Tramadol is indicated for the management of moderate to severe pain. It is commonly used in conditions such as:

• Postoperative pain
• Colicky and spasmodic pain
• Cancer-related pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis

Tramadol is a centrally acting synthetic analgesic. It works by inhibiting the reuptake of neurotransmitters such as serotonin and noradrenaline, thereby altering the transmission of pain signals. It enhances pain control by activating descending serotonergic and noradrenergic pathways involved in analgesia. Additionally, its analgesic effect is partly mediated through stimulation of mu-opioid receptors and modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4–6 hourly. The dose level and frequency of dosing will depend on the severity of the pain. The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours. The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50–100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain, the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

In general, tramadol has a low potential for drug interactions, and physicians usually do not need to be overly concerned. However, monoamine oxidase (MAO) inhibitors should not be used in combination with tramadol due to potential serious interactions. Co-administration with carbamazepine significantly increases the metabolism of tramadol, which may reduce its effectiveness and require dose adjustment.

Tramadol is contraindicated in patients with known hypersensitivity to the drug. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic medications.

Common side effects include dizziness or vertigo, nausea, constipation, headache, drowsiness, vomiting, pruritus, central nervous system stimulation, weakness, sweating, indigestion, dry mouth, and diarrhoea. Less common side effects may include malaise, allergic reactions, weight loss, vasodilation, palpitations, abdominal pain, loss of appetite, flatulence, gastrointestinal bleeding, hepatitis, and stomatitis.

The safety of Tramadol use during pregnancy has not been firmly established. Tramadol is known to cross the placenta, and there are no adequate and well-controlled studies in pregnant women. Therefore, it should be used during pregnancy only if the potential benefit justifies the possible risk to the foetus. Tramadol Hydrochloride should not be used during breastfeeding, as both the drug and its metabolites are excreted into breast milk.

Respiratory depression: The use of high doses of tramadol, especially when combined with anesthetic agents or alcohol, may lead to respiratory depression. Therefore, tramadol should be used cautiously in patients who are at risk of breathing difficulties.

Opioid dependence: Tramadol is not suitable for patients who are already dependent on opioids.

Concomitant CNS depressants: Caution is required when tramadol is given with other central nervous system depressants such as alcohol, opioids, anesthetics, phenothiazines, tranquilizers, or sedative-hypnotics. In such cases, lower doses should be considered.

Concomitant MAO inhibitors: Tramadol should be used with extreme caution in patients taking monoamine oxidase (MAO) inhibitors, as it affects the reuptake of norepinephrine and serotonin.

Tramadol should also be used carefully in patients with increased intracranial pressure, head injuries, or acute abdominal conditions.

Children: Tramadol may be given to children aged 1 year and above at a dose of 1–2 mg/kg. However, suppositories (100 mg) should not be used in children under 14 years. Sustained-release capsules (100 mg) are not recommended in children due to lack of safety data.

Opioid analgesic

Store below 30°C, protected from light and moisture. Keep out of reach of children.