DOXYCYCLINE DOXYCYCLINE 100 mg/10mL

DOXYCYCLINE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Dr. Reddy's Laboratories, Inc.

No Recall HistoryCurrently in Shortage

Plain English

DOXYCYCLINE DOXYCYCLINE is a injection, powder, lyophilized, for solution containing doxycycline at 100 mg/10mL, taken intravenous. Manufactured by Dr. Reddy's Laboratories, Inc..

Key Facts

Brand Name: DOXYCYCLINE DOXYCYCLINE
Generic Name: DOXYCYCLINE
NDC Code (Product): 43598-086
Manufacturer: Dr. Reddy's Laboratories, Inc.
Strength: 100 mg/10mL
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: ANDA218753
Marketing Start: 07/18/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective3,985 reports

off label use3,472 reports

nausea3,443 reports

fatigue3,093 reports

dyspnoea2,975 reports

rash2,901 reports

diarrhoea2,829 reports

pain2,723 reports

headache2,699 reports

vomiting2,667 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection 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. Doxycycline is indicated in infections caused by the following microorganisms: Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers). Mycoplasma pneumoniae (PPLO, Eaton Agent). Agents of psittacosis and ornithosis. Agents of lymphogranuloma venereum and granuloma inguinale. The spirochetal agent of relapsing fever ( Borrelia recurrentis ). The following gram-negative microorganisms: Haemophilus ducreyi (chancroid) Yersinia pestis Francisella tularensis Bartonella bacilliformis, Bacteroides species, Vibrio cholerae and Campylobacte fetus , Brucella s…

Dosage & Administration

DOSAGE AND ADMINISTRATION Note: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result. The usual dosage and frequency of administration of Doxycycline for Injection (100 to 200 mg/day) differs from that of the other tetracyclines (1 to 2 g/day). Exceeding the recommended dosage may result in an increased incidence of side effects. Studies to date have indicated that doxycycline hyclate at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Adults: The usual dosage of doxycycline for injection is 200 mg on the first day of treatment administered in one or two infusions. Subsequent daily dosage is 100 to 200 mg depending upon the severity of infection, with 200 mg administered in one or two infusions. In the treatment of primary and secondary syphilis, the recommended dosage is 300 mg daily for at least 10 days. In the treatment of inhalational anthrax (post-exposure) the recommended dose is 100 mg of doxycycline, …

Warnings

WARNINGS 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. Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline, 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 therap…

Contraindications

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

Drug Interactions

Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and Penthrane ® (methoxyflurane) has been reported to result in fatal renal toxicity. Concurrent use of tetracycline may render oral contraceptives less effective.

Adverse Reactions

ADVERSE REACTIONS Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported. Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development. (see WARNINGS .) Skin: Maculopapular and erythematous rashes and fixed drug eruption have been reported. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above (see WARNINGS ). Renal Toxicity: Rise in BUN has been reported and is apparently dose related. (see WARNINGS .) Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS). Other: Bulging fontanel…

Frequently Asked Questions

What is DOXYCYCLINE DOXYCYCLINE used for?

DOXYCYCLINE DOXYCYCLINE contains DOXYCYCLINE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.

Is DOXYCYCLINE DOXYCYCLINE a controlled substance?

DOXYCYCLINE DOXYCYCLINE is not classified as a controlled substance by the DEA.

What is the generic name for DOXYCYCLINE DOXYCYCLINE?

The generic name for DOXYCYCLINE DOXYCYCLINE is DOXYCYCLINE. There are 11 other brand versions of DOXYCYCLINE.

What is the NDC code for DOXYCYCLINE DOXYCYCLINE 100 mg/10mL?

The NDC (National Drug Code) for DOXYCYCLINE DOXYCYCLINE 100 mg/10mL is 43598-086, listed by Dr. Reddy's Laboratories, Inc..

Product NDC

43598-086

Package NDC

43598-086-58

Other Doxycycline Brands

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

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