doxycycline 100 mg Capsule, 30-count
🆔 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 — tap one for details:
Doxycycline 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
18 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxycycline 100 mg 60687-0716-21 | American | 30 capsules | $0.232 | AB | Availability likely | — |
| Doxycycline 100 mg 60687-0943-21 | American | 30 capsules | $0.232 | AB | Availability likely | — |
| Doxycycline 100 mg 64380-0922-01 | Strides | 50 capsules | $0.232 | AB | Availability likely | — |
| doxycycline 100 mg 50268-0281-15 | AvPAK | 50 capsules | $0.232 | AB | Availability likely | — |
| Doxycycline 100 mg 64380-0180-01 | Strides | 50 capsules | $0.232 | AB | Availability likely | — |
| Doxycycline 100 mg 68180-0652-08 | Lupin | 50 capsules | $0.232 | AB | Availability likely | — |
| doxycycline 100 mg 63187-0712-14 | Proficient | 14 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 46708-0250-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 50090-6783-00 | A-S | 20 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 68071-3752-02 | NuCare | 20 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 71335-2417-00 | Bryant | 2 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 71335-3064-00 | Bryant | 2 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 61919-0276-20 | DIRECT | 20 capsules | — | — | FDA listed | — |
| doxycycline 100 mg 65841-0823-01 | Zydus | 100 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 71335-1988-00 | Bryant | 2 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 82804-0171-06 | Proficient | 6 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 62332-0250-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 70518-0213-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 43386-0792-02 | Lupin | 250 capsules | — | — | FDA listed | — |
| Doxycycline 100 mg 82804-0050-02 | Proficient | 2 capsules | — | AB | FDA listed | — |
| doxycycline 100 mg 50090-4833-00 | A-S | 20 capsules | — | AB | FDA listed | — |
| doxycycline 100 mg 68382-0707-01 | Zydus | 100 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 51655-0711-20 | Northwind | 20 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 68071-2152-02 | NuCare | 20 capsules | — | AB | FDA listed | — |
| doxycycline 100 mg 72789-0491-14 | PD-Rx | 14 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 63187-0672-02 | Proficient | 2 capsules | — | AB | FDA listed | — |
| Doxycycline 100 mg 63304-0616-01 | Sun | 100 capsules | — | AB | FDA listed | — |
| doxycycline 100 mg 72789-0496-02 | PD-Rx | 2 capsules | — | AB | FDA listed | — |
| doxycycline 100 mgthis 67046-1260-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| doxycycline 100 mg 48433-0159-03 | Safecor | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67046-1260-03 You're viewing this | 30 CAPSULE in 1 BLISTER PACK (67046-1260-3) | 2026-08-18 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, 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.
Doxycycline capsules, USP are indicated for the treatment of the following infections: 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 caused by Chlamydia trachomatis.
Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis.
Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis.
Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi. 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. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline capsules, USP are indicated for treatment of infections caused 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. Doxycycline capsules, 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 .
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum.
Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme.
Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
In severe acne, doxycycline may be useful adjunctive therapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day.
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. Pediatric Patients For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g. anthrax, Rocky Mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours.
Children weighing 45 kg or more should receive the adult dose (see WARNINGS and PRECAUTIONS ). For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule 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 twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS ).
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
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. Acute epididymo-orchitis caused by N. gonorrhoeae 100 mg, by mouth, twice a day for at least 10 days.
Primary and secondary syphilis 300 mg a day in divided doses for at least 10 days. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis 100 mg, by mouth, twice a day for at least 7 days. Nongonococcal urethritis caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.
Acute epididymo-orchitis caused by C. trachomatis 100 mg, by mouth, twice a day for at least 10 days. Inhalational anthrax (post-exposure) ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 45 kg 2.2 mg/kg of body weight, by mouth, twice a day for 60 days.
Children weighing 45 kg or more should receive the adult dose.
⛔ Contraindications ▾
CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
⚠️ Warnings ▾
WARNINGS The use of drugs of the tetracycline class, including doxycycline, 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 it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Use of 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 capsules, 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 be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline capsules. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH.
Concomitant use of isotretinoin and doxycycline capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted.
Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures 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 embryo toxicity has been noted in animals treated early in pregnancy.
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 antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
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 reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. Fixed drug eruptions have occurred with…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Due to oral doxycycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines. Gastrointestinal Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and 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. Rare 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 ). Skin Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme 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 ). Hypersensitivity Reactions Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported with tetracyclines. Psychiatric Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination Other Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines (see PRECAUTIONS-General ). When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland.
No abnormalities of thyroid function are known to occur.
🆘 Overdosage ▾
OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values: Time (hr): 0.5 1 1.5 2 3 4 8 12 24 48 72 Conc. 1.02 2.26 2.67 3.01 3.16 3.03 2.03 1.62 0.95 0.37 0.15 (mcg/ mL) Average Observed Values Maximum Concentration 3.61 mcg/mL (± 0.9 sd) Time of Maximum Concentration 2.60 hr (± 1.10 sd) Elimination Rate Constant 0.049 per hr (± 0.030 sd) Half-life 16.33 hr (± 4.53 sd) Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min).
This percentage excretion may fall as low as 1 to 5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter serum half-life.
Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues. Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients (2 years to 18 years of age) showed that allometrically–scaled clearance (CL) of doxycycline in pediatric patients ≥2 years to ≤8 years of age (median [range] 3.58 [2.27 to 10.82] L/h/70 kg, N =11) did not differ significantly from pediatric patients >8 to 18 years of age (3.27 [1.11 to 8.12] L/h/70 kg, N=33).
For pediatric patients weighing ≤45 kg, body weight normalized doxycycline CL in those ≥2 years to ≤8 years of age (median [range] 0.071 [0.041 to 0.202] L/kg/h, N=10) did not differ significantly from those >8 years to 18 years of age (0.081 [0.035 to 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 years to ≤8 years (0.050 L/kg/h, N=1) and those >8 years to 18 years of age (0.044 [0.014 to 0.121] L/kg/h, N=25).
No clinically significant difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone. Microbiology 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 ). 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 Actinomyces species Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Mycoplasma pneumoniae Rickettsiae Treponema pallidum Treponema pallidum subspecies pertenue Ureaplasma urealyticum Parasites Balantidium coli Entamoeba species Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recogni…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Doxycycline Capsules USP, 50 mg are light yellow to yellow powder filled in hard gelatin capsule shell having an opaque yellow cap and an opaque white body printed with 782 on cap with black ink and are supplied as follows: NDC 68382-782-06 in bottle of 30 capsules with child-resistant closure NDC 68382-782-18 in bottle of 50 capsules with child-resistant closure NDC 68382-782-16 in bottle of 90 capsules with child-resistant closure NDC 68382-782-01 in bottle of 100 capsules NDC 68382-782-05 in bottle of 500 capsules NDC 68382-782-10 in bottle of 1000 capsules NDC 68382-782-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Doxycycline Capsules USP, 75 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque orange cap and an opaque white body printed with 706 on cap in black ink and are supplied as follows: NDC 68382-706-06 in bottle of 30 capsules with child-resistant closure NDC 68382-706-18 in bottle of 50 capsules with child-resistant closure NDC 68382-706-16 in bottle of 90 capsules with child-resistant closure NDC 68382-706-01 in bottle of 100 capsules NDC 68382-706-05 in bottle of 500 capsules NDC 68382-706-10 in bottle of 1000 capsules NDC 68382-706-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Doxycycline Capsules USP, 100 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque yellow cap and an opaque orange body printed with 707 on cap in black ink and are supplied as follows: NDC 68382-707-06 in bottle of 30 capsules with child-resistant closure NDC 68382-707-18 in bottle of 50 capsules with child-resistant closure NDC 68382-707-16 in bottle of 90 capsules with child-resistant closure NDC 68382-707-01 in bottle of 100 capsules NDC 68382-707-21 in bottle of 250 capsules NDC 68382-707-05 in bottle of 500 capsules NDC 68382-707-10 in bottle of 1000 capsules NDC 68382-707-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP. ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO 4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO 4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. Minocycline, tetracycline PO 4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet.
This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet. Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline).
Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.
📋 Description ▾
DESCRIPTION Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline.
Structural formula: C 22 H 24 N 2 O 8 • H 2 O M.W. = 462.45 Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red.
The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2.