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Salagen

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Salagen

Salagen

Salagen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Salagen (pilocarpine hydrochloride) is used in the treatment of dry mouth. It is a cholinergic agonist that increases saliva secretion in the mouth. This medication is available in generic form. Common side effects include changes in vision, increased sweating, dizziness, headache, runny nose, nausea, redness of the face and neck, chills, or increased urge to urinate.

The starting dose of Salagen in patients with moderate hepatic impairment is 5 mg twice daily, and then adjusted based on response and tolerability. The recommended initial dose for head and neck cancer patients is 5 mg three times a day. The recommended dose for Sjogren's Syndrome is 5 mg four times a day. Salagen may interact with heart or blood pressure medications, seizure medication, medication for Parkinson's disease or other medications for muscle control, antihistamines, allergy medications, medication for motion sickness, antidepressants, antipsychotic medications, or medication for stomach problems. Tell your doctor all medications you use. During pregnancy, Salagen should be used only if prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Salagen (pilocarpine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Salagen in Detail - Patient Information: Side Effects

Stop taking pilocarpine and seek emergency medical attention if you experience any of the following uncommon but serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • difficulty breathing;
  • irregular heartbeats;
  • eye pain; or
  • confusion or changes in mental status or behavior.

Other, less serious side effects may also occur. Continue to take pilocarpine and talk to your doctor if you experience

  • changes in vision;
  • increased sweating;
  • dizziness;
  • headache;
  • runny nose;
  • nausea;
  • redness of the face and neck;
  • chills; or
  • an increased urge to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Salagen (Pilocarpine Hydrochloride) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Salagen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Head & 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 and 64 years (51%), 33% were 65 years and older and 16% were younger than 50 years of age. The most frequent adverse experiences associated with SALAGEN® Tablets were a consequence of the expected pharmacologic effects of pilocarpine.

Adverse Event Pilocarpine HCI Placebo (tid.)
10 mg t.i.d. (30 mg/day) 5 mg t.i.d. (15 mg/day)
Sweating N=121/68% N=141/ 29% N=152/9%
Nausea 15 6 4
Rhinitis 14 5 7
Diarrhea 7 4 5
Chills 15 3 <1
Flushing 13 8 3
Urinary Frequency 12 9 7
Dizziness 12 5 4
Asthenia 12 6 3

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

Adverse Event Pilocarpine HCI Placebo (tid.)
5-10 mg t.i.d. (15-30 mg/day)
Headache N=212/11% N=152/8%
Dyspepsia 7 5
Lacrimation 6 8
Edema 5 4
Abdominal Pain 4 4
Amblyopia 4 2
Vomiting 4 1
Pharyngitis 3 8
Hypertension 3 1

The following events were reported with treated head and neck cancer patients at incidences of 1% to 2% at dosages of 7.5 to 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, hypesthesia, nervousness, parethesias, 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 were two patients with underlying cardiovascular disease of whom one experienced a myocardial infarct and another an episode of syncope. The association with drug 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 and 69 years (70%), 16% were 70 years and older and 14% were younger than 40 years of age. Of these patients, 161/629 (89/376 receiving pilocarpine) were over the age of 65 years. The adverse events reported by those over 65 years and those 65 years and younger 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 of the non-elderly. The incidence of dizziness was about three 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 drug 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® Tablets:

Adverse Event Pilocarpine HCI Placebo (qid)
5 mg q.i.d. (20 mg/day)
Sweating N=255/40% N=253/7%
Urinary Frequency 10 4
Nausea 9 9
Flushing 9 2
Rhinitis 7 8
Diarrhea 6 7
Chills 4 2
Increased Salivation 3 0
Asthenia 2 2

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

Adverse Event Pilocarpine HCI Placebo (qid)
5 mg q.i.d. 20 mg/day
Headache N=255/13% N=253/19%
Flu Syndrome 9 9
Dyspepsia 7 7
Dizziness 6 7
Pain 4 2
Sinusitis 4 5
Abdominal Pain 3 4
Vomiting 3 1
Pharyngitis 2 5
Rash 2 3
Infection 2 6

The following events were reported in Sjogren's patients at incidences of 1% to 2% at dosing of 20 mg/day: accidental injury, allergic reaction, back pain, blurred vision, constipation, increased cough, edema, epistaxis, face edema, fever, flatulence, glossitis, lab test abnormalities, including chemistry, hematology, and urinalysis, myalgia, palpitation, pruritus, somnolence, stomatitis, tachycardia, tinnitus, urinary incontinence, urinary tract infection, and vaginitis.

The following events were reported rarely in treated Sjogren's patients ( <1%) at dosing of 10-30 mg/day: 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 & vomiting, pancreatitis, parotid gland enlargement, salivary gland enlargement, sputum increased, taste loss, tongue disorder, tooth disorder

Hematologic: hematuria, lymphadenopathy, abnormal platelets, thrombocythemia, thrombocytopenia, thrombosis, abnormal WBC

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, hypesthesia, insomnia, leg cramps, nervousness, parethesias, 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 disorder, 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: A-V block, agitation, ciliary congestion, confusion, delusion, depression, dermatitis, middle ear disturbance, eyelid twitching, malignant glaucoma, iris cysts, macular hole, shock, and visual hallucination.

Read the entire FDA prescribing information for Salagen (Pilocarpine Hydrochloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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