Medication info
Enafon Tablet 5 mg (Amitriptyline Hydrochloride)

Enafon Tablet 5 mg (Amitriptyline Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Amitriptyline Hydrochloride›5mg / 1 tablet
Manufacturer / importer
Hanlin Pharmaceutical Co., Ltd.
Appearance
Blue round film-coated tablet
Packaging
200 tablets/bottle, 1000 tablets/bottle
Approval status
Active

MFDS item code 201309959 · Approved 2013.10.29 · Insurance code 657202640

Summary

Main use
Treatment of depression, depressive states, and nocturnal enuresis
Who takes it
Adults
Adult dose
○ Adults: Administer 30-75㎎ per day of amitriptyline hydrochloride orally in 2-3 divided doses, and gradually increase the dose up to 150㎎ per day if necessary. In rare cases, the dose may be increased up to 300㎎ per day. ○ For enuresis, administer 10-30㎎ per day before bedtime. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Hanlin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depression, depressive states, and nocturnal enuresis

  • Depression
  • depressive state
  • enuresis
View approved original text

1. Depression and depressive states are symptoms characterized by persistent low mood and lethargy. This medication is used to help stabilize the mind and alleviate symptoms. 2. Enuresis is a symptom primarily occurring in children and some adults characterized by frequent urination at night. This medication is used to improve such symptoms.

How to take

Adult dose

○ Adults: Administer 30-75㎎ per day of amitriptyline hydrochloride orally in 2-3 divided doses, and gradually increase the dose up to 150㎎ per day if necessary. In rare cases, the dose may be increased up to 300㎎ per day. ○ For enuresis, administer 10-30㎎ per day before bedtime. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication is mainly used to treat symptoms associated with depression. When taking this medication, there is an especially increased risk of suicidal thoughts or behavior in young individuals aged 18 to 24. Therefore, physicians must carefully assess the necessity and closely monitor the patient. This medication should not be administered to specific patients, such as those in the early recovery phase of myocardial infarction, glaucoma patients, patients in a central nervous system depression state, patients with prostatic hypertrophy, patients with arrhythmia, and certain genetically lactose intolerant patients. Additionally, caution should be exercised in patients with epilepsy, heart disease, hyperthyroidism, pregnant women, elderly patients, and those with a tendency towards schizophrenia. The onset of effect may take typically 4 to 10 days after administration of this medication and can occasionally take up to 6 weeks, necessitating consistent consumption. During treatment, drowsiness or decreased attention may occur, thus driving or operating dangerous machinery should be avoided. If suicidal thoughts, behavioral changes, anxiety, restlessness, insomnia, or other symptoms occur during the medication period, immediate consultation with a physician is recommended, and family members or guardians should closely monitor the patient's condition. Severe side effects may include neuroleptic malignant syndrome, inappropriate antidiuretic hormone secretion syndrome, and paralytic ileus. If abnormal symptoms occur, discontinue the medication immediately and seek medical assistance. This medication interacts with many other drugs, so especially when taking it with MAO inhibitors, alcohol, central nervous system depressants, certain antibiotics, heart-related medications, etc., it is essential to inform the physician. Pregnant or breastfeeding women may face risks when taking this medication, so it is crucial to consult a doctor before deciding and it is preferable to avoid administration during breastfeeding. Safety and efficacy of this medication in children and adolescents have not been sufficiently confirmed, so it is advisable to avoid use except in special cases. Elderly patients may be more sensitive to side effects from this medication, so it should be started in small doses and taken cautiously, with regular health status checks. Finally, this medication should be stored out of reach of children and not transferred to another container for safety.

Side effects

Exercise paralysis, severe muscle rigidity, dysphagia, tachycardia, blood pressure changes, sweating, fever, leukocytosis, elevated serum CPK, myoglobinuria, reduced kidney function, high fever, altered consciousness, respiratory distress, circulatory collapse, symptoms of dehydration, acute renal failure, hyponatremia, hypoconcentration, increased sodium excretion in urine, high urine output, seizures, altered consciousness, gastrointestinal paralysis, loss of appetite, nausea, vomiting, significant constipation, abdominal distension and relaxation, stasis of intestinal contents, myocardial infarction, stroke, syncope, hypotension, hypertension, tachycardia, bradycardia, palpitations, QT interval prolongation, arrhythmia, heart block, heart attack, abnormal ECG, allergic vasculitis, increased suicidal tendency, coma, concentration difficulties, disorientation, delusions, hallucinations, nonsensical speech, mental confusion, agitation, anxiety, insomnia, nightmares, paralysis, tinnitus, sensory disturbances in limbs, peripheral neuropathy, ataxia, seizure attacks, tremors, akathisia, headache, fatigue, drowsiness, speech disorder, EEG changes, restlessness, thirst, urinary difficulties, visual acuity disturbances, increased intraocular pressure, constipation, sweating, frequent urination, mydriasis, unusual high fever, rash, urticaria, facial and labial edema, photosensitivity, agranulocytosis, leukopenia, purpura, thrombocytopenia, eosinophilia, nausea, vomiting, loss of appetite, diarrhea, taste disturbances, upper abdominal disturbances, stomatitis, parotid gland swelling, black tongue, testicular swelling, gynecomastia, breast swelling, galactorrhea, decreased libido, increased libido, lowered blood sugar, elevated blood sugar, sexual dysfunction, hepatitis, jaundice, elevated ALT, elevated AST, fractures, drug reaction with eosinophilia and systemic symptoms (DRESS), dizziness, weakness, weight gain, weight loss, alopecia, involuntary movements around the mouth

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 degree Celsius and 30 degrees Celsius. Storing it this way helps to maintain the medication's efficacy.

Appearance and packaging

Appearance

Blue round film-coated tablet

Package unit

200 tablets/bottle, 1000 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.

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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.