NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2021. All Rights Reserved.
Date: Thursday, December 2, 2021 15:30

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 11.24
Corvental D Capsules
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Theophylline
Product:Corvental-D® Capsules
Product index: Corvental-D Capsules
Qualitative and quantitative composition
Composition (per capsule)
Active ingredient:
Theophylline 100 mg
200mg
500mg
Excipients:
Indigotine (E132), as colorant 0.048 mg
Titanium dioxide (E171), as colorant 1.152 mg
Ferric oxide (E172) 0.25 mg
For a full list of excipients, see Pharmaceutical particulars section.
Pharmaceutical form
100mg Capsule, hard. Opaque blue/opaque white coloured capsules, size 3. Each capsule half is printed in black with “Th100”.
200mg Capsule, hard. Opaque green/transparent green coloured capsules, size 2. Each capsule half is printed in white with “Th200”.
500mg Capsule, hard. Opaque green/transparent green coloured capsules, size 0/elongated. Each capsule half is printed in white with “Th500
Clinical particulars
Target species
Dogs.
Indications for use, specifying the target species
For the treatment of bronchitis and congestive heart failure in dogs.
Contraindications
Concurrent use of beta-sympathomimetics is contra-indicated, as additive or synergistic interactions, resulting in exaggerated side effects may result.
Do not use in dogs with a known history of epileptiform seizures as convulsions have been reported in patients on theophylline treatment, often with no preceding signs of toxicity and in otherwise apparently normal animals.
Special warnings for each target species
None known.
Special precautions for use
Special precautions for use in animals
Theophylline should be used with caution in patients with liver disease. If vomiting occurs, the dose should be reduced or the treatment discontinued.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
The following side effects have been reported: restlessness, agitation, excitement, vomiting, diarrhoea, polydipsia, sedation, reduced appetite and polyuria.
If signs of CNS excitement occur, (twitching, restlessness or convulsions) discontinue treatment immediately.
Use during pregnancy, lactation or lay
When theophylline is prescribed to pregnant bitches, the risk-benefit of the treatment should be assessed. Only small amounts of theophylline are excreted in milk.
Interaction with other medicinal products and other forms of interaction
Plasma theophylline levels may increase in patients under treatment with macrolide and fluoroquinolone antibiotics, such as erythromycin and enrofloxacin, and decrease in patients receiving phenobarbitone or phenytoin.
Theophylline may reduce the convulsive threshold in patients receiving ketamine.
Administration of theophylline shortly before halothane anaesthesia may result in arrhythmogenic effects.
Amounts to be administered and administration route
20 mg per kg bodyweight to be given orally once daily only.
Care should be taken to ensure that dogs are weighed carefully and accurately, and the dose does not exceed 20 mg/kg body weight.
Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no specific treatment for theophylline overdose in the dog. The condition should be treated symptomatically with emetics, oral activated charcoal or anti-convulsive drugs as necessary.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Systemic drugs for obstructive airway diseases, xanthines.
ATCvet code: QR03DA04
Pharmacodynamic properties
Theophylline is a dimethylated xanthine which was introduced into medicine in 1900. It is similar in structure to the common dietary xanthines, caffeine and theobromine, and has many pharmacological actions. It relaxes smooth muscle, relieves bronchospasm and has a stimulant effect on respiration. Theophylline dilates coronary arteries and increases the strength of contraction of the myocardium. It also acts on the kidney to induce diuresis and is a potent stimulant of the central nervous system.
Pharmacokinetic particulars
Absorption: The methylxanthines are readily absorbed following oral administration. Studies in man have shown that the administration of theophylline with food may slow but not reduce absorption of the drug, and help avoid local irritation of the gastro-intestinal tract. In the absence of food, theophylline solutions or uncoated tablets produce maximal plasma concentration within two hours. The rate and extent of absorption of theophylline differs between various slow release formulations and absorption of the drug appears to be slower at night. However, slow release formulations, if completed absorbed, allow longer dosing intervals with less fluctuation in serum concentration.
Distribution: Theophylline is distributed into all body compartments and human studies have shown that it crosses the placenta and diffuses into breast milk. The drug also crosses the blood brain barrier and enters the central nervous system. The apparent volume of distribution of theophylline in man ranges from 300 to 700 ml/kg and in dogs, 500 to 800 ml/kg. In humans, it is about 50% bound to plasma proteins, but in dogs is lower at about 9%.
Metabolism and Excretion: Little information is available concerning the metabolism and excretion of theophylline in dogs. In man, theophylline is eliminated from the body by hepatic biotransformation into relatively inactive metabolites which are excreted in the urine. Theophylline is metabolised by demethylation and oxidation, mainly to 1,3-dimethyluric acid. D-methyluric acid and 3-methylxanthine are also formed in smaller amounts, and about 10% of the drug is excreted unchanged in the urine. The half life of theophylline in adults is 8 to 9 hours, and in children it is 3.5 hours.
Pharmaceutical particulars
List of excipients
Povidone K-25
Silica Colloidal Anhydrous
Triethyl citrate
Poly (Ethylacrylate, Methylmethacrylate, trimethylammonio Ethylmethacrylate Chloride) 1:2:0.1 150,000 (Eudragit RS 100)
Poly (Ethylacrylate, Methylmethacrylate, trimethylammonio Ethylmethacrylate Chloride) 1:2:0.2 150,000 (Eudragit RL 100)
Talc purified
Capsule cap
Titanium dioxide (E171)
Indigotine (E132)
Gelatin
Water, purified
Capsule body
Titanium dioxide (E171)
Gelatin
Water, purified
Printing Ink
Ferric oxide (E172)
Shellac
Soya lecithin (E322)
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Special precautions for storage
Do not store above 30°C. Store in a dry place.
Nature and composition of immediate packaging
Cartons containing 3 or 5 PVC blister strips with aluminium foil seal.
Each blister strip contains 20 capsules.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Marketing Authorisation Holder (if different from distributor)
NA
Marketing Authorisation Number
Vm 00879/4014
Vm 00879/4015
Vm 00879/4016
Significant changes
Date of the first authorisation or date of renewal
16 February 1993.
Date of revision of the text
January 2016
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Corvental-D Capsules 100mg
GTIN:05037694024369
GTIN description:Corvental-D Capsules 200mg
GTIN:05037694024376
GTIN description:Corvental-D Capsules 500mg
GTIN:05037694024383