DOXYCYCLINE 40 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 used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. Doxycyline is also used to prevent malaria and to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face) Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by stopping bacteria from growing and spreading. It works to treat acne by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. It works to treat rosacea b...
Read the full MedlinePlus article ↗- 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 WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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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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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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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 MB5IUD6JUA
Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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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.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
15 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.295 | $128.85 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $12.49 | $374.70 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $14.01 | $420.21 / 30 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxycycline 40 mg 11788-0134-30 | AiPing | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mg 43547-0590-03 | Solco | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mg 43598-0457-30 | Dr.Reddys | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mg 60505-4775-03 | Apotex | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mgthis 62332-0785-30 | Alembic | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mg 68308-0668-30 | Mayne | 30 capsules | $4.295 | AB | Availability likely | — |
| Doxycycline 40 mg 70748-0308-06 | Lupin | 30 capsules | $4.295 | AB | Availability likely | — |
| Oracea 40 mg 00299-3822-02 | Galderma | 192 capsules | — | AB | Discontinued | — |
| doxycycline 40 mg 33342-0346-07 | Macleods | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 40 mg 46708-0785-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 40 mg 73190-0040-30 | AvKARE | 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?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62332-0785-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (62332-785-30) | 2024-06-27 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Doxycycline is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. (1.1) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
(1.2) Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. (1.2)
1.1Indication Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
1.2Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline capsules should be used only as indicated.
Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take one doxycycline capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. (2.1) Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms. (2.2, 5.9)
2.1General Dosing Information Take one doxycycline capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
2.2Important Considerations for Dosing Regimen The dosage of doxycycline capsules differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Doxycycline capsules 40 mg capsules are beige opaque cap/beige opaque body size ‘2’ hard gelatin capsule imprinted with ‘H1’ on cap, filled with pale yellow to yellow and beige colored pellets. 40 mg capsule. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. Doxycycline capsules are contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • The use of doxycycline during tooth development (the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. (5.1, 5.2, 8.1, 8.4) • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile . If C. difficile associated diarrhea occurs, discontinue doxycycline.
(5.3) • If renal impairment exists, doxycycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury. (5.4) • Photosensitivity can occur with doxycycline; Patients should minimize or avoid exposure to natural or artificial sunlight. (5.5) • Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue doxycycline immediately.
(5.6) • Doxycycline may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue doxycycline if symptoms occur. (5.8) • Bacterial resistance to tetracyclines may develop in patients using doxycycline.
It should only be used as indicated. (5.9)
5.1Inhibition of Bone Growth During Fetal and Pediatric Development Doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, and childhood. 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 6 hours.
This reaction was shown to be reversible when the drug was discontinued. If doxycycline is used during the second or third trimester of pregnancy, advise the patient of the potential risk to the fetus [see Use in Specific Populations (8.1)] .
5.2Tooth Discoloration During Fetal and Pediatric Development The use of tetracycline class drugs orally during tooth development (last half of pregnancy, infancy, and childhood up 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 drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Use of tetracycline drugs is not recommended during tooth development [see Use in Specific Populations (8.1)].
5.3Clostridium difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with 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 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 management should be instituted as clinically indicated.
5.4Metabolic Effects 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-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity.
Under such conditions, lower than…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Doxycycline: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Table 1.
Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline (n=269) vs. Placebo (n=268) Doxycycline Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages based on total number of study participants in each treatment group.
Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal : anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity. Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [see Dosage and Administration (2)] . Renal toxicity : Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions (5.4)] . Skin : maculopapular and erythematous rashes.
Exfoliative dermatitis. Photosensitivity is discussed above [see Warnings and Precautions (5.5)] . Hypersensitivity reactions : urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
6.2Postmarketing Adverse Reactions 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. The following adverse reactions have been identified during post approval use of doxycycline. Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. (7.1) • Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. (7.2) • The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. (7.3)
7.1Anticoagulants 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 tetracycline-class drugs in conjunction with penicillin.
7.3Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
7.4Antacids and Iron Preparations Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.
7.5Oral Retinoids There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.
7.6Barbiturates and Anti-epileptics Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
7.7Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels 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 may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.1 and 5.2)] . Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline during the second and third trimester of pregnancy.
The 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 Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous 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.
Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
8.2Lactation Risk Summary Based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. There is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. Because there are other antibacterial drug options available to treat rosacea in lactating women and 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 and for 5 days after the last dose.
8.4Pediatric Use Doxycycline should not be used in infants and children less than 8 years of age [see Warnings and Precautions (5.1)] . Doxycycline has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
8.5Geriatric Use Clinical studies of doxycycline 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 elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.1 and 5.2)] . Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline during the second and third trimester of pregnancy.
The 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 Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous 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.
Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
🧒 Pediatric Use ▾
8.4Pediatric Use Doxycycline should not be used in infants and children less than 8 years of age [see Warnings and Precautions (5.1)] . Doxycycline has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of doxycycline 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 elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of doxycycline in the treatment of inflammatory lesions of rosacea is unknown.
12.3Pharmacokinetics Doxycycline capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for doxycycline following single oral doses and at steady-state in healthy subjects are presented in Table 2.
Table 2. Pharmacokinetic Parameters [Mean (±SD)] for Doxycycline N C max * (ng/mL) T max + (hr) AUC 0-oo *(ng•hr/mL) t 1/2 * (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3(1 to 4.1) 9227 ± 3212.8 21.2 ±
7.6Steady-State# 40 mg capsules 31 600 ± 194.2 2(1 to 4) 7543 ± 2443.9 23.2 ± 6.2 *Mean +Median #Day 7 Absorption: In a single-dose food-effect study involving administration of doxycycline to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if doxycycline is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.
Distribution: Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of doxycycline.
Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients [see Warnings and Precautions (5.1)] Gender: The pharmacokinetics of doxycycline were compared in 16 male and 14 female subjects under fed and fasted conditions. While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass.
Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life of doxycycline.
Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH. This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric.
Drug Interactions: [see Drug Interactions (7)].
12.4Microbiology Doxycycline is a member of the tetracycline-class of drugs. The plasma concentrations of doxycycline achieved with doxycycline during administration [see Clinical Pharmacology (12.3) and Dosage and Administration (2.2)] are less than the concentration required to treat bacterial diseases. Doxycycline should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease [see Indications and Usage (1.2)] .
In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long term effects on bacterial flora of the oral cavity, skin, intestinal tract and vagina.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of doxycycline in the treatment of inflammatory lesions of rosacea is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Doxycycline capsules 40 mg are beige opaque cap/beige opaque body size ‘2’ hard gelatin capsule imprinted with ‘H1’ on cap, filled with pale yellow to yellow and beige colored pellets. Bottle of 30 capsules with child-resistant closure, NDC 62332-785-30 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] and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Doxycycline capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline pellets (24 mg immediate release and 16 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate.
It is very slightly soluble in water and in alcohol, practically insoluble in ether. It dissolves in dilute solutions of mineral acids and in solutions of alkali hydroxides and carbonates. Inert ingredients in the formulation are: FD&C Red No.
40 Aluminum Lake, hypromellose, methacrylic acid copolymer, polysorbate 80, sugar spheres (composed of corn starch, purified water and sucrose), talc, and triethyl citrate. Hard gelatin capsule shell contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.
FDA approved dissolution test method and specifications differ from USP. doxycycline-str.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Patients taking Doxycycline Capsules 40 mg should receive the following information and instructions: • Advise pregnant women that doxycycline, like other tetracycline-class drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.1 and 5.2) and Use in Specific Populations (8.1)]. • Advise women not to breastfeed during treatment with doxycycline capsules and for 5 days after the last dose [see Use in Specific Populations (8.2)] . • Advise patients that use of tetracycline class drugs orally during tooth development (infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). • Advise patients that use of doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during infancy and childhood. • Advise patients that pseudomembranous colitis can occur with doxycycline therapy.
If patients develop watery or bloody stools, they should seek medical attention. • Advise patients that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention. • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline.
If patients need to be outdoors while using doxycycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of sunburn. • Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. Symptoms may be manifested by arthralgia, fever, rash and malaise.
Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help. • Counsel patients about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy. • Advise patients to take doxycycline capsules exactly as directed. Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.