Medication info

Boryeong Pilocarpine Tablets (Pilocarpine Hydrochloride)

Prescription medicationTabletOralExpired
Ingredient · strength
Pilocarpine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
Boryeong Co., Ltd.
Appearance
White, round, film-coated tablets with both sides convex
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201310113 · Approved 2013.11.13

This product's status changed to Expired on 2023.11.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of xerostomia after head and neck radiotherapy and oral and ocular dryness associated with Sjögren's syndrome
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㎎; 2 tablets per dose). A beneficial response is observed when administered as maintenance therapy for at least 12 weeks, even if improvement occurred early in treatment. In general, the incidence of adverse effects increases as the dose is increased. Use the lowest dose that is tolerated and effective as the maintenance dose. 2) Patients with Sjögren's syndrome Administer 1 tablet orally 4 times daily for 6 weeks.

Ingredients

Manufacturer
Boryeong Co., Ltd.

Efficacy & effects

Treatment of xerostomia after head and neck radiotherapy and oral and ocular dryness associated with Sjögren's syndrome

  • Xerostomia
  • dry eyes
View approved original text

This medication is used to treat xerostomia resulting from salivary gland function impairment after radiotherapy in patients with head and neck cancer. It is also effective in alleviating xerostomia and dry eyes experienced by patients with Sjögren's syndrome. This improves the dryness of patients' mouths and eyes, thus enhancing their 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㎎; 2 tablets per dose). A beneficial response is observed when administered as maintenance therapy for at least 12 weeks, even if improvement occurred early in treatment. In general, the incidence of adverse effects increases as the dose is increased. Use the lowest dose that is tolerated and effective as the maintenance dose. 2) Patients with Sjögren's syndrome Administer 1 tablet orally 4 times daily for 6 weeks.

Precautions

This medication should be used with caution under strict medical observation in patients with severe cardiovascular diseases as it may cause abnormal blood flow or heart rhythm. When using this medication in the eyes, especially for night driving or in patients who have had vision correction, there may be blurred vision or visual disturbances, so caution is advised when driving at night or performing hazardous tasks in dark places. Increased airway resistance and heightened tension of bronchial smooth muscle may occur, so patients with asthma, chronic bronchitis, or chronic obstructive pulmonary disease should use it under medical supervision. Patients with asthma, hypersensitivity to the drug, acute iritis, or closed-angle glaucoma, as well as those with lactose intolerance or related genetic disorders, should not use this medication. This medication can cause various adverse reactions, including sweating, nausea, diarrhea, headache, visual disturbances, blood pressure changes, and skin rashes. If any unusual symptoms occur, consult a physician immediately. Patients suspected of having gallstones or biliary diseases should use it with caution due to the risk of problems with the gallbladder or bile ducts, and those with kidney stone disease should also be careful as renal colic may worsen. This medication can affect the central nervous system, so patients with mental disorders or cognitive impairment should use it based on physician judgment. Visual disturbances may occur during use so risky activities such as night driving or operating machinery should be avoided. Caution is needed for dehydration risk in patients who cannot maintain adequate fluid intake or who experience excessive sweating. Patients with moderate or severe liver dysfunction should start with a lower initial dose, and it is not recommended for patients with severe liver impairment. Patients with heart conduction disorders or those taking certain heart medications should exercise caution when using this drug, and co-administration with other parasympathetic agents may enhance or antagonize the effect. During pregnancy, this medication may pose a risk to the fetus, so it should only be used after consulting a physician if the benefits outweigh the risks. Nursing mothers should also consider discontinuing the drug or breastfeeding due to the possibility of excretion in breast milk. The safety and efficacy in pediatric patients have not been verified, so it is advisable not to use it in children. Elderly patients may experience increased blood concentrations of the drug and a heightened risk of side effects, so caution is advised. Severe side effects can occur with overdose, so immediate medical attention is required for appropriate treatment. This medication should be kept out of reach of children, and transferring it to another container could lead to degradation in quality or risk of accidents.

Side effects

  • Sweating
  • nausea
  • rhinitis
  • diarrhea
  • chills
  • flush
  • frequent urination
  • dizziness
  • weakness
  • headache
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  • dyspepsia
  • overflow
  • edema
  • abdominal pain
  • amblyopia
  • vomiting
  • pharyngitis
  • hypertension
  • visual disturbances
  • conjunctivitis
  • dysphagia
  • stagnation
  • myalgia
  • pruritus
  • rash
  • sinusitis
  • tachycardia
  • taste distortion
  • tremor
  • voice changes
  • body odor
  • hypothermia
  • mucosal abnormalities
  • bradycardia
  • ECG abnormalities
  • palpitations
  • syncope
  • anorexia
  • increased appetite
  • esophagitis
  • gastrointestinal disorders
  • tongue diseases
  • leukopenia
  • lymph node diseases
  • anxiety
  • confusion
  • depression
  • hyperactivity
  • perceptual decline
  • irritability
  • sensory abnormalities
  • speech disorders
  • spasms
  • increased sputum
  • wheezing
  • yawning
  • seborrhea
  • hearing loss
  • eye pain
  • glaucoma
  • urinary disorders
  • uterine bleeding
  • urinary tract disorders
  • body odor
  • hypothermia
  • mucosal abnormalities
  • chest pain
  • cysts
  • death
  • moniliasis
  • cervical pain
  • neck stiffness
  • phototoxic reactions
  • angina
  • arrhythmia
  • hypotension
  • intracranial hemorrhage
  • migraine
  • myocardial infarction
  • decreased appetite
  • bilirubinemia
  • cholelithiasis
  • colitis
  • dry mouth
  • belching
  • gastritis
  • gastroenteritis
  • gastrointestinal abnormalities
  • gingivitis
  • hepatitis
  • abnormal liver function tests
  • bleeding
  • nausea
  • pancreatitis
  • parotid gland enlargement
  • salivary gland enlargement
  • increased sputum
  • loss of taste
  • tongue abnormalities
  • dental abnormalities
  • hematuria
  • lymphadenopathy
  • platelet disorders
  • 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
  • hyperactivity
  • perceptual decline syndrome
  • insomnia
  • leg cramps
  • irritability syndrome
  • abnormal sensory syndrome
  • abnormal thought
  • tremor
  • bronchitis
  • dyspnea
  • hiccups
  • laryngeal spasms
  • laryngitis
  • pneumonia
  • viral infections
  • voice changes
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • nodular erythema
  • exfoliative dermatitis
  • herpes simplex
  • skin ulcers
  • maculopapular rash
  • cataract
  • conjunctivitis
  • dry eye
  • this condition
  • otalgia
  • eye diseases
  • eye bleeding
  • glaucoma
  • xerophthalmia
  • 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 should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the drug's efficacy and safety over time.

Appearance and packaging

Appearance

White, round, film-coated tablets with both sides convex

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.