Tramadol Hydrochloride Sustained Release Tablets

Tramadol hydrochloride mainly acts on specific pain-related receptors in the central nervous system. It has no effect on smooth muscle spasm. At the recommended dose, it does not produce respiratory depression and has no significant effect on hemodynamics. Drug resistance and dependence are very low. Animal experiments have not found that tramadol is teratogenic.

The main ingredient of this product is tramadol hydrochloride; chemical name: (±)-trans-1-(m-methylphenyl)-2-(dimethylaminomethyl)-cyclohexanol hydrochloride; molecular formula: C16H25NO2; molecular weight: 299.84

White or off-white, irregular film-coated tablets with a dividing line on one side.

Used for various moderate to severe pain such as cancer pain, fractures or postoperative pain.

Swallow without chewing. The dosage of this product depends on the degree of pain. For adults and patients over 14 years old with moderate pain, the single dose is 50~100mg. The dosage for children over 1 year old weighing not less than 25 kg is 1~2mg per kilogram of body weight, and the minimum dose of this product is 50mg (1/2 tablet). The maximum daily dose usually does not exceed 400mg. Relatively large doses can also be considered for the treatment of cancer pain. Patients with impaired liver and kidney function should use it as appropriate. The dosage for elderly patients should be considered to be reduced. The interval between two doses should not be less than 8 hours. The above recommended doses are for reference only. In principle, the lowest analgesic dose should be used. Take as directed by your doctor.

After taking the drug, symptoms such as nausea, vomiting, sweating, dry mouth, dizziness, and drowsiness may occur. Coma may occur occasionally. In a few cases, it can also be found that the cardiovascular system is affected (such as palpitations, tachycardia, postural hypotension, and circulatory collapse), especially when the patient is upright and fatigued. In addition, headaches, constipation, gastrointestinal disorders, skin itching, and rashes are less common. Weakness in movement, loss of appetite, and urination disorders rarely occur. Mental side effects are extremely rare and vary from person to person, including changes in mood (mostly high spirits, but sometimes also manifested as bad moods), changes in activities (mostly reduced activities, sometimes increased), and changes in cognitive and sensory abilities (impaired judgment and understanding). Convulsions have been reported in individual cases, but this situation generally occurs when high doses of tramadol hydrochloride are injected or used in combination with neuroleptics. Anaphylactic shock cannot be completely ruled out. Respiratory depression and coma usually do not occur at the dose recommended by the doctor.

1. People who are highly sensitive to this product and patients with acute poisoning by alcohol, sleeping pills, analgesics or other psychotropic drugs; 2. This product should be used with caution in patients with opioid dependence, confusion of unknown cause, disorders of the respiratory center and respiratory function, increased intracranial pressure without artificial respiration equipment, and infants under 1 year old.

Precautions for children: The safety of the drug for children under 16 years of age has not been established, so children should use this product with caution. Precautions during pregnancy and lactation: During pregnancy, the dosage of tramadol hydrochloride must be limited (only a single dose is allowed). Long-term use during pregnancy can lead to habituation to the drug, and newborns will experience withdrawal symptoms after birth. If a mother takes this drug immediately before or at the birth of the baby, it will not affect the contractile function of the uterus and may cause changes in the respiratory rate of the newborn, but this is not clinically relevant. If used during lactation, the amount of tramadol hydrochloride in breast milk is 0.1% of the maternal blood content, and a single dose does not require terminating breastfeeding. Precautions for the elderly:

1. When used in combination with central nervous system depressants or alcohol, the sedative effect of this product, especially the respiratory depressant effect, is enhanced. When used in combination with neuroleptics, convulsions have been reported in some cases; 2. Patients receiving monoamine oxidase (MAO) inhibitors may experience serious effects on the central nervous system, circulation, and respiratory systems when taking this product; 3. The effect of cimetidine on this product is very small.

Keep away from light and store in a sealed container.

0.1g

24 months

North China Pharmaceutical Company.Ltd

• Founded in:

  1992-12-20

• Address:

  No. 388, Heping East Road, Shijiazhuang City

• Tax NO.:

  91130100104397700P

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