Syndol 50

Generic

Tramadol Hydrochloride

 

Indications

Anadol ® (Tramadol) is used for the treatment of moderate to severe painful conditions. These include: Postoperative pain, Colic and spastic pain, Cancer pain, Joint pain, Neck and back pain & Pain associated with osteoporosis

 

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

Anadol ® Capsule: 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.

Anadol® SR capsule: One SR capsule 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 everey 12 hours. The total daily dosage by mouth should not exceed 400 mg.

Anadol ® Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous injection over 2 to 3 minutes 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.

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

 

Interaction

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

 

Contraindications

Tramadol is contraindicated in patients having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

 

Side Effects

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

 

Pregnancy & Lactation

Safe use of Tramadol in 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 be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

 

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. Protect from light and moisture. Keep out of the reach of children.

 

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.