Parastad Kid

OTC

Indications

• For treatment of mild to moderate pain and fever, especially in patients in whom salicylates are contraindicated or not tolerated.
• The drug is most effective in relieving low intensity pain of non-visceral origin.

Dosage

Children

• It is essential to respect the dosages defined according to the weight of the child and therefore to choose an appropriate presentation.
• The recommended daily dose of paracetamol is approximately 60 mg/kg/day, to be divided into 4 or 6 doses, i.e. approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours
• The total paracetamol dose should not exceed 80 mg/kg/day.
• Approximate ages by weight are given for information:
  13 – 20 kg (about 2 – 7 years old): 250 mg (1 tablet), every 6 hours, not exceed 1000 mg (4 tablets) daily.
  21 – 25 kg (about 6 – 10 years old): 250 mg (1 tablet), every 4 hours, not exceed 1500 mg (6 tablets) daily.
  26 – 40 kg (about 8 – 13 years old): 500 mg (2 tablets), every 6 hours, not exceed 2000 mg (8 tablets) daily.
  41 – 50 kg (about 12 – 15 years old): 500 mg (2 tablets), every 4 hours, not exceed 3000 mg (12 tablets) daily.
• Maximum recommended doses
  Children < 40 kg: The total dose of paracetamol should not exceed 80 mg/kg/day.
  Children from 41 – 50 kg: The total dose of paracetamol should not exceed 3 g per day.
  Adults and children > 50 kg: The total dose of paracetamol should not exceed 4 g per day.

Renal failure

• In case of renal insufficiency and except medical opinion, it is recommended to reduce the dose and to increase the minimum interval between 2 intakes according to the following:
  Creatinine clearance ≥ 50 ml/min: Every 4 hours.
  Creatinine clearance 10 – 50 ml/min: Every 6 hours.
  Creatinine clearance < 10 ml/min: Every 8 hours.
  The total dose should not exceed 3 g/day

Hepatic insufficiency

• In patients with active or compensated chronic liver disease, particularly those with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione stores), Gilbert’s syndrome (familial non-hemolytic jaundice), and dehydration, dose of paracetamol should not exceed 3 g/day.

Special clinical situations

• The lowest possible effective daily dose should be considered, without exceeding 60 mg/kg/day (without exceeding 3 g/day) under the following conditions:
  Adults < 50 kg.
  Mild to moderate hepatocellular insufficiency.
  Gilbert’s syndrome (familial non-hemolytic jaundice).
  Chronic alcoholism.
  Chronic malnutrition.
  Dehydration.

Frequency of administration

Systematic intakes make it possible to avoid oscillations of pain or fever:

• In children, they must be regularly spaced, including the night, preferably 6 hours, and at least 4 hours.
• In adults, they must be spaced at least 4 hours apart.

Usage

• Parastad Kid is administered orally.
• Place the tablets in a full tumbler of water and allow to dissolve completely before swallowing.
• Drink immediately after complete dissolution.

• Patients with known hypersensitivity to paracetamol or to any of the other ingredients.
• Severe hepatic impairment.

• Serious skin reactions such as Stevens-Johnson syndrome, Lyell’s syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis occur rarely, but potentially fatal. If patients get a rash or other skin manifestations, to stop taking drug and notify your physicians.
• Skin rash and other allergic reactions occur occasionally. The rash is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by fever and mucosal lesions. If patients have fever, blisters around the natural cavity, consider Stevens-Johnson syndrome, be discontinued paracetamol immediately.
• Paracetamol overdose can lead to severe liver damage and sometimes acute tubular necrosis. Patients who show hypersensitivity reactions to the salicylates only rarely exhibit sensitivity to paracetamol and related drugs. In a few isolated cases, the use of paracetamol has been associated with neutropenia, thrombocytopenia and pancytopenia.

• Paracetamol is relatively nontoxic in therapeutic doses. Dermatologic have sometimes reactions including pruritic maculopapular rash and urticaria; other sensitivity reactions including laryngeal edema, angioedema, and anaphylactoid reactions may occur rarely. Thrombocytopenia, leukopenia, and pancytopenia have been associated with the use of p-aminophenol derivatives, especially with prolonged administration of large doses. Neutropenia and thrombocytopenic purpura have been reported with paracetamol use. Rarely, agranulocytosis has been reported in patients receiving paracetamol.
• Paracetamol should be used with caution in patients with preexisting anemia, since cyanosis may not be apparent despite dangerously high blood concentrations of methemoglobin.
• Excessive intake of alcohol may increase the risk of paracetamol induced hepatotoxicity; avoid or limit alcohol intake.
• Caution is recommended when giving to patients with hepatic or renal impairment, chronic alcoholism, chronic malnutrition or dehydration.
• The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
• When detecting first signs of skin rash or any other hypersensitivity reactions, patients should stop using the drug. Patients who have experienced serious skin reactions caused by paracetamol shouldn’t use the medicine again and should inform the medical staff to know about this issue.
• Parastad Kid is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
• Parastad Kid contains aspartame, may be harmful if you have phenylketonuria (PKU).
• Paracetamol should be only used in pregnant women when clearly needed.
• In postpartum studies involving nursing mothers who were given paracetamol, no adverse effects were noted in infants receiving mother’s milk.
• There is no evidence that paracetamol affects the ability to drive or to operate machinery.