Serenace

Serenace - Precautions | Dosage | Effects

This article was medically reviewed by M.Pharm, Marko Tanaskovic on August 12, 2018. To read more about an author, click here.

Serenace is a drug containing an active substance called haloperidol and belongs to a pharmacological group known as neuroleptics. This group of drugs improves symptoms of a diseases characterized by a disorder of emotions and behavior.

Indications

Serenace is indicated for the treatment of the following diseases:

  • Schizophrenia.
  • Gilles de la Tourette syndrome.
  • Manic depression.
  • Psychosis that occurs due to brain damage.
  • Restlessness and anxiety in elderly patients.

Serenace can also be used for the short-term treatment of alcoholism (because it relieves the symptoms of alcohol withdrawal) as well as for alleviating nausea and vomiting following the radiation treatment of malignant diseases.

Serenace has been shown to be effective in the treatment of persistent hiccups because it acts as a dopamine antagonist. Although the FDA has only approved chlorpromazine for the treatment of hiccups, studies have shown that Serenace is better tolerated than chlorpromazine. However, doctors rarely prescribe it for the treatment of hiccups and Serenace is most commonly used in the treatment of serious psychiatric disorders.

Contraindications and Precautions

Serenace is contraindicated in the following conditions:

  • In patients who are allergic to the active substance - haloperidol, or other similar medicines (e.g. droperidol).
  • In patients with Parkinson's disease.
  • In patients with brain damage.
  • In patients with tachycardia or other forms of arrhythmia.
  • In patients who had a heart attack.
  • In patients taking medications for heart disease.
  • In patients who have severe toxic CNS depression.

An increased mortality rate has been reported in elderly patients suffering from dementia-related psychosis, and Serenace should not be used in these patients.

Serious arrhythmias (the so-called Torsade de pointes) that may be fatal have been reported in patients taking this medicine. Patients taking high doses of Serenace or patients with electrolyte imbalance (e.g. low potassium levels or low levels of magnesium in the blood) are at increased risk of experiencing arrhythmias. For this reason, Serenace should not be used in patients suffering from any heart disease or taking other drugs that may cause Torsade de pointes (e.g. erythromycin - an antibiotic).

Antipsychotic drugs, including Serenace, may cause a very dangerous (sometimes fatal) Neuroleptic Malignant Syndrome (NMS) characterized by the following symptoms:

  • Muscle rigidity.
  • Irregular blood pressure.
  • Rapid heartbeat.
  • Hyperpyrexia.
  • Rhabdomyolysis (a condition characterized by muscle decomposition which ultimately results in kidney failure).
  • Acute kidney failure.

If you notice any signs of NMS (especially muscle pain, which may be a sign of rhabdomyolysis), you should contact your doctor immediately.

Serenace should not be used in patients who have:

  • Thyroid disorders. The risk of serious arrhythmias is greater in these patients.
  • Liver or kidney damage. In these patients, the elimination of Serenace is slowed down, which leads to an increase in the level of Serenace in the blood and thus increasing the risk of adverse effects.
  • Epilepsy. Serenace has been reported to cause seizures and should be avoided in patients who have already experienced any type of seizures.
  • An adrenal gland tumor (pheochromocytoma). The risk of cardiovascular adverse events is significantly higher in these patients.

Serenace is a medicine that cannot be obtained without a prescription, and you should always consult your doctor before starting this medicine.

Interactions

A large number of drugs may interact with Serenace, either at the pharmacodynamic or pharmacokinetic level. Many medicines, if used concomitantly with Serenace, may increase the risk of serious (fatal) arrhythmias or other, very serious side effects, and it is very important that you inform your doctor about all the medicines you are taking.

Some of the drugs that should not be used concurrently with Serenace include:

  • Medicines used in the treatment of depression, the so-called serotonin reuptake inhibitors (SSRIs), such as: fluoxetine and paroxetine.
  • Opioid analgesics, drugs used in the treatment of severe pain.
  • Gastroprokinetic agents, such as cisapride. This medicine increases the risk of arrhythmias.
  • Fluoroquinolone antibiotics, such as: ciprofloxacin, norfloxacin, ofloxacin, sparfloxacin and moxifloxacin.
  • Antiarrhythmic drugs, such as: procainamide, sotalol, amiodarone, quinidine, etc.
  • Antifungal drugs, such as ketoconazole.
  • Macrolide antibiotics, such as erythromycin.
  • Medicines used in the treatment of epilepsy, such as carbamazepine and phenobarbitone.
  • Medicines used to treat hypertension, such as methyldopa.

Dosage

The usual dose in adult patients is 1 - 15 mg daily, depending on the severity of the disease.

In elderly patients, it is not recommended to take doses greater than 3 mg daily.

In children, the recommended dose is 0.05 mg / kg body weight.

Your doctor will determine which dose is best for you and you should never change the recommended dose without prior consultation with your doctor.

Serenace tablets can be taken independently of meals. Swallow the whole tablet with a glass of water.

Use of Serenace During Pregnancy and Breastfeeding

Although there are no clinical studies on the use of this medication during pregnancy, the FDA states that there are reported cases of limb malformation in patients who have used haloperidol together with some other drugs during the pregnancy. Although a causal relationship cannot be proven, caution should be exercised when taking Serenace during pregnancy. Therefore, Serenace should not be used during pregnancy unless your doctor considers it necessary.

Do not breastfeed your baby while taking Serenace, as this may lead to side effects in infants.

Side Effects

Serenace can cause the following side effects:

  • Extrapyramidal syndrome characterized by tremor of the hands, slow motion, restlessness in the legs, reduced mimics, etc.
  • Insomnia.
  • Drowsiness.
  • Headache.
  • Mental disorders and depression.
  • Dyskinesia.
  • Dizziness.
  • Hypotension.
  • Constipation.
  • Erectile dysfunction.
  • Nausea and vomiting.
  • Epileptic seizures.
  • Liver damage.
  • Painful menstrual periods.
  • Tachycardia.
  • Arrhythmias.
  • Neutropenia.
  • Hypoglycemia.
  • Breast enlargement in men.
  • Priapism.
  • Blurred vision.
  • Acute liver failure.

Tell your doctor if you are experiencing any side effects.

References

  1. TGA
  2. FDA
  3. Woelk CJ. Managing Hiccups. Can Fam Physician. 2011. 57(6): 672-675.

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