telmisartan

For the control of systemic hypertension in cats.

Semintra®

SEMINTRA is indicated for the control of systemic hypertension in cats.

Semintra® (telmisartan oral solution)10 mg/mL

Telmisartan is a selective angiotensin II subtype AT1 receptor blocker, with no relevant affinity for other receptors in general receptor-binding assays. Telmisartan is metabolized to the 1-O-acylglucuronide of telmisartan, which, in cats treated for 6 days at 1 mg/kg, was shown to be present in the plasma at levels approximately 21% of that of unchanged parent compound. Following an oral dose of 1 mg/kg telmisartan once daily for five days, the time to reach mean peak plasma concentration (Tmax) was 21 minutes and 32 minutes for fasted and fed cats, respectively. There was a higher systemic exposure to telmisartan in the fasted cats based on the maximum concentration (Cmax) and area under the concentration vs time curve (AUC). The mean terminal elimination half-life was approximately 8 hours. The mean systemic exposure of telmisartan (Cmax and AUC) was approximately 60% lower for female cats compared to male cats. However, dose adjustment for female cats is not necessary. An increase in dose from 1 to 5 mg/kg once daily resulted in a greater than proportional increase in telmisartan exposure. There could be low to moderate accumulation of drug upon repeated once daily or twice daily administrations of 1.5-2 mg/kg.

Semintra® (telmisartan oral solution)10 mg/mL

Do not use in cats with a hypersensitivity to telmisartan.

Semintra® (telmisartan oral solution)10 mg/mL

Not for human use. Keep out of reach of children. SEMINTRA is an angiotensin II antagonist/angiotensin receptor blocker (ARB). Pregnant women should avoid contact with SEMINTRA because substances that act on the renin-angiotensin-aldosterone system (RAAS) such as angiotensin receptor blockers (ARBs) can cause fetal and neonatal morbidity and death during pregnancy in humans.

Semintra® (telmisartan oral solution)10 mg/mL

28-day Field Effectiveness Study Safety was evaluated in a 28-day field study in 288 cats (192 SEMINTRA group cats, 96 control group cats) that received at least one dose of study drug. The control product was a vehicle control without telmisartan. Cats enrolled in the study had a median age of 14 years (7-20 years), and weighed 1.93-11.4 kg. SEMINTRA was administered orally at 1.5 mg/kg twice daily for 14 days, then 2 mg/kg once daily until study end; the control was administered at a volume equivalent to SEMINTRA. One hundred fourteen (59.4%) SEMINTRA group cats and 42 (43.8%) control group cats had at least one adverse reaction. Adverse reactions that occurred in at least 5% of either treatment group are presented in Table 1 below. Table 1 Adverse Reactions in the 28-Day Field Study Clinical Sign SEMINTRA N=192 Control N=96 Vomiting 46 (24.0%) 14 (14.6%) Diarrhea 18 (9.4%) 4 (4.2%) Lethargy 13 (6.8%) 3 (3.1%) Weight loss 13 (6.8%) 5 (5.2%) Decreased appetite/inappetence 13 (6.8%) 7 (7.3%) Non-regenerative anemia 11 (5.7%) 2 (2.1%) Dehydration 10 (5.2%) 4 (4.2%) Retinal lesions (target organ damage) 4 (2.1%) 6 (6.3%) Additional adverse reactions that occurred in <5% of the SEMINTRA group included (in order of decreasing frequency): anorexia, gagging, arrhythmia, cough, heart murmur, and regenerative anemia. Additional adverse reactions representing 2-5% of the control group included azotemia, not drinking and renal failure. Seven cats (five SEMINTRA and two control) either died or were euthanized during the study. None of the SEMINTRA group deaths were considered related to treatment. 5-month Field Effectiveness and Safety Study The long-term safety of SEMINTRA was evaluated in an open label, 5 month field effectiveness and safety study in 107 cats that received at least one dose of SEMINTRA. Cats enrolled in the study had a mean age of 14.1 years (7-20 years) and weighed 1.92-11.4 kg. SEMINTRA was administered orally at 2 mg/kg once daily. Ninety-four cats (87.9%) had at least one adverse reaction during the study. Adverse reactions that occurred in at least 5% of cats are presented in Table 2 below. Table 2 Adverse Reactions in the 5-Month Study Clinical Sign SEMINTRA N=107 Weight loss 37 (34.6%) Vomiting 32 (29.9%) Dehydration 18 (16.8%) Non-regenerative anemia 17 (15.8%) Anorexia 14 (13.1%) Diarrhea 12 (11.2%) Lethargy 12 (11.2%) Decreased appetite/inappetence 11 (10.3%) Heart murmur 10 (9.3%) Death, Euthanasia, Found dead 9 (8.4%) Cough 8 (7.5%) Retinal lesions (target organ damage) 6 (5.6%) Adverse reactions representing <5% of the study population were (in order of decreasing frequency): elevated liver enzymes, renal failure, tachycardia, arrhythmia, azotemia, depression, loose stool, constipation, gagging, hypotension, regenerative anemia, renal insufficiency, and vocalization. Nine cats died or were euthanized during the study. Three cats had progressive chronic kidney disease that may have been affected by telmisartan treatment, concurrent disease, or inadequate control of hypertension. The other six cats died of causes unrelated to treatment (e.g. neoplasia). To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Semintra® (telmisartan oral solution)10 mg/mL

The initial dose of Semintra® is 1.5 mg/kg (0.68 mg/lb) orally twice daily for 14 days, followed by 2 mg/kg (0.91 mg/lb) orally once daily. The dose may be reduced by 0.5 mg/kg (0.23 mg/lb) increments to a minimum of 0.5 mg/kg (0.23 mg/lb) orally once daily to manage Semintra®-induced hypotension. Semintra® can be administered directly into the mouth, or next to or on top of a small amount of food. Do not mix into food.

Oral

Semintra®

Always provide the Client Information Sheet with each prescription. The initial dose of SEMINTRA is 1.5 mg/kg (0.68 mg/lb) orally twice daily for 14 days, followed by 2 mg/kg (0.91 mg/lb) orally once daily. The dose may be reduced by 0.5 mg/kg (0.23 mg/lb) increments to a minimum of 0.5 mg/kg (0.23 mg/lb) orally once daily to manage SEMINTRA-induced hypotension. SEMINTRA can be administered directly into the mouth, or next to or on top of a small amount of food. Do not mix into food. SEMINTRA should be administered using the dosing syringe provided in the package. The dosing syringe fits onto the bottle and has 0.1 mL incremental marks. The dose should be rounded to the nearest 0.1 mL. After administration close the bottle tightly with the cap. Rinse the dosing syringe with water and let air dry. If the cat vomits within 30 minutes of dosing, the cat may be re-dosed.

ORAL

Semintra® (telmisartan oral solution)10 mg/mL