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Wednesday, September 12, 2012

colchicine

Generic Name: colchicine (KOL chi seen)

Brand Names: Colcrys

What is colchicine?

Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain.

The Colcrys brand of colchicine is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions.

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

What is the most important information I should know about colchicine?

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA. You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

Before taking colchicine, tell your doctor if yo have liver or kidney disease, heart disease, a stomach ulcer, ulcerative colitis, Crohn's disease, intestinal bleeding, or any other severe gastrointestinal disorder.

If you take colchicine over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Call your doctor at once if you have a serious side effect such as muscle pain or weakness, numbness or tingly feeling in your fingers or toes, severe vomiting or diarrhea, easy bruising or bleeding, feeling weak or tired, flu symptoms, blood in your urine, urinating less than usual or not at all, or a pale or gray appearance of your lips, tongue, or hands.

What should I discuss with my healthcare provider before taking colchicine?

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

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

liver disease;

kidney disease;

heart disease;

a stomach ulcer or severe gastrointestinal disorder;

ulcerative colitis;

Crohn's disease; or

intestinal bleeding or other disorder.

FDA pregnancy category C. It is not known whether colchicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether colchicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take colchicine?

If your doctor has prescribed the Colcrys brand of colchicine, do not use any other type or brand of the medication. Colcrys is the only brand of colchicine that has been approved by the FDA. If you use a generic brand of colchicine, you may be using an unapproved dose of this medication, which could be dangerous. Do not purchase colchicine on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

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.

Colchicine can be taken with or without food.

To treat a gout attack, for best results take colchicine at the first sign of the attack. The longer you wait to start taking the medication, the less effective it may be.

You may need to take a second lower dose of colchicine 1 hour after the first dose if you still have gout pain. Follow your doctor's instructions.

Your dose will depend on the reason you are taking this medication. Colchicine doses for gout and Mediterranean fever are different.

If you use this medication over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Keep using colchicine as directed, even if you feel well. Tell your doctor if the medicine seems to stop working as well in preventing gout attacks. Do not stop using colchicine without first talking to your doctor.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

See also: Colchicine dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of colchicine can be fatal.

Overdose symptoms may include diarrhea (may be bloody and severe), nausea, vomiting, stomach pain, heartburn, a burning feeling in your throat or stomach, muscle weakness, urinating less than usual, numbness or tingling, fainting, or seizure (convulsions).

What should I avoid while taking colchicine?

Grapefruit and grapefruit juice may interact with colchicine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Colchicine side effects

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

muscle pain or weakness;

numbness or tingly feeling in your fingers or toes;

pale or gray appearance of your lips, tongue, or hands;

severe vomiting or diarrhea;

easy bruising or bleeding, feeling weak or tired;

fever, chills, body aches, flu symptoms;

blood in your urine; or

urinating less than usual or not at all.

Less serious side effects may include:

mild nausea or vomiting, stomach pain; or

mild diarrhea.

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.

Colchicine Dosing Information

Usual Adult Dose for Acute Gout:

Oral:

Initial: Gout Flare: 1.2 mg orally at the first sign of the flare followed by 0.6 mg one hour later.
Maximum: Gout Flare: 1.8 mg orally over a one hour period

Coadministration with strong CYP450 3A4 inhibitors:
0.6 mg orally followed by 0.3 mg one hour later. Dose to be repeated no earlier than 3 days.

Coadministration with moderate CYP450 3A4 inhibitors:
1.2 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Coadministration with P-glycoprotein inhibitors:
0.6 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Usual Adult Dose for Familial Mediterranean Fever:

1.2 mg to 2.4 mg orally daily, administered in 1 or 2 divided doses

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

Coadministration with strong CYP450 3A4 inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Coadministration with moderate CYP450 3A4 inhibitors: 1.2 mg orally daily, may be given as 0.6 mg twice a day.

Coadministration with P-glycoprotein inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Usual Adult Dose for Gout -- Prophylaxis:

(Unlabeled use):
Oral:
0.5 to 0.6 mg orally once a day for 3 to 4 days a week (less than 1 attack/year).
0.5 to 0.6 mg orally once a day (greater than 1 attack/year).
Severe cases may require 1 to 1.8 mg/day.

Usual Adult Dose for Biliary Cirrhosis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Sarcoidosis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Pseudogout -- Prophylaxis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Fibromatosis:

(Unlabeled use):
Initial: 0.6 to 1.2 mg orally once a day each day for the first 1 to 2 weeks.
Maintenance: 0.6 to 1.2 mg orally once a day 1 to 2 times per week is often used to prevent recurrence of fibromatosis.

Usual Adult Dose for Aphthous Stomatitis -- Recurrent:

(Unlabeled use):
0.5 to 0.6 mg orally daily. The dose may be titrated upward while the patient is observed for signs of toxicity.

Usual Adult Dose for Behcet's Disease:

(Unlabeled use):
0.5 to 1.5 mg orally once a day.

Study (n=116)
Dosage adjusted to body weight:
less than 50 Kg: 1 mg daily
50 to 59 Kg: 1 mg and 1.5 mg on alternate days
60 to 75 Kg: 1.5 mg daily
76 to 84 Kg: 1.5 and 2 mg on alternate days
greater than or equal to 85 Kg: 2 mg daily

Usual Adult Dose for Constipation -- Chronic:

(Unlabeled use):
Study (n=16)
0.6 mg orally three times daily for 4 weeks

Usual Adult Dose for Sweet's Syndrome:

(Unlabeled use):
0.6 mg orally twice daily.

Usual Pediatric Dose for Familial Mediterranean Fever:

Oral:

4 to 6 years: 0.3 to 1.8 mg daily, administered in 1 or 2 divided doses.

6 to 12 years: 0.9 to 1.8 mg daily, administered in 1 or 2 divided doses.

Over 12 years: 1.2 to 2.4 mg daily, administered in 1 or 2 divided doses.

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

What other drugs will affect colchicine?

Colchicine can interact with certain other drugs. A colchicine drug interaction can be fatal. Tell your doctor about all other medications you use, especially:

conivaptan (Vaprisol);

digoxin (Lanoxin, digitalis);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

an antidepressant such as nefazodone;

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

cholesterol-lowering medicines such as atorvastatin (Lipitor), fenofibrate (Antara, Lipofen, TriCor), fluvastatin (Lescol), gemfibrozil (Lopid), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), simvastatin (Zocor, Simcor, Vytorin), and others;

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), reserpine, verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV or AIDS medication such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), ritonavir (Kaletra, Norvir), tipranavir (Aptivus); or

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with colchicine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More colchicine resources

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

colchicine Oral, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Colchicine MedFacts Consumer Leaflet (Wolters Kluwer)

Colchicine Professional Patient Advice (Wolters Kluwer)

Colchicine Monograph (AHFS DI)

Colcrys Prescribing Information (FDA)

Colcrys Consumer Overview

Colcrys MedFacts Consumer Leaflet (Wolters Kluwer)

Compare colchicine with other medications

Amyloidosis
Aphthous Stomatitis, Recurrent
Behcet's Disease
Biliary Cirrhosis
Constipation, Chronic
Familial Mediterranean Fever
Fibromatosis
Gout, Acute
Gout, Prophylaxis
Pseudogout, Prophylaxis
Sarcoidosis
Sweet's Syndrome

Where can I get more information?

Your pharmacist can provide more information about colchicine.

See also: colchicine side effects (in more detail)

Nizoral

Generic Name: Ketoconazole
Class: Azoles
VA Class: AM700
CAS Number: 65277-42-1

Oral ketoconazole has been associated with hepatoxicity, including some fatalities.²⁶³ Inform patients of the risk and monitor closely.²⁶³

Concomitant use with cisapride or with astemizole or terfenadine (drugs no longer commercially available in the US) is contraindicated.²⁶³ Pharmacokinetic interactions can occur and serious cardiovascular events have been reported with concomitant use.²⁶³ VT, VF, and torsades de pointes have been reported in patients receiving concomitant cisapride; death, VT, and torsades de pointes have been reported in patients receiving concomitant terfenadine.²⁶³ (See Interactions.)

Introduction

Antifungal; azole (imidazole derivative).¹²⁷ ²²²

Uses for Nizoral

Blastomycosis

Treatment of North American blastomycosis caused by Blastomyces dermatitidis.²¹³ ²²⁰ ²³⁴ ²³⁸ ²⁶³ ²⁶⁴ ²⁸⁸ ²⁹⁰ ²⁹¹ ²⁹² ²⁹⁹ ³⁰⁰

Drugs of choice are IV amphotericin B (especially for severe infections and those involving the CNS) or oral itraconazole;²³⁴ ²³⁸ ²⁶⁴ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹⁶ ²⁹⁷ ²⁹⁸ ²⁹⁹ ³³² ³³³ fluconazole and ketoconazole are considered alternatives.²³⁸ ²⁶⁴ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹⁶ ²⁹⁷ ²⁹⁹

Oral ketoconazole usually has been effective when used in immunocompetent individuals with mild to moderate pulmonary or extrapulmonary blastomycosis.²¹³ ²²⁰ ²⁹⁰ ²⁹¹ ²⁹² ²⁹⁷ Consider that treatment failures have been reported when ketoconazole was used for treatment of cutaneous or pulmonary blastomycosis in individuals who had asymptomatic or subclinical CNS involvement at the time of the initial diagnosis.²¹¹ ²⁹⁵ ²⁹⁶ (See Meningitis and Other CNS Infections under Cautions.)

Candida Infections

Treatment of candidiasis, candiduria, chronic mucocutaneous candidiasis, or oropharyngeal and esophageal candidiasis.²¹² ²³⁸ ²⁶³ ²⁷⁹ ²⁹¹ ²⁹² ³²⁰ ³²² ³²³ ³²⁶ ³²⁸ ³²⁹ ³³¹ ³³⁴ ³⁴¹

Has been used for treatment of uncomplicated vulvovaginal candidiasis†.³⁴⁰ ³⁴³ ³⁴⁴ Not a drug of choice for initial treatment; single-dose fluconazole is the only oral regimen included in current CDC recommendations for treatment of uncomplicated vulvovaginal candidiasis.²⁷⁰ ²⁷² Recommended by CDC and others as one of several alternatives for maintenance treatment of recurrent vulvovaginal candidiasis† in women with a history of recurrent infections.²⁷⁰ ²⁷¹ ³⁴⁰ ³⁴³ ³⁴⁴ ³⁴⁶

Chromomycosis

Treatment of chromomycosis (chromoblastomycosis) caused by Phialophora.²⁶³ ²⁸⁸ ³³⁵ A response may not be attained in those with more extensive disease.³³⁵

Optimum regimens for chromomycosis have not been identified.²⁸⁸ ³³⁵ Flucytosine may be a drug of choice used alone or in conjunction with another antifungal (e.g., IV amphotericin B, oral itraconazole, oral ketoconazole).²⁸⁸ ³³⁵

Coccidioidomycosis

Treatment of mild to moderate coccidioidomycosis caused by Coccidioides immitis.²³⁸ ²⁶³ ²⁸⁰ ²⁹⁰ ²⁹¹ ²⁹² ²⁹³ ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁷

Drugs of choice are IV amphotericin B (especially for severe infections and those in immunocompromised patients including HIV-infected individuals) or oral fluconazole; itraconazole and ketoconazole are considered alternatives.²³⁴ ²³⁸ ²⁷⁹ ²⁸⁰ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹³

Dermatophytoses

Treatment of certain dermatophytoses of the skin, scalp, and nails, including tinea capitis (scalp ringworm), tinea corporis (ringworm of the body), tinea cruris (jock itch; groin ringworm), tinea pedis (athlete’s foot, foot ringworm), tinea manuum (hand ringworm), and tinea unguium (onychomycosis; nail ringworm) caused by Epidermophyton, Microsporum, or Trichophyton.²⁶³ ²⁹¹ ³²⁴ ³²⁵

Used for severe recalcitrant cutaneous dermatophyte infections in patients who have not responded to topical therapy or have not responded to or are unable to take other oral antifungals (e.g., griseofulvin).²⁶³

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection does not respond to topical therapy, or the patient is immunocompromised or has a coexisting disease.³⁵² ³⁵³ ³⁵⁶ ³⁵⁷ ³⁵⁸ ³⁶⁰ Tinea capitis and tinea barbae generally are treated using an oral antifungal.³²⁵ ³⁵³ ³⁵⁹

While topical antifungals usually are effective for treatment of uncomplicated tinea manuum and tinea pedis,³⁵³ ³⁵⁶ ³⁵⁸ ³⁶⁰ an oral antifungal usually is necessary for treatment of severe, chronic, or recalcitrant tinea pedis, for treatment of chronic moccasin-type (dry-type) tinea pedis, and for treatment of tinea unguium (onychomycosis).³⁵³ ³⁵⁷ ³⁵⁸ ³⁶⁰

Histoplasmosis

Treatment of histoplasmosis caused by Histoplasma capsulatum.²¹³ ²³⁸ ²⁶³ ²⁸⁸ ²⁹⁰ ²⁹¹ ²⁹² ²⁹³ ³⁷⁵

Drugs of choice are IV amphotericin B (especially for life-threatening infections including those in HIV-infected individuals) or oral itraconazole; ketoconazole and fluconazole are considered alternatives.²³⁸ ²⁷⁹ ²⁸⁰ ²⁹⁰ ²⁹¹ ²⁹² ³⁷⁵

Paracoccidioidomycosis

Treatment of paracoccidioidomycosis (South American blastomycosis) caused by Paracoccidioides brasiliensis.²³⁸ ²⁶³ ²⁸⁸ ²⁹¹ ³¹¹ ³³⁵

Drug of choice for initial treatment of severe infections is IV amphotericin B;²³⁸ ²⁸⁸ ²⁹¹ ²⁹³ ³¹⁰ ³¹¹ ³³⁵ oral azole antifungals (e.g., ketoconazole, itraconazole) can be used in patients with less severe infections.²³⁸ ²⁸⁸ ²⁹¹ ³³⁵

Pityriasis (Tinea) Versicolor

Has been effective for treatment of pityriasis (tinea) versicolor†, a superficial infection caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).²³⁴ ³⁵⁴ ³⁵⁵

Pityriasis (tinea) versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%).²³⁴ ³²⁴ ³⁵² ³⁵⁴ ³⁵⁵ ³⁵⁷ An oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical agent, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.³²⁴ ³⁵⁴ ³⁵⁵ ³⁵⁷

Acanthamoeba Infections

Has been used in conjunction with a topical anti-infective (e.g., miconazole, neomycin, metronidazole, propamidine isethionate) in the treatment of Acanthamoeba keratitis†.¹³⁴ ¹³⁵ ¹³⁶ ¹³⁷ ¹³⁸ ¹³⁹ ¹⁴⁰ ²²⁶ Optimum therapy for Acanthamoeba keratitis remains to be clearly established, but prolonged local and systemic therapy with multiple anti-infectives and often surgical treatment (e.g., penetrating keratoplasty) usually required.¹³⁴ ¹³⁵ ¹³⁶ ¹³⁷ ¹³⁸ ¹³⁹ ¹⁴⁰

A regimen of oral ketoconazole, rifampin, and co-trimoxazole has been used for treatment of chronic Acanthamoeba meningitis† in several immunocompetent children.¹⁸⁷ ²²⁵ (See Meningitis and Other CNS Infections under Cautions.)

Leishmaniasis

Has been used for treatment of cutaneous or mucocutaneous leishmaniasis† caused by various Leishmania spp. (e.g., Leishmania major†, L. mexicana†, L. panamensis†, L. braziliensis†, L. tropica†).²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²³⁴ ²⁵⁰ ³¹⁴ ³¹⁶ ³¹⁷ Usual drugs of choice are pentavalent antimony compounds (e.g., sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]).²²⁵ ²³⁴ ³¹⁷ ³¹⁹ Preferred alternatives or additional drugs of choice are IV amphotericin B (conventional or liposomal formulations) and parenteral pentamidine; other alternatives include oral azole antifungals (e.g., itraconazole, ketoconazole) or topical paromomycin (for cutaneous leishmaniasis when there is a low potential for mucosal spread).²²⁵ ²³⁴ ³¹⁹

Has been used in a limited number of patients for treatment of antimony-resistant visceral leishmaniasis (kala-azar) caused by L. donovani†,²⁶¹ ²⁶² ³¹⁵ ³¹⁷ ³¹⁸ but may be less effective in these infections than in the treatment of cutaneous leishmaniasis.²⁶¹ ²⁶² ³¹⁷ Usual drugs of choice for initial treatment of visceral leishmaniasis are pentavalent antimony compounds, but resistance and treatment failures are becoming increasingly common;²⁸⁸ ³¹⁷ IV amphotericin B and pentamidine are considered alternatives.²⁸⁸ ³¹⁷ ³¹⁹

Prostate Cancer

Because of ketoconazole’s ability to inhibit testicular and adrenal steroid synthesis, the drug has been used in the treatment of advanced prostatic carcinoma†.¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹⁵¹ ¹⁷⁹ ¹⁸⁰ ¹⁸¹ ¹⁸² ¹⁸³ ¹⁸⁴ ²⁸⁴ ²⁸⁵ ²⁸⁶ ³⁶⁸ ³⁶⁹

Cushing’s Syndrome

Has been used effectively for palliative treatment of Cushing’s syndrome† (hypercortisolism), including adrenocortical hyperfunction associated with adrenal or pituitary adenoma or ectopic corticotropin-secreting tumors.¹¹² ¹¹³ ¹¹⁴ ¹⁵¹ ¹⁵⁴ ²²⁴ ³⁴²

Has been used in a limited number of geriatric patients ≥75 years of age for treatment of corticotropin-dependent Cushing’s syndrome; may provide an effective alternative in patients who cannot tolerate surgical treatment.³⁴²

Hirsutism and Precocious Puberty

Has been used with some success in a limited number of patients for treatment of dysfunctional hirsutism†.¹¹⁵ ³⁷⁰

Has been used in a limited number of boys for treatment of precocious puberty†.¹¹⁶ ¹⁸⁵ ¹⁸⁶

Hypercalcemia

Has been used with some success for treatment of hypercalcemia in adults with sarcoidosis†.³⁶³ ³⁶⁴ ³⁶⁵ ³⁶⁶ Has reduced serum calcium concentrations in some, but not all, patients with sarcoidosis-associated hypercalcemia;³⁶⁴ ³⁶⁵ ³⁶⁶ hypercalcemia and increased serum 1,25-dihydroxyvitamin D concentrations may recur when ketoconazole dosage is decreased or the drug discontinued.³⁶⁵ ³⁶⁶

Has been effective in a few adolescents for treatment of tuberculosis-associated hypercalcemia†.³⁶⁷

Nizoral Dosage and Administration

Administration

Oral Administration

Administer orally.²⁶³

To ensure absorption in patients with achlorhydria, each 200-mg ketoconazole tablet should be dissolved in 4 mL of 0.2N hydrochloric acid solution²⁶³ or taken with 200 mL of 0.1N hydrochloric acid.^a The resultant solution should be administered via a plastic or glass straw to avoid contact with the teeth, and a glass of water should be administered immediately after the solution.²⁶³ Alternatively, some clinicians recommend that each 200 mg of ketoconazole be given with ≥680 mg of glutamic acid hydrochloride.¹⁹⁸ ¹⁹⁹ Other clinicians suggest that each 200 mg of ketoconazole be administered with an acidic beverage (e.g., Coca-Cola, Pepsi)²⁷³ or the dose dissolved in 60 mL of citrus juice to ensure absorption; however, this strategy may not be adequate in all patients with achlorhydria and patients should be monitored closely for therapeutic failure.²⁷³

Dosage

Pediatric Patients

General Pediatric Dosage

Treatment of Fungal Infections

Oral

Children >2 years of age: 3.3–6.6 mg/kg once daily has been used.²³⁴ ²⁶³

Adults

General Adult Dosage

Treatment of Fungal Infections

Oral

200 mg once daily.²⁶³ Dosage may be increased to 400 mg once daily for severe infections or if the expected clinical response is not achieved.²⁶³

Blastomycosis

Oral

Some clinicians suggest 400 mg once or twice daily.²¹³ ²²⁰ ²³⁸ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹⁶ ²⁹⁹ ³⁰¹ ³²⁷ ³⁷⁵ Treatment usually continued for 6–12 months.^a

Candidiasis

Oropharyngeal and Esophageal Candidiasis

Oral

200–400 mg daily.²³⁸ ²⁷⁹

Vulvovaginal Candidiasis†

Oral

Treatment of uncomplicated vulvovaginal candidiasis† in nonpregnant women: 200–400 mg twice daily for 5 days.³⁴⁰ ³⁴³ ³⁴⁴

When used as a maintenance regimen to reduce the frequency of recurrent episodes of vulvovaginal candidiasis† in women who have received an initial intensive antifungal regimen (i.e., 7–14 days of an intravaginal azole antifungal or a 2-dose fluconazole regimen), ketoconazole has been given in a dosage of 100 mg once daily for up to 6 months.²⁷⁰ ³⁴⁰ ³⁴¹ ³⁴³ ³⁴⁴ ³⁴⁶

Chromomycosis

Oral

200–400 mg daily.³³⁵ Treatment usually continued for 6–12 months.

Coccidioidomycosis

Oral

400 mg once or twice daily.²¹³ ²²⁰ ²³⁸ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹⁶ ²⁹⁹ ³⁰¹ ³²⁷ ³⁷⁵ Treatment usually continued for 6–12 months.

Dermatophytoses

Oral

200–400 mg daily has been given for 1–2 months.^a Infections involving glabrous skin require a minimum of 4 weeks of treatment; palmar and plantar infections may respond more slowly.²⁶³ Tinea unguium (onychomycosis) may require ≥6–12 months of treatment.^a

Histoplasmosis

Oral

400 mg once or twice daily.²¹³ ²²⁰ ²³⁸ ²⁸⁸ ²⁹⁰ ²⁹² ²⁹⁶ ²⁹⁹ ³⁰¹ ³²⁷ ³⁷⁵ A dosage of 200 mg once or twice daily also has been used.³⁷⁵

A minimum of 6 months of therapy usually required, but 2–6 months has been effective in some patients.^a

Paracocciodioidomycosis

Oral

200–400 mg daily.³³⁵

A minimum of 6 months of therapy usually required, but 2–6 months has been effective in some patients.^a

Leishmaniasis†

Cutaneous and Mucocutaneous Leishmaniasis†

Oral

400–600 mg daily for 4–8 weeks has been used.²⁰³ ²⁰⁴ ²⁰⁷ ²⁰⁸ ³¹⁷

Visceral Leishmaniasis (Kala-Azar)†

Oral

400–600 mg daily for 4–8 weeks has been used.³¹⁵ ³¹⁷ ³¹⁸

Prostate Cancer†

Oral

400 mg every 8 hours has been used for treatment of prostatic carcinoma†¹⁰⁶ ¹⁰⁸ ¹⁸⁰ ¹⁸¹ ¹⁸² ¹⁸³ ²⁸⁵ or as an adjunct in the management of disseminated intravascular coagulation (DIC) associated with prostatic carcinoma†.¹⁵² ¹⁷⁸ Risk of depressed adrenocortical function at this high dosage should be considered.²⁶³ (See Endocrine and Metabolic Effects under Cautions.)

Cautions for Nizoral

Contraindications

Hypersensitivity to ketoconazole.²⁶³

Concomitant use with certain drugs metabolized by CYP3A4 isoenzymes (e.g., astemizole [no longer commercially available in the US], cisapride, midazolam, terfenadine [no longer commercially available in the US], triazolam).²⁶³ (See Specific Drugs under Interactions.)

Warnings/Precautions

Warnings

Hepatic Effects

Hepatotoxicity (usually the hepatocellular type) has been reported.¹⁶⁴ ¹⁶⁵ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁹¹ ¹⁹² ¹⁹³ ²⁶³

Symptomatic hepatotoxicity usually is apparent within the first few months of ketoconazole therapy (median 28 days),⁵⁰ ⁶¹ ¹⁶⁴ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹¹ ¹⁹² ²⁶³ but occasionally may be apparent within 3–7 days of initiation of therapy.¹⁶⁴ ¹⁶⁶ ¹⁶⁷ ¹⁹¹ ¹⁹² ²⁶³ Although ketoconazole-induced hepatotoxicity usually is reversible following discontinuance of the drug,⁵⁰ ¹⁶⁴ ¹⁶⁵ ¹⁶⁶ ¹⁶⁷ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹¹ ¹⁹² ²⁶³ recovery may take several months;¹⁶⁴ ¹⁶⁵ ¹⁶⁷ ¹⁸⁸ ¹⁹⁰ ²⁶³ rarely, death has occurred.¹⁶⁴ ¹⁶⁵ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁹¹ ¹⁹² ¹⁹³ ²⁶³

Most cases of hepatotoxicity have been reported in patients receiving the drug for tinea unguium (onychomycosis);⁵⁰ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹¹ ¹⁹² ¹⁹³ ²⁶³ many others were receiving the drug for chronic, refractory dermatophytoses.¹⁶⁷ ¹⁹¹ ¹⁹² Several cases of ketoconazole-induced hepatitis have been reported in children.¹⁶⁵ ¹⁶⁷ ¹⁸⁹ ¹⁹¹ ¹⁹² ²⁶³

Monitor closely for clinical and biochemical signs of hepatotoxicity.¹⁶⁴ ¹⁶⁶ ¹⁶⁷ ¹⁶⁹ ¹⁷⁰ ¹⁹² ²⁶³ Perform liver function tests (e.g., serum AST, ALT, alkaline phosphatase, γ-glutamyltransferase [γ-glutamyltranspeptidase, GGT, GGTP], bilirubin) prior to and frequently (e.g., biweekly during the first 2 months of therapy and monthly or bimonthly thereafter) during therapy, particularly in those receiving prolonged therapy, those receiving other potentially hepatotoxic drugs, and those with a history of hepatic disease.¹⁶⁴ ¹⁶⁶ ¹⁶⁷ ¹⁶⁹ ¹⁷⁰ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹³ ²⁶³

Minor, asymptomatic elevations in liver function test results may return to pretreatment concentrations during continued ketoconazole therapy.¹⁶⁴ ¹⁶⁷ ¹⁹¹ ¹⁹² ¹⁹³ If liver function test results are substantially elevated or if such abnormalities persist, worsen, or are accompanied by other manifestations of hepatic dysfunction, ketoconazole should be discontinued.¹⁶⁴ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁸⁹ ¹⁹⁰ ¹⁹¹ ¹⁹²

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and urticaria reported rarely.¹⁰² ²⁶³

General Precautions

Endocrine and Metabolic Effects

Ketoconazole can inhibit testosterone synthesis and transient decreases in serum testosterone may occur;¹⁰⁹ ¹¹⁰ ¹⁵¹ ¹⁷⁴ ²⁶³ concentrations usually return to baseline values after the drug is discontinued.²⁶³ Testosterone concentrations are impaired with ketoconazole dosage of 800 mg daily and abolished with dosage of 1.6 g daily.²⁶³

Ketoconazole may inhibit cortisol synthesis, particularly in patients receiving relatively high daily dosage or divided daily dosing.¹⁰⁹ ¹¹² ¹¹³ ¹¹⁴ ¹⁵¹ ¹⁵⁴ ¹⁵⁶ ¹⁵⁷ ¹⁵⁸ ¹⁵⁹ ¹⁶⁶ ¹⁷³ ¹⁹² ²²⁹ ²³⁰ The adrenocortical response to corticotropin (ACTH) may be at least transiently diminished and a reduction in urinary free and serum cortisol concentrations may occur.¹⁰⁹ ¹¹⁰ ¹¹² ¹¹³ ¹¹⁴ ¹⁵¹ ¹⁵⁴ ¹⁵⁶ ¹⁵⁷ ¹⁵⁸ ¹⁵⁹ ¹⁶⁶ ¹⁷³ ¹⁹² Adrenocortical insufficiency has been reported only rarely.¹⁰⁹ ¹⁵⁹ ¹⁶⁰ ¹⁶⁶ ¹⁷³ ¹⁹² ²²⁹ Adrenocortical hypofunction generally is reversible following discontinuance of the drug,¹⁵⁴ ¹⁵⁶ ¹⁵⁷ ¹⁶⁶ but rarely may be persistent.¹⁵⁹

To minimize the risk of possible endocrine and metabolic effects, dosages greater than those usually recommended should not be used.²⁶³

Meningitis and Other CNS Infections

Because CSF concentrations of ketoconazole are unpredictable following oral administration, the drug should not be used alone to treat CNS fungal infections, including candidal, coccidioidal, or cryptococcal meningitis.²⁶³ ²⁹¹ ³⁰² ³³⁰

Specific Populations

Pregnancy

Category C.²⁶³

Lactation

Probably distributed into human milk.²⁶³ Discontinue nursing or the drug.²⁶³

Pediatric Use

Use in pediatric patients only when potential benefits justify possible risks.²⁶³ Has not been systematically studied in children of any age,²⁶³ but has been used in a limited number of children >2 years of age.²⁶³ There is essentially no information available to date on use in children <2 years of age.²⁶³

Common Adverse Effects

GI effects (nausea, vomiting), hepatic effects, pruritus.²⁶³

Interactions for Nizoral

Inhibits CYP3A4.²⁶³

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are substrates of CYP3A4.²⁶³

Hepatotoxic Drugs

Monitor closely if used concomitantly with other potentially hepatotoxic drugs, especially in patients requiring prolonged therapy or with a history of liver disease.²⁶³ (See Hepatic Effects under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Alcohol	Disulfiram reactions (flushing, rash, peripheral edema, nausea, headache) have occurred rarely in patients who ingested alcohol while receiving ketoconazole;²⁶³ ²⁶⁷ ²⁶⁸ usually resolved within a few hours²⁶³	Some clinicians recommend that alcohol be avoided during and for 48 hours after discontinuance of ketoconazole therapy²⁶⁷
Antacids	Because gastric acidity is necessary for dissolution and absorption of ketoconazole, concomitant administration of antacids may decrease absorption of the antifungal²⁶³	Administer antacids at least 2 hours after ketoconazole²⁶³
Anticoagulants, oral (warfarin)	Possible enhanced anticoagulant effects²⁶³	Monitor PT or other appropriate tests closely; adjust anticoagulant dosage if necessary²⁶³
Anticonvulsants (phenytoin)	Possible pharmacokinetic interaction with changes in metabolism of one or both drugs²⁶³	Monitor serum concentrations if used concomitantly²⁶³
Antidiabetic agents, sulfonylureas	Increased plasma concentrations of the antidiabetic agent and symptoms of hypoglycemia reported with other azoles (e.g., itraconazole)²⁶³ ^b	Consider the possibility that hypoglycemia may occur when ketoconazole used concomitantly with antidiabetic agents²⁶³
Antihistamines (astemizole, loratadine, terfenadine)	Aztemizole and terfenadine (drugs no longer commercially available in the US): Pharmacokinetic interaction and potential for serious or life-threatening reactions (e.g., cardiac arrhythmias, prolonged QT interval)²⁵² ²⁵³ ²⁵⁴ ²⁵⁵ ²⁵⁶ ²⁵⁷ ²⁵⁹ ²⁶⁰ ²⁶³ ²⁸⁷ Loratadine: Increased plasma concentrations and AUCs of loratadine and its active metabolite, but no evidence of changes in QT interval or incidence of adverse effects²⁶³	Aztemizole and terfenadine: Concomitant use contraindicated²⁵² ²⁵⁴ ²⁶³ ²⁶⁵
Antimycobacterials (rifampin, isoniazid)	Rifampin: Decreased serum concentrations of ketoconazole¹¹¹ ¹⁴¹ ²²¹ ²⁶³ Isoniazid: May affect ketoconazole serum concentrations¹¹¹ ²⁶³	Do not use concomitantly with rifampin or isoniazid²⁶³
Benzodiazepines (midazolam, triazolam)	Increased plasma concentrations of midazolam or triazolam; possible prolonged sedative and hypnotic effects of the drugs²⁶³	Ketoconazole should not be used concomitantly with midazolam or triazolam²⁶³ Special precaution is required if parenteral midazolam is used in patients receiving ketoconazole because the sedative effects of midazolam may be prolonged²⁶³
Cisapride	Increased cisapride plasma concentrations and increased risk of adverse effects (e.g., cardiovascular effects)²⁶³ ²⁷⁶	Concomitant use contraindicated²⁶³
Digoxin	Increased plasma concentrations of digoxin reported; causative relationship unclear²⁶³	Closely monitor digoxin concentrations in patients receiving ketoconazole²⁶³
Histamine H₂-receptor antagonists (e.g., cimetidine, ranitidine)	Because gastric acidity is necessary for dissolution and absorption of ketoconazole, concomitant administration of histamine H₂-receptor antagonists may decrease absorption of the antifungal ²⁶³	Administer H₂-receptor antagonist at least 2 hours after ketoconazole²⁶³
Immunosuppressive agents (cyclosporine, methylprednisolone, prednisone, tacrolimus)	Cyclosporine or tacrolimus: Increased concentrations of the immunosuppressive agent¹⁴² ¹⁴³ ¹⁴⁴ ²⁶³ ³⁷² Methylprednisolone or prednisone: Increased concentrations of the corticosteroid and possible enhanced adrenal suppression²²⁷ ²²⁸ ²³² ²³³	Cyclosporine or tacrolimus: Use with caution and monitor concentrations of the immunosuppressive agent if possible; adjust cyclosporine or tacrolimus dosage if needed when ketoconazole is initiated or discontinued¹⁴⁶ ²⁶³ Methylprednisolone or prednisolone: Adjust dosage of the corticosteroid as needed²²⁷ ²²⁸ ²⁶³
Paclitaxel	In vitro evidence that ketoconazole can inhibit metabolism of paclitaxel²⁶⁹	Clinical importance unclear; use concomitantly with caution²⁶⁹
Sucralfate	Possible decreased absorption of ketoconazole³⁶²	Administer sucralfate at least 2 hours after ketoconazole³⁶²
Theophylline	Conflicting data;¹⁴⁷ ¹⁵⁰ possible decreased theophylline concentrations¹⁴⁷	Pending further accumulation of data, monitor serum theophylline concentrations and adjust theophylline dosage if necessary when ketoconazole is initiated or discontinued in patients receiving theophylline¹⁴⁷

Nizoral Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract;¹⁶² ¹⁶³ peak plasma concentrations attained within 1–2 hours.¹⁴⁹ ¹⁶² ²⁶³

Ketoconazole must be dissolved in gastric secretions and converted to the hydrochloride salt prior to absorption from the stomach.^a Bioavailability depends on the pH of the gastric contents in the stomach; an increase in pH results in decreased absorption of the drug.^a (See Absorption: Special Populations.)

Food

Effect of food on rate and extent of GI absorption of ketoconazole has not been clearly determined.¹⁶²

Plasma Concentrations

Considerable interindividual variations in peak plasma concentrations and AUCs have been reported.^a

Special Populations

Oral bioavailability may be decreased in patients with achlorhydria,^a including those with HIV-associated gastric hypochlorhydria.¹⁹⁸ ²⁰⁰ Concomitant administration of dilute hydrochloric acid solution usually normalizes absorption of the drug in these patients.¹⁹⁸ Concomitant administration of an acidic beverage may increase bioavailability in some individuals.²⁷³ (See Oral Administration under Dosage and Administration.)

Distribution

Extent

Distributed into urine, bile, saliva, sebum, cerumen, and synovial fluid.^a

May be distributed into CSF following oral administration, but CNS penetration is unpredictable and has generally been considered to be minimal.^a

Not known whether crosses the placenta in humans; crosses the placenta in rats.^a Distributed into milk of dogs; probably distributed into human milk.^a

Plasma Protein Binding

84–99% bound to plasma proteins, primarily albumin.²⁶³ ^a

Elimination

Metabolism

Partially metabolized in the liver to several inactive metabolites by oxidation and degradation of the imidazole and piperazine rings, by oxidative O-dealkylation, and by aromatic hydroxylation.^a

Elimination Route

Major route of elimination of ketoconazole and its metabolites appears to be excretion into the feces via the bile.^a

In fasting adults with normal renal function, approximately 57% of a single 200-mg oral dose is excreted in feces within 4 days (20–65% of this is unchanged drug); approximately 13% of the dose is excreted in urine within 4 days (2–4% of this is unchanged drug).^a

Half-life

Plasma concentrations appear to decline in a biphasic manner with a half-life of approximately 2 hours in the initial phase and 8 hours in the terminal phase.²⁶³

Special Populations

Plasma concentrations and half-life not substantially affected by renal or hep

Tuesday, September 11, 2012

Nucochem Pediatric Expectorant

Generic Name: codeine, guaifenesin, and pseudoephedrine (KOE deen, gwye FEN e sin, and soo doe e FED rin)

Brand Names: Ambifed CD, Ambifed CDX, Ambifed-G CD, Ambifed-G CDX, Biotussin DAC, Cheratussin DAC, Codafed, Codahistine Expectorant, Halotussin DAC, Maxifed CD, Medent C, Phenhist Expectorant

What is Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

Codeine is a narcotic cough suppressant.

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

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of codeine, guaifenesin, and pseudoephedrine is used to treat stuffy nose and cough, and to reduce chest congestion caused by the common cold, infections, or allergies.

Codeine, guaifenesin, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

What should I discuss with my healthcare provider before taking Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

severe or uncontrolled high blood pressure;

severe coronary artery disease; or

if you are breast-feeding a baby.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking codeine, guaifenesin, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease or high blood pressure;

ischemic heart disease (reduced circulation of blood to the heart);

asthma, COPD, sleep apnea, or other breathing disorders;

diabetes;

a thyroid disorder;

glaucoma;

liver or kidney disease;

a history of head injury or brain tumor;

epilepsy or other seizure disorder;

enlarged prostate, urination problems;

a stomach or intestinal disorder;

Addison's disease or other adrenal gland disorders;

if you have recently had surgery on your stomach, intestines, kidney, or bladder.

gallbladder disease;

mental illness; or

a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Codeine can cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Older adults may be more likely to have side effects from this medication.

How should I take Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Take codeine, guaifenesin, and pseudoephedrine with food if it upsets your stomach. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this 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 cough does not improve after 5 days of treatment, or if you also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

Keep track of how much of this medication has been used. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of codeine can be fatal.

Overdose symptoms may include nausea, vomiting, feeling restless or nervous, extreme dizziness or drowsiness, confusion, cold and clammy skin, shallow breathing, slow heart rate, pinpoint pupils, fainting, or coma.

What should I avoid while taking Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of codeine. Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). This medication can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine) 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 taking this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

slow heart rate, weak pulse, fainting, weak or shallow breathing;

severe dizziness, anxiety, restless feeling, or nervousness, headache, tremors;

confusion, unusual thoughts or behavior;

seizure (convulsions);

urinating less than usual or not at all; or

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects include:

dizziness or headache;

constipation;

nausea, vomiting, upset stomach, loss of appetite;

feeling excited or restless;

sleep problems (insomnia);

increased sweating;

warmth, tingling, or redness under your skin; or

mild skin rash or itching.

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 Nucochem Pediatric Expectorant (codeine, guaifenesin, and pseudoephedrine)?

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

Also tell your doctor if you are using any of the following drugs:

medicines to treat high blood pressure;

indomethacin (Indocin);

methyldopa (Aldomet); or

a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with codeine, guaifenesin, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Nucochem Pediatric Expectorant resources

Nucochem Pediatric Expectorant Side Effects (in more detail)
Nucochem Pediatric Expectorant Use in Pregnancy & Breastfeeding
Nucochem Pediatric Expectorant Drug Interactions
0 Reviews for Nucochem Pediatric Expectorant - Add your own review/rating

Ambifed CD MedFacts Consumer Leaflet (Wolters Kluwer)

Mytussin DAC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nucochem Pediatric Expectorant with other medications

Cold Symptoms

Where can I get more information?

Your pharmacist can provide more information about codeine, guaifenesin, and pseudoephedrine.

See also: Nucochem Pediatric Expectorant side effects (in more detail)

Anaprox

Generic Name: naproxen (Oral route)

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Aflaxen

Aleve

Aleve Arthritis

Anaprox

Anaprox DS

EC Naprosyn

Naprelan

Naprelan 500

Naprelan Dose Card

Naprosyn

In Canada

Naxen

Available Dosage Forms:

Tablet

Suspension

Tablet, Enteric Coated

Tablet, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Anaprox

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

This medicine is available only with your doctor's prescription.

Before Using Anaprox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Ardeparin

Argatroban

Aspirin

Beclamide

Beta Glucan

Bivalirudin

Caramiphen

Carbamazepine

Certoparin

Chlormethiazole

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Diazepam

Dipyridamole

Enoxaparin

Escitalopram

Ethotoin

Felbamate

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Fosphenytoin

Gabapentin

Ginkgo

Heparin

Lacosamide

Lepirudin

Mephenytoin

Mephobarbital

Methotrexate

Nadroparin

Nefazodone

Oxcarbazepine

Paraldehyde

Paramethadione

Parnaparin

Paroxetine

Pemetrexed

Phenacemide

Phenobarbital

Phenytoin

Piracetam

Pregabalin

Protein C

Reviparin

Rivaroxaban

Rufinamide

Sertraline

Sibutramine

Stiripentol

Tacrolimus

Tiagabine

Ticlopidine

Tinzaparin

Tirofiban

Topiramate

Trimethadione

Valproic Acid

Vigabatrin

Vilazodone

Warfarin

Zimeldine

Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Acetohexamide

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Cyclosporine

Delapril

Desvenlafaxine

Dilevalol

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Labetalol

Landiolol

Levobetaxolol

Levobunolol

Lisinopril

Lithium

Losartan

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Milnacipran

Moexipril

Nadolol

Nebivolol

Nipradilol

Olmesartan Medoxomil

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Tasosartan

Telmisartan

Temocapril

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Xipamide

Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of naproxen

This section provides information on the proper use of a number of products that contain naproxen. It may not be specific to Anaprox. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.
  - Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen controlled-release tablet (e.g., Naprelan®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.

For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Anaprox

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Anaprox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Belching

bruising

difficult or labored breathing

feeling of indigestion

headache

itching skin

large, flat, blue, or purplish patches in the skin

pain in the chest below the breastbone

shortness of breath

skin eruptions

stomach pain

swelling

tightness in the chest

wheezing

Less common

Bloating

bloody or black, tarry stools

blurred or loss of vision

burning upper abdominal or stomach pain

cloudy urine

constipation

decrease in urine output or decrease in urine-concentrating ability

disturbed color perception

double vision

fast, irregular, pounding, or racing heartbeat or pulse

halos around lights

indigestion

loss of appetite

nausea or vomiting

night blindness

overbright appearance of lights

pale skin

pinpoint red or purple spots on the skin

severe and continuing nausea

severe stomach burning, cramping, or pain

skin rash

swelling or inflammation of the mouth

troubled breathing with exertion

tunnel vision

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of material that looks like coffee grounds

weight loss

Rare

Anxiety

back or leg pains

bleeding gums

blindness

blistering, peeling, or loosening of the skin

blood in the urine or stools

blue lips and fingernails

canker sores

change in the ability to see colors, especially blue or yellow

chest pain or discomfort

clay-colored stools

cold sweats

coma

confusion

cool, pale skin

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

cracks in the skin

darkened urine

decreased vision

depression

diarrhea

difficult, burning, or painful urination

difficult, fast, or noisy breathing

difficulty with swallowing

dilated neck veins

dizziness

dry cough

dry mouth

early appearance of redness, or swelling of the skin

excess air or gas in the stomach

extreme fatigue

eye pain

fainting

fever with or without chills

fluid-filled skin blisters

flushed, dry skin

frequent urination

fruit-like breath odor

greatly decreased frequency of urination or amount of urine

hair loss

high fever

hives

increased hunger

increased sensitivity of the skin to sunlight

increased sweating

increased thirst

increased urination

increased volume of pale, dilute urine

irregular breathing

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas

light-colored stools

lightheadedness

loss of heat from the body

lower back or side pain

nervousness

nightmares

no blood pressure

no breathing

no pulse

nosebleeds

numbness or tingling in the hands, feet, or lips

pain in the ankles or knees

pain or burning in the throat

pain or discomfort in the arms, jaw, back, or neck

painful, red lumps under the skin, mostly on the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

red, irritated eyes

red skin lesions, often with a purple center

red-green color blindness

redness or other discoloration of the skin

redness, swelling, or soreness of the tongue

scaly skin

seizures

severe sunburn

shakiness

skin thinness

slurred speech

sneezing

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

spots on your skin resembling a blister or pimple

stiff neck or back

stomach cramps or tenderness

stomach upset

swelling in the legs and ankles

swelling of the face, fingers, feet, or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tiny bumps on the inner lining of the eyelid

unexplained weight loss

unpleasant breath odor

watery or bloody diarrhea

weakness or heaviness of the legs

weight gain

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bleeding under the skin

confusion about identity, place, and time

muscle tremors

restlessness

sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Continuing ringing or buzzing or other unexplained noise in the ears

hearing loss

Less common

Acid or sour stomach

change in hearing

feeling of constant movement of self or surroundings

passing gas

sensation of spinning

stomach soreness or discomfort

Rare

Appetite changes

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

difficulty with moving

discharge, excessive tearing

general feeling of discomfort or illness

lack or loss of strength

menstrual changes

muscle aching, cramping, stiffness, or weakness

not able to concentrate

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

seeing, hearing, or feeling things that are not there

shakiness in the legs, arms, hands, or feet

sleeplessness

swollen joints

trembling or shaking of the hands or feet

trouble getting pregnant

trouble performing routine tasks

trouble sleeping

unable to sleep

unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Anaprox side effects (in more detail)

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More Anaprox resources

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

Anaprox MedFacts Consumer Leaflet (Wolters Kluwer)

Naproxen Professional Patient Advice (Wolters Kluwer)

Naproxen Prescribing Information (FDA)

Naproxen Monograph (AHFS DI)

Aleve MedFacts Consumer Leaflet (Wolters Kluwer)

Aleve Consumer Overview

EC-Naprosyn Enteric-Coated Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Naprosyn Consumer Overview

Naprosyn Prescribing Information (FDA)

Compare Anaprox with other medications

Ankylosing Spondylitis
Aseptic Necrosis
Back Pain
Bursitis
Costochondritis
Diffuse Idiopathic Skeletal Hyperostosis
Dysautonomia
Fever
Frozen Shoulder
Gout, Acute
Headache
Juvenile Rheumatoid Arthritis
Muscle Pain
Osteoarthritis
Pain
Period Pain
Rheumatoid Arthritis
Sciatica
Spondylolisthesis
Tendonitis