Flucoldex-N
Flukoldeks-N: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Flucoldex-N
ATX code: N02BE71
Active ingredient: caffeine + paracetamol + chlorphenamine (Caffeine + Paracetamol + Chlorphenamine)
Manufacturer: Nabros Pharma, Pvt. Ltd. (Nabros Pharma, Pvt. Ltd.) (India)
Description and photo updated: 2020-19-03
Flucoldex-N is a combined drug that includes non-narcotic analgesic, psychostimulating and antihistamine drugs, which is highly effective in acute respiratory diseases (ARI) and colds.
Release form and composition
Dosage form - tablets: almost white or white, biconvex, round (in a carton pack 3 or 50 strips containing 4 tablets or 1 blister containing 12 tablets, and instructions for the use of Flucoldex-N).
Composition for 1 tablet:
- active substances: paracetamol - 500 mg; anhydrous caffeine - 30 mg; chlorphenamine maleate (chlorpheniramine maleate) - 2 mg;
- auxiliary components: polyvinylpyrrolidone 30 (povidone 30), sodium carboxymethyl starch, magnesium stearate, purified talc, corn starch, gelatin.
Pharmacological properties
Pharmacodynamics
Flucoldex-N is a combined drug, the pharmacological properties of which are due to the active components included in its composition:
- caffeine: stimulates the central nervous system, which helps to reduce fatigue and drowsiness, increase physical and mental performance. Through a combination of central and peripheral action, it tones the vessels of the brain, dilates the coronary vessels (as a rule), slightly increases blood pressure, often against the background of initial hypotension. Increases the basal metabolism, slightly increases diuresis, stimulates the secretion of the stomach glands. It has a moderate myotropic spasmolytic effect (expands the bile ducts, bronchi). Its pharmacological properties are due to inhibition of phosphodiesterase activity and competitive antagonism with adenosine at the A1 adenosine receptor level;
- paracetamol: has antipyretic and analgesic properties, which is due to inhibition of the synthesis of prostaglandins in the central nervous system. Reduces fever and relieves pain that occurs with colds (muscle, head and joint, sore throat). Virtually no anti-inflammatory effect;
- Chlorphenamine: belongs to the blockers of H1-histamine receptors. Has antiallergic effect - reduces exudative manifestations, eliminates hyperemia and swelling of the mucous membranes of the nasopharynx and paranasal sinuses, itching of the nasal cavity, eyes and throat. In addition, it has some local anesthetic, hypnotic, sedative, anticholinergic and antispasmodic properties. Shows effectiveness in Meniere's disease and kinetosis (motion sickness syndromes).
Pharmacokinetics
All active substances that make up Flucoldex-N are well absorbed in the gastrointestinal tract.
The bioavailability of paracetamol ranges from 70 to 90%. The time to reach the maximum concentration in blood plasma is 45 minutes. Plasma protein binding does not exceed 10%; in case of an overdose, it increases. The half-life is from 1 to 3 hours, it increases in newborns, with overdose and against the background of hepatic / renal failure. Paracetamol is metabolized in the liver with the formation of several metabolites, which are excreted over 24 hours, mainly through the kidneys (up to 5% of the dose is excreted unchanged). N-acetyl-benzoquinone imine, one of the metabolites, under certain conditions (lack of glutathione in the liver, paracetamol overdose) can have nephrotoxic and hepatotoxic effects, up to necrosis.
Time to reach the maximum concentration of caffeine in blood plasma - 1 hour; the half-life is 3.5 hours. From 65 to 80% of the dose is excreted through the kidneys, mainly in the form of acetylated derivatives of uracil, 1-methyl uric acid and 1-methylxanthine. A small amount is converted to theobromine and theophylline.
The time to reach the maximum concentration of chlorphenamine in the blood plasma is from 1 to 2 hours, the half-life is 7 hours. The metabolic process is mainly carried out in the liver. May lead to the induction of microsomal hepatic enzymes.
Indications for use
Flucoldex-N tablets are prescribed for symptomatic treatment of colds, acute respiratory viral infections (rhinorrhea, pain syndrome, fever) and flu.
Contraindications
Absolute:
- severe renal or liver dysfunction;
- combination therapy with other drugs, which include caffeine, paracetamol or chlorphenamine;
- age up to 12 years;
- established hypersensitivity to the components of the drug.
Relative (Flucoldex-N tablets must be taken with extreme caution and under close medical supervision):
- deficiency of glucose-6-phosphate dehydrogenase;
- severe atherosclerosis of the coronary arteries;
- arterial hypertension;
- congenital hyperbilirubinemia (Rotor, Dubin-Johnson, Gilbert syndromes);
- pathology of the blood system;
- hyperplasia of the prostate;
- angle-closure glaucoma;
- alcoholism;
- pregnancy;
- period of breastfeeding.
Flukoldeks-N, instructions for use: method and dosage
Flucoldex-N tablets are intended for oral administration.
It is usually recommended to take 1 tablet 2-3 times a day, observing an interval of 4 hours (at least). For children over 12 years old and adults, the maximum single dose of the drug is 2 tablets, the daily dose is 8 pcs.
The duration of the drug intake should not exceed 5 days. It is allowed to increase the duration of therapy as prescribed by a doctor.
Side effects
The reception of therapeutic doses of Flucoldex-N is usually well tolerated. In some cases, the development of allergic reactions (angioedema, urticaria, skin itching and rash), dryness of the mucous membrane (nasal cavity, mouth and throat), nausea, sleep disorders, dizziness, agitation, pain in the epigastric region, paresis of accommodation, arrhythmias, mydriasis, tachycardia, urinary retention, increased intraocular pressure.
Prolonged use of high doses of the drug can lead to pancytopenia, agranulocytosis, thrombocytopenia, methemoglobinemia, hemolytic or aplastic anemia, hepatotoxic action, nephrotoxicity (papillary necrosis, interstitial nephritis, glucosuria, renal colic).
Overdose
The main symptoms of paracetamol overdose: nausea, vomiting, loss of appetite, stomach pain, pallor of the skin; after 1-2 days, manifestations of liver damage are noted. In severe cases - liver failure, hepatonecrosis (its severity directly depends on the degree of overdose), encephalopathy and coma. In adults, the toxic effect can be observed after taking more than 10-15 g of the substance - the prothrombin time increases (after 12-48 hours after ingestion), the activity of hepatic transaminases increases. After 1–6 days, a detailed clinical picture of liver damage appears. In rare cases, liver failure develops with lightning speed and can be complicated by renal failure (tubular necrosis).
The main symptoms of caffeine overdose: cardiac arrhythmias, muscle cramps, increased urine output, tachycardia, periods of psychomotor agitation.
The main symptoms of a chlorpheniramine overdose: nausea, dizziness, depression of the central nervous system, dry mouth.
Therapy: when taken in a short time more than 15 tablets of Flucoldex-N, during the first 4 hours, gastric lavage is performed, adsorbents are prescribed, drugs that increase the formation of glutathione are administered (methionine - after 8-9 hours after an overdose, acetylcysteine - during the first 12 hours). Detoxification can be done through hemodialysis. In addition to these measures, symptomatic treatment is carried out.
special instructions
During the period of taking Flucoldex-N, you cannot use non-steroidal anti-inflammatory drugs, non-narcotic analgesics and drugs that depress the central nervous system. It is recommended to avoid excessive consumption of coffee, tea and other foods that contain methylxanthines.
In order to avoid the hepatotoxic effect of paracetamol during drug therapy, alcohol should not be consumed.
Influence on the ability to drive vehicles and complex mechanisms
During the period of therapy with Flucoldex-N, it is prohibited to drive vehicles, as well as perform other work associated with increased attention (due to the possible sedative effect of chlorphenamine).
Application during pregnancy and lactation
Flucoldex-N is prescribed with caution during pregnancy and during breastfeeding.
Pediatric use
The use of Flucoldex-N is contraindicated in children under the age of 12.
With impaired renal function
Renal failure is an absolute contraindication to the use of Flucoldex-N.
For violations of liver function
In case of liver failure, the drug is not used.
Drug interactions
Recommended combinations to take into account:
- drugs that depress the central nervous system, non-narcotic analgesics, non-steroidal anti-inflammatory drugs: can enhance the undesirable effects of Flucoldex-N;
- alcohol, rifampicin, carbamazepine, phenytoin, barbiturates, zidovudine and other inducers of liver microsomal enzymes: the risk of a hepatotoxic effect increases;
- chloramphenicol (chloramphenicol): its excretion slows down and toxicity increases;
- domperidone, metoclopramide: increase the absorption of paracetamol;
- cholestyramine: slows down the absorption of paracetamol.
Long-term use of Flucoldex-N in combination with indirect anticoagulants should be under constant medical supervision.
If the drug is used for more than 1 week, it is important to control the functional state of the liver and the picture of peripheral blood.
Analogs
Flukoldex-N analogues are AntiFlu, Gripand HotActive, Influnet, Kaffetin, Coldact with vitamin C, Coldrex FLU Plus, Coldrex HotRem, Lemsip Blackcurrant, Maxikold Rino, Rinikold HotMix, etc.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about Flukoldex-N
Patients leave mostly positive reviews about Flukoldex-N. The advantages most often include the budgetary cost of the drug, convenient dosage form, high efficiency and rapid development of therapeutic action.
In rare cases, there was a weak therapeutic effect of Flucoldex-N or its absence.
Price for Flucoldex-N in pharmacies
The approximate price for Flucoldex-N (12 tablets in a package) is 153 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
