Pharmaniaga Diphenhydramine Expectorant

Pharmaniaga Diphenhydramine Expectorant

Manufacturer:

Pharmaniaga Manufacturing Berhad

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Contents
Diphenhydramine HCl.
Description
Each 5 mL contains: Ammonium chloride 135 mg.
Diphenhydramine hydrochloride 12.5 mg.
Preservative: Sodium benzoate 0.10% w/v.
Action
Ammonium chloride is used as an expectorant.
Diphenhydramine is an ethanolamine derivative with the actions and uses of the histamine H1-receptor antagonist.
Ammonium chloride is absorbed from the gastro-intestinal tract. The ammonium ion is converted into urea in the liver, the anion thus liberated into the blood stream and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine; this is followed by transient diuresis.
Diphenhydramine is well absorbed from the gastro-intestinal tract, though high first-pass metabolism appears to affect systemic availability. Peak plasma concentrations are achieved about 1 to 4 hourrs after administration by mouth. Diphenhydramine is widely distributed throughout the body including the CNS.
It crosses the placenta and has been detected in breast milk. Diphenhydramine is highly bound to plasma proteins. Metabolism is extensive. Diphenhydramine is excreted mainly in the urine as metabolites, little is excreted as unchanged drug. Excretion is almost complete within 24 hours of administration.
Indications/Uses
Cough, nasal and bronchial congestion.
Dosage/Direction for Use
Adults: 10 mL every four to six hours. Do not exceed 60 mL in 24 hours.
Children (6-12 years): 5 mL every four to six hours. Do not exceed 30 mL in 24 hours.
Take with food or milk to minimise gastric irritation. Drink a glass of water after each dose to help loosen mucous in lungs.
Overdosage
Overdosage of antihistamine may be fatal especially in infants and children.
Symptoms: For antihistamines: In infants and children, CNS stimulation predominates over CNS depression, causing ataxia, excitement, tremors, psychoses, hallucinations and convulsion; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow.
In adults, CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse. Large doses of ammonium chloride may cause a profound acidosis and hypokalaemia.
Treatment: There is no specific antidote for overdosage with antihistamines and Ammonium chloride, treatment is symptomatic and supportive until possible utilisation of the following: induction of emesis (syrup of ipecac is recommended, however, precaution against respiration is necessary especially in infants and children); gastric lavage if patient is unable to vomit within 3 hours of ingestion; saline carthartics are sometimes used; vasopressors to treat hypotension, however, epinephrine should not be used since it may further lower blood pressure; oxygen and intravenous fluids; precaution against use of stimulant because they may cause seizures.
Contraindications
Premature infants or neonates, glaucoma, asthma, prostatic hypertrophy, nursing and pregnant women, presence of impaired hepatic/renal function, monoamine oxidase inhibitor therapy, intolerance to Diphenhydramine or Ammonium chloride.
Warnings
Not suitable to be used for children below 2 years of age.
Use carefully and follow the advice from doctor or pharmacist for children aged 2 to 6 years.
Special Precautions
This medication may cause drowsiness, patients so affected should not drive or operate machinery. Patients should avoid alcoholic drinks.
Caution is advised in conditions such as urinary retention, pyloroduodenal obstruction, epilepsy and severe cardiovascular disorder.
Consult a physician if symptoms persist for more than 7 days, or if high fever, skin rash or continuing headache is present with cough.
Paediatric: This medication should not be given to premature infants or neonates as this group of patients has an increased susceptibility to anticholinergic adverse effects of antihistamines such as CNS excitation and an increased tendency towards convulsions.
A paradoxical reaction characterised by hyperexcitability may occur in older children taking antihistamines.
Geriatrics: The elderly are more susceptible to many adverse effects of antihistamines including the antimuscarinic effects, sedation and hypertension.
Adverse Reactions
Antihistamines can cause drowsiness, thickening of mucous, blurred vision, confusion, difficult or painful urination, dizziness, dryness of mouth, nose or throat, fast heartbeat, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reactions (nightmares, unusual excitement, nervousness, restlessness or irritability), ringing or buzzing in ears, skin rash and stomach upset or pain.
Ammonium salts are irritant to the gastric mucosa, and may produce nausea and vomiting particularly in large doses.
Drug Interactions
(See table.)

Click on icon to see table/diagram/image
Storage
Store below 25°C.
Protect from light.
Keep container tightly closed.
Shelf-Life: Product should not be used beyond the expiry date imprinted on the product packaging.
ATC Classification
R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.
Presentation/Packing
Syr (clear brown) 120 mL.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in