- RESPIRATORY TRACT DRUGS
- Pharmaceutical Form : Syrup
- Composition : Each 5 mL syrup contains: Dyphylline 100mg Guaifenesin 50 mg
- Active Substance : Dyphylline
COMPOSITION AND EXCIPIENTS:
Each 5 mL syrup contains:
Guaifenesin 50 mg
Dyphylline is a xanthine derivative with pharmacological actions similar to theophylline and other members of this class of drugs. Its primary action is that of bronchodilation, but it also exhibits peripheral vasodilatory and other smooth muscle relaxant activity to a lesser degree.
Dyphylline was reported to be the least toxic of seven theophylline derivatives. Dyphylline exerts its bronchodilatory effects directly and, unlike theophylline, is excreted unchanged by the kidneys without being metabolized by the liver. Because of this, dyphylline pharmacokinetics and plasma levels are not influenced by various factors that affect liver function and hepatic enzyme activity, such as smoking, age, or concomitant use of drugs which affect liver function.
The elimination half-life of dyphylline is approximately two hours (1.8-2.1 hr) and approximately 88% of a single oral dose can be recovered from the urine unchanged. The renal clearance would be correspondingly reduced in patients with impaired function. In anuric patients, the half-life may be increased 3 to 4 times normal.
Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized
and excreted in the urine. Guaifenesin has a plasma half-life of one hour.
INDICATIONS AND USAGE:
This Syrup is indicated as a bronchodilator-expectorant for treating bronchial asthma, emphysema, bronchitis, pneumonitis and other related bronchopulmonary insufficiency conditions. This Syrup acts to dilate bronchioles and liquefy mucus, giving relief from dyspnea, non-productive cough and tracheobronchial irritation.
As with other theophylline-type drugs, combining dyphylline with ephedrine or other sympathomimetic drugs can cause excessive CNS stimulation. Such combinations are contraindicated in children unless accompanied by sufficient sedation to prevent CNS stimulation.
This formulation may cause nausea, headache, cardiac palpitation and CNS stimulation
Postprandial administration may help avoid gastric discomfort.
The following adverse reactions which have been reported with other xanthine bronchodilators, and which have most often been related to excessive drug plasma levels, should be considered as potential adverse effects when dyphylline is administered.
Gastrointestinal: nausea, vomiting, epigastric pain, hematemesis, diarrhea.
Central Nervous System: headache, irritability, restlessness, insomnia, hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions.
Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure, ventricular arrhythmias.
Renal: albuminuria, gross and microscopic hematuria, diuresis.
Other: hyperglycemia, inappropriate ADH syndrome.
Large doses of Guaifenesin may produce emesis, but gastrointestinal upset at ordinary dosage levels is rare.
This product is not indicated in the management of status asthmaticus, which is a serious medical emergency.
Excessive doses may be expected to be associated with an increased risk of adverse effects.
Use this product with caution in patients with severe cardiac disease, hypertension, glaucoma, hypothyroidism, severe renal and hepatic disease, acute myocardial injury or peptic ulcer.
Do not use in children under age six.
Do not exceed 3 mg of dyphylline per pound of body weight daily in older children. Because the xanthines also act as diuretics, special precaution regarding hydration and avoidance of acidosis should be observed in children.
The long-term use of xanthine derivatives may result in a cumulative effect with increase in adverse reactions, as well as the development of tolerance.
Synergism between xanthine bronchodilators (e.g., theophylline), ephedrine and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly.
Concurrent administration of dyphylline and probenecid, which competes for tubular secretion, has been shown to increase plasma half-life and dyphylline.
Pregnancy Category C.
It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This medication should be given to a pregnant woman only if clearly needed.
Dyphylline is present in human milk at approximately twice the maternal plasma concentration. Caution should be exercised when this product is administered to a nursing woman.
Safety and effectiveness in children below the age of six have not been established.
Use caution when administering to children six years of age or older.
Signs and Symptoms: Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache are typical symptoms resulting from a xanthine drug overdose.
Treatment: There is no specific antidote for overdosage with drugs of the xanthine class. Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintenance of vital signs, fluids and electrolytes. The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration, especially in comatose patients.
Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed.
Sympathomimetic agents should be avoided but sedatives such as short acting barbiturates may be useful.
DOSAGE AND ADMINISTRATION:
The usual adult dose is 1 or 2 teaspoonfuls of liquid 3 or 4 times a day. In severe cases, dosage may be doubled or tripled if necessary. Maintenance dosage should be adjusted according to patient response.
Although pediatric dosages of dyphylline are established, no firm dosage for a combination of dyphylline and guaifenesin can be recommended for children under the age of six. Dosage for children over six may be calculated on the basis of 2 to 3 mg of dyphylline per pound of body weight daily in divided doses.
Not recommended for children under 6 years.
STORAGE CONDITIONS: Store between (15–30) °C
PACKAGING: 100 mL