Russedyl Compound Linctus

Russedyl Compound Linctus

Manufacturer:

Pharmaniaga Manufacturing Berhad

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Contents
Pholcodine, promethazine HCl, phenylephrine HCl.
Description
Each 5 mL syrup contains pholcodine 5.0 mg, promethazine HCl 3.6 mg and phenylephrine HCl 10.0 mg.
Action
Pharmacology: Pharmacodynamics: Pholcodine: Pholcodine is a cough suppressant, which has a central action on the cough centre in medulla.
Although it is chemically related to morphine, Pholcodine has little or no analgesic properties and generally has a mild sedative effect, which relieves local irritation of the respiratory tract over 8 to 10 hours.
Unlike morphine, codeine and hydrocodeine therapeutic doses of pholcodine do not cause depression of respiration, CNS excitation, constipation or other side effects associated with narcotics. Pholcodine has a selective effect on the cough centre without affecting the respiratory centre.
Pholcodine is not euphorigenic therefore psychological dependence is unlikely to be a problem. There is no evidence of physical dependence after prolonged administration of pholcodine so it is not likely to be habit forming.
Promethazine HCl: Promethazine HCl is a H1-receptor antagonist, which has marked potency and prolonged duration antihistaminic action. It also acts on the CNS to provide antiemetic and sedative actions. It also reduces the sensitivity of the nerve endings in the labyrinth and blocks the transmission of excessive nerve impulses to the vomiting centre. It also produces sedation and light sleep effects.
Phenylephrine HCl: Phenylephrine HCl is a sympathomimetic with mainly direct effects on adrenergic receptors. It has mainly alpha-adrenergic activity and is without significant stimulating effects on the CNS at usual doses. Its pressor activity is weaker than that of noradrenaline but of longer duration.
Pharmacokinetics: Pholcodine: Pholcodine is readily absorbed from the gastrointestinal tract and does cross the blood brain barrier. It is metabolised in the liver and its action may be prolonged in hepatic insufficiency.
Promethazine HCl: Promethazine is well absorbed after oral administration. Peak plasma concentrations have been observed 2 to 3 hours after administration by this route, although there is low systemic bioavailability after oral administration, due to high first-pass metabolism in the liver.
Promethazine is widely distributed; it enters the brain and crosses the placenta. Promethazine undergoes extensive metabolism, predominantly to promethazine sulphoxide, and also to N-desmethylpromethazine. It is excreted slowly via the urine and bile, chiefly as metabolites.
Phenylephrine HCl: Phenylephrine has low oral bioavailability owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver.
Indications/Uses
An aid in the suppression of dry irritating coughs day and night.
Dosage/Direction for Use
Cough and Nasal Congestion: Usual Adult Dose: 5 mL orally every 4 to 6 hours as needed. Maximum Dose: 30 mL/day.
Usual Children Dose: Children 6 Years to 12 Years: 2.5 to 5 mL orally every 4 to 6 hours as needed. Maximum Dose: 30 mL/24 hours.
12 Years or Older: 5 mL orally every 4 to 6 hours as needed. Maximum Dose: 30 mL/24 hours.
Overdosage
Symptoms of overdosage with Russedyl Compound Linctus are variable. They are characterized in children by various combination of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions, may occur in both adults and children, coma may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is not uncommon. If the patient is seen soon after ingestion, it should be possible to induce vomiting with ipecacuanha despite the anti-emetic effect of promethazine; alternatively, gastric lavage may be used. Use of charcoal and purgatives may help in other cases. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable convulsant. Use of naloxone should be considered if respiratory or central depression dominate the clinical features.
Symptoms of overdosage for phenylephrine include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoceptor blocking drug, such as phentolamine. A beta-blocker may be required to control cardiac arrhythmias
Contraindications
Russedyl Compound Linctus should not be given concurrently with, or for two weeks after, treatment with MAOIs, as this may cause hypertensive effects. Contraindicated in individuals known to be hypersensitive to pholcodine, promethazine or phenylephrine. Contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma and in patients with liver disease.
Warnings
This product should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. To be used with caution and physician's advice in children 2 to 6 years of age (when used for treatment of cough and cold).
Special Precautions
Pholcodine depresses the respiratory centre to some extent and should be used with caution in asthmatics. Since pholcodine is metabolised in the liver, its action maybe prolonged in hepatic insufficiency. The dosage and frequency may need to be reduced in patients with impaired liver function.
Promethazine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranqullisers. Since antihistamines (e.g. promethazine) have some anticholinergic properties they should be used with care in conditions liable to be exacerbated or otherwise adversely affected by Atropine, such as glaucoma and prostatic hypertrophy. Also the effects of antichlolinergic drugs, such as atropine and tricyclic antidepressants, may be enhanced by the concomitant administration of those antihistamines processing similar activity.
It should also be used cautiously in patients with hepatic diseases.
Phenylephrine has mainly alpha-agonist effects. It has a longer duration of action than noradrenaline and an excessive vasopressor response may cause a prolonged rise in blood pressure. It induces tachycardia or reflex bradycardia and should therefore be avoided in severe hyperthyroidism and used with caution in severe ischaemic heart disease. Patients with diabetes mellitus or prostatic hyperplasia should also avoid phenylephrine.
Use In Pregnancy & Lactation
Do not use during pregnancy without medical advice. When given in high doses during late pregnancy, phenothiazines have caused prolonged extrapyramidal disturbances in the child.
Adverse Reactions
Drowsiness may occur initially in some patients. Initial doses should be small for those in charge of vehicles or machinery until it is evident that any soporific effect has not materialized or has subsided. Other side effects include nausea, vomiting, constipation, sedation, blurred vision, dryness of mouth, dizziness, increased or decreased blood pressure and rash.
Attempted suicide with promethazine have resulted in deep sedation, coma, rarely convulsions and cardiorespiratory symptoms compatible with the depth of sedation present.
Adverse effects of phenylephrine may include tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males.
Drug Interactions
Alcohol or other CNS depressants may lead to greater drowsiness and sedation. If pholcodine is taken within two weeks of MAOI therapy, CNS excitation may occur.
Drug interaction with promethazine may include tricyclic antidepressants; antidiarrhoeals and antiperistaltic agents; antihypertensive, diuretics; hydroxyzine; antithyroid agents and levodopa.
Phenylephrine should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (eg, decongestion). It should not be taken together with vasodilators, beta-blockers or enzyme inducers such as alcohol.
Storage
Store below 30°C.
Protect from light.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05DA20 - combinations ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
Presentation/Packing
Linctus (bottle) (clear, orange in colour with orange flavour) 60 mL, 90 mL.
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