Zitrams CR Sustained Release Tablet 75 mg (Tramadol Hydrochloride)

Adult dose

The initial dose is 1 tablet (75 mg) orally twice daily at 12-hour intervals. Do not chew but swallow whole. The dose should be adjusted according to the patient's pain intensity and clinical response, ensuring not to exceed 400 mg per day. Elderly patients (over 75 years) and those with renal or liver dysfunction may require adjustments in dosing intervals.

Using this medication in excess of the recommended dose can cause seizures, so it is crucial to adhere to the prescribed dosages. Furthermore, patients with epilepsy or a risk of seizures should use this medication only when absolutely necessary, and caution is needed if they are taking other medications that increase the risk of seizures. Long-term use may result in psychological and physical dependence, so it should be used only for a short duration under strict supervision in patients with a history of drug abuse or dependence. Taking this medication with other central nervous system depressants or alcohol can lead to severe drowsiness, respiratory depression, hypotension, or coma, hence great caution is needed when combining with these substances. Additionally, some individuals may metabolize this medication very rapidly, leading to unexpectedly strong medication effects and increased risk of respiratory depression, so dosage adjustments and symptom monitoring are necessary in such cases. This medication should not be used in children under 12 years of age or adolescents under 18 years of age who have undergone tonsillectomy or adenoidectomy. For adolescents between 12 and 18 years of age, it is advisable to avoid administration if there are specific risk factors. This medication can cause sleep apnea or hypoxemia; therefore, continuous monitoring for the occurrence or worsening of these symptoms is necessary, and dosage may need to be gradually reduced or stopped if required. It should not be used in patients with acute alcohol intoxication, central nervous system drug poisoning, severe respiratory depression, head trauma, those who have taken MAO inhibitors recently, patients with severe renal or liver dysfunction, pregnant or breastfeeding women, children under 12 years, or patients with allergies to this medication or opioids. Additionally, patients who are using morphine concurrently or repetitively, those with biliary disease or liver dysfunction, drinkers, patients sensitive to opioids, those with renal impairment, patients with a history of seizures, and those with a history of psychological dependence or drug abuse should use this medication with caution. During the course of treatment, symptoms such as drowsiness, dizziness, and nausea may occur, so it is advisable to avoid driving or operating hazardous machinery. Long-term use can result in tolerance, necessitating higher doses, and sudden discontinuation can induce withdrawal symptoms, so dosages should be gradually reduced. In case of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, with naloxone designated as an antidote. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration in quality.

Serious side effects

Seizures, severe allergic reactions (shock, anaphylaxis, itching, hives, bronchospasm, angioedema), respiratory depression, difficulty breathing, worsening of asthma, palpitations, hypotension, arrhythmias, facial pallor, fainting, orthostatic hypotension, tachycardia, bradycardia, hypertension, seizure-like episodes, anaphylactic reactions, severe skin reactions (Stevens-Johnson syndrome), severe edema, severe headache, consciousness disturbance, coma, serious neurological symptoms

Mild side effects

• Drowsiness
• dizziness
• nausea
• vomiting
• headache
• heavy-headedness
• excitement
• tremors
• tinnitus
• restlessness

Store this medication in a sealed container to prevent air exposure, and it is recommended to keep it at a temperature between 1 and 30 degrees Celsius. This helps maintain the medication's effectiveness and safety.

Appearance

Light gray, biconvex, round, film-coated sustained release tablet

Package unit

30 tablets/bottle