Non- Opioid Analgesics And Antipyretics

  • Chemical Composition

    Paracetamol 500 mg - Codeine phosphate 8 mg - Caffeine 30 mg

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Excipients Pregelatinized starch , Potassium sorbate , Microcrystalline cellulose , Povidone , Maize starch , Talc , Magnesium stearate.
Mechanism Of Action Paracetamol is a well-established analgesic, caffeine has a stimulating effect on the central nervous system and possesses a weak diuretic action. Codeine is a centrally acting weak analgesic. Codeine exerts its effect through µ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.
INDICATIONS In patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. For the relief of migraine, headache, backache, rheumatic pain, period pains and dental pain.
CONTRAINDICATIONS - Hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents. - In all pediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome due to an increased risk of developing serious and life-threatening adverse reactions. - In women during breastfeeding. - In patients for whom it is known they are CYP2D6 ultra-rapid metabolizers
Side EFFECTS Paracetamol : Body System:Undesirable effect Blood and lymphatic system disorders : Thrombocytopenia Agranulocytosis Immune system disorders :Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders : Bronchospasm* Hepatobiliary disorders :Hepatic dysfunction * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. Caffeine : Body System:Undesirable effect Central nervous system :Nervousness Dizziness When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations. Codeine Body System:Undesirable effect Psychiatric disorders :Drug dependency can occur after prolonged use of codeine at higher doses Gastrointestinal disorder :Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy Nervous system disorder:Dizziness, worsening of headache with prolonged use, drowsiness. Renal and urinary disorders :Difficulty with micturition Skin and subcutaneous tissue disorder:Pruritus, sweating Effects on ability to drive and use machines: Patients should be advised not to drive or operate machinery if affected by dizziness or sedation
WARNINGS - Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. - Do not exceed the stated dose. - Patients should be advised to consult their doctor if their headaches become persistent. - Patients should be advised not to take other paracetamol or codeine-containing products concurrently. - If symptoms persist consult your doctor. - Keep out of the reach and sight of children. - Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product. - Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. - Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product. CYP2D6 metabolism Codeine is metabolized by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Post-operative use in children There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnea, led to rare, but life threatening adverse events. All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolizers in their ability to metabolize codeine to morphine. Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
DRUG INTERACTIONS Paracetamol The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Codeine Codeine may antagonize the effects of metoclopramide and domperidone on gastrointestinal motility. Codeine potentiates the central depressive effects of central nervous system depressants including alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation. Opiate analgesics may interact with monoamine oxidase inhibitors (MAOI) and result in serotonin syndrome.
Pregnancy And lactations الحمل: ينبغي عدم استخدام المستحضر خلال فترة الحمل إلا باستشارة الطبيب. وينطبق هذا على الأم أثناء المخاض بسبب احتمال حدوث تثبيط تنفسي عند المولود. لم تثبت سلامة استخدام المستحضر خلال فترة الحمل بسبب الآثار الجانبية المحتملة على التطور الجنيني وينبغي تجنبه خلال فترة الحمل بسبب ازدياد خطورة حدوث انخفاض في وزن المولود وخطورة حدوث إجهاض تلقائي مرتبط بتناول الكافئين. الإرضاع: ينبغي عدم تناول الكودئين خلال فترة الإرضاع. في الجرعات الاعتيادية قد يظهر الكودئين ومستقلبه الفعال في حليب الأم المرضع بكميات قليلة جداً ومن غير المحتمل ظهور التأثيرات الجانبية على الطفل الرضيع. من ناحية ثانية، إذا كانت المريضة من النوع فائق سرعة الاستقلاب عبر CYP2D6، فإن مستويات أعلى من المستقلب الفعال، المورفين، قد تظهر في حليب الأم وفي حالات نادرة قد يسبب أعراض التسمم الأفيوني عند الرضيع، والتي قد تكون مميتة. رغم أنه لم يشاهد حدوث تسمم بالكافئين عند الأطفال الرضع، قد يكون للكافئين تأثير منبه على الرضيع. بسبب وجود الكافئين في المستحضر ينبغي عدم استخدام المستحضر خلال فترة الحمل والإرضاع.
Dosage And Administration Adults (including the elderly) 2 tablets up to 3 or 4 times a day if necessary. The dose should not be repeated more frequently than every four hours, and not more than 4 doses should be given in any 24 hour period. Pediatric population: Children and adolescents aged 12 – 18 years: 2 tablets up to 3 or 4 times a day if necessary. The dose should not be repeated more frequently than every four hours, and not more than 4 doses should be given in any 24 hour period. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine. For oral administration only. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
OVERDOSE Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped. Codeine: The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms: An overdose of codeine is characterized, in the first phase, by nausea and vomiting. An acute depression of the respiratory center can cause cyanosis, slower breathing, drowsiness, ataxia and, more rarely, pulmonary edema. Respiratory pauses, miosis, convulsion, collapse and urine retention. Signs of histamine release have been observed as well. Management: This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg. Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken. Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors. Risk Factors: If the patient Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. Or Regularly consumes ethanol in excess of recommended amounts. Or Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms: Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, hematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Caffeine: Symptoms and signs: Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions). It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity. Management: Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives. Summary: Treatment of overdose with PARACETAMOL BARAKAT CO PLUS Tablets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
Storage Conditions Store below 25° c. Keep out of reach of children .