Medication info
Aizart CR Tablets 12.5 mg (Paroxetine Hydrochloride Hydrate)

Aizart CR Tablets 12.5 mg (Paroxetine Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Paroxetine Hydrochloride Hydrate›14.25mg / 1 tablet
Manufacturer / importer
HK Inno.N Co., Ltd.
Appearance
Yellow round enteric-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200806300 · Approved 2008.06.05 · Insurance code 640004900

Summary

Main use
Treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
Major depressive disorder: The recommended initial dose is 25 mg once daily. If there is no response to 25 mg, the dose may be increased in increments of 12.5 mg up to a maximum of 62.5 mg once daily. Panic disorder: The starting dose is 12.5 mg once daily, increased by 12.5 mg each week. The daily dose should not exceed 75 mg. Social anxiety disorder/social phobia: The recommended starting dose is 12.5 mg once daily. The dose may be increased in increments of 12.5 mg at intervals of at least 7 days, up to a maximum of 37.5 mg once daily. Premenstrual dysphoric disorder: The recommended starting dose is 12.5 mg once daily. Allow an interval of at least 1 week between dose changes. Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose is 12.5 mg once daily. The dose may be increased if necessary, but should not exceed 50 mg once daily.

Ingredients

Manufacturer
HK Inno.N Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder

  • Major depressive disorder
  • agoraphobia
  • panic disorder
  • social anxiety disorder
  • social phobia
  • premenstrual dysphoric disorder
View approved original text

This medication is used for major depressive disorder, panic disorder (regardless of the presence of agoraphobia), social anxiety disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Major depressive disorder: The recommended initial dose is 25 mg once daily. If there is no response to 25 mg, the dose may be increased in increments of 12.5 mg up to a maximum of 62.5 mg once daily. Panic disorder: The starting dose is 12.5 mg once daily, increased by 12.5 mg each week. The daily dose should not exceed 75 mg. Social anxiety disorder/social phobia: The recommended starting dose is 12.5 mg once daily. The dose may be increased in increments of 12.5 mg at intervals of at least 7 days, up to a maximum of 37.5 mg once daily. Premenstrual dysphoric disorder: The recommended starting dose is 12.5 mg once daily. Allow an interval of at least 1 week between dose changes. Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose is 12.5 mg once daily. The dose may be increased if necessary, but should not exceed 50 mg once daily.

Precautions

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, thus physicians should exercise caution when prescribing. This drug should not be used in conjunction with certain medications, especially MAO inhibitors, and using it within 14 days after stopping MAO inhibitors can be dangerous. Additionally, it should not be prescribed to patients with hypersensitivity to this drug or certain genetic metabolic disorders. Patients with certain conditions such as those taking antipsychotics, anticoagulants, or patients with epilepsy, heart disease, or diabetes should be particularly careful when using this drug. This drug can cause various side effects, and especially during the initial dosing, dizziness, nausea, drowsiness, insomnia, weight changes, and sexual dysfunction may occur. Sudden discontinuation of this drug can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and headaches, thus dosage should be reduced gradually according to a physician's instructions. This drug can cause severe adverse effects such as serotonin syndrome, so caution is needed when combined with other serotonin-active medications. Women who are pregnant or nursing should consult with a physician before using this drug, as it may pose risks to the fetus or newborn. Use in children and adolescents is not recommended due to insufficient evidence of safety and efficacy. In cases of overdose, symptoms such as nausea, tremors, blood pressure changes, and anxiety may occur, necessitating immediate medical intervention. This drug should be kept out of reach of children, and transferring to other containers should be avoided.

Side effects

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, reduced appetite, hyponatremia, blurred vision, pupil dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal disorder, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts and behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, photosensitivity reactions, abnormal bleeding from the skin and mucous membranes, thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, severe allergic reactions, syndrome of inappropriate antidiuretic hormone secretion, yawning, tinnitus, arthralgia, myalgia, dizziness, sensory disturbances, sleep disturbances, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, thirst, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, drowsiness

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

Storage

This medication is sensitive to light and must be stored in a container that does not allow light in. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow round enteric-coated tablets

Package unit

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.

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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.