Poro Suspension

Paracetamol.

An orange color, orange-flavored suspension or a yellow color, pineapple-flavored suspension or a pink color, strawberry-flavored suspension.
Each 5 ml contains Paracetamol 250 mg.
Excipients/Inactive Ingredients: Preservatives: Methyl Paraben 0.18% w/v, Propyl Paraben 0.02% w/v.

Pharmacology: Pharmacodynamics: Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties.
Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (specifically cyclooxygenase (COX)-2) and, to a lesser extent, through a peripheral action by blocking pain impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Antipyretic: Paracetamol acts centrally on the hypothalamic heat-regulating center to produce peripheral vasodilatation, resulting in increased blood flow through the skin, sweating and heat loss. Paracetamol reduces fever by inhibiting the release of prostaglandins in the central nervous system and by inhibiting endogenous pyrogens at the hypothalamic thermoregulatory center.
Pharmacokinetics: Orange flavour: Following oral administration, paracetamol is rapidly absorbed.
Paracetamol absorption takes place mainly in the small intestine and therefore the rate of absorption is depending on the rate of gastric emptying. It has been shown that drugs which delay gastric emptying also delay the absorption of paracetamol, whereas metoctopramide (a drug which increases the rate of gastric emptying) accelerates absorption of the analgesic although the total absorbed amount does not increase.
The presence of food in the stomach has also been reported to reduce the rate of absorption of paracetamol. Alterations in gastric pH have no appreciable effect on paracetamol absorption.
During absorption, the amount of paracetamol which is inactivated is negligible and it has been shown that paracetamol does not affect gastric mucosal permeability and does not produce mucosal bleeding.
Peak plasma concentrations are reached 1 hour after absorption. The plasma half-life is 1 to 3 hours. Paracetamol penetrates the brain and is present in breast milk of human.
Paracetamol is metabolized by the microsomal enzyme system of the liver. This metabolism is mainly to the glucuronide and sulphate conjugates, accounting for approximately 49% and 26% of the ingested dose, respectively. About 4% is excreted as free paracetamol. Other minor pathways include the production of catechol derivatives and cysteine conjugates (via glutathione). Paracetamol excretion is rapid and occurs via the urine.
Pineapple & strawberry flavour: Therapeutic doses of Paracetamol have negligible effects on the cardiovascular respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

For the relief of fever and mild to moderate pain.

1-5 years: 2.5 ml-5 ml (½-1 teaspoon).
6-12 years: 5 ml-10 ml (1-2 teaspoon).
Doses may be repeated every 4-6 hours when necessary (max of 4 doses in 24 hours).
Route of Administration: To be taken orally.
Shake well before use.

Symptoms and Treatment for Overdosage and Antidote(s): Orange & strawberry flavour: Initial symptoms of overdosage include nausea, vomiting, hypotension and sweating. Liver damage is unlikely to occur after ingestion of less than 15 g Paracetamol (300 mL) as a single dose.
Jaundice, hypoglycaemia and metabolic acidosis are the major manifestations of liver failure, which may take at least three days to develop.
In cases of suspected overdose, Acetylcysteine is given by intravenous infusion as an antidote by a physician.
Pineapple flavour: Liver damage is possible in adults and adolescents (≥12 years of age) who have taken 7.5 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see as follows).
Risk factors: If the patient: a) Is on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes; or b) Regularly consumes ethanol in excess of recommended amounts; or c) Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms: Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, hyperhidrosis, malaise, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis.
Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased.
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.
Haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Haemolysis has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.
Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patient 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. Management should be in accordance with established treatment guidelines.
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. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Hypersensitivity to Paracetamol.

This preparation contains PARACETAMOL. Do not take any other paracetamol-containing medicines at the same time.

If fever persists for more than 3 days or recurs, or if pain continue for more than 5 days, consult a physician immediately.
Use with caution in patients with anemia or with cardiac, pulmonary, renal or hepatic disease.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening. blisters or rash.
These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.

Orange flavour: The analgesic of choice in pregnant patients. Paracetamol is considered to be safe in normal therapeutic doses for short-term use as a minor analgesic/antipyretic in pregnancy, although it crosses placenta.
Excreted in breast milk. Maternal ingestion of paracetamol in normal therapeutic doses does not appear to present a risk to the nursing infant.
Pineapple flavour: Fertility: There is no information relating to the effects of this medicine on fertility.
Pregnancy: A large amount of data on pregnant women indicates neither malformative nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy, however, it should be used at the lowest possible time and at the lowest possible frequency.
When given to the mother in therapeutic doses (1 g single dose), paracetamol crosses the placenta into foetal circulation as early as 30 minutes after ingestion and is metabolised in the foetus by conjugation with sulfate and increasingly with glutathione.
Breast-feeding: Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not contraindicate breast-feeding.
Strawberry flavour: Pharmaceutical studies in 12 nursing mothers given a single dose of Paracetamol suggested that maternal ingestion of Paracetamol in usual therapeutic doses does not appear to present a risk to nursing infants.
Paracetamol metabolites were found in the neonate following maternal overdose at 36 weeks. The baby was delivered by Caesarean section and did not suffer liver damage; the mother was treated with Acetylcysteine.

Side effects of Paracetamol are usually mild, though hematological reactions have been reported. Skin rashes and other allergic reactions occur occasionally.
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.

Concurrent chronic, high-dose administration of Paracetamol with anticoagulants may increase the anticoagulant effect.
Administration of Paracetamol with Aspirin increases blood concentration of unhydrolysed aspirin.

Keep in an airtight container. Store at temperature below 30°C. Protect from light and moisture.
Shelf-Life: Orange & pineapple flavour: 2 years from the date of manufacture.
Strawberry flavour: 3 years from the date of manufacture.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

NP