Prothiazine Expectorant Syrup

/ CTS

For adults and children over 10 years old: 10-15 ml 2-3 times a day.
For children between 6 and 10 years old: 5 ml 2-3 times a day.
This medicine is not intended for children and babies under 6 years of age.
Be sure to measure the dose with a measuring spoon or a special measuring cup, dropper etc.
See prescribing information for full details.

For temporary relief of cough due to colds, allergies.

Hypersensitivity to the active substance Promethazine, other phenothiazines, Guaiphenesin, Ipecacuanha or to any of the excipients.
This medicinal product should not be used in patients:
• In coma or suffering from CNS depression of any cause.
• In children under the age of 6 years.
• In patients taking monoamine oxidase inhibitors up to 14 days previously.
• In shock, at risk of seizure, or with cardiovascular disorders.
• With impaired renal hepatic or cardiac function.

Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Promethazine use. In case of allergic reaction, treatment with Promethazine must be discontinued and appropriate symptomatic treatment initiated.
Promethazine should be avoided in patients with liver or renal dysfunction, Parkinson’s disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.
Caution must be exercised when using H1-antihistamines such as Promethazine due to the risk of sedation. Combined use with other sedative medicinal products is not recommended.
Caution should be used in patients with:
Asthma, bronchitis or bronchiectasis. This medicinal product may thicken or dry lung secretions and impair expectoration.
Severe coronary artery disease
Epilepsy
bladder neck or pyloro-duodenal obstruction.
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment.
Photosensitivity reactions
Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment.
Use with care in patients who suffer from chronic cough, have asthma or is suffering from an acute asthma attack.
Do not give with a cough suppressant or any other cough and cold medicine.
Ipecac is cardio active and so should be avoided by patients on anti-arrhythmic drugs. It should be avoided by diabetics.
This medicinal product should not be used for longer than 7 days without seeking medical advice.
Excipients with known effect
This medicinal product contains sucrose, sorbitol and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Alcohol and alcohol-containing medicines should be avoided while on this medicine.
Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol.
The occurrence of unexplained infections or fever may be evidence of blood dyscrasia, and requires immediate hematological investigation.
All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.

Very common: Sedation or somnolence.
See prescribing information for full details.

This medicinal product will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines
This medicinal product may interfere with immunological urine pregnancy tests to produce false positive or false-negative results. This medicinal product should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false negative results.
If urine is collected within 24 hours of a dose of this drug, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.
Whilst unlikely at recommended doses, there is a theoretical risk of interaction of Ipecac with anti-arrhythmic drugs.
Cytochrome P450 2D6 Metabolism: Some phenothiazines are moderate inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co administration of promethazine with amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/amitriptylinoxide.
Promethazine should be avoided in patients taking monamine oxidase inhibitors within the previous 14 days, and monamine oxidase inhibitors should be avoided while using Promethazine.
Seizure threshold-lowering drugs: Concomitant use of seizure-inducing drugs or seizure threshold-lowering drugs should be carefully considered due to the severity of the risk for the patient.
Gastro-intestinal agents that are not absorbed (magnesium, aluminium and calcium salts, oxides and hydroxides): Reduced gastro-intestinal absorption of phenothiazines may occur. Such gastro-intestinal agents should not be taken at the same time as phenothiazines (at least 2 hours apart, if possible).
Drugs with anticholinergic properties: Concomitant use of Promethazine with drugs with anticholinergic properties enhances the anticholinergic effect.

Pregnancy: The use of Promethazine is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the potential benefits outweigh the potential risks. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant.
Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this medicine. Advise female patients of reproductive potential to use effective contraception.
There are no or limited amount of data from the use of Guaifenesin in pregnant women.
Guaifenesin is not recommended during pregnancy and in women of childbearing potential not using contraception.
No information or evidence is available on the safe use of ipecac during pregnancy is available.
Lactation: Promethazine is excreted in breast milk. There are risks of neonatal irritability and excitement. Promethazine is not recommended for use in breast-feeding.
Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin in breastfed newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy, taking into account the benefit of breast -feeding for the child and the benefit of therapy for the woman.
No information or evidence is available on the safe use of ipecac during lactation is available.

Symptoms
Symptoms of severe overdosage are variable. They are characterised in children by various combinations 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 or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes.
The effects of acute toxicity from guaifenesin may include gastrointestinal discomfort, nausea and drowsiness. When taken in excess, guaifenesin may cause renal calculi.
Large doses of ipecacuanha may irritate the gastrointestinal tract, and give rise to nausea, persistent bloody vomiting or bloody diarrhoea.
Mucosal erosions of the entire gastrointestinal tract have been reported
Overdosage is unlikely as a result of the emetic action of ipecacuanha,
however, if emetine is absorbed in sufficient amounts it may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These symptoms may also be combined with dehydration due to vomiting, and may cause vasomotor collapse followed by death.
Management
If the patient is seen soon enough after ingestion of promethazine, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.
Acute overdosage of ipecacuanha should be treated with activated charcoal to delay absorption. Prolonged vomiting should be controlled by intramuscular injection of antiemetics. Supportive measures should be taken to correct fluid and electrolyte imbalance and cardiac effects.

Shelf life after first opening: 2 months.
Store below 25^oC.