1. Name Of The Medicinal Product
CARISOMA TABLETS
2. Qualitative And Quantitative Composition
Each tablet contains 125mg or 350mg Carisoprodol.
3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
As an adjunct to the symptomatic treatment of acute musculoskeletal disorders associated with painful muscle spasm, where sedation is acceptable.
4.2 Posology And Method Of Administration
For oral administration and short term use only.
Adults:
The usual dose is 350mg three times a day.
Elderly:
Half the normal adult dose or less may be sufficient for a therapeutic response.
Children:
Not recommended.
4.3 Contraindications
Sensitivity to carisoprodol or related drugs such as meprobamate. Acute intermittent porphyrias. Breast feeding.
4.4 Special Warnings And Precautions For Use
Carisoprodol is metabolised by the liver and excreted by the kidneys. To prevent accumulation, administer with caution in renal and hepatic impairment.
The dependence potential of carisoprodol is not known. Dependence has occurred. As with other sedative drugs, dependence may possibly occur when carisoprodol is given in high dosage and for prolonged periods, especially in patients with a history of alcoholism or drug dependence or in patients with marked personality disorders. Withdrawal symptoms have been reported to occur in a study of the effects of abrupt cessation of higher than normal dosage.Safety in long term use has not been established.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In hepatic or renal insufficiency, the concurrent use of other CNS depressant drugs should be avoided. Little is known about the possibility of other drug interactions. Carisoprodol may cause hepatic enzyme induction. Therefore the availability and blood levels of drugs given concurrently that are metabolised by the liver, may be affected. These include coumarin-type anticoagulants, systemic steroids (including oral contraceptives), phenytoin, griseofulvin, rifampicin, phenothiazines and tricyclic antidepressants. The sedative effects of carisoprodol are potentiated by the use of alcohol.
4.6 Pregnancy And Lactation
Do not use during pregnancy, especially the first trimester, unless there are compelling reasons.
Carisoprodol is present in breast milk at two to four times that of maternal plasma. This factor should be taken into account when use of this drug is contemplated in breast-feeding patients.
4.7 Effects On Ability To Drive And Use Machines
Performance and alertness may be impaired. Patients should be warned of the hazard and advised not to drive or operate machines during treatment. These effects are potentiated by alcohol.
4.8 Undesirable Effects
Reported adverse effects include drowsiness, dizziness, nausea, vertigo, lassitude, weakness, flushing, headache, irritability and constipation. Skin rashes may occur.
Poor metabolisers of CYP2C19 may be at greater risk of drowsiness (see Section 5.2).
Rare reactions reported have included anaphylactic shock, syncope, tachycardia, confusion, transient quadriplegia, bronchospasm; such idiosyncratic reactions may occur after the first dose in patients not previously exposed to the drug.
4.9 Overdose
Overdosage of carisoprodol has produced stupor, coma, shock, respiratory depression and (very rarely) death. Effects can be additive with other CNS depressant drugs or alcohol taken concurrently. In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic therapy given.
Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated. Carisoprodol is metabolised in the liver and excreted by the kidney. Forced alkaline diuresis, peritoneal dialysis and haemodialysis have been used successfully. Careful monitoring of urinary output is necessary and caution should be taken to avoid over-hydration.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Carisoprodol is a centrally acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain.
5.2 Pharmacokinetic Properties
The onset of action is rapid and the duration of effect is 4 to 6 hours.
Carisoprodol is metabolised by the liver and excreted by the kidneys.
The metabolism of carisoprodol may be under the control of genetic polymorphism of CYP2C19 and an extended half-life has been reported in a 'poor metaboliser' phenotype. Thus, care should be exercised in known CYP2C19 'poor metabolisers' who may be at greater risk of drowsiness.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Alginic Acid
Magnesium Stearate
Methylcellulose
Corn Starch
Purified Water
6.2 Incompatibilities
None stated
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
Amber glass bottle with black urea formaldehyde cap with a steran faced pulpboard wad and acid-free tissue dunnage containing 100 tablets.
6.6 Special Precautions For Disposal And Other Handling
None stated
7. Marketing Authorisation Holder
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8. Marketing Authorisation Number(S)
125mg: PL 0108/0082
350mg: PL 0108/0081
9. Date Of First Authorisation/Renewal Of The Authorisation
125mg: 13 April 1984 / 31 October 2000
350mg: 13 April 1984 / 17 October 2000
10. Date Of Revision Of The Text
July 2006
11. Legal Category
POM
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