PARACETAMOL 120mg/5ml Syrup (Elixir)

What is PARACETAMOL 120mg/5ml

PARACETAMOL 120mg/5ml Syrup is an oral liquid medication formulated primarily for children to provide relief from mild to moderate pain and to reduce fever. Each 5 ml of this syrup contains 120 mg of paracetamol, a widely used analgesic (pain reliever) and antipyretic (fever reducer). It is also known by its international nonproprietary name (INN), acetaminophen in some countries.

• Generic Name: Paracetamol
• Form: Syrup / Elixir
• Concentration: 120 mg per 5 ml
• Pack Size: 100 ml bottle
• Route of Administration: Oral
• Therapeutic Class: Analgesic and antipyretic

This syrup is commonly used to treat conditions such as teething pain, headaches, sore throat, earaches, post-immunization fever, and minor injuries. It is well-tolerated and suitable for infants and young children when dosed correctly by weight and age.

How to use PARACETAMOL 120mg/5ml

Using PARACETAMOL 120mg/5ml Syrup correctly ensures both safety and therapeutic effectiveness, especially in children.

• Shake well: Always shake the bottle thoroughly before each use to ensure uniform distribution of the medicine.
• Use the dosing device: Always use a proper measuring spoon, oral syringe, or dosing cup provided with the medicine for accurate dosing. Avoid using household spoons.
• Administer by mouth: Give the dose orally at regular intervals (typically every 4 to 6 hours).
• Do not exceed: More than 4 doses in 24 hours should not be given. Always observe the maximum daily limit to prevent overdose.
• With or without food: This syrup can be taken with or without food. If the child has a sensitive stomach, it may help to give it after food.
• Stay consistent: If a dose is missed, administer it as soon as you remember unless it’s nearly time for the next dose. Never double the dose to make up for a missed one.

Always follow your healthcare provider’s or pharmacist’s instructions regarding dosage based on your child's weight and age. If symptoms persist for more than 3 days or worsen, consult a doctor immediately.

Mode of Action PARACETAMOL 120mg/5ml

Paracetamol works centrally in the brain and is effective in reducing both pain and fever through its unique pharmacological action. Here’s how it works:

• Inhibition of prostaglandin synthesis: Paracetamol selectively inhibits the enzyme cyclooxygenase (COX), particularly COX-2, in the central nervous system. This reduces the synthesis of prostaglandins—chemicals involved in pain signaling and inflammation.
• Antipyretic effect: It acts on the hypothalamic heat-regulating center in the brain to reduce elevated body temperature. This is particularly beneficial for fever management in children.
• Analgesic effect: By decreasing prostaglandin production in the brain, paracetamol elevates the pain threshold, thus reducing the sensation of pain.
• No significant anti-inflammatory activity: Unlike NSAIDs, paracetamol has minimal effect on peripheral COX enzymes, meaning it does not cause gastric irritation or platelet inhibition.
• Rapid onset: Oral syrup is quickly absorbed from the gastrointestinal tract, with onset of action within 30 minutes, and peak effect within 1–2 hours.

This dual action makes it an ideal first-line treatment for fever and minor aches in children, with a favorable safety profile when used appropriately.

PARACETAMOL 120mg/5ml Interactions PARACETAMOL 120mg/5ml

Paracetamol has a relatively low risk of drug interactions, especially in standard pediatric doses. However, certain interactions can still occur:

• Enzyme-inducing drugs (e.g., phenytoin, carbamazepine, rifampicin): These may increase the breakdown of paracetamol in the liver, potentially raising the risk of liver toxicity with chronic use.
• Alcohol (in adults): Chronic alcohol intake enhances the risk of hepatotoxicity due to reduced glutathione reserves.
• Warfarin and other coumarin anticoagulants: Prolonged use of high-dose paracetamol may enhance anticoagulant effect, increasing bleeding risk. Periodic monitoring of INR is advisable.
• Probenecid: May reduce paracetamol clearance. Dose adjustment may be required under supervision.
• Chloramphenicol: Co-administration may increase chloramphenicol levels and risk of toxicity due to inhibited metabolism.

Always inform your healthcare provider about any other medications, vitamins, or supplements your child is taking to avoid unintended interactions. It’s best to avoid combining multiple medications containing paracetamol to prevent accidental overdose.

Dosage of PARACETAMOL 120mg/5ml

Correct dosing of paracetamol is critical, particularly in children. Dosage is usually based on the child's weight and age. The following general guidelines can be used:

• Infants 2–3 months: Only under medical supervision. Typically 2.5 ml (60 mg) if fever is due to vaccination.
• 3–6 months: 2.5–5 ml every 4–6 hours as needed (max 4 doses in 24 hours)
• 6–24 months: 5 ml every 4–6 hours (max 4 doses daily)
• 2–4 years: 7.5 ml (180 mg) every 4–6 hours
• 4–6 years: 10 ml (240 mg) every 4–6 hours

Maximum daily dose should not exceed 60 mg/kg/day in children or 4 grams/day in adults. Overdosing can lead to severe liver injury, which may require immediate medical intervention.

For neonates and infants under 3 months, paracetamol should only be used under medical supervision. Always consult your healthcare provider or pharmacist before administering to children, especially for long-term use.

Possible side effects of PARACETAMOL 120mg/5ml

When used appropriately, paracetamol is generally very well tolerated. However, side effects, though rare, can occur:

• Common (usually mild):
  • Nausea or upset stomach
  • Mild allergic reactions (e.g., rash, itching)
• Uncommon to Rare:
  • Liver enzyme elevation (with high or prolonged doses)
  • Allergic skin reactions including urticaria and angioedema
  • Blood disorders (e.g., thrombocytopenia, leukopenia)
  • Severe skin reactions (e.g., Stevens-Johnson syndrome) – extremely rare
• Overdose Symptoms:
  • Loss of appetite, vomiting
  • Pain in the upper right abdomen
  • Confusion or drowsiness

If any unusual symptoms occur, particularly signs of liver damage or allergic reaction, discontinue use and seek immediate medical advice. Parents should be educated about not exceeding the recommended dose or frequency of administration.

PARACETAMOL 120mg/5ml Contraindications PARACETAMOL 120mg/5ml

Though paracetamol is considered safe for most individuals, it is contraindicated in certain situations:

• Hypersensitivity: Children with a known allergy to paracetamol or any of the syrup’s ingredients should not use this medication.
• Severe liver impairment: Use is contraindicated in patients with active or severe liver disease.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Use with caution due to risk of hemolysis.
• Phenylketonuria (if aspartame is present): Some formulations may contain sweeteners like aspartame, which can be harmful in individuals with PKU.

Always review the product label or consult a pharmacist for information about inactive ingredients such as coloring agents, flavorings, or sweeteners that may trigger sensitivities in children.

Storage of PARACETAMOL 120mg/5ml

Proper storage ensures the medication remains effective and safe throughout its shelf life. Follow these storage guidelines:

• Temperature: Store at room temperature (below 25°C). Do not refrigerate unless specified by the manufacturer.
• Protect from light and moisture: Keep the bottle tightly closed in its original packaging.
• Keep out of reach of children: Store in a secure place to prevent accidental ingestion.
• Shelf life: Check the expiration date on the bottle. Do not use after this date.
• After opening: Use within the period mentioned on the label (typically 1–2 months after opening).
• Disposal: Do not pour into drains or throw into household waste. Ask your pharmacist how to properly dispose of expired or unused syrup.

Improper storage may alter the taste, appearance, or potency of the medication. Always inspect the syrup before each use for signs of spoilage, such as color change or unusual smell.