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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
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 Therapeutic indications 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
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.
. Be careful and be sure to specify the information on the section Contraindications 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
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.
. Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Paranox-S directly from the package or from the pharmacist at the pharmacy.
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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.
. Be careful and be sure to specify the information on the section Undesirable effects 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
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.
more…
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:
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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.
тонкая брошюра
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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
Прочитать полный документ
Характеристики продукта
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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
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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
Страница осмотрена фармацевтом Милитян Инессой Месроповной Последнее обновление 2022-03-16
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Информация на странице предназначена только для медицинских работников!
Информация собрана в открытых источниках и может содержать значимые ошибки!
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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
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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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.
more…
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
внимательны и обязательно уточняйте информацию по разделу Терапевтические показания
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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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
внимательны и обязательно уточняйте информацию по разделу Способ применения и дозы
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
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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
внимательны и обязательно уточняйте информацию по разделу Противопоказания
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
more…
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
внимательны и обязательно уточняйте информацию по разделу Побочные эффекты
в инструкции к лекарству Paranox-S непосредственно из упаковки или у фармацевта в аптеке.
more…
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
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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
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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
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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
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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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Paranox-S
Paranox-S (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms.
Paranox-S is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.
Animal and clinical studies have determined that acetaminophen has both antipyretic and analgesic effects. This drug has been shown to lack anti-inflammatory effects. As opposed to the salicylate drug class, acetaminophen does not disrupt tubular secretion of uric acid and does not affect acid-base balance if taken at the recommended doses. Paranox-S does not disrupt hemostasis and does not have inhibitory activities against platelet aggregation. Allergic reactions are rare occurrences following acetaminophen use.
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Uses
Paranox-S is an analgesic drug used alone or in combination with opioids for pain management, and as an antipyretic agent.
In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever. It is available over the counter in various forms, the most common being oral forms.
Paranox-S injection is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics. Specific dosing guidelines should be followed when administering acetaminophen to children.
Paranox-S is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Musculoskeletal Pain, Allergies, Ankylosing Spondylitis (AS), Arthritis, Chills, Cold, Cold Symptoms, Common Cold, Common Cold/Flu, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Dyskinesia of the Biliary Tract, Dyskinesia of the Urinary Tract, Febrile Convulsions, Febrile Illness Acute, Fever, Fibromyalgia Syndrome, Flu caused by Influenza, Headache, Joint dislocations, Menstrual Distress (Dysmenorrhea), Mild pain, Muscle Inflammation, Muscle Injuries, Muscle Spasms, Musculoskeletal Pain, Nasal Congestion, Neuralgia, Osteoarthritis (OA), Pain, Pollen Allergy, Postoperative pain, Premenstrual cramps, Rheumatoid Arthritis, Rhinopharyngitis, Rhinorrhoea, Severe Pain, Sinusitis, Soreness, Muscle, Spasms, Spastic Pain of the Gastrointestinal Tract, Sprains, Tension Headache, Toothache, Upper Respiratory Tract Infection, Whiplash Syndrome, Acute Torticollis, Mild to moderate pain, Minor aches and pains, Minor pain, Moderate Pain, Airway secretion clearance therapy, Antispasmodic, Bronchodilation
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How Paranox-S works
According to its FDA labeling, acetaminophen’s exact mechanism of action has not been fully established — despite this, it is often categorized alongside NSAIDs (nonsteroidal anti-inflammatory drugs) due to its ability to inhibit the cyclooxygenase (COX) pathways. It is thought to exert central actions which ultimately lead to the alleviation of pain symptoms.
One theory is that acetaminophen increases the pain threshold by inhibiting two isoforms of cyclooxygenase, COX-1 and COX-2, which are involved in prostaglandin (PG) synthesis. Prostaglandins are responsible for eliciting pain sensations. Paranox-S does not inhibit cyclooxygenase in peripheral tissues and, therefore, has no peripheral anti-inflammatory effects. Though acetylsalicylic acid (aspirin) is an irreversible inhibitor of COX and directly blocks the active site of this enzyme, studies have shown that acetaminophen (paracetamol) blocks COX indirectly. Studies also suggest that acetaminophen selectively blocks a variant type of the COX enzyme that is unique from the known variants COX-1 and COX-2. This enzyme has been referred to as COX-3. The antipyretic actions of acetaminophen are likely attributed to direct action on heat-regulating centers in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat. The exact mechanism of action of this drug is not fully understood at this time, but future research may contribute to deeper knowledge.
Paranox-S
| Trade Name | Paranox-S |
| Availability | Rx and/or OTC |
| Generic | Acetaminophen |
| Acetaminophen Other Names | Acenol, Acetaminofén, Acetaminophen, Acétaminophène, APAP, Paracetamol, Paracétamol, Paracetamolum |
| Related Drugs | Buprenex, aspirin, ibuprofen, tramadol, cyclobenzaprine, Paracetamol, naproxen, diclofenac, Tylenol, oxycodone |
| Type | |
| Formula | C8H9NO2 |
| Weight | Average: 151.1626 Monoisotopic: 151.063328537 |
| Protein binding |
The binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%), when given at therapeutic doses. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | Turkey |
| Last Updated: | June 22, 2022 at 11:59 pm |
Structure
Table Of contents
- Paranox-S
- Uses
- Dosage
- Side Effect
- Precautions
- Interactions
- Uses during Pregnancy
- Uses during Breastfeeding
- Accute Overdose
- Food Interaction
- Half Life
- Volume of Distribution
- Clearance
- Interaction With other Medicine
- Contradiction
- Storage
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Toxicity
LD50 = 338 mg/kg (oral, mouse); LD50 = 1944 mg/kg (oral, rat)
Overdose and liver toxicity
Paranox-S overdose may be manifested by renal tubular necrosis, hypoglycemic coma, and thrombocytopenia. Sometimes, liver necrosis can occur as well as liver failure. Death and the requirement of a liver transplant may also occur. Metabolism by the CYP2E1 pathway releases a toxic acetaminophen metabolite known as N-acetyl-p-benzoquinoneimine(NAPQI). The toxic effects caused by this drug are attributed to NAPQI, not acetaminophen alone.
Carcinogenesis
Long-term studies in mice and rats have been completed by the National Toxicology Program to study the carcinogenic risk of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice consumed a diet containing acetaminophen up to 6,000 ppm. Female rats showed evidence of carcinogenic activity demonstrated by a higher incidence of mononuclear cell leukemia at doses 0.8 times the maximum human daily dose (MHDD). No evidence of carcinogenesis in male rats (0.7 times) or mice (1.2 to 1.4 times the MHDD) was noted. The clinical relevance of this finding in humans is unknown.
Mutagenesis
Paranox-S was not found to be mutagenic in the bacterial reverse mutation assay (Ames test). Despite this finding, acetaminophen tested positive in the in vitro mouse lymphoma assay as well as the in vitro chromosomal aberration assay using human lymphocytes. In published studies, acetaminophen has been reported to be clastogenic (disrupting chromosomes) when given a high dose of 1,500 mg/kg/day to the rat model (3.6 times the MHDD). No clastogenicity was observed at a dose of 750 mg/kg/day (1.8 times the MHDD), indicating that this drug has a threshold before it may cause mutagenesis. The clinical relevance of this finding in humans is unknown.
Impairment of Fertility
In studies conducted by the National Toxicology Program, fertility assessments have been performed in Swiss mice in a continuous breeding study. No effects on fertility were seen.
Use in pregnancy and nursing
The FDA label for acetaminophen considers it a pregnancy category C drug, meaning this drug has demonstrated adverse effects in animal studies. No human clinical studies in pregnancy have been done to this date for intravenous acetaminophen. Use acetaminophen only when necessary during pregnancy. Epidemiological data on oral acetaminophen use in pregnant women demonstrate no increase in the risk of major congenital malformations. While prospective clinical studies examining the results of nursing with acetaminophen use have not been conducted, acetaminophen is found secreted in human milk at low concentrations after oral administration. Data from more than 15 nursing mothers taking acetaminophen was obtained, and the calculated daily dose of acetaminophen that reaches the infant is about 1 to 2% of the maternal dose. Caution should be observed when acetaminophen is taken by a nursing woman.
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Food Interaction
- Avoid alcohol. Alcohol may increase the risk of hepatotoxicity.
- Take with or without food. The absorption is unaffected by food.
Paranox-S Alcohol interaction
[Major] GENERALLY AVOID:
Chronic, excessive consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity, which has included rare cases of fatal hepatitis and frank hepatic failure requiring liver transplantation.
The proposed mechanism is induction of hepatic microsomal enzymes during chronic alcohol use, which may result in accelerated metabolism of acetaminophen and increased production of potentially hepatotoxic metabolites.
In general, chronic alcoholics should avoid regular or excessive use of acetaminophen.
Alternative analgesic/antipyretic therapy may be appropriate in patients who consume three or more alcoholic drinks per day.
However, if acetaminophen is used, these patients should be cautioned not to exceed the recommended dosage (maximum 4 g/day in adults and children 12 years of age or older).
Paranox-S Drug Interaction
Unknown: aspirin, aspirin, diphenhydramine, diphenhydramine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, fluticasone nasal, fluticasone nasal, metoprolol, metoprolol, polyethylene glycol 3350, polyethylene glycol 3350, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine, cetirizine
Paranox-S Disease Interaction
Major: alcoholism, liver disease
Moderate: PKU
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Volume of Distribution
Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Paranox-S appears to be widely distributed throughout most body tissues except in fat.
Elimination Route
Paranox-S has 88% oral bioavailability and reaches its highest plasma concentration 90 minutes after ingestion.
Peak blood levels of free acetaminophen are not reached until 3 hours after rectal administration of the suppository form of acetaminophen and the peak blood concentration is approximately 50% of the observed concentration after the ingestion of an equivalent oral dose (10-20 mcg/mL).
The percentage of a systemically absorbed rectal dose of acetaminophen is inconsistent, demonstrated by major differences in the bioavailability of acetaminophen after a dose administered rectally. Higher rectal doses or an increased frequency of administration may be used to attain blood concentrations of acetaminophen similar to those attained after oral acetaminophen administration.
Half Life
The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.
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Clearance
Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose.
Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).
Elimination Route
Paranox-S metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as free (unconjugated) acetaminophen and at least 90% of the administered dose is excreted within 24 hours.
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Innovators Monograph
You find simplified version here Paranox-S
FAQ
What is Paranox-S used for?
Paranox-S is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever.
How safe is Paranox-S?
When used as directed, taking Paranox-S is generally safe and effective.
How does Paranox-S work?
Paranox-S relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before a person feels it. It reduces fever through its action on the heat-regulating center of the brain.
What are the common side effects of Paranox-S?
Common side effects of Paranox-S are include;
- nausea,
- stomach pain,
- loss of appetite,
- itching,
- rash,
- headache,
- dark urine,
- clay-colored stools,
- or jaundice (yellowing of skin or eyes).
Is Paranox-S safe during pregnancy?
Paranox-S as one of the only safe pain relievers for pregnant individuals during pregnancy.
Is Paranox-S safe during breastfeeding?
Paranox-S are safe to use when breastfeeding.
Can I drink alcohol with Paranox-S?
Mixing Paranox-S and alcohol can potentially lead to liver damage. Rarely, liver damage can be severe or even life-threatening.
Can I drive after taking Paranox-S?
You should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. you should know that Paranox-S and codeine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position.
How often can I take Paranox-S?
Take every 4 to 6 hours, as needed, up to 4 times in a 24-hour period.
How do I take Paranox-S?
Take Paranox-S exactly as directed on the prescription or package label.
How much Paranox-S can I take daily?
The usual dose is 325 mg to 650 mg. Take every 4 to 6 hours, as needed, up to 4 times in a 24-hour period. The maximum dose may vary from 3,000 mg to 4,000 mg, but do not take more than 4,000 mg in a 24-hour period.
How long does Paranox-S take to work?
It usually takes about 45 minutes for oral, liquid, or tablet Paranox-S to start working. The oral disintegrating tablets start to work in about 20 minutes.
What is the half life of Paranox-S?
The Paranox-S half-life was 5.4 hours (range, 0.8-119.7 hours).
How long can I take Paranox-S?
Don’t take Paranox-S for more than 10 days in a row unless you’ve been instructed to do so by your doctor.
Who should not take Paranox-S?
You should not take Paranox-S if you are allergic to it, or if you take other medications that contain acetaminophen. Ask a doctor or pharmacist if this medicine is safe to use if you’ve ever had cirrhosis of the liver, or if you drink alcohol daily.
What happens if I miss a dose?
Since Paranox-S is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention. An overdose of acetaminophen can be fatal. The first signs of an Paranox-S overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Should I stop taking Paranox-S?
It is suggested that you stop taking Paranox-S and talk with your doctor if: You still feel pain after 10 days (adult) or 5 days (children) You still have a fever after 3 days. Your symptoms get worse, or you feel new symptoms.
Can Paranox-S affects my heart ?
It is not known to increase risks of heart attack, heart failure, or stroke.
Can Paranox-S affect my kidneys?
Paranox-S broken down/metabolized almost completely by the liver, so the kidneys hardly do any of the work and are not affected by it. Paranox-S is safe for the kidneys.
Can Paranox-S affects my liver?
Paranox-S toxicity can quickly lead to liver damage. Liver damage associated with Paranox-S use sends thousand of Americans to the hospital each year.