Ultradol

Rx

Indications

• Ultradol is indicated for the symptomatic treatment of moderate to severe pain.

Dosage

• The dose should be adjusted to intensity of pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
  The total dose of 8 tablets per day should not be exceeded.
  The dosing interval should not be less than 6 hours.
• Adults and children 16 years of age and over:
  1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
• The use of Ultradol is contraindicated in children below 12 years of age.
• A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
• In older people over 75 years, the dosage interval is to be extended according to the patient’s requirements.

Usage

• Ultradol is orally administered.
• Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.

• Hypersensitivity to tramadol or opioids, paracetamol or to any of the ingredients.
• Acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs.
• Patients are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.
• Severe renal or hepatic impairment.
• Severe respiratory depression.
• Epilepsy not controlled by treatment.
• Tramadol should not be used to treat pain in children younger than 12 years.
• Tramadol is contraindicated in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

Paracetamol

• Skin rash and other allergic reactions occur occasionally. The rash is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by drug fever and mucosal lesions.

Tramadol

• Malaise.
• Vasodilation (hypotension).
• Anxiety, restlessness, confusion, coordination disorders, euphoria, nervousness, sleep disturbances.
• Vomiting, nausea, abdominal pain, loss of appetite, distension, constipation.
• Hypertonia.
• Vision disorders.
• Menopausal symptoms, micturition, urinary retention.

• Paracetamol is relatively nontoxic in therapeutic doses. Dermatologic reactions including pruritic maculopapular rash and urticaria have been reported and other sensitivity reactions including laryngeal edema, angioedema, and anaphylactoid reactions may occur rarely. Neutropenia and thrombocytopenic purpura have been reported with paracetamol use. Rarely, agranulocytosis has been reported in patients receiving paracetamol.
• Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
• Paracetamol administration should be cautioned in patients with anaemia, patients with impaired kidney or liver function, patients at risk for respiratory depression.
• Tramadol increases the seizure risk in patients taking selective serotonin-reuptake inhibitors (SSRIs), tricyclic antidepressants, other tricyclic compounds, or other opiate agonists, monoamine oxidase (MAO) inhibitors, antipsychotic agents, or other drugs that decrease the seizure threshold. Patients with epilepsy, those with a history of seizures, or patients with a recognized risk for seizure (e.g., head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections) may be at increased risk of seizure.
• Naloxone administration in patients with tramadol overdose also may increase the risk of seizure.
• Because tramadol may potentiate the respiratory and CNS depressant effects of other CNS depressants (e.g., alcohol, anesthetic agents, phenothiazines, sedatives and hypnotics, other centrally acting analgesics, opiate agonists), the drug should be used with caution and in reduced dosage in patients receiving such drugs.
• Caution in patients with increased intracranial pressure or head injury.
• Withdrawal symptoms may occur if tramadol is discontinued abruptly.
• In patients dependent on opiate agonists or in patients who are chronically using opiate agonists.
• The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
• Tramadol is not recommended in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
• Ultradol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Breastfeeding is not recommended when taking tramadol medicines.
• Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery.