Demeclocycline

Trade Names:
Declomycin
- Tablets 150 mg
- Tablets 300 mg

Pharmacology

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Inhibits bacterial protein synthesis.

Pharmacokinetics

Absorption

Peak concentration is reached in about 4 h. The mean concentrations 1 and 3 h after 150 mg oral dose are 0.46 and 1.22 mcg/mL, respectively.

Distribution

Penetrates well into various body fluids and tissues. Protein binding is about 40%.

Elimination

Concentrated in the liver and excreted into the bile. Renal Cl is about 35 mL/min/1.73 m ² . In data from a small number of patients, approximately 44% is excreted in the urine, and 13% to 46% is excreted in feces.

Indications and Usage

Treatment of infections caused by susceptible strains of gram-positive and gram-negative microorganisms.

Contraindications

Hypersensitivity to any tetracycline and any component of the product.

Dosage and Administration

PO 150 mg 4 times daily or 300 mg twice daily.

PO Usual dose is 7 to 13 mg/kg/day divided into 2 to 4 doses (max, 600 mg/day).

PO 600 mg followed by 300 mg every 12 h for 4 days (total 3 g).

General Advice

• Administer each dose with a full glass of water on an empty stomach at least 1 h before or 2 h after meals.
• Administer antacids containing aluminum, calcium, or magnesium, or preparations containing iron at least 2 h before or after the demeclocycline.

Storage/Stability

Store tablets at controlled room temperature (68° to 77°F).

Drug Interactions

May decrease the absorption of demeclocycline.

Effect of anticoagulant may be enhanced, necessitating a downward adjustment in dosage.

Increased potential for life-threatening renal toxicity.

May reduce the effectiveness of oral contraceptives.

The bactericidal action may be decreased by tetracyclines.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Pseudotumor cerebri; bulging fontanels (in infants); dizziness; headache; myasthenic syndrome.

Dermatologic

Maculopapular and erythematous rashes; erythema multiforme; exfoliative dermatitis; fixed drug eruptions; Stevens-Johnson syndrome; pigmentation of skin and mucous membranes; lesions on the glans penis causing balanitis; phototoxicity.

EENT

Esophageal ulcerations; tinnitus; visual disturbances.

GI

Anorexia; nausea; vomiting; diarrhea; glossitis; dysphagia; enterocolitis; pancreatitis; inflammatory lesions in the anogenital region (eg, monilial overgrowth); tooth discoloration (children younger than 8 yr of age).

Hematologic

Hemolytic anemia; thrombocytopenia; neutropenia; eosinophilia.

Hepatic

Increased liver enzymes; hepatic toxicity; hepatitis; liver failure.

Renal

Acute renal toxicity; increased BUN; nephrogenic diabetes insipidus.

Miscellaneous

Hypersensitivity (including urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of SLE, lupus-like syndrome, pulmonary infiltrates with eosinophilia); brown-black thyroid gland discoloration.

Precautions

Pregnancy

Category D .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 8 yr of age because abnormal bone formation and discoloration of teeth may occur.

Renal Function

May lead to excessive accumulation of the drug and possible liver toxicity; dosage reduction may be required.

Hazardous Tasks

Patients experiencing CNS symptoms should be cautioned about driving vehicles or using dangerous machinery.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth.

Photosensitivity

May manifest as exaggerated sunburn.

Diabetes insipidus syndrome

May occur.

Pseudotumor cerebri (benign intracranial hypertension)

Has been reported.

Patient Information

• Review dosing schedule and prescribed length of therapy with patient. Advise patient that dose and duration of therapy are dependent on site and cause of infection.
• Instruct patient to take prescribed dose with a full glass of water at least 1 h before or 2 h after meals.
• Advise patient taking iron-containing products or antacids containing aluminum, calcium, or magnesium to take these products either 2 h before or after the demeclocycline.
• Instruct patient to complete entire course of therapy, even if symptoms of infection have disappeared.
• Advise patient that diarrhea, headache, and nausea are most common adverse reactions and to inform health care provider if they occur and are intolerable.
• Advise patient to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, shortness of breath, headache, blurred vision, unexplained weakness or thirst, or frequent urination occur.
• Advise patient to avoid unnecessary exposure to sunlight or tanning lamps and to use sunscreens and wear protective clothing to avoid photosensitivity reactions.
• Caution women taking oral contraceptives that demeclocycline may make birth control pills less effective and to use nonhormonal forms of contraception during treatment.
• Caution patient that drug may cause dizziness, lightheadedness, or blurred vision and to use caution while driving or performing other hazardous tasks until tolerance is determined.
• Advise patient to report the following signs of superinfection to health care provider: black furry tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
• Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and to not treat at home.
• Advise patient to discard any unused demeclocycline by the expiration date noted on the label.

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