Overview

Indications of Napadol 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. Theropeutic Class Non-steroidal Anti-inflammatory Drugs (NSAIDs) Pharmacology Tramadol, a centrally-acting analgesic, exists as a racemic mixture of the trans isomer, with important differences in binding, activity, … ... See More Indications of Napadol 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. Theropeutic Class Non-steroidal Anti-inflammatory Drugs (NSAIDs) Pharmacology Tramadol, a centrally-acting analgesic, exists as a racemic mixture of the trans isomer, with important differences in binding, activity, and metabolism associated with the two enantiomers. 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 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. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Opiate antagonist naloxone only partially antagonized tramadol-induced analgesia.Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation. Dosage & Administration of Napadol For the management of 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. The dosing interval should not be less than six hours. This is not recommended in patients under 18 years of age. Dosage of Napadol 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. 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 of Napadol 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 Since it is a fixed combination of active ingredients including Tramadol Hydrochloride, it should not be used during pregnancy & lactation. 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. Storage Conditions Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children. Drug Classes Non-steroidal Anti-inflammatory Drugs (NSAIDs) Mode Of Action Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects 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. Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combinationpreparation 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. Pediatric Uses pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.Use in Renal Disease: This combination preparation has not been studied in patients with impaired renalfunction. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended. Disclaimer The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions. See Less