Medication info
Paroxetine CR Tablets 25 mg (Paroxetine Hydrochloride Hydrate)

Paroxetine CR Tablets 25 mg (Paroxetine Hydrochloride Hydrate)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Paroxetine Hydrochloride Hydrate›28.5mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceutical Co., Ltd.
Appearance
Pink round enteric-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202104811 · Approved 2021.06.23 · Insurance code 645306590

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (panic disorder and social phobia), and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
This medicine should be taken once daily, usually in the morning, with or without food. Swallow this medicine whole; do not chew or crush it. Major depressive disorder Starting dose: The recommended initial dose is 25 mg of paroxetine once daily. In some patients who do not respond to 25 mg, the dose may be increased by 12.5 mg, up to a maximum of 62.5 mg daily. Allow an interval of at least 1 week between dose changes. Maintenance therapy: Efficacy was maintained with an average dose of 30 mg administered for 1 year. Panic disorder Starting dose: Start at 12.5 mg daily and increase by 12.5 mg each week. The daily dose should not exceed 75 mg. Maintenance therapy: Continue treatment to prevent relapse and adjust to the minimum effective dose. Social anxiety disorder/social phobia Starting dose: 12.5 mg daily; increase by 12.5 mg at intervals of at least 7 days, up to a maximum of 37.5 mg daily. Maintenance therapy: Continue treatment in patients who respond and adjust to the minimum effective dose. Premenstrual dysphoric disorder Starting dose: 12.5 mg daily. Allow an interval of at least 1 week between dose changes. Maintenance therapy: Continue treatment in patients who respond and reassess periodically. Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose is 12.5 mg daily. The dose may be increased if necessary, but should not exceed 50 mg daily.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (panic disorder and social phobia), 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 the treatment of major depressive disorder, panic disorder (with or without agoraphobia), social anxiety disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

This medicine should be taken once daily, usually in the morning, with or without food. Swallow this medicine whole; do not chew or crush it. Major depressive disorder Starting dose: The recommended initial dose is 25 mg of paroxetine once daily. In some patients who do not respond to 25 mg, the dose may be increased by 12.5 mg, up to a maximum of 62.5 mg daily. Allow an interval of at least 1 week between dose changes. Maintenance therapy: Efficacy was maintained with an average dose of 30 mg administered for 1 year. Panic disorder Starting dose: Start at 12.5 mg daily and increase by 12.5 mg each week. The daily dose should not exceed 75 mg. Maintenance therapy: Continue treatment to prevent relapse and adjust to the minimum effective dose. Social anxiety disorder/social phobia Starting dose: 12.5 mg daily; increase by 12.5 mg at intervals of at least 7 days, up to a maximum of 37.5 mg daily. Maintenance therapy: Continue treatment in patients who respond and adjust to the minimum effective dose. Premenstrual dysphoric disorder Starting dose: 12.5 mg daily. Allow an interval of at least 1 week between dose changes. Maintenance therapy: Continue treatment in patients who respond and reassess periodically. Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose is 12.5 mg daily. The dose may be increased if necessary, but should not exceed 50 mg daily.

Precautions

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or psychiatric conditions, and should be monitored closely. Severe side effects may occur if this medication is used in combination with certain drugs, particularly in patients taking MAO inhibitors or specific heart disease medications. Patients with certain conditions such as those taking antipsychotics, anticoagulants, epilepsy patients, heart disease patients, diabetes patients should use this medication with caution and consult with healthcare professionals. Various adverse reactions such as blood pressure changes, dizziness, nausea, insomnia, drowsiness, weight changes, sexual dysfunction may occur; if symptoms worsen, inform healthcare professionals immediately. Discontinuing this medication abruptly may lead to withdrawal symptoms like dizziness, anxiety, sleep disturbances, hence dosage should be reduced gradually as per doctor's instructions. It is advisable to avoid taking this medication with alcohol, and caution is advised when combined with other serotonin-related medications due to the risk of serotonin syndrome. Women who are pregnant or planning to become pregnant should consult a doctor before using this medication, as it may pose risks to the fetus including cardiovascular defects. During breastfeeding, this medication can be passed into breast milk in small amounts, hence the decision to use this medication should consider the effects on the newborn. This medication is not recommended for use in children and adolescents under 18 years of age due to unclear safety and efficacy. In case of overdose, symptoms such as nausea, tremors, drowsiness, blood pressure changes may occur; hence the prescribed dosage must be strictly adhered to, and in case of overdose, immediate medical attention is necessary. This medication should be stored out of the reach of children and transferring it to another container is not advisable. Caution is required when driving or operating machinery while taking this medication, and if new symptoms or abnormal behaviors occur during the course of treatment, consult a doctor immediately.

Side effects

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupillary 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, agitation, depersonalization, panic attacks, suicidal ideation and behavior, 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 of 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 disorders, agitation, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, hyperreactivity, 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, agitation, anxiety, tachycardia

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

Storage

This medication is sensitive to light and should be stored in a special container that is protected from light. Additionally, it is important to store below 25 degrees Celsius to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink round enteric-coated tablets

Package unit

30 tablets/bottle, 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

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.