Clopamon Injection:Uses, Safety Instructions And Side Effect

CLOPAMON Injection 10 mg/2 ml is a powerful and reliable medication used primarily to treat nausea, vomiting, and certain gastrointestinal conditions. Its active ingredient, metoclopramide, is known for its dual action on the digestive system and central nervous system, providing symptomatic relief in a variety of clinical settings.

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1. Scheduling Status

CLOPAMON Injection falls under Schedule 4 (S4), which means it is a prescription-only medicine. It should be used under the supervision of a qualified healthcare provider.

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2. Proprietary Name and Dosage Form

• Brand Name: CLOPAMON INJECTION
• Strength: 10 mg of metoclopramide per 2 ml
• Form: Clear, colorless injectable liquid

This medication is supplied in ampoules for intramuscular (IM) or intravenous (IV) use.

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3. Composition

Each 2 ml ampoule of CLOPAMON Injection contains:

Component	Quantity
Metoclopramide	10 mg
Sodium chloride	As excipient
Water for injection	As excipient
Sugar	Free

The formulation is isotonic and stable when administered as intended. It must not be diluted before injection.

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4. Category and Class

CLOPAMON belongs to:

• Category: A 5.7.2
• Pharmacological Class: Anti-emetics and antivertigo preparations

It is primarily used to control nausea, vomiting, and gastrointestinal motility issues.

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5. CLOPAMON Injection Uses

CLOPAMON Injection works through multiple mechanisms, offering both gastrointestinal and anti-emetic benefits.

Pharmacodynamic Properties

Gastrointestinal Action

Metoclopramide stimulates the digestive tract by:

• Increasing the frequency and strength of antral (stomach) contractions
• Enhancing duodenal motility
• Accelerating gastric emptying

This action makes CLOPAMON useful in treating conditions involving delayed stomach emptying and gastrointestinal stasis.

Gastro-Oesophageal Junction

It increases pressure at the cardiac sphincter, helping to prevent acid reflux and regurgitation. This effect is more pronounced in individuals with normal resting sphincter pressure.

Effect of Anticholinergics

Anticholinergic medications like atropine can diminish the gastrointestinal effects of CLOPAMON if taken within three hours of administration.

Anti-Emetic Action

CLOPAMON works centrally by acting on the chemoreceptor trigger zone (CTZ) in the brain to suppress nausea and vomiting. This action remains effective even in the presence of anticholinergic medications.

Other Actions

Metoclopramide also stimulates prolactin secretion, which may lead to hormonal side effects in some users.

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6. Indications

CLOPAMON Injection is used in the following clinical situations:

Digestive Disorders

• Post-vagotomy syndrome
• Conditions associated with delayed gastric emptying or hypomotility

Nausea and Vomiting

Effective in controlling nausea and vomiting caused by:

• Medications
• Kidney failure (uraemia)
• Cancer
• Gastrointestinal disorders
• Post-anaesthetic recovery

Diagnostic Radiology

Improves visualization during imaging studies by:

Use Case	Purpose
Delayed barium meal studies	Reduces spasm in the duodenal cap
Hypotonic stomach (gastric stasis)	Enhances emptying and visual clarity
Preventing vomiting during barium exams	Reduces risk of emesis in sensitive patients

Duodenal Intubation

Facilitates gastrointestinal procedures by:

• Promoting gastric emptying
• Reducing nausea and gag reflexes

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7. Contraindications

CLOPAMON should not be used in the following conditions:

• Gastrointestinal bleeding, obstruction, or perforation
• Immediately post-operative GI surgery
• Phaeochromocytoma (risk of hypertensive crisis)
• Epilepsy (risk of seizures)
• Porphyria

Use is also discouraged in scenarios where increased gastrointestinal motility could be dangerous.

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8. Warnings and Special Precautions

• Pregnancy: Safety is not established. Use only if absolutely necessary.
• Children and Elderly: Higher risk of extrapyramidal symptoms. Caution is advised.
• Renal or Hepatic Impairment: Risk of fluid retention and toxicity; monitor closely.
• Dilution Warning: Do not dilute ampoules as it affects isotonicity and drug stability.
• Long-Term Use: Requires regular medical review.

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9. Interactions

CLOPAMON can interact with several medications:

Interacting Substance	Effect
Phenothiazines	Increased risk of extrapyramidal reactions
Lithium	Increased toxicity
Antidepressants & antiepileptics	Caution due to central nervous system effects
Antimuscarinics & opioids	Reduce CLOPAMON’s GI effects
Digoxin	Reduced stomach absorption
Aspirin, Paracetamol	Increased small intestine absorption
Suxamethonium	Prolonged neuromuscular blockade
Bromocriptine	Reduced effectiveness due to raised prolactin levels

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10. Human Reproduction

• Pregnancy: Not established as safe.
• Use during pregnancy only when clearly needed and under professional guidance.

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11. Dosage and Directions for Use

Parenteral Administration

Age Group	Dosage	Route
Adults & Children >14 yrs	10 mg (1 ampoule), 1–3 times daily	IV or IM
Children 5–14 yrs	2.5 mg (0.5 ml of ampoule), twice daily	IV or IM
Children 3–5 yrs	1 mg (0.2 ml), twice daily	IV or IM
Children 1–3 yrs	0.5 mg (0.1 ml), twice daily	IV or IM

Children’s doses should be given using a tuberculin syringe for accuracy.

For Diagnostic Radiology

Route	Dose	Timing Before Procedure
IV	10–20 mg (1–2 ampoules)	5–15 minutes before barium meal
IM	10–20 mg	10–15 minutes before barium meal

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12. Side Effects

CLOPAMON may cause various side effects, especially during prolonged use or in vulnerable populations.

Common Reactions

• Extrapyramidal symptoms (more common in young females)
• Restlessness, dizziness, drowsiness, and headaches
• Gastrointestinal upsets like diarrhea

Rare and Serious Reactions

Condition	Description
Parkinsonism, tardive dyskinesia	Usually in elderly or prolonged use
Hypotension/Hypertension	Blood pressure changes
Depression	Mood-related side effects
Blood disorders	Rare blood count abnormalities
Hypersensitivity reactions	Allergic responses
Neuroleptic malignant syndrome	Life-threatening, rare reaction
Urinary incontinence	Uncontrolled urination
Hormonal effects (galactorrhoea)	Due to prolactin stimulation
Raised aldosterone levels	Temporary hormonal imbalance

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13. Known Symptoms of Overdosage and Treatment

Symptoms of Overdose

Overdose may lead to:

• Dyskinetic reactions
• Muscle spasms (especially of the face and neck)
• Tongue protrusion
• In severe cases: opisthotonos (severe body arching)

Treatment

Treatment involves administering anti-Parkinson drugs such as procyclidine to counteract movement disorders.

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14. Identification

• Appearance: Clear, colorless liquid

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15. Presentation

CLOPAMON Injection is packaged as follows:

• 1 x 2 ml ampoule per unit
• 10 ampoules per pack, supplied in a polystyrene container
• Includes patient information leaflet

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16. Storage Instructions

Storage Parameter	Requirement
Temperature	Store at or below 25 °C
Light	Protect from light
Packaging	Keep in original packaging
Discoloration	Discard ampoules that appear yellow
Safety	Keep out of reach of children

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17. Name and Business Address of the Holder of the Certificate of Registration

Pharmacare Limited
Healthcare Park, Woodlands Drive
Woodmead 2191, South Africa

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Final Thoughts

CLOPAMON Injection 10 mg/2 ml is a versatile, clinically trusted medication with multiple uses across gastroenterology, radiology, and post-operative care. However, due to the potential for serious side effects, it should only be used under appropriate medical supervision. Patients and healthcare providers must be vigilant about dosage, contraindications, and possible interactions to ensure safe and effective treatment.

If you’re considering this medication or have been prescribed CLOPAMON, consult your healthcare provider for detailed guidance tailored to your medical history.

Sources: SAHPRA

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