Utramal Retard 50 mg

Description

Indications

Utramal Retard is used to treat moderate to severe pain in various conditions, including:

• Postoperative pain
• Colic and spastic pain
• Cancer-related pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis

Take this medication only as prescribed by a registered healthcare professional.

Pharmacology

Tramadol is a centrally acting synthetic analgesic. It works by inhibiting the reuptake of neurotransmitters serotonin and noradrenaline, which alters the transmission of pain signals. Tramadol activates both descending serotonergic and noradrenergic pathways involved in pain relief. Its analgesic effects are primarily mediated by stimulating mu-opioid receptors and indirectly modulating central monoaminergic inhibitory pathways.

Dosage and Administration

• Capsules or Tablets: The usual dose is 50 to 100 mg every 4 to 6 hours. For acute pain, an initial dose of 100 mg is recommended, while for chronic pain, an initial dose of 50 mg is advised. Subsequent doses should be 50 to 100 mg every 4 to 6 hours, depending on pain severity. The total daily dose should not exceed 400 mg.

• Sustained Release Capsules or Tablets: One SR capsule or tablet every 12 hours. For example, take one in the morning and one in the evening at the same time. The number of capsules may vary based on pain severity, but it should not be taken more frequently than every 12 hours. The total daily dose should not exceed 400 mg.

• Injection: 50-100 mg can be administered every 4 to 6 hours via intramuscular or intravenous infusion. For postoperative pain, an initial dose of 100 mg should be given, followed by 50 mg every 10 to 20 minutes as needed, up to a maximum of 250 mg in the first hour. Thereafter, doses of 50-100 mg may be given every 4 to 6 hours, up to a maximum of 600 mg daily.

• Suppository: For adults, the usual dose is 100 mg Tramadol every 6 hours. In general, a total of 400 mg per day (four suppositories) is sufficient, though higher doses may be required for cancer pain or severe post-operative pain.

Always follow the advice of a registered healthcare professional regarding dosage.

Drug Interactions

In general, there are no major concerns regarding drug interactions with Utramal Retard. However, the use of monoamine oxidase (MAO) inhibitors is not recommended with Utramal Retard. Additionally, the combination of carbamazepine and Utramal Retard may significantly increase the metabolism of Tramadol, requiring an adjustment in dose.

Contraindications

Tramadol is contraindicated in individuals who have a known hypersensitivity to this drug. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, central analgesics, opioids, or psychotropic medications.

Side Effects

Common side effects of Utramal Retard may include:

• Dizziness/vertigo
• Nausea
• Constipation
• Headache
• Somnolence
• Vomiting
• Itching (pruritus)
• CNS stimulation
• Weakness (asthenia)
• Sweating
• Indigestion (dyspepsia)
• Dry mouth
• Diarrhea

Less common side effects include:

• Malaise
• Allergic reactions
• Weight loss
• Vasodilatation
• Palpitations
• Abdominal pain
• Loss of appetite (anorexia)
• Flatulence
• GI bleeding
• Hepatitis
• Stomatitis

Pregnancy and Lactation

The safety of Tramadol during pregnancy has not been established, as it crosses the placenta. There are no adequate and well-controlled studies in pregnant women, so Tramadol should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.
Tramadol and its metabolites have been detected in breast milk, so it should not be used while breastfeeding.

Precautions and Warnings

• Respiratory Depression: Large doses of Tramadol, especially when combined with anesthetics or alcohol, may lead to respiratory depression. Caution is advised when prescribing to individuals at risk for respiratory issues.

• Opioid Dependence: Utramal Retard is not recommended for individuals dependent on opioids.

• Concomitant Use with CNS Depressants: Care should be taken when using Utramal Retard in combination with CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers, or sedative hypnotics, as this may increase the risk of side effects.

• Concomitant Use with MAO Inhibitors: Use with MAO inhibitors requires great caution, as Tramadol can inhibit norepinephrine and serotonin reuptake, which may lead to serious side effects.

• Intracranial Pressure and Abdominal Conditions: Utramal Retard should be used with caution in patients with increased intracranial pressure, head injuries, or acute abdominal conditions.

Use in Special Populations

• Children: Utramal Retard can be given to children aged 1 year and older at a dose of 1-2 mg/kg body weight. However, Tramadol suppositories (100 mg) should not be administered to children or adolescents under the age of 14. The safety and efficacy of Utramal Retard 100 mg SR capsules have not been established in children, so it should not be used in this age group.

Therapeutic Class

Utramal Retard belongs to the class of Opioid Analgesics.

Storage Conditions

Store the medication below 30°C, in a cool, dry place, away from light and moisture. Keep it out of reach of children.