Dyphylline and Guaifenesin Tablets

Similar medicines derived from the guaiac tree were in use as a generic remedy by Native Americans when explorers reached North America in the 1500s, but guaifenesin was first approved by the Food and Drug Administration (FDA) in 1952.

Get in touch
Phone, fax, e-mail

Address: Guai-Aid, Inc
Address: 8 Faneuil Hall MarketPlace, 3rd Floor, Boston, Ma
Telephone: 800-846-5525
E-mail: webadmin@guai-aid.com

 

picture

Dyphylline and Guaifenesin Tablets Description

.

View In Detail

Dyphylline and Guaifenesin Tablets are a bronchodilator/expectorant combination available for oral administration.

Each tablet contains:

Dyphylline 200 mg
Guaifenesin 200 mg

Dyphylline is a bronchodilator which occurs as a white, odorless, extremely bitter, amorphous or crystalline solid. It is freely soluble in water; sparingly soluble in alcohol and in chloroform; practically insoluble in ether. The chemical name is 1H-Purine-2,6-dione, 7-(2,3-dihydroxypropyl)-3,7-dihydro-1,3-dimethyl-, (±)-. Its structural formula is as follows:

C10H14N4O4      M.W. 254.24

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)-, (±)-. Its structural formula is as follows:

C10H14O4      M.W. 198.22

INACTIVE INGREDIENTS: Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silica and Stearic Acid.

Dyphylline and Guaifenesin Tablets - Clinical Pharmacology

.

Dyphylline is a xanthine derivative with pharmacologic 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 is well tolerated and produces less nausea than aminophylline and other alkaline theophylline compounds when administered orally. Unlike the hydrolyzable 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 concentration 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 renal 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.

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 β-(2-methoxyphenoxy) lactic acid.

Indications and Usage for Dyphylline and Guaifenesin Tablets

.

Dyphylline and Guaifenesin is indicated as a bronchodilator-expectorant for treating bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema. Dyphylline and Guaifenesin acts to dilate bronchioles and liquefy mucus, giving relief from dyspnea, non-productive cough and tracheobronchial irritation.

Contraindications

.

Hypersensitivity to any of the ingredients or related compounds.

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.

Do not use this product unless a diagnosis of asthma has been made by a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a doctor.

Precautions

.

General

Use Dyphylline and Guaifenesin with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury or peptic ulcer. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Drug/Laboratory Test 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 the plasma half-life of dyphylline. Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5- hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

.

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

Pregnancy

.

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

This product is not indicated for use in the pediatric population.

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, and 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, and ventricular arrhythmias.

Respiratory: tachypnea.

Renal: albuminuria, gross and microscopic hematuria, diuresis.

Other: hyperglycemia, inappropriate ADH syndrome.

Overdosage

.

There have been no reports, in the literature, of overdosage with this product. However, the following information based on reports of theophylline overdosage is considered typical of the xanthine class of drugs and should be kept in mind.

Signs and Symptoms

.

Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache. 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 occurred 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.

Dyphylline is dialyzable and, although not recommended as routine procedure in overdosage cases, hemodialysis may be of some benefit when severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.

Dyphylline and Guaifenesin Tablets Dosage and Administration

.

Dosage should be individually titrated according to the severity of the condition and the response of the patient.

Usual Adult Dosage

.

1 tablet four times daily.

This product is not indicated for use in the pediatric population. (see PRECAUTIONS, Pediatric Use.)

How is Dyphylline and Guaifenesin Tablets Supplied

.

Dyphylline and Guaifenesin are round, white, compressed tablets, debossed B 375. They are packaged in bottles of 100, NDC # 51991-375-01.

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a person control center immediately.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Storage

.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Manufactured by: Contract Pharmacal Corp., Hauppauge, NY 11788

Iss.10/03
Rev. 11/08

Made in USA

Principal Display Panel - 100 Tablet Bottle Label

.

Breckenridge
Pharmaceutical, Inc.

NDC 51991-375-01

Dyphylline
& Guaifenesin

Tablets, USP

Bronchodilator - Expectorant

Rx Only

100 Tablets

How to Cure Mucus Congestion

.

Congestion and mucus due to an upper respiratory infection can cause a chronic cough and stuffiness. However, you can relieve symptoms with home remedies and over-the-counter medications. These remedies help expel mucus, or phlegm, which stops symptoms and promotes better breathing.

Instructions

Things You'll Need:

  • Heater
  • Humidifier
  • Chicken broth
  • Liquids
  1. Keep warm. Congestion worsens in cold weather. Stay indoors and turn up your heater. If necessary, buy a portable heater to help maintain a warm temperature inside your home.

  2. Quit smoking. Tobacco use increases the production of mucus. To get rid of congestion and mucus, give up the cigarette habit.

  3. Humidify your space. Break up mucus in your nose and chest with a humidifier.

  4. Sip on soup and other hot liquids. Hot liquids such as hot teas are effective for reducing mucus and relieving congestion. Warm up a bowl of chicken soup. According to Kid's Health, chicken soup contains an amino acid that helps thin mucus in the body.

  5. Drink water. In conjunction with hot liquids, keep your body hydrated and loosen mucus congestion by consuming plenty of water (or juice), according to the Mayo Clinic.

  6. Find a sauna. If you're able to move around, visit your local health spa and sit in the sauna or steam room to thin mucus and restore breathing.

  7. Use medication. Look for an over-the-counter decongestant to get rid of mucus in the chest and promote nasal drainage. Use as directed.

Nasal congestion

.

Nasal congestion is the blockage of the nasal passages usually due to membranes lining the nose becoming swollen from inflamed blood vessels. It is also known as nasal blockage, nasal obstruction, blocked nose, stuffy nose, or stuffed up nose.

Nasal congestion has many causes and can range from a mild annoyance to a life-threatening condition. The newborn infant can only breathe through the nose (newborns are "obligate nose breathers"). Nasal congestion in an infant in the first few months of life can interfere with breastfeeding and cause life-threatening respiratory distress. Nasal congestion in older children and adolescents is often just an annoyance but can cause other difficulties.

Nasal congestion can interfere with the ears, hearing, and speech development. Significant congestion may interfere with sleep, cause snoring, and can be associated with sleep apnea. In children, nasal congestion from enlarged adenoids has caused chronic sleep apnea with insufficient oxygen levels and hypoxia, as well as right-sided heart failure. The problem usually resolves after surgery to remove the adenoids and tonsils. Nasal congestion can also cause mild facial and head pain, and a degree of discomfort.

How to Cure Chest Congestion Naturally

.

When you or your family need a cure for chest congestion, this is a natural cure. Instead of using over the counter drugs try this natural remedy. This works wonderfully. Well, it WORKS wonderful, doesn't smell wonderful.

Instructions

Things You'll Need:

  • Cornmeal
  • Onions
  • Cider Vinegar

Slice an onion very thin. Sautee' the slices in apple cider vinegar until clear. Add cornmeal to the onion/vinegar. Just enough to be slightly thicken. It will thicken more as it cools. Cut a square of a t-shirt. Put the mixture into the square and fold it over, like a pillow.

Put the t-shirt with the remedy directly onto the chest of the congested person, as hot as they can stand it. It will smell but that is why it works. The "fumes" from the onions and vinegar will penetrate and break up the chest congestion.

Hold the homemade pillow in your hand, under the blanket, so they will breathe it in. On babies, I wouldn't advise putting it on their chests. Rather, cradle the baby in your arms with a blanket thrown over them.

If you can get them to do it, the mucus will come up and be clear in an hour or two. Your family will fight you on this. You may need need to keep doing this for several applications if the congestion is really bad.

More Resources