Monday, October 10, 2016

Jay-Phyl Syrup



dyphylline and guaifenesin

Dosage Form: oral syrup
Jay-Phyl Syrup

Jay-Phyl Syrup


Bronchodilator/Expectorant

Rx Only


DESCRIPTION:

Jay-Phyl Syrup is a bronchodilator/expectorant combination supplied as a Orange, Vanilla flavored,

alcohol free and gluten free liquid for oral administration.


Each teaspoonful (5 mL) contains:

Dyphylline........... 100 mg

Guaifenesin........... 50 mg


Inactive ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium

Saccharin, Vanilla Flavor, FD and C Yellow No. 6, Purified Water.


Dyphylline is 7-(2,3-dihydroxypropyl)-theophylline, a white, extremely bitter, amorphous powder that is fully

soluble in water and soluble in alcohol to the extent of 2 g/100 mL. Dyphylline forms a neutral solution that

is stable in gastrointestinal fluids over a wide range of pH. It has the following chemical structure:





Guaifenesin is an expectorant which occurs as a white to slightly gray, crystalline powder, having a bitter

taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and

propylene glycol. The chemical name is 1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-. It has the following

chemical structure:



Jay-Phyl Syrup - Clinical Pharmacology


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. The

bronchodilatory action of dyphylline, as with other xanthines, is thought to be mediated through

competitive inhibition of phosphodiesterase with a resulting increase in cyclic AMP producing

relaxation of bronchial smooth muscle.


Dyphylline was reported to be the least toxic of seven theophylline derivatives, including the piperazine,

N, N-diethylamino ethyl and the 2-hydroxy ethyl derivatives. The toxicity of dyphylline is only one-fifth

that of aminophylline as determined intraperitoneally in mice, and only one-half as toxic in rats. Unlike

the hydrolysable salts of theophylline, dyphylline is not converted to free theophylline in vivo. It is

absorbed rapidly in therapeutically active form and in healthy volunteers reaches a mean peak plasma

concentraion of 17.1 mcg/mL in approximately 45 minutes following a single oral dose of 1000 mg of

dyphylline.


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. Dyphylline plasma levels are dose-related and generally predictable.

The therapeutic range of plasma levels within which dyphylline can be expected to produce effective

bronchodilation has not been determined.


Dyphylline plasma concentrations can be accurately determined using high pressure liquid

chromatography (HPLC) or gas-liquid chromatography (GLC). Guaifenesin is an expectorant whose

action helps increase the output of thin respiratory tract fluid to facilitate mucociliary clearance and

removal of inspissated mucus.


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. The major urinary metabolite

is p-(2-methoxyphenoxy) lactic acid.

INDICATIONS AND USAGE:


Jay-Phyl Syrup is indicated as a bronchodilator-expectorant for treating bronchial asthma,

emphysema, bronchitis, pneumonitis and other related bronchopulmonary insufficiency conditions.

Jay-Phyl Syrup acts to dilate bronchioles and liquefy mucus, giving relief from dyspnea,

non-productive cough and tracheobronchial irritation.

CONTRAINDICATIONS:


As with other theophylline-type drugs, combining dyphylline with epehdrine or other sympathomimetic

drugs can cause excessive CNS stimulation. Such combinations are contraindicated in children unless

accompanied by sufficient sedation to prevent undue CNS stimulation.

Warnings


This product is not indicated in the management of status asthmaticus, which is a serious

medical emergency.


Although the relationship between plasma levels of dyphylline and appearance of toxicity is

unknown, excessive doses may be expected to be associated with an increased risk of

adverse effects.

PRECAUTIONS:


General: 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.

Drug Interactions:


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 (See Clinical Pharmacology).

Carcinogenesis, Mutagenesis, Impairment of Fertility:


No long-term animal studies have been performed with this product.

Pregnancy: Teratogenic effects- Pregnancy Category C.


Animal reproduction studies have not been conducted with this formulation. 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.

Nursing Mothers:


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.

Pediatric Use:


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.

Adverse Reactions


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.


Respiratory: tachypnea.


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.

Overdosage


Signs and Symptoms: Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability,

and headache are typical symptoms resulting from a xanthine drug overdose. Marked overdosage

with resulting severe toxicity has produced agitation, severe vomiting, dehydration, excessive thirst,

tinnitus, cardiac arrhythmias, hyperthermia, diaphoresis, and generalized clonic and tonic

convulsions. Cardiovascular collapse has also occurred, with some fatalities. Seizures have

occured in some cases associated with very high theophylline plasma concentrations, without

any premonitory symptoms of toxicity.


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 stuporous or 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.


Dypyhlline is dialyzable and although not recommended as routine procedure in overdosage cases,

hemodialysis may be of some benefit with severe intoxication is present or when the patient has

not responded to general supportive and symptomatic treatment.

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.


Use in Children:

Altough pediatric dosages of dyphylline are established, no firm dosage for a combination of dyphylline

and guaifenesin USP 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.

HOW SUPPLIED:


Jay-Phyl Syrup is supplied as a orange, vanilla flavored, alcohol free and gluten free liquid in pint

bottles, NDC 64661-0814-16 and in 15 mL bottles, NDC 64661-0814-15.


Rx Only


WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR

CONTACT A POISON CONTROL CENTER IMMEDIATELY.

STORAGE:


Store at controlled room temperature 15o-30oC (59o-86oF).


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.


Manufactured by:

Great Southern Laboratories

Houston, TX 77099


Manufactured for:

JayMac Pharmaceuticals, Inc.

Sunset, LA 70584


Rev. 10/08

PRODUCT PACKAGING:


The packaging below represents the labeling currently used:


Principal Display Panel and Side Panel for 15 mL Label:


NDC 64661-814-15


Jay-Phyl Syrup


Each 5 mL contains:

Dyphylline............. 100 mg

Guaifenesin........... 50 mg


Sugar and Alcohol Free


Rx Only


1/2 fl oz (15 mL)


DOSAGE AND ADMINISTRATION:

Adults: 2 teaspoonfuls (10 mL) 3 or 4 times daily. Children 6 to 12 should be started on low doses

which are gradually increased to the lowest effective dose, not to exceed 10mg/kg/day in divided

doses. Not recommended for pediatric patients under 6 years.


See package insert for full prescribing information.


Store at controlled room temperature, 15o-30oC (59o-86oF).


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.


Manufactured for:

JayMac Pharmaceuticals

Sunset, LA 70584                 Rev. 11/07


PROFESSIONAL SAMPLE

NOT FOR RESALE










JAY-PHYL 
dyphylline and guaifenesin  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64661-814
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dyphylline (Dyphylline)Dyphylline100 mg  in 5 mL
Guaifenesin (Guaifenesin)Guaifenesin50 mg  in 5 mL


















Inactive Ingredients
Ingredient NameStrength
Glycerin 
Propylene Glycol 
Sorbitol 
Citric Acid 
Sodium Citrate 
Saccharin Sodium 
Water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164661-814-1515 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/02/2006


Labeler - JayMac Pharmaceuticals LLC (830767260)

Registrant - Great Southern Laboratories (056139553)









Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture
Revised: 08/2010JayMac Pharmaceuticals LLC

More Jay-Phyl Syrup resources


  • Jay-Phyl Syrup Side Effects (in more detail)
  • Jay-Phyl Syrup Dosage
  • Jay-Phyl Syrup Use in Pregnancy & Breastfeeding
  • Jay-Phyl Syrup Drug Interactions
  • Jay-Phyl Syrup Support Group
  • 0 Reviews for Jay-Phyl - Add your own review/rating


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