Medication info
Salagen Tablets (Pilocarpine Hydrochloride)

Salagen Tablets (Pilocarpine Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Pilocarpine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
Eisai Korea Inc.
Appearance
White, round, film-coated tablet with a convex shape on both sides
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 199806333 · Approved 1998.02.26 · Insurance code 621100040

Summary

Main use
Treatment of oral and ocular dryness in Sjögren syndrome and dry mouth following head and neck radiotherapy
Who takes it
Adults
Adult dose
1) Patients with head or neck cancer As the initial dose, administer 1 tablet (5㎎) orally 3 times daily. The usual daily dose is 3~6 tablets (15~30㎎, dose per administration: 2 tablets). Even if improvement occurs early in treatment, a beneficial response is seen when this drug is administered as maintenance therapy for at least 12 weeks. As the dose increases, the incidence of adverse effects generally also increases. Use the lowest dose that is tolerated and effective as the maintenance dose. 2) Patients with Sjögren's syndrome Administer 1 tablet per dose orally 4 times daily for 6 weeks.

Ingredients

Importer
Eisai Korea Inc.

Efficacy & effects

Treatment of oral and ocular dryness in Sjögren syndrome and dry mouth following head and neck radiotherapy

  • Xerostomia due to decreased salivary gland function from head and neck cancers
  • Sjögren's syndrome
  • dry eyes
View approved original text

This medication is used to treat xerostomia that occurs in patients with head and neck cancers due to decreased salivary gland function from radiation therapy. It also helps relieve xerostomia and dry eyes in patients with Sjögren's syndrome. This medicine improves discomfort from dryness, enhancing the patient's quality of life.

How to take

Adult dose

1) Patients with head or neck cancer As the initial dose, administer 1 tablet (5㎎) orally 3 times daily. The usual daily dose is 3~6 tablets (15~30㎎, dose per administration: 2 tablets). Even if improvement occurs early in treatment, a beneficial response is seen when this drug is administered as maintenance therapy for at least 12 weeks. As the dose increases, the incidence of adverse effects generally also increases. Use the lowest dose that is tolerated and effective as the maintenance dose. 2) Patients with Sjögren's syndrome Administer 1 tablet per dose orally 4 times daily for 6 weeks.

Precautions

This medication should be used with caution in patients with severe heart and vascular problems. It should be administered under close medical supervision, as it may cause abnormalities in heart rhythm or blood flow. As this medication is used in the eyes, it may cause decreased vision or blurred vision at night. Special caution should be taken when driving at night or performing dangerous tasks in dark environments. Patients with bronchial or lung problems, such as asthma or chronic obstructive pulmonary disease, should also use this medication carefully and follow their doctor's instructions. Patients with asthma or those who have allergic reactions to this medication, as well as those with certain eye diseases, should not use this medication. Various side effects may occur during the use of this medication, including sweating, nausea, diarrhea, dizziness, headache, visual disturbances, skin rashes, etc. In particular, long-term use may lead to serious side effects such as heart problems or myocardial infarction, therefore caution is required. Pregnant or breastfeeding women should consult with their doctor before using this medication, as it may affect the fetus or baby. The safety and efficacy of this medication in children have not been sufficiently confirmed, so its use is not recommended. Elderly patients may experience side effects more readily when using this medication, hence special caution is required. In case of overdose, serious side effects may occur, and immediate contact with a medical institution is necessary for appropriate treatment. This medication may interact with other drugs, so if there are any currently taken medications, it is essential to inform the doctor or pharmacist. This medication should be stored out of reach of children, and care should be taken not to transfer it to another container as it could negatively affect its quality.

Side effects

  • Sweating
  • nausea
  • rhinitis
  • diarrhea
  • chills
  • flushing
  • frequent urination
  • dizziness
  • weakness
  • headache
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  • indigestion
  • urinary incontinence
  • edema
  • abdominal pain
  • amblyopia
  • vomiting
  • pharyngitis
  • hypertension
  • visual disturbances
  • conjunctivitis
  • dysphagia
  • congestion
  • myalgia
  • pruritus
  • rash
  • sinusitis
  • tachycardia
  • taste impairment
  • tremor
  • voice changes
  • body odor
  • hypothermia
  • mucosal abnormalities
  • bradycardia
  • ECG abnormalities
  • palpitations
  • syncope
  • decreased appetite
  • increased appetite
  • esophagitis
  • gastrointestinal disorders
  • tongue disorders
  • leukopenia
  • lymphadenopathy
  • anxiety
  • confusion
  • depression
  • hyperactivity
  • sensory deficits
  • neuroexcitation
  • sensory disturbances
  • speech disorders
  • spasms
  • increased sputum
  • wheezing
  • yawning
  • seborrhea
  • hearing loss
  • eye pain
  • glaucoma
  • voiding disorders
  • uterine bleeding
  • urinary tract disorders
  • body odor
  • hypothermia
  • mucosal abnormalities
  • chest pain
  • cysts
  • death
  • moniliasis
  • neck pain
  • neck stiffness
  • photosensitivity
  • angina
  • arrhythmia
  • hypotension
  • intracranial hemorrhage
  • migraine
  • myocardial infarction
  • decreased appetite
  • hyperbilirubinemia
  • cholelithiasis
  • colitis
  • dry mouth
  • belching
  • gastritis
  • gastroenteritis
  • gastrointestinal abnormalities
  • gingivitis
  • hepatitis
  • abnormal liver function tests
  • hematochezia
  • nausea
  • pancreatitis
  • parotid gland enlargement
  • salivary gland enlargement
  • increased sputum
  • loss of taste
  • tongue abnormalities
  • dental abnormalities
  • hematuria
  • lymph node disorders
  • platelet abnormalities
  • thrombocytosis
  • thrombocytopenia
  • thrombosis
  • leukocyte abnormalities
  • peripheral edema
  • hypoglycemia
  • arthralgia
  • arthritis
  • bone abnormalities
  • spontaneous fractures
  • pathological fractures
  • myasthenia gravis
  • tendon disorders
  • dental diseases
  • aphasia
  • confusion
  • depression
  • abnormal dreams
  • emotional instability
  • insomnia
  • leg cramps
  • dysesthesia
  • abnormal thinking
  • tremor
  • bronchitis
  • dyspnea
  • hiccups
  • laryngeal spasms
  • laryngitis
  • pneumonia
  • viral infections
  • voice changes
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • erythema nodosum
  • exfoliative dermatitis
  • herpes simplex
  • skin ulcers
  • maculopapular rash
  • cataracts
  • conjunctivitis
  • dry eyes
  • ear diseases
  • otalgia
  • eye diseases
  • ocular hemorrhage
  • glaucoma
  • urinary incontinence disorders
  • retinal diseases
  • taste distortion
  • visual disturbances
  • breast pain
  • dysuria
  • mastitis
  • menorrhagia
  • uterine bleeding
  • ovarian disorders
  • pyuria
  • salpingitis
  • urethral pain
  • frequent urination
  • vaginal bleeding
  • vaginal moniliasis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it must be stored in an airtight container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, round, film-coated tablet with a convex shape on both sides

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.