kardegic medicine Uses, Dosage, Side Effects, Precautions &Warnings
what is kardegic used for and indication?
- Prevention of cardiovascular and cerebrovascular complications related to atherosclerosis in high-risk vascular patients with confirmed ischemic arterial pathology ( see Pharmacodynamics ).
- Reduced graft occlusion after coronary artery bypass grafting.
- Prevention of strokes in patients with atrial fibrillation for whom treatment with vitamin K antagonist is contraindicated or not indicated, after examination of the benefit and risk ( cf Pharmacodynamics ).
kardegic WHAT dosage
Reserved for adults. Intravenous use
- A single injection of 250 mg or 500 mg (ie, 1/2 vial or whole vial) as soon as possible after symptom onset, at loading dose.
- The relay will be provided by oral aspirin.
Method of administration :
- Dissolve extemporaneously the contents of the vial with 5 ml of water for injection.
- Administration is by intravenous direct injection in 1 to 3 minutes.
- This medicine can be injected into a tubing containing a solution of sodium chloride, glucose or sorbitol.
- It is recommended to avoid mixing in the same syringe this drug with other injectable specialties.
- This medication will only be given on a medical prescription.
This medication should never be prescribed in the following situations:
- history of hypersensitivity to salicylates and to substances of similar activity, in particular non-steroidal anti-inflammatory drugs (bronchospasm, anaphylactic reaction).
- The occurrence of an asthma attack, in some subjects, may be related to an allergy to nonsteroidal anti-inflammatory drugs or aspirin. In this case, this drug is contraindicated.
- developing peptic ulcer,
- any constitutional or acquired hemorrhagic disease,
– apart from extremely limited uses, and which justify specialized monitoring, any aspirin-based drug is CONTRA-INDICATED from the 6th month of pregnancy:
from the 6th month of pregnancy, aspirin in doses Analgesics, Antipyretics or anti-inflammatories, like all inhibitors of prostaglandin synthesis, can expose the fetus to cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension; renal dysfunction up to renal failure with oligohydramnios; the mother and the child, at the end of pregnancy, to an extension of the bleeding time. This anti-aggregating effect can appear even at very low doses.
- in case of combination with methotrexate if it is used at doses greater than 15 mg / week,
- in combination with oral anticoagulants (for aspirin at high doses> 3 g / d)
This medication is generally not recommended in the following situations:
– when used in combination with the following drugs:
- . oral anticoagulants (for low-dose aspirin)
- . uricosuric (benzbromarone, probenecid)
- . other NSAIDs if aspirin is prescribed in high doses (> 3 g / d),
- . heparins at curative doses in subjects under 65 years of age, and whatever the dose of heparin in subjects> 65 years, if aspirin is prescribed in analgesic, antipyretic and anti-inflammatory doses,
- – in the event of gout ,
- – in metrorrhagia and / or menorrhagia, because aspirin may increase the extent and duration of periods.
- – during breast-feeding: aspirin passing into breast milk, breast-feeding is not recommended during treatment with KARDEGIC 160 mg.
- Pregnancy from the 6th month
- History of asthma associated with taking NSAIDs
- History of asthma associated with taking aspirin
- Evolving peptic ulcer
- Hemorrhagic disease
- Haemorrhagic risk
- Severe hepatic impairment
- Severe renal failure (Clcr <= 30 ml / min)
- Severe uncontrolled heart failure
- Child under 18
- Woman’s fertility check-up
- Reduced female fertility
- Woman wishing to conceive
- Pregnancy before 5 months
- Feeding with milk
Hypersensitivity to the active substance (acetylsalicylic acid) or to any of the excipients listed in section Composition, or to other nonsteroidal anti-inflammatory drugs (cross reaction).
History of asthma induced by the administration of salicylates or substances of similar activity, in particular non-steroidal anti-inflammatory drugs.
Evolving peptic ulcer.
Any constitutional or acquired hemorrhagic disease
- Pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhea) for doses of aspirin greater than 100 mg per day (see section Fertility, pregnancy and lactation).
- Patients with mastocytosis, in whom the use of acetylsalicylic acid may cause severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).
- Risk of haemorrhage.
- Severe hepatic impairment.
- Severe renal impairment (Creatinine clearance <30 ml / min).
- Severe uncontrolled heart failure.
How it works KARDEGIC ?
ANTITHROMBOTIC / INHIBITOR OF PLATELET AGGREGATION, HEPARIN EXCLUDED.
(B01AC06: blood, hematopoietic organs).
- – Aspirin is an inhibitor of platelet activation: by blocking platelet cyclooxygenase by acetylation, it inhibits the synthesis of thromboxane A2, a physiological activator released by platelets, which plays a role in the complications of atherosclerotic lesions. .
- Clinical pharmacology studies of lysine acetylsalicylate have shown that the intravenous route achieves very rapidly an effective plasma level of acetylsalicylic acid, which results in a total inhibition of the synthesis of serum thromboxane B2 in 5 patients. minutes.
KARDEGIC Side Effects
- – Effects on the central nervous system : tinnitus , sensation of loss of hearing, headache, which are usually the mark of an overdose.
- – Gastrointestinal effects : gastric ulcers, overt gastrointestinal bleeding (haematemesis, melena …) or occult, responsible for iron deficiency anemia.
- – Hematological effects : haemorrhagic syndromes (epistaxis, gingivorragies, purpura …) with increased bleeding time. This action persists 4 to 8 days after stopping aspirin. It can create a haemorrhagic risk in case of surgery.
- – Hypersensitivity reaction: sensitization accidents (urticaria, asthma, angioedema, anaphylactic accident).
- – Other : abdominal pain.
- – Effects related to the route of administration : possibility of pain at the injection site and local reactions.
CONTRAINDICATED ASSOCIATIONS :
- – Methotrexate used at doses greater than 15 mg / week : increased haematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories in general and displacement of methotrexate from its binding to plasma proteins salicylates).
- – Salicylates in high doses (> 3 g / day in adults) with oral anticoagulants : increased risk of haemorrhage (inhibition of platelet function and aggression of the gastroduodenal mucosa as well as displacement of the oral anticoagulant from its protein binding plasma).
ASSOCIATIONS NOT RECOMMENDED :
– Oral anticoagulants: increased risk of haemorrhage of oral anticoagulants (inhibition of platelet function and aggression of the gastroduodenal mucosa).
Need for control, especially bleeding time.
– Other NSAIDs if aspirin is prescribed in high doses (> 3 g / day) : increased risk ulcerogenic and hemorrhagic digestive (additive synergy).
– Heparins (parenteral route) : increased risk of haemorrhage (inhibition of platelet function and aggression of the gastroduodenal mucosa by salicylates).
– Ticlopidine : increased risk of haemorrhage (synergy of anti-platelet aggregation activities).
If the combination can not be avoided, close clinical and biological monitoring (including bleeding time).
– Uricosuric agents (benzbromarone, probenecid) : decrease in the uricosuric effect (by competition from the elimination of uric acid in the renal tubules). Use another pain reliever.
For benzbromarone the effect is described even for doses of salicylates <= 3 g / d.
ASSOCIATIONS REQUIRING PRECAUTIONS FOR USE :
– Pentoxifylline : increased risk of haemorrhage.
Strengthen clinical monitoring and more frequent control of bleeding time.
– Antidiabetic agents (insulin, chlorpropamide): if aspirin is prescribed in high doses, increase the hypoglycemic effect by hypoglycemic action of acetylsalicylic acid and displacement of the sulfonamide from its binding to plasma proteins.
Prevent the patient and strengthen the self-monitoring glycemic.
– General glucocorticoids, except hydrocortisone used as replacement therapy in Addison’s disease : decreased salicylemia during treatment with corticosteroids and risk of salicylated overdose after discontinuation (increased salicylate elimination by corticosteroids).
Adapt doses of salicylates during combination and after discontinuation of glucocorticoid therapy.
– Diuretics: for salicylates in high doses (>, risk of acute renal failure in the dehydrated patient by reduction of glomerular filtration secondary to a decrease in renal prostaglandin synthesis.
Hydrate the patient and monitor kidney function at the beginning of treatment.
– Inhibitors of the conversion enzyme: for salicylates in high doses (> 3 g / d) , risk of acute renal failure in the dehydrated patient by reduction of glomerular filtration secondary to inhibition of vasodilator prostaglandins, due to NSAIDs. Moreover, reduction of the antihypertensive effect.
Hydrate the patient and monitor kidney function at the beginning of treatment.
– Interferon alpha: risk of inhibition of the action of interferon. Preferably use a non-salicylated antipyretic analgesic.
– Methotrexate used at doses below 15 mg / week : increased haematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories in general and displacement of methotrexate from its binding to plasma proteins by salicylates). Weekly control of the blood count during the first weeks of the association.
Increased monitoring for impaired (even mild) renal function, as well as in the elderly.
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
–Gastrointestinal topical (salts, oxides and hydroxides of magnesium, aluminum and calcium) : increased renal excretion of salicylates by alkalinization of urine.
Take a distance (2 hours) of salicylates.
- – Intrauterine device : ( controversial ) risk of reducing the effectiveness of intrauterine devices.
- – Thrombolytics : increased risk of bleeding.
KARDEGIC Warnings and Precautions
Aspirin vials for injection are not suitable for children.
- – history of gastric or duodenal ulcer, gastrointestinal bleeding,
- – renal failure,
- – asthma: the occurrence of an asthma attack, in some subjects, may be related to an allergy to anti-inflammatories nonsteroidal or aspirin. In this case, this medicine is contraindicated.
- – Given the platelet anti-aggregating effect of aspirin, occurring at very low doses and persisting for several days, the patient should be warned of the risk of bleeding that may occur in the event of even minor surgery (eg tooth extraction). ).
- – This medicine does not contain sodium, it can be administered in case of deodized or low sodium diet.
- – Pregnancy: studies in animals have shown a teratogenic effect of aspirin. The results of the epidemiological studies seem to rule out a particular malformative effect of aspirin, taken during the first trimester. There is currently no sufficient data to evaluate a possible malformative effect of aspirin when it is administered as a chronic treatment above 150 mg / day during the first trimester of pregnancy. During the 4th and 5th months, the analysis of a high number of exposed pregnancies in short treatment revealed no particular fetotoxic effect. However,
- Therefore, during the first five months of pregnancy, aspirin as a punctual treatment may be prescribed if necessary, as a precautionary measure, it is preferable not to use aspirin in chronic treatment beyond 150 mg / d .
Drive and use machines
KARDEGIC and PREGNANCY / BREAST FEEDING / FERTILITY
Studies in animals have shown a teratogenic effect of aspirin.
Clinical data concerning the aspect malformative (first trimester):
- – aspirin in point treatment: the results of the epidemiological studies seem to exclude a particular malformative effect of the aspirin, taken during the first trimester,
- – aspirin in chronic treatment: it does not There is currently no sufficient data to evaluate a possible malformative effect of aspirin when it is administered in chronic treatment above 150 mg / day during the first trimester of pregnancy.
- Clinical data concerning the fetotoxic aspect (second and third trimesters):
- – during the 4th and 5th month, the analysis of a high number of exposed pregnancies in short treatment revealed no particular foetotoxic effect. However, only epidemiological studies would verify the absence of risk,
- – from the 6th month of pregnancy, aspirin doses analgesic, antipyretic or anti-inflammatory (> = 500 mg per day and per dose), as all prostaglandin synthesis inhibitors may expose:
. the fetus to:
- . cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension;
- . renal dysfunction up to kidney failure with oligohydramnios,
- . the mother and the child, at the end of pregnancy, have a longer bleeding time. This anti-aggregating effect can occur even at very low doses.
– During the first five months of pregnancy
. Aspirin as a punctual treatment may be prescribed if needed
- . as a precautionary measure, it is preferable not to use aspirin in chronic therapy beyond 150 mg / day .
- – from the 6th month of pregnancy: except for extremely limited cardiological or obstetrical uses, which warrant specialized supervision, any aspirin-based medication is CONTRAINDICATED from the 6th month.
- As aspirin passes into breast milk, breastfeeding is not recommended.
What happens if I overdose from KARDEGIC ?
– Clinical symptoms :
- . moderate intoxication : tinnitus, feeling of low hearing, headache, dizziness, nausea, are the hallmark of overdose and can be controlled by reducing the dosage;
- . severe intoxication : fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, significant hypoglycaemia.
– Treatment :
- . immediate transfer to a specialized hospital,
- . Control of acid-base balance
- . forced alkuric diuresis, possibility of hemodialysis or peritoneal dialysis if necessary,
- . symptomatic treatment.
What is Forms and Composition KARDEGIC?
- Powder for oral solution at 160 mg and 300 mg: Sachets-dose, boxes of 30.
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