Description
For the reduction of proteinuria in cats with chronic kidney disease.
DIRECTIONS FOR USE
Precautions
The safety of telmisartan has not been established in breeding, pregnant or lactating cats or in cats under the age of 6 months.
Side effects
Semintra® is well tolerated in cats. In a blinded randomised controlled clinical study adverse reactions were rare. Gastrointestinal signs such as mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces may occur. Elevated liver enzymes have been very rarely observed and values normalized within a few days following cessation of therapy. Effects attributable to the pharmacological activity of the product on the Renin-Angiotensin- Aldosterone System (RAAS), observed at the recommended treatment dose, included reductions in blood pressure and decreases in red blood cell counts.
Dosage and administration
Discard unused product 6 months after initial use.
Administer orally once a day, either directly into the mouth or with a small amount of food at a dosage of 0.25 mL/kg body weight (equivalent to 1.0 mg telmisartan/kg body weight).
The solution is well accepted by most cats and should be administered using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale. After administration, close the bottle tightly with the cap.
General Directions
Action
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist which causes a dose dependent decrease in mean arterial blood pressure. The receptor binding is long lasting. Stimulation of the AT1 receptor is responsible for most of the pathologic effects in the kidney and other organs associated with angiotensin II, such as vasoconstriction, retention of sodium and water, increased aldosterone synthesis and organ remodelling. By selectively binding to only the AT1 receptor the beneficial effects associated with stimulation of the AT2 receptor such as vasodilatation, natriuresis and inhibition of inappropriate cell growth are not suppressed. As a result, it has been suggested that telmisartan may have renoprotective effects in cats with naturally occurring CKD, although improved survival times in treated cats have not yet been demonstrated.
Following oral administration telmisartan is rapidly absorbed, achieving maximum plasma concentration after 0.5 hours. Telmisartan is highly lipophilic which facilitates easy distribution into tissue. Food consumption does not affect the overall extent of absorption of telmisartan. Telmisartan is effectively glucuronidated in the cat. After oral administration, telmisartan is almost exclusively excreted with faeces mainly as unchanged compound.
In a large clinical trial in cats with chronic kidney disease, a rapid, consistent and significant reduction in proteinuria was seen within 7 days of starting treatment. Semintra also improved quality of life, an effect which can be observed even in the early treatment phase. Hypokalemia is associated with CKD, however telmisartan does not affect potassium excretion, as shown in the clinical field trial in cats.
Interactions
None known.
Overdose
Semintra® is well tolerated in cats. Administration of the product at up to 5-fold of the recommended dose for 6 months resulted in reductions in blood pressure and decreases in red blood cell count (effects attributable to the pharmacological activity of the product). These effects are unlikely to be observed under clinical conditions.
SAFETY DIRECTIONS
May be harmful if swallowed.
May irritate the eyes, avoid contact with eyes. Wash hands after use.
FIRST AID
If poisoning occurs contact a doctor or Poisons Information Centre.
Phone Australia 131126.
New Zealand 0800 764 766 (0800 POISON).
Additional user safety information
Pregnant women should use gloves when handling and administering Semintra®
4 mg/mL oral solution for cats.
Disposal
Dispose of empty container by wrapping with paper and putting in garbage.
Storage
Store below 30°C (Room temperature).
Presentation
Plastic bottle containing 30 mL with a measuring syringe.
Semintra® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH - used under license.
New Zealand
Boehringer Ingelheim (NZ) Limited Animal Health Division
Level 1, Unit 9
42 Ormiston Road
East Tamaki, Auckland
Phone: 0800 802 461
Restricted Veterinary Medicine. A011021 See www.foodsafety.govt.nz for registration conditions.
Active Constituents:
Telmisartan 4mg/ml
Registered pursuant to the ACVM Act 1997, No A011021
