Demeclocycline HCl

Demeclocycline hydrochloride tablets USP, 150 mg, are round, convex, red, film coated tablets, engraved with D11 on one side, and are supplied as follows:

Bottles of 100 NDC 64720-334-10

Demeclocycline hydrochloride tablets USP, 300 mg, are round, convex, red, film coated tablets, engraved with D12 on one side, and are supplied as follows:

Bottles of 48 NDC 64720-335-48

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured by: Patheon Puerto Rico, Inc. Manati, Puerto Rico 00674, USA. Distributed by: CorePharma, LLC Middlesex, NJ 08846. Rev. August, 2012.

DEMECLOCYCLINE HYDROCHLORIDE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg/ every six hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated and, if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Phototoxic reactions can occur in individuals taking demeclocycline, and are characterized by severe burns or exposed surfaces resulting from direct exposure of patients to sunlight during therapy with moderate or large doses of demeclocycline. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur and treatment should be discontinued at the first evidence of erythema of the skin.

Administration of demeclocycline hydrochloride has resulted in appearance of the diabetes insipidus syndrome (polyuria, polydipsia and weakness) in some patients on long-term therapy. The syndrome has been shown to be nephrogenic, dose-dependent and reversible on discontinuance of therapy. Patients, who are experiencing central nervous system symptoms associated with demeclocycline therapy, should be cautioned about driving vehicles or using hazardous machinery while on demeclocycline therapy.

Clostridium difficile associated with diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including demeclocycline hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to discontinue. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

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.

Throw away any unused demeclocycline after the expiration date on the label has passed.

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

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

• kidney disease;
• liver disease; or
• diabetes.

If you are being treated for gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

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.

Your pharmacist can provide more information about demeclocycline.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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