Napa One Tablet 1000 mg

নাপা ওয়ান হল প্যারাসিটামল-ভিত্তিক একটি জনপ্রিয় ব্যথানাশক ও জ্বর কমানোর ঔষধ, যা বেক্সিমকো ফার্মাসিউটিক্যালস লিমিটেড-এর উৎপাদিত। প্রতিটি ট্যাবলেট-এ ১০০০ মি.গ্রা. প্যারাসিটামল বিদ্যমান। প্রতি ট্যাবলেটের মূল্য ৳২.২৫, এবং ২০×১০ ট্যাবলেটের প্যাকের মূল্য ৳৪৫০.০০। আলো ও তাপ থেকে দূরে শুষ্ক স্থানে সংরক্ষণ করতে হবে। জ্বর, মাথাব্যথা, দাঁতে ব্যথা, অস্টিওআর্থ্রাইটিস, টিকা পরবর্তী ব্যথা ও ঋতুস্রাবজনিত যন্ত্রণায় কার্যকর। এটি সিএনএস-এ প্রোস্টাগ্ল্যান্ডিন সংশ্লেষণ বাধা দিয়ে কাজ করে। প্রাপ্তবয়স্কদের জন্য ডোজ: ৪-৬ ঘন্টা পরপর ১-২ ট্যাবলেট (দৈনিক সর্বোচ্চ ৮টি)। ৬-১২ বছর বয়সী শিশুদের জন্য আধা থেকে ১টি ট্যাবলেট দিনে ৩-৪ বার। যকৃত বা কিডনির সমস্যাযুক্ত রোগী, গর্ভবতী বা স্তন্যদানকারী মায়েদের চিকিৎসকের পরামর্শ নিতে হবে। এলকোহল সেবন বা বারবিচুরেট জাতীয় ঔষধের সাথে নাপা ওয়ান সেবনে লিভার ক্ষতির ঝুঁকি বাড়ে। পার্শ্বপ্রতিক্রিয়া হিসাবে চর্মরাশি বা অগ্নাশয়ের প্রদাহ দেখা দিতে পারে। ১০ গ্রামের বেশি ওভারডোজে যকৃতের ক্ষতি হতে পারে, যা এন-এসিটাইলসিস্টেইন দিয়ে চিকিৎসা করা হয়। বাচ্চা ও বয়স্ক রোগীদের ক্ষেত্রে ডোজ পরিমাপে বিশেষ সতর্কতা প্রযোজ্য। প্যারাসিটামল-এর এই ব্র্যান্ডটি তার দ্রুত কার্যকারিতা ও নিরাপদ ব্যবহারের জন্য বাংলাদেশে ব্যাপকভাবে ব্যবহৃত হয়।

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

IV Infusion:

• Adults and adolescents weighing 50 kg and over: the recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
• Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
• Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.

Side effects of Napa One are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Care is advised in the administration of Napa One to patients with severe renal or severe 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 not to take other Napa One-containing products concurrently. Napa One should only be used by the patient for whom it is prescribed when clearly necessary.

Administration of Napa One in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Napa One. Use caution when administering Napa One in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Napa One IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Napa One IV in patients with Napa One allergy.

Pediatric Use: The safety and effectiveness of Napa One IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Napa One IV in adults.

Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Patients with Hepatic Impairment: Napa One is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Napa One may be warranted.

Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Napa One may be warranted.

Liver damage is possible in adults who have taken 10 g or more of Napa One. Ingestion of 5 g or more of Napa One may lead to liver damage if the patient has following 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 Napa One 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, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Immediate treatment is essential in the management of Napa One overdose. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Napa One 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 Napa One. 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. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.