Drugplain

Demeclocycline Hydrochloride 150 mg/1

Demeclocycline · TABLET · Amneal Pharmaceuticals of New York LLC

No Recall History
Plain English

Demeclocycline Hydrochloride is a tablet containing demeclocycline at 150 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name
Demeclocycline Hydrochloride
Generic Name
Demeclocycline
NDC Code (Product)
53746-554
Manufacturer
Amneal Pharmaceuticals of New York LLC
Strength
150 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA065425
Marketing Start
05/25/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hyponatraemia39 reports
diarrhoea25 reports
asthenia22 reports
oedema peripheral16 reports
dizziness15 reports
fatigue15 reports
nausea15 reports
dehydration14 reports
acute kidney injury13 reports
pneumonia13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Demeclocycline HCl tablets 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 …

Dosage & Administration

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 m…

Warnings

WARNINGS DEMECLOCYCLINE HCl, 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, …

Contraindications

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.

Adverse Reactions

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 appare…

Frequently Asked Questions

What is Demeclocycline Hydrochloride used for?

Demeclocycline Hydrochloride contains Demeclocycline. It is a tablet taken oral. Consult your doctor for specific uses.

Is Demeclocycline Hydrochloride a controlled substance?

Demeclocycline Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Demeclocycline Hydrochloride?

The generic name for Demeclocycline Hydrochloride is Demeclocycline. There are no other listed brand versions of Demeclocycline.

What is the NDC code for Demeclocycline Hydrochloride 150 mg/1?

The NDC (National Drug Code) for Demeclocycline Hydrochloride 150 mg/1 is 53746-554, listed by Amneal Pharmaceuticals of New York LLC.

Product NDC

53746-554

Package NDC

53746-554-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)