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Colocol Suppo 150

Indications

For the treatment of pain and pyrexia including influenza, petechial fever, bacterial infections, viral infections, teething, post-vaccination, post-surgery.

Contraindications

- Hypersensitivity to paracetamol

- Glucose-6-phosphate dehydrogenase deficiency, liver failure.

- Children with diarrhea, anal inflammation or rectal bleeding.

Dosage & administration

Dosage:

The dosage should be based the weight of the child (the age of the child is for reference only).

The recommended dose of paracetamol is 60mg/kg body-weight/day in 4 divided doses (about 15mg/kg body-weight every 6 hours).

COLOCOL Suppo 150 is suitable for infants weighing 8 kg to 12 kg (about 6 to 24 months). The dosage is one suppository, repeat if necessary after 6 hours, without 4 suppositories per day.

Method of administration:

Rectal route (anus) – not oral administration.

COLOCOL Suppo 300 suppositories are released at the body temperature of 37oC, so they should be placed in a refrigerator (4-10oC) for 5 to 10 minutes before use.

Notes:

Prolonged self-administration should not be recommended. Ask a doctor if:

- any new symptoms occur.

- fever gets high (39.50C) and lasts more than 3 days or recurs.

- pain gets worse and lasts more than 5 days.

Precautions:

Severe renal failure.

Do not give with any other paracetamol-containing products to avoid overdose and poisoning.

Stevens-Johnson syndrome (SJS) is a hydatid-type drug allergy. The hydatids localized around natural cavities: eyes, noses, mouth, ears, genitals and anus. Symptoms of high fever, pneumonia, liver and kidney dysfunction have been accompanied. Stevens-Johnson syndrome (SJS) is diagnosed with at least two injured natural cavities.

Interactions

Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.

Pregnancy and lactation

The drug is used for children.

Adults should use another dosage form of paracetamol.

Paracetamol crosses the placental barrier and is excreted into human milk. However, experience with paracetamol has not identified any risk to pregnancy or embryonic development or breastfed infants.

Undesirable effects

Allergic reactions have been rarely reported.

Gastrointestinal disorders, including nausea, vomiting, diarrhea.

Inform your doctor about any side effects that may occur during the treatment.

Overdose

Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol, or from chronic ingestion of the drug. Hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal. Nausea, vomiting, and abdominal pain usually occurs within 2-3 hours after ingestion of toxic doses of the drug. Specific signs of overdose are methemoglobinemia, skin and mucosa cyanosis. Children tend to be more prone to cyanosis syndrome than adults.

CNS stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Fatal asphyxial seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days.

Clinical signs of live damage become apparent until 2-4 days after ingestion of the drug. Liver biopsy specifies central necrotizing fascioliasis except for the portal vein. In non-fatal cases, liver damage is restored after weeks or months.

Management

In addition to general detoxification measures, patients are advised to take a precursor of glutathione e.g., acetylcysteine or methionine as soon as possible. If treated slowly (after taking over 36 hours), recovery of liver damage is difficult.

Shelf-life: 36 months from the manufacturing date.

Storage: Store in cool dry places, protect from light.

Specifications: Manufacturer’s.
Factory:
Quang Minh Industrial Zone, Me Linh Dist., Hanoi, Vietnam
Tel: +84.4.3584 1213/14/16 - Fax: +84.4.3584 0788
Email: info@saokimpharma.com
Hanoi Office:
Floor 10, SkyCity Tower - No.88 Lang Ha, Dong Da, Hanoi
Tel: +844.7305.9668 Fax: +84.4.373.66669
Email: info@saokimpharma.com
HCMC Office:
Villa 185B1, Vo Thi Sau Str., Ward 7, Dist. 3, HCMC
Tel: +84.8.3864. 5584 Fax: +84.8.3864 5583
Email: info@saokimpharma.com
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