Tixol

Tixol - Precaution | Use during pregnancy

Tixol is a drug that contains duloxetine as an active pharmaceutical ingredient. It is characterized by mixed effects on both neuroamines involved in the pathogenesis of the depression (noradrenaline and serotonin) and is classified into a group of serotonin and noradrenaline reuptake inhibitors (SNRIs). It belongs to a relatively new drugs for the treatment of depression and exerts less side effects and better efficiency than tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs). It has very low affinity for alpha-1 adrenergic, alpha-2-adrenergic, histamine H1, dopamine D2, muscarinic and opioid receptors, thus exhibiting significantly fewer side effects than other anti-depressants.

It is used to treat the following conditions:

  • Depression - including recurrent depression
  • Fibromyalgia (long lasting pain in muscles and joints)
  • Generalized anxiety disorder (first-line therapy)
  • Diabetic neuropathic pain (burning, prickling or tingling sensation)
  • Urinary incontinence

Precautions

Tixol must not be used in the following situations:

  • Liver impairment. There have been reports of hepatotoxicity induced by this medication, which is why doctors recommend regular monitoring of liver function following Tixol treatment. If levels of liver enzymes (AST and ALT) are increased twofold or threefold above the reference, then discontinuation of therapy should be considered.
  • If you're taking other medications that increase the concentration of serotonin in the blood (e.g. SSRIs or monoamine oxidase inhibitors - MAOIs). Concomitant administration with these drugs increases the risk of serotonin syndrome - a potentially life-threatening condition. If you notice symptoms, such as:
    • heavy sweating
    • dilated pupils
    • loss of muscle coordination
    • tachycardia
    • hypertension
    • hyperthermia
    • confusion
    • anxiety or dizziness
    you should contact your doctor.
  • If you have low sodium level in the blood (hyponatremia). Cases of Tixol-induced hyponatremia have been reported.

According to PIL, this drug should not be used in patients who have an impaired renal function.

Tixol must be very cautiously applied in the following situations:

  • Epilepsy. There have been reports of seizures in patients who stopped taking this drug abruptly.
  • Mania or bipolar depression
  • Glaucoma
  • Bleeding disorders

Since it is metabolized by the CYP3A4 enzyme, it should not be administered simultaneously with the St. John's wort (which is a well-known inducer of this enzyme) because that will reduce the plasma levels of and efficiency of Tixol.

As with all antidepressants, there have been reports of suicidal thoughts associated with Tixol use. It is advisable that you inform your close friend or family member that you're suffering from depression and ask them to immediately inform your doctor if they notice any changes in your behavior.

The risk of suicidal thoughts is increased in patients under the age of 25.

Tixol, pregnancy and breastfeeding

Tixol should not be used during pregnancy because it increases the risk of persistent pulmonary hypertension of newborns. This side effect usually occurs within the first 24 hours after birth and is characterized by difficult and abnormally rapid breathing and severe redness of the face. In addition, following side effects have been reported in newborns:

  • Muscle weakness
  • Shivering
  • Seizures
  • Difficulty swallowing

It should not be used during breastfeeding.

Dosage instructions

The initial dose is usually 30 mg once a day. The usual maintenance dose is in the range of 40-120 mg per day.

Tixol enteric capsules should be taken once a day without regard to food. Swallow the capsule with plenty of liquid.

It is recommended that you take the capsule every day at the same time.

Never stop taking this drug abruptly because it can lead to withdrawal syndrome.

Interactions

Tixol can interact with the following medicines:

  • Tryptophan and 5-hydroxytryptophan
  • Dextromethorphan and phentermine (sympathomimetics)
  • Phenylpropanolamine
  • Palonosetron, ondansetron, granisetron and dolasetron (drugs which prevent the chemotherapy-induced nausea)
  • Almotriptan, zolmitriptan, naratriptan, sumatriptan, eletriptan, frovatriptan and (drugs for migraine)
  • Tramadol and morphine (opioid analgesic)
  • MAO inhibitors
  • Benzodiazepines
  • Antipsychotics
  • SSRIs

Adverse reactions

Tixol is associated with the following adverse reactions:

  • Blurred vision
  • Elevated intraocular pressure
  • Ringing in the ears and ear pain
  • Insomnia
  • Anxiety
  • Seizures
  • Muscle stiffness
  • Muscle pain
  • Loss of appetite and consequently weight loss
  • Tingling
  • Tympanites
  • Tachycardia
  • Flushing
  • Restless legs syndrome
  • Hyperglycemia
  • Hyponatremia
  • Arrhythmia
  • Hepatotoxicity
  • Weak urine stream
  • Heavy sweating
  • Heavy menstrual periods
  • Gastroenteritis
  • Mania
  • Galactorrhea
  • Suicidal thoughts
  • Syndrome of inappropriate secretion of antidiuretic hormone

References

  1. NCBI link 1
  2. NCBI link 2
  3. PIL
  4. NCBI link 3