Codipront

Codipront

Manufacturer:

RX Pharma

Distributor:

DCH Auriga
Full Prescribing Info
Contents
Codeine, phenyltoloxamine citrate.
Description
1 capsule contains: Codeine base 30mg (as Codeine phosphate hemihydrate) Phenyltoloxamine base 10mg (as Phenyltoloxamine citrate).
Excipients/Inactive Ingredients: Polyethylene glycol, lactose, dyes: erythrosin (E 127), titanium dioxide (E 171) , and iron oxide (E 172), gelatin, Sodium polystyrene sulfonate.
Action
Pharmacotherapeutic group: Antitussive.
Pharmacology: Codipront Capsules with sustained action contain two active ingredients with different sites of action, the effects of which are complementary. Codeine alleviates coughing by central suppression of the cough center.
Phenyltoloxamine, an antihistamine with spasmolytic properties, complements the central effect of codeine by broncholysis. As a highly effective antihistamine it has a beneficial action on allergic-inflammatory processes in the respiratory tract.
The special pharmaceutic form ensures a sustained action over several hours so that usually it is sufficient to take one Codipront Capsule with sustained action in the morning and in the evening.
Indications/Uses
Symptomatic treatment of dry cough (non-productive cough) such as during bronchitis, influenza as well as inflammations of the respiratory tract due to allergic and infectious causes.
Dosage/Direction for Use
The following applies to Codipront Capsules with sustained action unless otherwise prescribed by the doctor. Follow the instructions for use otherwise Codipront Capsules with sustained action may not work properly.
How much and how often should Codipront Capsules with sustained action be taken: The dosage and the duration of therapy depend on the disease as well as on the intensity and frequency of cough.
In certain cases of renal diseases (renal insufficiency) or in older patients other dosage recommendations may be necessary. In any case the individual dosage is determined by the treating physician.
Adults and children over 14 years take one capsule with sustained action in the morning and one in the evening.
How and when should Codipront Capsules with sustained action be taken: The capsules with sustained action should be swallowed whole with some liquid (e.g a glass of water).
How long should Codipront Capsules with sustained action be taken: The duration of treatment is determined by the healthcare professionals.
Overdosage
What should be done if too high amounts of Codipront Capsules with sustained action were taken (intentional or inadvertent dosage): Inform immediately a doctor who can institute the following measures, if necessary: Naloxone which reduces the harmful effect of codeine is available as specific drug against codeine overdosage.
Naloxone administration must be repeated since codeine's duration of action is longer than that of naloxone. If naloxone cannot be used , symptomatic measures are necessary such as for instance stable side position, artificial respiration, and shock treatment Patients with codeine intoxication should be continuously supervised (respiration, pulse, blood pressure). Physostigmine can reduce the impairment of the cerebral activity caused by antihistamines. Shortly (about 1 hour) after an antihistamine intoxication the administration of activated charcoal is indicated. Also the induction of vomiting is possible, provided that there are not yet any signs of intoxication and if the possibility of a penetration of solid and liquid components into the respiratory tract by aspiration is considered. In case of a severe overdosage a gastric lavage is recommended.
Generally, an antihistamine intoxication has to be treated symptomatically The bodily functions such as e.g. respiration and cardiovascular system, have to be monitored and supported if necessary. Spasms in children can be treated with diazepam 5-10 mg i. v. depending on the age or with an i.v.-barbiturate with a short duration of action.
Contraindications
Circumstances under which Codipront Capsules with sustained action should not be used: Do not use this medicine if the patient is breast-feeding.
Do not use this medicine shortly before or during labour.
Do not use in children below the age of fourteen.
Do not use if the patient is hypersensitive to one of its ingredients. Patients suffering from enlarged prostate gland, glaucoma, chronic constipation or asthma and/or lung insufficiency.
Do not use in disturbance of consciousness condition.
This medicine should not be used without consulting the physician prior to commencing treatment: If the patient is suffering from hypertension, convulsive diseases or CVA; If the patient suffers or have suffered in the past from impaired function of the: respiratory system, heart and/or blood vessels, liver, kidneys/urinary system, digestive system (e.g. ulcer), disturbances of consciousness, intracranial pressure, if the patient is addicted to opioids.
Elderly patients should be under medical supervision since they are more sensitive to the side effects.
Do not use in coma (unconsciousness) condition.
Special Precautions
Codeine has a primary dependence potential. Prolonged and high-dose use may produce tolerance as well as physical and mental dependence. Habituation to codeine may result in an habituation to other opioids and vice versa in case of a pre-existing opioid dependence severe recurrences have to be taken into account.
If cough persists for more than 2-3 weeks, further diagnostical advice has to be obtained.
Effects on ability to drive and use machines: Even when used according to instructions, this drug may change the reactivity to such an extent as to impair the ability to actively take part in road traffic or operate machinery. Therefore, driving motor vehicles or operating machinery or other dangerous activities should be avoided entirely or at least during the initial days of therapy. The treating physician decides in each individual case taking into consideration the individual reactivity and dosage. The combination of the active ingredients with alcohol or with central-active drugs (e.g. sleeping medicine, psychopharmacologic agents, some analgesics) results in a massive impairment of the psychomotor capacity (e.g. the capacity to concentrate, the perception of dangerous situations). Therefore, driving motor vehicles or operating machinery as well as other dangerous activities are excluded while on such combinations.
Use in pregnancy and lactation: Codeine should only be administered during pregnancy on the explicit instruction of the physician, since a slight teratogenic potential cannot be excluded. Codeine is contraindicated if delivery is approaching or if early delivery is imminent since it passes the placental barrier and may produce respiratory disorders in neonates Codeine appears in breast milk and may produce undesired effects for the child. The mother should interrupt nursing in case a therapy at high doses is necessary during lactation.
Use in children: Since the use of codeine is contraindicated in patients with acute asthmatic attacks it should be especially borne in mind that chronic cough in particular in children is frequently an early sign of bronchial asthma. Codeine is not indicated for the sedation of these coughing conditions.
Use in elderly: Elderly patients should be under medical supervision since they are more sensitive to the side effects.
Use In Pregnancy & Lactation
Codeine should only be administered during pregnancy on the explicit instruction of the physician, since a slight teratogenic potential cannot be excluded. Codeine is contraindicated if delivery is approaching or if early delivery is imminent since it passes the placental barrier and may produce respiratory disorders in neonates Codeine appears in breast milk and may produce undesired effects for the child. The mother should interrupt nursing in case a therapy at high doses is necessary during lactation.
Side Effects
Nervous System/Brain: Frequent side effects are mild headache and mild somnolence. States of excitation in infants (upon overdosage) are possible . Slowness of respiration and an exaggerated sense of "well-being" (euphoria) may also occur. Sleep disturbances or tinnitus have rarely been observed.
Gastrointestinal tract/smooth muscles: Nausea and vomiting may frequently be experienced at the beginning of treatment. Another frequent side effect is constipation.
Codeine may increase the tone of smooth muscles involuntary muscles, e.g intestinal musculature, muscles of the bladder), in particular after single doses of more than 60 mg. Urination may be impaired.
Eye: Induction of glaucoma (narrow-angle glaucoma) may occur. A dose-dependent impairment of visuomotoric coordination and visual capacity may occur after high doses or in particularly sensitive patients.
Skin, mucosa/allergy: Itching of the skin, skin reaction (e.g. reddening) and dry mouth are rare. Severe hypersensitivity reactions occur very rarely.
Others: In rare cases shortness of breath and in extremely rare cases changes in the blood picture were reported In individual cases weight increase has been described. High therapeutic doses or intoxication may result in loss of consciousness and blood pressure fall. Pulmonary oedema may occur in patients with pre-existing impairment of pulmonary function.
The side effects usually subside after a reduction of dose and can normally be avoided by carefully and individually adjusted doses.
Drug Interactions
Note that the following may also apply to drugs recently used.
Concomitant administration of other central depressant drugs, e.g. psychopharmacologic agents, sleeping medicine, in some cases analgesics, antiallergic agents (additional antihistamines) hypertensives may potentiate the sedating and respiratory depressive action.
Cimetidine and other medicinal products which influence liver metabolism may potentiate the effect of Codipront Capsules with sustained action. During morphine treatment an inhibition of morphine catabolism resulting in increased plasma concentrations has been observed. Such an interaction cannot be excluded for codeine.
The combination of alcohol and codeine/phenyltoloxamine reduces the psychomotor capacity (ability to concentrate and solve complex problems) more strongly than its individual components. During therapy with Codipront Capsules with sustained action the consumption of alcohol should therefore be avoided.
Storage
Do not store above = 25°C (77°F). Keep dry.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05DA20 - combinations ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
Presentation/Packing
Cap 50's.
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