Product Overview:

TAMOL PLUS 150ml Oral Suspension is a paracetamol-based analgesic and antipyretic medication, formulated for both adult and pediatric use. Each 5ml of suspension contains 250mg of paracetamol, a widely used and trusted compound for the relief of pain and reduction of fever. Manufactured by Sandoz, a globally recognized pharmaceutical company, TAMOL PLUS offers a reliable solution for managing mild to moderate pain and controlling fever across a wide age range.

Pharmacological Classification:

• Active Ingredient: Paracetamol (also known as acetaminophen)
• Strength: 250mg per 5ml of suspension
• Volume: 150ml per bottle
• Category: Analgesic and antipyretic

Indications:

TAMOL PLUS is indicated for the relief of mild to moderate pain and the reduction of fever in various conditions, including but not limited to:

• Headaches
• Muscle aches
• Backache
• Toothaches
• Arthritis
• Menstrual cramps
• Common cold and flu
• Post-immunization pyrexia in children

Dosage and Administration:

For Adults:

• The typical adult dosage of TAMOL PLUS is 325mg to 1000mg (approximately 6.5ml to 20ml) every 4 to 6 hours as needed.
• The maximum dose should not exceed 4 grams (80ml) in a 24-hour period to avoid toxicity.

For Children:

• The recommended pediatric dosage is based on the child’s weight, typically 15mg per kilogram of body weight every 4 to 6 hours.
• For children at risk of dehydration, a lower dose of 10mg per kilogram every 4 to 6 hours is advisable.
• Ensure accurate dosing using the provided measuring device, and do not exceed five doses within 24 hours.

Note: The suspension should be shaken well before each use to ensure the active ingredient is evenly distributed.

Pharmacokinetics and Mechanism of Action:

Paracetamol, the active ingredient in TAMOL PLUS, works primarily by inhibiting the production of prostaglandins in the brain, which are responsible for pain and fever. Unlike non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol does not exert significant anti-inflammatory effects and has a lower risk of gastrointestinal irritation.

Upon oral administration, paracetamol is rapidly absorbed from the gastrointestinal tract and reaches peak plasma concentrations within 30 to 60 minutes. It is extensively metabolized in the liver, and the metabolites are excreted primarily in the urine. The elimination half-life of paracetamol ranges between 1.5 to 3 hours in healthy individuals.

Special Populations:

• Pregnancy: TAMOL PLUS is classified as a Pregnancy Category B drug, indicating that there is no evidence of harm to the fetus in animal studies, but there are no well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
• Lactation: Paracetamol passes into breast milk in small amounts. However, it is generally considered safe for use during breastfeeding. Caution is advised, and breastfeeding mothers should consult their healthcare provider before using TAMOL PLUS.
• Elderly: Older adults may require lower doses due to the potential for decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Contraindications:

TAMOL PLUS should not be used in individuals with the following conditions:

• Hypersensitivity: Allergy to paracetamol or any of the excipients in the formulation.
• Severe Hepatic Impairment: Paracetamol is metabolized in the liver, and patients with severe liver disease are at an increased risk of hepatotoxicity.
• Severe Renal Impairment: Dosage adjustment may be required in patients with significant kidney dysfunction.

Drug Interactions:

Paracetamol, while generally safe, can interact with certain medications, which may enhance its effects or increase the risk of side effects. Notable interactions include:

• Anticonvulsants (e.g., phenytoin, carbamazepine): These drugs can increase the metabolism of paracetamol, potentially reducing its efficacy or increasing the risk of liver damage.
• Chloramphenicol: Paracetamol may prolong the half-life of chloramphenicol, leading to potential toxicity.
• Desipramine: The analgesic effects of paracetamol may be diminished by desipramine.
• Doxorubicin: Paracetamol may reduce the cardioprotective effect of doxorubicin.
• Anticoagulants (e.g., warfarin): Regular use of paracetamol may potentiate the effects of anticoagulants, increasing the risk of bleeding.
• Alcohol: Chronic consumption of alcohol increases the risk of hepatotoxicity with paracetamol use, even at recommended doses.

Side Effects:

TAMOL PLUS is generally well-tolerated when used as directed. However, as with any medication, there is a potential for side effects. Common and rare side effects include:

• Common Side Effects:
  • Nausea
  • Vomiting
  • Dyspepsia (indigestion)
• Allergic Reactions:
  • Urticaria (hives)
  • Rash
  • Angioedema
• Hematologic Reactions:
  • Methemoglobinemia (a condition where hemoglobin is unable to release oxygen effectively to body tissues)
  • Thrombocytopenia (low platelet count)
  • Hemolytic anemia in predisposed individuals
• Hepatic Effects:
  • Elevated liver enzymes, indicating liver stress
  • Hepatotoxicity in overdose or in patients with underlying liver disease

In the event of any severe adverse reaction, the use of TAMOL PLUS should be discontinued immediately, and medical attention should be sought.

Overdose and Treatment:

Paracetamol overdose is a medical emergency and can lead to severe liver damage, and in extreme cases, acute liver failure, and death. Symptoms of overdose may include:

• Nausea and vomiting
• Diaphoresis (excessive sweating)
• General malaise
• Elevated liver enzymes
• Hepatic necrosis (in severe cases)

In the case of suspected overdose, immediate medical intervention is necessary. Treatment may include the administration of activated charcoal (if the overdose is detected early) and N-acetylcysteine (NAC), an antidote that replenishes glutathione levels in the liver, thereby preventing further damage.

Storage and Handling:

• Storage Conditions: Store TAMOL PLUS in a cool, dry place away from direct sunlight. The ideal storage temperature is between 15°C and 30°C (59°F and 86°F).
• Shelf Life: Refer to the packaging for the expiration date. Do not use TAMOL PLUS beyond the expiration date as the effectiveness and safety of the medication may be compromised.
• Handling: Keep the bottle tightly closed when not in use. Always shake the bottle well before each dose to ensure proper suspension of the active ingredient. Keep out of reach of children to prevent accidental ingestion.

Patient Counseling Information:

When prescribing or dispensing TAMOL PLUS, healthcare providers should counsel patients or caregivers on the following points:

• Correct Dosing: Emphasize the importance of using the correct dose, particularly in children, based on weight. Overdose can lead to serious health complications.
• Avoiding Interactions: Advise against the concurrent use of other paracetamol-containing products or alcohol, as this can increase the risk of liver damage.
• Side Effects Awareness: Educate patients on recognizing signs of allergic reactions or overdose and instruct them to seek immediate medical help if they experience symptoms such as swelling, difficulty breathing, or jaundice (yellowing of the skin or eyes).
• Pregnancy and Lactation: Discuss the risks and benefits of using TAMOL PLUS during pregnancy and while breastfeeding.

Conclusion:

TAMOL PLUS 150ml Oral Suspension is a versatile and effective option for managing pain and fever in both adults and children. With its well-established safety profile, ease of administration, and rapid onset of action, it is a trusted choice for healthcare providers and patients alike. Always follow the prescribed dosage, be mindful of potential drug interactions, and seek medical advice in cases of uncertainty or adverse reactions.