Tramadol solution for injection

Tramadol solution for injection

ANALGESICS

Presentation:

Vial containing 50 mL

Species:

Composition

Tramadol hydrochloride 50 mg
Excipients q.s. 1 mL

Therapeutic Action

Opioid analgesic drug.

Indications for Use

To be used in dogs to alleviate moderate-to-severe pain caused by different etiologies.

Used to alleviate pain in acute trauma, to alleviate chronic pain and pain refractory to other treatments. Used in cancerous conditions and to treat osteoarticular and muscular pain, visceral pain in general, urologic syndrome in different species, post amputation syndrome, “phantom limb”.

To treat postoperative pain (due to its low potential to induce respiratory depression, it can be recommended as first-choice drug to treat postoperative pain instead of morphine).

Route of Administration

See DOSAGE AND INSTRUCTIONS FOR USE

Dosage and Instructions for Use

Dogs and cats: administer 1-3 mg/kg body weight 2 to 3 times a day, subcutaneous, intramuscular, slow intravenous or epidural administration.

Horses: administer 1 mg/kg body weight. Slow intravenous or epidural administration.

Directions for use: to dose 1 mg/kg administer 0.20 mL every 10 kg live weight, to dose 2 mg/kg administer 0.40 mL every 10 kg live weight, to dose 3 mg/kg administer 0.60 mL every 10 kg live weight.

For all species: it should be administered every 6 to 8 hours.

Duration of treatment will be determined by the prescribing veterinarian.

Contraindications / Warnings / Precautions

Do not use in patients with known hypersensitivity to tramadol or to any of the excipients.

Do not use in pregnant or lactating animals.

Simultaneous administration with deprenyl or with psychotropic drugs such as serotonin reuptake inhibitors, tricyclic antidepressants or monoamine oxidase inhibitors may increase seizure threshold. If administered in combination with drugs which are enzymatic inductors, such as carbamazepine, phenobarbital, phenytoin or rifampin, the dose of tramadol should be increased.

Inhibitors of isoenzyme CYP 2D such as amiodarone, cimetidine, clomipramine and haloperidol may decrease the metabolism of tramadol thus reducing the levels of metabolite M1 and, consequently, the analgesic effectiveness, and increasing the appearance of adverse reactions.

Tramadol is contraindicated in patients with respiratory depression, acute obstructive pulmonary disease, uncontrolled epilepsy and acute renal and/or hepatic failure. In patients with liver cirrhosis, the dosing interval shall be reduced. In patients with chronic renal and/or hepatic failure the dosing interval shall be increased.

Tramadol can cause miosis which may mask the presence or exacerbation of clinical features of intracranial hypertension.

Do not mix in the same syringe with diazepam, diclofenac sodium, indomethacin, midazolam or piroxicam.

Adverse reactions are rare. The most frequent ones include: gastrointestinal malaise such as nausea, vomiting, constipation or diarrhea. In connection with the nervous system, nervousness, anxiety, agitation, shaking, spasticity, euphoria, deterioration in coordination, somnolence or insomnia may be experienced. In case of apparent sedation or strange behavior, the dose should be reduced. Do not use in the treatment of pain caused by pancreatitis.

Side effects:
It is recommended to gradually increase the dose within 3 days, in order to reduce the presence of nausea and vomiting. The administration of an antiemetic drug during the first days of treatment can also be beneficial. Nausea and vomiting are more frequent when intravenous administration is very fast, it is recommended that the injection is administered in 1-2 minutes.

Observe normal aseptic precautions.

In case of overdose, somnolence, dizziness, bradycardia, dyspnea, miosis, sensory disorders and seizures may be experienced.

In these cases, administer Naloxone (dogs: 0.04 mg/kg body weight IM or IV, cats: 0.05 to 1 mg/kg body weight IV) and also provide parenteral hydration, oxygen therapy and ventilatory support.

In case of seizure, indicate diazepam.

Available

- Argentina
- Hong Kong
- Uruguay
- Perú
- Panamá