Lactulose (Accellac) 3.35/5ml Syrup Osmotic Laxative 60ml

Generic Name: Lactulose

Brand Name: Accellac

Strength: 3.35g / 5mL

Form: Syrup

Manufacturer: Opal Laboratories (Pvt.) Ltd.

Imported and Distributed by: AccessPoint Interntional Inc.

Classification: Laxatives, Purgatives

Indication/Uses: Lactulose is a synthetic disaccharide osmotic laxative used in the treatment of constipation and in hepatic encephalopathy. Lactulose is broken down by colonic bacteria mainly into lactic acid. This exerts a local osmotic effect in the colon resulting in increased faecal bulk and stimulation of peristalsis. It may take up to 48 hours before an effect is obtained. When larger doses are given for hepatic encephalopathy the pH in the colon is reduced significantly and the absorption of ammonium ions and othes toxic nitrogenous compounds is decreased, leading to a fall in blood-ammonia concentration and an improvement in mental function.

Product Description:

Lactulose (Accellac) 3.35g/5mL Syrup is an osmotic laxative used to treat constipation and to reduce blood ammonia levels in patients with liver disease, such as hepatic encephalopathy. Each 5 mL of syrup contains 3.35 grams of lactulose, which works by drawing water into the colon, softening stools, and stimulating bowel movements. The syrup is typically administered orally and is available in a 60 mL bottle.

Indications:

Lactulose (Accellac) Syrup is indicated for:

1. Constipation: It is commonly used to treat chronic constipation by promoting bowel movement.

2. Hepatic Encephalopathy: It helps in the treatment and prevention of hepatic encephalopathy, a condition caused by liver failure, by lowering the concentration of ammonia in the blood.

3. Bowel Preparation: It can also be used in preparing the bowel for diagnostic procedures such as colonoscopies, although this is a less common use.

Dosages:

The dosage of Lactulose (Accellac) Syrup varies depending on the condition being treated and the patient’s age.

• For Constipation:

  • Adults:

    • Initially, 15-30 mL once daily. The dose can be adjusted based on response.

    • Maintenance dose: 10-25 mL per day, depending on effectiveness.

  • Children (7-14 years):

    • Initial dose: 15 mL once daily. Adjust based on response.

  • Children (1-6 years):

    • Initial dose: 5-10 mL once daily.

  • Infants (under 1 year):

    • Typically, 1.25-2.5 mL per day, though this should be strictly under the guidance of a healthcare provider.

• For Hepatic Encephalopathy:

  • Adults:

    • Initially, 30-45 mL three to four times per day. The dose is adjusted according to the blood ammonia levels and the patient's response.

    • Maintenance dose: The dose is typically reduced to 15-30 mL per day once symptoms are controlled.

Note: Lactulose should be taken with or without food, and it is typically recommended to take it at the same time each day to establish a routine. It is also important to drink plenty of fluids to help the laxative work effectively.

Side Effects:

Common side effects of Lactulose (Accellac) Syrup include:

• Flatulence (Gas): Increased gas production is a common side effect, especially during the initial use.

• Abdominal Bloating: Some users may experience a feeling of fullness or bloating in the stomach.

• Diarrhea: Overuse or excessive dosage may lead to diarrhea.

• Stomach Cramps: Mild to moderate stomach cramps or discomfort can occur, especially when starting the medication or adjusting the dose.

• Nausea: Some individuals may feel nausea or discomfort in the stomach, particularly with high doses.

Less common but more serious side effects may include:

• Severe Diarrhea: If diarrhea is persistent or severe, it can lead to dehydration and electrolyte imbalances.

• Dehydration: Prolonged diarrhea and fluid loss may cause dehydration, especially in vulnerable individuals like the elderly or those with underlying health conditions.

If any of the following serious side effects occur, seek immediate medical attention:

• Severe abdominal pain or bloating that does not subside.

• Signs of dehydration: Such as dizziness, dry mouth, and decreased urination.

• Electrolyte imbalance: Symptoms such as weakness, fatigue, confusion, or irregular heartbeat (especially if diarrhea is excessive).

Contraindications:

Lactulose (Accellac) Syrup should not be used in the following situations:

• Hypersensitivity: If the patient is allergic to lactulose or any other ingredient in the syrup.

• Galactosemia: Lactulose is a synthetic sugar made from lactose and galactose, so it is contraindicated in individuals with galactosemia (a condition that prevents the metabolism of galactose).

• Severe Abdominal Pain of Unknown Origin: In conditions where abdominal pain is present without a clear diagnosis, lactulose should not be used until the cause is identified.

• Intestinal Obstruction: Lactulose should not be used in individuals with intestinal obstruction or other significant gastrointestinal conditions like perforation or ileus, as it may worsen the condition.

Warnings and Precautions:

• Electrolyte Imbalance: Since lactulose can cause diarrhea, there is a risk of electrolyte imbalances, especially if diarrhea is prolonged. Regular monitoring of electrolytes is recommended, particularly for vulnerable populations such as the elderly.

• Dehydration: Patients who experience prolonged diarrhea should increase fluid intake to avoid dehydration. If dehydration occurs, the dose should be adjusted accordingly.

• Use in Hepatic Encephalopathy: Lactulose should be used with caution in patients with severe liver disease, and the dosage should be carefully adjusted based on clinical response and blood ammonia levels.

• Long-term Use: Chronic use of lactulose for constipation should be done under medical supervision. It is not meant for long-term use unless prescribed by a healthcare provider, as the underlying cause of constipation should be identified and treated.

• Diabetes: Although lactulose does not raise blood sugar in the same way as glucose, patients with diabetes should consult their healthcare provider before using it regularly due to the presence of sugars in the syrup.

• Pregnancy and Breastfeeding: Lactulose is considered safe during pregnancy and breastfeeding, but it is always recommended to consult a healthcare provider before use.

Drug Interactions:

• Antacids: Use of lactulose with antacids may decrease its effectiveness as the altered pH of the stomach may affect the medication's osmotic action.

• Other Laxatives: Combining lactulose with other laxatives can increase the risk of dehydration and electrolyte disturbances.

• Diuretics: The use of diuretics (water pills) can increase the risk of electrolyte imbalance, particularly when combined with lactulose.

Conclusion:

Lactulose (Accellac) 3.35g/5mL Syrup is an effective osmotic laxative that helps relieve constipation and reduce blood ammonia levels in patients with liver disease. It is commonly used in both short-term and long-term treatment regimens for constipation and hepatic encephalopathy. However, it should be used with caution in individuals with certain medical conditions, including those with abdominal pain, intestinal obstruction, and electrolyte imbalances. Regular monitoring of electrolytes and hydration status is essential, particularly with long-term use. Always follow the recommended dosage and consult a healthcare provider if you experience severe side effects or have concerns about its use.