| Composition | : | Carisol Extra: Each tablet contains: Paracetamol 500 mg Carisoprodol 200 mg |
|---|---|---|
| Excipients | : | Pregelatenized Starch, Maize Starch, Povidon, Magnesium stearate, Sodium Lauryl Sulphate. |
| Therapeutic Action | : | Carisoprodol with an antipyretic analgesic, it has been described as a muscle relaxant for the central action. |
| Indications | : | Carisol Extra is designed for short-term treatment of the musculoskeletal disorders of acute pain accompanied with a muscle contraction. The duration of treatment should not exceed 2-3 weeks. |
| Pharmacological Action | : | Carisoprodol : acts at the central nervous system level through lowering of the multisynaptic reactions by depressing the neural activity in the descending reticular formation and in the spinal cord which produces a muscular sedative. Paracetamol: An antipyretic analgesic; the clinical activity in classifications like those similar to (non-steroidal anti-inflammatory medicine) but is inactive as an anti-inflammatory medicine. As for the mechanism of action for Paracetamol, it is considered might have the property of affinity to the central enzymes rather than the peripheral ones (situated at edges). |
| Pharmacokinetics | : | Carisoprodol: it is rapidly absorbed by the mouth; easily distributed and the metabolism is done in the liver. the average life is 8 hours and its elimination is renal. Paracetamol: It is fully absorbed if orally administered, it then passes through the blood where it reaches the maximal concentration from 1-2 hours and following digestion it is distributed in the tissues. Its metabolic transformation rapidity leads to a quick fall of the blood levels (average life 3-4 hours) and hence there is a very few accumulations. It is eliminated in the urine, 5% in a liberal form and about 85% is in conjunction with glucuronic acid and sulfuric acid; a small portion transforms to para aminophenol. |
| Contraindications | : | Leucopenia, thrombocytopenia, porphyria, acute intermittent porphyria, allergy, self sensitivity to Carisoprodol or some of its metabolites (meprobamate, mebutano, timabato) , hypersensitivity to any component of the formula , contraindication during the period of pregnancy and breastfeeding, children under 16 years old, contraindication in the acute renal and/or hepatic insufficiency. |
| Warning & Precautions | : | Patients should be warned that the active pharmaceutical ingredient (IFA) Carisoprodol has sedative properties, it may then diminishes the mental and/or physical skills that are required to complete the grave tasks or the ones needing attention or alert such as vehicles driving or machinery operation. There are described experiences where Carisoprodol might generate cases of abuse and dependence particularly due to the prolonged use of the medicine ; stopping it abruptly therefore may result in launching effects like anxiety, insomnia, tremors, hallucinations, convulsion and even addictive effects were noticed through the use of IFA Carisoprodol in conjunction with alcohol or depressors of the central nervous system. It is not recommended those under 16 years of age to administer such medicines. This medicine has been listed within an active pharmaceutical control plan. This drug should be administered with a special precaution if one has diseases affecting the liver or both kidneys, anemia, problems of the lungs or heart and for the patients having antecedents due to taking the drugs and alcohol excessively. The prolonged use particularly in high doses may cause dependence; to avoid this happens the medicine should be administered as mentioned without increasing the dose or the recommended duration. Suspending of administration of medicine should be done gradually especially if administration of the medicine has been for a long period of time. This medicine may cause vertigo, and drowsiness, it is not recommended to drive vehicles or work on dangerous machines during treatment and drinking alcohol must be avoided. Since Carisoprodol is metabolized in the liver and it is eliminated in the kidney, it should be administered carefully for the patients who suffer from a renal or hepatic insufficiency and diminishing of the dose should be taken into consideration. Over 65 years old people: it is only used if no other option is available and the dose is diminished to the half or less. |
| Drug Interactions | : | - Paracetamol: The hormonal contraceptives may accelerate its hepatic metabolism. Metoclopramide may accelerate its absorption in the small intestines. The caffeine increases its analgesic effectiveness, increases the plasmatic levels of Chloramphenicol. - Carisoprodol: Barbiturates: The administration of Carisoprodol and Barbiturates may cause synergy in the depressing effect at level of the respiratory and the central nervous system; take into consideration to diminish the dose of one of the two drugs or both together. Benzodiazepines: The administration of Carisoprodol and Benzodiazepines may cause synergy in the depressing effect at level of the respiratory and the central nervous system; take into consideration to diminish the dose of one of the two drugs or both together. Cimetidine: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Cholrpromazine: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Fluconazole: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Fluoxetine: Carisprodol may fortify the depressing effect of central nervous system. Fluoxetine may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically and precaution should be taken as much as possible when jointly used. Haloperidol: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Ketoconazole: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Lamotrigine: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Lansoprazole: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Olanzapine: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Omeprazole:: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Paroxetine: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Propofol: this drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. Respierdone: Carisoprodol may fortify the depressing effect of central nervous system for various drugs, precaution should be taken when jointly used. Sertraline: This drug may diminish the metabolism of Carisoprodol (being the inhibitor of Cytochrome P450 2C19) as a result its plasmatic levels and effects increase, it is recommended to control the patient clinically. |
| Pregnancy & Lactation | : | A contraindication in pregnancy Carisoprodol reaches in large quantities to mother's milk, therefore it is not an indication for the breastfeeding women. |
| Children's Use | : | Due to the limited clinical experience of Carisoprodol, it is not recommended for people under 16 year old. |
| Side Effects | : | Drowsiness may be noticed that generally disappears when dose is reduced. Less Frequently Appearing Manifestations: Neurology: vertigo, dizziness, ataxia, tremors, irritation, headache, depressive reactions, syncope or insomnia. Allergy: rash, pruritus, eruption, asthma episodes, fever, angioneurotic edema, eye irritation, anaphylactic shock. Cardiovascular: tachycardia, postural hypotension, blushing. Gastrointestinal: nausea, vomiting, abdominal pains. |
| Dosage | : | A usual therapeutic dose, one tablet 4 times daily (the last one taken before sleep). No more than one tablet is administered per dose. Doses may be arranged as per the physician's criteria. Maximum dose of Carisoprodol is 1400 mg per day. |
| Overdose | : | In case overdose administered go quickly to a medical center because symptoms: dizziness, vomiting, abdominal pains may emerge late and the consequences might be extremely serious. Treatment lies in provoking vomiting, gastric lavage, supplying it with active carbon orally, supplying it with N-acetylcysteine intravenously; and if necessary dialysis. If an overdose occurs, go quickly to the nearest hospital or call a toxicology center. |
| Storage | : | Store at temperature between (15-30)ºC. |
| Packaging | : | A carton box of 20 tablets packed in two blisters with a leaflet. |