Antirobe

Dosage Form: FOR ANIMAL USE ONLY
Antirobe®

clindamycin hydrochloride capsules, USP

Antirobe Aquadrops®

clindamycin hydrochloride liquid

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Antirobe Description

Antirobe Capsules and Antirobe AQUADROPS Liquid contain clindamycin hydrochloride which is the hydrated salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced antibiotic produced by Streptomyces lincolnensis var. lincolnensis.

Antirobe Capsules (For Use in Dogs Only):

25 mg Capsule, each yellow and white capsule contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.

75 mg Capsule, each green capsule contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.

150 mg Capsule, each light blue and green capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

300 mg Capsule, each light blue capsule contains clindamycin hydrochloride equivalent to 300 mg of clindamycin.

Antirobe AQUADROPS Liquid (For Use in Dogs and Cats) is a palatable formulation intended for oral administration. Each mL of Antirobe AQUADROPS Liquid contains clindamycin hydrochloride equivalent to 25 mg clindamycin; and ethyl alcohol, 8.64%.

Antirobe - Clinical Pharmacology

Absorption

Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastrointestinal tract.

Dog Serum Levels

Serum levels at or above 0.5 µg/mL can be maintained by oral dosing at a rate of 2.5 mg/lb of clindamycin hydrochloride every 12 hours. This same study revealed that average peak serum concentrations of clindamycin occur 1 hour and 15 minutes after oral dosing. The elimination half-life for clindamycin in dog serum was approximately 5 hours. There was no bioactivity accumulation after a regimen of multiple oral doses in healthy dogs.

Clindamycin Serum Concentrations 2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral Dose of Antirobe Capsules to Dogs

Cat Serum Levels

Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 5 mg/lb of clindamycin hydrochloride liquid every 24 hours. The average peak serum concentration of clindamycin occurs approximately 1 hour after oral dosing. The elimination half-life of clindamycin in feline serum is approximately 7.5 hours. In healthy cats, minimal accumulation occurs after multiple oral doses of clindamycin hydrochloride, and steady-state should be achieved by the third dose.

Clindamycin Serum Concentrations 5 mg/lb (11 mg/kg) After Single Oral Dose of Antirobe Aquadrops to Cats

Metabolism and Excretion

Extensive studies of the metabolism and excretion of clindamycin hydrochloride administered orally in animals and humans have shown that unchanged drug and bioactive and bioinactive metabolites are excreted in urine and feces. Almost all of the bioactivity detected in serum after Antirobe product administration is due to the parent molecule (clindamycin). Urine bioactivity, however, reflects a mixture of clindamycin and active metabolites, especially N-demethyl clindamycin and clindamycin sulfoxide.

Site and Mode of Action

Clindamycin is an inhibitor of protein synthesis in the bacterial cell. The site of binding appears to be in the 5OS sub-unit of the ribosome. Binding occurs to the soluble RNA fraction of certain ribosomes, thereby inhibiting the binding of amino acids to those ribosomes. Clindamycin differs from cell wall inhibitors in that it causes irreversible modification of the protein-synthesizing subcellular elements at the ribosomal level.

Microbiology

Clindamycin is a lincosaminide antimicrobial agent with activity against a wide variety of aerobic and anaerobic bacterial pathogens. Clindamycin is a bacteriostatic compound that inhibits bacterial protein synthesis by binding to the 5OS ribosomal sub-unit. The minimum inhibitory concentrations (MICs) of Gram-positive and obligate anaerobic pathogens isolated from dogs and cats in the United States are presented in Table 1 and Table 2. Bacteria were isolated in 1998-1999. All MICs were performed in accordance with the Clinical and Laboratory Standards Institute (CLSI).

Table 1. Clindamycin MIC Values (μg/mL) from Diagnostic Laboratory Survey Data Evaluating Canine Pathogens in the U.S. during 1998-99*

Organism	Number of Isolates	MIC50	MIC85	MIC90	Range
* The correlation between the in vitro susceptibility data and clinical response has not been determined. † Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass ‡ Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon § No range, all isolates yielded the same value ¶ Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip
Soft Tissue/Wound†
Staphylococcus   aureus	17	0.5	0.5	≥4.0	0.25-≥4.0
Staphylococcus   intermedius	28	0.25	0.5	≥4.0	0.125-≥4.0
Staphylococcus   spp.	18	0.5	0.5	≥4.0	0.25-≥4.0
Beta-hemolytic   streptococci	46	0.5	0.5	≥4.0	0.25-≥4.0
Streptococcus   spp.	11	0.5	≥4.0	≥4.0	0.25-≥4.0
Osteomyelitis/Bone‡
Staphylococcus   aureus	20	0.5	0.5	0.5	0.5§
Staphylococcus   intermedius	15	0.5	≥4.0	≥4.0	0.25-≥4.0
Staphylococcus   spp.	18	0.5	≥4.0	≥4.0	0.25-≥4.0
Beta-hemolytic   streptococci	21	0.5	2.0	2.0	0.25-≥4.0
Streptococcus   spp.	21	≥4.0	≥4.0	≥4.0	0.25-≥4.0
Dermal/Skin¶
Staphylococcus   aureus	25	0.5	≥4.0	≥4.0	0.25-≥4.0
Staphylococcus   intermedius	48	0.5	≥4.0	≥4.0	0.125-≥4.0
Staphylococcus   spp.	32	0.5	≥4.0	≥4.0	0.25-≥4.0
Beta-hemolytic   streptococci	17	0.5	0.5	0.5	0.25-0.5

Table 2. Clindamycin MIC Values (µg/mL) from Diagnostic Laboratory Survey Data Evaluating Feline Pathogens from Wound and Abscess Samples in the U.S. during 1998*

Organism	Number of Isolates	MIC50	MIC90	Range
* The correlation between the in vitro susceptibility data and clinical response has not been determined.
Bacteroides/ Prevotella	30	0.06	4.0	≤0.015-4.0
Fusobacterium spp.	17	0.25	0.25	≤0.015-0.5
Peptostreptococcus spp.	18	0.13	0.5	≤0.015-8.0
Porphyromonas spp.	13	0.06	0.25	≤0.015-8.0

INDICATIONS

Antirobe (brand of clindamycin hydrochloride) Capsules (for use in dogs only) and AQUADROPS Liquid (for use in dogs and cats) are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.

Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.

Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp. Deep wounds and infections due to Clostridium perfringens and Bacteroides fragilis.

Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.

Contraindications

Antirobe Capsules and Antirobe AQUADROPS Liquid are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Because of potential adverse gastrointestinal effects, do not administer to rabbits, hamsters, guinea pigs, horses, chinchillas or ruminating animals.

Warnings

Keep out of reach of children. Not for human use.

Precautions

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

The use of Antirobe occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of Antirobe should be avoided in those species sensitive to the gastrointestinal effects of clindamycin (see CONTRAINDICATIONS). Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Antirobe should be used with caution in animals receiving such agents.

Safety in gestating bitches and queens or breeding male dogs and cats has not been established.

Adverse Reactions

Side effects occasionally observed in either clinical trials or during clinical use were vomiting and diarrhea.

To report a suspected adverse reaction call 1-800-366-5288.

Antirobe Dosage and Administration

Dogs

Infected Wounds, Abscesses, and Dental Infections

Oral

2.5-15.0 mg/lb body weight every 12 hours.

Duration

Treatment with Antirobe products may be continued up to a maximum of 28 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three or four days if no response to therapy is seen.

Dosage Schedule

Capsules

Antirobe 25 mg, administer 1-6 capsules every 12 hours for each 10 pounds of body weight.

Antirobe 75 mg, administer 1-6 capsules every 12 hours for each 30 pounds of body weight.

Antirobe 150 mg, administer 1-6 capsules every 12 hours for each 60 pounds of body weight.

Antirobe 300 mg, administer 1-6 capsules every 12 hours for each 120 pounds of body weight.

Liquid

Antirobe AQUADROPS, administer 1-6 mL/10 lbs body weight every 12 hours.

Dogs

Osteomyelitis

Oral

5.0-15.0 mg/lb body weight every 12 hours.

Duration

Treatment with Antirobe is recommended for a minimum of 28 days. Treatment should not be continued for longer than 28 days if no response to therapy is seen.

Dosage Schedule

Capsules

Antirobe 25 mg, administer 2-6 capsules every 12 hours for each 10 pounds of body weight.

Antirobe 75 mg, administer 2-6 capsules every 12 hours for each 30 pounds of body weight.

Antirobe 150 mg, administer 2-6 capsules every 12 hours for each 60 pounds of body weight.

Antirobe 300 mg, administer 2-6 capsules every 12 hours for each 120 pounds of body weight.

Liquid

Antirobe AQUADROPS, administer 2-6 mL/10 lbs body weight every 12 hours.

Cats

Infected Wounds, Abscesses, and Dental Infections

5.0 - 15.0 mg/lb body weight once every 24 hours depending on the severity of the condition.

Duration

Treatment with Antirobe AQUADROPS Liquid may be continued up to a maximum of 14 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three to four days if no clinical response to therapy is seen.

Dosage Schedule

Antirobe AQUADROPS, to provide 5.0 mg/lb, administer 1 mL/5 lbs body weight once every 24 hours; to provide 15.0 mg/lb, administer 3 mL/5 lbs body weight once every 24 hours.

ANIMAL SAFETY SUMMARY

Rat and Dog Data

One year oral toxicity studies in rats and dogs at doses of 30, 100 and 300 mg/kg/day (13.6, 45.5 and 136.4 mg/lb/day) have shown clindamycin hydrochloride capsules to be well tolerated. Differences did not occur in the parameters evaluated to assess toxicity when comparing groups of treated animals with contemporary controls. Rats administered clindamycin hydrochloride at 600 mg/kg/day (272.7 mg/lb/day) for six months tolerated the drug well; however, dogs orally dosed at 600 mg/kg/day (272.7 mg/lb/day) vomited, had anorexia, and subsequently lost weight. At necropsy these dogs had erosive gastritis and focal areas of necrosis of the mucosa of the gallbladder.

Safety in gestating bitches or breeding males has not been established.

Cat Data

The recommended daily therapeutic dose range for clindamycin hydrochloride (Antirobe AQUADROPS Liquid) is 11 to 33 mg/kg/day (5 to 15 mg/lb/day) depending on the severity of the condition. Clindamycin hydrochloride (Antirobe AQUADROPS Liquid) was tolerated with little evidence of toxicity in domestic shorthair cats when administered orally at 10X the minimum recommended therapeutic daily dose (11 mg/kg; 5 mg/lb) for 15 days, and at doses up to 5X the minimum recommended therapeutic dose for 42 days. Gastrointestinal tract upset (soft feces to diarrhea) occurred in control and treated cats with emesis occurring at doses 3X or greater than the minimum recommended therapeutic dose (11 mg/kg/day; 5 mg/lb/day). Lymphocytic inflammation of the gallbladder was noted in a greater number of treated cats at the 110 mg/kg/day (50 mg/lb/day) dose level than for control cats. No other effects were noted. Safety in gestating queens or breeding male cats has not been established.

STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F).

How is Antirobe Supplied

Antirobe Capsules are available as:

 

25 mg - bottles of 600

 

75 mg - bottles of 200

 

150 mg - bottles of 100

 

150 mg - blister packages of 100

 

300 mg - blister packages of 100

 

NADA #120–161, Approved by FDA

Antirobe AQUADROPS Liquid is available as 20 mL filled in 30 mL bottles (25 mg/mL) supplied in packers containing 12 cartoned bottles with direction labels and calibrated dosing droppers.

NADA #135–940, Approved by FDA

To request a material safety data sheet (MSDS), call 1-800-733-5500.

Antirobe AQUADROPS

Distributed by:

Pharmacia & Upjohn Company

Division of Pfizer Inc

New York, NY 10017

Antirobe Capsules

Made in Canada

Distributed by:

Pharmacia & Upjohn Company

Division of Pfizer Inc

New York, NY 10017

Revised March 2010

11104900

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label

600 Capsules

Antirobe®

clindamycin hydrochloride

capsules, USP

25 mg

Equiv. to 25 mg clindamycin

For Use in Dogs Only

Caution: Federal (USA) law

restricts this drug to use by or on

the order of a licensed

veterinarian.

NADA #120-161, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label

200 Capsules

Antirobe®

clindamycin hydrochloride

capsules, USP

75 mg

Equiv. to 75 mg clindamycin

For Use in Dogs Only

Caution: Federal (USA) law

restricts this drug to use by or on

the order of a licensed

veterinarian.

NADA #120-161, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label

100 Capsules

Antirobe®

clindamycin hydrochloride

capsules, USP

150 mg

Equiv. to 150 mg clindamycin

For Use in Dogs Only

Caution: Federal (USA) law

restricts this drug to use by or on the order of a licensed veterinarian.

NADA #120-161, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label

Antirobe™

Capsules

clindamycin hydrochloride capsules, USP

300 mg

Equivalent to 300 mg clindamycin

For Use In Dogs Only

Caution: Federal (USA) law restricts this drug to

use by or on the order of a licensed veterinarian.

NADA # 120-161 Approved by FDA

Pharmacia

& Upjohn

Antirobe  clindamycin hydrochloride  capsule

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0009-3043 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 25 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW, WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code Antirobe;25;MG Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3043-01 600 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120161	05/31/1984

Antirobe  clindamycin hydrochloride  capsule

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0009-3044 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 75 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score no score Shape CAPSULE Size 16mm Flavor Imprint Code Antirobe;75;MG Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3044-01 200 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120161	05/31/1984

Antirobe  clindamycin hydrochloride  capsule

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0009-3045 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 150 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE (light blue) , GREEN Score no score Shape CAPSULE Size 20mm Flavor Imprint Code Antirobe;150;MG Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3045-01 100 CAPSULE In 1 BOTTLE, PLASTIC None 2 0009-3045-08 100 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120161	05/31/1984

Antirobe  clindamycin hydrochloride  capsule

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0009-5015 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 300 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE (Light Blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Antirobe;300;MG Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-5015-01 100 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120161	05/31/1984	05/18/2010

Labeler - Pharmacia and Upjohn Company (829076566)

Establishment
Name	Address	ID/FEI	Operations
Patheon Whitby Inc.		205475333	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Patheon Inc., Toronto Region Operations		243790024	MANUFACTURE

Revised: 05/2010Pharmacia and Upjohn Company

Elimite Cream

Pronunciation: per-METH-rin
Generic Name: Permethrin
Brand Name: Examples include Acticin and Elimite

Elimite Cream is used for:

Treating scabies.

Elimite Cream is a scabicide. It works by killing the scabies mite (Sarcoptes scabiei).

Do NOT use Elimite Cream if:

• you are allergic to any ingredient in Elimite Cream

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

Before using Elimite Cream:

Some medical conditions may interact with Elimite Cream. 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

Some MEDICINES MAY INTERACT with Elimite Cream. Because little, if any, of Elimite Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Elimite Cream 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 Elimite Cream:

Use Elimite Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Thoroughly massage into the skin from the head to the soles of the feet. It is not necessary to put the medicine on the scalp except in children and older patients.


• Remove the medicine by washing after 8 to 14 hours.


• You may experience itching after treatment. This is not a sign of treatment failure. However if living mites are seen after 14 days, retreatment is necessary.


• If you miss a dose of Elimite Cream, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Elimite Cream.

Important safety information:

• Elimite Cream is for external use only. Do not use it near the eyes or allow it to come into contact with the inside of the nose, mouth, or genitals. Irritation may occur if Elimite Cream comes into contact with these areas. If Elimite Cream gets in your eyes, flush with water immediately.


• Elimite Cream should not be used in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Elimite Cream while you are pregnant. It is not known if Elimite Cream is found in breast milk after topical use. Do not breast-feed while using Elimite Cream.

Possible side effects of Elimite Cream:

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:

Itching; mild burning or stinging; redness; swelling.

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).

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: Elimite 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. Elimite Cream may be harmful if swallowed. Symptoms may include dizziness; headache; loss of appetite; loss of consciousness; seizures; vomiting; weakness.

Proper storage of Elimite Cream:

Store Elimite Cream at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep Elimite Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Elimite Cream, please talk with your doctor, pharmacist, or other health care provider.


• Elimite Cream 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 Elimite Cream. 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 Elimite resources

• Elimite Side Effects (in more detail)
• Elimite Dosage
• Elimite Use in Pregnancy & Breastfeeding
• Elimite Support Group
• 1 Review for Elimite - Add your own review/rating

Compare Elimite with other medications

• Head Lice
• Lice
• Scabies

Terbinafine Hydrochloride topical

Class: Allylamines
VA Class: DE102
Chemical Name: 1-Naphthalenemethanamine,N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride
Molecular Formula: C₂₁H₂₅N•ClH
CAS Number: 78628-80-5
Brands: Lamisil

Introduction

Antifungal; synthetic allylamine structurally and pharmacologically related to naftifine.^{1 2 11 12 19}

Uses for Terbinafine Hydrochloride

Dermatophytoses

Treatment of tinea corporis (body ringworm)^{1 2 9 10 11 19 20 21} and tinea cruris (jock itch)^{1 2 6 8 9 10 11 19 20 21} caused by Trichophyton mentagrophytes, T. rubrum, or Epidermophyton floccosum.

Treatment of tinea pedis (athlete's foot) caused by T. mentagrophytes, T. rubrum, or E. floccosum^{1 2 3 4 5 9 10 11 14 19 20 21} and plantar tinea pedis (moccasin type) caused by T. mentagrophytes or T. rubrum.¹

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum ovale).¹⁹

Terbinafine Hydrochloride Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a cream or solution.^{1 2 3 4 5 6 7 8 9 10 11 13 14 15 18 19 20 21}

Do not apply to the eye or administer orally or intravaginally.^{1 19 20 21}

Do not use on nails or scalp; avoid contact with the nose, mouth, and other mucous membranes.^{1 19 20 21}

Do not use the solution spray on the face.²¹

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.^{1 19 20 21}

Cream or Solution

The affected skin and surrounding areas should be washed with soap and water and dried completely before the drug is applied.^{20 21}

Apply a sufficient amount of cream or solution either once or twice daily (as directed); rub gently into affected area and surrounding skin.^{1 3 4 5 9 10 11 13 14 15 18}

Dosage

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

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Children ≥12 years of age: apply cream once or twice daily for ≥1 week.^{1 2 6 8 9 10 11 16 17 20 21} Alternatively, apply solution once daily for 1 week.^{19 21}

For self-medication, treatment usually is continued for 1 week.^{20 21} When directed by clinician, treatment is ≥1 week but should not be >4 weeks.¹

Tinea Pedis

Topical

Children ≥12 years of age: apply cream or solution twice daily (morning and evening) for ≥1 week.^{1 3 4 5 9 10 11 13 14 15 18}

For plantar/moccasin-type tinea pedis, apply cream twice daily for 2 weeks.¹

For self-medication, treatment usually is continued for 1 week.^{20 21} When directed by clinician, treatment is ≥1 week but should not be >4 weeks.¹

Pityriasis (Tinea) Versicolor

Topical

Children ≥12 years of age: apply solution twice daily for 1 week.¹⁹

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply cream once or twice daily for ≥1 week.^{1 2 6 8 9 10 11 16 17 20 21} Alternatively, apply solution once daily for 1 week.^{19 21}

For self-medication, treatment usually is continued for 1 week.^{20 21} When directed by clinician, treatment is ≥1 week but should not be >4 weeks.¹

Tinea Pedis

Topical

Apply cream or solution twice daily (morning and evening) for ≥1 week.^{1 3 4 5 9 10 11 13 14 15 18}

For plantar/moccasin-type tinea pedis, apply cream twice daily for 2 weeks.¹

For self-medication, treatment usually is continued for 1 week.^{20 21} When directed by clinician, treatment is ≥1 week but should not be >4 weeks.¹

Pityriasis (Tinea) Versicolor

Topical

Apply solution twice daily for 1 week.¹⁹

Cautions for Terbinafine Hydrochloride

Contraindications

• 
  

  Hypersensitivity to terbinafine or any ingredient in the formulation.^{1 19}

  
  

Warnings/Precautions

Sensitivity Reactions

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.^{1 19}

General Precautions

Selection and Use of Antifungals

Prior to administration of terbinafine for dermatophytoses or pityriasis (tinea) versicolor, diagnosis should be confirmed either by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.^{1 19}

Clinical improvement usually is evident within the first week of therapy, and patients treated for 1–2 weeks usually show continued improvement for several weeks after completion of treatment.^{1 2 4 6 8 11 14 18} If clinical improvement is not evidence within 2–6 weeks after completion of topical therapy, the diagnosis should be reevaluated.¹

Local Effects

The solution contains 28.7% alcohol which may be irritating or drying.¹⁹

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling of lamotrigine (Lamictal) and terbinafine (Lamisil) may result in errors.^{22 23}

Specific Populations

Pregnancy

Category B.^{1 19}

Lactation

Distributed into milk following oral administration.^{1 19} Discontinue nursing or the drug.^{1 19}

Pediatric Use

Safety and efficacy not established in children <12 years of age.^{1 19 20 21}

Common Adverse Effects

Irritation, burning/tingling, pruritus, dryness, skin exfoliation, erythematous rash.^{1 19}

Terbinafine Hydrochloride Pharmacokinetics

Absorption

Percutaneous absorption occurs following topical application of the cream or solution to intact skin.^{1 19}

Distribution

Extent

Penetration into stratum corneum is similar following topical application of the cream or solution.^{1 19}

Distributed into milk following oral administration.^{1 19}

Elimination

Metabolism

Systemically absorbed drug is extensively metabolized.^{1 19}

Elimination Route

Approximately 75% of cutaneously absorbed drug is eliminated in urine, principally as metabolites.^{1 19}

Half-life

Half-life when absorbed through the skin is approximately 21 hours.¹⁹

Stability

Storage

Topical

Cream

20–25°C;²⁰ may be stored at 5–30°C.¹

Solution

8–25°C;²¹ do not refrigerate.¹⁹

Actions and SpectrumActions

• 
  

  May be fungicidal or fungistatic in action, depending on concentration of the drug and specific fungus tested.^{1 2 3 4 11 15 19}

  
  


• 
  

  Appears to interfere with sterol biosynthesis in susceptible fungi by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase).^{1 2 19} The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol,^{1 2 19} may contribute to the antifungal effects.²

  
  


• 
  

  Active against many fungi, including dermatophytes (Trichophyton, Microsporum, Epidermophyton), filamentous (e.g. Aspergillus), dimorphic (e.g., Blastomyces), and dematiaceous fungi and yeasts.^{1 2}

  
  


• 
  

  Dermatophytes: active in vitro and in clinical infections against T. rubrum, T. mentagrophytes, and E. floccosum.^{1 19} Also active in vitro against M. canis, M. gypseum, M. nanum, and T. verrucosum.^{1 19} More active than azole antifungals (e.g., fluconazole, itraconazole, ketoconazole) against dermatophytes.^{5 8 15}

  
  


• 
  

  Other fungi: active in vitro and in clinical infections against Malassezia furfur.¹⁹ Also active in vitro against some Candida, including C. albicans and C. parapsilosis.^{2 3 4 11 15} Less active than azole antifungals against Candida.^{2 9 11}

  
  

Advice to Patients

• 
  

  Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.^{1 19 20 21} Importance of not using occlusive dressings, unless otherwise directed by clinician.^{1 19}

  
  


• 
  

  Advise patient not to use spray solution on the face.¹⁹ If accidental contact with eyes occurs, importance of rinsing eyes thoroughly with running water and consulting a clinician if symptoms persist.^{19 20 21}

  
  


• 
  

  Advise patients to wash their hands after touching the affected areas so that the infection is not spread to other areas of the body or to other individuals.^{20 21}

  
  


• 
  

  For patients with tinea pedis (athlete's foot), importance of wearing well-fitting, ventilated shoes and changing socks at least once daily.^{20 21}

  
  


• 
  

  Importance of completing full course of therapy, even if symptoms improve.^{1 19}

  
  


• 
  

  Importance of notifying clinician if improvement does not occur after 1 week of treatment.¹⁹

  
  


• 
  

  Importance of consulting clinician if treated area becomes irritated (e.g., erythema, pruritus, burning, blistering, swelling, oozing).^{1 19 20 21}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Terbinafine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	1%	Lamisil AT (with benzyl alcohol)	Novartis
	Solution	1%	Lamisil (with cetomacrogol, ethanol, and propylene glycol)	Novartis
			Lamisil AT Spray Pump (with cetomacrogol, ethanol, and propylene glycol)	Novartis

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 October 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceuticals Corporation. Lamisil (terbinafine hydrochloride) 1% cream prescribing information (dated 1997 Mar). In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998;1859-61.

2. Balfour JA, Faulds D. Terbinafine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial mycoses. Drugs. 1992; 43: 259-84.

3. Savin RC. Treatment of chronic tinea pedis (athlete’s foot type) with topical terbinafine. J Am Acad Dermatol. 1990; 23:786-9. [PubMed 2229524]

4. Berman B, Ellis C, Leyden J et al. Efficacy of a 1-week, twice-daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. J Am Acad Dermatol. 1992; 26:956-60. [PubMed 1607415]

5. Smith EB, Noppakun N, Newton RC. A clinical trial of topical terbinafine (a new allylamine antifungal) in the treatment of tinea pedis. J Am Acad Dermatol. 1990; 23:790-4. [PubMed 2229525]

6. Greer DL, Jolly HW Jr. Treatment of tinea cruris with topical terbinafine. J Am Acad Dermatol. 1990; 23: 800-4. [PubMed 2229527]

7. Aste N, Pau M, Pinna AL et al. Clinical efficacy and tolerability of terbinafine in patients with pityriasis versicolor. Mycoses. 1991; 34:353-7. [PubMed 1803242]

8. Millikan LE. Efficacy and tolerability of topical terbinafine in the treatment of tinea cruris. J Am Acad Dermatol. 1990; 23:795-9. [PubMed 2229526]

9. Kagawa S. Clinical efficacy of terbinafine in 629 Japanese patients with dermatomycosis. Clin Exp Dermatol. 1989; 14:114-5. [PubMed 2689013]

10. Villars V, Jones TC. Clinical efficacy and tolerability of terbinafine (Lamisil)—a new topical and systemic fungicidal drug for treatment of dermatomycoses. Clin Exp Dermatol. 1989; 14:124-7. [PubMed 2689015]

11. Shear NH, Villars VV, Marsolais C. Terbinafine: an oral and topical antifungal agent. Clin Dermatol. 1992; 9:487-95.

12. Lyman CA, Walsh TJ. Systemically administered antifungal agents: a review of their clinical pharmacology and therapeutic applications. Drugs. 1992; 44:9-35. [PubMed 1379913]

13. Anon. Topical terbinafine for tinea infections. Med Lett Drugs Ther. 1993; 35:76-8. [PubMed 8341207]

14. Bergstresser PR, Elewski B, Hanifin J et al. Topical terbinafine and clotrimazole in interdigital tinea pedis: a multicenter comparison of cure and relapse rates with 1- and 4-week treatment regimens. J Am Acad Dermatol. 1993; 28:648-51. [PubMed 8463471]

15. Smith EB. Topical antifungal drugs in the treatment of tinea pedis, tinea cruris, and tinea corporis. J Am Acad Dermatol. 1993; 28(5 Part 1):S24-8. [PubMed 8496408]

16. Sandoz Pharmaceutical Corporation, East Hanover, NJ: Personal communication.

17. Reviewers’ comments (personal observations).

18. Evans EGV, Dodman B, Williamson DM et al. Comparison of terbinafine and clotrimazole in treating tinea pedis. BMJ. 1993; 307:645-7. [IDIS 320437] [PubMed 8401048]

19. Novartis Pharmaceuticals Corporation. Lamisil (terbinafine hydrochloride) 1% solution prescribing information. East Hanover, NJ; 1999 Feb.

20. Novartis Consumer Health, Inc. Lamisil AT (terbinafine hydrochloride 1%) cream patient information. Summit, NJ; 1999.

21. Novartis Consumer Health, Inc. Lamisil AT (terbinafine hydrochloride solution 1%) Spray Pump patient information. Summit, NJ; 2000.

22. Kent RS. Dear health professional letter: Dispensing errors alert. Research Triangle Park, NC: Glaxo Wellcome, Inc; 2000 Aug.

23. Sykes NS. Dear pharmacist letter: Dispensing errors alert. Research Triangle Park, NC: Glaxo Wellcome, Inc; 2000 Jun 6.

More Terbinafine Hydrochloride topical resources

• Terbinafine Hydrochloride topical Dosage
• Terbinafine Hydrochloride topical Use in Pregnancy & Breastfeeding
• Terbinafine Hydrochloride topical Support Group
• 5 Reviews for Terbinafine Hydrochloride - Add your own review/rating

Compare Terbinafine Hydrochloride topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Solaraze

Solaraze 3%, gel

Diclofenac Sodium 3% w/w

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Solaraze is and what it is used for


• 2. Before you use Solaraze


• 3. How to use Solaraze


• 4. Possible side effects


• 5. How to store Solaraze


• 6. Further information

What Solaraze is and what it is used for

Solaraze is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Solaraze gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure.

Before you use Solaraze

Do not use Solaraze

• If you are allergic to diclofenac or any of the ingredients in Solaraze.


• If you have had an allergic reaction such as skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory agents.


• If you are in the final 3 months of your pregnancy.

Take special care with Solaraze

• You should consult your doctor if:
  
  
  • You have, or have had in the past, a stomach ulcer or bleeding from the stomach,
  • You have heart, liver or kidney problems,
  • You have any type of bleeding disorder or bruise very easily.


• Avoid sun exposure, including tanning salons, when using Solaraze. If skin reactions occur, discontinue use.


• Do not apply to skin wounds, infected skin or dermatitis.


• Do not allow Solaraze to come into contact with your eyes or the inside of your nose or mouth.

Pregnancy/Breastfeeding

Speak to your doctor if you are, or could be pregnant. Solaraze should be used with caution during the first six months of pregnancy but must not be used during the last three months of pregnancy.

If you are pregnant, and your doctor considers treatment appropriate, Solaraze must not be applied to an area of the skin larger than about a third of your body and must not be used for longer than three weeks.

Solaraze can be used whilst breastfeeding but should not be used on the breasts.

Ask your doctor or pharmacist for advice before taking or using any medicine.

How to use Solaraze

• Solaraze is not suitable for children.


• Use the gel as directed by your doctor.


• Pierce the aluminium membrane across the tube opening with the cap before using.


• Gently smooth a small amount of gel onto the skin over the area to be treated. The amount of gel needed will vary depending upon the size of the area to be treated. Usually 0.5 grams of gel (about the size of a pea) will be enough for one area (5cm x 5cm) but not more than 8 grams should be used per day.


• You can apply Solaraze twice daily unless your doctor tells you differently. You may notice a slight cooling effect when you smooth the gel onto your skin.


• The usual period of treatment is 60-90 days. Maximum effect has been seen with treatment times closer to 90 days. Complete healing may not occur for up to a month after treatment has stopped.


• Wash your hands after applying the gel, unless your hands are being treated.

If you use more Solaraze than you should

Remove the excess gel by washing with water.

If you forget to use Solaraze

Continue to apply as directed but do not apply twice as much to make up for the missed application.

Solaraze Side Effects

Like all medicines, Solaraze can have side effects although not everybody gets them.

If you have any of the following side effects, stop using Solaraze and contact your doctor as soon as possible:

skin rash (nettle rash); breathing difficulties (wheezing); runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solaraze.

If any of the following common side effects are severe or last for more than a few days you should stop using Solaraze and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain and blistering.

Other Common side effects: (occur in between 1 and 10 out of every 100 patients)

Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the skin is touched, pins and needles, muscle stiffness, dry skin, swelling, rash (including scaly or blistering), sagging of the skin, and skin ulcer.

Uncommon side effects: (occur in between 1 and 10 out of every 1,000 patients)

eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling sick, hair loss, facial swelling, a skin sensitivity to sunlight, excessive bleeding or oily skin, a measles-like rash.

Very rare side effects (occur in fewer than 1 in 10,000 patients)

bleeding from your stomach or problems with your kidneys.

Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping treatment.

If any of the side effects becomes serious or you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.

How to store Solaraze

Keep Solaraze out of the reach and sight of children.

Do not use after the expiry date (shown as ‘EXP’) on the tube and carton. The date refers to the last date of that month.

Do not store above 25ºC.

Shelf life after opening: 6 months

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Solaraze contains

• 
  Each gram of gel contains the equivalent of 30mg diclofenac sodium (the active substance).


• The gel also contains sodium hyaluronate, benzyl alcohol, macrogol monomethyl ether 350 and purified water.

What Solaraze looks like and contents of the pack

Solaraze gel is a clear, transparent, colourless or pale yellow gel packed in tubes containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of product.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

The manufacturer is

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465 Reinbek

Germany

This leaflet was written on 13/01/2010

Monoclonal antibodies

Monoclonal antibodies used in immunotherapy are produced artificially from a cell clone therefore consist of a single type of immunoglobulin. They are targeted towards specific antigens and bind to the antigens to form a complex. The monoclonal antibody-antigen complex can be recognized and destroyed by phagocytes or it can used for other diagnostic purposes.

Natural antibodies are proteins made by the B-lymphocytes in response to antigens. Each B-cell makes only one type of antibody. For therapeutic purposes a significant amount of a particular antibody is needed. These are obtained from a culture that gives one type of antibody, which are called monoclonal antibodies.

Monoclonal antibodies are used as chemotherapeutic agents to treat malignant tumors and viral infections. They are also used in tests to detect AIDS (acquired immunodeficiency syndrome) and in pregnancy test kits.

See also

• anti-CTLA-4 monoclonal antibodies
• antineoplastic monoclonal antibodies
• CD20 monoclonal antibodies
• CD30 monoclonal antibodies
• CD33 monoclonal antibodies
• CD52 monoclonal antibodies
• RANK ligand inhibitors
• trifunctional monoclonal antibodies

Drug List:

Pancof XP

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

What is Pancof XP (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 Pancof XP (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 Pancof XP (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 Pancof XP (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.

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 Pancof XP (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.

Pancof XP (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.

What other drugs will affect Pancof XP (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:

• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  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 Pancof XP resources

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

• CodiCLEAR DH Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Entuss Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tusso-HC Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pancof XP with other medications

• Cough

Where can I get more information?

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

See also: Pancof XP side effects (in more detail)