Paracetamol; Codeine phosphate
Visa No.: 893111213225
Product: Tatanol CODEIN
API: Paracetamol; Codeine phosphate
Product Category: Pain Relief
Version approved leaflet: 165/QĐ-QLD_20/03/2019_164
INDICATIONS
TATANOL CODEIN is indicated in patients over 12 years of age for the relief of moderate acute pain when other analgesics such as acetaminophen or ibuprofen (used alone) are ineffective.
Indicated for pain relief in conditions such as low back pain, headache, neuralgia, generalized body pain, and muscle pain.
DOSAGE AND ADMINISTRATION
Adult: Take 1–2 tablets every 4–6 hours depending on the severity of pain. Doses should be spaced at least 4 hours apart. Do not exceed 8 tablets per day..
The duration of analgesic treatment should be limited to 3 days. If adequate pain relief is not achieved, the patient or caregiver should seek medical advice.
Notice: The maximum dose of codeine for analgesia should not exceed 240 mg per day. The dose should be adjusted as appropriate based on the amounts of other active ingredients combined with codeine in the product.
Children 12–18 years of age: The recommended codeine dose for pain relief is 30–60 mg every 6 hours. If necessary, the dose may be increased up to a maximum of 240 mg per day.
Dosing should be based on body weight (0.5–1 mg/kg per dose).
Children under 12 years of age: TATANOL CODEIN is not recommended for pain relief due to the risk of opioid toxicity resulting from unpredictable variability in the metabolism of codeine to morphine (see Warnings and Precautions).
Elderly: The initial dose should be reduced to half of the recommended adult dose and may be increased depending on tolerability.
Patients with renal impairment: There is a risk of drug accumulation. The dosing interval should be at least 8 hours, and dose reduction should be considered. Closer monitoring is required in pediatric patients.
Patients with hepatic impairment: In patients with chronic liver disease—particularly those with hepatic impairment, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), Gilbert’s syndrome (familial non-hemolytic jaundice), and dehydration—the acetaminophen dose should not exceed 3 g per day.
CONTRAINDICATIONS
Hypersensitivity to any component of the product.
Respiratory depression or asthma. Patients with recurrent anemia or with cardiac, pulmonary, renal, or hepatic disease.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Pregnancy and breastfeeding (see Use in Pregnancy and Lactation).
Patients known to be CYP2D6 ultra-rapid metabolizers.
Children and adolescents (0–18 years) who have undergone tonsillectomy and/or adenoidectomy for the treatment of obstructive sleep apnea, due to an increased risk of serious and life-threatening adverse reactions (see Warnings and Precautions).
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
