doxycycline monohydrate

doxycycline monohydrate

Monodox

Pharmacologic class: Tetracycline

Therapeutic class: Anti-infective

Pregnancy risk category D

Action

Unclear. Thought to inhibit bacterial protein synthesis at 30S and 50S ribosomal subunit and to alter cytoplasmic membrane of susceptible organisms.

Availability

Capsules: 50 mg, 100 mg, 150 mg

Capsules (coated pellets): 40 mg, 75 mg, 100 mg

Powder for injection: 100 mg, 200 mg

Powder for oral suspension: 25 mg/5 ml

Syrup: 50 mg

Tablets: 20 mg, 50 mg, 75 mg, 100 mg

Indications and dosages

Rosacea

Adults: 40 mg P.O. daily in the morning

Infections caused by various organisms, including Mycoplasma, Chlamydia, and Rickettsia organisms, and Borrelia burgdorfer

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. q 12 hours on first day, followed by 100 to 200 mg P.O. once daily; or 50 to 100 mg P.O. q 12 hours; or 200 mg I.V. once daily; or 100 mg I.V. q 12 hours on first day, followed by 100 to 200 mg I.V. once daily; or 50 to 100 mg I.V. q 12 hours

Children weighing 45 kg (99 lb) or less: 2.2 mg/kg P.O. q 12 hours on first day, followed by 2.2 to 4.4 mg/kg/day P.O. once daily; or 1.1 to 2.2 mg/kg P.O. q 12 hours; or 4.4 mg/kg I.V. once daily; or 2.2 mg/kg I.V. q 12 hours on first day, followed by 2.2 to 4.4 mg/kg I.V. once daily; or 1.1 to 2.2 mg/kg I.V. q 12 hours

Gonorrhea in penicillin-allergic patients

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. q 12 hours for 7 days; or 300 mg P.O. initially, followed by another 300 mg P.O. 1 hour later

Lyme disease

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. b.i.d. for 10 to 30 days

Periodontitis

Adults and children weighing more than 45 kg (99 lb): 20 mg P.O. b.i.d. for up to 9 months

Anthrax

Adults and children weighing more than 45 kg (99 lb): 100 mg P.O. b.i.d. for 60 days; or 100 mg I.V. q 12 hours for 60 days, changing to oral route when appropriate

Children weighing 45 kg (99 lb) or less: 2.2 mg/kg P.O. b.i.d. for 60 days; or 100 mg I.V. q 12 hours for 60 days, changing to oral route when appropriate

Prevention of malaria caused by Plasmodium falciparum in short-term travelers (less than 4 months)

Adults: 100 mg/day P.O. starting 1 to 2 days before travel begins and continuing during and for 4 weeks after travel

Children: 2 mg/kg/day P.O., up to adult dosage of 100 mg/day, starting 1 to 2 days before travel begins and continuing during and for 4 weeks after travel

Off-label uses

• Traveler's diarrhea
• Pleural effusion

Contraindications

• Hypersensitivity to drug, other tetracyclines, or bisulfites (with some drug products)

Precautions

Use cautiously in:
• renal disease, hepatic impairment, nephrogenic diabetes insipidus, cachexia
• pregnant or breastfeeding patients
• children younger than age 8.

Administration

• Obtain specimens for culture and sensitivity testing, as ordered, before first dose.

Don't give in conjunction with methoxyflurane anesthetic. Severe or fatal kidney damage may result.
• Reconstitute powder for injection with dextrose 5% in water, normal saline solution, lactated Ringer's solution, or dextrose 5% in lactated Ringer's solution.
• Don't infuse solutions with concentrations above 1 mg/ml.
• Infuse 100-mg dose over at least 1 hour.
• Complete infusion within 12 hours of dilution, unless diluted with lactated Ringer's solution or dextrose 5% in lactated Ringer's solution; in this case, complete infusion within 6 hours.

Don't give during last half of pregnancy or to children under age 8 unless other drugs are likely to be ineffective or are contraindicated. Drug may retard bone growth and cause tooth discoloration and malformation.
• Be aware that capsules with coated pellets contain immediate- and delayed-release pellets.

Adverse reactions

CNS: paresthesia, pseudotumor cerebri

CV: phlebitis, thrombophlebitis, pericarditis

EENT: vestibular reactions, hoarseness, pharyngitis

GI: nausea, vomiting, diarrhea, esophagitis, epigastric distress, enterocolitis, anogenital lesions or inflammation, glossitis, oral candidiasis, black hairy tongue, pancreatitis

GU: dark yellow or brown urine, vaginal candidiasis

Hematologic: hemolytic anemia, neutropenia, thrombocytopenia

Hepatic: hepatotoxicity

Musculoskeletal: bone growth retardation (in children younger than age 8)

Skin: photosensitivity, maculopapular or erythematous rash, hyperpigmentation, urticaria

Other: tooth enamel defects, increased appetite, phlebitis at I.V. site, superinfection, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug.Adsorbent antidiarrheals; antacids; calcium, iron, and magnesium preparations: decreased doxycycline absorption

Barbiturates, carbamazepine, hormonal contraceptives containing estrogen, phenytoin, rifamycin: decreased doxycycline efficacy

Cholestyramine, colestipol: decreased oral absorption of doxycycline

Methoxyflurane: increased nephrotoxicity

Penicillin: decreased penicillin activity

Sucralfate: prevention of doxycycline absorption from GI tract

Warfarin: enhanced warfarin effects

Drug-diagnostic tests.Alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, blood urea nitrogen (BUN), eosinophils: increased levels

Hemoglobin, neutrophils, platelets, white blood cells: decreased levels

Urine catecholamines: false elevations

Drug-food.Calcium-containing foods: decreased drug absorption

Drug-behaviors.Alcohol use: decreased anti-infective effect of doxycycline

Sun exposure: increased risk of photosensitivity

Patient monitoring

• Evaluate I.V. site regularly. Apply cool compresses as needed.

Monitor for hypersensitivity reactions, including anaphylaxis.
• Monitor hepatic profile, CBC, BUN, and creatinine levels.
• Assess for hypercoagulability in patients taking warfarin concurrently.
• Monitor for digoxin toxicity in patients taking digoxin concurrently.

Patient teaching

• Advise patient to take with 8 oz of water to ensure passage into stomach.
• Tell patient to take on empty stomach at least 1 hour before meals or 2 hours afterwards.
• Instruct patient to take at least 1 hour before bedtime to prevent esophagitis.

Tell patient to immediately report painful swallowing, abdominal pain, easy bruising or bleeding, or signs of hypersensitivity (such as rash).
• Advise female patient to tell prescriber if she is pregnant.
• Instruct patient to avoid alcohol use and large amounts of calcium-containing foods (such as dairy products and some green leafy vegetables, such as spinach).
• Stress importance of good oral hygiene.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

References in periodicals archive ?
Anti-inflammatory-dose doxycycline is a 40-mg, controlled-release doxycycline monohydrate capsule that is administered once a day.
NanoDOX([R]) Hydrogel is composed of doxycycline monohydrate, a currently marketed antibiotic available only in tablet and injectable forms.
In other clinical updates, a Phase IIa clinical trial of NanoDOX[TM] 1% Doxycycline Monohydrate Hydrogel, a topical formulation of doxycycline for chronic wounds, has been enrolling patients since February 2009 and is expected to be completed by fourth quarter 2009.
today announced the launch of its authorized generic version for ADOXA(R) 150 mg strength doxycycline monohydrate tablets.
The company has begun recruiting patients for a phase IIa clinical study of NanoDOX[TM] 1% Doxycycline Monohydrate Hydrogel, a topical formulation of doxycycline for chronic wounds.
In addition to the ADOXA(R) family's new ADOXA(R) Pak(TM) 1/75mg strength, the ADOXA(R) Pak(TM) 1/150mg is the first and only 150 mg doxycycline monohydrate scored tablet that provides the physician with dosing flexibility.
NanoDOX[TM] Hydrogel is composed of doxycycline monohydrate, a currently marketed antibiotic available in tablet and injectable forms.
today announced that it has begun shipping doxycycline monohydrate tablets, an authorized generic version of Adoxa(R) licensed from Bradley Pharmaceuticals, Inc.
Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Doxycycline Monohydrate Tablets 50mg and 100mg; the first generic approval of this product.
Pursuant to this Agreement, Bradley has granted Par a license to be Bradley's exclusive distributor throughout the United States of Bradley's authorized generic version of the 50mg and 100mg strengths of ADOXA(R) doxycycline monohydrate tablets, an antibiotic therapy primarily used for the adjunctive treatment of severe acne.
This product along with an existing product portfolio of anti-infectives has grown significantly and includes Cefaclor capsules and suspensions, Cephalexin capsules and suspensions, Amoxicillin capsules, tablets and chewable tablets, Cefadroxil tablets and capsules, Minocycline capsules, Doxycycline Monohydrate capsules, Clindamycin capsules and Acyclovir tablets and capsules.
Eon has begun shipping 150,000 capsules of 100mg strength Doxycycline Monohydrate and is also discussing future assistance to the Department of Health.