Promethazine contraindications and warnings


Following is information on contraindications to the use of promethazine in general, pregnancy & amp; Breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).

When should Promethazine not be used?

The active substance should not be used in the case of hypersensitivity to promethazine or other phenothiazines, in patients with circulatory shock or coma, and in acute poisoning with central depressants such as painkillers, sleeping pills or alcohol.

In very rare cases, the treatment with promethazine can lead to a neuroleptic malignant syndrome. This symptom is life-threatening and manifests itself in fever, muscle rigidity, circulatory collapse and loss of consciousness. Therefore, especially in case of high fever, a careful medical examination must take place and if necessary the active substance promethazine should be discontinued.

Promethazine must be administered only after careful benefit / risk assessment in the presence of a previously damaged heart, severe hepatic dysfunction, blood or bone marrow disease (pheochromocytoma), tumors that respond to the milk-forming hormone prolactin such as breast cancer and pituitary tumors, marked low blood pressure (Hypotension) or increased blood pressure drop when standing (orthostatic circulatory disorder), chronic respiratory problems or asthma, narrow-angle glaucoma, bladder emptying disorders with residual urine, narrowing (stenosis) in the gastrointestinal tract or depression.

The drug may also be prescribed in patients with seizures only after careful consideration by the physician. Patients with a history of known epilepsy, in particular, should be monitored with care during treatment with promethazine. Only in exceptional medical cases may patients with organic brain damage or brain stem diseases such as Parkinson’s disease or Parkinson’s syndrome receive promethazine.

Promethazine is predominantly excreted via the kidneys, so the doctor should reduce the dose if renal function is impaired (kidney failure). In severe renal impairment, the drug should be taken only after careful medical attention and with regular medical supervision.
A particularly careful medical monitoring should also be ensured in patients with hyperthyroidism (hyperthyroidism), reduced blood potassium (hypokalaemia) and disorders of blood formation .

In case of slow heartbeat (bradycardia), congenital cardiac conduction disturbances (QT syndrome), cardiac arrhythmia or other arrhythmias, promethazine should be taken only with regular medical check-up of cardiac function.

What should you watch out for during pregnancy and lactation?

It is recommended that you take a pregnancy test before taking the drug and take appropriate precautions while on promethazine.

If treatment becomes necessary during pregnancy, the physician must carefully weigh the benefit and risk, as there is not enough evidence for the use of promethazine in pregnancy. Promethazine should enter the unborn child’s organism via the placenta and damage it, so Promethazine should only be used in urgent exceptional cases during pregnancy. Mothers who take the drug in the last trimester of pregnancy endanger their newborns by side effects such as movement disorders and withdrawal symptoms. These can be in excitement, muscle tension or flaccidity, tremor, drowsiness, dyspnoea or disturbances in food intake. Such newborns must be carefully monitored by a doctor.

Promethazine also passes into breast milk. In breastfed children whose mothers have taken similar drugs, so-called extrapyramidal symptoms such as uncontrolled, involuntary muscle movements have been observed. Therefore, while taking the drug should not be breastfed.

What should be considered in children?

Children over the age of two and adolescents should be treated with the active substance promethazine only if they are of necessity and after careful medical benefit-risk assessment.

Children under the age of two should not be treated with the drug because of the risk of sudden infant death syndrome.

Warnings and Precautions

  • No alcohol should be drunk while using the drug.
  • Blood count, liver function, kidney function and circulatory situation should be checked regularly during treatment.
  • At the beginning of treatment with the drug, initial EEG and baseline ECG should be prepared for later follow-up visits by the physician.
  • During treatment, the result of a pregnancy test may be falsified (false-positive result).
  • Coffee and tea in larger quantities during treatment should be avoided.
  • If fever is present, the doctor must be consulted to rule out neuroleptic malignant syndrome.
  • If you have sudden muscle stiffness in the head and neck and shoulder area, the doctor should be informed.
  • Treatment with the drug should always be stopped at a slowly reduced dose (“creeping”).
  • If the drug is given into the vein, it can cause severe tissue damage.
  • The drug can reduce attention, concentration and responsiveness when driving and operating machinery.
  • An increased effect of alcohol and drugs while taking the drug also affects the ability to react.

Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.