Pendol

Generic

Tramadol Hydrochloride

 

Indications

• Tramadol is a pain reliever that is used to treat moderate to severe pain. Postoperative discomfort is one of them.
• Irritable bowel syndrome (IBS) with spastic discomfort
• Cancer-related discomfort
• Joint discomfort
• Pain in the neck and back
• Osteoporosis pain is a common symptom.

 

Pharmacology

Tramadol is a synthetic analgesic with a central action. It prevents neurotransmitters like serotonin and noradrenaline from being reabsorbed. As a result, it alters the transmission of pain impulses by activating both descending serotonergic and noradrenergic analgesia pathways. Tramadol's analgesic effects are mediated through mu-opioid receptor stimulation and indirect regulation of central monoaminergic inhibitory pathways.

 

Dosage & Administration

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 is sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

 

Interaction

In general, there are no medicines that interact with Tramadol that doctors should be concerned about. Monoamine oxidase (MAO) inhibitors are the only pharmacological class that should not be used in conjunction with Tramadol. The combination of carbamazepine and Tramadol induces a considerable increase in Tramadol metabolism, necessitating an increase in Tramadol dosage.

 

Contraindications

People who are hypersensitive to tramadol should avoid using it. Intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic medications is also contraindicated.

 

Side Effects

Dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, and diarrhoea are all common adverse effects. Malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis, and other less common side effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis, and others.

 

Pregnancy & Lactation

Tramadol has not been proven to be safe during pregnancy. It has been proven that tramadol crosses the placenta. In pregnant women, there are no sufficient and well-controlled trials. Tramadol should therefore only be used during pregnancy if the possible benefit outweighs the risk to the fetus. Because tramadol and its metabolites have been found in breast milk, Tramadol Hydrochloride should not be given to a nursing mother.

 

Precautions & Warnings

Respiratory depression: When large doses of tramadol are administered with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression. Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids. Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics. Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin. Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

 

Therapeutic Class

Opioid analgesics

 

Storage Conditions

Store below 250 C. Protects from light and moisture. Keep out of the reach of children.

 

Pharmaceutical Name

Alco Pharma Ltd.