Tablet Manufacturer/Distributor: Delta Pharma Limited Generic Name: Paracetamol 325 mg + Tramadol Hydrochloride 37.5 mg Tablet
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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 analgesic and antipyretic properties and its anti-inflammatory activity is weak. Paracetamol (acetaminophen) is believed to act primarily on the central nervous system, increasing pain threshold by inhibiting the two isomers of cyclooxygenase COX1, COX2 and COX3 that are involved in prostaglandin (PG) synthesis. Paracetamol is a derivative of p-aminophenol, which has analgesic and antipyretic effects, and has a weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest, and fast-acting pain relievers. It is well tolerated and does not have the various side effects of aspirin.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not fully understood, from animal experiments, at least two complementary mechanisms seem to be applicable: the binding of father and M1 metabolites to μ-opioid receptors and the weak reuptake of norepinephrine and serotonin inhibition. The opioid activity is due to the low-affinity binding of the parent compound and the high-affinity binding of the Odemethylated metabolite M1 to the μ opioid receptor. Like some other opioid analgesics, tramadol has been shown to inhibit the reuptake of norepinephrine and serotonin in vitro. These mechanisms may independently affect the overall analgesic properties of tramadol.
Dosage & Administration
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
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. are all possible side effects of this therapy.
Pregnancy & Lactation
Pregnancy Classification C. In pregnant women, there are no sufficient and well-controlled trials. Only if the possible benefit outweighs the risk to the fetus should this combo preparation be used during pregnancy. Because the safety of this combination preparation in babies and newborns has not been tested, it is not advised for obstetrical preoperative medication or post-delivery analgesia in nursing mothers.
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.
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