Paltaramadol Injection (Tramadol Hydrochloride)

Adult administration

As Tramadol Hydrochloride, administer 50-100 mg by intravenous or intramuscular injection once. Repeat injections may be given every 4-5 hours as needed, with a maximum daily dose of 400 mg.

This medication should be taken at the recommended dosage, as exceeding it may cause seizures. Patients with a history of epilepsy or risk of seizures should use this medication only when necessary. Long-term use may lead to psychological and physical dependence; thus, patients with a history of drug abuse or dependence should use it for a short duration only. Caution is advised when combined with alcohol or central nervous system depressants, as it may lead to severe drowsiness, respiratory depression, or coma. Some patients may metabolize this medication very quickly, leading to unexpected severe side effects, necessitating special monitoring. This medication should not be used in children under 12 years of age or adolescents under 18 years who've had a tonsillectomy or adenoidectomy. Care should be taken to avoid glass fragments when using the injection, especially in children and the elderly. It should not be used in patients with acute alcohol poisoning, severe respiratory depression, severe liver or kidney disorders, pregnant or breastfeeding women, or patients taking certain medications. Caution is also required for patients using morphine, those with liver or kidney disorders, and those who consume alcohol, as well as those with a history of seizures. Drowsiness and dizziness may occur while taking this medication, so driving or operating dangerous machinery should be avoided. Additionally, it’s important to taper the dosage gradually to prevent withdrawal symptoms after discontinuation. This medication may interact with various drugs; therefore, discussions with healthcare providers regarding concurrent medications are crucial. Pregnant or breastfeeding women should avoid its use, particularly during breastfeeding due to the potential for serious side effects in the infant. For elderly patients, a lower dosage is advised for safety. In cases of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, with naloxone potentially being used as an antidote. This medication must be stored according to the specified storage instructions, out of reach of children.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe skin reactions (severe rashes, blisters, skin peeling, mucosal pain in mouth/eyes), respiratory issues (difficulty breathing, asthma attacks accompanied by cough and fever), yellowing of the skin or eyes (jaundice), systemic fatigue, liver abnormalities, sudden severe headaches, thunderclap headaches, seizures, loss of consciousness.

Mild side effects

• Drowsiness
• dizziness
• headache
• feeling of heaviness
• excitement
• tremors
• tinnitus
• numbness
• anxiety
• weakness

This medication should be stored in a sealed container that protects it from light, at a safe temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevents deterioration.

Appearance

A colorless and transparent liquid in a brown ampoule injection.

Package unit

50 ampoules/box [(1 milliliter/ampoule)]