied topically to the eye as a single dose, it causes miosis, spasm of accommodation, and may cause a transitory rise in intraocular pressure followed by a more persistent fall. Dose-related smooth muscle stimulation of the intestinal tract may cause increased tone, increased motility, spasm and tenesmus. Bronchial smooth muscle tone may increase. The tone and motility of urinary tract, gallbladder and biliary duct smooth muscle may be enhanced. Pilocarpine may have paradoxical effects on the cardiovascular system. The expected effect of a muscarinic agonist is vasodepression, but administration of pilocarpine may produce hypertension after a brief episode of hypotension. Bradycardia and tachycardia have both been reported with use of pilocarpine.
In a study of 12 healthy male volunteers, there was a dose-related increase in unstimulated salivary flow following a single 5- and 10-mg oral doses of Salagen. This effect of pilocarpine on salivary flow was time-related with an onset at 20 min and a peak effect at 1 hr with a duration of 3-5 hrs. (See Pharmacokinetics in the succeeding text.)
Head and Neck Cancer Patients: In a 12-week, randomized, double-blind, placebo-controlled study in 207 patients (placebo, N=65; 5 mg, N=73; 10 mg, N=69), increases from baseline (means 0.072 and 0.112 mL/min, ranges -0.69 to 0.728 and -0.38 to 1.689) of whole saliva flow for the 5-mg (63%) and 10-mg (90%) tablets, respectively, were seen 1 hr after the 1st dose of Salagen. Increases in unstimulated parotid flow were seen following the 1st dose (means 0.025 and 0.046 mL/min, ranges 0-0.414 and -0.07 to 1.002 mL/min for the 5- and 10-mg dose, respectively). In this study, no correlation existed between the amount of increase in salivary flow and the degree of symptomatic relief.
Sjogren's Syndrome Patients: In two 12-week, randomized, double-blind, placebo-controlled studies in 629 patients (placebo, N=253; 2.5 mg, N=121; 5 mg, N=255; 5-7.5 mg, N=114), the ability of Salagen to stimulate saliva production was assessed. In these trials using varying doses of Salagen (2.5-7.5 mg), the rate of saliva production was plotted against time. An area under the curve (AUC) representing the total amount of saliva being produced during the observation interval was calculated. Relative to placebo, an increase in the amount of saliva being produced was observed following the 1st dose of Salagen and was maintained throughout the duration (12 weeks) of the trials in an approximate dose response fashion (see Clinical Studies in the succeeding text).
Clinical Studies: Head and Neck Cancer Patients: A 12-week randomized, double-blind, placebo-controlled study in 207 patients (142 men, 65 women) was conducted in patients whose mean age was 58.5 years with a range of 19-77; the racial distribution was Caucasian, 95%; Black, 4%; and others, 1%. In this population, a statistically significant improvement in mouth dryness occurred in the Salagen 5-mg and 10-mg tablet-treated patients compared to placebo-treated patients. The 5- and 10-mg treated patients could not be distinguished. (See Pharmacology: Pharmacodynamics in the previous text for flow study details.)
Another 12-week, double-blind, randomized, placebo-controlled study was conducted in 162 patients whose mean age was 57.8 years with a range of 27-80; the racial distribution was Caucasian, 88%; Black, 10%; and others, 2%. The effects of placebo were compared to 2.5 mg 3 times a day of Salagen for 4 weeks followed by titration of 5 mg 3 times a day and 10 mg 3 times a day. Lowering of the dose was necessary because of adverse events in 3 of 67 patients treated with Salagen 5 mg and in 7 of 66 patients treated with Salagen 10 mg. After 4 weeks of treatment, Salagen-2.5 mg tablets 3 times a day was comparable to placebo in relieving dryness. In patients treated with Salagen 5 mg and 10 mg, the greatest improvement in dryness was noted in patients with no measurable salivary flow at baseline.
In both studies, some patients noted improvement in the global assessment of their dry mouth, speaking without liquids and a reduced need for supplemental oral comfort agents.
In the 2 placebo-controlled clinical trials, the most common adverse events related to drug, and increasing in rate as dose increases, were sweating, nausea, rhinitis, diarrhea, chills, flushing, urinary frequency, dizziness and asthenia. The most common adverse experience causing withdrawal from treatment was sweating (5 mg 3 times daily, ≤1%; 10 mg 3 times daily, =12%).
Sjogren's Syndrome Patients: Two separate studies were conducted in patients with primary or secondary Sjogren's syndrome. In both studies, the majority of patients best fit the European criteria for having primary Sjogren's syndrome.
A 12-week, randomized, double-blind, parallel-group, placebo-controlled study was conducted in 256 patients (14 men, 242 women) whose mean age was 57 years with a range of 24-85 years. The racial distribution was as follows: Caucasian, 91%; Black, 6%; and others, 3%.
The effects of placebo were compared with those of Salagen 5 mg 4 times a day (20 mg/day) for 6 weeks. At 6 weeks, the patients' dosage was increased from Salagen 5 mg 4 times daily to 7.5 mg 4 times daily. The data collected during the first 6 weeks of the trial were evaluated for safety and efficacy, and the data of the second 6 weeks of the trial were used to provide additional evidence of safety.
After 6 weeks of treatment, statistically significant global improvement of dry mouth was observed compared to placebo. Global improvement is defined as a score of ≥55 mm on a 100-mm visual analogue scale in response to the question, "Please rate your present condition of dry mouth (xerostomia) compared with your condition at the start of this study. Consider the changes to your dry mouth and other symptoms related to your dry mouth that have occurred since you have taken this medication". Patients' assessments of specific dry mouth symptoms eg, severity of dry mouth, mouth discomfort, ability to speak without water, ability to sleep without drinking water, ability to swallow food without drinking and a decreased use of saliva substitutes were found to be consistent with the significant global improvement described.
Another 12-week, randomized, double-blind, parallel-group, placebo-controlled study was conducted in 373 patients (16 men, 357 women) whose mean age was 55 years with a range of 21-84. The racial distribution was Caucasian, 80%; Oriental, 14%; Black, 2%; and 4% of other origin. The treatment groups were pilocarpine 2.5 mg, Salagen 5 mg and placebo. All treatments were administered on a 4-times-a-day regimen.
After 12 weeks of treatment, statistically significant global improvement of dry mouth was observed at a dose of 5 mg compared with placebo. The 2.5-mg (10 mg/day) group was not significantly different than placebo. However, a subgroup of patients with rheumatoid arthritis tended to improve in global assessments at both the 2.5-mg 4 times daily (9 patients) and 5-mg 4 times daily (16 patients) dose (10-20 mg/day). The clinical significance of this finding is unknown.
Patients' assessments of specific dry mouth symptoms eg, severity of dry mouth, mouth discomfort, ability to sleep without drinking water and decreased use of saliva substitutes were also found to be consistent with the significant global improvement described when measured after 6 weeks and 12 weeks of Salagen use.
Pharmacokinetics: In a multiple-dose pharmacokinetic study in male volunteers following 2 days of 5 or 10 mg of oral pilocarpine HCl tablets given at 8:00 in the morning, noontime and 6:00 in the evening, the mean elimination t½ was 0.76 hr for the 5-mg dose and 1.35 hrs for the 10-mg dose. Time to maximum plasma concentration (Tmax) values were 1.25 hr and 0.85 hr. Peak plasma concentration (Cmax) values were 15 ng/mL and 41 ng/mL. The area under the concentration-time curve (AUC) trapezoidal values were 33 ng·hr/mL and 108 ng·hr/mL, respectively, for the 5-mg and 10-mg doses following the last 6-hr dose.
Pharmacokinetics in elderly male volunteers (N=11) were comparable to those in younger men. In 5 healthy elderly female volunteers, the mean Cmax and AUC were approximately twice that of elderly males and young normal male volunteers.
When taken with a high fat meal by 12 healthy male volunteers, there was a decrease in the rate of absorption of pilocarpine from Salagen. Mean Tmax were 1.47 hrs and 0.87 hr, and the mean Cmax were 51.8 ng/mL and 59.2 ng/mL for the fed and fasted, respectively.
Limited information is available about the metabolism and elimination of pilocarpine in humans. Inactivation of pilocarpine is thought to occur at neuronal synapses and probably in plasma. Pilocarpine and its minimally active or inactive degradation products, including pilocarpic acid, are excreted in the urine. Pilocarpine does not bind to human or rat plasma proteins over a concentration range of 5-25,000 ng/mL. The effect of pilocarpine on plasma protein-binding of other drugs has not been evaluated.
Indications/Uses
Treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; treatment of symptoms of dry mouth in patients with Sjogren's syndrome.
Dosage/Direction for Use
Head and Neck Cancer Patients: Recommended Initial Dose: One tab (5 mg) taken 3 times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dose range is up to 3-6 tab/day or 15-30 mg/day (not to exceed 2 tab/dose). Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with Salagen may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.
Sjogren's Syndrome Patients: Recommended Dose: One tab (5 mg) taken 4 times a day. Efficacy was established by 6 weeks of use.
Overdosage
Fatal overdosage with pilocarpine has been reported in the scientific literature at doses presumed to be >100 mg in 2 hospitalized patients. Pilocarpine 100 mg is considered potentially fatal. Overdosage should be treated with atropine titration (0.5-1 mg given SC or IV) and supportive measures to maintain respiration and circulation.
Epinephrine (0.3-1 mg given SC or IM) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if pilocarpine is dialyzable.
Contraindications
Uncontrolled asthma, known hypersensitivity to pilocarpine and when miosis is undesirable eg, in acute iritis and in narrow-angle (angle-closure) glaucoma.
Warnings
Cardiovascular Disease: Patients with significant cardiovascular disease may be unable to compensate for transient changes in hemodynamics or rhythm induced by pilocarpine. Pulmonary edema has been reported as a complication of pilocarpine toxicity from high ocular doses given for acute angle-closure glaucoma. Pilocarpine should be administered with caution in and under close medical supervision of patients with significant cardiovascular disease.
Pulmonary Disease: Pilocarpine has been reported to increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Pilocarpine HCl should be administered with caution to and under close medical supervision in patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease requiring pharmacotherapy.
Special Precautions
General: Pilocarpine toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia and tremors.
The dose-related cardiovascular pharmacologic effects of pilocarpine include hypotension, hypertension, bradycardia and tachycardia.
Pilocarpine should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder or biliary smooth muscle could precipitate complications including cholecystitis, cholangitis and biliary obstruction.
Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic (or ureteral reflux), particularly in patients with nephrolithiasis.
Cholinergic agonists may have dose-related central nervous system effects. This should be considered when treating patients with underlying cognitive or psychiatric disturbances.
Renal Insufficiency: The pharmacokinetics of orally administered pilocarpine in patients with renal and hepatic disease is not known.
Information for Patients: Patients should be informed that pilocarpine may cause visual disturbances, especially at night, that could impair their ability to drive safely.
If a patient sweats excessively while taking pilocarpine HCl and cannot drink enough liquid, the patient should consult a physician. Dehydration may develop.
Effects on the Ability to Drive or Operate Machinery: Ocular: Ocular formulations of pilocarpine have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.
Carcinogenicity, Mutagenicity & Impairment of Fertility: No definitive long-term animal studies have evaluated the carcinogenic potential of pilocarpine. No evidence that pilocarpine has the potential to cause genetic toxicity was obtained in a series of studies that included: Bacterial assays (Salmonella and E. coli) for reverse gene mutations; an in vitro chromosome aberration assay in a Chinese hamster ovary cell line; an in vivo chromosome aberration assay (micronucleus test) in mice; and a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures.
Oral administration of pilocarpine to male and female rats at a dosage of 18 mg/kg/day [approximately 5 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] resulted in impaired reproductive function, including reduced fertility, decreased sperm motility and morphologic evidence of abnormal sperm. It is unclear whether the reduction in fertility was due to effects on male animals, female animals or both males and females. In dogs, exposure to pilocarpine at dosage of 3 mg/kg/day [approximately 3 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] for 6 months resulted in evidence of impaired spermatogenesis. The data obtained in these studies suggest that pilocarpine may impair the fertility of male and female humans.
Salagen should be administered to individuals who are attempting to conceive a child only if the potential benefit justifies potential impairment of fertility.
Use in pregnancy: Pregnancy Category C: Pilocarpine was associated with a reduction in the mean fetal body weight and an increase in the incidence of skeletal variations when given to pregnant rats at a dosage of 90 mg/kg/day [approximately 26 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates]. These effects may have been secondary to maternal toxicity. In another study, oral administration of pilocarpine to female rats during gestation and lactation at a dosage of 36 mg/kg/day [approximately 10 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] resulted in an increased incidence of stillbirths; decreased neonatal survival and reduced mean body weight of pups were observed at dosages of 18 mg/kg/day [approximately 5 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] and above. There are no adequate and well-controlled studies in pregnant women. Salagen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether pilocarpine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Salagen, a decision should be made whether to discontinue nursing or to discontinue Salagen, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in pediatric patients have not been established.
Use in the elderly: Head and Neck Cancer Patients: In the placebo-controlled clinical trials (see Clinical Studies under Actions), the mean age of patients was approximately 58 years (range 19-80). Of these patients, 97/369 (61/217 receiving pilocarpine) were >65 years. In the healthy volunteers studies, 15/150 subjects were >65 years. In both study populations, the adverse events reported by those >65 years and those ≤65 years were comparable. Of the 15 elderly volunteers (5 women, 10 men), the 5 women had higher peak plasma concentration (Cmax) and area under the curve (AUC) than the men. (See Pharmacokinetics under Actions.)
Sjogren's Syndrome Patients: In the placebo-controlled clinical trials (see Clinical Studies under Actions), the mean age of patients was approximately 55 years (range 21-85). The adverse events reported by those >65 years and those ≤65 years were comparable except for notable trends for urinary frequency, diarrhea and dizziness (see Adverse Reactions).
Use In Pregnancy & Lactation
Use in pregnancy: Pregnancy Category C: Pilocarpine was associated with a reduction in the mean fetal body weight and an increase in the incidence of skeletal variations when given to pregnant rats at a dosage of 90 mg/kg/day [approximately 26 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates]. These effects may have been secondary to maternal toxicity. In another study, oral administration of pilocarpine to female rats during gestation and lactation at a dosage of 36 mg/kg/day [approximately 10 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] resulted in an increased incidence of stillbirths; decreased neonatal survival and reduced mean body weight of pups were observed at dosages of 18 mg/kg/day [approximately 5 times the maximum recommended dose for a 50-kg human when compared on the basis of body surface area (mg/m2) estimates] and above. There are no adequate and well-controlled studies in pregnant women. Salagen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether pilocarpine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Salagen, a decision should be made whether to discontinue nursing or to discontinue Salagen, taking into account the importance of the drug to the mother.
Adverse Reactions
Head and Neck Cancer Patients: In controlled studies, 217 patients received pilocarpine, of whom 68% were men and 32% were women. Race distribution was 91% Caucasian, 8% Black and 1% of other origin. Mean age was approximately 58 years. The majority of patients were between 50 years and 64 years (51%), 33% were ≥65 years and 16% were <50 years.
The most frequent adverse experiences associated with Salagen were a consequence of the expected pharmacologic effects of pilocarpine. (See Table 1.)

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In addition, the following adverse events (≥3% incidence) were reported at dosages of 15-30 mg/day in the controlled clinical trials. (See Table 2.)

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The following events were reported with treated head and neck cancer patients at incidences of 1-2% at dosages of 7.5-30 mg/day: Abnormal vision, conjunctivitis, dysphagia, epistaxis, myalgias, pruritus, rash, sinusitis, tachycardia, taste perversion, tremor, voice alteration.
The following events were reported rarely in treated head and neck cancer patients (<1%): Causal relation is unknown.
Body as a Whole: Body odor, hypothermia, mucous membrane abnormality.
Cardiovascular: Bradycardia, ECG abnormality, palpitations, syncope.
Digestive: Anorexia, increased appetite, esophagitis, gastrointestinal disorder, tongue disorder.
Hematologic: Leukopenia, lymphadenopathy.
Nervous: Anxiety, confusion, depression, abnormal dreams, hyperkinesia, hypoesthesia, nervousness, paresthesias, speech disorder, twitching.
Respiratory: Increased sputum, stridor, yawning.
Skin: Seborrhea.
Special Senses: Deafness, eye pain, glaucoma.
Urogenital: Dysuria, metrorrhagia, urinary impairment.
In long-term treatment of 2 patients with underlying cardiovascular disease, one experienced a myocardial infarct and the other an episode of syncope. The association with pilocarpine is uncertain.
Sjogren's Syndrome Patients: In controlled studies, 376 patients received pilocarpine, of whom 5% were men and 95% were women. Race distribution was 84% Caucasian, 9% Oriental, 3% Black and 4% of other origin. Mean age was 55 years. The majority of patients were between 40 years and 69 years (70%), 16% were ≥70 years and 14% were <40 years. Of these patients, 161/629 (89/376 receiving pilocarpine) were >65 years. The adverse events reported by those >65 years and those ≤65 years were comparable except for notable trends for urinary frequency, diarrhea and dizziness. The incidences of urinary frequency and diarrhea in the elderly were about double those in the non-elderly. The incidence of dizziness was about 3 times as high in the elderly as in the non-elderly. These adverse experiences were not considered to be serious. In the 2 placebo-controlled studies, the most common adverse events related to Salagen use were sweating, urinary frequency, chills and vasodilatation (flushing). The most commonly reported reason for patient discontinuation of treatment was sweating. Expected pharmacologic effects of pilocarpine include the following adverse experiences associated with Salagen: See Table 3.

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In addition, the following adverse events (≥3% incidence) were reported at dosing of 20 mg/day in the controlled clinical trials: See Table 4.

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The following events were reported in Sjogren's patients at incidences of 1-2% at dosing of 20 mg/day: Accidental injury, allergic reaction, back pain, blurred vision, constipation, increased cough, edema, epistaxis, facial edema, fever, flatulence, glossitis, laboratory test abnormalities including chemistry, hematology and urinalysis, myalgia, palpitation, pruritus, somnolence, stomatitis, tachycardia, tinnitus, urinary incontinence, urinary tract infection, vaginitis, vomiting.
The following events were reported rarely in treated Sjogren's patients (<1%): Causal relation is unknown.
Body as a Whole: Chest pain, cyst, death, moniliasis, neck pain, neck rigidity, photosensitivity reaction.
Cardiovascular: Angina pectoris, arrhythmia, ECG abnormality, hypotension, hypertension, intracranial hemorrhage, migraine, myocardial infarction.
Digestive: Anorexia, bilirubinemia, cholelithiasis, colitis, dry mouth, eructation, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis, hepatitis, abnormal liver function tests, melena, nausea and vomiting, pancreatitis, parotid gland enlargement, salivary gland enlargement, increased sputum, taste loss, tongue disorder, tooth disorder.
Hematologic: Hematuria, lymphadenopathy, abnormal platelets, thrombocythemia, thrombocytopenia, thrombosis, abnormal white blood cells.
Metabolic and Nutritional: Peripheral edema, hypoglycemia.
Musculoskeletal: Arthralgia, arthritis, bone disorder, spontaneous bone fracture, pathological fracture, myasthenia, tendon disorder, tenosynovitis.
Nervous: Aphasia, confusion, depression, abnormal dreams, emotional lability, hyperkinesia, hypoesthesia, insomnia, leg cramps, nervousness, paresthesias, abnormal thinking, tremor.
Respiratory: Bronchitis, dyspnea, hiccup, laryngismus, laryngitis, pneumonia, viral infection, voice alteration.
Skin: Alopecia, contact dermatitis, dry skin, eczema, erythema nodosum, exfoliative dermatitis, herpes simplex, skin ulcer, vesiculobullous rash.
Special Senses: Cataract, conjunctivitis, dry eyes, ear disorder, ear pain, eye disorder, eye hemorrhage, glaucoma, lacrimation and retinal disorder, taste perversion, abnormal vision.
Urogenital: Breast pain, dysuria, mastitis, menorrhagia, metrorrhagia, ovarian disorder, pyuria, salpingitis, urethral pain, urinary urgency, vaginal hemorrhage, vaginal moniliasis.
The following adverse experiences have been reported rarely with ocular pilocarpine: Atrioventricular block, agitation, ciliary congestion, confusion, delusion, depression, dermatitis, middle ear disturbance, eyelid twitching, malignant glaucoma, iris cysts, macular hole, shock and visual hallucination.
Drug Interactions
Pilocarpine should be administered with caution to patients taking β-adrenergic antagonists because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with pilocarpine would be expected to result in additive pharmacologic effects. Pilocarpine might antagonize the anticholinergic effects of drugs used concomitantly. These effects should be considered when anticholinergic properties may be contributing to the therapeutic effect of concomitant medication (eg, atropine, inhaled ipratropium).
While no formal drug interaction have been performed, the following concomitant drugs were used in at least 10% of patients in either or both Sjogren's efficacy studies: Acetylsalicylic acid, artificial tears, calcium, conjugated estrogens, hydroxychloroquine sulfate, ibuprofen, levothyroxine sodium, medroxyprogesterone acetate, methotrexate, multivitamins, naproxen, omeprazole, paracetamol and prednisone.
Storage
Store at controlled room temperature 15-30°C (59-86°F).
ATC Classification
N07AX01 - pilocarpine ; Belongs to the class of other parasympathomimetics.
Presentation/Packing
Tab 5 mg (white, film-coated, round, coded MGI 705) x 100's.
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