Medication info
Pharmadoxepin Tablet 3 mg (Doxepin Hydrochloride)

Pharmadoxepin Tablet 3 mg (Doxepin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Doxepin Hydrochloride›3.39mg / 1 tablet
Manufacturer / importer
HanKook Pharma Co., Ltd.
Appearance
Blue oval-shaped tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 200 tablets/bottle
Approval status
Active

MFDS item code 202301840 · Notified 2023.06.14 · Insurance code 653006890

Summary

Main use
Short-term treatment of insomnia characterized by difficulty maintaining sleep
Who takes it
Adults
Adult dose
Adults: The recommended dose of this medication is 6 mg once daily; for patients, 3 mg once daily may be appropriate as prescribed by a physician. Adults aged 65 years and older: The recommended initial dose of this medication is 3 mg once daily. It may be administered at a maximum dose of 6 mg per day as prescribed by a physician. This medication must not be administered at a dose exceeding 6 mg per day. This medication should be taken within 30 minutes before bedtime and should not be taken within 3 hours after a meal to minimize its effects on the following day.

Ingredients

Manufacturer
HanKook Pharma Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia characterized by difficulty maintaining sleep

  • Difficulty maintaining sleep
  • insomnia
View approved original text

This medication is used for the short-term treatment of insomnia with difficulties in maintaining sleep. By taking this medication, patients can sleep longer and improve the issue of waking up frequently during the night. It is effective for short-term use and helps improve the quality of sleep, aiding in recovery from fatigue and enhancing concentration in daily life. Therefore, this medication can be a good choice for alleviating insomnia.

How to take

Adult dose

Adults: The recommended dose of this medication is 6 mg once daily; for patients, 3 mg once daily may be appropriate as prescribed by a physician. Adults aged 65 years and older: The recommended initial dose of this medication is 3 mg once daily. It may be administered at a maximum dose of 6 mg per day as prescribed by a physician. This medication must not be administered at a dose exceeding 6 mg per day. This medication should be taken within 30 minutes before bedtime and should not be taken within 3 hours after a meal to minimize its effects on the following day.

Precautions

This medication may be a symptom of physical or mental disorders, so a thorough evaluation of the patient's condition is necessary before administration. If insomnia does not improve after 7 to 10 days of use, there may be other psychiatric or internal medical conditions, and consultation with a specialist should be sought. While taking this medication, behaviors such as sleep driving that the patient cannot remember may occur, and taking it with alcohol or other central nervous system depressants may increase risks. Patients may experience exacerbation of depression or suicidal thoughts while on this medication, so any new unusual behaviors or mood changes should be reported to a doctor immediately. This medication suppresses the central nervous system, which may cause drowsiness or decreased concentration; patients should avoid driving or operating hazardous machinery after taking it. Caution is needed when taking it with alcohol, antihistamines, or other central nervous system depressants, as this may enhance sedative effects. Patients with allergies to this medication or similar medications, those taking specific drugs (MAO inhibitors), or those with untreated glaucoma or severe urinary difficulties should not take this medication. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may affect the fetus or neonate. Safety and efficacy in children have not been established, and use is not recommended. Elderly patients may be more sensitive to this medication; they should start at a lower dose and be closely monitored. Patients with poor liver function may experience elevated blood concentrations, requiring dose adjustment and careful monitoring. Patients with respiratory issues, such as sleep apnea, should exercise caution when taking this medication, and it is not recommended for severe cases. This medication has a low potential for abuse and dependence, but it is important to notify a doctor if unusual behaviors or drug-seeking behavior occur during use. In cases of overdose, serious side effects may arise, necessitating immediate hospital treatment, including gastric lavage, ECG monitoring, and observation of central nervous system and cardiovascular symptoms; appropriate medication should be administered if seizures occur. Regularly check the patient's condition according to the doctor's instructions while on this medication, and consult a doctor immediately if any unusual symptoms occur.

Side effects

Drowsiness, sedation, upper respiratory tract infection, pharyngitis, gastroenteritis, nausea, hypertension, anemia, thrombocytosis, atrioventricular block, palpitations, tachycardia, ventricular ectopy, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid spasm, double vision, eye pain, decreased urination, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, dyspepsia, constipation, gum retraction, blood in stool, perioral vesicles, weakness, chest pain, fatigue, chills, gait abnormalities, peripheral edema, hyperbilirubinemia, hypersensitivity reaction, bronchitis, fungal infection, laryngitis, sinusitis, dental infection, urinary tract infection, viral infection, soft tissue infection, eye infection, folliculitis, viral gastroenteritis, herpes zoster, tenosynovitis, influenza, lower respiratory tract infection, onychomycosis, pharyngitis, pneumonia, abdominal injury, falls, joint sprain, fracture, skin laceration, increased blood sugar, ALT elevation, decreased blood pressure, increased blood pressure, abnormal ST-T segments in ECG, abnormal QRS complexes in ECG, decreased heart rate, decreased neutrophil count, abnormal QRS axis in ECG, increased aminotransferases, decreased appetite, appetite loss, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, joint pain, back pain, myalgia, cervical pain, limb pain, decreased joint range of motion, muscle cramps, lethargy, stage I lung adenocarcinoma, malignant melanoma, dizziness, taste disturbances, somnolence, tingling in hands and feet, syncope, loss of taste, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vasovagal syncope, tremor, abnormal dreams, adjustment disorder, anxiety, depression, confusion, euphoric mood, insomnia, decreased libido, nightmares, breast cysts, dysmenorrhea, dysuria, nocturia, hemoglobinuria, nocturnal urination, congestion, throat pain, sinus congestion, wheezing, cough, dysphonia, pharyngeal disorder, runny nose, dyspnea, skin irritation, cold sweat, dermatitis, erythema, hyperhidrosis, pruritus, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, disorientation, hallucinations, numbness, sensory disturbances, extrapyramidal symptoms, seizures, tardive dyskinesia, hypotension, aphthous stomatitis, dyspepsia, increased libido, scrotal swelling, gynecomastia, hypersecretion of milk, breast enlargement, increased blood sugar, decreased blood sugar, syndrome of inappropriate antidiuretic hormone secretion, tinnitus, weight gain, sweating, flushing, jaundice, hair loss, asthma exacerbation, high fever, confusion, concentration difficulties, transient hallucinations, pupil dilation, anxiety, hyperactive reflexes, lethargy, drowsiness, muscle rigidity, vomiting, hypothermia, high fever

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

Storage

This medication should be stored in a tightly sealed container to prevent contact with air or moisture, and it is safest to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Blue oval-shaped tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 200 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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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.