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Bactidol Itchy Cough Relief

Bactidol Itchy Cough Relief

Manufacturer:

PT Integrated Healthcare Indonesia

Distributor:

JNTL Consumer Health
Full Prescribing Info
Contents
Ammonium chloride, diphenhydramine hydrochloride.
Description
Ammonium Chloride + Diphenhydramine Hydrochloride (Bactidol Itchy Cough Relief) 125 mg/12.5 mg per 5 mL Syrup is a clear slightly opalescent red liquid, with a raspberry colour.
Each 5 mL contains: Ammonium chloride, BP 125 mg, Diphenhydramine HCl BP 12.5 mg.
Action
Antitussive/Expectorant/Antihistamine.
Indications/Uses
For the relief of symptoms associated with common cold, such as cough, rhinorrhea, nasal congestion, sneezing and throat irritation.
Dosage/Direction for Use
Adults and Children 12 years and over: 10 mL (2 teaspoons) every 4 hours. Do not exceed 6 doses in 24 hours.
Children aged 6 to less than 12 years: 5 mL (1 teaspoon) every 4 hours. Do not exceed 6 doses in 24 hours.
Not recommended for use in children under 6 years of age.
What to do when the patient has taken more than the recommended dosage: Consult the doctor if the patient has taken more than the recommended dosage.
Overdosage
Signs and Symptoms of Overdose: There are no reports found in the literature describing the overdose potential of the combination ammonium chloride and diphenhydramine hydrochloride (with or without sodium citrate).
The information presented as follows describes overdose with the single active ingredients.
Ammonium chloride: Overdose from oral formulation has been reported in medical literature. In these cases, overdose resulting in metabolic acidosis occurred in the setting of prolonged intake of ammonium chloride above the recommended dose and/or renal impairment. From these reports, symptoms of metabolic acidosis ma include headache, generalized muscle weakness, hyperventilation, hyper-reflexia, progressive drowsiness, mental confusion and coma.
Diphenhydramine: Mild to Moderate Symptoms: Somnolence, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, mild hypertension, nausea and vomiting are common after overdose. Agitation, confusion and hallucinations may develop with moderate poisoning.
Severe Symptoms: Effects may include delirium, psychosis, seizures, coma. hypotension, QRS widening, and ventricular dysrhythmias, including torsades de pointes, but are generally only reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures. Death may occur as a result of respiratory failure or circulatory collapse.
Contraindications
Hypersensitivity to ammonium chloride, diphenhydramine, menthol or to any of the ingredients. Patients with liver or renal impairment.
Special Precautions
Patients with the following conditions should be advised to consult a physician before using diphenhydramine: a respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma; glaucoma, prostate hyperplasia with urinary retention (adult products).
Do not use with any other product containing diphenhydramine, even one used on skin.
May cause drowsiness.
Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking this product, avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.
Patients should not use this product for persistent or chronic cough, such as occurs with asthma. or where cough is accompanied by excessive secretions, unless directed by a physician.
If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.
When should the patient consult their doctor: If symptoms persist or worsen, or if new symptoms occur, stop use and consult the doctor.
Effects on Ability to Drive or Use Machines: Use caution when driving a motor vehicle or operating machinery.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies of ammonium chloride and diphenhydramine (with or without menthol, sodium citrate) in pregnant or breast-feeding women.
Ammonium chloride: It is not known whether ammonium chloride or its metabolites are excreted in breast milk.
Diphenhydramine: There are no adequate and well-controlled clinical studies of diphenhydramine in pregnant or breast-feeding women. Diphenhydramine crosses the placenta and is excreted into breast milk, but levels have not been reported.
The combination of Ammonium chloride/Diphenhydramine (with or without Menthol, Sodium Citrate) should not be used during pregnancy or breastfeeding unless the potential benefit of treatment to the mother outweighs the possible risk to the developing fetus or the nursing infant. Ask a physician before use if the patient is pregnant or breastfeeding.
Adverse Reactions
See table.

Click on icon to see table/diagram/image
Drug Interactions
Diphenhydramine: Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives and tranquilizers.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.
Presentation/Packing
Form
Bactidol Itchy Cough Relief syr
Packing/Price
100 mL x 1's;50 mL x 1's
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