Sodium Polystyrene Sulfonate Oral Powder

Sodium Polystyrene

Sulfonate Suspension, USP

Sorbitol Free

Sodium Polystyrene Sulfonate Oral Powder Description

Sodium Polystyrene Sulfonate Suspension, USP can be administered orally or in an enema. It is a raspberry-flavored suspension containing 15 grams of cation-exchange resin (sodium polystyrene sulfonate, USP); 0.12 mL (0.2%) of alcohol per 60 mL of suspension. Also contains purified water, propylene glycol, magnesium aluminum silicate, xanthan gum, sodium saccharin, citric acid, methylparaben, propylparaben, and flavor.

Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with anin-vitroexchange capacity of approximately 3.1 mEq (in-vivoapproximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

Sodium Polystyrene Sulfonate Oral Powder - Clinical Pharmacology

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

INDICATION AND USAGE

Sodium Polystyrene Sulfonate Suspension, USP is indicated for the treatment of hyperkalemia.

Contraindications

Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (seePRECAUTIONS).

Warnings

Alternative Therapy in Severe Hyperkalemia

Since the effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia

Serious potassium deficiency can occur from sodium polystyrene sulfonate therapy. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with sodium polystyrene sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances

Like all cation-exchange resins, sodium polystyrene sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative (seePRECAUTIONS, Drug Interactions).

Colonic Necrosis

Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (seePRECAUTIONS, Drug Interactions).

Precautions

Caution is advised when sodium polystyrene sulfonate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances, compensatory restriction of sodium intake from other sources may be indicated.

Caution is advised when Sodium Polystyrene Sulfonate Suspension, USP is administered to patients with end stage diabetic renal disease.

Sodium Polystyrene Sulfonate Suspension, USP should not be administered to patients following surgery until normal bowel function resumes.

Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

In the event of clinically significant constipation, treatment with Sodium Polystyrene Sulfonate Suspension, USP should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives should not be used (seePRECAUTIONS, Drug Interactions).

Drug Interactions

Antacids

The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

Non-absorbable cation-donating antacids and laxatives

Systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported.

Digitalis

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (seeWARNINGS).

Sorbitol

Concomitant use of sorbitol with Sodium Polystyrene Sulfonate Suspension, USP is not recommended.

Lithium

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of lithium.

Thyroxine

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with sodium polystyrene sulfonate. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium polystyrene sulfonate is administered to a nursing woman.

Pediatric Use

The effectiveness of Sodium Polystyrene Sulfonate Suspension, USP in pediatric patients has not been established. The use of Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in neonates and especially in premature infants. In children, particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

Adverse Reactions

Sodium Polystyrene Sulfonate Suspension, USP may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur (seeWARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (seePRECAUTIONS). Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

The following events have been reported from worldwide post marketing experience:

• Fecal impaction following rectal administration, particularly in children;


• Gastrointestinal concretions (bezoars) following oral administration;


• Gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and


• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate.

Overdosage

Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.

Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

Sodium Polystyrene Sulfonate Oral Powder Dosage and Administration

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Sodium Polystyrene Sulfonate Suspension, USP one to four times daily. Each 60 mL of Sodium Polystyrene Sulfonate Suspension, USP contains 1500 mg (65 mEq) of sodium. Since thein-vivoefficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Sodium Polystyrene Sulfonate Suspension, USP may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

Sodium Polystyrene Sulfonate Suspension, USP may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Sodium Polystyrene Sulfonate Suspension, USP should not be heated for to do so may alter the exchange properties of the resin.

How is Sodium Polystyrene Sulfonate Oral Powder Supplied

Sodium Polystyrene Sulfonate Suspension, USP is a light brown, raspberry-flavored suspension supplied as follows:

480 mL (16 Fluid Ounce)	NDC 0574-2003-16
Unit-Dose 60 mL (2 Fluid Ounce), 10 bottles per carton	NDC 0574-2003-02

Dispense in tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

SHAKE WELL BEFORE USING.

Store at 20 to 25 C (68 to 77 F) [see USP controlled room temperature].

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(04-11A)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0574-2003-02

SODIUM POLYSTYRENE

SULFONATE SUSPENSION, USP

15 g/60 mL

Does not contain Sorbitol

Dispense in tight container.

SHAKE WELL BEFORE USING

See package insert for complete prescribing information.

FOR ORAL OR RECTAL USE

Protect from freezing and excessive heat.

NET CONTENTS 60 mL (2 fl oz)

Rx ONLY

Paddock

Laboratories, Inc.

SODIUM POLYSTYRENE SULFONATE  sodium polystyrene sulfonate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-2003 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Polystyrene Sulfonate (Sodium Cation) Sodium Polystyrene Sulfonate 15 g  in 60 mL

Inactive Ingredients Ingredient Name Strength Alcohol 0.12 mL  in 60 mL water   propylene glycol   magnesium aluminum silicate   xanthan gum   saccharin sodium   citric acid monohydrate   methylparaben   propylparaben

Product Characteristics Color BROWN (Light-brown) Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-2003-02 60 mL In 1 BOTTLE None 2 0574-2003-16 480 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090590	09/21/2011

Labeler - Paddock Laboratories, LLC (967694121)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, LLC		967694121	Manufacture

Revised: 09/2011Paddock Laboratories, LLC

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• Sodium Polystyrene Sulfonate Oral Powder Side Effects (in more detail)
• Sodium Polystyrene Sulfonate Oral Powder Use in Pregnancy & Breastfeeding
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• Hyperkalemia

Acea 0.75% w / w Gel

1. Name Of The Medicinal Product

Acea 0.75% w/w Gel

Metronidazole 0.75% w/w Gel

2. Qualitative And Quantitative Composition

Metronidazole 0.75% w/w

For full list of excipients see 6.1.

3. Pharmaceutical Form

Gel.

Clear very pale yellow gel.

4. Clinical Particulars

4.1 Therapeutic Indications

(i) The treatment of acute inflammatory exacerbations of rosacea.

4.2 Posology And Method Of Administration

For cutaneous use only.

(i) For adults and the elderly. Apply the gel to the affected area of the skin in a thin film twice daily for 8 weeks. Thereafter further applications may be necessary depending on the severity of the condition.

(ii) For Children. Not recommended.

4.3 Contraindications

Known hypersensitivity to metronidazole, parabens or any of the constituents.

4.4 Special Warnings And Precautions For Use

Warnings: Avoid contact with the eyes. If contact with the eyes occurs the gel should be washed out carefully with water.

Precautions: The following statements take into account the possibility that metronidazole may be absorbed after topical application. However there is no evidence of any significant systemic concentrations of metronidazole following topical applications. Peripheral neuropathy has been reported in association with prolonged use of oral metronidazole. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. Such patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However in patients undergoing haemodialysis, metronidazole and its metabolites are efficiently removed.

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214), may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients are advised not to take alcohol during systemic metronidazole therapy because of the possibility of a disulfiram-like reaction.

Some potentiation of anti-coagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants.

Patients receiving phenobarbitone metabolise metronidazole at a much faster rate than normal, reducing the half-life to 3 hours.

4.6 Pregnancy And Lactation

The safety of topically applied metronidazole in pregnancy and lactation has not been adequately established and should not be used in these circumstances unless the physician considers it essential.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects on the ability to drive or use machines has been reported following the topical application of metronidazole.

4.8 Undesirable Effects

Dryness or irritation of the skin may be experienced after application to unbroken skin. Systemic metronidazole therapy may occasionally cause an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastro-intestinal disturbance, urticaria, angioedema and anyphylaxis. Drowsiness, dizziness, headache, ataxia, skin rash, pruritis and darkening of urine has been reported, but rarely.

4.9 Overdose

Overdose is unlikely. If necessary remove the medication by washing with warm water. If accidental ingestion occurs, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: D06BX01

Metronidazole is a 5-nitroimidazole derivative with activity against anaerobic protozoa and anaerobic bacteria. It also has a radiosensitising effect of hypoxic tumour cells. Its mechanism of action is thought to involve interference with DNA by a metabolite in which the nitro group of metronidazole has been reduced. The mode of action of topical metronidazole in the treatment of rosacea is not known.

5.2 Pharmacokinetic Properties

No bioavailability studies have been carried out with this formulation.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which have additional to those already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Hydroxyethylcellulose

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Ethyl parahydroxybenzoate (E214)

Disodium edetate

Sodium hydroxide

Potassium dihydrogen phosphate

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months from the date of manufacture of the unopened container.

8 weeks from the date of opening.

6.4 Special Precautions For Storage

Do not store above 25°C.

Do not refrigerate or freeze.

6.5 Nature And Contents Of Container

Aluminium tube with a polypropylene screw cap.

The pack sizes are 5 g, 25 g and 40 g. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd. 12 York Place, Leeds, LS1 2DS, United Kingdom.

8. Marketing Authorisation Number(S)

PL 20685/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

27 February 2004 / 17^th September 2007

10. Date Of Revision Of The Text

19 August 2010.

Tums Ultra

Generic Name: calcium carbonate (KAL see um KAR boe nate)

Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra

What is Tums Ultra (calcium carbonate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tums Ultra (calcium carbonate)?

Do not take calcium carbonate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium carbonate works best if you take it with food.

What should I discuss with my healthcare provider before taking Tums Ultra (calcium carbonate)?

To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:

• 
  

  a history of kidney stones; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium carbonate if you are pregnant. Talk to your doctor before taking calcium carbonate if you are breast-feeding a baby.

How should I take Tums Ultra (calcium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium carbonate works best if you take it with food. Swallow the calcium carbonate tablet or capsule with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Tums Ultra (calcium carbonate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Tums Ultra (calcium carbonate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  decreased appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs can affect Tums Ultra (calcium carbonate)?

Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids or other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


• 
  

  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium carbonate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium carbonate.

See also: Tums Ultra side effects (in more detail)

Phenergan Injection

Generic Name: promethazine hydrochloride

Dosage Form: injection
Phenergan Injection (promethazine hydrochloride Injection, USP)

Rx only

WARNINGS

Respiratory Depression – Pediatrics

Phenergan Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Caution should be exercised when administering Phenergan Injection to pediatric patients 2 years of age and older (see WARNINGS - Respiratory Depression).

Severe Tissue Injury, Including Gangrene

Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS - Severe Tissue Injury, Including Gangrene).

Due to the risks of intravenous injection, the preferred route of administration of Phenergan Injection is deep intramuscular injection. Subcutaneous injection is contraindicated. See DOSAGE AND ADMINISTRATION for important notes on administration.

Phenergan Injection Description

Phenergan Injection (promethazine hydrochloride injection, USP), is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:

C17H21ClN2S       MW 320.88

Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate.

Phenergan Injection (promethazine hydrochloride injection, USP) is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

Phenergan Injection - Clinical Pharmacology

Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H1 receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8 ± 3.4 hours.

Indications and Usage for Phenergan Injection

Phenergan Injection is indicated for the following conditions:

1. Amelioration of allergic reactions to blood or plasma.


2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.


3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.


4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.


5. Active treatment of motion sickness.


6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.


7. As an adjunct to analgesics for the control of postoperative pain.


8. Preoperative, postoperative, and obstetric (during labor) sedation.


9. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Contraindications

Children Less Than 2 Years of Age

Phenergan Injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression (see  WARNINGS - Respiratory Depression).

Comatose State

Phenergan Injection is contraindicated in comatose states.

Intra-Arterial Injection

Under no circumstances should Phenergan Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene).

Subcutaneous Injection

Phenergan Injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.

Idiosyncratic Reaction or Hypersensitivity

Phenergan Injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

Warnings

Respiratory Depression

Pediatrics

Phenergan Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of Phenergan Injection have resulted in respiratory depression in these patients.

Caution should be exercised when administering Phenergan Injection to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of PHENERGAN Injection be used in pediatric patients 2 years of age and older. Avoid concomitant administration of other drugs with respiratory depressant effects because of an association with respiratory depression, and sometimes death, in pediatric patients.

Other

Because of the risk of potentially fatal respiratory depression, use of Phenergan Injection in patients with compromised respiratory function or patients at risk for respiratory failure (e.g. COPD, sleep apnea) should be avoided.

Severe Tissue Injury, Including Gangrene

Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse event reports include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required.

Because of the risks of intravenous injection, the preferred route of administration of Phenergan Injection is deep intramuscular injection (see DOSAGE AND ADMINISTRATION). Subcutaneous injection is contraindicated. Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Aspiration of dark blood does not preclude intra-arterial needle placement because blood is discolored upon contact with Phenergan Injection. Use of syringes with rigid plungers or of small-bore needles might obscure typical arterial backflow if this is relied upon alone.

In the event that a patient complains of pain during intravenous injection of Phenergan Injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.

There is no proven successful management of unintentional intra-arterial injection or perivascular extravasation after it occurs. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants.

CNS Depression

Phenergan Injection may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see PRECAUTIONS - Information for Patients and Drug Interactions).

Lower Seizure Threshold

Phenergan Injection may lower seizure threshold and should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression

Phenergan Injection should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered.

Sulfite Sensitivity

Phenergan Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthma episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Visual Inspection

This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.

Cholestatic Jaundice

Administration of promethazine has been associated with reported cholestatic jaundice.

Precautions

General

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Phenergan Injection should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Information for Patients

Patients should be advised of the risk of respiratory depression, including potentially fatal respiratory depression in children less than 2 years of age (see WARNINGS - Respiratory Depression).

Patients should be advised of the risk of severe tissue injury, including gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene). Patients should be advised to immediately report persistent or worsening pain or burning at the injection site.

Phenergan Injection may cause marked drowsiness or impair the mental or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers may enhance impairment (see WARNINGS - CNS Depression and PRECAUTIONS - Drug Interactions).

Patients should be advised to report any involuntary muscle movements (see  ADVERSE REACTIONS - Paradoxical Reactions).

Patients should be advised to avoid prolonged exposure to the sun (see ADVERSE REACTIONS - Dermatologic).

Drug Interactions

CNS Depressants

Phenergan Injection may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine hydrochloride. When given concomitantly with Phenergan Injection, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of Phenergan Injection relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine

Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenergan Injection overdose.

Anticholinergics

Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase (MAO) Inhibitors

Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO Inhibitors and phenothiazines are used concomitantly. This possibility should be considered with Phenergan Injection.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with PHENERGAN Injection:

Pregnancy Tests

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test

An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of Phenergan Injection, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Phenergan Injection was nonmutagenic in the Salmonella test system of Ames.

Pregnancy

Teratogenic Effects—Pregnancy Category C

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Phenergan Injection. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

There are no adequate and well-controlled studies of Phenergan Injection in pregnant women. Because animal reproduction studies are not always predictive of human response, Phenergan Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adequate studies to determine the action of the drug on parturition, lactation and development of the animal neonate have not been conducted.

Nonteratogenic Effects

Phenergan Injection administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Phenergan Injection may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of Phenergan Injection during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Pregnancy - Nonteratogenic Effects.)

Nursing Mothers

It is not known whether Phenergan Injection is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Phenergan Injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Phenergan Injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Phenergan Injection should be used with caution in pediatric patients 2 years of age and older (see WARNINGS - Respiratory Depression).

Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. The extrapyramidal symptoms which can occur secondary to PHENERGAN Injection administration may be confused with the CNS signs of undiagnosed primary disease, e.g. encephalopathy or Reye's syndrome. The use of Phenergan Injection should be avoided in pediatric patients whose signs and symptoms may suggest Reye's syndrome or other hepatic diseases.

Excessively large dosages of antihistamines, including Phenergan Injection, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Phenergan Injection in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of Phenergan Injection.

Geriatric Use (patients approximately 60 years or older)

Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.

Adverse Reactions

Respiratory Depression

Phenergan Injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Phenergan Injection should be used with caution in pediatric patients 2 years of age and older (see WARNINGS - Respiratory Depression).

Severe Tissue Injury, Including Gangrene

Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS - Severe Tissue Injury, Including Gangrene; and DOSAGE AND ADMINISTRATION).

Central Nervous System

Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular

Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic

Dermatitis, photosensitivity, urticaria.

Hematologic

Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal

Dry mouth, nausea, vomiting, jaundice.

Respiratory

Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Respiratory Depression.)

Other

Angioneurotic edema. Neuroleptic Malignant Syndrome (potentially fatal) has also been reported. (See WARNINGS - Neuroleptic Malignant Syndrome.)

Paradoxical Reactions

Hyperexcitability and abnormal movements have been reported in patients following a single administration of Phenergan Injection. Consideration should be given to the discontinuation of Phenergan Injection and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

Overdosage

Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms-dry mouth; fixed, dilated pupils; flushing; etc., as well as gastrointestinal symptoms, may occur.

Treatment

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of PHENERGAN Injection are not reversed by naloxone.

Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.

Phenergan Injection Dosage and Administration

Important Notes on Administration

Phenergan Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration (see WARNINGS - Severe Tissue Injury, Including Gangrene).

• The preferred parenteral route of administration for Phenergan Injection is by deep intramuscular injection.


• Under no circumstances should Phenergan Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene).


• Subcutaneous injection is contraindicated as it may result in tissue necrosis.


• When administered intravenously, Phenergan Injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. It is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.


• In the event that a patient complains of pain during intravenous injection of Phenergan Injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use Phenergan Injection if solution has developed color or contains precipitate.

To avoid the possibility of physical and/or chemical incompatibility, consult specialized literature before diluting with any injectable solution or combining with any other medication. Do not use if there is a precipitate or any sign of incompatibility.

Allergic Conditions

The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.

Sedation

In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of PHENERGAN Injection.

Nausea and Vomiting

For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the dosage of analgesics and barbiturates should be reduced accordingly (see PRECAUTIONS – Drug Interactions).

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see PRECAUTIONS – Pediatric Use).

Preoperative and Postoperative Use

As an adjunct to preoperative or postoperative medication, 25 to 50 mg of Phenergan Injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly (see PRECAUTIONS – Drug Interactions).

PHENERGAN is contraindicated for use in pediatric patients less than two years of age.

Obstetrics

Phenergan Injection in doses of 50 mg will provide sedation and relieve apprehension in the early stages of labor. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) Phenergan Injection may be given with an appropriately reduced dose of any desired narcotic (see PRECAUTIONS – Drug Interactions). If necessary, Phenergan Injection with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. A maximum total dose of 100 mg of PHENERGAN Injection may be administered during a 24-hour period to patients in labor.

Pediatric Patients

Phenergan Injection is contraindicated for use in pediatric patients less than 2 years of age (see WARNINGS – Respiratory Depression). Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age or older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided (see WARNINGS – Respiratory Depression).

In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 1.1 mg per kg of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug (see PRECAUTIONS – Drug Interactions). Antiemetics should not be used in vomiting of unknown etiology in pediatric patients.

How is Phenergan Injection Supplied

Phenergan Injection (promethazine hydrochloride injection, USP) is available as follows:

25 mg/mL

     1 mL ampuls packaged in 25s (NDC 0641-6082-25)

     1 mL vials packaged in 25s (NDC 0641-6084-25)

50 mg/mL

     1 mL ampuls packaged in 25s (NDC 0641-6083-25)

     1 mL vials packaged in 25s (NDC 0641-6085-25)

Storage

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Protect from light. Keep covered in carton until time of use.

Do not use if solution has developed color or contains a precipitate.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at

1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Phenergan is a registered trademark of Wyeth and is used under license.

Manufactured by:

WEST-WARD PHARMACEUTICALS

Eatontown, NJ 07724 USA

Revised May 2011

462 - 024 - 04                                                                                                                                                      

PRINCIPAL DISPLAY PANEL

Phenergan Injection (Promethazine HCI Inj., USP)

25 mg/mL 1 mL Ampul

NDC 0641-6082-01

Phenergan Injection (Promethazine HCI Inj., USP)

25 mg/mL

25 x 1 mL Ampuls

NDC 0641-6082-25

PRINCIPAL DISPLAY PANEL

Phenergan Injection (Promethazine HCI Inj., USP)

25 mg/mL 1 mL Vial

NDC 0641-6084-01

Phenergan Injection (Promethazine HCI Inj., USP)

25 mg/mL

25 x 1 mL Vials

NDC 0641-6084-25

PRINCIPAL DISPLAY PANEL

Phenergan Injection (Promethazine HCI Inj., USP)

50 mg/mL 1 mL Ampul

NDC 0641-6083-01

Phenergan Injection (Promethazine HCI Inj., USP)

50 mg/mL

25 x 1 mL Ampuls

NDC 0641-6083-25

PRINCIPAL DISPLAY PANEL

Phenergan Injection (Promethazine HCI Inj., USP)

50 mg/mL 1 mL Vial

NDC 0641-6085-01

Phenergan Injection (Promethazine HCI Inj., USP)

50 mg/mL

25 x 1 mL Vials

NDC 0641-6085-25

PHENERGAN  promethazine hydrochloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0641-6082 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.1 mg  in 1 mL CALCIUM CHLORIDE 0.04 mg  in 1 mL SODIUM METABISULFITE 0.25 mg  in 1 mL PHENOL 5 mg  in 1 mL WATER   ACETIC ACID   SODIUM ACETATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0641-6082-25 25 AMPULE In 1 CARTON contains a AMPULE (0641-6082-01) 1 0641-6082-01 1 mL In 1 AMPULE This package is contained within the CARTON (0641-6082-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA083312	09/19/1973

PHENERGAN  promethazine hydrochloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0641-6083 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.1 mg  in 1 mL CALCIUM CHLORIDE 0.04 mg  in 1 mL SODIUM METABISULFITE 0.25 mg  in 1 mL PHENOL 5 mg  in 1 mL WATER   ACETIC ACID   SODIUM ACETATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0641-6083-25 25 AMPULE In 1 CARTON contains a AMPULE (0641-6083-01) 1 0641-6083-01 1 mL In 1 AMPULE This package is contained within the CARTON (0641-6083-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA083312	09/19/1973

PHENERGAN  promethazine hydrochloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0641-6084 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.1 mg  in 1 mL CALCIUM CHLORIDE 0.04 mg  in 1 mL PHENOL 5 mg  in 1 mL WATER   ACETIC ACID   S

guaifenesin and hydrocodone

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)

Brand names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX, ...show all 47 brand names.Codiclear DH (obsolete), Vicodin Tuss, Pneumotussin HC, Propatuss Expectorant, Co-Tussin, Codotuss, Fentuss Expectorant, Co-Tuss V Expectorant, Vicoclear, Hycosin Expectorant, Vicotuss, G-Tuss, Hycoclar Tuss, Hydrotuss, Entuss, Gua HC, Hycoclear, Medcodin, Vortex, Pneumotussin, Atuss HX, Tusso-HC, Hydro-Tussin HG, Execof, Endacof XP

What is guaifenesin and hydrocodone?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Guaifenesin and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about guaifenesin and hydrocodone?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking guaifenesin and hydrocodone?

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

To make sure you can safely take guaifenesin and hydrocodone, tell your doctor if you have any of these other conditions:

• 
  

  liver or kidney disease;

  
  


• 
  

  asthma;

  
  


• 
  

  urination problems;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  a head injury; or

  
  


• 
  

  Addison's disease.

  
  

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Guaifenesin and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take guaifenesin and hydrocodone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Guaifenesin and hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Guaifenesin and hydrocodone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking guaifenesin and hydrocodone?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, or sleep medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

Guaifenesin and hydrocodone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  slow heart rate, weak or shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  blurred vision;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  sweating.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Guaifenesin and hydrocodone Dosing Information

Usual Adult Dose for Cough:

1 extended release tablet (1200 mg-20 mg) orally every 12 hours (maximum dose is 2 tablets/day)
2 extended release tablets (575 mg-5 mg) orally every 12 hours (maximum dose is 6 tablets/day)
1 to 2 extended release tablet(s) (600 mg-5 mg) orally every 12 hours
1 to 1.5 tablet(s) (300 mg-5 mg) orally 4 times a day
1 to 2 tablet(s) (300 mg-2.5 mg) orally 4 times a day (maximum dose is 8 tablets/day)
5 mL syrup (100 mg-5 mg/5 mL) orally every 4 after meals and at bedtime
10 mL syrup (200 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 40 mL/day)
10 mL syrup (100 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 60 mL/day)
5 mL to 10 mL syrup (90 mg-3 mg/5 mL) orally every 4 to 6 hours
1 or 2 capsule(s) (300 mg-5 mg) orally every 8 hours
1 extended release tablet (1000 mg-10 mg) orally every 12 hours (maximum dose is 2 tablets/day)
5 mL syrup (100 mg-3.5 mg/5 mL) orally every 4 after meals and at bedtime (not to exceed 30 mL in a 24 hour period). Treatment should be initiated with 5 mL and subsequent doses, up to a maximum single dose of 15 mL, adjusted as required.
10 mL liquid (150 mg-5 mg/5 mL) orally every 6 hours (not to exceed 40 mL in 24 hours)
5 mL syrup (300 mg-3.5 mg/5 mL) orally every 4 to 6 hours (not to exceed 30 mL in 24 hours)
5 mL liquid (100 mg-4 mg/5 mL) orally every 4 to 6 hours
5 mL to 7.5 mL liquid (200 mg-7.5 mg/5 mL) orally every 6 hours

Usual Pediatric Dose for Cough:

2 years to under 6 years:
2.5 mL syrup (90 mg-3 mg/5 mL) orally every 4 to 6 hours
2.5 mL liquid (150 mg-5 mg/5 mL) orally every 6 hours (not to exceed 10 mL in 24 hours)
1.25 mL liquid (100 mg-4 mg/5 mL) orally every 4 to 6 hours

3 years to under 6 years:
2.5 mL syrup (100 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 15 mL/day)
1.25 mL liquid (200 mg-7.5 mg/5 mL) orally every 6 hours

over 6 years to 12 years:
2.5 mL to 5 mL syrup (100 mg-5 mg/5 mL) orally 4 times a day.
2.5 mL to 5 mL syrup (90 mg-3 mg/5 mL) orally 4 times a day
5 mL syrup (200 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 20 mL/day)
5 mL syrup (100 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 30 mL/day)
1/2 to 1 extended release tablets (600 mg-5 mg) orally every 12 hours
1 capsule (300 mg-5 mg) orally every 8 hours
1/2 extended release tablet (1000 mg-10 mg) orally every 12 hours (maximum dose is 1 tablet/day)
5 mL liquid (150 mg-5 mg/5 mL) orally every 6 hours (not to exceed 20 mL in 24 hours)
2.5 mL liquid (100 mg-4 mg/5 mL) orally every 4 to 6 hours
2.5 mL liquid (200 mg-7.5 mg/5 mL) orally every 6 hours

over 12 years:
10 ml liquid (150 mg-5 mg/5 mL) orally every 6 hours (not to exceed 40 mL in 24 hours)
5 mL syrup (300 mg-3.5 mg/5 mL) orally every 4 to 6 hours (not to exceed 30 mL in 24 hours
5 mL syrup (100 mg-5 mg/5 mL) orally 4 times a day
1 extended release tablet (1200 mg-20 mg) orally every 12 hours (maximum dose is 2 tablets/day)
10 mL syrup (200 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 40 mL/day)
10 mL syrup (100 mg-2.5 mg/5 mL) orally every 4 to 6 hours (maximum dose is 60 mL/day)
5 mL to 10 mL syrup (90 mg-3 mg/5 mL) orally 4 times a day
1 to 2 extended release tablets (600 mg-5 mg) orally every 12 hours
2 extended release tablets (575 mg-5 mg) orally every 12 hours (maximum dose is 6 tablets/day)
1 or 2 capsule(s) (300 mg-5 mg) orally every 8 hours
1 extended release tablet (100 mg-10 mg) orally every 12 hours (maximum dose is 2 tablets/day)
5 mL syrup (100 mg-3.5 mg/5 mL) orally every 4 after meals and at bedtime. Maximum single dose is 10 mL.
5 mL liquid (100 mg-4 mg/5 mL) orally every 4 to 6 hours
5 mL to 7.5 mL liquid (200 mg-7.5 mg/5 mL) orally every 6 hours

What other drugs will affect guaifenesin and hydrocodone?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

Tell your doctor about all other medicines you use, especially:

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  antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


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  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


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  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


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  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


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  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with guaifenesin and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More guaifenesin and hydrocodone resources

• Guaifenesin and hydrocodone Side Effects (in more detail)
• Guaifenesin and hydrocodone Dosage
• Guaifenesin and hydrocodone Use in Pregnancy & Breastfeeding
• Guaifenesin and hydrocodone Drug Interactions
• Guaifenesin and hydrocodone Support Group
• 2 Reviews for Guaifenesin and hydrocodone - Add your own review/rating

Compare guaifenesin and hydrocodone with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and hydrocodone.

See also: guaifenesin and hydrocodone side effects (in more detail)