Sericol

Uses

Citric Acid Monohydrate contains the active ingredient Citric Acid Monohydrate which helps to reduce the dry cough and soothes the throat from any related discomfort and pain. Citric Acid is a demulcent which relieves irritation of the mucous membrane in the throat by forming a protective film. Citric Acid is absorbed after oral administration. It is found naturally in the body and is widely distributed.

Pholcodine is used for a cough suppressant for the temporary relief of non-productive dry cough. It is stated to present a required label indication of "temporary relief of dry cough". Cough is the respiratory movement that occurs after an irritation signal is transmitted to the central nervous system and further stimulates the medulla oblongata. This stimulation causes a motor output that is sent through motoneurons to the respiratory muscles. A non-productive cough is a type of cough characterized by the absence of sputum, and it has a large inspiration that will cause continuous coughing.

Sericol is also used to associated treatment for these conditions: Acidosis, Catheter site calcification caused by appetite, Catheter site calcification caused by struvite, Gouty Arthritis, Headache, Heartburn, Kidney Stones, Metabolic Acidosis, Blood Specimen Collection, Blood sample storage, Bowel preparation therapy, Chemical contraception, Potassium placement, Urine alkalinization therapy, Cleansing of the colon as a preparation for colonoscopy, Oral antisepsisCough, Cough caused by Common Cold, Flu Like Symptom, Flu caused by Influenza, Irritative cough, Rhinorrhoea, Sinusitis, Sneezing, Throat irritation, Dry cough, Watery eyes

How Sericol works

The mechanism of action of pholcodine is directly performed in the medulla oblongata. In this site, it exerts analgesic properties on the peripheric reflexogenic receptors. This site is commonly known as the "cough center."

Dosage

Sericol dosage

Age Dose Dose frequency

1-5 years 5 ml Upto 4 times daily

6-12 years 10 ml Upto 4 times daily

>12 years & Adults 20 ml 3-4 times daily

Adult:

• Symptomatic relief of non-productive cough: 5-10 mg 3-4 times daily.

Child:

• 12-18 year: 5-10 mg 3-4 times daily.
• 6-12 year: 2-5 mg 3-4 times daily.
• Children under the age of 6 year:Not to be used

Side Effects

There are no known side effects from using this medicine when used as directed. If taken excessively above the stated dose, glycerol present in the medicine may cause headache, stomach upset and diarrhea.

Dizziness, occasional drowsiness, nausea, vomiting, constipation, rash, sputum retention, excitation, confusion, ataxia.

Toxicity

ORAL (LD50): Acute: 5040 mg/kg [Mouse]. 3000 mg/kg [Rat].

Generally, pholcodine is significantly less toxic than codeine. Nonetheless, it is important to consider the significant depressive respiratory effect.

Precaution

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Renal and/or hepatic impairment. Caution in patients with impaired respiratory function and asthma. May cause occasional drowsiness, caution when driving or operating machinery. Pregnancy and lactation.

Interaction

Not to be used with MAOI or within 14 days of stopping treatment. May enhance sedative effect of alcohol and other CNS depressants e.g. sedatives, hypnotics, barbiturates, narcotic analgesics, phenothiazines, tricyclic antidepressants. Hypotensive effect may be enhanced when used with antihypertensive agents and diuretics. Interaction with neuromuscular blocking agent has been reported.

Volume of Distribution

The reported volume of distribution depends on the pharmacokinetic model and it can be of 265L based on a one-compartment model to 3207L in a two-compartment model.

Elimination Route

After oral administration of 60 mg of pholcodine, the Tmax and Cmax are reported to be 1.3 hours and 26.3 ng/ml. In the same administration, the AUC in plasma and saliva are reported to be 1.67 and 6.61 mg h/l respectively. The absorption of pholcodine is reported to represent approximately 88% of the administered dose.

Half Life

After oral administration of 60 mg of pholcodine, the half-life in plasma, saliva and urine are 45, 55 and 45 hours respectively.

Clearance

After oral administration of 60 mg of pholcodine, the clearance rate was reported to be 126 ml/min.

Elimination Route

After oral administration of pholcodine, the serum concentration peaks and declines in a monoexponential manner. The percent of the dose excreted unchanged is of approximately 25-30%. Part of the administered dose is composed by metabolites that can be recovered in urine. From the administered dose, the fecal excretion corresponds to the 5% of the administered dose as unchanged pholcodine.

Pregnancy & Breastfeeding use

There are no or limited amount of data from the use of Citric Acid Monohydrate in pregnant women. There is insufficient information on the excretion of Citric Acid Monohydrate & its metabolites in human milk.

Category not classified

Contraindication

Patients in, or at risk of developing respiratory failure. Chronic bronchitis, COPD, bronchiolitis, and bronchiectasis due to sputum retention. Concurrent or recent use (within preedicing 14 days) of MAOIs. Children <6 yr

Acute Overdose

Symptoms: Drowsiness, nausea, restlessness, excitement, ataxia and respiratory depression.

Management: Provide symptomatic and supportive treatment. Maintain respiration; may use activated charcoal or gastric lavage to remove the ingested Pholcodine. In cases of severe overdosage, naloxone may be given to reverse the central and peripheral opioid effects.

Storage Condition

Keep in a cool and dry place, away from light. Keep out of the reach of children.

Store below 25° C.

Innovators Monograph

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