Medication info

Doxepin 6mg (Doxepin Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Doxepin Hydrochloride›Strength being verified
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White-yellow oval tablet
Packaging
200 tablets/bottle, 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201602081 · Notified 2016.04.12

This product's status changed to Approval withdrawn on 2023.03.14.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 sleep quality and supports stable sleep for quick recovery.

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 may be a symptom of another physical or mental condition related to sleep disorders, so the patient's condition should be carefully evaluated before use. If symptoms do not improve after using the medication for 7 to 10 days, it is necessary to consult a specialist as there may be other underlying conditions. During the use of this medication, dangerous behaviors such as sleep driving may occur, so driving or operating dangerous machinery should be avoided. Taking this medication with alcohol or other central nervous system depressants may increase these risks, so they should not be taken together. In patients with depression, thoughts or behaviors of suicide may worsen, so if new behavioral changes occur, immediate consultation with a physician is necessary. This medication has strong sedative effects, so after taking it, it is advisable to limit activities other than preparing for bed. This medication should not be used if there is an allergy to this or similar medications, or if taking certain drugs (e.g., MAO inhibitors). Patients with liver dysfunction may have increased blood concentration, so starting with a low dose and closely monitoring the condition is essential. If pregnant or breastfeeding, it is necessary to consult a doctor before using this medication as it may affect the fetus or baby. In children, safety and efficacy have not been established, so use is not recommended. Elderly patients may be more sensitive to this medication, so starting at a lower dose and closely monitoring should be observed. In cases of overdose, serious side effects may occur, so if suspected, immediate medical attention is required, and emergency care should be obtained. This medication may interact with other medications, so if other drugs are being taken, it is essential to inform a physician or pharmacist.

Side effects

drowsiness, sedation, upper respiratory tract infection, pharyngitis, gastritis, nausea, hypertension, anemia, thrombocytosis, atrioventricular block, palpitations, tachycardia, premature ventricular contractions, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid spasm, double vision, eye pain, decreased lacrimation, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, indigestion, constipation, gum hyperplasia, melena, oral mucosal vesicles, asthenia, chest pain, fatigue, chills, abnormal gait, 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, elevated ALT, decreased blood pressure, increased blood pressure, ECG ST-T segment abnormality, ECG QRS complex abnormality, decreased heart rate, decreased neutrophil count, ECG QRS axis abnormality, increased aminotransferases, decreased appetite, appetite loss, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, arthralgia, back pain, myalgia, cervical pain, limb pain, decreased joint range of motion, muscle cramps, lethargy, lung cancer stage 1, malignant melanoma, dizziness, taste disturbance, somnolence, paresthesia, syncope, loss of taste, ataxia, cerebrovascular accident, attention disorder, migraine, sleep paralysis, vasovagal syncope, tremors, abnormal dreams, adjustment disorder, anxiety, depression, confusion, elevated mood, insomnia, decreased libido, nightmares, breast cyst, dysmenorrhea, dysuria, nocturia, hematuria, nocturnal enuresis, 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, numbness, sensory disturbance, extrapyramidal symptoms, seizures, delayed onset movement disorders, hypotension, aphthous stomatitis, indigestion, 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, exacerbation of asthma, high fever, confusion, concentration disorder, transient visual hallucinations, pupillary dilation, anxiety, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, decreased body temperature

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, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

White-yellow oval tablet

Package unit

200 tablets/bottle, 30 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

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.