Medication info

Diclamine Enteric-Coated Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Pyridoxine Hydrochloride›10mg / 1 tabletDoxylamine Succinate›10mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
White, bilaterally convex, round, film-coated enteric-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201804470 · Notified 2018.11.09

This product's status changed to Approval withdrawn on 2024.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Control of nausea and vomiting in pregnant women
Who takes it
Adults
Adult dose
This medication should be taken on an empty stomach with water. It should be swallowed whole. This medication should not be crushed, cut, or chewed. Initial dosage: Take 2 tablets once daily before bedtime (on the first day). If symptoms are adequately controlled the following day, continue taking 2 tablets before bedtime once daily. If symptoms persist through the afternoon of the second day, take 2 tablets before bedtime on the second day and 3 tablets on the third day.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Control of nausea and vomiting in pregnant women

  • Nausea and vomiting in pregnant women
View approved original text

This medication is used to manage nausea and vomiting in pregnant women that do not respond to conservative therapy.

How to take

Adult dose

This medication should be taken on an empty stomach with water. It should be swallowed whole. This medication should not be crushed, cut, or chewed. Initial dosage: Take 2 tablets once daily before bedtime (on the first day). If symptoms are adequately controlled the following day, continue taking 2 tablets before bedtime once daily. If symptoms persist through the afternoon of the second day, take 2 tablets before bedtime on the second day and 3 tablets on the third day.

Precautions

This medication should not be administered to certain patients. Individuals allergic to this drug, its components, or similar antihistamines should not take it. Patients at risk for asthma attacks should also not use this medication. Patients with high intraocular pressure due to glaucoma and those with gastrointestinal narrowing due to peptic ulcers should avoid this medication. Patients with blockage between the stomach and duodenum and those with blockage at the bladder neck should not take this medication. Additionally, patients taking a specific type of antidepressant known as monoamine oxidase inhibitors should be cautious, as this drug may exacerbate central nervous system side effects. This medication should be used with caution in pregnant women and in patients with liver or kidney dysfunction. Moreover, caution is advised when this medication is taken in conjunction with central nervous system depressants, such as alcohol, sedatives, or tranquilizers, as side effects may become more severe. Taking this medication may cause drowsiness; therefore, activities requiring alertness, such as driving or operating machinery, should be avoided. The use of alcohol or other central nervous system depressants is not recommended as it may increase the risk of severe drowsiness and accidents. Taking this medication with food may delay absorption or reduce effectiveness; thus, it is recommended to take this medication on an empty stomach with water. This medication can cause various side effects, commonly including drowsiness, dizziness, headache, insomnia, dyspepsia, and skin rashes. In severe cases, symptoms such as shortness of breath, palpitations, blurred vision, and urination difficulties may occur, and any unusual symptoms should be reported to a doctor immediately. There are no reports indicating an increased risk of congenital malformations from taking this drug during pregnancy. However, the use of this medication during pregnancy should be carefully considered for safety. While breastfeeding, this medication may be excreted in breast milk and could affect the baby; therefore, it is advisable to discontinue breastfeeding during treatment. The safety and effectiveness of this medication have not been established for children, and there is a risk of severe side effects and death in case of overdose, so it should not be used in children. In cases of overdose, symptoms may include dry mouth, pupil dilation, drowsiness, dizziness, mental confusion, and increased heart rate; in severe cases, seizures, renal failure, or death may occur. In case of overdose, immediate medical attention should be sought for treatment, including gastric lavage and administration of adsorbent agents. This medication should be stored away from direct sunlight and kept at a temperature between 15-30 degrees Celsius, out of reach of children. Also, the desiccant inside the bottle should not be removed.

Side effects and when to seek care immediately

Serious side effects

  • Shortness of breath
  • chest tightness
  • difficulty breathing
  • asthma attacks
  • urination difficulties
  • urinary retention

Mild side effects

  • Drowsiness
  • palpitations
  • tachycardia
  • dizziness
  • blurred vision
  • visual disturbances
  • abdominal bloating
  • abdominal pain
  • constipation
  • diarrhea
Show 17 more
  • chest discomfort
  • fatigue
  • irritability
  • lethargy
  • dizziness
  • headache
  • migraine
  • sensory disturbances
  • psychomotor hyperactivity
  • anxiety
  • disorientation
  • insomnia
  • nightmares
  • sweating
  • itching
  • rashes
  • maculopapular rashes

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature at room temperature between 15 and 30 degrees Celsius.

Appearance and packaging

Appearance

White, bilaterally convex, round, film-coated enteric-coated tablets

Package unit

30 tablets/bottle, 100 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.