Consists of aceclofenac, paracetamol, serratiopeptidase
Overdose of Aceclofenac (Gag SP) in details
Symptoms: SR tab: Headache, nausea, vomiting, epigastric pain, GI irritation and bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
Gel: The low systemic absorption of topical aceclofenac renders overdosage extremely unlikely. In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with NSAID should be used.
Treatment: Patients should be treated symptomatically as required. Within 1-hr of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within 1-hr of ingestion of a potentially life-threatening overdosage. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least 4 hrs after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with diazepam IV. Other measures may be indicated by the patient's clinical condition. Specific therapies eg, dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein-binding and extensive metabolism. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.
Aceclofenac (Gag SP) warnings
History of GI ulceration; impaired cardiac, renal or hepatic function; hypertension; lactation. IV admin in patients with moderate or severe renal impairment; hypovolaemia or dehydration; asthma, porphyria. Monitor LFTs in patients on prolonged therapy. May prolong bleeding time; caution when used in patients with coagulation disorders or on anticoagulants. Prolonged therapy may increase risk of anaemia. 1st and 2nd trimester of pregnancy. Elderly, debilitated patients.
pregnancy:
Category B(Parenteral): Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Category C(Ophth /
Topical): Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Aceclofenac (Gag SP) precautions
Aceclofenac (Gag SP) should be used cautiously in patients with gastrointestinal disorders, with a history of gastrointestinal ulceration, severe impairment of hepatic function, renal or cardiac impairment, patients in recovery after major surgery, the elderly.
Effects on the Ability to Drive or Operate Machinery: Patients suffering from dizziness, vertigo or other central nervous system disorders while taking NSAIDs should refrain from driving or handling dangerous machinery.
Use in pregnancy & lactation: There is no information on the use of aceclofenac during pregnancy and on the secretion of aceclofenac to breast milk.
The use of aceclofenac should therefore be avoided in pregnancy and lactation unless, the potential benefits to the other outweigh the possible risks to the fetus.
Use in children: There are no clinical data on the use of Aceclofenac (Gag SP) in children and therefore, it is not recommended for use in children.
What happens if I overdose Paracetamol (Gag SP)?
Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an Paracetamol (Gag SP) 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.
Overdose of Paracetamol (Gag SP) in details
Paracetamol (Gag SP) in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with Paracetamol (Gag SP) <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of Paracetamol (Gag SP) ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Paracetamol (Gag SP) level drawn and be treated with N-acetylcysteine. Do not await results of assays for plasma Paracetamol (Gag SP) levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended. Promptly initiate decontamination of the stomach. A plasma Paracetamol (Gag SP) assay should be obtained as early as possible, but not sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.
Serious toxicity or fatalities have been extremely infrequent following acute overdosage in young children, possibly because of differences in the way they metabolize Paracetamol (Gag SP). In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of Paracetamol (Gag SP) was ingested, obtain a plasma Paracetamol (Gag SP) level as soon as possible but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated Paracetamol (Gag SP) ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
What should I avoid while taking Paracetamol (Gag SP)?
Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Paracetamol (Gag SP) is contained in many combination medicines. If you use certain products together you may accidentally use too much Paracetamol (Gag SP). Read the label of any other medicine you are using to see if it contains Paracetamol (Gag SP), acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Paracetamol (Gag SP).
Paracetamol (Gag SP) warnings
Paracetamol (Gag SP) Sante Naturelle is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.
Patients with high content body iron should apply ascorbic acid in minimal doses.
Paracetamol (Gag SP) Sante Naturelle is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.
The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.
Data on the diabetogenic Paracetamol (Gag SP) of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.
It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.
Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.
What should I discuss with my healthcare provider before taking Paracetamol (Gag SP)?
Do not use this medication if you are allergic to acetaminophen or Paracetamol (Gag SP).
Ask a doctor or pharmacist if it is safe for you to take Paracetamol (Gag SP) if you have:
- liver disease; or
-
a history of alcoholism;
It is not known whether Paracetamol (Gag SP) will harm an unborn baby. Before using Paracetamol (Gag SP), tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use Paracetamol (Gag SP) without telling your doctor if you are breast-feeding a baby.
Paracetamol (Gag SP) precautions
Care is advised in the administration of Paracetamol (Gag SP) 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 instructed. If the patient did not get better, talk to the physician.
Do not take anything else containing Paracetamol (Gag SP) while taking Paracetamol (Gag SP).
Inform the physician at once if the patient take too much of Paracetamol (Gag SP), even if the patient feel well. This is because too much Paracetamol (Gag SP) can cause delayed, serious liver damage.
Patients should be advised that Paracetamol (Gag SP) may cause severe skin reactions. If a skin reaction eg, skin reddening, blisters or rash occurs, they should stop use and seek medical assistance right away.
Use in pregnancy & lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol (Gag SP) used in the recommended dosage, but patients should follow the advice of the physician regarding its use. Paracetamol (Gag SP) is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
What happens if I miss a dose of Paracetamol (Gag SP)?
Since Paracetamol (Gag SP) is often used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and use your next dose as directed. Do not use extra medicine to make up for a missed dose.
Serratiopeptidase (Gag SP) warnings
Abnormal blood coagulation, severe hepatic or renal dyscrasias.
References
- DrugBank. "Aceclofenac". http://www.drugbank.ca/drugs/DB06736 (accessed September 17, 2018).
- MeSH. "Anti-Inflammatory Agents, Non-Steroidal". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- Burnham Center for Chemical Geno. "SID50085951: Aqueous solubility in buffer at pH 7.4". https://pubchem.ncbi.nlm.nih.gov/bio... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
