Isopto Alkaline

1. Name Of The Medicinal Product

ISOPTO ALKALINE

2. Qualitative And Quantitative Composition

Hypromellose 1.0% w/v

3. Pharmaceutical Form

Eye drops, solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).

Also used as an ocular lubricant for artificial eyes.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

The dose depends on the need for lubrication. Usually one to two drops to each eye three times daily or as prescribed.

4.3 Contraindications

Hypersensitivity to any component of the product. The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.

4.4 Special Warnings And Precautions For Use

If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue use and consult a physician.

To preserve sterility do not allow the dropper to touch the eye or any other surface.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is insufficient evidence as to safety in pregnancy and this product should, therefore, only be used in pregnancy if it is considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

May cause transient mild stinging or temporarily blurred vision.

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ophthalmologicals: Other ophthalmologicals

ATC code: SO1X A20

Hypromellose is an inert substance. It has no pharmacological activity.

5.2 Pharmacokinetic Properties

Hypromellose is an inert substance. It has no pharmacological activity and, hence, the pharmacokinetic properties have not been studied.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium citrate dihydrate, Disodium Phosphate anhydrous, Sodium biphosphate, Sodium chloride, Benzalkonium chloride, Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months (unopened), 1 month (after first opening).

6.4 Special Precautions For Storage

Do not store above 25°C. Do not refrigerate.

Keep container tightly closed.

Discard 1 month after opening

.

6.5 Nature And Contents Of Container

10 mL Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug

Polystyrene or Polypropylene cap

6.6 Special Precautions For Disposal And Other Handling

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason, instil another drop.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD. UK

8. Marketing Authorisation Number(S)

PL 0649/5900R

9. Date Of First Authorisation/Renewal Of The Authorisation

9th October 1990/19th December 1996

10. Date Of Revision Of The Text

February 2002

Condylox

podofilox

Dosage Form: gel
Physician Information

Condylox® Gel 0.5%

(podofilox gel)

(con' de lox)

Revised: March 2011

Rx only

129503

Condylox Description

Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Condylox Gel 0.5% is formulated for topical administration. Each gram of gel contains 5 mg of podofilox in a buffered alcoholic gel containing alcohol, glycerin, lactic acid, hydroxypropyl cellulose, sodium lactate, and butylated hydroxytoluene.

Podofilox has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is [5R,-(5α, 5aβ, 8aα, 9α]-5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl) furo[3',4':6,7]naphtho-[2,3,-d]-1,3-dioxol-6(5aH)-one.

Podofilox has the following structural formula:

Condylox - Clinical Pharmacology

Mechanism of Action

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.

Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05 mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments1.

Clinical Studies

In the first multicenter clinical study in 326 patients with anogenital warts, Condylox Gel 0.5% and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with Condylox Gel 0.5%. Patients applied Condylox Gel 0.5% twice daily for three consecutive days followed by a 4 day “rest” period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with Condylox Gel 0.5%.

In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, Condylox (podofilox) Topical Solution 0.5% was compared with Condylox Gel 0.5% for efficacy. As in the first clinical trial, patients applied Condylox Gel 0.5% twice daily for three consecutive days followed by a four day “rest” period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with Condylox Gel 0.5%.

Indications and Usage for Condylox

Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS).

Diagnosis

Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.

Contraindications

Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Warnings

Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Condylox Gel 0.5% is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.

Drug Product is Flammable.

Keep Away From Open Flame.

Precautions

General

Data are not available on the safe and effective use of this product for treatment of warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded (see DOSAGE AND ADMINISTRATION).

Information for Patients

Patients using Condylox Gel 0.5% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects.

1. 
   

   This medication should be used only as directed by the health care provider. Patients should be instructed to wash their hands thoroughly before and after each application. It is for external use only. Avoid contact with the eyes.

   
   


2. 
   

   Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

   
   


3. 
   

   Patients should report any signs of adverse reactions to the health care provider.

   
   


4. 
   

   If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.

   
   

Carcinogenesis, Mutagenesis and Impairment of Fertility

An 80-week carcinogenicity study in the mouse was performed using a 0.5% podofilox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the podofilox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, podofilox, to be carcinogenic.2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ.7 These changes were reversible at five weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin8 (the drug was applied twice weekly over a 15-month period).

Podofilox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to podofilox at concentrations up to 0.008 μg/mL, without metabolic activation and 12 μg/mL podofilox with metabolic activation. Results from the mouse micronucleus in vivo assay using podofilox 0.5% solution at doses up to 25 mg/kg (75 mg/m2), indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).

Daily topical application of 0.5% podofilox solution at doses up to the equivalent of 0.2 mg/kg (1.18 mg/m2, approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.

Pregnancy

Pregnancy Category C: 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m2, approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m2, approximately 19 times the recommended maximum human dose.)9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Condylox Gel 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from podofilox, 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

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

In clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.

Adverse Reaction	Mild	Moderate	Severe
Inflammation	32.2%	30.4%	9.3%
Burning	37.1%	25.9%	11.5%
Erosion	27.0%	20.8%	8.9%
Pain	23.7%	20.4%	11.5%
Itching	32.2%	16.0%	7.8%
Bleeding	19.2%	3.0%	0.7%

Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.

The most common systemic adverse event reported during the clinical studies was headache (7%).

Overdosage

Topically applied podofilox may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible.10 Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures.11 Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.

Condylox Dosage and Administration

The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated.

Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles. If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Condylox Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm2 or less of wart tissue and to no more than 0.5 g of the gel per day.

Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.

How is Condylox Supplied

Condylox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 52544-045-13. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Avoid excessive heat. Do not freeze.

Keep out of reach of children.

Rx only

REFERENCES

1. 
   

   Von Krogh G. Podophyllotoxin in serum: Absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata. Sex Trans Disease 1982: 9: 26-33.

   
   


2. 
   

   Berenblum I. The effect of podophyllotoxin on the skin of the mouse, with reference to carcinogenic, cocarcinogenic, and anticarcinogenic action. J Cancer Inst 11:839-841, 1951.

   
   


3. 
   

   Kaminetzky HA, Swerdlow M. Podophyllin and the mouse cervix: assessment of carcinogenic potential. Am J Obst Gyn 95:486-490, 1965.

   
   


4. 
   

   McGrew EA, Kaminetzky HA. The genesis of experimental cervical epithelial dysplasia. Am J Clin Path 35:538-545, 1961.

   
   


5. 
   

   Roe FJC, Salaman MH. Further studies on incomplete carcinogenesis: triethylene melamine (T.E.M.) 1,2 benxanthracene and beta-propiolactone as initiators of skin tumor formation in the mouse. Brit J Cancer, 9:177-203, 1955.

   
   


6. 
   

   Taper HS. Induction of the deficient acid DNAase activity in mouse interfollicular epidermis by croton oil as a possible tumor promoting mechanism. Zeitschrift fur Krebsforschung and Klinisch Onkologie (Cancer Research and Clinical Oncology, Berlin) 90:197-210, 1977.

   
   


7. 
   

   Kaminetzky HA, McGrew EA, Phillips RL. Experimental cervical epithelial dysplasia. J Obst Gyn 14:1-10, 1959.

   
   


8. 
   

   Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix: Effect of long term application. Arch Path 73:481-485, 1962.

   
   


9. 
   

   Thiersch JB. Effect of podophyllin (P) and podophylotoxine (PT.) on the rat litter in utero. Soc Exptl Biol Med Proc. 113:124-127, 1963.

   
   


10. 
    

    Savel H.: Clinical experience with intravenous podophyllotoxin. Proc Amer Assoc Cancer Res, 1964; 5: 56.

    
    


11. 
    

    Cassidy DE, Dewry J and Fanning JP: Podophyllum toxicity: A report of a fatal case and a review of the literature. J Toxicol Clinic Toxicol 1982: 19: 35-44.

    
    

For all medical inquiries contact:

WATSON

Medical Communications

Parsippany, NJ 07054 USA

800-272-5525

Distributed By:

Watson Pharma, Inc.

Parsippany, NJ 07054 USA

Manufactured By:

DPT Laboratories, Ltd.

San Antonio, TX 78215

129503

Revised: March 2011

PRINCIPAL DISPLAY PANEL

Condylox Gel

3.5 g

NDC 52544-045-13

Condylox  podofilox  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-045 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PODOFILOX (PODOFILOX) PODOFILOX 5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ALCOHOL   GLYCERIN   LACTIC ACID   HYDROXYPROPYL CELLULOSE   SODIUM LACTATE   BUTYLATED HYDROXYTOLUENE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-045-13 3.5 g In 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020529	03/13/1997

Labeler - Watson Pharma, Inc. (966714656)

Revised: 08/2011Watson Pharma, Inc.

More Condylox resources

• Condylox Side Effects (in more detail)
• Condylox Use in Pregnancy & Breastfeeding
• Condylox Support Group
• 3 Reviews for Condylox - Add your own review/rating

• Condylox Monograph (AHFS DI)


• Condylox Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Condylox Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Condylox Consumer Overview

Compare Condylox with other medications

• Condylomata Acuminata

Zanaflex

Generic Name: Tizanidine Hydrochloride
Class: Centrally Acting Skeletal Muscle Relaxants
VA Class: MS200
Chemical Name: 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine monohydrochloride
Molecular Formula: C₉H₈ClN₅S•HCl
CAS Number: 64461-82-1

Introduction

Skeletal muscle relaxant; centrally acting α₂-adrenergic agonist.^{1 2}

Uses for Zanaflex

Spasticity

Management of spasticity associated with cerebral or spinal injury, alone or in conjunction with other standard therapies (e.g., baclofen).^{1 2 5}

Zanaflex Dosage and Administration

General

• 
  

  Individualize dosage according to the patient's requirements and response using the lowest dosage that produces optimum response without adverse effects.^{1 2}

  
  

Administration

Oral Administration

Clinically important differences (e.g., increased adverse effects, delayed or more rapid onset of activity) may be apparent when switching administration of capsules or tablets between fed and/or fasting states, switching between capsules and tablets in fed state, or switching between administration of intact capsule and sprinkling capsule contents on applesauce.¹ Be thoroughly familiar with possible pharmacokinetic changes associated with these conditions.¹ (See Absorption under Pharmacokinetics.)

Dosage

Available as tizanidine hydrochloride; dosage expressed in terms of tizanidine.¹

Adults

Spasticity

Oral

Initially, 4 mg; single doses <8 mg not effective in clinical trials, but 4-mg dose used to minimize the incidence of common dose-related adverse effects (e.g., orthostatic hypotension).^{1 2}

Repeat 4-mg dose every 6–8 hours as needed for a maximum of 3 doses in 24 hours.^{1 2}

Increase dosage gradually in increments of 2–4 mg daily over a period of 2–4 weeks until optimum therapeutic effects are obtained with tolerable adverse effects.^{1 2} (See Limited Experience with Long-term Use of Higher Dosages under Cautions.)

Prescribing Limits

Adults

Spasticity

Oral

Maximum 36 mg in a 24-hour period.^{1 2}

Special Populations

Renal Impairment

Initiate with caution in patients with renal impairment (Cl_cr <25 mL/minute).¹ In these patients, use smaller individual doses during dosage titration; if higher doses are needed, increase the amount of each individual dose rather than increasing the frequency of dosing.¹

Cautions for Zanaflex

Contraindications

• 
  

  Concomitant therapy with ciprofloxacin or fluvoxamine.^{1 6 7 8} (See Specific Drugs under Interactions.)

  
  


• 
  

  Known hypersensitivity to tizanidine or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Limited Experience with Long-term Use of Higher Dosages

Only limited clinical experience with long-term use of tizanidine at single doses of 8–16 mg or total daily dosages of 24–36 mg.¹ Therefore, only adverse effects with a relatively high incidence were likely to be identified in clinical studies.¹ (See Dosage and Administration.)

Hypotension

Hypotension,^{1 2} occasionally associated with bradycardia, orthostatic effects, dizziness, and, rarely, syncope, reported.¹ Hypotensive effect is dose related.¹

Minimize risk of marked hypotension by careful dosage titration; observe patients for manifestations of hypotension prior to dosage adjustment.¹ Patients moving from supine to upright position may be at increased risk for hypotension and orthostatic effects.¹

Use caution in patients receiving concomitant antihypertensive therapy and avoid use with other α₂-adrenergic agonists (e.g., clonidine).¹ Because clinically important hypotension reported with concurrent use of either fluvoxamine or ciprofloxacin, these drugs are contraindicated in patients receiving tizanidine.¹ (See Interactions.)

Risk of Liver Injury

Liver injury (most often hepatocellular) reported occasionally.¹ Elevations (i.e., >3 times ULN, or 2 times ULN if baseline levels were elevated) of ALT or AST reported in about 5% of tizanidine-treated patients in controlled studies.¹ In most cases, resolved rapidly upon drug discontinuance without residual problems.¹ In patients with elevated aminotransferase concentrations, nausea, vomiting, anorexia, and jaundice occasionally reported.¹ Death associated with liver failure reported rarely.¹

Monitor serum aminotransferase concentrations prior to and during the first 6 months of treatment (e.g., at baseline and at 1, 3, and 6 months) and periodically thereafter based on clinical status.¹

Avoid tizanidine or use only with extreme caution in patients with hepatic impairment. ¹ (See Hepatic Impairment under Cautions.)

Sedation

Dose-related sedation, sometimes severe.¹ May interfere with daily activity.¹

Hallucinations/Psychotic-like Symptoms

Hallucinations (formed, visual) or delusions reported in 3% of tizanidine-treated patients in 2 controlled studies; all cases reported within first 6 weeks of therapy.¹ Psychoses associated with hallucinations reported in at least 1 patient.¹

Potential Interaction with Fluvoxamine or Ciprofloxacin

In pharmacokinetic studies, substantial increases in serum tizanidine concentrations observed during concurrent administration of fluvoxamine or ciprofloxacin^{1 6 8 10} (potent CYP1A2 inhibitors); potentiated hypotensive and sedative effects also observed.^{1 6 8 10} Concurrent administration of fluvoxamine or ciprofloxacin contraindicated.^{1 6 7 8} (See Interactions.)

Potential Interaction with Other CYP1A2 Inhibitors

Potential drug interactions with other CYP1A2 inhibitors; ordinarily should avoid concurrent use.¹ If combined use is necessary, use drugs with caution.¹ (See Interactions.)

General Precautions

Cardiovascular Effects

Potential for prolongation of the QT interval and bradycardia based on animal studies.¹

Pulse rate reduction associated with decreases in BP reported.¹

Ocular Effects

Dose-related retinal degeneration and corneal opacities observed in animal studies.¹ No reports of corneal opacities or retinal degeneration in clinical studies.¹

Use in Women Taking Oral Contraceptives

Concurrent use of tizanidine and oral contraceptives may substantially reduce the clearance of tizanidine; ordinarily should avoid concomitant use.¹ If clinically necessary, reduce initial tizanidine dosage and titration rate.¹ (See Specific Drugs under Interactions.)

Discontinuance of Therapy

Possible rebound manifestations with abrupt withdrawal of therapy, including hypertension, tachycardia, hypertonia, tremor, and anxiety.¹

If therapy is to be discontinued, decrease dosage gradually, particularly in patients who have been receiving high dosages for prolonged periods, to minimize the risk of withdrawal and rebound symptoms.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether tizanidine is distributed into milk.¹ However, because it is lipid-soluble, tizanidine might be expected to pass into milk.¹ Use caution in nursing women.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Clearance is decreased 4-fold; use with caution.¹

Hepatic Impairment

Tizanidine undergoes extensive first-pass metabolism in the liver; hepatic impairment is likely to substantially affect the drug's pharmacokinetics.¹ Avoid use or use only with extreme caution in patients with hepatic impairment.¹ (See Risk of Liver Injury under Cautions.)

Renal Impairment

Clearance is reduced by >50% in patients with Cl_cr <25 mL/minute.¹ Use with caution in patients with renal impairment.¹ Monitor closely for onset or increased severity of adverse effects (e.g., dry mouth, somnolence, asthenia, dizziness) that may indicate potential overdosage.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Dry mouth,^{1 2 3 4} somnolence,^{1 2 3 4} asthenia (weakness, fatigue, and/or tiredness),^{1 2 3} dizziness.^{1 2 3}

Interactions for Zanaflex

Extensively metabolized, mainly by CYP1A2.¹

Drugs Affecting Hepatic Microsomal Enzymes

CYP1A2 inhibitors: Potential pharmacokinetic interaction (decreased plasma clearance of tizanidine).^{1 6 7 8 9} Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution.¹ (See Specific Drugs under Interactions.)

Drugs Metabolized by Hepatic Microsomal Enzymes

Not likely to affect metabolism of CYP substrates.¹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Peak plasma concentrations of acetaminophen may be delayed; no effect on tizanidine pharmacokinetics1
Acyclovir	Possible increased plasma tizanidine concentrations1	Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1
Alcohol	Increased AUCs and peak concentrations of tizanidine; potential additive CNS depression1 11
Antiarrhythmics (amiodarone, mexiletine, propafenone, verapamil)	Possible increased plasma tizanidine concentrations1	Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1
Antihypertensive agents	Potential additive hypotensive effects1 11	Use antihypertensive agents concomitantly with caution; avoid concurrent use with other α2-adrenergic agonists (e.g., clonidine)1
CNS depressants (e.g., baclofen, dantrolene, diazepam)	Potential additive CNS depression1
Fluoroquinolones	Ciprofloxacin: Markedly increased plasma concentrations and AUCs of tizanidine; 1 10 increased risk of adverse cardiovascular and CNS effects1 10 Other fluoroquinolones: Possible increased plasma tizanidine concentrations1	Ciprofloxacin: Concomitant use contraindicated1 Other fluoroquinolones: Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1
Fluvoxamine	Markedly increased plasma concentrations, elimination half-life, and AUCs of tizanidine1 6 8 Increased risk of adverse cardiovascular and CNS effects1 6 8	Concomitant use contraindicated1 6 7 8
Histamine H2-receptor antagonists (cimetidine, famotidine)	Possible increased plasma tizanidine concentrations1	Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1
Oral contraceptives	Potential decreased plasma clearance of tizanidine (by ≤50%)1	Avoid concurrent use, if possible1 If concomitant use is necessary, reduce initial tizanidine dosage and rate of subsequent dosage titration1
Ticlopidine	Possible increased plasma tizanidine concentrations1	Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1
Zileuton	Possible increased plasma tizanidine concentrations1	Ordinarily avoid concomitant use; if concomitant use is necessary, use with caution1

Zanaflex Pharmacokinetics

Absorption

Bioavailability

Essentially completely absorbed following oral administration of capsules and tablets; peak plasma concentrations attained in about 1 hour.¹

Commercially available capsules and tablets are bioequivalent under fasting conditions, but not under nonfasting conditions.¹

Food

Tablets: Food increases the mean peak plasma concentration by about 30%, increases the median time to peak plasma concentration from about 60 minutes to 85 minutes, and increases the extent of absorption by about 30%.¹

Capsules: Food decreases the mean peak plasma concentration by 20% and increases the median time to peak plasma concentration from about 1 hour to 3 hours, and increases the extent of absorption by about 10%.¹ When given with food, the amount of tizanidine absorbed from the capsules about 80% of the amount absorbed from the tablet.¹

Administration of the capsule contents sprinkled on applesauce is not bioequivalent to intact capsule under fasting conditions and results in a 15–20% increase in peak plasma concentration and AUC and a 15-minute decrease in median lag time and time to achieve peak plasma concentration compared with administration of intact capsule while fasting.¹

Distribution

Plasma Protein Binding

About 30%.¹

Elimination

Metabolism

Undergoes extensive first-pass hepatic metabolism.¹ Metabolized mainly by CYP1A2. ¹

Elimination Route

Recovered in urine (60%) and feces (20%) following administration of single or multiple radiolabeled doses.¹

Half-life

About 2.5 hours.¹

Stability

Storage

Oral

Capsules and Tablets

25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Centrally acting α₂-adrenergic agonist with myotonolytic effects on skeletal muscle.^{1 2 3 4}

  
  


• 
  

  Exact mechanism in reducing muscle tone and spasm frequency is not clear.¹ Reportedly decreases the frequency and amplitude of muscle spasms (tonic reflexes) that arise in response to muscle stretching in patients with various spinal cord lesions.² Appears to reduce spasticity by increasing presynaptic inhibition of motor neurons, leading to reduced facilitation of spinal motor neurons and a resultant decrease in muscle tone.^{1 5}

  
  


• 
  

  Greatest effects on polysynaptic pathways, with no important effect on monosynaptic spinal reflexes.^{1 2} The drug does not have direct effects on skeletal muscle fibers or the neuromuscular junction.¹

  
  


• 
  

  Shown to have antinociceptive effects in animals,^{2 3} and some reports have suggested that it may improve pain associated with muscle spasm.²

  
  


• 
  

  Structurally and pharmacologically related to clonidine and other α₂-adrenergic agonists;¹ however, tizanidine has only one-tenth to one-fiftieth of clonidine's antihypertensive potency.¹

  
  

Advice to Patients

• 
  

  Importance of advising patients that clinical experience with long-term or high-dose tizanidine therapy is limited.¹

  
  


• 
  

  Risk of marked orthostatic hypotension; importance of exercising caution when moving from a supine to a fixed upright position.¹

  
  


• 
  

  Risk of sedation, which may be additive when taken in conjunction with alcohol or other CNS depressants; importance of exercising caution when performing activities requiring alertness, including driving a motor vehicle or operating machinery.¹

  
  


• 
  

  Importance of advising patients of potential changes in absorption profile and resulting changes in efficacy and adverse effect profile when taken with food.¹ (See Pharmacokinetics.)

  
  


• 
  

  Importance of not discontinuing abruptly because of potential for rebound hypertension and tachycardia.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses, and of informing clinicians or pharmacists whenever any drug is added or discontinued.¹ Importance of not taking tizanidine concomitantly with either ciprofloxacin or fluvoxamine.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tizanidine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	2 mg (of tizanidine)	Zanaflex	Acorda
		4 mg (of tizanidine)	Zanaflex	Acorda
		6 mg (of tizanidine)	Zanaflex	Acorda
	Tablets	2 mg (of tizanidine)*	Tizanidine Hydrochloride Tablets
			Zanaflex (scored)	Acorda
		4 mg (of tizanidine)*	Tizanidine Hydrochloride Tablets
			Zanaflex (scored)	Acorda

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

TiZANidine HCl 2MG Tablets (SANDOZ): 90/$20.99 or 100/$22.97

Zanaflex 2MG Capsules (ACORDA THERAPEUTICS): 150/$376.00 or 450/$1,059.99

Zanaflex 4MG Capsules (ACORDA THERAPEUTICS): 150/$470.00 or 450/$1,359.96

Zanaflex 4MG Tablets (ACORDA THERAPEUTICS): 90/$215.00 or 270/$613.95

Zanaflex 6MG Capsules (ACORDA THERAPEUTICS): 150/$680.02 or 450/$2,000.94

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 25, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Acorda Therapeutics, Inc. Zanaflex (tizanidine hydrochloride) capsules and tablets prescribing information. Hawthorne, NY; 2008 Apr.

2. Wagstaff AJ, Bryson HM. Tizanidine: a review of its pharmacology, clinical efficacy, and tolerability in the management of spasticity associated with cerebral and spinal disorders. Drugs. 1997; 53:435-52. [PubMed 9074844]

3. Nance PW, Bugaresti J, Shellenberger K et al. and the North American Tizanidine Study Group. Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. Neurology. 1994; 44:S44-52. [IDIS 339523] [PubMed 7970010]

4. United Kingdom Tizanidine Trial Group. A double-blind, placebo-controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. Neurology. 1994; 44:S70-8.

5. Lataste X, Emre M, Davic C et al. Comparative profile of tizanidine in the management of spasticity. Neurology. 1994; 44:S53-9.

6. Granfors MT, Backman JT, Neuvonen M et al. Fluvoxamine drastically increases concentrations and effects of tizanidine: a potentially hazardous interaction. Clin Pharmacol Ther. 2004; 75:331-41. [IDIS 514169] [PubMed 15060511]

7. Momo K, Doki K, Hosono H et al. Drug interaction of tizanidine and fluvoxamine. Clin Pharmacol Ther. 2004; 76:509-10. [PubMed 15536467]

8. Barr Laboratories, Inc. Fluvoxamine maleate tablets prescribing information. Ponoma, NY; 2005 Jan.

9. Granfors MT, Backman JT, Laitila J et al. Tizanidine is mainly metabolized by cytochrome p450 1A2 in vitro. Br J Clin Pharmacol. 2004; 57:349-53. [PubMed 14998432]

10. Granfors MT, Backman JT, Neuvonen M et al. Ciprofloxacin greatly increases concentrations and hypotensive effect of tizanidine by inhibiting its cytochrome P450 1A2-mediated presystemic metabolism. Clin Pharmacol Ther. 2004; 76:598-606. [PubMed 15592331]

11. Publow SW, Branam DL. Hypotension and bradycardia associated with concomitant tizanidine and lisinopril therapy. Am J Health Syst Pharm. 2010; 67:1606-10. [PubMed 20852161]

c. Drug interaction of tizanidine and fluvoxamine. Clin Pharmacol Ther. 2004; 76:509-10. Letter.

More Zanaflex resources

• Zanaflex Side Effects (in more detail)
• Zanaflex Use in Pregnancy & Breastfeeding
• Drug Images
• Zanaflex Drug Interactions
• Zanaflex Support Group
• 49 Reviews for Zanaflex - Add your own review/rating

• Zanaflex Prescribing Information (FDA)


• Zanaflex Consumer Overview


• Zanaflex Advanced Consumer (Micromedex) - Includes Dosage Information


• Zanaflex MedFacts Consumer Leaflet (Wolters Kluwer)


• Tizanidine Prescribing Information (FDA)

Compare Zanaflex with other medications

• Cluster Headaches
• Muscle Spasm

Pro Pet Antiseptic

Generic Name: chlorhexidine spray

Dosage Form: FOR ANIMAL USE ONLY
Antiseptic Medicated Spray

Helps the healing process of minor cuts, flea bites and skin irritations

With Aloe Vera to soothe the skin

Non-stinging formula with bitter chew deterrents

Dr. Jeff Tip:

Treat skin irritations as soon as they are detected to avoid further aggravation from licking, biting, and scratching.

Clean area thoroughly. Spray as needed to sore areas, abrasions, lesions, and other minor skin irritations. Consult your veterinarian if the condition persists. May be covered or bandaged after application.

Chlorhexidine Diacetate 0.05%

Aloe Vera, Bitter Extractives, Boric Acid, Fragrance, Glycerin, Isopropyl Alcohol, Propylene Glycol, Water,

Consult your veterinarian in cases of deep or puncture wounds, serious burns or if redness and irritation persists or increases.

Keep this product out of reach of children  and pets to avoid unintended consumption

Pro Pet

Antiseptic

Medicated Spray

Helps the healing process of minor cuts, flea bites and skin irritations

Non-stinging formula with bitter chew deterrents


With Aloe Vera


Veterinarian Approved Dr. Jeff Werber, D.V.M..


Net Wt.

4 Fl. oz.

(118 ml)

PRO PET  antiseptic medicated spray  spray

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 24730-627 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE (CHLORHEXIDINE) CHLORHEXIDINE 0.06 g  in 118 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF   BORIC ACID   GLYCERIN   ISOPROPYL ALCOHOL   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24730-627-04 118 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2001

Labeler - United Pet Group (931135730)

Establishment
Name	Address	ID/FEI	Operations
JUNGLE LABORATORIES CORPORATION		032615270	manufacture

Revised: 02/2010United Pet Group

Procainamide Controlled-Release

Pronunciation: proe-KANE-a-mide
Generic Name: Procainamide
Brand Name: Examples include Procanbid and Pronestyl-SR

Taking Procainamide Controlled-Release for a prolonged period of time may lead to the development of antibodies in your blood that are sometimes associated with autoimmune diseases such as lupus. If you experience butterfly-shaped rash on the face, swollen or tender joints, unexplained fever, or severe or persistent tiredness, seizures, or mental or mood changes, contact your doctor.

Procainamide Controlled-Release should only be used to treat life-threatening irregular heartbeat. It has been associated with an increased risk of death when used to treat non-life-threatening irregular heartbeat. Talk with your doctor for more information.

Procainamide Controlled-Release may cause severe and sometimes fatal blood problems (eg, bone marrow suppression, low blood platelet or white blood cell levels, anemia). These side effects have occurred most often during the first 12 weeks of therapy. Lab tests, such as complete blood cell counts, may be performed weekly for the first 3 months of therapy and then periodically to monitor for these side effects. If you experience fever, chills, sore throat, mouth sores or irritation, or unusual bruising or bleeding, contact your doctor immediately. Your risk may be greater if you already have bone marrow or blood problems.

Procainamide Controlled-Release is used for:

Treating certain abnormal heart rhythms.

Procainamide Controlled-Release is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).

Do NOT use Procainamide Controlled-Release if:

• you are allergic to any ingredient in Procainamide Controlled-Release


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a local anesthetic (eg, procaine)


• you have complete heart block, lupus, or certain severe abnormal heart rhythms (eg, torsades de pointes)


• you are taking astemizole, cisapride, dofetilide, a phenothiazine (eg, chlorpromazine), a phosphodiesterase type 5 inhibitor (eg, sildenafil), terfenadine, or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Procainamide Controlled-Release:

Some medical conditions may interact with Procainamide Controlled-Release. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of liver or kidney disease; heart block, congestive heart failure, QT prolongation, or other heart problems; bone marrow problems; blood problems (eg, low blood platelet or white blood cell levels); myasthenia gravis; or digitalis (digoxin) toxicity

Some MEDICINES MAY INTERACT with Procainamide Controlled-Release. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, quinidine), anticholinergics (eg, hyoscyamine), arsenic, astemizole, cisapride, dofetilide, droperidol, H₂ antagonists (eg, cimetidine), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), terfenadine), trimethoprim, or ziprasidone because the risk of side effects, including irregular heartbeat, may be increased


• Neuromuscular blockers (eg, succinylcholine) because actions or side effects may be increased by Procainamide Controlled-Release

This may not be a complete list of all interactions that may occur. Ask your health care provider if Procainamide Controlled-Release may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Procainamide Controlled-Release:

Use Procainamide Controlled-Release as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Procainamide Controlled-Release may be taken on an empty stomach or with food.


• Swallow Procainamide Controlled-Release whole. Do not break, crush, or chew before swallowing.


• Take Procainamide Controlled-Release regularly to receive the most benefit from it.


• Continue to use Procainamide Controlled-Release even if you feel well. Do not miss any doses.


• If you miss a dose of Procainamide Controlled-Release, take it as soon as possible. If it is almost time for our next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Procainamide Controlled-Release.

Important safety information:

• Procainamide Controlled-Release may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Procainamide Controlled-Release.


• Drinking alcohol may decrease the effectiveness of Procainamide Controlled-Release. Check with your doctor before drinking alcohol.


• Do not exceed the recommended dose or use Procainamide Controlled-Release for longer than prescribed without checking with your doctor.


• Do not suddenly stop taking Procainamide Controlled-Release without checking with your doctor.


• Procainamide Controlled-Release may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Procainamide Controlled-Release may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Procainamide Controlled-Release.


• Procainamide Controlled-Release may interfere with certain lab tests. Make sure your doctor and laboratory personnel know you are using Procainamide Controlled-Release.


• With some brands of Procainamide Controlled-Release, you may see what looks like the original tablet in your stool. This is normal.


• LAB TESTS, including heart function tests, complete blood cell counts, and serum ANA titers, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Procainamide Controlled-Release with caution in the ELDERLY because they may be more sensitive to its effects.


• Use Procainamide Controlled-Release with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Procainamide Controlled-Release during pregnancy. Procainamide Controlled-Release is excreted in breast milk. Do not breast-feed while you are taking Procainamide Controlled-Release.

Possible side effects of Procainamide Controlled-Release:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bitter taste.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly-shaped rash on the face; chest pain; dark urine; depression; diarrhea; dizziness or lightheadedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; loss of appetite; mood or mental changes; mouth sores or irritation; muscle pain or weakness; nausea; pale stools; seizures; stomach pain; severe or persistent tiredness; shortness of breath; swollen or tender joints; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Procainamide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fast or irregular heartbeat; irregular or difficult breathing; severe drowsiness; tremor.

Proper storage of Procainamide Controlled-Release:

Store Procainamide Controlled-Release between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Procainamide Controlled-Release out of the reach of children and away from pets.

General information:

• If you have any questions about Procainamide Controlled-Release, please talk with your doctor, pharmacist, or other health care provider.


• Procainamide Controlled-Release is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Procainamide Controlled-Release. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Procainamide resources

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

Compare Procainamide with other medications

• Arrhythmia

Poly-Histine-D

Generic Name: pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill toe LOX a meen/fen ill proe pa NOLE a meen)

Brand Names: Delhist D, Delhistine D, Histine-D, Iohist D, KG-Hist D, Liqui-Histine-D, Metahistine D, Multihist D, Multihistamine-D, Poly-D, Poly-Histine-D, Prohistine-D, Trihist-D

What is Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Pheniramine, pyrilamine, and phenyltoloxamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine, pyrilamine, and phenyltoloxamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking this medication.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of this medication.

To ensure that you get a correct dose, measure the liquid form of pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose can cause serious harm.

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine.

Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Poly-Histine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine, phenyltoloxamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Poly-Histine-D resources

• Poly-Histine-D Drug Interactions
• Poly-Histine-D Support Group
• 0 Reviews for Poly-Histine-D - Add your own review/rating

Compare Poly-Histine-D with other medications

• Allergies
• Eye Dryness/Redness
• Eye Redness/Itching
• Hay Fever
• Nasal Congestion
• Rhinorrhea
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is available with a prescription under the brand names Poly-Histine-D (capsules and elixir) and Liqui-Histine Elixir. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Theracodophen Low 90

Generic Name: hydrocodone bitartrate and acetaminophen

Dosage Form: tablet
Theracodophen-Low-90 Hydrocodone Bitartrate and Acetaminophen

NDC 53746-111-05


Hydrocodone

Bitartrate and

Acetominophen

Tablets, USP


Multiple Strengths:

Do not dispense unless

strength is stated.


Rx only      500 TABLETS


Each tablet contains:


hydrocodone bitartrate                5 mg

acetaminophen                          500 mg


Usual adult dosage: See package insert.


Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C

(59 - 86 degrees F). [See USP Controlled Room Temperature].


Dispense in tight, light-resistant container as defined in the USP.


Protect from light.


Do not accept if inner seal is broken or missing.


Manufactured by:    Amneal Pharmaceticals of NY

                             Hauppauge, NY 11788


Distributed by:        Amneal Pharmaceuticals

                             Glasgow, KY 42141

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for

oral administration.


Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs

as fine, white crystals or as a crystalline powder. It is affected by light.

The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one

tartrate (1:1) hydrate (2:5). It has the following structural formula:

Acetaminophen, 4’-Hyroxyacetanilide, a slightly bitter, white, odorless,

crystalline powder, is a non-opiate, non-salicylate analgesic and

antipyretic. It has the following structural formula:

Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration

are available in a variety of strengths as described in the following table.

Strength                          Hydrocodone Bitartrate                    Acetaminophen

2.5 mg/500mg                           2.5mg                                       500mg

5mg/500mg                               5mg                                         500mg

7.5mg/325mg                            7.5mg                                       325mg

7.5mg/500mg                            7.5mg                                       500mg

7.5mg/650mg                            7.5mg                                       650mg

7.5mg/750mg                            7.5mg                                       750mg

10mg/325mg                             10mg                                        325mg

10mg/500mg                             10mg                                        500mg

10mg/650mg                             10mg                                        650mg

10mg/660mg                             10mg                                        660mg

10mg/750mg                             10mg                                        750mg

In addition, each tablet contains the following inactive ingredients:

anhydrous lactose, croscarmellose sodium, crospovidone, magnesium

stearate, microcrystalline cellulose, povidone, starch and stearic acid;

except the 7.5 mg/325 mg, 10 mg/325 mg and 10 mg/500 mg tablets do

not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD

and C Yellow Number 6 Aluminum Lake; the 7.5 mg/650 mg tablets include

FD and C Red Number 40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750

mg tablets include D and C Yellow Number 10 Aluminum Lake; the 10 mg/500

mg include FD and C Blue Number 2 Aluminum Lake; and the 10 mg/650 mg

tablets include FD and C Blue Number 1 Aluminum Lake and D and C Yellow

number 10 Aluminum Lake. Meets USP Dissolution Test 1.

Hydrocodone is a semisynthetic narcotic analgesic and antitussive

with multiple actions qualitatively similar to those of codeine. Most

of these involve the central nervous system and smooth muscle. The

precise mechanism of action of hydrocodone and other opiates is not

known, although it is believed to relate to the existence of opiate receptors

in the central nervous system. In addition to analgesia, narcotics may

produce drowsiness, changes in mood and mental clouding.


The analgesic action of acetaminophen involves peripheral influences, but

the specific mechanism is as yet undetermined. Antipyretic activity is

mediated through hypothalamic heat regulating centers. Acetaminophen

inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen

have negligible effects on the cardiovascular or respiratory systems; however,

toxic doses may cause circulatory failure and rapid, shallow breathing.


Pharmacokinetics: The behavior of the individual components is described

below.


Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to

five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL.

Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was

determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of

metabolism including O-demethylation, N-demethylation and 6-keto reduction

to the corresponding 6-α- and 6-β-hydroxymetabolites.

See OVERDOSAGE for toxicity information.


Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal

tract and is distributed throughout most body tissues. The plasma half-life is

1.25 to 3 hours, but may be increased by liver damage and following overdosage.

Elimination of acetaminophen is principally by liver metabolism (conjugation) and

subsequent renal excretion of metabolites. Approximately 85% of an oral dose

appears in the urine within 24 hours of administration, most as the glucuronide

conjugate, with small amounts of other conjugates and unchanged drug.

See OVERDOSAGE for toxicity information.

Hydrocodone and acetaminophen tablets are indicated for the relief of

moderate to moderately severe pain.

This product should not be administered to patients who have

previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit

cross-sensitivity to hydrocodone.

Respiratory Depression: At high doses or in sensitive patients,

hydrocodone may produce dose-related respiratory depression

by acting directly on the brain stem respiratory center. Hydrocodone

also affects the center that controls respiratory rhythm, and may

produce irregular and periodic breathing.


Head Injury and Increased Intracranial Pressure: The respiratory

depressant effects of narcotics and their capacity to elevate cerebrospinal

fluid pressure may be markedly exaggerated in the presence of head injury,

other intracranial lesions or a pre-existing increase in intracranial pressure.

Furthermore, narcotics produce adverse reactions which may obscure the

clinical course of patients with head injuries.


Acute Abdominal Conditions: The administration of narcotics may obscure

the diagnosis or clinical course of patients with acute abdominal conditions.

General:

Special Risk Patients: As with any narcotic analgesic agent,

hydrocodone bitartrate and acetaminophen tablets should be used with

caution in elderly or debilitated patients, and those with severe impairment

of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic

hypertrophy or urethral stricture. The usual precautions should be observed

and the possibility of respiratory depression should be kept in mind.


Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics,

caution should be exercised when hydrocodone bitartrate and acetaminophen

tablets are used postoperatively and in patients with pulmonary disease.


Information for Patients: Hydrocodone, like all narcotics, may impair mental

and/or physical abilities required for the performance of potentially hazardous tasks

such as driving a car or operating machinery; patients should be cautioned accordingly.


Alcohol and other CNS depressants may produce an additive CNS depression, when

taken with this combination product, and should be avoided.


Hydrocodone may be habit-forming. Patients should take the drug only for as long as

it is prescribed, in the amounts prescribed, and no more frequently than prescribed.


Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy

should be monitored with serial liver and/or renal function tests.


Drug Interactions: Patients receiving narcotics, antihistamines, antipsychotics,

antianxiety agents, or other CNS depressants (including alcohol) concomitantly with

hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS

depression. When combined therapy is contemplated, the dose of one or both agents

should be reduced.


The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations

may increase the effect of either the antidepressant or hydrocodone.


Drug/Laboratory Test Interactions: Acetaminophen may produce false-positive

test results for urinary 5-hydroxyindoleacetic acid.


Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies

have been conducted in animals to determine whether hydrocodone or acetaminophen

have a potential for carcinogenesis, mutagenesis, or impairment of fertility.


Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and

well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen

tablets should be used during pregnancy only if the potential benefit justifies the potential

risk to the fetus.


Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly

prior to delivery will be physically dependent. The withdrawal signs include irritability and

excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased

stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not

always correlate with the duration of maternal opioid use or dose. There is no consensus

on the best method of managing withdrawal.


Labor and Delivery: As with all narcotics, administration of this product to the mother

shortly before delivery may result in some degree of respiratory depression in the newborn,

especially if higher doses are used.


Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the

significance of its effects on nursing infants is not known. It is not known whether hydrocodone

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 hydrocodone, 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: Safety and effectiveness in pediatric patients have not been established.


Geriatric Use: Clinical studies of hydrocodone bitartrate 5 mg and acetaminophen 500 mg did not

include sufficient numbers of subjects aged 65 and over to determine whether they respond

differently from younger subjects. Other reported clinical experience has not identified differences

in responses between the elderly and younger patients. In general, dose selection for an elderly

patient should be cautious, usually starting at the low end of the dosing range, reflecting the

greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease

or other drug therapy.


Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted

by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function

due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly

patients are more likely to have decreased renal function, care should be taken in dose selection, and

it may be useful to monitor renal function.


Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should

be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

The most frequently reported adverse reactions are lightheadedness, dizziness, sedation,

nausea and vomiting. These effects seem to be more prominent in ambulatory than in

nonambulatory patients, and some of these adverse reactions may be alleviated if the

patient lies down.


Other adverse reactions include:

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental

and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.


Gastrointestinal System: Prolonged administration of hydrocodone bitartrate and

acetaminophen tablets may produce constipation.


Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention

have been reported with opiates.


Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory

depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).


Special Senses: Cases of hearing impairment or permanent loss have been reported

predominantly in patients with chronic overdose.


Dermatological: Skin rash, pruritus.


The following adverse drug events may be borne in mind as potential effects of acetaminophen:

allergic reactions, rash, thrombocytopenia, agranulocytosis.


Potential effects of high dosage are listed in the OVERDOSAGE section.

Controlled Substance: Hydrocodone Bitartrate and Acetaminophen Tablets are

classified as a Schedule III controlled substance.


Abuse and Dependence: Psychic dependence, physical dependence, and tolerance

may develop upon repeated administration of narcotics; therefore, this product should

be prescribed and administered with caution. However, psychic dependence is unlikely

to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short

time for the treatment of pain.


Physical dependence, the condition in which continued administration of the drug is required

to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions

only after several weeks of continued narcotic use, although some mild degree of physical

dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly

large doses are required in order to produce the same degree of analgesia, is manifested initially

by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of

analgesia. The rate of development of tolerance varies among patients.

Following an acute overdosage, toxicity may result from hydrocodone or

acetaminophen.


Signs and Symptoms

Hydrocodone: Serious overdose with hydrocodone is characterized by

respiratory depression (a decrease in respiratory rate and/or tidal volume,

Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to

stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and

sometimes bradycardia and hypotension. In severe overdosage, apnea,

circulatory collapse, cardiac arrest and death may occur.


Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially

fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis,

hypoglycemic coma and thrombocytopenia may also occur.


Early symptoms following a potentially hepatotoxic overdose may include: nausea,

vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of

hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.


In adults, hepatic toxicity has rarely been reported with acute overdoses of less than

10 grams, or fatalities with less than 15 grams.


Treatment: A single or multiple overdose with hydrocodone and acetaminophen is a

potentially lethal polydrug overdose, and consultation with a regional poison control

center is recommended.


Immediate treatment includes support of cardiorespiratory function and measures to

reduce drug absorption. Vomiting should be induced mechanically, or with syrup of

ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral

activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be

accompanied by an appropriate cathartic. If repeated doses are used, the cathartic

might be included with alternate doses as required. Hypotension is usually hypovolemic

and should respond to fluids. Vasopressors and other supportive measures should be

employed as indicated. A cuffed endotracheal tube should be inserted before gastric

lavage of the unconscious patient and, when necessary, to provide assisted respiration.


Meticulous attention should be given to maintaining adequate pulmonary ventilation. In

severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be

considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K

should be administered intravenously.


Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated

with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since

the duration of action of hydrocodone may exceed that of the naloxone, the patient should

be kept under continuous surveillance and repeated doses of the antagonist should be

administered as needed to maintain adequate respiration. A narcotic antagonist should not

be administered in the absence of clinically significant respiratory or cardiovascular depression.


If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be

administered as early as possible. Serum acetaminophen levels should be obtained, since

levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await

acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained

initially, and repeated at 24-hour intervals.


Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous

administration.


The toxic dose for adults for acetaminophen is 10 g. Dosage should be adjusted according to the severity of the pain and the response

of the patient. However, it should be kept in mind that tolerance to hydrocodone

can develop with continued use and that the incidence of untoward effects is dose

related.

2.5 mg/500 mg 5 mg/500 mg	The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dose should not exceed 8 tablets.
7.5 mg/325 mg 7.5 mg/500 mg 7.5 mg/650 mg	The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.
7.5 mg/750 mg	The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 5 tablets.
10 mg/325 mg 10 mg/500 mg 10 mg/650 mg 10 mg/660 mg	The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.
10 mg/750 mg	The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 5 tablets.

Hydrocodone Bitartrate and Acetominophen Tablets USP are available

in the following strengths:

2.5 mg/500 mg      2.5 mg hydrocodone bitartrate and 500 mg acetaminophen,

                            oblong, white tablets bisected on one side and debossed

                            with WATSON 388on the other side, supplied in bottles of

                            100.

5 mg/500 mg         5 mg hydrocodone bitartrate and 500 mg acetaminophen,

                            capsule-shaped, white tablets bisected on one side and

                            debossed with WATSON 349 on the other side, supplied

                            in bottles of 100 and 500.


7.5 mg/325 mg      7.5 mg hydrocodone bitartrate and 325 mg acetaminophen,

                            capsule-shaped, light orange tablets bisected on one side

                            and debossed with WATSON 3203 on the other side,

                            supplied in bottles of 100.


7.5 mg/500 mg      7.5 mg hydrocodone bitartrate and 500 mg acetaminophen,

                            capsule-shaped, white tablets bisected on one side

                            and debossed with WATSON 385on the other side,

                            supplied in bottles of 100 and 500.


7.5 mg/650 mg      7.5 mg hydrocodone bitartrate and 650 mg acetaminophen,

                            capsule-shaped, pink tablets bisected on one side

                            and debossed with WATSON 502 on the other side,

                            supplied in bottles of 100 and 500.


7.5 mg/750 mg      7.5 mg hydrocodone bitartrate and 750 mg acetaminophen,

                            capsule-shaped, white tablets bisected on one side

                            and debossed with WATSON 387 on the other side,

                            supplied in bottles of 100 and 500.


10 mg/325 mg       10 mg hydrocodone bitartrate and 325 mg acetaminophen,

                            capsule-shaped, yellow tablets bisected on one side

                            and debossed with WATSON 853 on the other side,

                            supplied in bottles of 100 and 500.


10 mg/500 mg       10 mg hydrocodone bitartrate and 500 mg acetaminophen,

                            capsule-shaped, blue tablets bisected on one side

                            and debossed with WATSON 540 on the other side,

                            supplied in bottles of 100 and 500.


10 mg/650 mg       10 mg hydrocodone bitartrate and 650 mg acetaminophen,

                            capsule-shaped, light green tablets bisected on one side

                            and debossed with WATSON 503 on the other side,

                            supplied in bottles of 100 and 500.


10 mg/660 mg       10 mg hydrocodone bitartrate and 660 mg acetaminophen,

                            oval-shaped, white tablets bisected on one side

                            and debossed with WATSON 517 on the other side,

                            supplied in bottles of 100 and 500.


10 mg/750 mg       10 mg hydrocodone bitartrate and 750 mg acetaminophen,

                            capsule-shaped, yellow tablets bisected on one side

                            and debossed with WATSON 3228 on the other side,

                            supplied in bottles of 100.


Store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F). [See USP

controlled room temperature.]


Dispense in a tight, light-resistant container with a child-resistant closure.


Watson Laboratories, Inc.                                    Revised: March 2007

Corona, CA 92880 USA                                                            0907B

                                                                                              14715

A Convenience Packed Medical Food and Drug

Theracodophen-Low-90

Physician Therapeutics

- Theramine 90 Capsules

- Hydrocodone 5 mg plus

  Acetaminophen 500 mg 30 Tablets

                                                                     Rx Only

No Refills Without                 NDC Number 68405-298-36

Physician Authorization                          of this co-pack

Theracodephen-Low-90

Convenience Pack

Hydrocodone-Acetaminophen: Why is this medication prescribed?

Hydrocodone-Acetaminophen is a combination of a narcotic (hydrocodone) and a non-narcotic (acetaminophen)

used to relieve moderate to severe pain. Hydrocodone works by binding to opioid receptors in the brain and spinal

cord, and acetaminophen decreases the formation of prostaglandins, therefore relieving pain.

Theramine: Why is this medication prescribed?

Theramine is a Medical Food product designed to aid in the nutritional management of pain syndromes.

Theramine stimulates production of serotonin, GABA, norepinephrine, nitric oxide, and acetylcholine, the

neurotransmitters that are involved in pain disorders. If the timing and secretion of these neurotransmitters are

effectively modulated, acute, and chronic pain disorders are more effectively managed. Theramine provides L-

arginine at a low dose along with choline and L-glutamine to inhibit the NMDA and opioid receptors.

Theramine aids in the nutritional management of serotonin, GABA, and acetylcholine production deficiencies in

patients with pain sydromes

NDC Number 68405-298-36

THERACODOPHEN-LOW-90  hydrocodone bitartrate and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68405-298 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CROSCARMELLOSE SODIUM   CROSPOVIDONE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   STEARIC ACID

Product Characteristics Color white Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code WATSON;349 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68405-298-36 1 BOTTLE In 1 PACKAGE contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the PACKAGE (68405-298-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040729	12/11/2009

Labeler - Physician Therapeutics LLC (931940964)

Establishment
Name	Address	ID/FEI	Operations
Targeted Medical Pharma, Inc.		126962740	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	manufacture, repack

Revised: 03/2010Physician Therapeutics LLC

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