Fedac Compound

Fedac Compound

Manufacturer:

Teva

Distributor:

KLN Pharma
Concise Prescribing Info
Contents
Per 5 mL Triprolidine HCl 1.25 mg, pseudoephedrine 30 mg, codeine phosphate 10 mg
Indications/Uses
Relief of coughs & upper resp symptoms including nasal congestion associated w/ allergy or the common cold.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ severe HTN, severe coronary artery disease; patients on MAOIs. Should not be used in newborn or premature infants & in treating lower resp tract symptoms including asthma. Post-op management in childn <18 yr following tonsillectomy &/or adenoidectomy. Childn <12 yr.
Special Precautions
Elderly or debilitated patients. Severe impairment of renal or hepatic function. May impair ability to drive or operate machinery. May cause psychological dependence, physical dependence & tolerance. Should only be used to treat acute moderate pain in childn >12 yr, & only if it cannot be relieved by other painkillers eg, paracetamol or ibuprofen. Adolescents 12-18 yr who have other risk factors that may increase sensitivity to the resp depressant effects of codeine. Patients known to be ultra-rapid metabolisers. Lactation.
Adverse Reactions
Drowsiness; disturbed coordination, dry mouth, nose & throat.
MIMS Class
Cough & Cold Preparations / Antihistamines & Antiallergics
ATC Classification
R05DA20 - combinations ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
P1S1, DD (PII & III)
Presentation/Packing
Form
Fedac Compound linctus
Packing/Price
3.8 L x 1's
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