Generic

Indications

This tablet is indicated for-

• The management of moderate to moderately severe pain in adults.
• The short-term (five days or less) management of acute pain.

Pharmacology

Paracetamol has pain relieving and antipyretic properties with powerless anti-inflammatory action. Paracetamol (Acetaminophen) is thought to act fundamentally within the CNS, expanding the torment edge by repressing both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 chemicals included in prostaglandin (PG) synthesis. Paracetamol could be a para aminophenol subsidiary, has pain relieving and antipyretic properties with powerless anti-inflammatory action. Paracetamol is one of the foremost broadly utilized, most secure and quick acting pain relieving. It is well endured and free from different side impacts of aspirin.Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M₁ metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M₁ to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.

Administration & Dosage

For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

This tablet can be administered without regard to food.

Interaction

Antidepressants such as SSRIs and related antidepressants should not be started for at least two weeks after stopping an MAOI. An MAOI, on the other hand, should not be started until at least one week after an SSRI or similar antidepressant has been discontinued (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

Contraindications

Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.

Side Effects

The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.

Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.

Precautions & Warnings

• This combination preparation may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
• This combination preparation should not be taken with alcohol containing beverages.
• The patient should be instructed not to take this combination preparation in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations.
• This combination preparation should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.

Therapeutic Class

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Protect from light and moisture by storing below 30°C. Keep the medicine out of children’s reach.

Pharmaceutical Name