Combispasm
Kombispasm: 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. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Combispasm
ATX code: N02BE51
Active ingredient: paracetamol (paracetamol) + dicycloverine hydrochloride (dicycloverine hydrochloride)
Producer: Organosyn Life Sciences (India)
Description and photo updated: 2019-27-08
Kombispasm is a combined non-steroidal anti-inflammatory drug (NSAID) that has analgesic, antipyretic, spasmolytic, myotropic and anticholinergic effects.
Release form and composition
The dosage form of the release is tablets: round, with a notch, white, without a shell (10 pcs. In a blister, in a carton of 1 or 10 blisters and instructions for use of Combispasm).
Composition of 1 tablet:
- active substances: paracetamol - 500 mg, dicyclomine hydrochloride - 20 mg;
- auxiliary components: corn starch, povidone, talc, sodium starch (type A), microcrystalline cellulose, magnesium stearate, anhydrous silicon dioxide.
Pharmacological properties
Pharmacodynamics
Kombispasm is a combined drug that has analgesic and antispasmodic effects.
The effect of Kombispasm is due to the properties of the active ingredients:
- paracetamol: a substance with analgesic and antipyretic properties, which is associated with its effect on the center of thermoregulation in the hypothalamus, as well as the ability to inhibit the synthesis of prostaglandins;
- dicyclomine hydrochloride: a substance with anticholinergic, myotropic, antispasmodic properties. Helps to eliminate spasm of smooth muscles of the gastrointestinal tract and reduce the resulting pain syndrome. Also, due to the use of dicyclomine, the secretion of sweat, salivary, gastric and bronchial glands decreases. The effect of the substance is due to two mechanisms of action: a specific anticholinergic effect on acetylcholine receptors, similar to the action of atropine, and a direct effect on smooth muscle, indicating the ability of the substance to block histamine- and bradykinin-induced spasms.
Pharmacokinetics
Paracetamol
After oral administration, paracetamol is rapidly and almost completely absorbed in the gastrointestinal tract, C max (maximum concentration of the substance) in the blood plasma is reached in 10-60 minutes. Binds to plasma proteins at a level of about 10%.
Metabolism occurs in the liver, mainly with the formation of inactive metabolites - glucuronide and paracetamol sulfate (60–80% and 20–30%, respectively). To a lesser extent (≤ 4%) it is metabolized by oxidation with the formation of mercaptopuric acid and cysteine (cytochrome P 450 is involved in the process).
T 1/2 (half-life) ranges from 2 to 2.5 hours. It is excreted in the urine, mainly in the form of metabolites. Approximately 5% of the substance is excreted unchanged. In liver failure, the metabolism of paracetamol does not change.
Dicyclomine hydrochloride
After oral administration, the substance is rapidly absorbed and distributed in tissues. C max in blood plasma is reached in 60–90 minutes.
According to the results of the study, T 1/2 is 1.8 hours in the presence of the drug in the blood plasma for 9 hours after taking one dose. In the course of further studies, it was found that the concentration of the substance in the blood plasma is maintained for 24 hours after taking one dose, in the second phase of elimination, T 1/2 increases slightly.
Excretion is carried out mainly in the urine (79.5%), approximately 8.4% of the dose is excreted in the feces.
Indications for use
Combispazm tablets are used to reduce or relieve pain syndrome of various origins:
- Headache;
- Renal colic;
- Toothache;
- Radiculitis, neuralgia, myalgia;
- Rheumatic pain;
- Algomenorrhea.
Contraindications
- Glaucoma;
- Myasthenia gravis;
- Violation of the patency of the urinary tract;
- Tachycardia;
- Severe renal and / or liver dysfunction;
- Breastfeeding period;
- Age up to 7 years;
- Pregnancy;
- Hypersensitivity to drug components.
With extreme caution, Combispasm should be prescribed for cardiovascular insufficiency, intestinal obstruction, pyloric stenosis, ulcerative colitis, impaired renal and / or liver function, benign hyperbilirubinemia, enlarged prostate.
Kombispasm, instructions for use: method and dosage
Combispazm tablets are taken orally with plenty of water.
The dose and frequency of administration are prescribed by the doctor based on clinical indications.
The recommended dosage has age restrictions:
- Patients over 15 years old: 1-2 tablets 1-4 times a day. Treatment should start with 4 tablets per day; to achieve a clinical effect, it is allowed to increase the dose to 8 tablets (provided there are no side effects);
- Children 7-13 years old: 1/2 tablet 1-2 times a day;
- Children 13-15 years old: 1 tablet 1-3 times a day.
The maximum daily dose of paracetamol for children should not exceed 0.15 g per 1 kg of the child's weight, for adults - 12 tablets, or 6 g.
The drug should be taken no more than 1 time in 4 hours.
Side effects
The use of Kombispasm can cause side effects:
- Allergic reactions: urticaria, skin rashes, erythema;
- Cardiovascular system: tachycardia, arrhythmia, bradycardia;
- Others: difficulty swallowing, dry mouth and thirst, constipation, impaired accommodation, increased intraocular pressure, dilated pupils, hyperemia and dry skin, difficulty urinating; rarely - fever, confusion, leukopenia, agranulocytosis, thrombocytopenia, neutropenia.
The appearance of rashes on the patient's body requires immediate discontinuation of the drug.
Overdose
Taking high doses for a long period and overdosing of the drug can cause toxic liver damage. Clinical signs of an overdose are nausea, vomiting, pallor of the skin, abdominal pain, anorexia. There is a pronounced change in laboratory parameters of liver function: an increase in the concentration of bilirubin and the activity of liver enzymes, a decrease in the level of prothrombin.
Therapy: gastric lavage, administration of N-acetylcysteine, symptomatic treatment.
special instructions
The use of the drug can exacerbate gastroesophageal reflux.
If adverse events occur while taking low doses of Combispasm or if there is no therapeutic effect after 2 weeks of use, the drug should be canceled.
Influence on the ability to drive vehicles and complex mechanisms
During the period of use of the drug, care should be taken when performing work depending on the speed of psychomotor reactions and increased attention, including when driving vehicles and mechanisms.
Application during pregnancy and lactation
Combispasm is not prescribed during pregnancy / lactation.
Pediatric use
For patients under 7 years of age, the drug is not prescribed.
With impaired renal function
- severe renal dysfunction: therapy is contraindicated;
- impaired renal function: Combispasm should be used under medical supervision.
For violations of liver function
- severe violations of hepatic function: therapy is contraindicated;
- hepatic dysfunction: Kombispasm should be used under medical supervision.
Use in the elderly
Elderly patients should use the drug with caution.
Drug interactions
Combispasm can reverse the effects of drugs used to treat glaucoma and gastrointestinal motility (metoclopramide).
An increase in the anticholinergic action of the drug occurs with the simultaneous administration of benzodiazepines, antihistamines, antipsychotic (meperidine) drugs, monoamine oxidase inhibitors, sympathomimetics, amantadine, class I antiarrhythmic drugs, narcotic analgesics, tricyclic antidepressants, nitrites and nitrates.
An increase in the hepatotoxic effect of paracetamol is caused by a combination with alcohol, anticonvulsants, barbiturates, rifampicin.
Against the background of increased intraocular pressure, it is dangerous to use Kombispasm simultaneously with glucocorticosteroids.
Antacids impair the absorption of anticholinergics; this combination should be avoided.
The drug suppresses the secretion of hydrochloric acid in the stomach, this must be taken into account in the treatment of achlorhydria or in a laboratory study of gastric secretion.
Analogs
The analogues of Kombispazm are: Apap, Bol-ran Neo, Diklo-p, Dollar, Sedalgin Neo, Tsefekon, Solpalgin, Kaffetin, Dolaren, Novalgin, Sigan-DBS, Spazgo, Solpadein, Unispaz, Paracetamol, Trigan-D.
Terms and conditions of storage
Store at 15-25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Combispasm
According to reviews, Combispasm effectively relieves pain syndrome of various etiologies. However, in many cases, taking the drug is accompanied by the development of severe side effects, including drowsiness and decreased performance. Also, the disadvantages include the large size of the tablets, which makes it difficult to swallow.
Price for Combispasm in pharmacies
The price of Combispasm is unknown, as the drug is not available in pharmacies.
The approximate cost of analogs: Sedalgin-Neo (10 tablets) - 152-295 rubles, Unispaz N (12 tablets) - 85-105 rubles, Paracetamol (10 tablets) - 3-7 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
