Utramal Retard 50

Generic

Tramadol Hydrochloride

 

Indications

Tramadol is used to treat moderate to severe pain conditions. These include:

• Postoperative pain
• Colon and spastic pain
• Cancer pain
• Arthralgia
• Neck and back pain
• Pain associated with osteoporosis.

 

Pharmacology

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the reuptake of the neurotransmitters serotonin and norepinephrine. Thus, it regulates the transmission of pain-inducing impulses by activating both the descending serotonin pathway and the noradrenergic pathway involved in pain relief. The analgesic effect of tramadol is mediated through stimulation of muopioid receptors and indirect modulation 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 sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

 

Interactions

In general, doctors should not worry about drugs that interact with tramadol. Monoamine oxidase (MAO) inhibitors are the only drug category that is not recommended in combination with tramadol. Simultaneous administration of carbamazepine and tramadol will cause a significant increase in tramadol metabolism, and the dose of tramadol needs to be increased.

 

Contraindications

People allergic to tramadol should not use tramadol. Acute intoxication by alcohol, hypnotics, central analgesics, opioids or psychotropic drugs is also prohibited.

 

Side Effects

Common side effects are dizziness / dizziness, nausea, constipation, headache, drowsiness, vomiting, itching, CNS irritation, asthenia, sweating, dyspepsia, dry mouth and diarrhea. Less commonly occurring side effects include fatigue, allergic reactions, weight loss, vascular dilation, palpitation, abdominal pain, loss of appetite, high swelling, gastrointestinal bleeding, hepatitis, and stomatitis.

 

Pregnancy

The safety of tramadol use during pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, tramadol should only be used during pregnancy if the potential benefit is equivalent to the risk to the fetus. Tramadol hydrochloride should not be used during breast-feeding because tramadol and its metabolites have been detected in breast milk.

 

Precautions

Respiratory depression: Respiratory depression may occur when large doses of anesthetic tramadol are administered with anesthetic drugs or alcohol. Therefore, patients at risk of respiratory depression should use tramadol with caution.

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

Concomitant central nervous system depressants: Tramadol should be used with caution and reduce the dose in patients receiving central nervous system depressants such as alcohol, opioids, anesthetics, phenothiazines, sedatives or sedative hypnotics.

Concomitant MAO inhibitors: Patients taking MAO inhibitors should use tramadol with caution, because tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with elevated intracranial pressure or head trauma and patients with acute abdomen.

 

Therapeutic Class

Opioid analgesics

 

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name

UniMed UniHealth Pharmaceuticals Ltd.