Medication info

Doxepin 3 mg (Doxepin Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Doxepin Hydrochloride›Strength being verified
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White oval tablet
Packaging
200 tablets per bottle
Approval status
Approval withdrawn

MFDS item code 201602091 · Notified 2016.04.14

This product's status changed to Approval withdrawn on 2023.03.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Short-term treatment of insomnia characterized by difficulty maintaining sleep
Who uses it
Adults
Adult dosage
Adults: The recommended dose of this medicine is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Elderly patients aged 65 years and older: The recommended initial dose of this medicine is 3mg once daily. A maximum of 6mg once daily may be administered as prescribed by a physician. Do not administer more than 6mg of this medicine 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 its effects on the following day.

Ingredients

Manufacturer
Hanmi Pharmaceutical 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 patients who have difficulty maintaining sleep. It helps improve symptoms such as difficulty falling asleep or frequent awakenings, facilitating comfortable sleep. This allows for restful sleep, aiding recovery of condition the following day. It supports patients in maintaining healthy sleep patterns.

Dosage and Administration

Adult dosage

Adults: The recommended dose of this medicine is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Elderly patients aged 65 years and older: The recommended initial dose of this medicine is 3mg once daily. A maximum of 6mg once daily may be administered as prescribed by a physician. Do not administer more than 6mg of this medicine 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 its effects on the following day.

Precautions

This medication should only be used after a thorough assessment of the patient's condition, as sleep disorders may be symptoms of other physical or psychological illnesses. If insomnia does not improve after taking this medication for 7-10 days, further testing may be necessary to rule out other underlying conditions. During treatment with this medication, there may be complex behaviors such as sleep driving that the patient does not remember; this risk is particularly heightened when taken with alcohol or other central nervous system depressants. If such dangerous behaviors occur, the immediate discontinuation of the medication should be seriously considered. Patients with depression may experience worsening suicidal thoughts or behaviors when taking this medication, and should consult healthcare professionals immediately upon any new behavioral changes. This medication depresses the central nervous system, hence driving or operating dangerous machinery should be avoided after taking it, and it should not be taken with alcohol or other sedatives. Patients with hypersensitivity to this medication or those taking MAO inhibitors, uncontrolled glaucoma, or severe urinary disorders should not use this medication. During pregnancy, it may pose risks to the fetus, so it should only be taken under medical supervision when absolutely necessary, and caution is required while breastfeeding. Safety in children has not been established; therefore, use in children is not recommended. Elderly patients may be more sensitive to this medication; thus, starting at a lower dose and careful monitoring is advised. Patients with impaired liver function may experience increased drug concentration, necessitating dosage adjustments and careful observation. This medication is not recommended for patients with poor respiratory function or sleep apnea. While this medication has a low potential for abuse and dependency, any unusual behaviors or suspicious signs during treatment should be reported to healthcare professionals. In cases of overdose, severe side effects may occur, and immediate emergency treatment is required along with specialized care such as gastric lavage and ECG monitoring.

Side effects

drowsiness, sedation, upper respiratory tract infection, pharyngitis, enteritis, nausea, hypertension, anemia, thrombocytosis, heart block, palpitations, tachycardia, premature ventricular contractions, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid twitching, double vision, eye pain, decreased lacrimation, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, dyspepsia, constipation, gum bleeding, hematochezia, 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 wall injury, falls, joint sprain, fracture, skin laceration, increased blood sugar, elevated ALT, decreased blood pressure, increased blood pressure, abnormal ST-T segment in ECG, abnormal QRS complex in ECG, decreased heart rate, decreased neutrophil count, abnormal QRS axis in ECG, elevated aminotransferases, decreased appetite, reduced appetite, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, arthralgia, back pain, myalgia, cervical pain, limb pain, decreased joint range of motion, muscle cramps, lethargy, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disturbance, somnolence, paresthesia, syncope, taste loss, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vasovagal syncope, tremor, 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, shortness of breath, skin irritation, cold sweat, dermatitis, erythema, hyperhidrosis, pruritus, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, disorientation, hallucinations, numbness, sensory disturbance, extrapyramidal symptoms, seizures, delayed onset dyskinesia, hypotension, aphthous stomatitis, dyspepsia, increased libido, testicular swelling, gynecomastia, galactorrhea, breast enlargement, increased blood sugar, decreased blood sugar, syndrome of inappropriate antidiuretic hormone secretion, tinnitus, weight gain, sweating, flushing, jaundice, alopecia, exacerbation of asthma, high fever, confusion, concentration impairment, transient visual hallucinations, pupil dilation, restlessness, hyperactive reflexes, confusion, drowsiness, 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 closed container to avoid exposure to air or moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval tablet

Package unit

200 tablets per 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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.