Cloperan Side effects

• Side effects of Cloperan in details
• Cloperan contraindications
• Cloperan reviews

What are the possible side effects of Cloperan?

Get emergency medical help if you have any of these signs of an allergic reaction to Cloperan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Cloperan and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Stop taking Cloperan and call your doctor at once if you have any of these other serious side effects:

• slow or jerky muscle movements, problems with balance or walking;

• mask-like appearance in your face;

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• depressed mood, thoughts of suicide or hurting yourself;

• hallucinations, anxiety, agitation, jittery feeling, trouble staying still;

• swelling, feeling short of breath, rapid weight gain;

• jaundice (yellowing of your skin or eyes); or

• seizure (convulsions).

Less serious Cloperan side effects may include:

• feeling restless, drowsy, tired, or dizzy;

• headache, sleep problems (insomnia);

• nausea, vomiting, diarrhea;

• breast tenderness or swelling;

• changes in your menstrual periods; or

• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Cloperan in details

Neurological: Adverse reactions to Cloperan that are most frequently seen are restlessness, drowsiness, fatigue and lassitude, which occur in approximately 10% of patients. Insomnia, headache, dizziness have been reported less frequently. Acute depression has been reported rarely (<1 in 1000 cases). Symptoms of Cloperan induced depression have ranged from mild to severe and have included suicidal ideation and suicide. Anxiety or agitation may occur, especially after rapid injection. Delirium, severe dysphoria, obsessive rumination and mania have been reported occasionally.

Parkinsonian symptoms including tremor, rigidity, bradykinesia and akinesia, occur rarely in patients receiving Cloperan but may be associated with usual or excessive doses or with decreased renal function.

Various extrapyramidal reactions to Cloperan, usually of the dystonic type, have been reported. Acute dystonic reactions occur in approximately 0.2% of patients treated with Cloperan 30-40 mg/day. In cancer chemotherapy, patients receiving 1-2 mg/kg/dose, the incidence is 2% in patients over the ages of 30-35, and 25% or higher in children and young adults who have not had prophylactic administration of diphenhydramine. Reactions include spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of the extraocular muscles including oculogyric crisis, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hrs of starting treatment and the effects usually disappear within 24 hrs of withdrawal of the drug. However, close observation is required, and in cases of more severe reactions, an antiparkinson drug eg, benztropine or an anticholinergic antihistamine eg, diphenhydramine should be given.

A fatal acute dystonic reaction has been reported in a patient who received hexamethylmelamine, cisplatin and Cloperan high dose. Dystonic reactions may present rarely as upper airway obstruction with stridor and dyspnoea, possibly secondary to laryngospasm or supraglottic dystonia. A fatal cardiorespiratory arrest occurred in at least 1 patient with an acute dystonic reaction.

Tardive dyskinesia, which may be persistent, has been reported particularly in elderly patients (particularly women) following long-term therapy with Cloperan. Tardive dyskinesia is most frequently characterised by involuntary movements of the tongue, face, mouth or jaw, and sometimes by involuntary movements of the trunk and/or extremities. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase with increasing duration of therapy and total cumulative dose. Although tardive dyskinesia can occur after relatively brief therapy with the drug at low doses, it appears to be more readily reversible under such circumstances.

Neuroleptic Malignant Syndrome (NMS): It has been reported very rarely (<2 in 10,000). NMS is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK, and must be treated urgently (recognised treatments include dantrolene and bromocriptine).

Cloperan should be stopped immediately if NMS occurs.

Gastrointestinal: Nausea or bowel disturbances have been reported.

Cardiovascular: A single case of supraventricular tachycardia following IM administration has been reported. Cardiac conduction abnormalities (eg, bradycardia and heart block) have occurred very rarely (<1 in 10,000) in association with IV Cloperan. Atrial fibrillation, oedema, ventricular fibrillation, ventricular tachycardia, palpitations and tachycardia have also been associated with the use of Cloperan. In 1 study in hypertensive patients, IV administered Cloperan was shown to release catecholamines; hence, caution should be exercised when Cloperan is used in patients with hypertension.

Endocrine: Raised serum prolactin levels have been observed during Cloperan therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during Cloperan therapy.

Hypersensitivity: There have been isolated reports of hypersensitivity reactions (eg, urticaria, maculopapular rash) in patients receiving the drug.

Respiratory: Respiratory failure, secondary to dystonic reaction, acute asthmatic symptoms of wheezing and dyspnoea may occur.

Genitourinary: Urinary incontinence, sexual dysfunction, priapism and muscle spasm may also occur.

Other Effects: There have been isolated reports of blood disorders. Methaemoglobinaemia, particularly following overdose in neonates, has also occurred in patients receiving the drug. Agranulocytosis and hyperthermia have also been observed.

What is the most important information I should know about Cloperan?

• Cloperan syrup may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cloperan syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Cloperan syrup without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Diabetes patients- Cloperan syrup may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Cloperan syrup. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Cloperan syrup may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Cloperan syrup in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Cloperan syrup.
• Lab tests, including liver and kidney function tests, may be performed while you use Cloperan syrup. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Cloperan syrup should not be used in CHILDREN younger than 15 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cloperan syrup while you are pregnant. Cloperan syrup is found in breast milk. If you are or will be breast-feeding while you use Cloperan syrup, check with your doctor. Discuss any possible risks to your baby.

Cloperan contraindications

NEVER TAKE Cloperan IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of Cloperan can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Cloperan, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women, diabetics, and older adults.

You should not take this medication if you are allergic to Cloperan, or if you have bleeding or blockage in your stomach or intestines, epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

Before you take Cloperan, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of Cloperan.

There are many other medicines that can interact with Cloperan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using Cloperan and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

References

1. European Chemicals Agency - ECHA. "Metoclopramide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
2. HSDB. "Metoclopramide". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Metoclopramide: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology