Zoletil™ comprises a synergistic balance between Tiletamine & Zolazepam. Tiletamine – a dissociative anesthetic. Zolazepam – a benzodiazepine tranquilizer group of drugs.
Recommended for
– As a sedative (for restraint, diagnostic or painless examination procedures)
– As a sole anesthetic for minor surgeries or in combination with a potent analgesic for major surgeries
– As an induction agent, prior to inhalant anesthesia

With two proven ingredients, Zoletil™ is a smart option for general anesthesia combining sedation, muscle relaxation, and analgesia in dogs and cats. Zoletil™ offers peace of mind owing to its rapid onset of action, the smooth recovery process, and wide safety margin. With the use of Zoletil™ comes the convenience of flexible dosing based on the procedure to be conducted, multiple modes of administration – IV or IM, and the possibility to integrate Zoletil™ into existing anesthetic protocols. In addition to the 30 years of experience with Zoletil™ in small animal practice, Zoletil™ has versatility and scientific recognition in a plethora of wildlife species.

Composition:
Zoletil™ 50 = One vial of 675 mg freeze-dried powder contains:
Tiletamine (as Hydrochloride) 125 mg
Zolazepam (as Hydrochloride) 125 mg
Excipients qs

ONE VIAL OF 5 ML SOLVENT CONTAINS:
Sterile Water for injections lP 5 ml

ONE ML OF RECONSTITUTED SOLUTION CONTAINS:
Tiletamine (as Hydrochloride) 25 mg
Zolazepam (as Hydrochloride) 25 mg

Zoletil™ 100 = One vial of 970 mg freeze-dried powder contains:
Tiletamine (as Hydrochloride) 250 mg
Zolazepam (as Hydrochloride) 250 mg
Excipients qs

ONE VIAL OF 5 ML SOLVENT CONTAINS:
Sterile Water for injections lP 5 ml

ONE ML OF RECONSTITUTED SOLUTION CONTAINS:
Tiletamine (as Hydrochloride) 50 mg
Zolazepam (as Hydrochloride) 50 mg

Dosage and Direction for use:

Multiple administrations to be avoided and is associated with delayed recovery, but if given, re-administration should only be at 1/3 to ½ of the initial dose, but the total dosage is should not exceed 26.4 mg/kg.

Storage:
Prior to opening store in a cool & dry place, protect from exposure to light. Post-re-constitution store at 2 to 8°C and use within 24 hours.

Suggestions:
12 hours of fasting prior to anesthesia
Removal of anti-parasite collars 24 hours prior to anesthesia
Anticholinergic drugs (such as Atropine) may be used 15 mins. prior to Zoletil™ administration
Apneustic breathing may be observed in cats given in IV mode. This abnormality may last for up to 15 mins & then breathing returns to normal. If not, respiratory assistance needs to be provided.
Eyes remain open and hence should be protected from excessive dryness (especially in major surgeries, a damp cloth can be placed upon the eyes)
Animal to be placed in a calm environment during the recovery phase

Contraindications:
Cardiac disease or severe hypertension; respiratory disease; renal, pancreatic, and hepatic insufficiency; head trauma or intracranial tumors
Caesarean section or in pregnant bitches and queens
In conjunction with phenothiazine tranquilizers

Warnings: For use in dogs and cats only.

When using Zoletil for Injection for induction of anesthesia, patients should be continuously monitored. Facilities for the maintenance of a patent airway, artificial ventilation and oxygen supplementation should be available.

Pulmonary edema has been reported to occur in cats with the use of tiletamine and zolazepam for injection. Signs and symptoms include dyspnea, lethargy, anorexia and abnormal behavior. Deaths have been reported occasionally in severely affected individuals. Cats should be observed closely for any signs and symptoms which may suggest pulmonary edema so that appropriate therapy may be instituted.

The principal route of excretion of both components in the cat is the urine; therefore, Zoletil for Injection is not recommended for use in cats suffering from renal insufficiency.

Balance studies in dogs indicated extensive biotransformation of both components with less than 4% of the dose excreted unchanged in the urine.

Zoletil for Injection is excreted predominantly by the kidneys. Preexistent renal pathology or impairment of renal function may be expected to result in prolonged duration of anesthesia.

Phenothiazine-derivative drugs should not be used with Zoletil for Injection at dosages indicated for intramuscular (IM) injection because the combination produces respiratory and myocardial depression, hypotension and hypothermia.

The safe use of Zoletil for Injection in pregnant animals or on reproduction has not been established. Zoletil for Injection crosses the placental barrier and causes respiratory depression in the neonate.

Precautions:

The dosage of Zoletil for Injection should be reduced in geriatric dogs and cats, in animals in debilitated condition and in animals with impairment of renal function. Death has occurred in both cats and dogs following intramuscular tiletamine and zolazepam for injection administration. Preexisting pulmonary disease, renal disease (see Contraindications and Warnings) and shock were causally implicated at necropsy; however, death was drug attributable in at least one dog (of 1072) and one cat (of 1095).

Intravenous tiletamine and zolazepam for injection has been demonstrated to be safe in a field study in dogs when used in conjunction with phenothiazine-derivative drugs (acepromazine) administered at dosages from 0.04-0.06 mg/kg IM.

Cats and smaller dogs with small body masses in relation to large body surfaces should be protected from heat loss during Zoletil for Injection anesthesia. Body temperature should be monitored, and supplemental heat may be required to control hypothermia. As with other anesthetics, it is prudent to provide for hemostasis during any surgical procedure.

During Zoletil for Injection anesthesia, athetoid movement may occur. This athetosis should not be mistaken for lack of anesthesia nor is it indicative of lack of analgesia. Do not give additional anesthesia in an attempt to abolish the athetoid movement. Efforts to eliminate athetoid movement with additional doses of Zoletil for Injection can result in anesthetic overdosage.

Zoletil for Injection does not abolish laryngeal, pharyngeal, pinnal, palpebral, and pedal reflexes, and may not be adequate as the sole anesthetic for surgical procedures in these areas. Endotracheal tubes are not well tolerated in connection with Zoletil for Injection anesthesia in the cat and their use may result in impaired respiration. After removal of the tube, normal respiration should resume.

The stimulation of surgical procedures aids in maintaining adequate ventilation. The anesthetized patient must be monitored throughout the procedure, and if cardiopulmonary problems do occur, measures must be taken to assure that alveolar ventilation and cardiovascular functions are maintained.

The eyes normally remain open with the pupils dilated. The use of a bland ophthalmic ointment is advisable to protect the corneas from desiccation. The concurrent use of chloramphenicol will prolong the duration of anesthesia in cats.

Copious salivation may occur during Zoletil for Injection anesthesia. Ptyalism may be controlled in dogs and cats by administering atropine sulfate, USP, 0.02 mg/lb (0.04 mg/kg) body weight (IV, IM, or SC) as concurrent medication. Exaggerated swallowing, reflex action and accumulation of saliva may give rise to vomiting and retching.