Anadol Capsule, Injection, Suppository

Anadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Anadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Uses

Anadol 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.

Anadol is also used to associated treatment for these conditions: Pain, Acute, Premature Ejaculation, Severe Pain, Acute, moderate, severe Pain, Moderate Pain

Trade Name Anadol
Generic Tramadol
Other Names Tramadol, Tramadolum
Weight 50mg, 100mg/2ml, 100mg
Type Capsule, Injection, Suppository
Formula C16H25NO2
Weight Average: 263.3752
Monoisotopic: 263.188529049
Protein binding

About 20% of the administered dose is found to bind to plasma proteins. Protein binding appears to be independent of concentrations up to 10μg/mL. Saturation only occurs at concentrations outside of the clinical range.

Therapeutic Class Opioid analgesics
Manufacturer Square Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:26 am

Dosage

Anadol dosage

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: Anadol suppository should be administered rectally. For adults usual dose is 100 mg Anadol Hydrochloride 6 hourly. In general, 400 mg Anadol 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.

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.

Precaution

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

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

Concomitant CNS depressants: Anadol 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: Anadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Anadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

Interaction

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

Food Interaction

  • Avoid alcohol. Co-administration of alcohol may potentiate the CNS effects of tramadol.
  • Take with or without food. Co-administration of food does not affect pharmacokinetics.

Volume of Distribution

The volume of distribution of tramadol is reported to be in the range of 2.6-2.9 L/kg. Anadol has high tissue affinity; the total volume of distribution after oral administration was 306L and 203L after parenteral administration. Anadol crosses the blood-brain barrier with peak brain concentrations occurring 10 minutes following oral administration. It also crosses the placental barrier with umbilical concentrations being found to be ~80% of maternal concentrations.

Half Life

Anadol reported a half-life of 5-6 hours while the M1 metabolite presents a half-life of 8 hours.

Clearance

In clinical trials, the clearance rate of tramadol ranged from 3.73 ml/min/kg in renal impairment patients to 8.50 ml/min/kg in healthy adults.

Pregnancy & Breastfeeding use

Safe use of Anadol in pregnancy has not been established. Anadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Anadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Anadol Hydrochloride should not be administered during breast feeding as Anadol and its metabolites have been detected in breast milk.

Contraindication

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

Special Warning

Paediatric use: The paediatric use of Anadol is not recommended because safety and efficacy in patients under 16 years of age have not been established.

Use in children: Use in children from the age of 1 year Anadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Anadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Anadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore,safety and efficacy have not been established and the product should not be used in children.

Renal Impairment: Oral: 

  • CrCl <10: Contraindicated.
  • CrCl 10 to <30: Increase dosing interval to 12. Max: 200 mg/day; Contraindicated (extended-release tab).

Parenteral: 

  • CrCl <10: Contraindicated.
  • CrCl 10-30: Increase dosing interval to 12 hrly.

Hepatic Impairment: 

  • Oral: Severe: Increase dosing interval to 12 hrly; Contraindicated (extended-release).
  • Parenteral: Severe: Increase dosing interval to 12 hrly.

Storage Condition

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

Anadol contains Tramadol see full prescribing information from innovator Monograph