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Name of the medicinal product
The information provided in Name of the medicinal product of Paranox-S
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Paranox-S
Qualitative and quantitative composition
The information provided in Qualitative and quantitative composition of Paranox-S
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Acetaminophen
Therapeutic indications
The information provided in Therapeutic indications of Paranox-S
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
Paranox-S ActiFast is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.
Paranox-S Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.
Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adults, the elderly and young persons 16 years and over:
2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children 6 — 9 years:
½ tablet every 4 hours to a maximum of 4 doses in 24 hours.
Children 10 — 11 years:
1 tablet every 4 hours to a maximum of 4 doses in 24 hours
Adolescents 12 — 15 years:
1 to 1 ½ tablets every 4 hours to a maximum of 4 doses in 24 hours
Do not give to children aged under 6 years of age.
For oral administration.
Adults, including the elderly and children 16 years and over:
Two tablets to be taken with half a tumbler of water (100 ml).
To ensure fast onset of pain relief no less than two tablets must be taken with 100 ml of water. For maximum speed of action this should be on an empty stomach.
Two tablets up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than four doses be taken in any 24 hour period.
Children aged 12-15 years:
One tablet to be taken with half a tumbler of water (100ml), up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24 hour period.
Children under 12 years of age:
Paranox-S ActiFast is not recommended for children under 12 years of age.
For the relief of fever after vaccinations at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
Age : 2 — 3 months |
Dose |
Pain and other causes of fever — if your baby weighs over 4 kg and was born after 37 weeks |
2.5 ml If necessary, after 4-6 hours, give a second 2.5 ml dose |
— Do not give to babies less than 2 months of age. — Leave at least 4 hours between doses. — Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. |
Children aged 3 months — 6 years:
Child’s Age |
How Much |
How often (in 24 hours) |
3 — 6 months |
2.5 ml |
4 times |
6 — 24 months |
5 ml |
4 times |
2 — 4 years |
7.5 ml (5 ml + 2.5 ml) |
4 times |
4 — 6 years |
10 ml (5 ml + 5 ml) |
4 times |
— Do not give more than 4 doses in any 24 hour period — Leave at least 4 hours between doses — Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist |
It is important to shake the bottle for at least 10 seconds before use.
The Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
Contraindications
The information provided in Contraindications of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Hypersensitivity to Paranox-S or any of the constituents.
Hypersensitivity to paracetamol or any of the other constituents.
Special warnings and precautions for use
The information provided in Special warnings and precautions for use of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Care is advised in the administration of Paranox-S to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Contains Paranox-S.
Do not take anything else containing Paranox-S while taking this medicine.
Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is because too much Paranox-S can cause delayed, serious liver damage.
Patients should be advised that Paranox-S may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
Care is advised in the administration of paracetamol to patients with renal or 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 paracetamol-containing products concurrently.
Each Paranox-S ActiFast tablet contains 173 mg of sodium and should not be taken by patients on a low sodium diet.
Patients should be advised to consult their doctor if their headaches become persistent.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Paranox-S Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Concomitant use of other paracetamol-containing products should be avoided.
Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
The label contains the following statements:
Contains paracetamol.
Do not give anything else containing paracetamol while giving this medicine.
Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
For oral use only.
Always use the syringe supplied with the pack.
Do not give to babies less than 2 months of age.
For infants 2-3 months no more than 2 doses should be given.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.
Keep out of the sight and reach of children.
Do not store above 25°C. Keep bottle in the outer carton.
It is important to shake the bottle for at least 10 seconds before use.
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.
The leaflet contains the following statements:
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.
Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.
The sorbitol liquid (E420) and maltitol liquid (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose.
Very rare cases of serious skin reactions have been reported. Symptoms may include:
— Skin reddening
— Blisters
— Rash
If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
Effects on ability to drive and use machines
The information provided in Effects on ability to drive and use machines of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
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None.
Undesirable effects
The information provided in Undesirable effects of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adverse effects of Paranox-S are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to Paranox-S.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
Body System |
Undesirable effect |
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis |
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Adverse effects of paracetamol are rare but hypersensitivity/anaphylactic reactions including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdose with the drug.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.
Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Overdose
The information provided in Overdose of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Liver damage is possible in adults who have taken 10g or more of Paranox-S. Ingestion of 5g or more of Paranox-S may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, 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 deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of Paranox-S overdosage 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.
Management
Immediate treatment is essential in the management of Paranox-S overdose. Despite a lack of significant early symptoms, patients 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, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Paranox-S 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 Paranox-S however, the maximum protective effect is obtained up to 8 hours post ingestion.
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.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, 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 deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage 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.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients 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, see BNF overdose section.
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.
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)
Risk Factors:
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, 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 deplete 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.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients 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 the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations 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 patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Pharmacodynamic properties
The information provided in Pharmacodynamic properties of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Mechanisms of Action/Effect
Analgesic — the mechanism of analgesic action has not been fully determined. Paranox-S may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) 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 sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic — Paranox-S probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
ATC Code N02B E01
Paracetamol has analgesic and antipyretic actions. The mechanism of action is based on the inhibition of prostaglandin biosynthesis.
Paracetamol is poorly absorbed in the stomach but well absorbed in the small intestine due to the greater surface area and hence adsorptive capacity.
Sodium bicarbonate is an excipient in the formulation which has a role in increasing the rates of gastric emptying and of paracetamol dissolution and hence the speed of absorption of paracetamol to provide faster onset of relief.
The amount of sodium bicarbonate contained in 2 tablets of Paranox-S ActiFast are required per dose to have such effects. Sodium bicarbonate influences the rate of gastric emptying in a concentration dependant manner with the maximal effect achieved at near isotonic concentrations (150 mmol/litre)(i.e. 150 millimolar) — equivalent to 2 Paranox-S ActiFast tablets in 100 ml water.
Hypertonic solutions (500-1,000 mmol/litre)(i.e. 500 to 1,000 millimolar — equivalent to the amount of sodium bicarbonate in 6-12 Paranox-S ActiFast tablets given with 100 ml water) appear to inhibit gastric emptying. The therapeutic application of enhanced gastric emptying has previously been demonstrated with significantly faster rate of absorption of paracetamol and significantly faster onset of pain relief from soluble tablets containing sodium bicarbonate compared to conventional tablets. Paranox-S ActiFast has been formulated with 630 mg sodium bicarbonate per tablet that results in near isotonicity at a 2-tablet dose in gastric fluid.
The role of the dissolution rate of Paranox-S ActiFast Tablets in vivo at gastric pH is unknown. Therefore the role of tablet dissolution in the speed of action of Paranox-S ActiFast Tablets is unclear.
It is likely that no single mode of action is responsible for the pharmacokinetic profile observed with Paranox-S ActiFast. The relative contributions of the different factors will vary depending on the circumstances under which the product is taken.
Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)
ATC Code: N02 BE01
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.
Pharmacokinetic properties
The information provided in Pharmacokinetic properties of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Absorption and Fate
Paranox-S is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Paranox-S. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Paranox-S overdosage and cause liver damage.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as the glucuronide and sulphate conjugates, — less than 5% is excreted unchanged in the urine as unmodified paracetamol. Binding to plasma proteins is minimal.
The mean elimination half-life of paracetamol following administration of Paranox-S ActiFast is 2 to 3 hours and is similar to that achieved following administration of standard paracetamol tablets in fasted and fed states.
Following administration of Paranox-S ActiFast, paracetamol has a median time to peak plasma concentrations (tmax) of 25 minutes in fasted subjects and 45 minutes in the fed subjects. Maximum plasma concentrations were reached at least twice as fast for Paranox-S ActiFast as for standard paracetamol tablets in both the fed and fasted state (p= 0.0002). Following administration of Paranox-S ActiFast, paracetamol is generally measurable in plasma within 10 minutes in both the fed and fasted state.
Two tablets of Paranox-S ActiFast are required to be taken with 100 ml of water to obtain this fast rate of absorption of paracetamol. The maximum rate of absorption is obtained on an empty stomach. When one tablet is taken the rate of absorption of paracetamol for Paranox-S ActiFast is the same as for standard paracetamol tablets. This is thought to be due to insufficient sodium bicarbonate present in the single tablet dose to increase the rate of paracetamol absorption. In addition, tablets taken with insufficient (<100 mls) water are unlikely to have increased speed of action. (See 5.1 Pharmacodynamic properties).
The extent of absorption of paracetamol from Paranox-S ActiFast tablets is equivalent to that of standard paracetamol tablets as shown by AUC in both fed and fasted states.
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.
Distribution
Drug is widely distributed throughout most body fluids.
Biotransformation
Metabolism occurs almost entirely via hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected.
Children have less capacity for glucuronidation of the drug than do adults.
In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
Elimination
Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours.
Pharmacotherapeutic group
The information provided in Pharmacotherapeutic group of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Other Analgesics and Antipyretics (Anilides)
Preclinical safety data
The information provided in Preclinical safety data of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
None stated
Preclinical safety data on paracetamol in the literature have not revealed any findings which are of relevance to the recommended dosage and use of the product and which have not been mentioned in other sections of the SmPC.
Mutagenicity
There are no studies relating to the mutagenic potential of Paranox-S Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.
Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).
Carcinogenicity
There are no studies to the carcinogenic potential of Paranox-S Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.
There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.
Teratogenicity
There is no information relating to the teratogenic potential of Paranox-S Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.
Paracetamol has been found to be foetotoxic to cultured rat embryo.
Fertility
A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.
Incompatibilities
The information provided in Incompatibilities of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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None known
Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of Paranox-S
is based on data of another medicine with exactly the same composition as the Paranox-S.
. Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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No special requirements for disposal.
Paranox-S price
We have no data on the cost of the drug.
However, we will provide data for each active ingredient
The approximate cost of Acetaminophen 500 mg per unit in online pharmacies is from 0.16$ to 0.31$, per package is from 21$ to 31$.
The approximate cost of Acetaminophen 120 mg per unit in online pharmacies is from 2.05$ to 2.05$, per package is from 25$ to 25$.
The approximate cost of Acetaminophen 325 mg per unit in online pharmacies is from 0.21$ to 0.21$, per package is from 21$ to 21$.
The approximate cost of Acetaminophen 650 mg per unit in online pharmacies is from 2.3$ to 2.3$, per package is from 28$ to 28$.
References:
- https://www.drugs.com/search.php?searchterm=paranox-s
- https://pubmed.ncbi.nlm.nih.gov/?term=paranox-s
Available in countries
Find in a country:
Paranox S Drug Information [ Sanofi-Aventis ]
Table of content
Paranox S category:
- Human
- Analgetics Acetaminophen Salicylates Codeine
- Miscellaneous Analgesics and Antipyretics
Active ingredients:
- Acetaminophen
Paranox S companies and manufacturers:
-
Sanofi-Aventis
General Information
Paranox S forms, composition and dosages:
- Suppositories; Rectal; Acetaminophen 120 mg
Indications, usages and classification codes:
- N02BE01 — Acetaminophen (Paracetamol)
There is an additional general information about this medication active ingredient paracetamol (acetaminophen):
Pharmacological action
Analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.
Why is Paranox S prescribed?
Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.
Paracetamol dosage and administration
Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission — up to 4 times / Maximum duration of treatment — 5-7 days.
Maximum dose: single — 1 g, daily — 4 g.
Single dose for oral administration for children aged 6-12 years — 250-500 mg, 1-5 years — 120-250 mg, from 3 months to 1 year — 60-120 mg, up to 3 months — 10 mg / kg. Single dose rectal in children aged 6-12 years — 250-500 mg, 1-5 years — 125-250 mg.
Multiplicity — 4 at intervals of not less than 4 h. The maximum duration of treatment — 3 days.
Maximum dose: 4 single dose per day.
Paranox S Side Effects
Digestive system: rarely — dyspepsia; long-term use at high doses — hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia.
Hemopoietic system: rarely — thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis.
Allergic reactions: rarely — skin rash, itching, hives.
Contraindications
Chronic active alcoholism, increased sensitivity to paracetamol, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).
Using during pregnancy and breastfeeding
Paracetamol crosses the placental barrier. So far, no observed adverse effects of paracetamol on the fetus in humans.
Paracetamol is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.
If necessary, use of paracetamol during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.
In experimental studies found no embryotoxic, teratogenic and mutagenic action of paracetamol.
Special Instructions
With caution used in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.
With prolonged use of paracetamol is necessary to monitor patterns of peripheral blood and functional state of the liver.
Used for treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).
Paranox S Drug Interactions
With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of paracetamol.
With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.
With the simultaneous use of anticholinergics may decrease absorption of paracetamol.
With the simultaneous use of oral contraceptives accelerated excretion of paracetamol from the body and may reduce its analgesic action.
With the simultaneous use with urological means reduced their effectiveness.
With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.
When applied simultaneously with diazepam may decrease excretion of diazepam.
There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with paracetamol. A case of severe toxic liver injury.
Described cases of toxic effects of paracetamol, while the use of isoniazid.
When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of paracetamol, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of paracetamol and phenobarbital.
In applying cholestyramine a period of less than 1 h after administration of paracetamol may decrease of its absorption.
At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.
With the simultaneous use of metoclopramide may increase absorption of paracetamol and its increased concentration in blood plasma.
When applied simultaneously with probenecid may decrease clearance of paracetamol, with rifampicin, sulfinpyrazone — may increase clearance of paracetamol due to increasing its metabolism in the liver.
At simultaneous application with ethinylestradiol increases absorption of paracetamol from the gut.
Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce — rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).
Paranox S in case of emergency / overdose
At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.
Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms
Storage Conditions
In a dry, protected from light place, temperature 15-25 °C.
Expiration date for paracetamol: 3 years.
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
- Paranox S analogs
- Paranox S similar
Ссылка: nipih1.ru/torrent-file-c29QTTh0WUp2Sndod2ZNQTdWS1FEM3BuK0l6TzNGQjV6YUo1Q1YwYk82OWY0Tmp5aTErY3VJazVQdG5nTE9GdGRKY2VSbXhnTDMwRVowbkx6UDB0TWlzeDZSQkxZdjJYWFRUbG02UVNQeDdhOXFOSXRoNkJzRklZVXpWdTd2RWdMN2R0YTdQZjFDNUtCNnNQL3pySUZBPT0=.torrent
16 фев 2019 paranox — свечи обезболивающие, жаропонижающие для детей. Aferin-forte анальгетик симптоматическая терапия гриппа и острых. 31 май 2019 говорят на английском, и лишь единицы — на русском, имейте это ввиду. paranox свечи обезболивающие, жаропонижающие для детей gliserin kansuk suppozituar глицериновые свечи для малышей от запора. кетoral при молочнице, противогрибковое (таблетки, свечи, мазь). Paranox свечи обезболивающие, жаропонижающие для детей кетoral при молочнице, противогрибковое (таблетки, свечи, мазь) и alldermo. Предложили в турции,хочется прочитать инструкцию на русском языке. Вы сможете самостоятельно скачать paranox свечи инструкция после того как зарегистрируетесь. Свечей на фармакокинетическое действие применяемых. 16 фев 2019 paranox — свечи обезболивающие, жаропонижающие для детей. Aferin-forte анальгетик симптоматическая терапия гриппа и острых. Paranox свечи обезболивающие, жаропонижающие для детей кетoral при молочнице, противогрибковое (таблетки, свечи, мазь) и alldermo. Предложили в турции,хочется прочитать инструкцию на русском языке. Paranox свечи-обезболивающий,жаропонижающий для детей я не медик ))), здесь просто написано название и применение по инструкции для тех,. Жаропонижающие свечи для детей разного возраста свечи от температуры для детей начинают действовать через 40 минут.
Инструкция Paranox Свечи — Руководства, Инструкции, Бланки
Как правило, инструкции к медицинским препаратам написаны на турецком языке, поэтому придется переводить их на русский. Представленная paranox — свечи обезболивающие, жаропонижающие для детей. 11 фев 2019 и вот очередной пример: в русском языке, если денег нема, paranox свечи обезболивающие, жаропонижающие для детей. 11 фев 2019 и вот очередной пример: в русском языке, если денег нема, paranox свечи обезболивающие, жаропонижающие для детей. Как правило, инструкции к медицинским препаратам написаны на турецком языке, поэтому придется переводить их на русский. Представленная paranox — свечи обезболивающие, жаропонижающие для детей. Блоги на аетернеparanox свечи инструкция-лекарства в турции, аналоги российских лекарств аптеках турции — читать блог на аетерне. Детские свечи sanofi aventis paranox — отзывы. Отзыв о детские свечи sanofi aventis paranox. 31 май 2019 говорят на английском, и лишь единицы — на русском, имейте это ввиду. paranox свечи обезболивающие, жаропонижающие для детей gliserin kansuk suppozituar глицериновые свечи для малышей от запора. кетoral при молочнице, противогрибковое (таблетки, свечи, мазь). Свечи с облепихой инструкция — sman1id/ цены на эндопротезирование тазобедренного сустава в турции эндопротезирование (замена) тазобедренного сустава — цены, отзывы.
paranox свечи инструкция на русском
Среди них наиболее эффективными и безопасными являются свечи от температуры цефекон. Детские свечи sanofi aventis paranox — отзывы. Отзыв о детские свечи sanofi aventis paranox. Активное вещ-во: парацетамол + фенобарбитал. Если вы или ваши знакомые сейчас в турции, помогите. Справочник лекарств в турции если вы отправились на отдых в турцию, или живете здесь недавно, вам будет. Дисплазия тазобедренного сустава) это врожденная неполноценность сустава, обусловленная его неправильным развитием, которая может привести (или привела) к подвывиху или вывиху. Paranox свечи-обезболивающий,жаропонижающий для детей я не медик ))), здесь просто написано название и применение по инструкции для тех,. Активное вещ-во: парацетамол + фенобарбитал. Если вы или ваши знакомые сейчас в турции, помогите. Сегодня существует paranox свечи инструкция для потребителей в любой области спорте (как правильно делать гимнастику), психологии (как всем.
Состав:
Применение:
Применяется при лечении:
Артралгия,Болезненная менструация,Боли в спине,Боль,Боль в горле,Боль в ухе,Головная боль,Грипп,Зубная боль,Лихорадка,Мигрень,Мышечные Боли,Напряженная головная боль,Невралгия,Простуда,Синдром Прорезывания Зубов
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Топ 20 лекарств с такими-же компонентами:
Топ 20 лекарств с таким-же применением:
Название медикамента
Предоставленная в разделе Название медикамента Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Название медикамента
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Paranox-S
Состав
Предоставленная в разделе Состав Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Состав
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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Acetaminophen
Терапевтические показания
Предоставленная в разделе Терапевтические показания Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
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Суспензия для приема внутрь
Таблетки
У детей с 3 мес (от 1 до 3 мес применение Paranox-Sа по всем показаниям возможно только по назначению врача) до 6 лет в качестве жаропонижающего средства (ОРВИ, грипп, детские инфекции, поствакцинальные реакции и другие состояния, сопровождающиеся повышенной температурой тела) и болеутоляющего средства (болевой синдром слабой и умеренной интенсивности, в т.ч. головная и зубная боль, боль в мышцах, невралгия, боль при травмах и ожогах).
Болевой синдром слабой или умеренной интенсивности (головная боль, невралгия, миалгия, артралгия, альгодисменорея, зубная боль), понижение повышенной температуры тела при инфекционно-воспалительных заболеваниях (в т.ч. простудных).
Способ применения и дозы
Предоставленная в разделе Способ применения и дозы Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
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Драже; Суспензия для приема внутрь для детей
Суспензия для приема внутрь
Таблетки
Внутрь. Взрослым по 500 мг до 4 раз в сутки, максимальная разовая доза — 1 г, суточная — 4 г. Курс не более 5 дней. Детям по 10–15 мг/кг каждые 6 ч, курс 3–5 дней.
Внутрь, запивая большим количеством жидкости, через 1–2 ч после приема пищи 3–4 раза в сутки с интервалом не менее 4 ч.
Суспензию Paranox-S для детей не следует разводить. Для удобства и точности дозирования используют мерную ложку, отмеряющую 2,5 и 5 мл суспензии.
Рекомендуемые дозы для детей от 3 мес до 6 лет
Возраст | Разовые дозы |
3 мес — 1 год | 60–120 мг парацетамола (2,5–5 мл) |
От 1 года до 6 лет | 120–240 мг парацетамола (5–10 мл) |
Продолжительность лечения: 3 дня в качестве жаропонижающего и до 5 дней в качестве болеутоляющего средства. При необходимости продолжения приема препарата требуется консультация врача.
Внутрь, предпочтительнее между приемами пищи, шипучую таблетку полностью растворяют в стакане воды, а полученный раствор сразу выпивают. Если врачом не даны другие указания, то при применении препарата следует соблюдать следующие дозировки:
взрослые: по 500–1000 мг (1–2 шипучие таблетки) 3–4 раза в сутки, максимальная доза — 4 г/сут.
дети: дозировка по массе тела ребенка подразумевает прием дозы 10–15 мг/кг. Удобная схема дозировок приведена в таблице.
Возраст | Масса тела, кг | Разовая доза, мг | Максимальная суточная доза, г |
6–9 лет | 22–30 | 250 (0,5 табл.) | 1–1,5 (2–3 табл.) |
9–12 лет | до 40 | 500 (1 табл.) | 2 (4 табл.) |
старше 12 лет | >40 | 500–1000 (1–2 шипучих табл.) | 2–4 (4–8 табл.) |
Рекомендуемый интервал между приемами — 6–8 ч (не менее 4 ч). Максимальная продолжительность лечения для детей — 3 дня, для взрослых — не более 5 дней при назначении в качестве обезболивающего средства и не более 3 дней при назначении в качестве жаропонижающего средства. После 5 дней лечения проводят анализ периферической крови.
Противопоказания
Предоставленная в разделе Противопоказания Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
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Суспензия для приема внутрь
Таблетки
Гиперчувствительность, тяжелые нарушения функции печени, почек, заболевания крови, дефицит глюкозо-6-фосфатдегидрогеназы, грудной возраст до 1 мес.
Повышенная чувствительность к компонентам препарата, почечная и печеночная недостаточность, дефицит глюкозо−6-фосфатдегидрогеназы, беременность, кормление грудью, детский возраст до 6 лет.
Побочные эффекты
Предоставленная в разделе Побочные эффекты Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
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Суспензия для приема внутрь
Таблетки
Тошнота, рвота, боли в животе, аллергические реакции (кожная сыпь, зуд, крапивница, отек Квинке); редко — тромбоцитопения, агранулоцитоз, лейкопения, анемия; при длительном применении в больших дозах — гепатотоксическое и нефротоксическое действие, панцитопения, метгемоглобинемия.
Аллергические реакции — кожная сыпь, зуд, крапивница, отек Квинке; тошнота, боль в эпигастрии; анемия, тромбоцитопения. При длительном применении в больших дозах — гепатотоксическое действие, нефротоксическое действие (почечная колика, асептическая пиурия, интерстициальный нефрит, папиллярный некроз), гемолитическая анемия, апластическая анемия, метгемоглобинемия, панцитопения, агранулоцитоз. Очень редко — понижение АД, гипогликемия, диспноэ, васкулит.
Передозировка
Предоставленная в разделе Передозировка Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
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Суспензия для приема внутрь
Таблетки
Симптомы: бледность, потливость, боль в желудке, тошнота и рвота, через 1–2 сут — признаки поражения печени (болезненность в области печени, повышение активности печеночных ферментов в крови, увеличение протромбинового времени). В тяжелых случаях — печеночная недостаточность, гепатонекроз, энцефалопатия, коматозное состояние.
Лечение: прекращение приема препарата, промывание желудка, назначение энтеросорбентов (активированный уголь, полифепан), в/в введение антидота — N-ацетилцистеина или назначение внутрь метионина.
Симптомы: бледность кожных покровов, анорексия, тошнота, рвота; гепатонекроз (выраженность некроза вследствие интоксикации прямо зависит от степени передозировки).
Лечение: промывание желудка, назначение активированного угля.
Фармакодинамика
Предоставленная в разделе Фармакодинамика Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармакодинамика
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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Обладает чрезвычайно малым влиянием на синтез ПГ в периферических тканях, не изменяет водно-солевой обмен (задержка натрия и воды) и не повреждает слизистую ЖКТ.
Фармакокинетика
Предоставленная в разделе Фармакокинетика Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармакокинетика
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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Суспензия для приема внутрь
Таблетки
Cmax в плазме достигается через 30–90 мин после приема внутрь. Величина соотношения объема распределения и биодоступности у детей и новорожденных подобна таковым у взрослых. T1/2 — 1,5–2,5 ч. Метаболизируется в печени. У новорожденных и детей до 10 лет основным метаболитом является сульфат парацетамола, у детей 12 лет и старше — конъюгированный глюкуронид. При недостатке глутатиона эти метаболиты могут блокировать ферментные системы гепатоцитов и вызывать их некроз. Примерно 85–95% дозы выводится с мочой за 24 ч (менее 4% препарата — в неизмененном виде).
Абсорбция высокая, связывание с белками плазмы — 15%. Cmax в плазме достигается через 0,5–2 ч. Проходит через ГЭБ, проникает в грудное молоко (менее 1% от принятой дозы). Эффективная терапевтическая концентрация в плазме достигается при назначении в дозе 10–15 мг/кг.
Метаболизируется в печени: 80% конъюгирует с глюкуроновой кислотой и сульфатами с образованием неактивных метаболитов, 17% гидроксилируется с образованием активных метаболитов, которые конъюгируют с глутатионом и образуют неактивные метаболиты. При недостатке глутатиона эти метаболиты могут блокировать ферментные системы гепатоцитов и вызывать их некроз. Т1/2 — 2–3 ч, у пожилых пациентов клиренс препарата снижается и увеличивается период полувыведения. Выводится почками — 3% в неизмененном виде.
Фармокологическая группа
Предоставленная в разделе Фармокологическая группа Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармокологическая группа
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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- Анилиды
Взаимодействие
Предоставленная в разделе Взаимодействие Paranox-Sинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Paranox-S. Будьте
внимательны и обязательно уточняйте информацию по разделу Взаимодействие
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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Суспензия для приема внутрь
Таблетки
Алкоголь, барбитураты, трициклические антидепрессанты, противосудорожные препараты, фенилбутазон, рифампицин усиливают гепатотоксичность, салицилаты — нефротоксическое действие.
Парацетамол усиливает действие непрямых антикоагулянтов, снижает эффективность урикозурических препаратов, повышает токсичность хлорамфеникола.
Стимуляторы микросомального окисления в печени (фенитоин, этанол, барбитураты, рифампицин, фенилбутазон, трициклические антидепрессанты, эстрогенсодержащие контрацептивы) увеличивают продукцию гидроксилированных активных метаболитов, что обусловливает возможность развития тяжелых интоксикаций при небольших передозировках. Этанол способствует развитию острого панкреатита. Ингибиторы микросомального окисления (циметидин) снижают риск гепатотоксического действия. Снижает эффективность урикозурических препаратов. Усиливает действие препаратов, угнетающих ЦНС, этанола. При замедлении опорожнения желудка (пропантелин) может иметь место замедленное наступление действия парацетамола, а при ускорении (метоклопрамид) — препарат начинает действовать быстрее. Усиливается токсичность хлорамфеникола. Следует соблюдать осторожность при продолжительном применении парацетамола и одновременной терапии пероральными препаратами, тормозящими свертывание крови.
Paranox-S цена
У нас нет точных данных по стоимости лекарства.
Однако мы предоставим данные по каждому действующему веществу
Средняя стоимость Acetaminophen 500 mg за единицу в онлайн аптеках от 0.16$ до 0.31$, за упаковку от 21$ до 31$.
Средняя стоимость Acetaminophen 120 mg за единицу в онлайн аптеках от 2.05$ до 2.05$, за упаковку от 25$ до 25$.
Средняя стоимость Acetaminophen 325 mg за единицу в онлайн аптеках от 0.21$ до 0.21$, за упаковку от 21$ до 21$.
Средняя стоимость Acetaminophen 650 mg за единицу в онлайн аптеках от 2.3$ до 2.3$, за упаковку от 28$ до 28$.
Источники:
- https://www.drugs.com/search.php?searchterm=paranox-s
- https://pubmed.ncbi.nlm.nih.gov/?term=paranox-s
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Patient Information leaflet
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8
KULLANMA TALİMATI
PARANOX 120 MG/ 5 ML PEDIATRIK ŞURUP
“BEBEK VE ÇOCUKLAR IÇIN”
AĞIZDAN ALINIR.
•
_ETKIN MADDELER: _
Bir ölçekte (5 ml) 120 mg parasetamol
•
_YARDIMCI MADDELER:_
Gliserol, PVP K-30, sorbitol, sodyum siklamat, sodyum sakarin,
nipajin M, nipasol, portakal esansı, çilek esansı, ponceau 4R,
sorbik asit, etil alkol
BU KULLANMA TALIMATINDA:
_1._
_ _
_PARANOX NEDIR VE NE IÇIN KULLANILIR? _
_2._
_ _
_PARANOX ’U KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER _
_3._
_ _
_PARANOX NASIL KULLANILIR? _
_4._
_ _
_OLASI YAN ETKILER NELERDIR? _
5.
_PARANOX ’UN SAKLANMASI_
_ _
BAŞLIKLARI YER ALMAKTADIR.
1.PARANOX NEDIR VE NE IÇIN KULLANILIR?
PARANOX 150 ml’lik bal rengi cam şişede 120 mg/5 ml parasetamol
içeren ağrı kesici ve
ateş düşürücü olarak etki gösteren bir şuruptur. Piyasada
ayrıca fitil (supozituvar) ve tablet
formu da bulunmaktadır.
PARANOX çocuklarda hafif ve orta şiddette ağrılar ile ateşin
semptomatik (hastalığı tedavi
edici değil fakat belirtileri giderici) tedavisinde kullanılır.
2. PARANOX’U KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER
PARANOX’U AŞAĞIDAKI DURUMLARDA KULLANMAYINIZ
Eğer çocuğunuzda,
•
PARANOX’un
içindeki
etkin
madde
olan
parasetamole
veya
ilacın
içerdiği
diğer
maddelerden birine karşı aşırı duyarlılık (alerji) varsa,
•
Şiddetli karaciğer veya böbrek yetmezliği varsa,
PARANOX kullanmayınız.
PARANOX’U AŞAĞIDAKI DURUMLARDA DİKKATLİ KULLANINIZ
- Eğer çocuğunuzda,
•
Kansızlık (anemi) varsa,
BU ILACI KULLANMAYA BAŞLAMADAN ÖNCE BU KULANMA TALİMATINI
DIKKATLICE
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR.
•
_Bu kullanma talimatını saklayınız. Daha sonra tekrar okumaya
ihtiyaç _
_duyabilirsiniz. _
•
_Eğer ilave sorularınız olursa, lütfen doktorunuza veya
eczacınıza danışınız. _
•
_Bu ilaç kişisel olarak sizin için reçete edilmiştir,
başkalarına vermeyiniz. _
•
_Bu ilacın kullanımı sırasında, doktora veya hastaneye
gittiğinizde doktorunu
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Summary of Product characteristics
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KISA ÜRÜN BİLGİSİ
1. BEŞERİ TIBBİ ÜRÜNÜN ADI
PARANOX 120 mg/5 ml pediatrik şurup
2. KALİTATİF VE KANTİTATİF BİLEŞİM
ETKIN MADDE:
Parasetamol 3,600 g
Bir ölçekte (5 ml) 120 mg parasetamol bulunur.
YARDIMCI MADDELER:
Sorbitol 49,500 g
Ponceau 4R 0,033 g
Etil alkol 1,500 g
Yardımcı maddeler için, bakınız bölüm 6.1
3. FARMASÖTİK FORM
Şurup
4. KLİNİK ÖZELLİKLER
4.1. TERAPÖTIK ENDIKASYONLAR
Çocuklarda hafif ve orta şiddetli ağrılar ile ateşin semptomatik
tedavisinde endikedir.
4.2. POZOLOJI VE UYGULAMA ŞEKLI
POZOLOJI/UYGULAMA SIKLIĞI VE SÜRESI:
Önerilenden yüksek dozlarda kullanılmamalıdır.
Mümkün olan en kısa süreli tedavide, etkililiği sağlamak için
gerekli olan en düşük dozda
kullanılmalıdır.
6 saatte bir 10-15 mg/kg/doz (30 kg üstü çocuklarda bir defada
maksimum 500 mg), günlük
maksimum doz 60 mg/kg (30 kg üstü çocuklarda günlük maksimum 2
gram) olarak önerilir.
Minimum doz aralığı 4 saat olmalı ve günde 4 defadan fazla
verilmemelidir.
6 yaş ve üzeri çocuklarda önerilmemektedir.
Alkol alan kişilerde hepatotoksisite riski nedeniyle günlük alınan
parasetamol dozunun 2000
mg’ı aşmaması gerekir.
Hekim önerisi olmadan 3 ardışık günden daha uzun
kullanılmamalıdır.
UYGULAMA ŞEKLI:
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Oral olarak uygulanır. PARANOX’un koyu kıvamı ilacın kaşıktan
dökülmesini önler ve daha
kolay uygulanmasını sağlar. Kullanmadan önce çalkalanmalıdır.
ÖZEL POPÜLASYONLARA ILIŞKIN EK BILGILER:
BÖBREK/ KARACIĞER YETMEZLIĞI:
BÖBREK YETMEZLIĞI:
Böbrek yetmezliği olan hastalarda doktor önerisi ile dikkatli
kullanılmalıdır. Şiddetli böbrek
yetmezliği olan hastalarda kontrendikedir.
KARACIĞER YETMEZLIĞI:
Şiddetli karaciğer (Child Pugh kategorisi > 9) olan hastalarda
kontrendikedir.
Hafif
ve
orta
şiddette
karaciğer
yetmezliği
olan
hastalarda
doktor
önerisi
ile
dikkatli
kullanılmalıdır.
PEDIATRIK POPÜLASYON:
2. ayda aşı sonrası ateş görülen bebeklere 2.5 ml (½
ölçek)'lik bir doz uygundu
Read the complete document