Medication info
Pharmadoxepin Tablet 6 mg (Doxepin Hydrochloride)

Pharmadoxepin Tablet 6 mg (Doxepin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Doxepin Hydrochloride›6.78mg / 1 tablet
Manufacturer / importer
HanKook Pharma Co., Ltd.
Appearance
Green oval-shaped tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 200 tablets/bottle
Approval status
Active

MFDS item code 202301841 · Notified 2023.06.14 · Insurance code 653006900

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 medicine is 6 mg once daily. For patients, 3 mg once daily may be appropriate as prescribed by a physician. Elderly patients aged 65 years or older: The recommended initial dose of this medicine is 3 mg once daily. As prescribed by a physician, it may be administered up to a maximum of 6 mg per day. This medicine must not be administered at doses exceeding 6 mg per day. This medicine should be taken within 30 minutes before bedtime and should not be taken within 3 hours after a meal to minimize effects on the following day.

Ingredients

Manufacturer
HanKook Pharma Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia characterized by difficulty maintaining sleep

  • Insomnia with difficulty maintaining sleep
View approved original text

This medication is used for the short-term treatment of insomnia characterized by difficulty maintaining sleep. It helps patients who frequently awaken or have trouble falling asleep due to insomnia. It is used to improve the quality of sleep, enabling patients to sleep longer and alleviating symptoms of insomnia. It is suitable for short-term treatment and contributes to restoring the patient's sleep patterns. It is used to safely and effectively improve insomnia symptoms.

How to take

Adult dose

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

Precautions

This medication may be a symptom of sleep disorders related to other physical or mental illnesses, so the patient's condition should be carefully evaluated before use. If insomnia does not improve after 7 to 10 days of use, further investigation may be necessary as there could be an underlying condition. During the use of this medication, behaviors such as sleep driving may occur without the patient realizing it, so it is advisable to avoid driving or operating dangerous machinery. The risks are increased if taken with alcohol or other central nervous system depressants, so caution is advised. Patients with depression may experience worsening of suicidal thoughts or behaviors when taking this medication, so immediate consultation with a healthcare provider is required if any new unusual behaviors occur. This medication has a central nervous system depressant effect, which may cause drowsiness or decreased concentration afterwards. Patients with hypersensitivity to this medication or those taking certain drugs (MAO inhibitors) should not use it, nor should it be administered to patients with untreated glaucoma or severe urinary dysfunction. Pregnant or breastfeeding women should consult a doctor before using this medication, as it may affect the fetus or newborn. Safety in children has not been established, so it is preferable not to use it in children. Elderly patients may be more sensitive to this medication, so it is recommended to start with a lower dosage and closely monitor their condition. Patients with impaired liver function may need dosage adjustments and careful monitoring due to potentially higher blood concentrations. Patients with sleep apnea should exercise caution when taking this medication, as it may make breathing more difficult, and it is generally not recommended for severely affected patients. While this medication has a low potential for abuse and dependence, careful monitoring of drug use history and unusual behaviors is always necessary. In case of overdose, serious side effects may occur, requiring immediate evaluation and appropriate treatment at a medical facility. Particularly, there may be issues with the heart and central nervous system, so ECG testing and continuous monitoring are required if an overdose is suspected. Do not consume alcohol while taking this medication, and always check for potential interactions with other medications.

Side effects

Drowsiness, sedation, upper respiratory tract infection, nasopharyngitis, gastritis, nausea, hypertension, anemia, thrombocytosis, heart block, palpitations, tachycardia, ventricular premature contractions, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid twitching, diplopia, eye pain, reduced tear secretion, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, indigestion, constipation, gum bleeding, bloody stool, oral vesicles, weakness, chest pain, fatigue, chills, gait abnormality, 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, shingles, tenosynovitis, influenza, lower respiratory tract infection, onychomycosis, pharyngitis, pneumonia, abdominal injury, falls, joint sprain, fracture, skin laceration, increased blood glucose, elevated ALT, decreased blood pressure, increased blood pressure, abnormal ST-T segment on ECG, abnormal QRS complex on ECG, decreased heart rate, decreased neutrophil count, abnormal QRS axis on ECG, increased aminotransferases, loss of appetite, decreased appetite, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, arthralgia, back pain, myalgia, neck pain, limb pain, decreased joint range of motion, muscle cramps, lethargy, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disturbance, somnolence, numbness in hands and feet, syncope, loss of taste, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vasovagal syncope, tremors, abnormal dreams, adjustment disorder, anxiety, depression, confusional state, euphoric mood, insomnia, decreased libido, nightmares, breast cyst, dysmenorrhea, dysuria, nocturia, hemoglobinuria, nocturia, congestion, throat pain, sinus congestion, wheezing, cough, dysphonia, nasopharyngeal disorder, rhinorrhea, dyspnea, skin irritation, cold sweat, dermatitis, erythema, hyperhidrosis, pruritus, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, disorientation, hallucination, anesthesia, sensory disturbance, extrapyramidal symptoms, seizure, delayed onset movement disorder, hypotension, aphthous stomatitis, indigestion, increased libido, testicular swelling, gynecomastia, excessive milk secretion, breast enlargement, increased blood glucose, decreased blood glucose, syndrome of inappropriate antidiuretic hormone secretion, tinnitus, weight gain, sweating, flushing, jaundice, hair loss, asthma exacerbation, high fever, confusion, concentration difficulties, transient hallucination, pupil dilation, restlessness, hyperactive reflexes, stupor, 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 sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Green 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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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.