Demeclocycline

Name: Demeclocycline

Brand names

  • Declomycin®

Demeclocycline Interactions

Do not take demeclocycline with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medicine.

Demeclocycline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Demeclocycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking demeclocycline. Also avoid a product that contains bismuth subsalicylate (such as Pepto-Bismol) within 2 hours before or after taking demeclocycline. These medications can make it harder for your body to absorb demeclocycline.

Tell your doctor about all other medicines you use, especially:

  • colestipol (Colestid);
  • methotrexate (Rheumatrex, Trexall);
  • isotretinoin (Accutane);
  • vitamin A or a retinoid such as acitretin (Soriatane) or tretinoin (Renova, Retin-A, Vesanoid);
  • an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;
  • a blood thinner such as warfarin (Coumadin); or
  • a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, others), penicillin (BeePen-VK, Pen-Vee K, Veetids, others), dicloxacillin (Dynapen), oxacillin (Bactocill), and others.

This list is not complete and other drugs may interact with demeclocycline. 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.

Demeclocycline Dosage

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.

Take demeclocycline on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Demeclocycline is usually given for up to 2 days after lab tests show that the infection has cleared. Demeclocycline will not treat a viral infection such as the common cold or flu.

Do not share this medication with another person, even if they have the same symptoms you have.

If you take this medication long-term, your blood will need to be tested often. Your kidney and liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and light. Throw away any unused demeclocycline after the expiration date on the label has passed.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

How should I take demeclocycline?

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.

Take demeclocycline on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Demeclocycline is usually given for up to 2 days after lab tests show that the infection has cleared. Demeclocycline will not treat a viral infection such as the common cold or flu.

Do not share this medication with another person, even if they have the same symptoms you have.

If you take this medication long-term, your blood will need to be tested often. Your kidney and liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and light. Throw away any unused demeclocycline after the expiration date on the label has passed.

Demeclocycline 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 demeclocycline and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale skin, dark colored urine, jaundice (yellowing of the skin or eyes);

  • confusion, mood changes, weakness, increased thirst or urination;

  • swelling, weight gain, urinating less than usual or not at all;

  • chest pain, wheezing, dry cough, rapid breathing, feeling short of breath;

  • severe tingling, numbness, pain, muscle weakness;

  • headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

  • sore throat and headache with a severe blistering, peeling, and red skin rash; or

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

  • sores or swelling in your rectal or genital area;

  • mild nausea, vomiting, diarrhea, loss of appetite;

  • white patches or sores inside your mouth or on your lips;

  • swollen tongue, trouble swallowing; or

  • vaginal itching or discharge.

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.

How is this medicine (Demeclocycline) best taken?

Use demeclocycline as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Take on an empty stomach. Take 1 hour before or 2 hours after meals.
  • Take with a full glass of water.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Do not take bismuth (Pepto-Bismol®), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids within 2 hours of demeclocycline.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Indications and Usage for Demeclocycline

Demeclocycline HCl tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below:

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae;

Respiratory tract infections caused by Mycoplasma pneumoniae

Lymphogranuloma venereum due to Chlamydia trachomatis

Psittacosis (Ornithosis) due to Chlamydia psittaci

Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence

Inclusion conjunctivitis caused by Chlamydia trachomatis

Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis

Relapsing fever due to Borrelia recurrentis

Chancroid caused by Haemophilus ducreyi

Plague due to Yersinia pestis

Tularemia due to Francisella tularensis

Cholera caused by Vibrio cholerae

Campylobacter fetus infections cause by Campylobacter fetus

Brucellosis due to Brucella species (in conjunction with streptomycin);

Bartonellosis due to Bartonella bacilliformis

Granuloma inguinale caused by Calymmatobacterium granulomatis

Demeclocycline HCl tablets, USP are indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes

Shigella species

Acinetobacter species

Respiratory tract infections caused by Haemophilus influenzae

Respiratory tract and urinary tract infections caused by Klebsiella species

Demeclocycline HCl tablets, USP are indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Upper respiratory infections caused by Streptococcus pneumoniae

Skin and skin structure infections caused by Staphylococcus aureus. (Note: Tetracyclines, including Demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection).

When penicillin is contraindicated, tetracyclines, including Demeclocycline HCl, USP, are alternative drugs in the treatment of the following infections:

Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections

Infections in women caused by Neisseria gonorrhoeae

Syphilis caused by Treponema pallidum subspecies pallidum

Yaws caused by Treponema pallidum subspecies pertenue

Listeriosis due to Listeria monocytogenes

Anthrax due to Bacillus anthracis

Vincent’s infection caused by Fusobacterium fusiforme

Actinomycosis caused by Actinomyces israelii

Clostridial diseases caused by Clostridium species

In acute intestinal amebiasis, Demeclocycline HCl, USP may be a useful adjunct to amebicides.

In severe acne, Demeclocycline HCl, USP may be a useful adjunctive therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Demeclocycline HCl tablets, USP and other antibacterial drugs, Demeclocycline HCl tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Adverse Reactions

The following reactions have been reported in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely.

Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines.

Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down. (See DOSAGE AND ADMINISTRATION.)

Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above. (See WARNINGS.)

Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus. (See WARNINGS.)

Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia.

Hematologic: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported.

CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants (see PRECAUTIONS – General). Dizziness, headache, tinnitus and visual disturbances have been reported. Myasthenic syndrome has been reported rarely.

Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration has occurred in pediatric patients less than 8 years of age (see WARNINGS), and has been reported rarely in adults.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email
drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Demeclocycline Dosage and Administration

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals.

In patients with renal impairment: (See WARNINGS.) Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

In patients with liver impairment: Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)

Adults: Usual daily dose – Four divided doses of 150 mg each or two divided doses of 300 mg each.

For pediatric patients above eight years of age: Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day.

Gonorrhea patients sensitive to penicillin may be treated with Demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Pregnancy Risk Factor D Pregnancy Considerations

Demeclocycline crosses the placenta (Gibbons 1960). Tetracyclines accumulate in developing teeth and long tubular bones (Mylonas 2011). Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure.

As a class, tetracyclines are generally considered second-line antibiotics in pregnant women and their use should be avoided (Mylonas 2011). Demeclocycline is not recommended for the treatment of Rocky Mountain Spotted Fever (Biggs 2016), Q fever (Anderson 2013), or anthrax infection (Meaney-Delman 2014) in pregnant women. When systemic antibiotics are needed for dermatologic conditions in pregnant women, other agents are preferred (Kong 2013; Murase 2014).

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