Doxycycline Hyclate 75 mg Tablet, Film Coated, 20-count
Other active recalls for Doxycycline Hyclate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Tetracycline-class Drug class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Doxycycline is quite versatile. It treats a wide range of bacterial infections — respiratory infections, STIs like chlamydia and gonorrhea, tick-borne illnesses like Rocky Mountain...
- What kinds of infections does doxycycline actually treat?
- It depends on the tablet strength your doctor prescribed. In general, if doxycycline bothers your stomach, taking it with food or milk can help — and for the 200 mg tablet specific...
- Should I take doxycycline with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Doxycycline Hyclate — tap one for details:
Doxycycline Hyclate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.382 | $7.63 / 20 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $3.91 | $78.26 / 20 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxycycline hyclate 75 mg 27241-0153-02 | Ajanta | 60 tablets | $0.382 | AB | Availability likely | — |
| Doxycycline Hyclate 75 mgthis 62135-0907-20 | Chartwell | 20 tablets | $0.382 | AB | Availability likely | — |
| Doxycycline Hyclate 75 mg 62332-0387-60 | Alembic | 60 tablets | $0.382 | AB | Availability likely | — |
| Doxycycline Hyclate 75 mg 46708-0387-60 | Alembic | 60 tablets | — | AB | FDA listed | — |
| doxycycline hyclate 75 mg 68180-0653-06 | Lupin | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62135-0907-20 You're viewing this | 20 TABLET, FILM COATED in 1 BOTTLE (62135-907-20) | 2025-03-26 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Doxycycline hyclate tablets and doxycycline hyclate capsules are tetracycline class drugs indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
( 1.10 )
1.1Rickettsial Infections Doxycycline hyclate tablets and capsules are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae .
1.2Sexually Transmitted Infections Doxycycline hyclate tablets and capsules are indicated for treatment of the following sexually transmitted infections: Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis . Nongonococcal urethritis caused by Ureaplasma urealyticum . Lymphogranuloma venereum caused by Chlamydia trachomatis .
Granuloma inguinale caused by Klebsiella granulomatis . Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . Chancroid caused by Haemophilus ducreyi .
1.3Respiratory Tract Infections Doxycycline hyclate tablets and capsules are indicated for treatment of the following respiratory tract infections: Respiratory tract infections caused by Mycoplasma pneumoniae . Psittacosis (ornithosis) caused by Chlamydophila psittaci . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract infections caused by Klebsiella species . Upper respiratory infections caused by Streptococcus pneumoniae .
1.4Specific Bacterial Infections Doxycycline hyclate tablets and capsules are indicated for treatment of the following specific bacterial infections: Relapsing fever due to Borrelia recurrentis . Plague due to Yersinia pestis . Tularemia due to Francisella tularensis .
Cholera caused by Vibrio cholerae . Campylobacter fetus infections caused by Campylobacter fetus . Brucellosis due to Brucella species (in conjunction with streptomycin).
Bartonellosis due to Bartonella bacilliformis . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline hyclate tablets and capsules are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: Escherichia coli Enterobacter aerogenes Shigella species Acinetobacter species Urinary tract infections caused by Klebsiella species.
1.5Ophthalmic Infections Doxycycline hyclate tablets and capsules are indicated for treatment of the following ophthalmic infections: Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis .
1.6Anthrax Including Inhalational Anthrax (Post-Exposure) Doxycycline hyclate tablets and capsules are indicated for the treatment of Anthrax due to Bacillus anthracis , including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Important Administration Instructions for doxycycline hyclate tablets and doxycycline hyclate capsules: Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 50 mg and 100 mg strength, respectively. ( 2.1 ) Swallow doxycycline hyclate capsule whole. Do not break, open, crush, dissolve or chew the capsule.
( 2.1 ) Dosage in Adults for doxycycline hyclate tablets and doxycycline hyclate capsules: The usual dosage is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. ( 2.1 ) In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. ( 2.1 ) Dosage in Pediatric Patients for doxycycline hyclate tablets and doxycycline hyclate capsules: For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dose is 2.2 mg per kg of body weight administered every 12 hours.
Pediatric patients weighing 45 kg or more should receive the adult dose. ( 2.3 ) For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dose is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into two doses. For pediatric patients weighing over 45 kg, the usual adult dose should be used.
( 2.3 ) See Full Prescribing Information for additional indication specific dosage information and important administration instructions for doxycycline hyclate tablets and doxycycline hyclate capsules. ( 2.1 , 2.4 , 2.5 )
2.1Important Administration Instructions The usual dosage and frequency of administration of doxycycline hyclate tablets and capsules differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions. Administer doxycycline hyclate tablets and capsules with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6) ] .
If gastric irritation occurs, doxycycline hyclate tablets and capsules may be given with food or milk [see Clinical Pharmacology (12.3) ] Swallow doxycycline hyclate capsules whole. Do not break, open, crush, dissolve or chew the capsule. Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively [see FDA-approved patient labeling ].
2.2Dosage in Adult Patients The usual dosage of doxycycline hyclate tablet is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For certain selected specific indications, the recommended duration or dosage and duration of doxycycline hyclate tablets and capsules in adult patients are as follows: Streptococcal infections, therapy should be continued for 10 days. Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis : 100 mg by mouth twice-a-day for 7 days. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days.
As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg by mouth twice‑a‑day for 7 days. Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.
Syphilis of more than one year’s duration: Pati…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Doxycycline Hyclate Tablets, USP: Doxycycline Hyclate Tablets, USP 75 mg are round convex light blue, film-coated, compressed tablet with “ 75'' debossed on one side of the tablet and "AQ" over "101" debossed on the other (each tablet contains 75 mg doxycycline as 86.6 mg doxycycline hyclate). Doxycycline Hyclate Tablets, USP 150 mg are capsule-shaped, convex, mossy-green, film-coated compressed tablet. Each side of the tablet is trisected with an " A " debossed on each portion of one side of the tablet, and no debossing on the other (each tablet contains 150 mg doxycycline as 173.1 mg doxycycline hyclate).
Doxycycline Hyclate Capsules, USP: Doxycycline Hyclate Capsules, USP 75 mg are size #2, hard gelatin capsules, blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 227 ” on the body in black ink, filled with yellow powder (each capsule contains 75 mg doxycycline as 86.6 mg doxycycline hyclate). Doxycycline Hyclate Tablets, USP: 75 mg and 150 mg (functionally scored) ( 3 ) Doxycycline Hyclate Capsules, USP: 75 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Doxycycline hyclate are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Doxycycline hyclate are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS The use of doxycycline hyclate 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) and enamel hypoplasia Advise the patient of the potential risk to the fetus during pregnancy. ( 2.2 , 5.1 , 8.1 , 8.4 ) The use of doxycycline hyclate during the second and third-trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Advise the patient of the potential risk to the fetus during pregnancy.
( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported. Evaluate patients if diarrhea occurs. ( 5.3 ) Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
Limit sun exposure. ( 5.4 ) Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and institute appropriate therapy.
( 5.10 )
5.1Tooth Development The use of doxycycline hyclate 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 of the tetracycline class, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with drugs of the tetracycline class.
Advise the patient of the potential risk to the fetus if doxycycline hyclate is used during pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )]. Use doxycycline hyclate 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.
5.2Inhibition of Bone Growth The use of doxycycline hyclate during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
This reaction was shown to be reversible when the drug was discontinued. Advise the patient of the potential risk to the fetus if doxycycline hyclate tablets and capsules are used during pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )] .
5.3Clostridioides difficile Associated Diarrhea Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate , 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 antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.4Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reac…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis.
Hepatotoxicity has been reported. 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 and Precautions (5.1) ] . Instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed [see Dosage and Administration (2.1) ] .
Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and fixed drug eruption have been reported. Photosensitivity has been reported [see Warnings and Precautions (5.4) ] . Renal: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions (5.7) ] .
Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS). Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported. Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines [see Warnings and Precautions (5.6) ] .
Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur. Psychiatric: Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination.
Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) Avoid co-administration of tetracyclines with penicillin. ( 7.2 ) Absorption of tetracyclines, including doxycycline hyclate is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations.
( 7.3 ) Concurrent use of tetracyclines, including doxycycline hyclate may render oral contraceptives less effective. ( 7.4 ) Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline. ( 7.5 )
7.1Anticoagulant Drugs Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
7.2Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines, including doxycycline hyclate in conjunction with penicillin.
7.3Antacids and Iron Preparations Absorption of tetracyclines, including doxycycline hyclate is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
7.4Oral Contraceptives Concurrent use of tetracyclines, including doxycycline hyclate may render oral contraceptives less effective.
7.5Barbiturates and Anti-Epileptics Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
7.7Drug and Laboratory Test Interactions False elevations of urinary catecholamines may occur due to interference with the fluorescence test.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 )
8.1Pregnancy Risk Summary Doxycycline hyclate, like other tetracycline-class antibacterial drugs, may cause discoloration deciduous teeth, and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 ) and ( 5.2 )]. Available data from published studies over decades have not shown a difference in major birth defect risk compared to unexposed pregnancies with doxycycline exposure in the first trimester of pregnancy ( see Data ). There are no available data on the risk of miscarriage following exposure to doxycycline in pregnancy.
Advise the patient of the potential risk to the fetus if doxycycline hyclate is used during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data A retrospective cohort study of 1,690 pregnant patients who received doxycycline prescriptions in the first trimester of pregnancy compared to an unexposed pregnant cohort showed no difference in the major malformation rate. There is no information on the dose or duration of treatment, or if the patients actually ingested the doxycycline that was prescribed.
Other published studies on exposure to doxycycline in the first trimester of pregnancy have small sample sizes; however, these studies have not shown an increased risk of major malformations. The use of tetracyclines during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. [see Warnings and Precautions ( 5.1 , 5.2 )].
Animal Data 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 also has been noted in animals treated early in pregnancy.
8.2Lactation Risk Summary Based on available published data, doxycycline is present in human milk. There are no data that inform the levels of doxycycline in breastmilk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline hyclate and for 5 days after the last dose.
8.3Females and Males of Reproductive Potential Infertility Based on findings from a fertility study in animals, doxycycline may impair female and male fertility. The reversibility of this finding is unclear. [see Nonclinical Toxicology (13.1) ] .
8.4Pediatric Use Because of the effects of drugs of the tetracycline-class on tooth development and growth, use doxycycline hyclate 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 [see Warnings and Precautions ( 5.1 , 1.1 ) and Dosage and Administration ( 2.1 , 2.5 )] .
8.5Geriatric Use Clinical studies of doxycycline hyclate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Doxycycline hyclate tablets each contains less than 1 mg of sod…
🆘 Overdosage ▾
10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Doxycycline is a tetracycline-class antimicrobial drug [see Microbiology (12.4) ] .
12.3Pharmacokinetics Absorption Doxycycline hyclate tablets: Following administration of a single 300 mg dose to adult volunteers, average peak plasma doxycycline levels were 3.0 mcg per mL at 3 hours, decreasing to 1.18 mcg per mL at 24 hours. The mean C max and AUC 0-∞ of doxycycline are 24% and 15% lower, respectively, following single dose administration of doxycycline hyclate tablets, 150 mg tablets with a high fat meal (including milk) compared to fasted conditions. The clinical significance of these decreases is unknown.
Doxycycline hyclate capsules : Following administration of a single 300 mg dose to adult volunteers, average peak plasma doxycycline levels were 2.8 mcg per mL at 3 hours, decreasing to 1.1 mcg per mL at 24 hours. The mean C max of doxycycline is approximately 20% lower and the AUC 0-∞ is unchanged following single dose administration of doxycycline hyclate capsules with a high fat meal (including milk) compared to fasted conditions. The clinical significance of this decrease in C max is unknown.
Excretion Tetracyclines are concentrated in bile by the liver and excreted in the urine and feces at high concentrations and in a biologically active form. Excretion of doxycycline by the kidney is about 40% per 72 hours in individuals with a creatinine clearance of about 75 mL per minute. This percentage may fall as low as 1% per 72 hours to 5% per 72 hours in individuals with a creatinine clearance below 10 mL per minute.
Studies have shown no significant difference in the serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life. Pediatric Patients Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years of age) showed that allometrically-scaled clearance of doxycycline in children ≥2 to ≤8 years of age (median [range] 3.58 [2.27-10.82] L/h/70 kg, N=11) did not differ significantly from children >8 to 18 years of age (3.27 [1.11-8.12] L/h/70 kg, N=33).
For pediatric patients weighing ≤45 kg, body weight normalized doxycycline CL in those ≥2 to ≤8 years of age (median [range] 0.071 [0.041-0.202] L/kg/h, N=10) did not differ significantly from those >8 to 18 years of age (0.081 [0.035-0.126] L/kg/h, N=8). In pediatric patients weighing >45 kg no clinically significant differences in body weight normalized doxycycline CL were observed between those ≥2 to ≤8 years (0.050 L/kg/h, N=1) and those >8 years of age (0.044 [0.014-0.121] L/kg/h, N=25). No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone.
12.4Microbiology Mechanism of Action Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria. Resistance Cross resistance with other tetracyclines is common.
Antimicrobial Activity Doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ]. Gram-negative bacteria Acinetobacter species Bartonella bacilliformis Brucella species Campylobacter fetus Enterobacter aerogenes Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella granulomatis Klebsiella species Neisseria gonorrhoeae Shigella species Vibrio cholerae Yersinia pestis Gram-positive bacteria Bacillus anthracis Listeria monocytogenes Streptococcus pneumoniae Anaerobic bacteria Clostridium species Fusobacterium fusiforme Propionibacterium acnes Other bacteria Nocardiae and other aerobic Actinomyces s…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxycycline Hyclate Tablets, USP 75 mg are round convex light blue, film-coated, compressed tablet with “ 75 ” debossed on one side of the tablet and "AQ" over "101" debossed on the other. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 20 tablets: NDC 62135-907-20 Doxycycline Hyclate Tablets, USP 150 mg are capsule-shaped, convex, mossy-green, film-coated compressed tablet.
Each side of the tablet is trisected with an " A " debossed on each portion of one side of the tablet, and no debossing on the other. Each 150 mg tablet contains 173.1 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Bottles of 20 tablets: NDC 62135-908-20 Doxycycline Hyclate Capsules, USP 75 mg are size #2, hard gelatin capsules, blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 227 ” on the body in black ink, filled with yellow powder .
Each 75 mg capsule contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 20 capsules: NDC 62135-975-20 Storage Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Doxycycline Hyclate Tablets, USP and Doxycycline Hyclate Capsules, USP contain Doxycycline Hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
The structural formula for doxycycline hyclate is: Figure 1: Structure of Doxycycline Hyclate Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline Hyclate Tablets, USP : Doxycycline Hyclate Tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline.
Each 150 mg tablet contains 173.1 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Film-coating contains: FD&C Blue#2/Indigotine Aluminum Lake, polyvinyl alcohol, polyethylene glycol 8000, talc, titanium dioxide and yellow iron oxide (150 mg Tablet).
Doxycycline Hyclate Tablets, USP 75 mg contain 0.95 mg (0.041 mEq) of sodium. Doxycycline Hyclate Tablets, USP 150 mg contain 1.89 mg (0.082 mEq) of sodium. Doxycycline Hyclate Capsules, USP: Doxycycline Hyclate Capsules, USP are available as 75 mg capsules.
Each 75 mg capsule contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Inactive ingredients in the capsule formulation are magnesium stearate, microcrystalline cellulose, and a hard gelatin capsule which contains FD&C Blue #1, FD&C Red #3 and titanium dioxide. The capsules are printed with edible ink containing alcohol, black iron oxide, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, D&C Yellow #10 Aluminum Lake, and shellac glaze. "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Important Administration and Safety Information for Patients and Caregivers Advise patients taking doxycycline hyclate for malaria prophylaxis: that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria. to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent). that doxycycline prophylaxis: should begin 1 day to 2 days before travel to the malarious area, should be continued daily while in the malarious area and after leaving the malarious area, should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area, should not exceed 4 months.
Advise all patients taking doxycycline hyclate: that doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third at the scored lines to provide 100 mg or 50 mg strength doses, respectively. that they must swallow doxycycline hyclate capsules whole. They must not break, open, crush, dissolve or chew the capsule [see Dosage and Administration (2.2) ] . to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs.
Sunscreen or sunblock should be considered [see Warnings and Precautions (5.4) ]. to drink fluids liberally along with doxycycline hyclate to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6) ] . that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium [see Drug Interactions (7.3) ]. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk [see Clinical Pharmacology (12.3) ] . that if gastric irritation occurs, doxycycline hyclate may be given with food or milk [see Clinical Pharmacology (12.3) ]. that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [see Drug Interactions (7.3) ]. that the use of doxycycline might increase the incidence of vaginal candidiasis.
Tooth Discoloration and Inhibition of Bone Growth Advise patients that doxycycline hyclate, like other tetracycline-class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during pregnancy. Tell your healthcare provider right away if you become pregnant during treatment [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 , 8.4 )] . Lactation Advise women not to breastfeed during treatment with doxycycline hyclate and for 5 days after the last dose [see Use in Specific Populations (8.2) ] .
Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.
Development of Resistance Counsel patients that antibacterial drugs including doxycycline hyclate should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When doxycycline hyclate are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of…