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Date: Wednesday, May 22, 2024 16:53

Release 2.60
Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Enteric preparations
Active ingredient: Cimetidine
Product:Zitac® vet 100 mg tablets for dogs
Zitac® vet 200 mg tablets for dogs
Product index: Zitac® vet 100 mg and 200 mg tablets
Incorporating:
Qualitative and quantitative composition
Active substance:
Zitac vet 100 mg: cimetidine 100 mg per tablet.
Zitac vet 200 mg: cimetidine 100 mg per tablet.
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Tablet. Oblong tablets, scored on both sides
Clinical particulars
Target Species
Dogs.
Indications for use
Symptomatic treatment for the reduction of vomiting associated with chronic gastritis in dogs.
Contraindications
None.
Special warnings for each target species
Treatment with cimetidine is symptomatic only and does not result in resolution of histopathological changes associated with gastritis. It is recommended that dogs showing persistent vomiting should undergo appropriate investigations to diagnose the underlying cause before starting treatment. This is especially important in older animals. The reduction of gastric acidity caused by cimetidine may contribute to bacterial overgrowth and antigenic stimulation.
Special precautions for use
In case of renal dysfunction, adjustment of the dose may be required as the clearance of cimetidine may be decreased. If the response to treatment is poor within 15 days, the diagnosis and treatment plan should be re-evaluated.
Operator warnings
None.
Adverse Reactions
Transient and self-resolving slight swelling of mammary glands may be observed in female dogs (gynaecomastia; anti-androgenic activity). A reduction of prostate weight was also observed in male rats and dogs, with no impact on reproductive performances; this effect was reversible. No other undesirable effects were reported.
Use during pregnancy or lactation
The use of the product during pregnancy and lactation in the target species has not been investigated. Therefore, use of the veterinary medicinal product during pregnancy and lactation should be based on a risk benefit-assessment by the responsible veterinarian.
Interactions
Due to inhibition of cytochrome P-450 activity by cimetidine, the metabolism and elimination of some drugs can be reduced. Clinically relevant interactions may occur with compounds having a narrow therapeutic index, e.g. beta-blockers, calcium channel blockers, benzodiazepines, barbiturates, phenytoin, theophylline, aminophylline, warfarin and lidocaine. Doses of such drugs may need to be reduced when administered concomitantly with cimetidine.
The increased gastric pH resulting from cimetidine administration may lead to reduced absorption of drugs requiring an acid medium for absorption. It is recommended that at least 2 hours should elapse between administration of cimetidine and aluminium or magnesium hydroxide, metoclopramide, digoxin or ketoconazole when possible.
Amounts to be administered and administration route
Dose and route of administration: 5 mg of cimetidine per kg of bodyweight administered three times daily by the oral route (see respective indicative table below). The concomitant use of appropriate dietary measures is strongly recommended. In clinical trials the efficacy of cimetidine has only been studied concomitantly with a hypoallergenic diet.
Table: Number of Zitac vet 100 mg tablets to be administered three times daily according to body weight.
Weight (kg)
Number of Zitac vet 100 mg tablets
6 to 10
½
11 to 20
1
Table: Number of Zitac vet 200 mg tablets to be administered three times daily according to body weight.
Weight (kg)
Number of Zitac vet 200 mg tablets
11 to 20
½
21 to 40
1
41 to 60
1 ½
Recommended treatment scheme: reduction of vomiting is achieved in about 2 weeks. Animals should however be treated for at least 2 weeks after the remission of clinical signs, so a minimum treatment duration of 28 days is usually necessary and therefore recommended. If considered successful, medication should be withdrawn for 2 weeks. If vomiting occurs again, treatment can be re-initiated without risk of intolerance.
Depending on the response, treatment can be adapted to the individual animal until the response is considered to be adequate and continued. Dietary measures should always be maintained.
Overdose
Acute exposure to cimetidine yielded LD50 values above 2600 mg/kg, i.e. over 170 times the recommended daily dosage in dogs. A target animal safety study in dogs demonstrated that the product administered orally at 75 mg cimetidine/kg/day (five times the recommended daily dose) for a period of 91 days was well tolerated by dogs.
No signs of overdose are known.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATC Vet Code: QA02BA01
Pharmacotherapeutic group: H2-receptor antagonists
Pharmacodynamic properties
Cimetidine is an antagonist of the histamine H2-receptors present in the gastric parietal cells. Stimulation of H2-receptors by histamine activates gastric acid secretion. Cimetidine, via its antagonistic properties toward histamine H2-receptors, strongly reduces gastric acid secretion. This may result in the diminution of gastric irritation and subsequent vomiting during chronic gastritis. No accompanying improvement in the inflammatory status of the gastric mucosa was observed in dogs.
Pharmacokinetic particulars
After oral administration of the product at a dose rate of 5 mg/kg body weight to fasted dogs, maximal plasma levels of approximately 2 µg/ml are reached after 1.5 hours post-administration. Bioavailability is about 95%. The extent of absorption of cimetidine in dogs is delayed and reduced by approximately 40 % in the presence of food (Cmax fasted 2.94 mcg/ml, Cmax fed 1.12 mcg/ml, AUC0-∞ fasted 8.23 mcg.h/ml and AUC0-∞ fed 5.43 mcg.h/ml). However, this does not affect the efficacy of treatment
The plasma half-life of cimetidine is approximately 2 hours at a dosage of 5 mg/kg. Cimetidine is rapidly and almost completely excreted into the urine. No drug accumulation occurs after repeated oral treatment at 5 mg/kg three times daily over 30 consecutive days.
Pharmaceutical particulars
Excipients
Lactose monohydrate
Microcrystalline cellulose
Maize starch pregelatinised
Sodium starch glycolate type A
Magnesium stearate
Major incompatibilities
Not applicable.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Store the blisters in the original package to protect from light. Remaining tablet halves should be stored in the original blister pocket in order to protect from light.
Immediate packaging
The tablets are packed in push-through blisters (white opaque PVC/Aluminium foil) in an outer printed carton box.
Authorised pack sizes:
Carton box containing 30 tablets (3 blister with 10 tablets per blister)
Carton box containing 100 tablets (10 blister with 10 tablets per blister)
Not all pack sizes may be marketed.
Disposal
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)
Marketing Authorisation Number
UK: Vm 01708/4638-9
Significant changes
Date of the first authorisation or date of renewal
22 February 2007
Date of revision of the text
July 2020
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Zitac Vet 100mg 3x10tab:
GTIN:08713184062765
GTIN description:Zitac Vet 200mg 3x10tab:
GTIN:08713184066657