Sunex

Sunex

Manufacturer:

Sunward

Distributor:

Antah Pharma
Full Prescribing Info
Contents
Diphenhydramine HCl, ammonium chloride, sodium citrate.
Description
Each 5 mL contains diphenhydramine HCl 14 mg, ammonium chloride 135 mg, sodium citrate 57.5 mg.
Action
Pharmacology: Diphenhydramine hydrochloride is well absorbed following oral administration but apparently undergoes first-pass metabolism in the liver and only about 40-60% of an oral dose reaches systemic circulation as unchanged diphenhydramine. Following oral administration of a single dose of diphenhydramine, the drug appears in plasma within 15 minutes and peak plasma concentrations are attained within 1-4 hours. Distribution of diphenhydramine into human body tissues and fluids has not been fully characterized. The terminal elimination half-life of diphenhydramine has not been fully elucidated but appears to range from 2.4-9.3 hours in healthy adults. The terminal elimination half-life reportedly is prolonged in adults with liver cirrhosis. Diphenhydramine is rapidly and apparently almost completely metabolized principally to diphenylmethoxyacetic acid which may further undergo conjugation. The drug also undergoes dealkylation to form the N-demethyl and N, N-didemethyl derivatives. Diphenhydramine and its metabolites are excreted principally in urine.
Ammonium chloride, following oral administration, is rapidly absorbed from the GI tract, complete absorption occurring within 3-6 hours. The drug is metabolized in the liver to form urea and hydrochloric acid. Sodium citrate is an alkalinizing agent whose activity depends on conversion to bicarbonate. When oxidative activity is intact, oxidation of the citrate salt is essentially complete and less than 5% of the drug is excreted in urine unchanged.
Actions and Mode or Mechanisms of Action: Diphenhydramine is an ethanolamine-derivative antihistamine. It shares the action and uses of other antihistamines. It is also used as an antifussive for temporary relief of cough caused by minor throat and bronchial irritation such as may occur with common colds or inhaled irritants.
It has been suggested that ammonium chloride may act as an expectorant by reflex stimulation of bronchial mucous glands resulting from irritation of gastric mucosa following oral administration. Sodium citrate is used as a source of bicarbonate when employed as alkalinizing agent.
Indications/Uses
It is indicated as an expectorant for control of cough due to cold or allergy.
Dosage/Direction for Use
Adults: Two teaspoonfuls every four hours not to exceed twelve teaspoonfuls or 60 ml in 24 hours.
Children: (6 to 11 Years): One teaspoonful every four hours not to exceed six teaspoonfuls or 30 ml in twenty-four hours.
Administration: Oral administration.
Take with food/milk to minimize gastric irritation. Drink a glass of water after each dose to help loosen mucus in lungs.
Overdosage
Anti-histamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms – dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur. If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having the patient drink a glass of water or milk after which, patient should be made to gag.
Precaution against aspiration must be taken especially in infants and children. If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given before hand. Isotonic or ½ isotonic saline is the lavage solution of choice.
Saline cathartics, as milk of magnesia, by osmosis draw water into bowel and therefore are valuable for their action in rapid dilution of bowel content. Vasopressors may be used to treat hypotension. Stimulants should not be used.
Contraindications
This product should not be taken for persistent chronic cough such as occurs with smoking, asthma, emphysema, or when cough is accompanied by excessive secretions, or if the patient has epilepsy, glaucoma, or difficulty in urination due to enlargement of the prostate gland except under the advice and supervision of physician. Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers).
This drug should not be used in newborn or premature infants. Because of the higher risk of anti-histamine for infants generally and for newborns and prematures in particular, anti-histamine therapy is contraindicated in nursing mothers.
Anti-histamines should not be used to threat lower respiratory tract symptoms, including asthma. Anti-histamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramines of similar chemical structure. Monoamine oxidase inhibitor therapy.
Special Precautions
Anti-histamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction. In infants and children, especially, anti-histamines in overdosage may cause hallucinations, convulsions or death.
As is adults, anti-histamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.
Experience with this drug in pregnant women is inadequate determine whether there exists a potential for harm to the developing foetus.
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery etc.
Anti-histamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Diphenhydramine hydrochloride has an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension.
MAO inhibitors prolong and intensify the anti-cholinergic (drying) effects of anti-histamines.
Consult a physician if symptoms persist for more than 7 days, or if high fever, skin rash or continuing headache is present with cough. Not recommended for children below 2 years.
Use with caution and on physician's/pharmacist's advice in children 2 to 6 years of age.
Use In Pregnancy & Lactation
There is no adequate and controlled studies to date for the use of diphenhydramine maleate in pregnant and nursing mother. Hence the drug should be used in these situation only when clearly needed.
Adverse Reactions
The Adverse Reactions Reported are: General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.
Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.
Hematologic System: Hemolytic anaemia, thrombocytopenia, agranulocytosis.
Nervous System: Sedation, sleepiness dizziness, disturbed co-ordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo,tinnitus, acute labyrinthitis, hysteria, neuritis, convulsion.
G.I. Systems: Epigastric distress, anorexia nausea, vomiting, diarrhoea, constipation.
G.U. System: Urinary frequency, difficult urination, urinary retention, early menses.
Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Drug Interactions
Additive effects if used with hypnotics, sedatives and tranquilizers. Avoid drinking alcoholic beverages when taking Sunex Cough Syrup.
Storage
Store at temperature 25ºC. Protect from light.
Shelf-Life: 3 years.
ATC Classification
R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.
Presentation/Packing
Syr (clear, dark brown, raspberry flavour) 60 mL, 90 mL, 100 mL, 120 mL.
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